DHC vacates injunction in favour of AstraZeneca for Ticagrelor

The Delhi High Court (DHC) has vacated an interim injunction granted in favor of AstraZeneca for their drug Ticagrelor as the court held that the Patents covering the drug are prima facie in-valid. Brief facts of the case and summary of the decision is provided below:

BRIEF FACTS

  1. Three suits were filed by the Astrazeneca (Astrazeneca AB & Ors. v. P. Kumar & Anr [CS(COMM) 749/2018], Astrazeneca AB & Anr v. T. Rao & Anr. [CS(COMM) 792/2018], Astrazeneca AB & Anr v. Dr. Reddys Laboratories Ltd. [CS(COMM) 1023/2008]) seeking a decree of permanent injunction to restrain the defendants from marketing, selling, distributing, etc. any product that infringes the subject matter of Indian Patent Nos. IN 209907 (hereinafter, IN 907, i.e. the Species Patent), IN 247984 (hereinafter, IN 984, i.e. the Polymorph Patent) and IN 272674 (hereinafter, IN 674, i.e. the Formulation Patent).
  2. The plaintiff contends that the drug in question, Ticagrelor falls within the scope of Indian Patent No.907 and 984. The finished formulation of Ticagrelor is said to be covered within the scope of IN 674. Additionally, the drug is said to have proved to be an effective platelet aggregation inhibitor.
  3. The plaintiffs received approval for the drug in the USA in 2011 and were marketed under the trademark BRILINTA. It has been approved in more than 100 countries. In India the plaintiff received drug regulatory approval in May 2012 and was commercially launched in India in October 2012 under the same trademark BRILINTA.

The Defendants had separately filed written statements and some of the main contentions raised are as follows: –

  1. Plaintiff’s have deliberately suppressed material facts due to their failure to mention that the patent No.241229 expressly covers and discloses TICAGRELOR and has expired on 14.7.2018. Further, the defendant stated that the plaintiff has given a false impression that the TICAGRELOR cannot be recognized from the said patent No.241229.
  2. The plaintiff have deliberately failed to state that the foreign patent equivalents of the said patent have been held invalid in contested proceedings in China, Europe and South Korea.
  3. The plaintiffs are attempting to illegally extend patent monopoly granted to them vide IN’229 and subsequently in IN’907 and IN’984 with respect to TICAGRELOR.
  4. Regarding the patent IN 907 the defendant has relied on Section 64(1)(a) of the Patents Act to state that IN 907 lacks novelty and is comprehensively covered in IN 229 which has an earlier priority date than IN907 i.e. 22.07.1997. Compounds as disclosed and covered in IN 907 are known and anticipated through prior claiming based on IN 229. Such compounds can be easily developed by a person skilled in the art based on performing routine/regular experimentation. The defendant has also stated that the subject matter of the claims IN 907 does not qualify as an invention within the meaning of the Patents Act.
  5. TICAGRELOR is covered within the generic scope of IN 229 genus patent which has expired on 14.07.2018. However, the plaintiffs are trying to create a false dichotomy of ‘coverage’ and ‘disclosure’ to artificially extend its monopoly through subsequent patents on TICAGRELOR.

The main contentions raised by the Plaintiff’s are as follows:

  1. On the plea of the defendants on anticipation i.e. section 13(1)(a) of the Act the plaintiff has stated that the genus patent (IN 229) was published on 2nd February 1999 i.e. after the priority date of the species patent (IN907) on 4.12.1998. Therefore, the genus patent cannot constitute a prior art document for evaluating the novelty of the species patent. It is further stated by the plaintiff that there is no specific or enabling disclosure of TICAGRELOR in the genus patent. A person of ordinary skill in the art would not have been able to identify or isolate TICAGRELOR based on the teaching of the genus patent.
  2. On the contention of the defendants of prior claiming i.e. section 13(1)(b) of the Act, the plaintiff stated that the same requires a specific individualized claim. A broad claim which may cover TICAGRELOR among millions of other compounds is insufficient for the purpose of prior claiming.
  3. On the applicability of section 3(d) of the Patent Act i.e. ‘Ever-greening’, the plaintiffs pleaded that the defendants have not been able to point out any known substance from the genus patent of which TICAGRELOR could be considered a new form/derivative. Further, the plaintiff states that mere structural similarity is not sufficient to trigger section 3(d) of the Act.
  4. On the argument about non-disclosure of various revocation proceedings outside India i.e. alleged non-compliance of Section 8 of the Act it is stated that equivalent of IN 907 was revoked in China but an appeal has been filed which implies an automatic stay of the operation of the revocation order. It is further stated that 57 countries have granted patent for the same. Regarding IN 984 it is accepted that in Europe and China the patent was revoked. However, as an appeal has been filed and there is an automatic stay in operation. It is reiterated that the patent has been granted in 55 countries. Regarding the patent IN 674 it is stated that there is no revocation order passed and the patent is subsisting in 60 countries. Further, there is substantial compliance of the statutory provisions by the plaintiff and there is no mala fide suppression and hence section 8 of the Patent Act would have no application.
  5. Regarding the reliance of the defendants on the alleged admissions made by the plaintiff in the US Patent Term extension applications and in form 27 filed by the plaintiff in India, it is stated that form 27 only states that the genus patent has worked through TICAGRELOR. This does not mean that TICAGRELOR has been disclosed therein. It is stated that multiple patents can cover a single product. Further, the genus patent discloses an entire class of compounds and thus does not pertain to a commercialized substance. It is the only after the act of isolation of TICAGRELOR through species patent that the plaintiff has been able to state that the genus patent is being worked or commercialized through Brilinta.

The various issues dealt with by the Hon’ble Court and the opinion of the Court regarding the same is provided below: –

ISSUE I: Is TICAGRELOR disclosed and covered in the now expired patent IN 229

The Court relied on the judgment passed by the Supreme Court in Novartis AGs v. Union of India & Ors. which held that “the scope of coverage is distinct from the scope of disclosure in a patent. It was further contended that coverage under a patent of the Markush kind cannot lead to any presumption of disclosure, much less any enabling disclosure of all the compounds”. The Supreme Court negated the argument that is sought by learned counsel for the plaintiff that coverage in a patent might go much beyond disclosure.

The plea of the plaintiff that genus patent has worked through TICAGRELOR though TICAGRELOR is not disclosed in IN 229 cannot be accepted at this stage. The plaintiff have prima facie failed to explain the admissions/conduct as contained in Form 27 filed as noted above and the litigation commenced in USA against Mylan INC.

The Court further held that the plaint is strikingly silent about the said aspect of the patent IN 229 especially keeping in view the own admissions of the plaintiff whereby they have claimed that IN 229 is worked through TICAGRELOR. The Court stated that:

“It is the case of the plaintiffs in their submissions that it is only the act of isolation of TICAGRELOR through the species patent i.e. IN 907 that the plaintiffs have been able to state that the genus patent is being worked or commercialized through Brilinta. Hence, the stand is that prior to isolation of TICAGRELOR through species patent, there was no commercial working of IN 229. Surprisingly, no such averment has been made in the plaint by the plaintiffs. The only averment in the plaint about the patent IN 229 is that the same is a genus patent covering vast number of compounds and TICAGRELOR is not specifically disclosed in the genus patent though it is technically within the generic scope of numerous compounds including in Formula-I of the said application. It is further stated that a person skilled in the art could not have recognized TICAGRELOR from the genus patent. That is the sum and substance of the averment made by the plaintiffs in the plaint regarding the patent IN 229 and it‘s connect with TICAGRELOR. None of the above facts/explanations were pleaded or stated in the plaint. There is no averment in the plaint to claim that IN 229 (genus patent) was worked through TICAGRELOR though not disclosed in the said patent as is now sought to be pleaded in course of arguments. There is no averment in the plaint that IN 229 does not pertain to a commercialized patent.”

The Court held that the facts of this case show that the plaintiffs have been showing working of IN 229 through TICAGRELOR to the Controller of Patents while filing Form 27. The Plaintiffs have filed proceedings for breach of IN 229 when the drug in question was TICAGRELOR in USA. The Court further held that these being material facts should have been revealed in full in the plaint. This is especially so keeping in view the fact that Micro Labs Ltd. had already filed an application for revocation of the suit patent before the IPAB in 2015 where various grounds were urged including the fact that the suit patents are disclosed and covered in IN 229.

ISSUE II: Objections under section 3(d) of the Patents Act

While addressing the issue u/s 3(d) of the Patent Act the court noted the admissions of the plaintiff as contained in the Form 27 filed before the concerned authority in India where the patent IN 229 is shown to be working through TICAGELOR and the admissions made in the proceedings in the American Court filed against Mylan INC. The Court came to the conclusion that the plaintiffs have not been able to explain these admissions as the suit patents cannot be said to be “something altogether new or completely unfamiliar”. The Court further held that the plaintiffs had to show compliance of section 3(d) of the Patent Act. However, the plaint is completely silent about any enhancement of known therapeutic efficacy for the suit patents.

On the point of the enhancement of therapeutic efficacy, the affidavit of filed states that equivalent of IN 907 shows advantage of a lower predicated dose and increased metabolic stability. The Court, at this point, observed that there is no explanation from the plaintiff as to how the lower dose and increased metabolic stability would tantamount to enhancement of therapeutic efficacy over IN 229. The Court relied on the judgment passed by Hon’ble Supreme Court in Novartis v. UOI where the court held that:

‘Not all advantageous or beneficial properties are relevant but only such properties that directly relate to therapeutic efficacy.’

 The Court in this case held that the plaintiff has failed to show enhancement of known efficacy of the suit patents over the products and failed the test of section 3(d) of the Act.

ISSUE III: Non-compliance of Section 8 read with section 64(1)(m) of the Act

In the present case the Court observed that the plaintiffs have given reasonable explanation about the proceedings abroad stating that IN 907 was revoked in China but an appeal was filed and there is an automatic stay of the operation of the impugned order. Similarly IN 984 was revoked by EPO and China and an appeal has been filed which initiated an automatic stay of the operations. The Court was of the opinion that the plaintiffs have not failed to disclose any relevant facts in this case and have complied with section 8 of the Act. The Court further states that the failure of the plaintiffs to mention about the proceedings in China, and the proceedings regarding the European Patent are not material enough to warrant vacation of the interim orders passed by this Court.

 ISSUE IV: Should the court continue the interim injunction granted earlier?

While addressing this issue, the Hon’ble Court relied on the judgment passed by the Division bench in F. Hoffmann-LA Roche Ltd. & Ors. vs. Cipla Ltd which held that:

‘(vi) Notwithstanding the above, assuming that the plaintiffs held a patent for the product which was the subject matter of the suit for infringement, the grant of such patent to the plaintiffs will not ipso facto entitle them to an interim injunction if the defendant is able to satisfy the court that there is a serious question to be tried as to the validity of the patent. In the present case, the defendant has raised a credible challenge to the validity of the patent by raising a serious triable and substantial question that renders it vulnerable to challenge.’

The Court observed that the plaintiffs have failed to make out a prima facie case. The balance of convenience is also in favour of the defendant. This is especially so as the original patent in question IN 229 has already expired on 14.07.2018. Further, the drugs being sold by the defendants are substantially at a lower price. The Court therefore vacated the interim order/injunction passed. The defendants however have been asked to continue to maintain correct and true accounts regarding the sale of the impugned drugs which are sold or dealt by them in any manner.

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Injunction granted even when the Patent was under challenge

Pfizer Inc. filed a suit for permanent injunction restraining infringement of Indian patent no. IN209250 (which covers and claims the commercial product Sunitinib) and IN268331 (which covers the claims the commercial product Tigecycline) against Nagesh Palepu and others. The Defendants list Tigecycline and Sunitinib on their website in their list of pipeline products.

The Defendant argued that the patent is under credible challenge as two post grant oppositions and a revocation are pending in respect of the Patent and that the registration of the patent do not lead to presumption of validity. The Court did not agree with the Defendant and held that if the registration of a patent is not a proof of its validity, it is certainly not a proof to its invalidity. The Court granted a preliminary injunction holding that the balance conveniences is in favour of the plaintiff and if the injunction is not granted, it will suffer irreparable lose and injury.

“Hot tubbing” for expert witness by the DHC

The Delhi High Court (DHC) in the Micromax Vs. Ericsson case, based on the suggestions exchanged by the parties and considering the procedure adopted by the Federal Courts in Australia and in the United Kingdom, would be adopting the “hot tubbing” procedure to facilitate appreciation of expert technical evidence, in a shortened procedure.

The Court may devise a slightly modified hot tubbing procedure for the present case, considering the facts of the case.

 

 

Non-compliant defendants face permanent injunction

DSM Sinochem Pharmaceuticals has been granted permanent injunction against Sinopharma Weiqida pharmaceuticals as the defendants failed to timely submit the defense (written statement) and pay the costs imposed by the Court.

The Plaintiffs DSM Sinochem Pharmaceuticals sued Sinopharma Weiqida pharmaceuticals for permanent injunction to restrain them from using , manufacturing , distributing, selling, offering for sale or dealing directly or indirectly in API Amoxixillin Trihydrate produced by a process that amounts to infringement of Indian Patent number 247301, or a formulation thereof.

The defendants did not file the written statement inspite of three opportunities and did not pay the costs imposed by the court. During a hearing on 16th May 2017, the counsel of the Defendants said that the written statement is ready, an advanced copy of which would be handed over to the counsel of the Plaintiffs and the cost imposed would be remitted in the course of the day.  The matter was listed for the next day, provided an additional cost of 50,000 is paid.

During the hearing on the next day, the Court observed that no written statement has been filed nor the cost imposed on the Defendants has been paid. Considering the same, the Court closed the rights of the Defendants to file a written statement. The Plaintiff’s in the absence of any challenge to its patent was considered to be entitled to a decree of permanent injunction in its favour.

DHC reinstates the agreement between Monsanto Inc and Nuziveedu Seeds

Justice R. K. Gauba of the Delhi high court (DHC) by an order dated 28th March 2017 ruled that Monsanto Technology LLC’s termination of its sub- licence agreement with Nuziveedu Seeds Ltd was illegal and arbitrary.

DHC has reinstated the agreement, however, the trait fee to be paid to the plaintiffs, for the use of the suit patent and trademarks have been directed by the Court, to be in accord with the prevalent local laws, as in force. The court also directed the agreement to be modified according to the format of the GM Technology Agreement Guidelines, 2016 issued by the government.

The facts of the case are as follows:-

  1. Suit for infringement and passing off was filed by Monsanto Technology LLC, Monsanto Holdings Private Limited and Mahyco Monsanto Biotech (India) Pvt. Ltd. impleading three defendants, namely Nuziveedu Seeds Limited, Prabhat Agri Biotech Limited and Pravardhan Seeds Private Ltd., on the groubds that the defendants were continuing to “market and sell” Genetically Modified Hybrid Cotton Planting Seeds inspite of termination of the sub-license agreements between the parties, alleging violation of their intellectual property rights covered by the registered patent (214436), and trademarks BOLLGARD and BOLLGARD II.

  1. The defendant submitted two counter claims. One counter claim prayed for a declaration that the sub-licensing agreements (of 2015) is “valid, binding and in force” and consequently, the defendants being entitled to “all the rights and benefits” thereunder. The other counter claim prayed for revocation of the plaintiffs‟ patent 214436.

  1. The Plaintiffs patent 214436 claims a method for producing a transgenic plant comprising incorporating into its genome a nucleic acid sequence comprising a plant functional promoter sequence operably linked to a first polynucleotide sequence encoding a plastid transit peptide, which is linked in frame to a second polynucleotide sequence encoding a Cry2Ab Bacillus thuringiensis ᴕ- endotoxin protein, wherein said plastid transit peptide functions to localize said ᴕ- endotoxin protein to a subcellular organelle or compartment” (claims 1 to 24) and a nucleic acid sequence comprising a promoter operably linked to a first polynucleotide sequence encoding a plastid transit peptide, which is linked in frame to a second polynucleotide sequence encoding a Cry2Ab Bacillus thuringiensis 8-endotoxin protein, wherein expression of said nucleic acid sequence by a plant cell produces a fusion protein comprising an amino-terminal plastid transit peptide covalently linked to said 5-endotoxin protein, and wherein said fusion protein functions to localize said 5-endotoxin protein to a subcellular organelle or compartment” (claims 25 to 27).

  1. The marks “BOLLGARD” and “BOLLGARD-II” having been registered, in India, under the Trademarks Act, 1999.

  1. Mahyco Monsanto Biotech (India) Pvt. Ltd. entered into sub-license agreements with defendants (2004), and under such sub-license agreements, the defendants received 50 grams of Transgenic Bt. Cotton seeds in consideration of Rupees Fifty Lakhs. The said sublicense agreement also contained an obligation on the defendants to pay a “trait value”.

  1. During the currency of the sub-license agreements of 2004, some dispute arose with regard to the “trait value” and the 2004 sub-license agreements were replaced by new sublicense agreements executed separately in favor of each of the three defendants (sub-license agreements of 2015).

  1. In the meantime, the Central Government in terms of Cotton Seeds Price (Control) Order, 2015, issued a notification via which the maximum selling price of Bt. Cotton Seeds packets were fixed. The MSP for BG I being Rs. 635 per packet, with zero trait value being payable, while the MSP for BG II version being Rs. 800 per packet inclusive of Rs.751 towards seed value and Rs. 49 on account of trait value.(The  intervention of the Central Government by above noted Cotton Seeds Price (Control) Order, 2015, was challenged and such challenges by and large being still sub-judice.)

  1. Licensing and Formats for GM Technology Agreement Guidelines, 2016, were also notified and published by the Government of India. These Guidelines primarily made to ensure non-discriminative licensing to encourage competition and availability of GM cotton seeds to cotton farmers at fair and reasonable prices.

  1. The defendants by their communication informed Mahyco Monsanto Biotech (India) Pvt. Ltd. that the trait value payable under the 2015 Sub-License Agreements stood statutorily modified and that Mahyco Monsanto Biotech (India) Pvt. Ltd. should charge the trait value. This request was turned down and this took the matter to the High Court of Judicature at Bombay.

  1. For the kharif 2015-16 season, Mahyco by further communications called upon the defendants to pay the trait value in terms of 2015 Sub-License Agreements, but such demand was not being complied with. Instead, by their similar communications, the first and second defendant requested the plaintiff to refund the trait fee statedly paid “in excess”, referring to the Government of India price control orders. This demand did not find favour with Mahyco and Plaintiffs alleging breach terminated the agreement. Hence the present suit.

Arguments and finding

 

  • Validity of suit patent:-

Validity of the suit patent was challenged under various provisions of the law like Section 3(f), 3(h) and (j), Section 8, Section 10 (4) and Section 59 (1) etc.

The court held that, whether or not the suit patent is liable to be revoked is a question which would need to be addressed at an appropriate stage only after pleadings in that regard are complete and evidence is adduced on issues thereby raised. No comments were made on such aspect of the dispute.

The court however made a prima-facie finding regarding patentability under section 3(j). The Court agreed with the submissions of the plaintiffs that Section 3(j) of the Patents Act, cannot deprive the patentee of due reward of human skill and ingenuity resulting in human intervention and innovations over and above what occurs in nature. Suit patent involve laboratory processes and are not naturally occurring substances which only are to be excluded from the purview of what is an invention by virtue of the provision contained in Section 3(j). These claims being products or processes of biotechnology are rightly entertained by the Indian Patent office.

  • Protected by the Plant Varieties Act

 It was also submitted by the defendants that impugned acts on the part of defendants are protected by the provisions of the Protection of Plant Varieties and Farmers Rights Act, 2001, by virtue of Section 92, overriding the Patents Act, 1970. The use of any variety as an initial source for the purpose of growing other varieties as is the activity undertaken by the defendants, the limited right of the person claiming ownership of the intellectual property right of such variety is to claim “benefit sharing” under Section 26.

The Court however did not agree with the Defendant and held that the invention which is the subject matter of suit patent is not same as development of a variety within the meaning of Plant Varieties Act. The right to use the genetic material is the subject matter of a patent granted and protected by the Patents Act, in general, and Section 48 thereof, in particular. Section 30 of the Plant Varieties Act is a provision meant only for “researchers” and not for entities such as defendants out to make commercial exploitation and further that it gives, at the most, right to use a “variety” to develop other varieties but not so as to confer the right to use DNA or genetic material.

The contentions of the defendants based on the provisions of the Plant Varieties Act or the import of possible remedy of “benefit sharing” available to the plaintiffs thereunder, or the question as to whether the same would be more efficacious, or extinguishes or erodes the rights conferred by Section 48 of the Patents Act, 1970 has however been left to be addressed at the time of final adjudication

  • Infringement:-

It was also contended that the fact that the defendants’ product comprises of components or genetic material conferring other traits in addition to the DNA construct or nucleotide sequences of the suit patent therefore there is no infringement. However this was considered to be irrelevant, as the presence of other components is immaterial so long as the patented invention is contained within the defendants’ product, this itself being sufficient to constitute infringement.

It was also argued by the Defendants that the claims are directed to a method performed in lab, the biological process adopted by the defendants however is essentially based on the other claims which though submitted with the application under PCT (Patent Corporation Treaty), were withdrawn, the same not being not patentable under section 3(j) and 3(h). The claims were therefore argued to be not infringed.

The court disagreed with the Defendants and accepted the argument of the Plaintiff that infringement by “use” of the patented invention in claims 25 to 27 stands made out because the defendants have admitted that their cotton varieties and hybrid exhibit Bt. trait which would have been triggered only on account of DNA construct or nucleotide sequence on claim nos.25 to 27. The use of the claimed construct was therefore held to be infringement. Court in this respect also relied upon the view taken by the Supreme Court of Canada in Percy Schmeiser vs. Monsanto, (2004) 1 SCR 902, wherein it was argued that ultimately what matters is whether the defendants are taking advantage (in whole or in part – directly or indirectly) of the technical contribution or patented invention of the plaintiffs.

  • Agreement

 The court held that the plaintiffs were duty bound to consider the request of the defendants as made by the communications beginning July 2015, for modification of the terms as to the rate of trait fee payable under the 2015 sub-license agreements for which the mechanism had been agreed upon in the agreement. Since the plaintiffs did not adhere to their obligation under the contract, the demand of payment under the contract terms being not lawful, it apparently being higher than the trait fee permitted by the law in force, the defendants could not have been found to be in default or to have breached their obligations. The termination of the sub-license agreements was therefore held to be prima facie illegal and arbitrary. The parties remain bound by their obligations under the terms and conditions of the 2015 Sub-License Agreements for the period(s) stipulated therein, or till the same are lawfully terminated.

The court also directed that the plaintiffs would be entitled to all the rights under the 2015 Sub License Agreements except as to the rate of trait value payable thereunder and the same has to be in accord with the prevalent local laws prescribed by Cotton Seeds Price (Control) Order, 2015 as indeed of the Licensing and Formats for GM Technology Agreement Guidelines, 2016, both promulgated by the Government of India.

DHC reinstates the agreement between Monsanto Inc and Nuziveedu Seeds

Monsanto Inc, sued Nuziveedu Seeds and its subsidiaries for continuing to sell cotton seeds using its patented technology despite termination of its sub-licence agreement in December 2015.

Justice R. K. Gauba of the Delhi high court (DHC) by an order dated 28th March 2017 ruled that Monsanto Technology LLC’s termination of its sub- licence agreement with Nuziveedu Seeds Ltd was illegal and arbitrary.

DHC has reinstated the agreement, however, the trait fee to  be paid to the plaintiffs, for the use of the suit patent and trademarks, have been directed by the Court, to be in accord with the prevalent local laws, as in force.

The court also directed the  agreement to be modified according to the format of the GM Technology Agreement Guidelines, 2016 issued by the government.

 

Stay tuned for a detailed report of the 96 page order!

DHC maintains the injunction on Cipla for Onbrez

The Delhi High Court (DHC) by its decision dated 9th March 2017 continues to bar Cipla Ltd from selling copies of Novartis AG’s drug Onbrez in India.

The entire controversy is respect of Indacaterol, which Novartis holds a patent for. Novartis markets Indacaterol under the name Onbrez. Indacaterol is a bronchodilator and provides symptomatic relief to persons suffering from chronic obstructive pulmonary disease (COPD). Cipla launched its generic version of the drug, Unibrez, in October, 2004. Cipla changed the name from Unibrez to Indaflo due to an undertaking which Cipla gave in a trademark infringement action filed by Novartis.

An order was passed by Justice Manmohan Singh in January 2015 which restrained Cipla from selling copies of Onbrez (Indacaterol).

An appeal was thereafter filed by Cipla against the order of January 2015. Cipla argued that, Novartis does not manufacture Indacaterol in India. The drug is manufactured by the Novartis in Switzerland and only small quantities are imported catering to a negligible number of patients. Thus, according to the appellant, the respondents are not working the patent in India and consequently, they are not entitled to an injunction.

It was also argued that right under section 48 would be subject to the fact that the patent is worked in India on a commercial scale; that the patent is not used by a patentee merely to enjoy a monopoly for the importation of the article

It was submitted that the non-availability was further aggravated by the fact that the price of the respondents Indacaterol was exorbitant as compared to Indacaterol manufactured, supplied and sold by the appellant. The price of the respondents product was five times that of the price of the appellant‘s product

The Respondent argued that, while public interest considerations may be a relevant factor in certain circumstances such as in the case of life saving drugs, it cannot by itself outweigh the rights of a patentee in the case of infringement of the patent as provided under the said Act.

It was also submitted on behalf of the respondents that the statistics said to have been provided by the appellant with regard to the extent of COPD patients in India is not reliable. References were made to certain articles to suggest that COPD does not include an asthma-like respiratory symptom or chronic bronchitis and, therefore, the number of patients suffering from asthma or chronic bronchitis cannot be considered as part of COPD patients. It was also stated that manufacturing in India is not necessary for the working of a patent. The respondents have patents in several countries and this does not mean that they have to manufacture in each country. All that is required is that the manufacturing facilities must be capable of supplying worldwide depending on the demand.

The Division bench, after considering the arguments of both he parties, held that the injunction granted by the learned single Judge ought not to be disturbed.

The various reasons for the same stated by the bench are as follows: –

  • There is no credible challenge to the respondent‘s patent No.222346. Therefore, prima facie, the respondent is straightaway entitled to an injunction in view of the rights available to it as a patentee under Section 48 of the said Act;
  • The provisions of Section 83 (working and CL ) do not curtail or circumscribe the rights of the patentees under Section 48, except in the backdrop of compulsory licences and ancillary issue;
  • It is not at all necessary that for a patent to be worked in India, the product in question must be manufactured in India. A patent can be worked in India even through imports. All that is to be seen is that the imports are of a sufficient quantity so as to meet the demands for the product. Whether the extent of imports is not sufficient for meeting the demands of COPD patients in India, would be a matter of evidence which can only be thrashed out in the course of a trial.
  • 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.