Asthristis Relied Plus Ltd. vs Controller Of Patents And Designs

,,,

The present appeal is filed under Section 117A of the Indian Patents Act, 1970, against the order dated 11/12/2015, passed by the Respondent,",,,

being the then Assistant Controller of Patents & Designs, under Section 15 of the Indian Patents Act, refusing to grant the Appellant’s Indian",,,

patent application no. 1904/KOLNP/2009.,,,

It is the case of the appellant that the impugned Order is bad in law inasmuch as the impugned Order:,,,

2.1 is based upon prior art documents which were cited for the first time in the notice of hearing dated 15 September 2015, thereby depriving the",,,

Appellant any opportunity to the Respondent to differentiate the said citations with the present invention;,,,

2.2 has been passed without application of mind, simply on the basis of a mosaic of prior art documents cited in various jurisdictions and does not",,,

provide any reasoning as to how the cited documents are relevant for determining the inventive step of the present invention;,,,

2.3 fails to consider that the cited document D5 was published in the year 2009 i.e., D5 was published after the priority date (15 November 2007) of",,,

the present invention and thus, cannot be considered for examining the inventive step of thepresent invention in view of Section 13(1)(a) of the Act;",,,

2.4 is an unreasoned order and does not take into consideration even a single submission of the Appellant filed on 14 October 2015 differentiating the,,,

cited art or explaining how the present invention is outside the ambit of Section 3 of the Act;,,,

2.5 fails to appreciate that every single prior art except D5 was found to be irrelevant for the purposes of novelty and inventive step in all other,,,

jurisdictions;,,,

2.6 errs in the interpretation and application of Section 3(e) and Section 3(j) of the Act and completely disregards scientific data substantiating efficacy,,,

/ synergy of the present invention, in refusing the subject application;",,,

2.7 the unreasoned nature of the impugned Order and the prosecution history of the subject application reveal that every time the Appellant filed,,,

submissions to overcome the objections raised by the Respondent, a new objection was raised and a new document was cited. It appears that the",,,

Respondent had, from the very beginning, made up its mind to refuse the subject application; and,",,,

2.8 fails to appreciate that an invention may be simple but as long as the invention is novel, inventive, industrially applicable and patentable, protection",,,

ought to be granted in accordance with the spirit of the Act.,,,

The learned counsel for the appellant has brought to our notice that:,,,

3.1 Cited documents D6 and D12 to D19 in the FER were identical to and quoted verbatim from the Written Opinion of ISA;,,,

3.2 Cited documents D1 to D5 in the FER were identical to and quoted verbatim from the search report dated 30 August 2012 in the corresponding,,,

US Application No. 12/515,254;",,,

3.3 Cited documents D7 to D11 in the FER were cited from the search report dated 13 April 2010 on the corresponding EP application.,,,

3.4 Thus, it is evident that the Respondent had merely mosaiced citations from different jurisdictions / corresponding applications and cited them in the",,,

present application. Yet, the Respondent conveniently ignored that fact that despite the citations above, the corresponding foreign applications were",,,

held to be novel, inventive and patentable in various jurisdictions as well.",,,

3.5 The FER also raised objections of disunity of invention and non-patentability of the present invention under Section 3(c), Section (e), Section 3(i)",,,

and Section 3(j).,,,

3.6 The lackadaisical manner in which the present application was examined is evident from the fact that while citing Section 3(c) and Section 3(j), the",,,

Respondent thought it fit to simply state that ‘the formulation of the alleged invention incudes extract and parts of many plants, thus it attracts the",,,

provisions of 3(c) and 3(j) of the Act’, without giving any reasoning thereto.",,,

3.7 A Notice of Hearing was issued wherein the Respondent:,,,

3.7.1 maintained the objections in respect of cited documents D7 to D13 of the FER;,,,

3.7.2 maintained the objection on disunity of invention;,,,

3.7.3 cited eight (08) documents (D1, D8 to D14 of the hearing notice) for the first time.",,,

3.8 Surprisingly, the Respondent issued another communication on 16 September 2015 (page 157 of appeal brief) citing Section 3(p) for the first time,",,,

basing reliance on two (02) TKDL citations.,,,

3.9 Further, the hearing notice dated 15 September 2015 did not cite the objections of Section 3(c), Section (e), Section 3(i) and Section 3(j). Thus,",,,

these objections were deemed to have been met.,,,

3.10 Pursuant to a request for adjournment, the Respondent issued a second hearing notice.",,,

3.11 To the Appellant’s surprise, the hearing notice dated 30 September 2015 reintroduced the objections of Section 3(c) and Section (e).",,,

The invention as explained by the learned counsel of the appellant is as under:,,,

4.1 The present invention provides a topical formulation of herbal extracts for prophylactic management and / or treatment of arthritis;,,,

4.2 More specifically, the present invention provides a topical formulation of the compounds obtained from the plant ‘Comfrey’ i.e., comfrey or",,,

comfrey-derived compound such as allantoin, and tannic acid, and may optionally comprise a penetration enhancer (to promote absorption of drug",,,

through the skin);,,,

We have noted that first hearing notice was issued on 15/09/2015 and pursuant to an adjournment request by the appellant, a second hearing notice",,,

was issued on 30/09/2015 and the hearing was held on 12/10/2015. We also noticed that hearing notice included fresh citations, hence adequate time",,,

should have been given to the appellant to prepare their counter arguments properly.,,,

The learned counsel of the appellant has argued that no proper opportunity was given to them to address the newly cited documents in hearing,,,

notice by the Respondent.,,,

They have drawn our attention to a previous order of this Board as follows:,,,

7.1 Reliance is also placed on the order of the Hon’ble IPAB in Tibotec Pharmaceuticals Ltd. vs. The Controller of Patents and Designs â€",,,

Order No. 82 of 2015 in OA/24/2011/PT/DEL [being filed herewith as Annexure F] which held:,,,

“…9. The reading of the impugned order passed by the Assistant Controller of Patents & Designs reveals that the Controller relied on the,,,

objection raised for lack of inventive step and the insufficiency of disclosure during examination by citing prior arts namely US 6248775 and CA,,,

2472133. But the fact remains on the basis of the perusal of the FER dated 11.06.2008 there is not a whisper made about the above said so called,,,

prior arts.,,,

It is pertinent to note at this stage in respect of US 6248775 there is no mention about the said prior art even in the hearing notice or the same was,,,

revealed on the date of exact hearing and the same is mentioned for the first time only in the impugned order.,,,

It is seen that in the hearing notice, the prior art cited was entirely different as the same reveals that they have sought to rely the prior art",,,

mentioned is US 6428775 which is nothing to do with the present patent of the appellant and the same is related to “Makeup remover,,,

compositionâ€. The yet another infirmity found on the face of the impugned order is that the other two prior arts CA 2472133 and WO 99/67417 have,,,

been mentioned only in the hearing notice and no adequate and reasonable opportunity was given to the appellant to give their reply or explanation.,,,

Therefore, it is crystal clear that the Assistant Controller has placed reliance on a wrong prior art and also over looked the fact of not furnishing the",,,

specific objections relating to the prior arts relied by the Controller for arriving at the conclusion to the effect of rejecting the application on the ground,,,

of lack of obviousness and inventive step. Therefore, we have no hesitation to hold that the impugned order was passed in flagrant violation of",,,

principles of natural justice and the entire impugned order is vitiated on that ground.…â€​,,,

7.2 The appellant further submitted that the Respondent, thus, passed the impugned Order in violation of the Principles of Natural Justice, in view of",,,

the well-settled judicial precedents, and the same ought to be set aside.",,,

Now, we look at the order of the Respondent. The operating portion of the order is quoted herein below:",,,

8.1 Upon consideration of the objection vis a vis the arguments placed by the agent of the applicant followed by written submission under the provision,,,

of section of the Patent Act, I shall turn my eyes one by one to the objection raised in hearing letter dtd.30/09/2015 and submission thereby.",,,

8.2 First of all I need to mention that the present application deals with a topical formulation including comfrey or comfrey derived compounds and,,,

tannic acid (as per proposed amended claims during hearing) which is used for the treatment of arthritis.,,,

8.3 Though there in definite mention of comfrey derived compounds whereas no individual specific compounds has been disclosed in the specification,,,

all along, but only comfrey extract has been mentioned. The term comfrey derived compounds as proposed in amended claims still lack clarity without",,,

having clear definition. This unclear term as used in the proposed claim also lead to more than one formulation and eventually failed to overcome,,,

objection 6 of the hearing letter. Another pertinent point is that composition is depended on parts of plant used which should be dependent on specific,,,

extraction process , but surprisingly the whole specification is silent regarding the same. The formulation includes the compounds as extracted from",,,

comfrey root extract , comfrey leaf extract or a combination thereof as mentioned in even in proposed claims attracts the provision of section 3(j) of",,,

the Act as objected vide hearing objection 5 of the hearing letter. There is a disclaimer that the biological material used in the present application are,,,

neither obtained from India not it is based on any research or information on such material obtained from India which addresses National Biodiversity,,,

issue and hence it was not objected in the hearing.,,,

8.4 With these remarks I am switching to the next issue of inventive step with regard to prior art D1 (and D6-D8) which disclose the use of a cream,,,

comprising comfrey root extract (Kytta) for the treatment of arthritis. D1 discloses that comfrey root extract contains tannins, and tannic acid",,,

derivatives and D2 discloses the use of tannic acid in the treatment of arthritis. Moreover D3 discloses a gel comprising arnica extract which contains,,,

tannic acid and D4 discloses the anti -pain and anti - inflammatory effect of tannic acid. So it can be concluded from prior art that comfrey and its,,,

comfrey derived compounds and tannic acid are widely known including its topical formulation. Hence I am in the opinion that with these teachings the,,,

skilled person may arrive to the final result by routine experimentation to the subject application. Further , I am in the opinion that the mere trial of",,,

already described method and compounds in prior art are considered as a matter of mere judicious selection and routine optimization of the same by,,,

the skilled person to arrive at the desired result.,,,

8.5 In this juncture I need to mention in the section 2(1)(j) of the Act which states that invention means a new product or process involving an,,,

inventive step and capable of industrial application and as per section 2(1) (ja) inventive step means a feature of an invention that involves technical,,,

advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in,,,

the art.,,,

8.6 In proposed amended claim there is a mention of eucalyptus oil but it is inferred that without unexpected effect and support of the same in the,,,

specification, it does not contribute the subject application to overcome the objection related to inventive step issue. Another constituent Wthania",,,

Somnifera is also useful in the treatment of osteoarthritis as evident from the search report of traditional knowledge.,,,

8.7 In the light of above definition of the Act it can be summarized that inventive step of the subject composition is not at all substantiated with regard,,,

to prior arts. It can be stated that the subject invention is unable to qualify for waiving the objection against inventive step ground over the cited,,,

documents.,,,

8.8 And also considering the section 3(e) of the Act which states that a substance obtained by mere admixture resulting only in the aggregation of the,,,

properties of the components thereof or a process for producing such substance.,,,

8.9 In the context of above mentioned section I am still in opinion that the subject of the application is an aggregation or duplication of known,,,

properties of prior art compounds having known components and known uses. Besides the application lacks to substantiate the synergism as provided,,,

CITED DOCUMENT,"INDIAN PATEN

APPLICATION NO.

1904/KOLNP/2009",,

D1

Discloses a topical formulation of

Kytta-Balsam, comprising an

extract of comfrey. D1 is

completely silent as to a

composition

comprising tannic acid in an

amount 2% or more of the","As opposed to the present invention,

there is nothing in D1 to suggest that

the composition disclosed therein

comprises tannic acid in an amount

2% or

more of the weight of the formulation.

Moreover, any trace",,

total    weight

of        t he

formulation.","amount of tannic acid that may be

present in a comfrey root or leaf

extract will be significantly lower than

the claimed amount of 2% or more.",,

D2

D2 discloses a method for

treating a disease associated

with hyperproliferation of

endothelial cells and/or

neovascularization    by

administering to a subject an

effective amount of tannins, or a

pharmaceutically acceptable salt,

metabolite, derivative or pro-

drug thereof. In fact, D2 teaches

that tannic acid has anti-

angiogenic activity and not anti-

inflammatory activity (page 17,

lines 9 to 16 and

claim 15).","D2, thus, teaches away from the

present invention. Neither is there any

disclosure nor any teaching in D2 for

a combination of comfrey and tannic

acid. Further, since D2 does not teach

anti-inflammatory activity of tannic

acid, there will be no motivation for a

person skilled in the art to arrive at the

present invention on the basis of D2

o r combine D 2 with any other

document.",,

D3

D3 discloses a gel for treatment

of arthritis comprising arnica

extract of about 10% by weight

and

Symphytum        Â

officinale (comfrey) extract of

about 10% (paragraph 40 of D3).

D3 does not disclose or teach

the specific amounts of tannic

acid in the arnica extract nor the

final concentration of tannic acid.","As opposed to the present invention,

there is nothing in D3 to suggest a

composition comprising comfrey and

tannic acid, wherein tannic acid is in

a n amount of 2% or more of the

weight of the formulation. Based on

the disclosure of D3, it would not be

evident to a person skilled in the art as

to how much tannic acid (if any) is

present in the arnica extract of D3. In

view thereof, there will be no

motivation for a person skilled in the

art to arrive at the present invention

on the basis of D3 or combine D3

with any other

document.",,

D4

D4 discloses an extraction

process of tannic acid from

Geranium wilfordii tuber root as

raw material using ethanol

(Abstract).","As opposed to the present invention,

D4 does not disclose a composition /

formulation of tannic acid in

combination with

comfrey extract.",,

D5

D5 is a post-published document and is, thus, irrelevant for

examining the inventive step of the present invention.",,,

D6 and D7

D6 and D7 teach use of comfrey

extract to treat unilateral ankle

pain. These documents do not

teach or suggest the use of

tannic acid

(in any concentration) alone","D6 and D7 do not disclose a

composition / formulation of tannic

acid in combination with comfrey

extract as in the present invention.",,

D8

D8 is a monograph of a

marketed       Â

formulation comprising comfrey root

extract that is prepared by ethanol

extraction. There is no disclosure or

teaching of tannic acid (in any

concentration) alone or in

combination with comfrey extract in

the said

monograph.","As opposed to the present invention,

t here is nothing in D8 to suggest that

the composition disclosed therein

comprises tannic acid in an amount

2% or more of the weight of the

formulation and a person skilled in the

art will not consider D8 to arrive at

the present invention.",,

D9 and D12

D9 and D12 disclose compositions

comprising comfrey.","D9 and D12 do not disclose a

composition / formulation of tannic

acid in combination with comfrey

extract or suggest that the

composition disclosed therein

comprises tannic acid in an amount

2% or more of the

weight of the formulation as in the

present invention.",,

D10, D11 and D13

D10, D11 and D13 disclose

compositions comprising tannic acid

or extracts containing tannins.","D10, D11 and D13 do not disclose a

composition / formulation of tannic

acid in combination with comfrey

extract or suggest that the

composition disclosed therein

comprises tannic acid in an amount

2% or more of the weight of the

formulation as in the present

invention.",,

Formulation,"Comfrey extract and

tannic acid values","Reduction in

WOMAC

index","% reduction in

stiffness

G1,"20% comfrey extract

and 10% tannic acid",59.88,57.48

G2,"10% comfrey extract

and 10% tannic acid",75.42,62.37

G3,"0% comfrey extract

and 10% tannic acid",22.37,21.33

G4,"20% comfrey extract

and 0% tannic acid",29.29,31.26

by this Board, in its order in PHARMACYCLICS, LLC IPAB OA/46/2000/PT/DEL and for sake of brevity we are not inclined to repeat it here.",,,

Thus, keeping in view the submissions and facts as reviewed by us the objection unber section 2(1) (ja); as lacking inventive step, does not sustain.",,,

We look at the relevant provisions of section 3(e) and 3 (j) of the Patents Act, 1970 as under:",,,

CHAPTER II Available at https://ipindia.gov.in/writereaddata/Portal/ev/sections/ps3.html INVENTIONS NOT PATENTABLE,,,

Section 3,,,

What are not inventions,,,

The following are not inventions within the meaning of this Act,â€"",,,

(e) a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing,,,

such substance;,,,

(j) plants and animals in whole or any part thereof other than micro- organisms but including seeds, varieties and species and essentially biological",,,

processes for production or propagation of plants and animals;,,,

The provisions relating to Section 3(e) in GUIDELINES FOR EXAMINATION OF BIOTECHNOLOGY APPLICATIONS FOR PATENT,,,

Available at https://www.ipindia.gov.in/writereaddata/Portal/IPOGuidelinesManuals/1_38_1_4-biotech- guidelines.pdf SECTION 3 (e): MERE,,,

ADMIXTURE RESULTING ONLY IN AGGREGATION OF THE PROPERTIES OR A METHOD OF MAKING SUCH MERE ADMIXTURE,,,

It is a well-accepted principle of Patent Law that mere placing side by side of old integers so that each performs its own proper function independently,,,

of any of the others is not a patentable combination, but that where the old integers when placed together has some working interrelation producing a",,,

new or improved result, then there is patentable subject matter in the idea of the working inter relations brought about by the collocation of the",,,

integers.,,,

In Ram Pratap v Bhaba Atomic Research Centre (1976) IPLR 28 at 35, it was held that a mere juxtaposition of features already known before the",,,

priority date which have been arbitrarily chosen from among a number of different combinations which could be chosen was not a patentable,,,

invention.,,,

Section 3(e) of the Act reflects the legislative intent on the law of patenting of combination inventions in the field of chemical as well as,,,

biotechnological sciences.,,,

Plain reading of the section of the 3(e) and by going through the relevant provisions of Guidelines quoted above that the instant invention does not,,,

attract the provisions of section 3(e) as the relevant data shown in the specification proves the existence of synergistic effect. The holding of the,,,

respondent that “Besides the application lacks to substantiate the synergism as provided in example 17 of the specification where remarkable,,,

activity is not observed with regard to commercial topical drug formulation having unknown composition†does not hold water as first remarkable,,,

activity is not the requirement of law and secondly the data shown in the table above shows G1 and G2 each provided a greater reduction in the,,,

WOMAC index of 59.88% and 75.42%, respectively, indicating a synergistic effect of the combination on joint stiffness.",,,

Now moving on to applicability of section 3(j), it is clear from plain reading of the above quoted legal provisions, that the invention is neither",,,

claiming plants and animals in whole or any part thereof nor relating to seeds, varieties and species and essentially biological processes for production",,,

or propagation of plants and animals; rather it relates a ‘topical formulation’ prepared of a combination of (i) comfrey and (ii) tannic acid in a,,,

particular proportion. There could be a debate on the proportion mentioned therein. But nevertheless the provisions of section 3(j) of the Patents Act,",,,

1970 won’t be attracted for the reasons mentioned above, in the instant case.",,,

Since learned counsel of the appellant has drawn our attention to granted case in foreign jurisdiction. We found the US granted claims clearly,,,

mentions the upper and lower weight percentage of both comfrey and tannic acid in the formulation. But in contrast herein, they have shown lower",,,

limit of 4% and 2% for comfrey and tannic acid respectively but left upper limit open ended, when they say “present in 4% or more of the weight",,,

of the formulationâ€​ in case of comfrey and “2% or more of the total weight of the topical formulation in case of tannic acid.,,,

We are, therefore, of the opinion that while we accept the auxiliary claims, filed by the appellant deleting the feature(s) of Comfrey derived",,,

compounds; they should further amend the claims sufficiently defining the invention particularly incorporating the upper limit of the % by weight of,,,

‘comfrey’ and ‘tannic acid’ both, with respect of the weight of the formulation.",,,

We further observe that the respondent has left certain objections of hearing notice unaddressed. This practice is very unfair and against the set,,,

legal norms. The Controller is first quasi-judicial body who adjudicates the matter and he/she has no option to issue half-cock orders. The unaddressed,,,

objections may have never ending effect on a case. This Board cautions the respondent to refrain from such practices in future. We have considered,,,

the submissions of the appellant at various stages of prosecution as well as those made in front of us and are convinced to accept their arguments and,,,

proposed amended set of claims 1-7. Keeping in view the submissions of the learned counsel of the appellant, we are inclined to waive off all the other",,,

unaddressed issues by the respondent.,,,

We, therefore, direct to appellant to submit the auxiliary set of claims deleting the features of comfrey-derived compound from the existing set of",,,

claims, clearly defining the upper limit of % by weight of the formulation for both ‘comfrey’ and ‘tannic acid’ based on the description;",,,

within 3 weeks from the date of issuance of this order to the respondent.,,,

We set aside the impugned order dated 11/12/2015 issued by the respondent, and direct the respondents to grant patent to the appellant on the",,,

amended set of claims 1-7, within 3 weeks from the date of submission of the amended set of claims by the appellant.",,,

Keeping in view the above facts and circumstances, the instant appeal is allowed. No cost.",,,