Msn Laboratories Pvt. Ltd vs Novartis Ag
2022 Latest Caselaw 617 Tel

THE HON'BLE THE CHIEF JUSTICE SATISH CHANDRA SHARMA
                        AND
        THE HON'BLE SRI JUSTICE N.TUKARAMJI

                      COMCA No.21 OF 2021

JUDGMENT: (Per the Hon'ble the Chief Justice Satish Chandra Sharma)

      The present appeal is arising out of an order dated

26.02.2021 passed in I.A.No.1 of 2020 in TR COS No.1 of

2020, by which the application preferred under Order

XXXIX Rules 1 and 2 of the Code of Civil Procedure, 1908

(CPC) has been allowed.


2.    The facts of the case reveal that the respondents

herein/plaintiffs have initially filed a civil suit i.e.,

O.S.No.209 of 2020 before the IX Additional Chief Judge,

City Civil Court, Hyderabad in respect of infringement of

suit patent being IN 229051 on 07.10.2020, wherein an ad

interim injunction order dated 19.10.2020 was passed by

the Court holding that the respondents/plaintiffs have

established prima facie case of infringement against the

appellant herein/defendant. The suit pertains to a novel

and inventive pharmaceutical composition comprising of

Valsartan (or a pharmaceutically acceptable salt thereof),

Sacubitril (or a pharmaceutically acceptable salt thereof)

and a pharmaceutically acceptable carrier. The patent is

valid and subsistent till 16.01.2023. The cause of action

for filing of the suit arose as the appellant/defendant had

obtained manufacturing approval for a formulation of

Sacubitril/Valsartan tablet from Central Drugs Standard

Control Organization (CDSCO) which constitutes an

imminent threat to the respondents/plaintiffs and that the

appellant/defendant would launch such product in the

market which if not prevented, would lead to infringement

of the suit patent IN 229051. An interim injunction was

granted on 19.10.2020 by the IX Additional Chief Judge,

City Civil Court, Hyderabad. The Order of injunction was

served to the appellant/defendant and the appellant/

defendant did not file any written statement or counter

claim, however, filed an Application under Order VII Rule

11 of CPC in the former suit, i.e., O.S.No.630 of 2020

seeking rejection of the plaint on the ground of under

valuation of the suit. The plaint was filed by the

respondents/plaintiffs on valuation of Rs.21 lakhs, which

was enhanced to Rs.40 lakhs to the satisfaction of the

Chief Judge, City Civil Court, Hyderabad and the Plaint

was returned by the IX Additional Chief Judge, City Civil

Court, Hyderabad and the contention of the respondents/

plaintiffs is that the plaint was returned by the IX

Additional Chief Judge, City Civil Court, Hyderabad

without giving any opportunity to the respondents/

plaintiffs.

3. The respondents/plaintiffs thereafter increased the

valuation of the suit to Rs.1,05,00,000/- and presented the

same before the Commercial Court-cum-XXIV Additional

Chief Judge, City Civil Court, Hyderabad and prayed for an

interim injunction on 17.11.2020. A caveat was filed by the

appellant/defendant and time was granted to file a Written

Statement by the Commercial Court. The appellant/

defendant filed a written statement and a counter claim,

and the maintainability of the counter claim was

challenged by the respondents/plaintiffs. The Commercial

Court, after hearing the parties at length, granted an order

of status quo on 30.11.2020, which was continued on

02.12.2020, 03.12.2020 and 04.12.2020 till 09.12.2020.

The suit was transferred by the Commercial Court to this

Court keeping in view the provisions of Section 104 of the

Patents Act, 1970 by an order dated 09.12.2020. However,

the suit was transferred without extending the order of

status quo on the ground of lack of jurisdiction. The refusal

of extending the status quo order by the Commercial Court

vide order dated 09.12.2020 led to filing of Civil Revision

Petition on 10.12.2020 being CRP No.1323 of 2020. The

Commercial Suits, i.e., TRCOS No.1 of 2020 and TRCOS

No.2 of 2020 were listed before this Court on 11.12.2020

and this Court has granted an order of status quo.

4. The facts further reveal that the appellant/defendant

in the civil suit, as the status quo order was not in

existence from 10.12.2020 to 11.12.2020, has released the

infringing product in the market and in those

circumstances, an Application was preferred, i.e., I.A.No.1

of 2020 in TRCOS No.1 of 2020 under Order XXXIX Rules

1 and 2 read with Section 151 CPC by the respondents/

plaintiffs praying for grant of interim injunction restraining

the appellant/defendant by itself or through its Directors,

group company, associates, divisions, assigns in business,

licensees, franchisees, agents, distributors and dealers

from using, manufacturing, importing, selling, offering for

sale, exporting, directly or indirectly dealing in

pharmaceutical composition comprising combination of

Valsartan or a pharmaceutically acceptable salt thereof

and Sacubitril or a pharmaceutically acceptable salt, and a

pharmaceutically acceptable carrier or more specifically a

pharmaceutical composition comprising combination of

Sacubitril + Valsartan as sodium salt complex/compound

or in any other form as may amount to infringement of

Indian Patent IN 229051 of the respondents/plaintiffs. The

learned Single Judge after hearing the Parties at length has

allowed the Application preferred under Order XXXIX Rules

1 and 2 of CPC. The relevant portion of the Order reads as

under:-

"12. The present statutory regime enables to secure product patent protection to pharmaceutical inventions. The Patent Act, 1970 requires the applicant to satisfy the Controller that his 'invention' has an inventive step, is capable of industrial application and is not prior art.

13. Patent law is unique in itself. The Patent Act, 1970 provides an opportunity to oppose a patent claim at the pre-grant stage and within one year of post-grant. Though a patent is granted after thorough examination and publication, it has a limited term of protection in contrast to Trade Marks. While it seeks to protect a patented product from infringement, it does not give finality to a patent and is open for challenge at any time, unlike Trademarks Law (Ref to Section 31 of Trade Marks Act, 1999). At this stage, it is appropriate to note Sections 13(4)1, 482 and 64 of the Act. These three provisions deal with two opposite aspects of a patent. While Section 48 gives protective layer to a patented product, Sections 13 (4) and 64 vest right in a rival claimant to pierce the protective layer. [F. Hoffmann La Roche Ltd. Vs. Cipla Limited]3. Claim and counter claim are built into the scheme of the Act.

14. Grant of patent after amendment of the Patent Act has more weightage for deciding prima facie case in favour of patentee and patentee has exclusive right to prevent third parties who do not have his consent from using

1 Section 13(4). "The examination and investigations required under Section 12 and this section shall not be deemed in any way to warrant the validity of any patent, and no liability shall be incurred by the Central Government or any officer thereof by reason of, or in connection with, any such examination or investigation or any report or other proceedings consequent thereon."

2 Section 48. Rights of Patentees: Subject to the other provisions contained in this Act and the conditions specified in Section 47, a patent granted under this Act shall confer upon the patentee--

(a) where the subject-matter of the patent is a product, the exclusive right to prevent third parties, who do not have his consent, from the act of making, using, offering for sale, selling or importing for those purposes that product in India;

(b) where the subject-matter of the patent is a process, the exclusive right to prevent third parties, who do not have his consent, from the act of using that process, and from the act of using, offering for sale, selling or importing for those purposes the product obtained directly by that process in India:

3 [148 (2008) DLT 598] = 2016 (65) PTC 1 [Del} [DB}

product applying patented process. [Mariappan v. A.R. Safiullah]4. To guard his patent, a patentee can institute injunction suit. Per contra, Section 64 of the Patent Act provides one more opportunity to a competitor to challenge the patent. The objection can be raised before the Controller or as a counter claim in an infringement suit. Thus, while patentee is required to guard against patent violation, his security layer is vulnerable to a challenge to granting patent to him.

15. Injunction is essentially an equitable and discretionary relief. In considering the application to grant injunction, Court must exercise sound discretion. The parameters to consider an injunction application are well laid down and need not be elaborated. Three known parameters to consider injunction application, 'triple test' of American Cyanamid Co v. Ethicon Ltd.,5 case, are, (i) 'prima facie' case; (ii) 'irreparable loss' and (iii) 'balance of convenience'. Indian Courts have applied these parameters to address the issue of grant of injunctions, including in patent litigations6.

16. Considering the above, the first and foremost question to be considered in an injunction application in a patent infringement suit, when a counter claim is mounted on invalidity of patent per se is can prima facie infringement be decided upon without going into the question of patent validity? That is, can a patent as granted by the Patent Office be presumed valid?

17. To protect his patent from imminent threat of rival product a patentee can file suit to injunct a person violating his patent. He can also file suit in anticipation of such violation in the form of quia timet injunction suit. 'Quia timet' means 'because he fears' and is an injunction to prevent a possible future injury. A quia timet action is brought against an apprehension of infringement of a

4 (2008) 5 CTC 97.

5 (1975) 1 All.ER 504 = (1975) 2 WLR 316 6 Hoffmann's case

patent right. In such injunction suit, the Court has to examine whether such apprehension is prima facie credible enough to grant an injunction even before any harm arises. While the degree of threat required to justify such intervention by Court and the standard of proof required to allow quia timet injunctions have so far proven to be subjective, in the instant case the RTI response dated 20.08.2020 reveals that the defendant has obtained approval from CDSCO to manufacture a formulation of the Sacubitril and Valsartan tablet. Obtaining regulatory approvals/marketing and manufacturing authorizations much ahead of patent expiry, coupled with a counter claim for revocation of patent filed by defendant are indicative of an imminent intent to launch, justifying a plea for quia timet injunctive relief.

18. While considering an injunction application, in a patent suit of a concerning pharmaceutical product, the Court requires to assess the facts and circumstances of the case. More so, when counter claim is mounted, more strict scrutiny is required and scope of discretion narrows down. In such case the threshold for granting injunction is higher.

19. Way back in 1978, the Supreme Court in Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries7, rejected the argument that there is a presumption of validity of patent. The Hon'ble Supreme Court held:

"It is noteworthy that the grant and sealing of the patent, or the decision rendered by the Controller in the case of opposition, does not guarantee the validity of the patent, which can be challenged before the High Court on various grounds in revocation or infringement proceedings. It is pertinent to note that this position, viz. the validity of a patent is not guaranteed by the grant, is now expressly provided in Section 13(4) of the Patents Act, 1970."

7 AIR 1982 SC 1444

20. In F. Hoffmann-LA Roche Ltd. v. Cipla Limited [2008 SCC OnLine Del 382], the Delhi High Court held:

"70. To summarize, on the issue of interlocutory injunctions:

(i) In patent infringement actions, the Courts should follow the approach indicated in American Cyanamid, by applying all factors;

(ii) The Courts should follow a rule of caution, and not always presume that patents are valid, especially if the defendant challenges it;

(iii) The standard applicable for a defendant challenging the patent is whether it is a genuine one, as opposed to a vexatious defense. Only in the case of the former will the Court hold that the defendant has an arguable case."

21. In Natco Pharma Ltd v. Bayer Healthcare [2019 SCC OnLine Del 9124], a Division Bench of the Delhi High Court held:

"25. Again, each case of alleged infringement of patent, particularly a pharmaceutical patent, would turn on its own facts. It is not possible to conceive an 'across- the-board' blanket approach that would apply to all such cases, where as a matter of routine at the first hearing there would be a grant of injunction in favour of the Plaintiff. The decision in the application of interim injunction has to necessarily indicate the view of the Court on the three elements mentioned herein before and the additional features when it involves a case of alleged infringement of a patent, and in particular, a pharmaceutical patent. It is not the length of the order or its precise wording that matters. It is necessary, however, that the factors mentioned hereinbefore must be discernible from the order which comes to a conclusion one way or the other regarding grant of an interim injunction."

22. Correspondingly, the following can be considered in the instant case. So far the process of granting patents seems elaborate, with clear scrutiny of 'patentability' of the

product (Section 3)8. The application for the suit patent underwent a detailed examination where all aspects of the application were considered. The application was then placed before the Controller (usually a person with subject matter expertise) who duly considered the examiner's observations regarding novelty and inventive step and took note of the view that 'synergistic, unexpected and surprising effects on the treatment of hypertension were observed when compared to monotherapy'. Specific objections raised in the First Examination Report were addressed and the application was published in the patent journal for any pre-grant opposition (six months). It is well within the rights of the Patent Office to seek any document related to these applications and can be made immediately aware of any objections raised in other jurisdictions. The plaintiff also disclosed the status of patent applications made in 21 nations as of that time and additionally provided the application and declaration for patent grant as filed in the United States of America Patent and Trademark Office. It revealed that three countries had granted the patent while the rest were still pending. After undertaking elaborate exercise, suit patent was granted to the petitioners on 13.02.2009, effective from 16.01.2003. It appears from material placed on record that the Controller was satisfied on all aspects of patent claim, (i) novelty; (ii) innovative step; (iii) therapeutic efficacy and (iv) industrial application to grant patent. There was no opposition at pre-grant stage or post grant. Product was launched and has received wide acceptance. Prima facie, this lends credence to the claim of plaintiff on validity of his patent.

23. It is pertinent to note that prior to the 2002 amendment of the Act, the patentee had exclusive right to use the product by himself or through agents but after amendment, patentee has exclusive right to prevent third

8 Section 3, of the Act, describes 'what are not inventions', section 3(d) represents patentability. And in medicines claiming to cure/treat a disease the explanation added to the section stating efficacy has to be tested as 'therapeutic efficacy'

parties from using or selling patented products9. Even though Section 48 as amended does not create presumption of validity of patent, grant of patent after amendment has more weightage for deciding prima facie case in favour of patentee. [Mariappan (supra)].

24. As such it is well within the patentee's right (as the owner of patent) to seek an injunction against an infringement, both real and imminent, especially in the instant case where defendant is clear in their intent to market their drug formulation.

25. The Specification filed by the petitioner as part of suit patent describes the nature of invention and the manner in which it is to be performed. As part of the details disclosed, it is noted that the nature of hypertensive vascular disease is multifactorial. 'Under certain circumstances, drugs with different mechanisms of action have been combined. However, just considering any combination of drugs having different mode of action does not necessarily lead to combinations with advantageous effects. Accordingly, there is a need for more efficacious combination therapy which has less deleterious side effects'. Also, it observes the effects of the present invention in different pharmaceutical combinations and their various embodiments. Further it is noted, 'the combined administration of Valsartan or a pharmaceutically acceptable salt there of and a NEP inhibitor or a pharmaceutically acceptable salt thereof results in a significant response in a greater percentage of treated patients, that is, a greater responder rate results, regardless of the underlying etiology of the condition. This

9Subs. by Act 38 of 2002, (w.e.f. 20-5-2003). Prior to substitution it read as: "48. Rights of patentees.--(1) Subject to the other provisions contained in this Act, a patent granted before the commencement of this Act, shall confer on the patentee the exclusive right by himself, his agents or licensees to make, use, exercise, sell or distribute the invention in India. (2) Subject to the other provisions contained in this Act and the conditions specified in Section 47, a patent granted after the commencement of this Act shall confer upon the patentee--

(a) where the patent is for an article or substance, the exclusive right by himself, his agents or licensees to make, use, exercise, sell or distribute such article or substance in India;

(b) where a patent is for a method or process of manufacturing an article or substance, the exclusive right by himself, his agents or licensees to use or exercise the method or process in India."

is in accordance with the desires and requirements of the patients to be treated.'

26. Therefore, plaintiff No.1 has discharged his initial burden in establishing that his product meets the parameters required to secure a patent from the Indian Patent Office.

27. In the instant case, commercial activity by the defendant is at a nascent stage. Defendant claims that his product is far cheaper as compared to plaintiff's produce. Thus, even if defendant is asked to maintain a book of accounts, what can be recovered from him is only profit earned by him, whereas the difference of price between plaintiff's product and defendant's product still remains. Further, the issue is not confined to the defendant and plaintiffs. There are others staring down the barrel, ready to fire. There are generic companies making similar claims as that of defendant's. Seemingly, allowing several persons to operate in the market only increases the difficulty of arriving at the estimated loss caused to plaintiff by one producer of the drug. Further, in addition to plaintiff no.1 selling the drug under the brand name of 'Vymeda', he has authorized other drug companies to manufacture and sell the drug with their own brand name. It is, therefore, not practicable to make an assessment of loss to plaintiffs and to compensate them if they succeed in the suit.

28. The term of a patent is limited compared to Trademarks and Copyright and allows a monopoly over the market for a relatively shorter period of time. But, during the subsistence of patent, the patentee is entitled to enjoy the monopoly. It is a reward for innovation and experimentation and hard work put into bringing a better therapeutic medicine which will save lives of millions. Suit patent is set to expire in 2023 and patent infringement suits especially with a counter claim for revocation take a considerable amount of time to be determined. In the

meanwhile, if the defendant is allowed to launch his drug it will cause irreparable damage to the plaintiffs.

29. It is appropriate to note that plaintiffs were granted patent in the year 2009, operative retrospectively from 2003. There was no opposition at pre-grant stage or within one year after grant of patent. Plaintiffs have been enjoying the patent rights for more than a decade successfully. The product received wide acceptance. While so, in the recent past other pharmaceutical companies came out with their own drugs which are bio-equivalent of the tested drug, the one made by plaintiffs, and plaintiffs are fighting litigation against them alleging violation of its patent. In the suits pending in Delhi High Court either the Court restrained the defendants from launching the product or the defendants gave an undertaking not to launch the product. This suit is instituted as a quia timet injunction suit to prevent similar drug being introduced into the market by the defendant. Though, defendant claims to be doing research to make a viable drug to treat heart failure by using Valsartan and Sacubitril, defendant never challenged the validity of the patent granted to plaintiffs. For the first time he raised objection to the plaintiff's patent as a counter claim that too, after receiving regulatory approvals.

30. Primarily, the contention of defendant against granting injunction to plaintiff is that Valsartan and Sacubitril are known pharmaceutical components/ compounds and therefore there is no 'novelty' and 'inventive step' and is obvious to person skilled in the art. Thus granting patent itself was illegal. By using known compounds when defendant makes a drug it does not amount to infringement of patent. The defendant further justifies his product by contending that the methodology adopted by him to make his drug is different from one adopted by plaintiffs. Prima facie, it appears the challenge to validity of patent is reactive to a quia timet injunction suit to blunt the challenge to defendant's product as

violating the patented drug. Prima facie and subject to consideration of the issue during the course of trial, as noticed above, plaintiff No.1 answers the parameters to grant a patent and therefore is entitled to protection of the patent granted to plaintiff No.1.

31. This leaves consideration of public interest. Defendant is also claiming that his drug is priced at half the price of the patentee and any interim orders preventing him from sale of its drug will impact the availability of an alternative and cheaper option to a life saving drug.

32. In the American Cyanamid Lord Diplock stated: "... the governing principle is that the court should first consider whether, if the plaintiff were to succeed at trial in establishing his right to a permanent injunction, he would be adequately compensated by an award of damages for the loss he would have sustained as a result of the defendant's continuing to do what was sought to be enjoined between the time of the application and the time of the trial. If damages in the measure recoverable would be [an] adequate remedy and the defendant would be in a financial position to pay them, no interim injunction should normally be granted, however strong the plaintiff's claim appeared to be at that stage."

33. In India, Courts have recognized public interest both as a separate factor and as a factor read into the "balance of convenience" test. Whether the public interest exists in a case involving infringement of Patents is essentially a question of fact which has to be determined on case-to-case basis and no straight jacket formula can be devised in order to infer the public interest in a patent infringement action.

34. According to the defendant, he plans to sell his product at 1500/- for 30 tablets, whereas the plaintiff is selling his at 2265/- for 28 tablets, therefore, the

difference is about 800/-, and hence it cannot be said that difference is so unreasonable so as to enable the defendant to sell his product, when plaintiff has made out a prima facie case on the validity of his patent. In the earlier paragraphs the difficulty in making assessment of profit and loss is also noted.

35. In a case of similar nature, the Division Bench of the Delhi High Court in Cipla Limited v. Novartis AIG and another10 held as under:

"26. Fourthly, even though the question of public interest may be a factor in considering the grant of an injunction, it is only one of the factors which needs to be kept in mind. In any event, in the present case, we do not feel that the appellant has even made out a case that public service would be disserved by the grant of an injunction. On the other hand, the respondents have established a prima facie case in that that patent is valid and, therefore, there is no credible challenge to the validity of the patent. The balance of convenience is also in favour of the respondent. We are also of the view that in case an injunction is not granted in the circumstances, the respondents would suffer irreparable injury as their rights under Section 48 would be seriously impaired in a manner which cannot be restituted by damages."

36. Therefore, there can be no comparison on price of the drug, even before efficacy of patented drug is tested in the suit. Patent law protects patentee from such threats, for a reasonable period. As noticed above, the special features of Patent Act is, while it grants protection to an invention leading to a marketable product, it encourages to do research and innovate to bring a better product. However, once a patent is granted, on being satisfied that patentee has made a product after complying the parameters to obtain a patent, is entitled to protection.

37. For all the aforesaid reasons, there shall be interim injunction restraining the defendant/respondent, by itself

2017 SCCOnLine Delhi 7393

or through its directors, group company, associates, divisions, assigns in business, licensees, franchisees, agents, distributors and dealers from using, manufacturing, importing, selling, offering for sale, exporting, directly or indirectly dealing in pharmaceutical composition comprising combination of valsartan or a pharmaceutically acceptable salt thereof and sacubitril or a pharmaceutically acceptable salt, and a pharmaceutically acceptable carrier or more specifically a pharmaceutical composition comprising combination of sacubitril + valsartan as sodium salt complex/compound or in any other form as may amount to infringement of Indian Patent No.229051 of the plaintiff No.1.

38. Accordingly, Interlocutory Application No.1 of 2020 is ordered.

39. At this stage, it is represented by Sri Ashok Ram Kumar that before the status quo order was granted and after the transfer of the suit to this Court, the defendant has manufactured certain quantity of subject drug and they have expiry date and unless said stock is disposed of, grave prejudice will be caused to the defendant. He therefore submits that defendant may be permitted to sell the said quantity of drug. Having regard to this submission, defendant is permitted to sell the quantity of drugs already manufactured before the status quo order was granted by this Court on 11.12.2020. However, the defendant shall maintain account of the details of quantity of drugs already manufactured, sold in pursuant to this order and the sale proceeds. He shall furnish the details to the plaintiff no.1 and shall also file an affidavit to that effect in the suit. The permission to sell the drugs already manufactured is without prejudice to the claims of the plaintiffs and defendant in the suit."

5. This Court has heard the learned counsel for parties

at length and perused the record.

6. The learned counsel for the appellant/defendant has

placed reliance on the Judgment delivered in the case of

M/s. Bishwanath Prasad Radhey Shyam v. Hindustan Metal

Industries11.

In the aforesaid case, the Hon'ble Supreme Court

while dealing with Indian Patents and Designs Act, 1911

(Act 2 of 1911) has exhaustively dealt with Sections 10 and

2(8) (10) and 11 of the Indian Patents and Designs Act and

also the issue of grant of patent also. It has been held that

grant of patent is for 'manner of new manufacture' and the

invention must involve 'inventive step' having novelty and

utility. It must be something more than a mere workshop

improvement.

In the aforesaid case, one of the partners of the

plaintiff/respondent firm claimed to have invented a new

device and method in manufacturing utensils and the firm

got it patented under the Indian Patents and Designs Act,

1911. Subsequently, the plaintiff having learnt that the

defendant/appellant was using that device and method,

filed a suit praying for injunction and damages. The

(1979) 2 SCC 511

defendant also filed a counter-claim praying for revocation

of the patent. Both the suits were transferred to the High

Court under proviso to Section 29 of the Indian Patents

and Designs Act and the learned Single Judge of the High

Court held that the patent did not involve any inventive

step or novelty and revoked the patent. The Division Bench

has reversed the Judgment of the learned Single Judge

holding that the patented device and method did involve an

inventive step and was a manner of new manufacture and

improvement. The matter thereafter travelled to the Hon'ble

Supreme Court and the Hon'ble Supreme Court has set

aside the order of the Division Bench holding that the

invention patented by the respondent was neither a

manner of new manufacture nor a distinctive improvement

on the old contrivance, involving any novelty or inventive

step having regard to what was already known and

practiced in the country for a long time before that.

The facts of the aforesaid case are all together

distinguishable. In the present case, the respondents/

plaintiffs' company was granted patent in the year 2009 for

manufacturing a particular drug by combining two salts.

In the considered opinion of this Court, it was the

invention of the respondents/plaintiffs' company of making

two salts and making a drug for the purpose of controlling

blood pressure and therefore, the Judgment does not help

the appellant/defendant. It is nobody's case that the

subject matter of the patent was also in existence earlier in

some form or the other. The appellant/defendant has not

placed reliance upon any other Judgment before this

Court.

7. The learned counsel for the respondents/plaintiffs

has placed reliance on the following Judgments.

F.Hoffmann-La Roche Limited v. Cipla Limited (supra),

Merck Sharp and Dohme Corporation v Glenmark

Pharmaceuticals12, Hindustan Lever Limited v. Lalit Wadhwa13,

Elsai Company Limited v. Satish Reddy14, Astrazeneca Ab v.

Emcure Pharmaceuticals15, Dr Reddy's Laboratories (UK) Limited

v. Eli Lilly and Company Limited16, Bishwanath Prasad Radhey

Shyam v. Hindustan Metal Industries (supra), Eli Lilly and

Company Limited v. Apotex Pty Limited17, Dr Reddy's

Laboratories (UK) Limited v. Eli Lilly and Company Limited18,

Bristol-Myers Squibb Holdings Ireland Unlimited Company v.

BDR Pharmaceuticals International Private Limited19,

Technograph Printed Circuits Limited v. Mills & Rockley

(Electronics) Limited20, Windsurfing International Inc v. Tabur

(2015) 63 PTC 257

2007 (35) PTC 377 (Del)

Manu/DE/1621/2019

2020 SCC Online Del 101

[2008] EWHC 2345 = [2009] F.S.R. 5

[2003] FCA 214

[2009] EWCA 1362

MANU/DE/0299/2020

[1972] R.P.C. 346

Marine (Great Britain) Limited21, University of Miami v. the

Controller of Patent22, Kirin Amgen Inc v. Hoechst Marion

Roussel Limited23, Communication Components Antenna Inc v.

ACE Technologies Corp24, Strix Limited v. Maharaja Appliances

Limited25, CTR Manufacturing Industries Limited v. Sergi

Transformer Explosion Prevention Technologies Private

Limited26, Bristol-Myers Squibb Company v. J.D.Joshi27, Cipla

Limited v. Novartis AIG (supra), Novartis AG v. Cipla Limited28,

Wander Limited v. Antox India Private Limited29, Telemecanique

& Controls (I) Limited v. Schneider Electric Industries SA30,

American Cyanamid Company v. Ethicon Limited31, National

Research Development Corporation of India v. Delhi Cloth &

General Mills Company Limited32, Indian Household and

Healthcare Limited v. LG Household and Healthcare Limited33,

Hindustan Lever Limited v. Rameshwar Mundia34, Tayabbhai M.

Bagasarwalla v. Hind Rubber Industries Private Limited35, CTR

Manufacturing Industries Limited v. Sergi Transformer

Explosion Prevention Technologies Limited36, Hind Mosaic and

Cement Works v. Shree Sahjanand Trading Corporation37, Cheni

Chenchaiah v. Shaik Ali Saheb38, Hotel Leela Venture Limited v.

[1985] R.P.C. 59

OA/3/2015/PT/KOL, dated 25.08.2020.

[2002] EWCA Civ 1096

2019 (PC) PTC 270 [Del]

2009 SCC OnLine 2825

2016 (65) PTC 262 [Bom}

MANU/DE/1889/2015

2015 (61) PTC 363 [Del]

1990 (Supp) SCC 727

2002 (24) PTC 632 (Del) (DB)

[1975] R.P.C. 513

PTC (Suppl)(1) 95 (Del)

(2007) 5 SCC 510

2009 (39) PTC 570 (Del) (DB)

(1997) 3 SCC 443

10`3 (1) Bom CR 403 = 2012 (114) BOMLR 1371

2008 (37) PTC 128 (Guj) (DB)

1993 SCC Online AP 51 : AIR 1993 AP 292

Yaseen Begum39, Kavita Trehan v. Balsara Hygiene Products40,

Paramanand Agarwal v. Sudera Enterprises Private Limited41, Jai

Barham v. Kedar Nath Marwari42, Astrazeneca AB v. Torrent

Pharmaceuticals Limited43, Novartis AG v. Torrent

Pharmaceuticals Limited (decided on 08.10.2020 passed in CS

(Comm) No.425 of 2020 by the High Court of Delhi) and Novartis

AG v. Eris Lifesciences Limited (decided on 21.12.2020 passed

in CS (Comm) No.557 of 2020 by the High Court of Delhi).

8. The respondents/plaintiffs pray for grant of interim

injunction restraining the appellant/defendant by itself or

through its Directors, group company, associates,

divisions, assigns in business, licensees, franchisees,

agents, distributors and dealers from using,

manufacturing, importing, selling, offering for sale,

exporting, directly or indirectly dealing in pharmaceutical

composition comprising combination of Valsartan or a

pharmaceutically acceptable salt thereof and Sacubitril or

a pharmaceutically acceptable salt, and a pharmaceutically

acceptable carrier or more specifically a pharmaceutical

composition comprising combination of Sacubitril +

Valsartan as sodium salt complex/compound or in any

other form as may amount to infringement of Indian Patent

IN 229051 of the respondents/plaintiffs.

2008 SCC Online AP 517 : 2009 (1) ALD 519 (DB) : 2009 (1) ALT 386 (DB)

(1994) 5 SCC 380

2000 SCC OnLine Cal 215

The Calcutta Weekly Notes Vol. XXVII, p 582

2020 SCC OnLine Del 1446

9. The undisputed facts of the case makes it very clear

that the respondents/plaintiffs has filed an Application for

grant of Patent under the Patents Act and the suit patent

was granted as Indian Patent No.IN 229051 on 13.02.2009.

The respondents/plaintiffs are certainly in the business of

selling pharmaceutical products in India under the brand

names VYMADA, AZMARDA and CIDMUS and in the rest

of the world under the brand name NTRESTO. It is sold

through various marketing partners under the brand

names, namely AZMARDA by Cipla Limited and CIDMUS

by Lupin Limited. The appellant/defendant herein obtained

approval on 23.06.2020 for manufacturing formulation of

Sacubitril and Valsartan and as it was going to be

launched commercially infringing the patent of the

respondents/plaintiff, a civil suit was filed. It is also a

matter of record that the appellant/defendant has filed a

written statement as well as a counter claim for revocation

of the Indian Patent No.IN 229051.

10. The respondents/plaintiff's suit patent IN 229051

reads as under:-

"1. A pharmaceutical composition comprising

(i) the AT 1-antagonist valsartan or a pharmaceutically acceptable salt thereof and

(ii)N-(3-carhoxy-l-oxopropyl)-(4S)-phenylphenylmethyl)-4- amino-2R-methylbutanoic acid ethyl ester or N-(3-carboxy-

loxopropyl)-(4S)-p-phenylphenylmethyl)-4-amino- 2Rmethylbutanoic acid or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier."

11. The aforesaid patent makes it very clear that the suit

patent is a pharmaceutical composition comprising

Valsartan or pharmaceutically acceptable salt thereof and

Sacubitril or pharmaceutically acceptable salt thereof and

a pharmaceutically carrier.

12. Section 10(1) and (4) of the Patents Act reads as

follows:-

"10. Contents of specifications:-

(1) Every specification, whether provisional of complete, shall describe the invention and shall begin with a title sufficiently indicating the subject matter to which the invention relates.

*****

(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;

(d) be accompanied by an abstract to provide technical information on the invention:

****

13. The contents of specification which are subject matter

of the suit patent IN 229051 makes it very clear that the

appellant/defendant is manufacturing the same product

by combing two salts in respect of which the

respondents/plaintiffs company is having patent in its

favour, which is impermissible in law and contrary to the

statutory provisions as contained under the Patents Act

(See F.Hoffmanna-La Roche Limited v Cipla Limited (supra) and

Merck Sharp and Dohme Corporation v Glenmark

Pharmaceuticals (surpa)).

14. In the considered opinion of this Court, as the

respondents/plaintiffs company was granted patent in the

year 2009 and by combining two salts, for which the

respondents/plaintiffs company is holding a patent, the

appellant/defendant was manufacturing a drug carrying

the same two salts is violation of the Patent Laws and

keeping in view the principles laid down in the CPC and by

the Hon'ble Supreme Court from time to time, and also

keeping in view the principles of prima facie case, balance

of convenience and irreparable loss, the learned Single

Judge was justified in granting injunction subject to

certain terms and conditions. Much has been argued

before this Court by the learned counsel for the

appellant/defendant in respect of the counter claim.

15. In the considered opinion of this Court, the counter

claim has to be decided after the evidence is adduced by

the parties and the learned Single Judge has rightly dealt

with the Application preferred under Order XXXIX Rules 1

and 2 of CPC and has rightly granted injunction in favour

of the respondents/plaintiffs. The plaintiffs' suit and the

counter claim are to be decided on merits and therefore, it

is made clear that the observations made by the learned

Single Judge will not come in the way of the parties in

respect of the main suit.

16. In the light of the aforesaid, this Court does not find

any reason to interfere with the Order passed by the

learned Single Judge and accordingly, the appeal is

dismissed.

Miscellaneous applications, pending if any, shall

stand closed. There shall be no order as to costs.

_____________________________ SATISH CHANDRA SHARMA, CJ

____________________ N.TUKARAMJI, J

14.02.2022 pln