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:
- 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).
- 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.
- 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: –
- 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.
- 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.
- 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.
- 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.
- 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:
- 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.
- 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.
- 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.
- 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.
- 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.