Novertis Ag vs Controller General Of Patens, Designs And Trade Marks And Ors.

Sl No.,Date,Actions

1.,16/06/2009,3951/DELNP/2009 Filed

2.,20/11/2007,PCT/US2007/085304

3.,08/12/2006,PRIORITY DATE

4.,16/06/2009,REQUEST FOR EXAMINATION DATE

5.,04/12/2009,PUBLICATION DATE (U/S. 11A)

6.,28/09/2016,Patent Granted

7.,30/09/2016,Grant Published under se ction 43(2)

8.,26/09/2017,"Notice of Opposition on Form 7 together with Affidavit of Dr K Durga

Prasad

9.,08/11/2017,"Form 30 filed for Payment of Balance Fee of ` 9600/- (Admitted

that ` 2400 paid earlier with Form 7 on 26/09/2017) Available at

http://ipindiaservices.gov.in/PatentSearch/PatentSearch/ViewDocuments

10.,13/11/2017,"Petition u/r 138 was filed by the Patentee for one month extension to file

Reply Statement and Evidence u/r 58

11.,22/12/2017,Reply Statement from Patentee Filed u/r 58

12.,19/01/2018,"Petition u/r 138 was filed by the Opponent for one month extension to

file Reply evidence by Opponent u/r 59

13.,22/02/2018,Rejoinder by Opponent filed under section 25(2) and u/r 59

14.,18/05/2018,Recommendation of Opposition Board

15.,25/09/2018,Hearing date Fixed

16.,17/09/2018,Request for Adjournment of Hearing by the Opponents filed u/r 129A

17.,15/02/2019,Hearing Adjourned (First Adjournment)

18.,23/01/2019,Request for Adjournment of Hearing by the Opponents filed u/r 129A

19.,09/04/2019,Hearing Adjourned (Second Adjournment)

20.,01/04/2019,Notice of Opponents u/r 62 to attend Hearing

21.,04/04/2019,"Petition u/r 138 was filed by the Opponents to take additional Statement

and Evidence and Affidavit of Dr Ramesh Dandala on Record.

22.,04/04/2019,"Statement of Evidence and Affidavit of Dr Ramesh Dandala filed,

Requesting therein that these documents may also be given to

Opposition Board

23.,05/04/2019,Notice of Patentee u/r 62 to attend Hearing

24.,08/04/2019,"Letter from Patentee that the Documents filed with Petition u/r 138 is

not maintainable

25.,09/04/2019,"Petition u/r 137 was filed by the Opponents for sending affidavit of Dr

Durga Prasad other documents to opposition Board

26.,09/04/2019,Hearing

27.,10/04/2019,Hearing

28.,25/04/2019,Written Arguments by Opponents

29.,02/05/2019,Written Arguments by opponent

,,

31.,24/05/2019,Reply to Additional Submissions by the Patentee

32.,24/05/2019,Written Submission of Patentee

33.,09/07/2019,"Filing of two affidavits by the Patentee Permission to take on Records

the two affidavits by the Patentee

34.,11/07/2019,Filing of two affidavits by the Patentee

35.,01/08/2019,"Order of Delhi High Court in CS(COMM.) 229/2019 dated 11/07/2019

filed at Patent Office by the Patentee

36.,16/08/2019,Order of Controller revoking the patents

37.,21/08/2019,Appeal to IPAB against the Order of the Controller u/s. 117A

Court of Delhi against the Controller for accepting the document under Rule 138 of the Patents Rules 2003 in spite of the objection from,,

patentee/appellant.,,

2.18 Hon'ble Delhi High Court in CS (Comm.)229/20192 passed an order observed as under:-,,

The Controller General was expected to follow strict timelines once judgment was reserved. Neither party ought to have been permitted to file",,

anything further. However, the same has been breached as the Controller did not give any clarity as to whether affidavit dated 30th April, 2019 was",,

taken on record or not and whether any submissions were to be filed by the parties after the hearing was concluded.,,

The Court further held that ""the Patent Office shall ensure that when the hearing is concluded, it is clarified whether any timeline is being given for",,

filing written submission or not..,,

Controller General shall now go ahead and proceed to pass order within one month from today. No further filing shall be done by either party.""",,

2.19 The Learned Controller finally issued the impugned order dated 16/08/2019, revoking the patents no. 276026 (IN'026) on the ground of lack of",,

novelty, lack of inventive step, under the provisions u/s. 3(d) and lack of sufficiency of disclosure.",,

2.20 Aggrieved by that order the patentee/appellant had filed the present appeals under section 117A of the Patents Act. 1970, to this Board.",,

2.21 Earlier, a petition, MP. NO. 8/2019 in OA/20/2019/PT/DEL was filed by the appellant for staying the orders of the Controller dated 16/08/2019;",,

which was decided by this tribunal vide orders dated 20/07/2020 after providing sufficient opportunity of being heard to both the parties.,,

2.22 Further, an application to appoint the scientific advisors to assist the Board was also decided keeping in view the already available affidavits of",,

experts from either side. We will analyze their affidavits thoroughly in later part of our discussion as both the parties have agreed to take these,,

documents into account. 2.23 By this order we propose to decide the main appeal no. OA/20/2019/PT/DEL arising from impugned order dated,,

16.08.2019 passed by the Respondent No. 2 revoking patent IN 276026 (IN'026).,,

Main Issues in the Appeal,,

3.1 The Patentee/Appellant herein has filed this appeal mainly raising the following contentious issues:,,

3.1.1 The present Appeal is being filed by the Appellant, being aggrieved on account of impugned order dated 16.08.2019 passed by Respondent no. 2",,

wherein the Respondent no. 2 in utter disregard of the evidence on record and in violation of the principles of natural justice revoked the patent being,,

IN 276026 of the Appellant. In particular, the Respondent No. 2 has disregarded the following:",,

a. The recommendation of the Opposition Board. The findings of the Respondent No. 2 in the impugned order is limited to the issue of novelty and the,,

Respondent No. 2 has not given any reasons or distinguished the recommendation of the Opposition Board which had extensively dealt with and had,,

given findings in favour of the Appellant on all the points raised in the impugned order;,,

b. The Respondent No. 2 has passed an order against the principles of natural justice. The Respondent No. 2 has taken the position that she has,,

disregarded the evidence filed by both the parties. However, the Respondent No. 2 has considered the evidence filed by the Respondent No. 3 in",,

relation to patent term extension and orange book listing but has disregarded the rebuttal evidence filed by the Appellant. It is on this ground itself that,,

the impugned order is liable to be set aside;,,

c. The Respondent No. 2 has failed to consider the arguments on novelty given by the Appellant and has also failed to rely upon the expert affidavit,,

and the documents filed therewith;,,

The Submissions of the Patentee/Appellant,,

4.1 The present appeal arises from impugned order dated 16.08.2019 passed by the Respondent No. 2 revoking patent IN 276026 (IN'026). The said,,

order is liable to be set aside as it suffers from grave error of law, fact as well as violation of principles of natural justice. The entire finding of",,

invalidity is based on ground of lack of novelty/anticipation without any prior art cited which discloses or exemplifies Ceritinib, the compound subject",,

matter of IN 276026.,,

4.2 The entire finding of the Controller is based on ""hindsight analysis"" of subject patent which is contrary to law. The Controller has engaged in",,

prohibited act of ""cherry picking"" of the constituents, substituents, their arrangement, their positioning, their linkage and interplay from the subject",,

patent IN 276026 and tried to locate them in the vast pool of possible substituents contained in markush claims of prior art citations. Even these prior,,

art citations are the subsisting patents that belong to the Appellant and do not disclose or exemplify Ceritinib or any other compound subject matter of,,

IN 276026.,,

4.3 The impugned order further suffers from error of law as the Controller has failed to apply the test of anticipation/lack of novelty in arriving at the,,

impugned finding, which is that, the compound disclosed and claimed by subject patent should be disclosed in a singular prior art document. It is not the",,

coverage of subject patent compound but its disclosure by way of identification, description or exemplification that is required to be established to",,

prove anticipation/lack of novelty.,,

4.4 The impugned order further suffers from violation of principles of natural justice and arbitrariness in exercise of discretion. The Controller has,,

taken into consideration subsequent evidence filed by the Respondent No. 3 beyond prescribed limits of timeline but disregarded the rebuttal evidence,,

filed by the Appellant thereto.,,

4.5 Subject matter in patent IN 276026,,

4.5.1 IN'026 covers and discloses a new class of chemical compounds of Formula-2 as set out in Claim 1 thereof. One of such novel and inventive,,

compounds specifically exemplified, described and disclosed by way of Examples 7 and 66 is ""Ceritinib"". The said compound has been given",,

International Non-Proprietary Name (INN) of Ceritinib being ""New Chemical Entity"" (NCE).",,

4.5.2 None of the prior art cited by the Respondent No. 3 either discloses or describes or exemplifies Ceritinib or any other compound of Formula-2.,,

4.5.3 Novelty of the said compound is therefore beyond any possible doubt and the impugned order to the contrary is baseless and liable to be set,,

aside. All other findings of lack of inventive step or section 3 (d) are all based on such erroneous finding of anticipation and are therefore equally,,

fallacious and baseless.,,

4.6 Invention of patent IN 276026,,

4.6.1 The present invention as claimed under patent being Indian Patent No. 276026, is the compound of Formula 2 or pharmaceutically acceptable",,

salts thereof, as recited in claim 1 of the patent and illustrated as under:",,

(Markush structure of Formula 2 as per claim 1),,

4.6.2 The invention claimed in patent is novel pyrimidine compounds having two phenyl rings attached to the pyrimidine ring at its 2nd and 4th position,,

via amine groups wherein the phenyl group attached to pyrimidine ring at the 2-position is tri-substituted (i.e. R6, R8 and R9 may not be hydrogen",,

atom) and one of R8 and R9 is a heterocyclic ring of pyrrolidinyl, piperidinyl or azetidinyl, each of which is attached to the phenyl ring via a carbon",,

atom. This combination of the tri-substituted phenyl ring and the heterocyclic group of either R8 or R9 attached to that phenyl ring via a carbon atom,,

renders the compound of Formula 2 as per claim 1 novel and inventive.,,

4.7 CLAIMS:,,

4.7.1 Claim 1 of the patent, being Markush claim, encompasses a number of different compounds covered by formula (2). One of the compounds",,

synthesized in accordance with formula (2) and specifically disclosed in the patent as Examples 7 and 66 is ""Ceritinib"" wherein R1 represents Chloro,",,

R2 represents Hydrogen; R3 represents isopropyl Sulfonyl; R4 does not represent any functional group when n is zero/0; R6 represents isopropoxy;,,

one of R8 is (CR2)qY wherein q is 0 and ""Y is Piperidinyl, pyrrolidinylor azetidinyl, each of which is attached to the phenyl ring via a carbon atom.""",,

R9 represents Methyl. The said compound is specifically claimed in claim 4 and 5 in free form or in form of a pharmaceutically acceptable salt. All,,

other compounds exemplified have same structure but differ in substitutions and positioning of the carbon to carbon bond, all falling within the",,

coverage of claim 1. The structure of Ceritinib is derived from Markush structure of claim 1 and is illustrated as under:,,

Molecular structure of Ceritinib,,

5-Chloro-N2-(2 -isopropoxy-5-methyl-4-piperidin-4-yl-phenyl) N4[2-(propane-2-sulfonyl)-phenyl]-pyrimidine-2, 4-diamine",,

Claim 5 of the patent specifically recites Ceritinib as 5-Chloro-N2-(2 -isopropoxy-5-methyl-4-piperidin-4-yl-phenyl)-N4-[2-(propane-2-sulfonyl)-,,

phenyl] pyrimidine-2, 4-diamine.",,

4.7.2 Claim 6 of the patent recites a pharmaceutical composition comprising a therapeutically effective amount of compounds claimed in claim 1-5,,

(which includes Ceritinib) and a pharmaceutically acceptable carrier. The patent compound is specifically described and exemplified in patent,,

specification (Examples 7 and 66 as Ceritinib).,,

4.7.3 Ceritinib is a novel and inventive compound which has been given International Non-proprietary Name (INN) of Ceritinib being a New Chemical,,

Entity (NCE). None of the prior arts disclose Ceritinib, subject matter of the patent IN 276026. The claims in the patent are limited to pyrimidine",,

compounds having two phenyl rings attached to 2nd and 4th position to the pyrimidine ring via amine groups wherein the phenyl group attached to,,

Pyrimidine ring at the second position is tri-substituted (i.e. R6, R8 and R9 may not be hydrogen atom) and one of R8 and R9 is pyrrolidinyl, piperidinyl",,

or azetidinyl, each of which is attached to the phenyl ring via a carbon atom. This combination of tri-substituted phenyl ring and heterocyclic group",,

attached to the phenyl ring via a carbon atom is one of the novel features of the presently claimed compound.,,

4.8 Novelty and inventive step of IN 276026,,

4.8.1 The invention claimed in IN'026 constitutes:,,

- novel pyrimidine compounds having two phenyl rings attached to the pyrimidine ring at its 2nd and 4th position via amine groups;,,

- wherein the phenyl group attached to pyrimidine ring at the 2- position is tri-substituted (i.e. R6, R8 and R9 may not be hydrogen atom);",,

- and one of R8 and R9 is a heterocyclic ring of pyrrolidinyl, piperidinyl or azetidinyl, each of which is attached to the phenyl ring via a carbon atom.",,

4.8.2 This combination of the tri-substituted phenyl ring and the heterocyclic group of either R8 or R9 attached to that phenyl ring via carbon atom,,

renders the compound of Formula-2 as per Claim 1 novel and inventive.,,

Submissions of the Respondents/Opponent,,

5.1 Learned counsel of the opponent argued on all the points of the appellants and tried to justify the Controller's order wherein she has attempted to,,

show lack of novelty through substitutions.,,

5.2 The submissions of the learned counsel of the opponent, supporting the order of the Controller on pointed issues together with the comments of the",,

learned counsel of the appellant w.r.t. prior art document IN'653 is shown below in the table 2:,,

Table: 2,,

The comparative chart showing the arguments of both the parties w.r.t. other prior art IN'560 is given herein below in table 3:,,

Table: 3,,

COMPARISON CHART OF PATENT IN' 232560 AND IN' 267026,,

The following table No. 4 shows the chart of pharmacological activity of IN'026, IN'653 and IN'560 cited by Natco together with the comments of",,

the counsel of the appellant i.e. Novartis's,,

Table: 4,,

The appellant has relied on several case laws in support of his contention to show that how the courts are applying the tests of novelty and inventive,,

step determination:,,

8.1 Dr. Reddy's Laboratories vs. Eli Lilly & Co. [2009] F.S.R. 5,,

Para 78,,

It follows from the above that a generic disclosure will not normally take away the novelty of a subsequent claim to a member of the class. For,,

example disclosure of ""fixing means"" is not a disclosure of a nail.",,

Para 79,,

The particular question which arises in this case concerns the effect of a particular kind of disclosure, namely that made by a chemical class formula",,

or ""Markush"" formula. Such formulae are capable of encompassing many millions of compounds. In theory a person (or more likely a computer) could",,

sit down and create a list of all possible individual compounds covered by the formula. As I have mentioned, 235 contains one such formula which",,

extends to more than 10 19 compounds. Does the fact that the skilled person or robot could write down all those compounds satisfy the requirements,,

of a disclosure of an individual compound made the subject of a later claim?,,

Para 80,,

This question is addressed on a regular basis by the EPO in deciding applications for chemical patents under the EPC. They have developed a doctrine,,

that a chemical class disclosure does not necessarily take away the novelty of an individual compound falling within the class.,,

Para 90-93,,

The Court of Appeal in H. Lundbeck A/S v. Generics (UK) Ltd. [2008] EWCA Civ 311 : [2008] R.P.C. 19 regarded para. 6.2 of the reasons set out,,

above as settled jurisprudence of the EPO and applied it: see per Lord Hoffmann at [9].,,

The notion that a prior disclosure does not take away the novelty of a claim to a specific compound unless the compound is disclosed in ""individualised",,

form"" is, I believe, a sound one. I will endeavour to explain why.",,

First, a general formula is an extremely powerful way of covering large number of chemical compounds: hence their frequent use in patent disclosure.",,

It is, of course possible that someone could write down in succession all the compounds covered by all possible permutations of the variable",,

substituents of the formula: but it is wholly artificial to suppose that anyone would. Attention would focus on compounds actually described, the",,

remainder of the class being no more than a theoretical penumbra around those compounds.,,

Secondly, in those circumstances, I do not think it can be said that the prior document ""contains a clear description of, or clear instructions to do or",,

make, something which would infringe the patentee's claim"". The description is not *300 clear because of the need to make a combination of",,

substituents before the compound could be regarded as ""unalterably established"".",,

I would accordingly hold that a general formula with multiple substituents chosen from lists of some length will not normally take away the novelty of a,,

subsequent claim to an individual compound.,,

8.2 Dr. Reddy's Laboratories vs. Eli Lilly & Co. [2010] R.P.C. 9,,

Lack of Novelty,,

Olanzapine is one of the 1019 compounds of formula (I) and one of the 86,000 compounds of the ""preferred"" class. It is not mentioned",,

specifically.,,

DRL contends that nonetheless this specific compound lacks novelty - that in the language of EPC Art. 54 it formed ""part of the state of the art""",,

having been ""made available to the public by means of a written description."" The contention amounts to this: that every chemical class disclosure",,

discloses each and every member of the class. It would, it seems, even apply if the formula had simply been written down without any suggested",,

utility.,,

[We observed that It is 1019 and not 1019; Emphasis added],,

I reject the contention for two reasons: firstly as a matter of a priori reasoning and secondly because it is inconsistent with settled EPO Board of,,

Appeal case law.,,

First then, the a priori considerations apart from case-law. An old question and answer runs as a follows: ""Where does a wise man hide a leaf? In",,

a forest."" It is, at least faintly, ridiculous to say that a particular leaf has been made available to you by telling you that it is in Sherwood Forest. Once",,

identified, you can of course see it. But if not identified you know only the generality: that Sherwood Forest has millions of leaves. 27 The contention",,

has no logical stopping place. If there is disclosure of olanzapine here, why would one not regard an even more general disclosure as a disclosure of it.",,

Suppose the prior art had merely been of ""3-ringed organic compounds?"" Such a description would encompass much bigger numbers than the 1019 of",,

formula I. Yet the logic of the argument would be the same - that there is a disclosure of each and every member of the class.,,

30 Thus logic dictates rejection of the argument that a disclosure of a large class is a disclosure of each and every member of it. .",,

So what one must look for by way of an anticipation is an ""individualised description"" of the later claimed compound or class of compounds. This case",,

is miles from that.""",,

8.3 The General tire & Rubber Company vs. Firestone Tyre & Rubber Company 1972] R.P.C. 457,,

To anticipate the patentee's claim the prior publication must contain clear and unmistakable directions to do what the patentee claims to have",,

invented: 10 Flour Oxidizing Co. Ltd. v. Carr & Co. Ltd. ((1908) 25 R.P.C. 428 at 457, line 34, approved in B.T.H. Co. Ltd. v. Metropolitan Vickers",,

Electrical Co. Ltd. (1928) 45 R.P.C. 1 at 24, line 1). A signpost, however clear, upon the road to the patentee's invention will not suffice. The prior",,

inventor must be clearly shown to have planted his flag at the precise destination before the patentee.,,

8.4 Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius and Bruning a Corporation Etc. vs. Unichem Laboratories and Others AIR 1969,,

BOM 255,,

That brings me to the next ground of alleged invalidity of the plaintiffs' patent viz. want of novelty. The test of novelty as formulated by Halsbury,",,

is in the following terms: ""To anticipate a patent, a prior publication or activity must contain the whole of the invention impugned; i.e., all the features",,

by which the particular claim attacked is limited. In other words, the anticipation must be such as to describe, or be an infringement of the claim",,

attacked..""",,

8.5 Eli Lilly & Company Limited v. Apotex Pty Ltd. [2013] FCA 214,,

Para 325,,

In these circumstances, I cannot accept that Professor Black's evidence established that a person skilled in the art could clearly and unmistakably",,

arrive at olanzapine based on the teachings of the 235 Patent, or that olanzapine is produced as an inevitable result of following the teachings in this",,

patent,,

Para 326,,

I do not consider that it is as simple as he suggests, namely, that the skilled addressee would begin with the thienobenzodiazepine of the core and",,

build"" appropriate analogies by the use of the variable substituents that need to be added to the core to arrive at olanzapine. No other witness",,

accepted that this was the position. I accept the submission of Eli Lilly that it is only by the ex post facto ""cherry-picking"" of specific substituents that",,

one is able to reach olanzapine from the compounds disclosed in the 235 Patent. The large number of compounds disclosed in the 235 Patent reflects,,

the breadth of the teaching of that patent, and underscores the magnitude of the difficulty in selecting a single compound from the extensive class",,

identified. Even if the skilled addressee limited attention to the most preferred class, there is no real guidance as to why it is preferred.",,

The opponent too submitted their arguments on cited case laws and tried to show some other case laws as well, to support their contention.",,

9.1 Eli Lily & Co. Limited v. Apotex Pty Limited, [2013] FCA 214 (2013)",,

i. In Apotex, the originating patent was '235', which was the patent of 1971 with the same patentee viz. Eli Lilly. It contained in excess of 5 X 108",,

compounds and one of 86000 compounds in the most preferred class (Para 321/Page 41). This was filed in 1970s and this was followed by a further,,

application being 267 which was filed in 1990 for a single compound olanzepine; the claim to the compound Olanzepine was made after a lot of,,

research, testing and trials of various compounds, some of which were from the 235 patent and found to be toxic;",,

ii. The only beneficial use in the originating patent '235' was set out in para 320 [Page 40] namely ""compounds have a useful nerve system activity"".",,

The Federal Court noted that ""it goes no further (than that)"". In other words, there was a vague assertion that the group of compounds useful to nerve",,

system activity.,,

iii. In the impugned patent '267' (1990) the invention was described as comprising of three main parts:-,,

a. The compound Olanzapine;,,

b. The process for producing Olanzapine; AND,,

c. Pharmaceutical compounds including Olanzapine. (Para 1, Page 5)",,

It is also pointed that Olanzapine was used to treat ""schizophrenia, a debilitating psychiatric disease"". It was pointed out that Olanzapine has had",,

considerable commercial and therapeutic success in the treatment of schizophrenia.,,

iv. It would thus be seen that really speaking the earlier patent '235' was nothing but a paper patent as it did not teach anything in regard to the level of,,

activities of any of the thieno compounds, nor anything in regard to the safety, side effect or effectiveness of the compound (Para 316, Page 40). This",,

was pointed out in the evidence on behalf of the patent holder of one Dr. Robertson and Professor Nichols.,,

v. It was in this background that the findings of the Federal Court are to be appreciated in paragraph 325-326. It was Olanzapine in respect of which,,

specific disclosure was made in the later patent '267' regarding the use (treatment of schizophrenia, the doses and the administration thereof). It is in",,

this context that the evidence on behalf of the challenger Apotex in the form of its expert witness Professor Black was rejected as the evidence had,,

Olanzapine in mind and set up a challenge only on the basis of the ex-post facto cherry-picking.,,

vi. A very important factor was the testing of some compounds from the earlier 235 patent which were found to be toxic - such as flumazepine.,,

vii. It was in this context that the Federal court held that where the prior art is a vague disclosure, picking fragments of molecules to construct a fresh",,

molecule would be ""cherry picking"". In the case at hand, the markush is the invention and deconstruction of the markush to isolate each individual",,

compound is not a exercise of cherry picking-it is following the teachings of the patent.,,

viii. On the other hand, in the present case, the prior art namely IN'653 and IN'560 both disclose in the Markush structure ceritinib and more",,

importantly specify:-,,

a. The utility or use which is principally, inter alia, to act as ALK inhibitors (Anaplastic Lymphoma Kynase) checking the activity of the Tyrosine",,

Kynase;,,

b. the exact doses per kilogram of body weight;,,

c. Administration thereof were all set out in both '560' and '653'.,,

d. There is nothing extra, or technical advance that IN026 makes over IN '653 and IN '560",,

As held in the case of Merrel Dow Pharmaceuticals Inc. vs. HN Norton & Co. Ltd. 1996 RPC 76 there is no specific requirement in law that a,,

compound must be disclosed by name, structure or formula in prior art. If the teachings of the prior art leads a person skilled in the art to the",,

compound, then the compound is anticipated by prior art. Therefore, the judgment in Apotex has no applicability, because IN'653 and IN'560 are not",,

paper patents and they clearly teach Ceritinib which is evident from the admission of the experts and the filing of PTE to the USPTO.,,

Therefore, the judgment in Apotex has no applicability.",,

ix. It is also to be noticed that unlike in the Apotex judgment where specifically the compound Olanzapine was disclosed, in the instant case what has",,

been done is that the claims have retained their Markush structure and one of the illustrations of the claim 4 is the illustration related to ceritinib.,,

x. There is yet another aspect. In the Apotex case, the very heading on the top of paragraph 314, Page 40 shows that '235' patent is silent about any",,

structure-activity, relationship (Para 314-317). It concluded by stating that ""clear discernible preference for the halogen , the '235' does not teach",,

whether any particular substituent that might be important for biological activities"" [Para 317, Page 40]. To the same effect is the finding in the",,

previous paragraph [Para 316, Page 40], wherein the Court points out that the concerned passage referred to earlier [Para 315, Page 40]""does not",,

teach anything in regard to the level of activities of any of the thieno compounds, nor anything in regard to the safety, side effect or effectiveness of",,

the compounds"". This aspect has already been referred to in the previous paragraph of this note. The judgment then points out that the effect of",,

substituting the halogen in the compounds with a hydrogen as was done in the impugned patent '267' was to do away with the toxicity encountered,,

earlier. To use the expression of IG Farbenindustrie, this would qualify as the surprising and unexpected result.",,

xi. The interesting part is that as far as the three patents in our case are concerned, none of them teach anything with regard to the level of activity or",,

any of the substituent or constituents of the compound other than while dealing with the pharmacological activity, the doses and administration thereof",,

and the benefit which are more or less similar and in fact identical in all the patents in respect of which the teaching in the three patents are quite,,

similar to each other.,,

9.2 Dr. Reddy's Laboratories (UK) Limited v. Eli Lilly & Co. Limited, [2010] RPC 9",,

i. The case concerned Olanzapine. Here in the facts of the case, the prior art was 30 years old - and the second patent was later. The second had",,

clinical data in support. No efficacy was shown in the 1st patent. Therefore, the court held that it could not be said that prior art anticipates the second",,

patent.,,

ii. In the case at hand, the efficacy is the same in all the three patents.",,

9.3 Eisai Co. Ltd. v. Dr. Reddy's Laboratories Limited,,

i. The Plaintiff here held a patent for the compound Lorcaserin and the defendant was selling Locarserin Hydrochloride Hemihydrates (LHH).,,

ii. The suit patent was the main compound and the second patent was the species, since LHH could not be made without the first.",,

iii. The said judgment is not applicable in view of the following reasons:-,,

a. Firstly, paragraphs 18 & 19 of the judgment which are sought to be relied upon by the Appellant herein are indeed submissions of the Plaintiff",,

advanced in Eisai. The findings of the Court start at paragraph 52.,,

b. Secondly, the observations of the Court at paragraph 61 to the effect that ""Merely because the plaintiffs have applied for a patent separately for a",,

specific species of the genus, it does not mean that the species patent cannot be granted or that the species patent would not fall within the coverage",,

of the genus patent (i.e. the suit patent in the present case). Grant of a subsequent patent, which is an improvement invention, does not take the said",,

forms out of the first/basic patent, which in the present case is the suit patent."" is of no assistance to the Appellant herein. A species patent would",,

nevertheless have to be granted on the basis of the well-established law of selection patents as laid down in I.G. Farbenindustries'.,,

c. Lastly, while proceeding to grant interim injunction, the Court also relied upon the admission made by the officer of the Defendant therein whereby",,

the officer admitted that they were aware of the senior patent which formed the basis for the suit patent. The Court proceeded to hold that the,,

Defendant had failed to explain the said admission.,,

9.4 Hindustan Unilever Limited v. Lalit Wadhwa & Anr. (Vipin Singhi, J)",,

i. Reliance is placed on Para 14- which para refers to the arguments made by the plaintiff's counsel; the decision of the court starts at Para 16.,,

ii. In the facts of this case, the plaintiff had its own patent and the defendant had its own patent for its own product. When suit for infringement was",,

brought the defendant defended the same by filing application under order 7 rule 11 arguing that since the defendant has its own patent, no suit for",,

infringement will lie. [Para 7 & 13],,

iii. This argument of the defendant was rejected by the Court in Para 22.,,

iv. The factual matrix itself is totally different - in the present case, the Respondent herein has no patent. It is the validity of the Appellant's patents",,

that are in question.,,

i. Bristol-Myers Squibb v. BDR Pharmaceuticals International Private Limited, ii. The Plaintiff here held patent IN '381 for Apixaban. The argument",,

of the Defendant was not on grounds of anticipation, but obviousness in view of the prior art.",,

iii. The portion of Para 36 on which reliance has been placed does not apply to the instant case as it refers to instances where parts from different,,

prior arts are taken to test obviousness.,,

iv. The said Order is in the nature of an ad-interim order and is the subject matter of appeal before the Division Bench in FAO (Comm.) No.,,

377/2019.,,

9.5 Astrazeneca Ab v. Emcure Pharmaceuticals Limited, [Para 33-37]",,

i. Reliance was placed by the Appellant herein on paragraphs 33-37 to show that Coverage and disclosure were not the same.,,

ii. It is respectfully submitted that the High Court quoted the paragraphs from the judgment in Novartis, but proceeds to note that a species patent",,

could be granted once a genus patent had been granted.,,

9.6 FarbwerkeHoescht AG v. Unichem Laboratories & Ors., AIR 1969 BOM 255 [Para 15]",,

i. This was a case wherein plaintiff claimed product patent for tolbutamide. The defendant alleged that the claims to tolbutamide lack novelty/inventive,,

step and various prior art were cited.,,

ii. At Para 15 the prior art cited for lack of novelty was one where 'sulphonylureas' were known, but they had the wrong radicals at the wrong place",,

and it was not known that they could have anti-diabetic effect.,,

iii. In fact the Plaintiff in this case had tested some compounds from the genus patent and found them to be toxic - e.g., carbutamide. And tolbutamide",,

was found to be non-toxic and claimed in the second patent.,,

iv. In our case the same compound - Ceritinib is found in the prior art as it is - without any change. It is a case of re-patenting which is not,,

recommended by this case.,,

v. Further, the portion of this judgment that is extracted actually supports the case of the Respondent, ""to anticipate A patent, a prior publication or",,

activity must contain the whole of the invention impugned, i.e. all the features by which the particular claim attacked is limited. In other words, the",,

anticipation must be such as to describe, or be an infringement of the claim attacked..""",,

9.7 General Tire & Rubber Company v. Firestone Tyre & Rubber Company, [1972] RPC 457",,

i. This was a case concerning a device - does not relate to chemical compounds. As is known the novelty and inventive step for chemical compounds,,

is different as compared to devices.,,

ii. The patent was for a process for making a compound suitable for tyre treads by mixing synthetic rubber with oil and carbon black,,

iii. No evidence is led by Appellant that prior art cannot be made in a way that would not lead to Ceritinib.,,

iv. In fact, the said judgment contains findings which are favourable to the case of the Respondent No. 3:-",,

a. If the prior art gives a description to do something that if carried out after the patent is granted is infringing - then it is anticipating. i.e., if the making",,

of compound Ceritinib by the Respondent would be infringed by IN653 and IN560 - then they also anticipate the impugned patent,,

b. Comparison is the correct methodology to determine anticipation, however, in this comparison, the state of affairs will be as it existed on the date of",,

publication of the impugned patent.,,

9.8 F. Hoffman La-Roche v. Cipla Limited, i. A reading of the said judgment makes it clear that the argument of anticipation was not taken up, and",,

was in fact given up by the Defendant. On the contrary, the whole argument in the instant case is about anticipation.",,

ii. In the instant case, concrete evidence is placed on record in the form of prior art to show that the compound ceritinib itself was anticipated in its",,

entirety without any substitutions.,,

F. Hoffman La-Roche v. Cipla Limited,",,

i. The DB clearly notes that anticipation as a ground was given up by the Respondent since the molecule in question was not published in any prior,,

publication. The only issue was of obviousness.,,

ii. In the present case however concrete evidence is placed on record in the form of prior art to show that the compound Certinib itself was,,

anticipated in its entirety, without any substitutions.",,

We decline to agree with the submission of the opponents particularly on interpretation of the Merrel Dow Pharmaceuticals Inc. vs. HN Norton &,,

Co. Ltd Available at https://www.bailii.org/uk/cases/UKHL/1995/14.html. 1996 RPC 76. It was rather held in that case that:,,

10.1 ""the composition or internal structure of a product become part of the state of the art if it is possible for a skilled person to discover it and",,

reproduce it without any undue burden.,,

Under decisions of the EPO seem to me to make it clear that at least for some purposes, products need not be known under their chemical description",,

in order to be part of the state of the art. The decision T12/81 Bayer/Diastereomers (1979-85) EPOR vol. B.308, 312, the technical board of appeal",,

said ""the concept of novelty must not be given such a narrow interpretation that only what has already been described in the same terms is prejudicial",,

to it. The purpose of article 54 (1) EPC is to prevent the state of the art being patented again. Article 54(2) EPC defines the state of the art as,,

comprising everything made available to public before the date of filing in any way, including be written description. There are many ways of",,

describing a substance in chemistry and this is usually done by giving its precise scientific designation. But the latter is not always available on the date,,

of filing..,,

It is the practice of a number of patent offices to accept the process parameter in the form of a product by process claim. .. To the boards knowledge,,

this is also the practice of the European Patent Office. if invention related to chemical substances define by the claims of this kind are patented, it",,

necessarily follow that the resulting patent documents once they enter the state of the art will be prejudicial to the novelty of applications claiming the,,

same substance although in a different perhaps more closely defined forms.""",,

10.2 Therefore, in view of the above, the interpretation of the opponents that ""there is no specific requirement in law that a compound must be",,

disclosed by name, structure or formula in prior art"" is not the correct interpretation.",,

Now having narrated the brief background, facts and the major arguments counter-arguments, the case laws both in favour of the appellant and",,

the opponents, we will try addressing these issues one by one:",,

Maintainability of Post-Grant Opposition Proceedings at The Patent Office,,

12.1 It is noted from Form -30 filed by the opponent/respondent no. 3 to the office of Controller Supra 1, stating that Payment of balance fees of INR",,

9600 for Notice of opposition to grant of patent under Section 25(2) for large entity. Fee of INR 2400 as natural person has already been paid,,

electronically via Form-7 on 26th September, 2017. It is found from the records that the opposition was filed by M/s. Natco Pharma Limited on",,

26/09/2017. So, filing the opposition by a legal entity and paying the prescribed fee of filing opposition with the fee which is applicable to natural person",,

is not justifiable. If the balance fee of ` 9600 was paid on 08/11/2017 (Tabel-1 Sl. No. 8) - a date much later than the last date of filing opposition i.e.,,

30/09/2017, the opposition was not maintainable as per the provisions of the Patents Act and the Rules made there under:",,

12.2 The provisions relating to the payment of fee under section 142 of the Act,,

Section 142 Available at http://ipindia.nic.in/writereaddata/Portal/ev/sections/ps142.html",,

Fees,,

(1) There shall be paid in respect of the grant of patents and applications therefor, and in respect of other matters in relation to the grant of patents",,

under this Act, such fees as may be prescribed by the Central Government.",,

(2) Where a fee is payable in respect of the doing of an act by the Controller, the Controller shall not do that act until the fee has been paid.",,

(3) Where a fee is payable in respect of the filing of a document at the patent office, the fee shall be paid along with the document or within the",,

prescribed time and the document shall be deemed not to have been filed at the office if the fee has not been paid within such time.,,

(4) Where a principal patent is granted later than two years from the date of the filing of the application, the fees which have become due in the",,

meantime may be paid within a term of three months from the date of the recording of the patent in the register or within the extended period not later,,

than nine months from the date of recording.""",,

12.3 The provisions relating to payment of fee under the Patents Rules 2003 are quoted herein below:,,

Rule 7 Available at http://ipindia.nic.in/writereaddata/Portal/ev/rules/pr7.html",,

Fees,,

(1) The fees payable under section 142 in respect of the grant of patents and applications therefor, and in respect of other matters for which fees are",,

required to be payable under the Act shall be as specified in the First Schedule.,,

Provided that ten per cent additional fee shall be payable when the applications for patent and other documents are filed through physical mode,",,

namely, in hard copy format: Provided further that in the case of a small entity, every document, for which a fee has been specified, shall be",,

accompanied by Form-28.,,

(2) (a) The fees payable under the Act or these rules may be paid at the appropriate office either in cash or through electronic means or may be sent,,

by bank draft or banker's cheque payable to the Controller of Patents and drawn on a scheduled bank at the place where the appropriate office is,,

situated and if the draft or banker's cheque is sent by post, the fees shall be deemed to have been paid on the date on which the draft or banker's",,

cheque has actually reached the Controller.,,

(b) omitted,,

(c) Where a fee is payable in respect of a document, the entire fee shall accompany the document.",,

(3) In case an application processed by a natural person is fully or partly transferred to a person other than a natural person, the difference, if any, in",,

the scale of fee(s) between the fee(s) charged from a natural person and the fee(s) chargeable from the person other than the natural person in the,,

same matter shall be paid by the new applicant with the request for transfer.,,

(3A) In case an application processed by a small entity is fully or partly transferred to a person other than a natural person (except a small entity), the",,

difference, if any, in the scale of fee(s) between the fee(s) charged from a small entity and the fee(s) chargeable from the person other than a natural",,

person (except a small entity) in the same matter shall be paid by the new applicant with the request for transfer.,,

(3B) In case an application processed by a startup is fully or partly transferred to any person other than a natural person or a startup, the difference, if",,

any, in the scale of fees between the fees charged from a startup and such person to whom the application is transferred, shall be paid by the new",,

applicant along with the request for transfer: Explanation.- Where the startup ceases to be a startup after having filed an application for patent due to,,

lapse of more than five years from the date of its incorporation or registration or the turnover subsequently crosses the financial threshold limit as,,

defined, no such difference in the scale of fees shall be payable.",,

(4) Fees once paid in respect of any proceeding shall not ordinarily be refunded irrespective of whether the proceeding has taken place or not:,,

Provided that, if the Controller is satisfied that during the online filing process, the fee was paid more than once for the same proceeding, the excess",,

fee shall be refunded.,,

(4A) Notwithstanding anything contained in sub-rule (4), upon the withdrawal of an application in respect of which a request for examination has been",,

filed, but before issuance of first statement of objection, the fee may be refunded to the extent prescribed in the First Schedule on a request made by",,

the applicant in Form 29.,,

(5) (i) Subject to the approval of the Controller, any person may deposit money in advance and request the Controller to realise any fee payable by him",,

from the said deposit and in such case the date of the receipt of the request to realise the fee or the date on which the request to realise the fee is,,

deemed to have been received, whichever is earlier, shall be taken as the date of payment of the fee:",,

Provided that the requisite amount of money is available at the credit of the person making such request.,,

(ii) Subject to the approval of the Controller, any person may discontinue the deposit of money in advance and in such case the balance, if any, shall be",,

refunded.""",,

12.4 It is evident from Rule 7(2) (c) that where a fee is payable in respect of a document, the entire fee shall accompany the document. Also Section",,

142 (2) stipulates that where a fee is payable in respect of the doing of an act by the Controller, the Controller shall not do that act until the fee has",,

been paid.,,

12.5 It is, therefore, clear from the records that on the date of filing of the notice of opposition, the fee was not paid in full as prescribed in the first",,

schedule of the Patents Rules, 2003 and hence the opposition should not have been taken on records by the Controller.",,

12.6 The last date of filing the document with the complete fee was 30/09/2017 i.e. one year from the publication of grant of the impugned patent.,,

Since only ` 2400 was paid with Form 7 filed by M/s. Natco Pharma Ltd. and the balance of fee (alleged difference between natural person and legal,,

entity) of ` 9600 was paid on 08/11/2017 i.e. after the expiry of the statuary period of 1 year from the date of publication of grant; literally the notice of,,

opposition filed on Form 7 was deemed not to have been filed as per the teachings of section 142(3) of the Act. 12.7 Since this issue was not agitated,,

before this tribunal, we are of the opinion that we will not decide the case in front of us only on this ground alone but we certainly direct the",,

Controller's office to be more vigilant in future and avoid recurrence of such cases. The Controller's office may take a general survey in all the cases,,

where the incomplete fee was paid and the actions have been taken, contrary to law in order to enhance transparency measures.",,

Scheme of the Post-Grant Opposition at The Patent Office,,

13.1 The Following is the graphic presentation of the provisions of Rules 57-60 & 62(4) of the Patents Rules, 2003 as they relate to post-grant",,

opposition:,,

13.2 It is evident that on 04/04/2019, exactly five days prior to the date of hearing which was fixed on 09/04/2019, the opponent/respondent no. 3 filed",,

two documents a) Petition u/r 138 to take Statement and Evidence and Affidavit of Dr Ramesh Dandala on Record and b) Statement of Evidence and,,

Affidavit of Dr Ramesh Dandala. The opponent/respondent no. 3 requested to the Controller that the documents may also be given to Opposition,,

Board for its consideration.,,

13.2.1 There is no evidence before us to show that the Controller first decided on the Petition u/r 138 as to whether to allow the additional documents,,

filed by Respondent No. 3 or not. However, with regard to document filed along with Form- 7 i.e. notice of opposition, it is obvious that opposition",,

board must have drawn its conclusion after considering all the available documents on records.,,

13.2.2 For clarity let's see the scheme of Rule 138 Available at http://ipindia.nic.in/writereaddata/Portal/ev/rules/pr138.html:,,

Rule 138",,

Power to extend time prescribed,,

(1) Except for the time prescribed in clause (i) of sub-rule (4) of rule 20, sub-rule (6) of rule 20, rule 21, sub-rules (1), (5) and (6) of rule 24B, sub-",,

rules (10) and (11) of rule 24C, sub-rule (4) of rule 55, sub-rule (1A) of rule 80 and sub-rules (1) and (2) of rule 130, the time prescribed by these rules",,

for doing of any act or the taking of any proceeding thereunder may be extended by the Controller for a period of one month, if he thinks it fit to do so",,

and upon such terms as he may direct.,,

(2) Any request for extension of time prescribed by these rules for the doing of any act or the taking of any proceeding thereunder shall be made,,

before the expiry of such time prescribed in these rules.""",,

13.2.3 The prayer of the opponent in the petition in as follows:,,

Upon deeper scrutiny of the matter, the Opponent has found some documents which were not available earlier. Hence, the Opponent is submitting",,

further evidence under Rule 60;,,

The Opponent prays that such further evidence filed be taken on record and be considered during the hearing scheduled. It is also prayed that these,,

documents also be provided to the Opposition Board.""",,

13.2.4 The provisions of Rule 60 Available at http://ipindia.nic.in/writereaddata/Portal/ev/rules/pr60.html are quoted herein below for reference:,,

Rule 60",,

Further evidence to be left with the leave of the Controller,,

No further evidence shall be delivered by either party except with the leave or directions of the Controller:,,

Provided that such leave or direction is prayed before the Controller has fixed the hearing under rule 62.""",,

13.2.5 Thus it is evident from the plain reading of the Rules that after the Controller has fixed the hearing under Rule 62, no further evidence can be",,

delivered by any party and Controller's leave, if any, could have been sought only prior to the fixing of the hearing under 62. It is evident that the",,

hearing was fixed on 25/09/2018. It was on the behest of the opponent that the said hearing was adjourned twice i.e. on 15/02/2019 and 09/04/2019,,

under the provisions of Rule 129A. Therefore, the Rules do not permit taking any additional document into consideration after fixation of the hearing",,

date by the Controller. Further Rule 138 provides for extension of time where some time period is prescribed under the Rules subject to exceptions,,

provided under Rule 138. Since there is no timeline provided in specific terms u/r 60, there is no question of filing petition u/r 138. The leave of",,

Controller as provided in Rule 60 may be requested only prior to the fixation of hearing. Therefore, in neither case Petition u/r 138 can be entertained",,

in such circumstances.,,

13.2.6 We have heard the arguments of either party on this issue of additional document. While the Counsel for the Appellant argued that the,,

Controller selectively considered the additional documents and considered those filed by the opponents, the Counsel of the opponent was of the view",,

that the Controller did not take any additional document on record from either parties.,,

13.2.7 Lets now look at the relevant portion of the impugned order of the Controller dated 16/08/2019:,,

3) The Agent for the Opponent submitted additional submissions on 7th May 2019. Thereafter, Patentee filed a document on 9th July 2019. The",,

Patentee and the Opponent are regularly filing further evidences after the completion of hearing and written submissions. Since Opponent and,,

Patentee were instructed not to file further evidences after filing written submissions, therefore, further evidences submitted by Opponent and",,

Patentee are not taken into record.,,

During Hearing the Opponent has submitted an important document (seeking extension of Patent term in USA by Patentee) which has brought into,,

light the relationship of the impugned Patent 276026 (corresponding US patent no. 8377921) with cited documents IN 232653 (corresponding US,,

patent no. 7964592); IN240560 (corresponding US patent no. 7893074) and WO2001/64654 (corresponding US patent no. 7153964). Since, this",,

document was very important and relevant in deciding the case before me, therefore, document was taken into record and a copy was given to",,

Patentee to rebut the objection raised by opposition. The Patentee was given additional time (written submission filed on 24.05.2019) to file the rebuttal,,

regarding this disclosure of Orange Book where the details of extension was filed, but Patentee failed to give any reasonable and convincing",,

argument.""",,

13.2.8 Plain reading of these two paragraphs of the Controller's order conveys that the order lacks clarity and presents a mutually confusing,,

statements in para 3 and 6 of the impugned order. While para 3 says that ""Since Opponent and Patentee were instructed not to file further evidences",,

after filing written submissions, therefore, further evidences submitted by Opponent and Patentee are not taken into record."", para 6 thereof reads that",,

During Hearing the Opponent has submitted an important document (seeking extension of Patent term in USA by Patentee) which has brought into",,

light the relationship of the impugned Patent 276026 (corresponding US patent no. 8377921) with cited documents IN 232653 (corresponding US,,

patent no. 7964592); IN240560 (corresponding US patent no. 7893074) and WO2001/64654 (corresponding US patent no. 7153964). Since, this",,

document was very important and relevant in deciding the case before me, therefore, document was taken into record.."". In paragraph 3 the Controller",,

says that no documents are taken into consideration and para 6 of the same order puts the contradictory statement that some document were found to,,

be important document and hence taken on records.,,

13.2.9 It is worth noting here that the patentee/appellant herein requested the Controller not to take these additional documents into account and once,,

the Controller reserved her order after hearing on 09/04/2019 and 10/04/2019, they approached Hon'ble High Court Delhi against the Controller with",,

regard to accepting/not accepting the additional documents.,,

13.2.10 Hon'ble High Court of Delhi directed the Controller in CS (Comm.) 229/2019 vide order dated 11/07/2019 as follows:,,

.The Controller General shall now go ahead and proceed to pass order within one month from today. No further filing shall be done by either party.""",,

13.2.11 During the arguments, we noticed that both the counsels had different views on para 3 and 6 of the Controller's order. The findings of",,

paragraphs 3 and 6 are contrary to each other. We are of the view that the respondent no. 2 ought to have considered the rebuttal evidence filed by,,

the appellant, once the orders was passed by the High Court and secondly when the evidence of the respondent no. 3 was considered. Once it was",,

pointed to the Counsel for respondent no. 3, upon instruction, the consent was given before us that IPAB may consider the rebuttal evidence while",,

deciding the appeal. Mr. Hemant Singh, the leaned counsel of the appellant was also agreeable to the said suggestions. They both agreed that Hon'ble",,

High Court also impliedly meant the same and agreed that this tribunal may consider all the exiting documents on record including the affidavits,,

presented by either party. Therefore, we are inclined to deal with the same.",,

Mr. Hemant Singh, the learned counsel of the appellant while arguing the matter brought to our notice that these two documents namely IN 653",,

and IN560 were cited at the stage of examination of the patent application at Indian Patent Office and after satisfactory reply rendered by them these,,

objection were dropped. In order to check the veracity of these arguments we would like to trace back the prosecution history of this application.,,

14.1 The First Examination Report Available at http://ipindiaservices.gov.in/PatentSearch/PatentSearch/ViewPDF sent dated 12/11/2013 contained,,

the following main objections,,

Novelty: No, Claims 1-10, 16-20",,

Inventive step: No, Claims 1-20",,

D1: WO 2006/021454,,

D2: WO 2005/016894,,

D3: WO 2004/080980,,

Novelty,,

Document D1-D3 disclose 4-phenylamino-2-arylamino-pyrimidine derivatives, as protein kinase inhibitors (ALK, FAK, ZAP70, IGF1 R) for treating",,

immune diseases or cell proliferative disorders. The huge number of compounds as claimed in claim 1-10 is overlapping with the compounds of as,,

disclosed in prior art document D1-D3 and the applicant has not defined in which way this overlap could be regarded as novel vis-a-vis documents,,

D1-D3, that is to say, the applicant has not defined the new technical element common to the compounds of the present application which fall within",,

the overlap and which can be regarded as adding a new element to the state of the art. As stated above, the only structural element common to all the",,

compounds claimed is the presence of a 6-membered aromatic ring containing at least one nitrogen atom and substituted in 4-position with a 2-,,

substituted phenylamino group and in 2-position with a (6-membered aromatic ring) amino moiety. All the other structural elements vary and no,,

common feature could be identified between the claimed alternatives. Since, the new technical feature, which is necessary to established novelty, fails,",,

and the overlap is considered identical to what has already been disclosed in D1-D3. Moreover the content of D1-D3 is neither limited to its example,,

nor to the preferred embodiments disclosed therein, and hence the content of these documents (D1-D3) should be regarded as a whole and all the",,

information contained therein is state of the art, the result of which is attract the u/s. 2(1)(j) and novelty of the claims 1-10 and 16-20 cannot be",,

acknowledged.,,

Inventive step:,,

Documents D1 and D2 may be considered as the closest prior art since their scope overlaps with the present claimed subject-matter. The difference,,

between the compounds of the prior art and the compounds presently claimed is that the claimed compounds are generically described in the prior art,",,

as follows: The pyrimidine derivatives or a pharmaceutically acceptable salt thereof, of D1 are:",,

(i) Inhibitors of the IGF-IR (insulin like growth factor receptor 1) and are therefore useful in the treatment of IGF-1 R mediated diseases for example,,

such diseases include proliferative diseases, such as tumours [Page 27 last para], (ii) Inhibitors of the tyrosine kinase activity of anaplastic lymphoma",,

kinase (ALK) and the fusion protein of NPM-ALK leading to hema tological and neoplastic diseases, for example in anaplastic large-cell lymphoma",,

(ALCL) and non-Hodgkin's lymphomas (NHL), specifically in ALK+ NHL or Alkomas, in inflammatory myofibroblastic tumors (IMT) and",,

neuroblastomas [Page 28 para 1],,

(iii) Inhibitors of Focal Adhesion Kinase (FAK), and are useful as pharmaceuticals to treat conditions caused by a malfunction of signal cascades",,

connected with Focal Adhesion Kinase, in particular tumors as described [Page 25 last para]. (iv) Inhibitors of ZAP 70 [Page 33 last para]. And the",,

other pyrimidine derivatives or a pharmaceutically acceptable salt thereof as mentioned in D2 and D3 are also useful for the inhibition of FAK and/or,,

ALK and/or ZAP-70 and/or IGF-IR [(D2: Claim 15), D3: (Pg 17, Para 3 1st line), (Pg 17, Last Para, 2nd line), in claim 15 and in several places]",,

The problem to be solved by the present invention may therefore be considered as the provision of further 4-phenylamino-2-arylamino-pyrimidine,,

derivatives as protein kinase inhibitors (ALK, FAK, ZAP-70, IGF1 R) for treating same diseases or disorders.",,

Starting from D1 or D2, it appears that all the compounds claimed therein are expected to exhibit the claimed activity as long as the characteristic core",,

structure is present. The indiscriminate selection of some defined compounds among many is prima facie obvious. The motivation to make the claimed,,

compounds derives from the expectation that structurally similar compounds would possess similar activity. One skilled in the art would thus be,,

motivated to prepare products embraced by the prior art to arrive at the instant claimed products with the expectation of obtaining additional beneficial,,

products which would be useful in treating, for example, cancer. In this context, it is well-known that in the field of drug design that structurally similar",,

molecules possess similar biological activities. Indeed, small structural modifications within a core structure known for its biological activity come",,

within the scope of the customary practice followed by persons skilled in the art to provide new active compounds. In the present case, the",,

compounds exemplified in D1 and D2 are structurally very close to the present claimed compounds. Such changes within a known active structure are,,

considered to stay within a common practice in the field of drug design.,,

Moreover, since applicant is failed to provide the precise biological data about the actual physiological properties of claimed compounds have been",,

provided by the applicant, it is not clear if the problem had actually been solved or not, the mere selection of a specific family of compound within a",,

broader group known for its biological activity is considered as just an alternative having no technical advancement over the prior art, and the claims 1-",,

20 cannot be considered as inventive in the sense of u/s. 2(1)(ja) of the Patent Act.,,

1. The variation in position of sulfonyl group and pipyridyl derivatives and addition of some extra functionality over the prior art makes the claimed,,

compounds. Since applicant is failed to provide the biological data about the actual physiological properties of claimed compounds, they are considered",,

as, just the mere derivative of the known compounds having no advancement over known therapeutic efficacy and claims 1-20 are not allowable u/s.",,

3(d).,,

Claims 17 attracts the clause (i) of section 3 of Patents Act, 1970, which says method of treatment claim is not allowable.",,

The subject matter of Claims 18-20, refer to the use of the compound, which neither refers a product nor a process, hence claim 18-20 are not",,

allowable u/s. 2(1)(j) of Patents Act 1970,,

14.2 The patentee/appellant herein submitted their arguments to these official requirements vide their letter dated 03/06/2013 and the Controller being,,

satisfied by the arguments dropped the objections on novelty (anticipation) while they retained the objection on inventive step which is evident by the,,

order of the Controller dated 28/09/2016, who granted the patent. It is worth noting here that the patentee amended the claims at this stage to satisfy",,

the official requirements and submitted that the patents with claims have been granted in other jurisdictions as well such as US, Australia and Canada.",,

14.3 The Learned Controller who granted the impugned patent In'026 holds in para 6 of his order Available at,,

http://ipindiaservices.gov.in/PatentSearch/PatentSearch/ViewDecision dated 28/09/2016 as follows:,,

A hearing was appointed on the above application for October 19, 2015 and by the hearing notice dated October 8, 2015, the following objections",,

were communicated to the Applicant:,,

(i) Invention Step: No, Claims 1-13 D1: WO2006/021454D2: WO2005/016894D3: WO2004/080980 In D1 R12 substituent is attached via-N-atom, but",,

here it is directly or via-N-atom (-morpholine, pyrolidine) whereas 02 (p 99) says about the direct attachment of the R12 to the-N atom. Both the D1",,

and D2 is saying about the R12 substituent exactly same or similar to that of the present invention [where R12 is-morpholine (ex 16B of D2), -isobutyl",,

(p 85), -cyclopentyl ring attached to the-N atom]. Hence, the selection of the substituent as R12 has already been disclosed in both D1 and/or D2.",,

.,,

Now, the next part is substituent at the 2-position of pyrimidine ring: Although, most of the examples of D1-D3 are refers to a disubstituted attached to",,

the 2-position of pyrimidine ring, but there are few examples already furnished in the D1 and D; e.g. at pg 80, 81, 85 (20-35) of D2 refers to the",,

examples where the ring is trisubstituted. Hence the concept of introduction of trisubstitutedring is not new and already been taught by the D1 or D2.,,

Now, from the claims it appears that the additional substituent (i.e. third substituent) is a-methyl group (as per the claims) and other two substituents",,

are same as disclosed in D1-03 (examples). Hence, from the above discussion and the disclosure of D1-D3 any person having ordinary skill in the art",,

may easily reach to the present alleged invention and an inventive step cannot be acknowledged.,,

(ii) Broad and need to restrict as per the embodiments:,,

The substituent as defined in claim 1 (and also in claim 6, claim 6 supposed to merge with claim 1 as it cannot be an independent claim), where, F1 has",,

been referred as halo, but the embodiments refers to-Cl only (compound 1 and most of the compounds) or C1-C6 alkyl: but only-CH3 (Compound 35,",,

37, 56 74 etc) R2 is H only, hence R2 may be replaced by-H; R3 is either-C(O)-R12 or-SO2-R12, but there is no example both-C(O)- and-",,

SO2•and hence, the substituent as claimed in claim 1 [(CR2)0-2SO2R12] need to be restricted as such.",,

R4 is only -H,,

R6 is only -isopropoxy,,

One of RB and R9 may be either-methyl or any one from the group piperidine, or N-substituted [substitution may be methyl-, methyl piperidyl-or-2",,

(hydroxy or methoxy) ethyl] piperidine R12 may be-n propyl, -isopropyl, -morpholine, pyrolidine, or cyclobutyl.",,

(iii) In reply, pg 2, it has mentioned that 'one of RB and R9 is attached to the phenyl ring via a carbon atom' but, it appears that, all the substituents are",,

attached to the ring directly.,,

(iv) Claim 1 & 6 are independent, not properly independent claim: Claim 6 may not be considered as independent claim vis-a-vis claim 1, as the subject",,

matter of both the claim refers to 'pyrimidine compound'.,,

14.4 The Learned Controller also refer to GSH assay data submitted by the applicants and comments as under:,,

GSH Trapping Assay,,

14.4.1 As illustrated in the GSH assay data (Annexure A), a compound within the scope of the claims (i.e., Compound 2 in Annexure A) produces a",,

low number of reactive adducts in the GSH assay compared to Compound 1 in Annexure A. The low percentage of reactive adducts observed in the,,

GSH assay is a benefit of the presently claimed compounds that is not expected from any of the cited references.,,

14.4.2 Both compounds have a phenyl ring substituted with a methyl group, anisopropoxy group and a substituted piperidine group (para to an amine",,

group). However, the piperidine group of compound 1 is attached to the phenyl ring via the nitrogen, whereas the piperidine group of compound 2 is",,

attached to phenyl ring via a carbon atom (as required by the present claims).,,

14.4.3 Annexure A shows that Compound 2 advantageously forms significantly fewer reactive adducts than Compound 1 in a GSH trapping assay.,,

The lower reactive adduct formation is an additional advantage to the inhibition of ALK exhibited by the present compounds, as discussed in",,

paragraph [0045] of the present application.,,

14.4.4 The low reactive adduct formation of the presently claimed compounds is shown for the compounds of Annexes I and II. In addition, the",,

inhibition of ALK by the presently claim compounds is supported by the present application in paragraph [0045], where it states that ""in general,",,

compounds of the invention have IC50 values from 1 nM to 10µM.""",,

14.5 Therefore, it is evident that the Controller who offered the hearing under section 14 and granted the patent, was satisfied by the submissions of",,

the patentee on the ground of 'novelty' even before hearing as he didn't mention objections in hearing notice on the grounds of novelty.,,

14.6 It is further evident vide the concluding paragraph of his order dated 28/09/2016 where he holds:,,

The cited documents have been carefully examined. However, none found to afford the similar knowledge either indecently, jointly or in any",,

combination. Therefore, the present compound is novel and inventive. I have considered the submissions and explanation given by the Applicant.",,

I am therefore of the opinion that claims of 3951/DELNP/2009 are novel and inventive and the compound claimed is absolutely novel and there is no,,

nearest prior art compound that is structurally and functionally similar for comparing with the presently claimed molecule and therefore Section 3(d) is,,

not attracted. [Emphasis added],,

The Applicant has complied with all the remaining objections.,,

I hereby order the grant of a patent on Indian Application No. 3951/DELNP/2009.""",,

It is worth noting herein that the prior arts cited in post-grant opposition are only these documents which were considered during examination and,,

grant procedures at the patent office. The only additional information which was given was about application of PTE in one of the citations.,,

(Corresponding US patent to IN'653). Therefore, no additional document, no additional facts were to be considered at patent office during post-grant",,

opposition which was not considered at the examination and grant stage.,,

Now a look at the recommendations of the opposition board:,,

16.1 Finding on anticipation/lack of novelty:,,

a) ""However, none of the documents cited for the prior publication anticipates the compounds with the combination of the tri-substituted phenyl ring",,

and the heterocyclic group attached to that phenyl ring via a carbon atom as claimed in claims 1-7 of the impugned Patent. Therefore, the opponent's",,

contention that the cited prior documents anticipate the claims of the alleged invention has failed to establish the above ground of opposition.""",,

b) The Board further observed dealing with cited prior art in reference to WO'980 (IN '653) and WO' 894(IN '560) as under:,,

Further, WO'980 also does not disclose how to make a 2, 4-di(phenylamino)pyrimidine compounds, wherein the phenyl group attached to amino group",,

at 2-position of pyrimidine ring is tri-substituted (i.e. R6, R8 and R9 may not be hydrogen atom) and one of R8 and R9 is pyrrolidinyl, piperidinyl or",,

azetidinyl, each of which is attached to the phenyl ring via a carbon atom. More specifically, WO'980 does not provide any working example of how to",,

synthesize any 2, 4-di(phenylamino)pyrimidine compounds, with phenyl group attached to amino group at 2-position of pyrimidine ring is tri-substituted",,

and with one of R8 and R9 as pyrrolidinyl, piperidinyl or azetidinyl, each of which is attached to the phenyl ring via a carbon atom.""",,

..WO'894 also describes a series of compounds by way of a Markush Structure, but none of the exemplified compounds of WO'894 suggest the",,

modifications required in the claims of the impugned patent wherein the phenyl group attached to pyrimidine ring at the 2-position is tri-substituted (i.e.,,

R6, R8 and R9 may not be hydrogen atom) and one of R8 and R9 is pyrrolidinyl, piperidinyl or azetidinyl, each of which is attached to the phenyl ring",,

via a carbon atom. In fact, it lacks even a single example teaching how to synthesize 2, 4-di(phenylamino)pyrimidine compounds with such an",,

attachment arrangement. Importantly, synthesis route provided in WO'894 cannot be said to motivate a person skilled as on the priority date of present",,

application to arrive at 2, 4-di(phenylamino)pyrimidine compounds, with such an arrangement as in claimed compounds. Accordingly, WO'894 cannot",,

anticipate the claimed compound. Therefore, in the absence of any documentary proof or evidence this ground of opponent is not sustained regarding",,

claims 1-7.,,

16.2 Finding on obviousness/lack of inventive step:,,

The technical problem solved by the claims 1-7 of instant application is to provide pyrimidine compounds effective in the treatment of cell proliferative",,

disorders. In claim 1, patentee has provided pyrimidine compounds or pharmaceutically acceptable salts of Formula 2. It is observed by the opposition",,

board that none of the cited references describe or suggest the compounds claimed in claims 1-5 of the present patent. Compounds claimed in claims,,

1-5 showed substitution pattern of pyrrolidinyl, piperidinyl, or azetidinyl ring attached to tri-substituted phenyl ring via a carbon atom of the heterocyclic",,

ring. None of the cited references provide any exemplified compound for the pyrimidine compounds having two phenyl rings attached to the pyrimidine,,

ring at the 2-position is tri-substituted (i.e. R6, R8 and R9 may not be hydrogen atom) and one of R8 and R9 is pyrrolidinyl, piperidinyl or azetidinyl,",,

each of which is attached to the phenyl ring via a carbon atom and none of them discuss or suggest the particular substitution pattern in pyrimidine,,

compounds having two phenyl rings attached to the pyrimidine ring via amine groups"" (see Pg. 270-271, appeal paper book, Vol. 2)",,

.It is observed by the opposition board that the compounds of Markush formula (2), claimed in current patent possess two characteristic substitution",,

requirements:,,

(a) Phenyl group attached to the pyrimidine ring at the 2-position is tri-substituted (i.e. R6, R8 and R9 may not be a hydrogen atom), and (b) One of",,

substituents R8 and R9 is pyrrolidinyl, piperidinyl or azetidinyl, each of which is attached to the phenyl ring via a carbon atom. This substitution pattern",,

is not disclosed by any cited documents and no suggestion about such substitution pattern is provided by these documents. Therefore subject matter of,,

claims 1-7 of current patent is inventive.,,

The Leaned Controller in her order dated 16/08/2019 holds as follows:,,

17.1 ""4) In Notice of opposition filed via Form 7 u/s. 25(2)of the Patents Act, 1970 and u/r 55A and 57 of the Patents Rules, 2003 (as amended in",,

2016) on 26/09/2017, following grounds of opposition were raised:",,

i. Section 25(2)(b)/(c): Lack of novelty and prior claiming;,,

ii. Section 25(2)(e): Lack of inventive step;,,

iii. Section 25(2)(f): Subject of claims 1 to 7 are not an invention within the meaning of this Act or is not patentable under this Act;,,

iv. Section 25(2)g: The complete specification does not sufficiently and clearly describe the invention or the method by which it is to be performed;,,

v. Section 25(2)h:,,

vi. The Applicant has failed to disclose to the Controller the information required under Section 8,,

17.2 5) In the following paragraphs, I wish to analyze the relevant grounds which the Opponent has raised:",,

i) Lack Of Novelty,,

IN 232653 (2241/CHENP/2005),,

If the compounds claimed in IN276026 (3951/DELNP/2009) and IN 232653 (2241/CHENP/2005) are compared then both Patents disclose substituted,,

pyrimidine compounds.,,

The structure I is a structure claimed in claim-1 of impugned Patent IN276026 (3951/DELNP/2009). This structure I is the representative of the,,

compounds claimed in IN276026 (3951/DELNP/2009). The structure II is the representative of the compounds claimed in IN232653,,

(2241/CHENP/2005). The structure I and II are structurally same only the presentation on paper is different. The tri substituted phenyl moiety,,

attached to-NH is horizontally placed in structure II whereas it is vertically placed in structure I.,,

In Structure I R4 is Hydrogen and n is 0 or 1 which means R4 is hydrogen when n=0 While in structure II R0 R1 and R2 are also hydrogen. In,,

Structure I R3 is (CR2)0-2SO2R12 means it includes only SO2 R12 when (CR2) is 0 while R12 is C1-C6 alkyl. Whereas in structure II R3 also,,

discloses C1-C8 alkyl (includes C1-C6 alkyl), sulphonyl which is equivalent to SO2 R12",,

In Structure I linking nitrogen (N) between the rings is attached with hydrogen (H) while in Structure II nitrogen is attached to R4 wherein R4 is,,

disclosed as hydrogen.,,

In Structure I R1 & R2 is equivalent to R5 and R6 of structure II.,,

In Structure I R1 is halo or C1-6 alkyl; R2 is H; in Structure II each of R5 and R6 is independently hydrogen, C1-C8 alkyl (which includes C1-C6",,

alkyl) or halogen.,,

In Structure I, tri substituted phenyl moiety is substituted by R6, R9 and R8 which is equivalent to R10, R7 and R8 respectively of structure II.",,

In Structure I R6 is isopropoxy or methoxy; in Structure II R10 is C1-C8 alkoxy (which includes isopropoxy or methoxy),,

In Structure I R9 is Cl-6 alkyl, cyano, CONR(R12); R12 is H or C1-6 alkyl.",,

In Structure II R7 is C1-C8 alkyl or cyano. For e.g. R9 in Structure I and R7 in Structure II are methyl group. In Structure I R8 is (CR2)qY wherein,,

q=0 which means R8 is Y and is directly attached to C atom of the ring; Y is pyrrolidinyl, piperidinyl or azetidinyl, each of which is attached to the",,

phenyl ring via a carbon atom.,,

In Structure II R8 is unsubstituted or substituted 5 or 6 membered heterocyclyl comprising 1, 2, or 3 hetero atoms selected from N, O and S (which",,

includes pyrrolidinyl, piperidinyl or azetidinyl). Thus, these hetrocycles are also attached to ring through C atom.",,

In Structure II if R9 is hydrogen and A is equal to carbon then Structure II is equivalent to structure I with respect to the position 3 in phenyl ring (in,,

between R6 and R8 of structure I).,,

Therefore, Structure I is narrower Markush structure of Structure II [Emphasis added].",,

IN240560 (553/CHENP/2006),,

The substitutents R1' R2' R3' R'6 as defined in IN240560 when substituted in Markush structure given in claim 1 of IN240560 results in the structure,,

given in claim 4 of IN276026 (impugned Patent) as shown below:-,,

.,,

Therefore, conclusively it can be said that impugned Patent IN276026 (3951/DELNP/2009) lacks novelty with respect to IN232653",,

(2241/CHENP/2005) and IN240560 (553/CHENP/2006).,,

Since IN232653 (2241/CHENP/2005) and IN240560 (553/CHENP/2006) was published by WIPO on 23/09/2004 and 24/02/2005 respectively. The,,

priority date of the impugned Patent IN276026 (3951/DELNP/2009) was 08/12/2006; therefore, it lacked novelty on the date of filing of first",,

convention application filed in USA i.e. 08 Dec 2006.,,

ii) Lack of Inventive Step,,

The novelty aspect of the impugned Patent IN276026 (3951/DELNP/2009) with respect to IN232653(2241/CHENP/2005) and IN240560,,

(553/CHENP/2006) has been discussed in detail earlier, therefore, for the sake of brevity I am of the opinion that the impugned Patent IN276026",,

lacks inventive step also. Similarly impugned Patent IN276026 (3951/DELNP/2009) lacks inventive step with respect to WO2001/64654 also.,,

Considering above reasons subject matter of granted claims does not constitute an invention under section 2(1) (j) of the Patents Act 1970, therefore, I",,

allow ground raised by the opponent under Section 25(2)(b) of the Patents Act 1970.,,

iii) Section 25(2)(f): Subject of claims are not an invention within the meaning of this Act or is not patentable under this Act,,

Section 3(d) in The Patents Act, 1970 states that (d) the mere discovery of a new form of a known substance which does not result in the",,

enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere,,

use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Explanation.",,

-For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes,",,

combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with",,

regard to efficacy;,,

Since the compounds lack novelty and inventiveness, therefore, the subject matter of claims is not patentable under Section 3(d) of The Patent Act,",,

1970. The Patentee has not provided any in vivo efficacy data in comparison to compounds disclosed in IN232653 (2241/CHENP/2005) and,,

IN240560 (553/CHENP/2006). Interestingly, it has been noted that the applicant of the impugned Patent and both the prior art documents is same i.e.",,

Novartis AG. Considering above reasons, I allow ground under Section 25(2)(f) of the Patents Act 1970 raised by the opponent.",,

.,,

As decided in the preceding grounds of opposition, granted claims are already in public domain before priority date of the granted claims. Therefore",,

these claims are not new and have no inventive step.,,

Considering above reasons subject matter of granted claims does not constitute an invention under section 2(1) (j) of the Patents Act 1970.,,

The Opponent has succeeded in the grounds under sections 25(2) (b), 25(2) (e) and 25(2) (f) of the Patents Act, 1970. I do not agree with the",,

recommendations of the opposition Board. Having considered all the relevant documents and pleadings of both the parties, and in view of my findings",,

above, as per Section 25(4) of the Patents Act 1970. I hereby revoke the Patent numbered 276026 granted on the Patent Application No.",,

3951/DELNP/2009.""",,

In paragraph 5 ante, we have already put the contentions of both the parties for and against the decision of the Controller.",,

Coverage and Disclosure:,,

19.1 Learned counsels of both the parties relied on Novartis Novartis Ag v. Union of India (2013) 6 SCC 1 Judgment of Hon'ble Supreme Court of,,

India on this issue. Mr. Parag P Tripathi, learned counsel of the opponent argued that SC rejected the difference between ""Coverage and Disclosure""",,

while Mr. Hemant Singh, learned counsel of the appellant argued that there should not be vast difference between these two. Mr. Singh further",,

submitted that these concepts are applied for the same patent not for two separate patents.,,

19.2 We would like to refer to two paragraphs of the same Judgment of Hon'ble Supreme court Supra 11 on this issue to clarify the whole issue:,,

The submissions of Mr. Andhyarujina and Mr. Subramanium are based on making a distinction between the coverage or claim in a patent and",,

the disclosure made therein. The submissions on behalf of the appellant can be summed up by saying that the boundary laid out by the claim for,,

coverage is permissible to be much wider than the disclosure/enablement/teaching in a pa tent. [Emphasis Added] 139. The dichotomy that is sought,,

to be drawn between coverage or claim on the one hand and disclosure or enablement or teaching in a patent on the other hand, seems to strike at the",,

very root of the rationale of the law of patent. Under the scheme of patent, a monopoly is granted to a private individual in exchange of the invention",,

being made public so that, at the end of the patent term, the invention may belong to the people at large who may be benefited by it. To say that the",,

coverage in a patent might go much beyond the disclosure thus seem to negate the fundamental rule underlying the grant of patents."" [Emphasis",,

Added],,

19.3 It is evident from paragraph 138 that Hon'ble Court summaries as ""The submissions of Mr. Andhyarujina and Mr. Subramanium are based on",,

making a distinction between the coverage or claim in a patent and the disclosure made therein. The discussion herein is, therefore, for the coverage",,

or claim and disclosure made therein of the same patent.,,

In very next paragraph 139 Hon'ble Court holds the very principle of patent law when it says ""the coverage in a patent might go much beyond the",,

disclosure thus seems to negate the fundamental rule underlying the grant of patents.""",,

19.4 Therefore the judgment is not in favour of the coverage of a claim going much beyond the disclosure in a patent.,,

Now lets us view the provisions of the Patents Act, 1970 in this regard.",,

19.5 The relevant portions of Sub-sections 4 and 5 of Section 10 Available at http://ipindia.nic.in/writereaddata/Portal/ev/sections/ps10.html of the,,

Patents Act, 1970 is quoted herein below:",,

(4) Every complete specification shall--,,

(a) fully and particularly describe the invention and its operation or use and the method by which it is to be performed;,,

(b) disclose the best method of performing the invention which is known to the applicant and for which he is entitled to claim protection; and,,

(c) end with a claim or claims defining the scope of the invention for which protection is claimed; ..,,

(5) The claim or claims of a complete specification shall relate to a single invention, or to a group of inventions linked so as to form a single inventive",,

concept, shall be clear and succinct and shall be fairly based on the matter disclosed in the specification.",,

[Emphasis Added],,

19.6 The provisions of the law is very clear that for any patent to be held patentable, the requirement is that the Complete Specification shall ""fully and",,

particularly describe the invention, its operation or use and the method of its performance and also disclose the best method of its performance which",,

is known to the applicant and for which he is entitled to claim the protection. The Complete Specification shall end with the claim/claims defining the,,

scope of the invention. Further sub-section 5 further clarifies the issue which says that the claim/claims shall be clear and succinct and shall be fairly,,

based on the matter disclosed in the specification.,,

19.7 Now, a close look on the provisions of the patents law and the opinion of Hon'ble Supreme Court i.e. the claim/claims shall be clear and succinct",,

and ""shall be fairly based on the matter disclosed in the specification"" and ""the coverage of a claim going much beyond the disclosure in a patent",,

negate the fundamental rule underlying the grant of patents."" are just complementing each other. It is cardinal principals of the Patents law which the",,

Hon'ble Supreme Court emphasized in their Judgments.,,

19.8 Therefore, the whole argument of coverage or claim in a patent and the disclosure made therein is relating to the patentability test of any given",,

patent. The Controller ensures before grant of any patent that these requirement of sufficiency of disclosure and that whether the claims are fairly,,

based on the disclosure in the specification is met or not. If the Controller finds that either of these requirements is not fulfilled, the patents are not held",,

patentable. Therefore, in a particular case, if some matter was covered but not disclosed as alleged by the counsel of the opponents, then that",,

particular patent should be in question and not a subsequent patent which describes and claims a specific subject matter.,,

19.9 Further, if the contention of either party is that the subject matter was covered in prior arts but not disclosed, it appears out of context as if it was",,

claimed or covered it must have been disclosed as well. 19.10 Therefore, if IN'653 and IN'560 both were granted by the Indian Patent Office. The",,

natural presumption is that the claims or coverage in each one of them were based on the subject matter disclosed in the Complete Specifications of,,

each of these patents individually. Now, whether these disclosures were fully and particularly describing the invention claimed therein, whether these",,

patents described the method by which the inventions would be performed and whether the best method was disclosed or not, all these questions ought",,

to have been answered by the patentee of both these patents while their prosecution. Therefore, ""coverage and disclosure"" of any cited prior art",,

cannot be held to have vast difference between the two as it is against the law.,,

We will now look at the provisions of the tests applied for judging the novelty (anticipation).,,

20.1 The novelty should be judged on the available facts in the prior art and not on imaginary attributions therein.,,

20.2 Test of Novelty (anticipation),,

20.3 The test of novelty as provided in the Manual Of Patent Office Practice and Procedures Available at,,

http://www.ipindia.nic.in/writereaddata/Portal/Images/pdf/Manual_for_Patent_Office_Practice_and_Procedure_.pdf at its para 09.03.02 is as,,

follows:,,

An invention is considered as new (novel), if it is not anticipated by prior publication in patent and non-patent literature, i.e., an invention is novel if it",,

has not been disclosed in the prior art, where the prior art means everything that has been published, presented or otherwise disclosed to the public",,

before the date of filing/priority date of complete specification.,,

An invention is considered as novel, if it has not been anticipated by prior use or prior public knowledge in India.",,

For the purpose of determining novelty, an application for patent filed at the Indian Patent Office before the date of filing of complete specification",,

of a later filed application, but published after the same, is considered for the purposes of prior claiming.",,

While ascertaining novelty, the Examiner takes into consideration, inter alia, the following documents:-",,

-which have been published before the date of filing of the application in any of the specifications filed in pursuance of application for patent in India,,

on or after 1st January, 1912.",,

-such Indian Patent Applications which have been filed before the date of filing of complete specification and published on or after the date of filing of,,

the complete specification, but claims the same subject matter.",,

The examiner shall make such investigation for purpose of ascertaining whether the invention, so far as claimed in any claim of the complete",,

specification, has been anticipated by publication in India or elsewhere in any document other than those mentioned in section 13(1) before date of",,

filing of the applicant's complete specification.,,

A prior art is considered as anticipating novelty if all the features of the invention under examination are present in the cited prior art document.,,

The prior art should disclose the invention either in explicit or implicit manner. Mosaicing of prior art documents is not allowed in determination of,,

novelty.,,

A generic disclosure in the prior art may not necessarily takeaway the novelty of a specific disclosure. For instance, a metal spring may not take",,

away the novelty of a copper spring.,,

A specific disclosure in the prior art takes away the novelty of a generic disclosure. For instance, a copper spring takes away the novelty of a metal",,

spring.,,

In a case where a prior art is cited as an anticipation in the Examination Report, the onus of proving that the same is not to be an anticipation by",,

reason of Section 29-34, lies on the applicant.",,

20.4 It is settled practice that in order to demonstrate lack of novelty, the anticipatory disclosure must be entirely contained within a single",,

document Ammonia's Application, 49 RPC 409.. If more than one document is cited, each must stand on its own. The cumulative effect of the",,

disclosures cannot be taken into consideration nor can the lack of novelty be established by forming a mosaic of elements taken from several,,

documents. This may be done only when arguing obviousness.,,

20.5 However, if a cited document refers to a disclosure in another document in such a way as to indicate that, that disclosure is intended to be",,

included in that of the cited document, then the two are read together as though they were a single document.",,

20.6 The invention is taken as lacking in novelty if information about anything falling within its scope has already been disclosed. A generic disclosure,,

does not impugn the novelty of a more specific claim, so that an earlier reference to a metal coil spring cannot be used to attack the novelty of a claim",,

specifying such a spring made of copper.,,

20.7 In case of Selection Patents a prior disclosure in general terms, embracing a number of alternatives may amount to no more than a mere",,

suggestion that any of the members, including any specifically exemplified, might be used and may, therefore, is regarded as not anticipating a claim to",,

a specific one of the members. An invention so claimed is generally referred to as a ""selection"" invention and is required to meet the following",,

criteria IG Farbenindustrie AG's Patent, 47 RPC 289 P. 322:",,

(a) the selection is based on some substantial advantage gained or some substantial disadvantage avoided,",,

(b) substantially all the selected members necessarily possess the advantage in question, and",,

(c) the selection is in respect of a quality of special character which can fairly be peculiar to the selected group. However, this is not necessarily",,

nullified if it transpires that some other members of the class from which the selection is made have this quality, but the claim may be invalid if it is",,

found that the quality is common to many other members in addition to those selected.,,

The Affidavits of the Experts:,,

21.1 There are three affidavits filed by the experts in this case. The one filed by Dr. Ramesh Dandala and Dr. Hans Josef Altenbach deals with,,

technical aspects of the subject patent IN'026 with the prior arts, while that submitted by Mr. Irving Fishman deals more specifically with the aspects",,

of Patent Term Extension (PTE) in US.,,

21.2 Dr. Dandala also reveals the filing of PTE in respect of US patent '592 corresponding to IN'653. He compares IN'026 with IN'514 and says in,,

paragraph 8 of his affidavit that ""subject matter of claim of impugned patent has been prior claimed by IN239514"". This is factually incorrect",,

statement as the publication under Section 11A of the Patents Act, 1970 in respect of the patent application number 1139/KOLNP/2004 (IN239514)",,

was done much earlier to that of IN'026 on 12/05/2006. At the most, if he was pointing out lack of novelty of the IN'026 with respect to IN'514, he",,

should have raised the ground of ""prior publication"" and not ""prior claiming"".",,

21.3 Dr. Dandala has considered IN232653, IN240560, US8188276 (Rigel Patent), IN239514, US7153964 (Astrazenca Patent), Report of Conference",,

dated November, 2006 (Conference: ASH Annual Meeting 2006) and holds that these patents anticipate and disclose the claimed compound including",,

Ceritinib. He further holds in paragraph 4 of his affidavit that before the priority date, it was known in the art that pyrimidine derivatives are used for",,

treatment of a disease associated with tyrosine kinase activity of Anaplastic Lymphoma Kinase (ALK). He holds IN'653 and IN'560 have been,,

asserted by the opponent as documents that disclose such compounds (as those claimed in the impugned patent). It appears that he is depending on,,

the assertion of the opponent instead of giving his own opinion.,,

21.4 Further, he again commits a factual error in paragraph 6 of his affidavit wherein he says that ""I also note the contention of the patentee that the",,

patents IN232653 and IN276026 do not claim or cover Ceritinib"". While the patentee has always emphasized that his patent IN IN276026 does claim",,

and cover Ceritinib. In our opinion, it may be a result of typographical error on the part of the Dr. Dandala, wherein he may have thought about",,

IN240560.,,

21.5 In paragraph 11 of his affidavit, he says that IN'560 and IN'653 cover and disclose Ceritinib in the Markush claims. He further declares that",,

Novartis has filed a petition for Patent Term Extension (PTE) wherein they have admitted that Ceritinib is disclosed by these patents. In paragraph 6,,

of his affidavits he states that ""US Patent No. 7964592 (IN'653) assigned to Novartis claims the approved product, a method of manufacturing the",,

approved products, and a method of using the approved product. Claims 1-4, 7-10, 14 and 15 read on the approved product. Claim 13 reads on a",,

method of manufacturing the approved product. Claim 16 reads on a method of using the approved product"".",,

[Emphasis Added],,

21.6 Dr. Hans Josef Altenbach has revealed in his affidavit that he has reviewed:,,

a) Indian Patent No. 276026;,,

b) The AstraZeneca Patent; U.S. Patent No. 7,153,964 (""AstraZeneca Patent"");",,

c) The Rigel Patents;,,

d) The '592 Patent; and,,

e) The '074 Patent.,,

He holds that ""Although, Ceritinib is among the millions of compounds encompassed by this broad genus in the AstraZeneca Patent, many specific",,

substitutions must be selected to arrive at the Ceritinib species"". He adds in point 9 of his affidavit that ""None of the 31 exemplary species disclosed in",,

the specification of the AstraZeneca Patent is Ceritinib"".",,

21.7 Dr. Hans Josef Altenbach further states in paragraph 11 of his affidavit that ""The specifications of the Rigel Patents do not specifically identify",,

the sub-genus encompassing Ceritinib or distinguish it in any way from the multitude of other potential genera"". In paragraph 13, he further adds that",,

Rigel Patents do not disclose the structure of Formula II or Ceritinib in any manner. With regard to US'592 he adds that there are over five hundred,,

exemplary compounds disclosed in the specification of the US'592 Patent. None of these disclosed Ceritinib and the disclosure of the '592 Patent does,,

not point to certain general chemical features of Cerinitib, let alone specific chemical features of Ceritinib and holds that specifically none of the",,

compound disclosed in '592 patent comprise a tri-substituted phenyl ring at the N2 position having one of the disclosed heterocyclic groups lined at a,,

carbon atom.,,

21.8 With regard to US'074 (IN'560) he declares that this genus encompasses compounds having similar substituents to those encompassed by the,,

genus of US'592 (IN'653) patent. Thus, the genus disclosed in the US'074 (IN'560) Patent encompasses the Ceritinib species as one of the vast",,

number of possible compounds, and encompasses Formula 2 as one of many possible sub-genera. However, the US'074 (IN'560) Patent does not",,

describe Ceritinib or Formula 2 from among the multitude of compounds or sub-genera encompassed by the genus of the US'074 (IN'560). He further,,

declares that the US'074 (IN'560) also discloses over 450 additional chemical species beyond those described in the US'592 (IN'653), none of which",,

are Ceritinib. He went on to say that he had reviewed the disclosure and claims of IN276026, the AstraZeneca Patent, each of the Rigel Patents, the",,

US'592 Patent, and the US'074 Patent. Neither the AstraZeneca Patent, any of the Rigel Patents, the US'592 Patent, nor the US'074 Patent discloses",,

or describes the chemical name or structure of Ceritinib or Formula 2 of IN276026.,,

21.9 Mr. Irving Fishman declares the mandate of his affidavit that he was asked to comment on whether under U.S. law, patents that disclose and",,

claim chemical genera that encompass Ceritinib without specifically disclosing the molecule Ceritinib itself can (1) be listed in the Orange Book and,,

(2) be the subject of applications for Patent Term Extensions (PTE). He answers both these questions in affirmative. Further, he was asked as",,

whether under U.S. Law (1) the listing in the Orange Book of a patent for an approved drug product or (2) the application for a PTE for a patent, is",,

an admission that the subject patent mentioned in the Orange Book listing or PTE application discloses the particular molecule contained in the drug,,

product. He answers both these questions in negative.,,

21.10 In paragraph 9 of his affidavit, he explains that in U.S., a first patent that discloses a genus of significant size may be supported by a few",,

specific examples that are related to one or more species within the scope of the genus and not have any specific disclosure with respect to other,,

embodiments that are within the scope of the genus. A subsequent patent claiming a narrower range or ""sub-genus"" of embodiments that are not",,

specifically disclosed in the first patent may perfectly well co-exists and be valid as to such narrower sub-genus.,,

21.11 Mr. Irving Fishman in paragraph 17 of his affidavit notes ""that Dr. Altenbach has analyzed the AstraZeneca Patent, the Rigel Patents and the",,

US'592 Patent, and the US'074 Patent and has concluded that each of these patents contains genus claims that encompass or ""read on"" Ceritinib,",,

although none of these patents describes the compound Ceritinib itself"". He further observes that ""each of the aforementioned patents was properly",,

listed in the Orange Book for Ceritinib even though none of them specifically described the compound Ceritinib itself. Therefore, the listing of the",,

AstraZeneca Patent, the Rigel Patents, the '592 Patent, and the '074 Patent in the Orange Book was in no way an admission that any of these patents",,

disclosed the molecule Ceritinib itself.,,

21.12 Mr. Irving Fishman in paragraph 20 of his affidavit notes that Novartis also filed a PTE application under 35 U.S.C. § 156 for US Patent,,

8,377,921 corresponding to impugned patent IN276026, which is also listed in the Orange Book for Ceritinib.",,

21.13 Mr. Irving Fishman holds that Dr. Dandala nearly supports the well known principle of U.S. Patent Law that the disclosure of a genus does not,,

render unpatentable a later-discovered species within that genus that was neither specifically described nor specifically taught by the prior art.,,

21.14 Mr. Irving Fishman quotes two judgments of Federal Circuit In re Jones, 958 F.2d 347 (Fed. Cir. 1992) holding patentable a claim to specific",,

molecule falling within scope of a prior art genus; and In re Baird, 16 F. 3d 380 (Fed. Cir. 1994) holding patentable a claim to specific molecule falling",,

within scope of a prior art genus.,,

21.15 In paragraph 19, he states that eligibility for a PTE is based on whether the claims of the patent ""read on"" or ""encompasses"" the ""approved",,

product"", not whether the patent discloses or describes the specific compound. This fact was narrated by Dr. Dandala as well.",,

[Emphasis added],,

21.16 We have considered all the three affidavits in details and come to conclusion that subject matter of the cited prior arts, especially IN'653 and",,

IN'560 may have general disclosures of genus but none of these cited prior arts either describes or claims the compound of Ceritinib (Formula 2) as,,

described and claimed in the Patent IN '026. Further, the requirement of PTE is only ""reading on"" or ""encompassing"" the FDA ""approved product"".",,

Enlisting in orange book for the purpose of PTE does not require specific disclosure. It is also evident from these affidavits that if all the patents i.e.,,

AstraZeneca Patent, the Rigel Patents, the US'592 Patent, the US'074 patent and lastly the US Patent 8,377,921 which is corresponding to impugned",,

patent IN276026 are all listed in orange book, does it mean that none of them had novelty barring the first one? The answer is No. The requirement of",,

listing in orange book and patent term extension (PTE) is governed by a separate legislation called ""Drug Price Competition and Patent Term",,

Restoration Act of 1984 Available at https://www.uspto.gov/web/offices/pac/mpep/s2750.html,"" also known as the Hatch-Waxman Amendments in",,

USA.,,

21.17 Manual of Patent Examining Procedure (USPTO) provides under 37 CFR 1.785 Multiple applications for extension of term of the same patent,,

or of different patents for the same regulatory review period for a product ibid that ""If more than one application for extension is filed by a single",,

applicant for the extension of the terms of different patents based upon the same regulatory review period for a product, the certificate of extension",,

will be issued on the application for extension of the patent having the earliest date of issuance of those for which extension is sought unless one,,

patent for which extension has been sought is expressly elected and all others are voluntarily withdrawn by the applicant.""",,

21.18 If more than one patent are applied for PTE, which is the case here, the Patent term of only one patent will be extended. It is also evident that if",,

the law provides for application for PTE in respect of multiple patents for the same approval, all the patents must have been found novel before grant",,

and valid till such application.,,

21.19 Further, the determination of novelty and inventive step is carried out worldwide under the Patents Act of that particular jurisdiction. Therefore,",,

mixing up these two concepts i.e. requirements of PTE and the requirements of novelty/inventive step determination, will not take us any where as",,

both the concepts cover two different domains.,,

21.20 In India, we do not have any corresponding law. We do not extend the term of patent. The term of patents once granted is for 20 years from",,

the date of filing of the patent application.,,

21.21 In view the previous discussions, we are of the view that patent term extension documents, cannot be relied upon for the determination of",,

novelty of a subsequent patent.,,

Allegation of fraud,,

22.1 On this issue, the learned counsel of the opponents have submitted that at the first available opportunity the Respondent No. 3 filed an affidavit",,

stating that the five compounds out of a total of 36 compounds were shown erroneously as being from WO '980 and that the same was a bona fide,,

mistake which went unnoticed at the time of drafting of the rejoinder.,,

22.2 This issue was brought to the notice of this tribunal during previous hearing wherein the counsel of the appellant argued that such mistakes by the,,

professional attorneys are rare. Further, they argued that if it was genuine mistake the numbers should not have been selectively chosen.",,

22.3 However, keeping in view the affidavit of the opponents, we just caution them to be more vigilant in future.",,

Conclusion:,,

23.1 We have thoroughly considered the facts on records, the submissions of both the parties, the evidence adduced by all the three experts, reviewed",,

all the relevant case laws presented by the parties and reached the following conclusions:,,

23.2 The post-grant opposition was not maintainable ab initio for lack of filing proper prescribed fee. The Controller should not have acted upon the,,

post-grant opposition as the proper fee of ` 12000 was not paid by the opponent being a legal entity within the prescribed time period of filing the,,

opposition. The fee remitted to patent office was only ` 2400- a fee applicable to natural person as evident by Form 30 filed on 08/11/2017. How come,,

an opponent having stature of legal entity, pay a fee applicable to natural person? The balance fee was remitted on 08/11/2017 after the statutory time",,

period expired on 30/09/2017. Therefore, the post-grant opposition itself was not maintainable and the office of the Learned Controller is expected to",,

exercise due diligence in future. On this ground, we hold that the order passed by Controller on 16/08/2019, being an order on non-existent post-grant",,

opposition, does not have merit to stand.",,

23.3 Secondly, we have thoroughly studied the complete specifications of both the cited patents in'653 and IN'560 and come to conclusion that there is",,

no clear and unambiguous disclosure of all of the essential elements of the invention described and claimed in IN'026, in these prior arts by which the",,

novelty of the instant patent will be destroyed. None of the prior art document describe or exemplify the structure and the compound as claimed and,,

described in the subject patent IN '026. But for the ""hindsight analysis"", it was not possible to arrive near to the structure of the instant patent. The",,

hindsight analysis"" is not allowable under ""inventive step"" determination let alone ""novelty"" consideration.",,

23.4 Further, the Learned Controller took help of two cited prior arts to attack ""novelty' of the subject patent by picking suitable equivalent",,

substitutions, keeping inventive structure of the subject patent IN'026 in sight. As discussed in para 20.3 and 20.4 above, it is settled practice that in",,

order to demonstrate lack of novelty, the anticipatory disclosure must be entirely contained within a single document. If more than one document is",,

cited, each must stand on its own. This is not the case here, as the Controller is comparing some claims from first prior art IN'653 and one claim with",,

IN'560. The Formula 2 of IN'026 is never exemplified either in the description or claims of both these prior arts IN'653 or IN'560. All compounds,,

exemplified in IN'653 or IN'560 wherein piperidinyl or pyrrolidinyl is linked to phenyl ring either through the hetero atom which is Nitrogen atom or,,

through oxygen linker. These prior arts do not disclose to link pyrrolidinyl, piperidinyl or azetidinyl with the phenyl ring with a C-C atom. Therefore, the",,

cumulative effect of unclear and ambiguous prior arts disclosures cannot be taken into consideration for destruction of ""novelty"".",,

23.5 Further, as per General Tire & Rubber Co General Tire & Rubber Co. v. Firestone Tyre & Rubber Co. Ltd. [1972] RPC 457 (at page 486) ""To",,

anticipate the patentee's claim, the prior publication must contain clear and unmistakable directions to do what the patentee claims to have invented ...",,

A signpost, however clear, upon the road to the patentee's invention will not suffice. The prior inventor must be clearly shown to have planted his flag",,

at the precise destination before the patentee."" Again the cited prior arts do not describe and exemplify the structure and the product of the subject",,

patent IN'026 and hence cannot be held as ""anticipating"" the subject patent IN'026.",,

23.6 The Learned Controller ought to have considered the view of the members of the opposition board who were of the opinion that ""the present",,

opposition may be dismissed and the current patent may be allowed to stand."" As both the sub-groups involved in ""novelty"" search of the invention i.e.",,

examination and grant"" and the ""opposition board"" have considered the invention to be ""novel"" based on the same cited prior arts (IN'653 and IN'560)",,

and no additional prior art was relied upon by the Learned Controller during post - grant opposition other than these two, the views of members of",,

opposition board appears very crucial. If at all the Learned Controller was to defer from the opinion of the opposition Board, the point of disagreement",,

should have been annotated in the order, which is not present in the order of the Learned Controller dated 16/08/2019.",,

23.7 It is evident that the other grounds such as ""lack of inventive step', objection under section 3(d) and that related to ""insufficiency of disclosures""",,

were also decided without proper reasoning.,,

We, therefore, order that the impugned order of the Controller dated 16/08/2019 is void of merit and is being set aside forthwith.",,

A copy of this order be served to Respondent No. 1 to take immediate step to affect necessary changes in the records and the e-register.,,

The appeal is allowed. All the related applications/petitions are also disposed of herewith. No cost.,,