Centrient Pharmaceuticals Netherlands B.V. Anr. vs Dalas Biotech Limited

,,

V. Kameswar Rao, J",,

I.A. 15057/2019,,

By this order I shall decide this application filed by the plaintiffs under Order XI Rule 2 CPC, as amended by the Commercial Courts Act, 2016",,

read with Section 151 CPC for discovery by interrogatories filed on behalf of the plaintiffs. The prayer made in the application is the following:,,

“IN THE PREMISES STATED ABOVE, IT IS THEREFORE, MOST RESPECTFULLY PRAYED THAT, THIS HON'BLE COURT MAY BE",,

PLEASED TO:-,,

a) Allow the present application be allowed in the interest of justice, thereby directing the Defendant to file its response to the",,

aforementioned interrogatories within the time stipulated by this Hon'ble Court;,,

b) any further order as this Hon'ble Court may deem fit in the facts and circumstances of the instant case.â€​,,

It is the case of the plaintiffs and submitted by Mr. Lall, learned Senior Counsel appearing for the plaintiffs that the aforesaid suit has been filed by",,

the plaintiffs seeking permanent injunction against the defendant restraining the defendant from violating and infringing the rights of the plaintiffs in its,,

patent being IN 247301 titled as “Process for preparing Amoxicillin Trihydrateâ€​.,,

According to Mr. Lall, the plaintiffs have discharged the onus to prove infringement of the suit patent in its plaint by way of test reports. However,",,

the defendant has completely failed to discharge the burden of proof as stipulated in Section 104A (1),,

(b) of the Patents Act. In substance, the submission of Mr. Lall in support of this application is that the defendant, who has filed written statement had",,

in paragraph 94 disclosed its alleged process for manufacture of Amoxicillin Trihydrate, which according to him, is ambiguous and not suitable for",,

filing with the regulatory authorities.,,

He qualifies his submission by stating that the defendant purposefully and deceitfully adds optionality to key sections of the process that are covered,,

by the suit patent of the plaintiffs. In this regard, he has drawn my attention to paragraph 94 wherein according to him, the defendant has defined",,

“whether or not the “Penicillin G Acylase Enzyme†is Immobilized or non-Immobilized.†According to him, any commercially viable",,

manufacturing process for enzymatic amoxicillin must utilize an “Immobilized†enzyme. He stated that the defendant has in fact using immobilized,,

enzyme has deliberately not mentioned it to fall outside the scope of the claims. He qualifies his submission by stating that the defendant depicting in,,

their written statement that after the crude Amoxicillin Trihydrate is separated, “Penicillin G Acylase enzyme is washed with waterâ€​.",,

According to him, this is an indication that the defendant is actually using enzyme that has been immobilized and are hiding the fact from the Court.",,

That apart, he stated that the “Penicillin G Acylase†enzyme is expensive, inasmuch as it costs approximately 25 USD per KG, which would be",,

higher than the current market price for amoxicillin API which is approximately 22 USD per KG. Therefore, the enzymatic manufacturing process is",,

only commercially viable if the enzyme is immobilized and re-used.,,

According to him, by using “/†symbol the defendant is inferring that either a salt of PHPGM, likely PHPGME.HCL or PHPGME may be used",,

interchangeably. He stated that it is unlikely that the defendant used the salt of PHPGME because the salt is more soluble in water and would,,

necessitate the use of a base for pH control in the enzymatic conversion. HPGM free base has a low solubility and therefore has a high yield in,,

isolation. Therefore, the defendant’s disclosed process is contradictory and interchanging of a salt of HPGM and the HPGM free base would",,

require two different processes.,,

He vehemently argued that the defendant has stated that an “acid solution is added into crude amoxicillin mixture till clarity is achieved;,,

(the acid used may be Nitric Acid / Sulphuric Acid / Hydrochloric Acid)â€. According to Mr.Lall, these solvents are not interchangeable in a",,

single process; particularly if that process is cGMP approved. The argument of Mr.Lall is that the defendant is misleading by referring to three,,

separate acids for use in the crystallization solution. Apart from hydrochloric acid, the defendant claims the use of sulfuric or nitric acid.",,

He stated that sulphuric acid is impossible for use with amoxicillin; therefore, at a low pH the sulphuric acid salt of amoxicillin precipitates out of",,

solution. Therefore, one cannot add sulphuric acid “till clarity is achievedâ€. Further, a solid sulphuric acid salt of amoxicillin is neither acceptable",,

for human consumption, nor is it an approvable product. Similarly, he stated that the use of nitric acid is technically possible, but has the risk of",,

formation of nitrosamines that are potentially toxic.,,

In other words, it is his submission that the defendant is making fraudulent claims about the use of sulfuric acid and nitric acid, to hide use of",,

hydrochloric acid in the process. This stand of the defendant is purposeful to create a list of optional acids for use in this step because they are aware,,

that hydrochloric acid is the most efficient solvent applied in the crystallization step and the use of such solvent would be within the claims of the suit,,

patent. According to Mr.Lall, as the defendant has sought approval of the regulatory authority, it is incumbent for them to place before Court the",,

process filed by the defendant to manufacture of Amoxicillin Trihydrate, as according to him, no regulatory authority would allow a company to submit",,

a process with three possible acid solutions that could be used interchangeably. Further, the defendant claims in step 10 that it “increase the pH",,

by addition of NaOH or NH3 until full crystallization of Amoxicillin Trihydrate occur(s). At pH (of) 1.6 crystallization should be observed at,,

(a) temperature (of) 23-28°Câ€. He states that the defendant is again misleading the Court as according to him, the crystallization may start at a",,

pH of 1.6, as the defendant is using batch operation manufacturing as evidenced by the use of seeding for crystallization, the pH would necessarily",,

need to be raised to up to a pH of 5, which represents the minimum solubility of amoxicillin.",,

According to him, the calculated solubility at pH of 1.6 is 48 mmol/kg, whereas the calculated solubility at pH of 5 is 4.7 mmol/kg, representing a",,

tenfold decrease in solubility at a pH of 5. Therefore, should the defendant stop crystallization at a pH 1.6 the yield would be commercially unviable.",,

He stated that the defendant has not disclosed the correct process being used by it for manufacturing of Amoxicillin Trihydrate and has been,,

evasive in its written statement regarding infringement of the suit patent. In other words, the defendant is unable to discharge the burden of proof as",,

stipulated in Section 104A of the Patents Act.,,

It is in this above background, the plaintiffs served a notice dated August 02, 2019 upon the defendant to produce the documents for inspection.",,

The defendant sent a preliminary response on August 17, 2019 informing the plaintiffs that the defendant would be taking additional seven days time to",,

respond to the notice to produce documents. Finally, a detailed response was sent to the plaintiffs on August 29, 2019, whereby the defendant refused",,

to produce any other approvals / applications made to the regulatory authorities. The documents sought for by the plaintiffs and the response of the,,

S. No.,Document sought to be produced,Response by Defendant

1.,"Copies of all manufacturing approvals

obtained by the Defendant for

manufacture of Amoxicillin Trihydrate by

the process described in paragraph 94 of

the written statement","The Defendant has already placed on record the Drug

Manufacturing License received from the Drug

Controller, Jaipur, Rajasthan bearing License No.

Raj.2144 pertaining to Amoxicillin Trihydrate, along

with subsequent renewals. The initial license and

subsequent renewals have been applied as per Rule 76

of the Drugs and Cosmetics Rules, 1945 which does

not provide for any requirement of disclosure of

specific manufacture process while procuring or

renewing a license to manufacture drugs. Accordingly,

your request is contrary to the statutory requirements.

2.,"Copy of the complete Drug Manufacturing

license approved by the Drug Controller,

Jaipur, Rajasthan bearing license

No.Raj.2144","Copy of the Drug Manufacturing License approval for

manufacture of Amoxicillin Trihydrate as granted by

Drug Controller to Dalas Biotech has been filed by the

Defendant before the Hon‟ble Delhi High Court

However, we are again providing you with a copy of

the same along with all subsequent renewals, which

are attached herewith as Annexure A (Colly).

3.,"Copy of the Site Master File for

Manufacture of Amoxicillin Trihydrate by

the Defendant","The Site master file is a confidential document

comprising information related to manufacturing

facility (layout and equipment), officials (in-house and

external expoerts being retained), organizational chart

for all personnel, premises, different drugs being

manufactured or in the pipeline to be manufactured

shortly, documentation, details of loan license, testing

laboratories, etc. which is required as per the Drugs

and Cosmetics Act to be maintained at the Defendant‟s

premises. The Defendant considers the information

contained therein as confidential, especially as the

Plaintiffs are its business rival. Accordingly, the

Defendant objects to the request for production and

inspection of site master file. It is imperative to state

that there is no „patent linkage‟ in India and all

quarries related to drug approvals, facilities, etc. lie

exclusively in the domain of Drug Controller and

under the guise of the present notice, it is not

permissible for the Plaintiff to seek such information.

4.,"Copy of the Master Formula Records

pertaining to license granted to Dalas

Biotech from the Drug Controller, Jaipur,

Rajasthan bearing License No. Raj.2144","Master Formula Records / Records of production are

maintained by a company in compliance of

requirements of the Drugs and Cosmetics Act. Such

record contains information related to Defendant‟s

facilities, employees, equipment used, analytical

procedures, batch analysis, reference standard, testing

data etc. As Plaintiffs are the Defendant‟s business

rival, the Defendant objects to the request for

production and inspection of the same.

5.,"The application made by Dalas Biotech

Limited for obtaining the Drug

Manufacturing license for manufacture of

Amoxicillin Trihydrate filed before the

Rajasthan Drug Control Organization","The Defendant is currently unable to locate a copy of

the original application as filed by it in the year 2002,

as it is an old record dating back more than 15 years,

and has undertaken appropriate step towards locating

the same. The Defendant is also taking steps towards

procuring a copy of the same from the concerned Drug

Regulatory Authority. Further, the Defendant has

previously filed the manufacturing approval granted to

it by the Drug Controller along with subsequent

renewals. Accordingly, in view of the fact that the final

granted approval has already been placed on record,

the present request by the Plaintiffs is without merit.

6.,"Copy of the Common Technical Document

submitted to the Drug Controller,

Rajasthan.","The Defendant has not submitted any “Common

Technical Document†to the Drug Controller

Rajasthan as the Drugs and Cosmetics Act, 1940 doe

not contain any requirement pertaining to the same.

Accordingly, the present request is contrary to any

statutory requirement and without merit.

documents, as it is clear that the defendant is manufacturing Amoxicillin Trihydrate with identical process claimed and granted in the suit patent. The",,

reasons given by the defendant is that the Drugs and Cosmetics Rules do not provide for disclosure of the manufacturing process and does not show,,

bona fide on the part of the defendant.,,

He stated that through the process disclosed by the defendant in paragraph 94 of the written statement, it is incapable of getting approval from any",,

regulatory authority. Hence, it is imperative that the defendant should be directed to disclose the aforesaid documents as sought, for appropriate",,

adjudication of the case. According to him, the documents disclosed surely will depict the manner in which the defendant has followed the process for",,

manufacturing of Amoxicillin Trihydrate.,,

On the other hand, Mr. Nalin Kohli, learned counsel appearing for the defendant would oppose the application filed by the plaintiffs by stating that",,

the documents sought by the plaintiffs are not relevant for the effective adjudication of the dispute on the following grounds:,,

a) Regulatory approvals procured by the defendant for manufacture of Amoxicillin Trihydrate, is not the subject matter of the present suit, and neither",,

this Court is the appropriate judicial forum to adjudicate the disputes in a patent infringement suit.,,

b) The details of defendant’s manufacturing unit/facilities, which again is not relevant to the present dispute.",,

Mr. Kohli stated that the allegation of the plaintiffs in the plaint is qua infringement of its patent being IN 247301 wherein it has been asserted that,,

the claimed process is being used by the defendant to produce Amoxicillin Trihydrate, is baseless and a written statement has been filed by the",,

defendant to the plaint explaining the position.,,

According to Mr. Kohli, the information which has been sought by the plaintiffs in the present application filed by the plaintiffs only with an",,

intention to get privy to the regulatory approvals granted in favour of the defendant along with use of other ingredients / chemicals. The said,,

information is not the subject matter of the present suit.,,

He stated that the burden to prove the patent infringement lies on the plaintiffs by first proving that the product obtained by the defendant is,,

identical to the product obtained by the patented process. According to him, the plaintiffs have filed a manipulated test report to discharge its burden,",,

which is challenged by the defendant. In addition, the defendant, by way of positive evidence, has also submitted third party test reports to prove that",,

the product obtained by the process employed by the defendant is not identical to the product the plaintiffs claim to obtain by the impugned patented,,

process. He submitted that all such evidences are required to be proved by the parties by way of expert testimonies and cross-examination at the,,

stage of trial and not by interrogatories.,,

He relied upon the judgment of the Supreme Court in Raj Narain v. Smt. Indira Nehru Gandhi & Anr. (1972) 3 SCC 850 to contend that the,,

questions that may be relevant during cross-examination are not relevant as interrogatories. Further, it is the settled position of law that interrogatories",,

cannot be used as a substitute for cross-examination and are much narrower in scope than cross-examination. Further, the information sought by the",,

plaintiffs is confidential information and ought not to be allowed to be disclosed, particularly when the plaintiffs are the business rival of the defendant.",,

The case of the plaintiffs that the stand taken by the defendant in paragraph 94 of the written statement is ambiguous and not suitable to be filed,,

before a regulatory authority to obtain manufacturing approval for the production of Amoxicillin Trihydrate, which the defendant denies, inasmuch as",,

the plaintiffs have based their arguments only on the basis of apprehensions and conjectures and not on any evidence. Rather an attempt is being,,

made by the plaintiffs to collect the evidence in its favour rather than proving its case on the basis of evidence available with it and also by way of,,

cross examination. He seeks the dismissal of the application.,,

Having heard the learned counsel for the parties, the issue which arises for a decision in this application is whether the defendant should be",,

directed to answer the interrogatories detailed by the plaintiffs in para 18 of this application.,,

The plea of Mr. Lall, primarily is that the written statement of the defendant being vague, the interrogatories are required to be answered by the",,

plaintiffs for proper adjudication of the case. This is said by Mr. Lall because the defendant has added optionality to the process purposefully to show,,

that the suit parent has not been infringed like (i) Penicillin G Acylase enzyme is immobilized or non-immobilized; (ii) by using the “/†symbol, the",,

defendant inferring that salt of PHPGM, likely PHPGME.HCL or PHPGME may be used interchangeably; (iii) three separate acids are used in",,

crystallization etc.,,

Mr. Lall’s submission was that the defendant must answer (i) to disclose the process for manufacturing Amoxicilin Trihydrate as disclosed in,,

para 94 to any statutory authorities; (ii) does the Site Master File in relation to manufacturing of Amoxicilin Trihydrate under license from RDSCO,,

contain flow charts mentioning procedure and process flow? (iii) does the Master Formula Records in relation to manufacture of Amoxicilin,,

Trihydrate under License from RDSCO contain detailed stepwise processing, instructions and the time taken for each step? (iv) does the Master",,

Formula Records in relation to manufacture of Amoxicilin Trihydrate under License from RDSCO contain name, quantity, and reference number of all",,

the starting materials to be used as well as any substance that may disappear in the course of processing? if yes, to provide copies of the relevant",,

pages of the Master Formula Record.,,

Having noted the broad submissions of Mr. Lall in support of this application, I may at the outset state that as a general rule interrogatories are to",,

be allowed whenever the answer to them will serve either to maintain the case of the party administering them or to destroy the case of the,,

adversary.,,

Insofar as the plea that written statement is vague, it was the submission of Mr. Kohli that the written statement filed by the defendant explain its",,

position that the process does not infringe the patent of the plaintiffs. In other words, the written statement filed by the defendant is not vague. Mr.",,

Kohli has primarily stated that since the regulatory approvals procured by the defendant for manufacturing of Amoxicilin Trihydrate is not the subject,,

matter of the present suit, such an information cannot be sought for, by the plaintiffs. Though, the plea of Mr. Kohli is not appealing, what is important",,

is, there is a burden on the plaintiffs to prove that the patent infringement lies on the plaintiffs by first proving that the product obtained by the",,

defendant is identical to the product obtained by the patented process.,,

It was submitted by Mr. Kohli that the plaintiffs have filed a manipulated test report to discharge its burden, which is challenged by the defendant.",,

That apart, I find, the attempt of the plaintiffs is to discover the fact, what constitute the exclusive evidence of the opponent’s case. Further, the",,

attempt is also for doing a roving and fishing inquiry, which cannot be allowed through the process of interrogatories.",,

The plea of Mr. Lall that the defendant has added optionality to the process to contend that the patent has not been infringed, can be taken care of",,

by the plaintiffs through the process of cross examination of the defendant’s witness to test the credibility of the stand of the defendant. In other,,

words, interrogatories by the plaintiffs to extract something, which it could do so in the course of cross examination, cannot be allowed.",,

Under such circumstances, this Court is of the view that the application filed by the plaintiffs calling upon the defendant to file response to the",,

interrogatories cannot be allowed. I do not see any merit in the application. The same is dismissed.,,