Astrazeneca AB & Anr. V. Emcure Pharmaceuticals Ltd. & Anr.

Important Issues

  1. Application for injunction- anticipation tested against Markush claim.
  2. Determination of date for assessing anticipation by prior art

Summary

Title: Astrazeneca Ab and Another v. Emcure Pharmaceuticals Limited and MSN Labaratories

Short Description of Patent: Plaintiffs are owners of Indian Patent Nos. IN 209907, IN 247984 and IN 272674 which cover the pharmaceutical compound TICAGRELOR. This compound was being manufactured and sold under the trade name BRILINTA as an oral anti-platelet treatment for Acute Coronary Syndrome (ACS). According to the plaintiff BRILINTA is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclopentyltriazolopyrimidines (CPTPs) and the first reversibly-binding oral ADP receptor antagonist. 

Factual matrix

  1. The Plaintiffs owned/continue to own the following four patents in relation to the drug:
  • IN 241229 (Genus patent/Markush patent)
  • IN 209907 (Species patent)
  • IN 247984 (Polymorph patent for the crystalline form)
  • IN 272674 (Formulation patent for the finished product)
  • The patents relate to the pharmaceutical compound “TICAGRELOR” which is a major component of the drug manufactured and sold by the Plaintiffs under the trade name BRILINTA as an oral anti-platelet treatment for Acute Coronary Syndrome (ACS). 
  • The Plaintiffs instituted suits against the Defendants in the years 2018 and 2019 seeking an injunction to restrain them from selling, marketing or dealing with TICAGRELOR or any product which is in violation of the subsisting suit patents. The suits were with respect to generic drugs consisting of TICAGRELOR manufactured and sold by Emcure Pharmaceuticals Limited as Ticaplat and by MSN Laboratories Pvt. Ltd. as Tiare.   

Submission by Plaintiffs

  • The Genus patent containing the Markush claim expired on 14.07.2018 and the Species patent relevant to the suit expired on 02.12.2019. While addressing arguments on the application learned counsel for the plaintiffs confined his arguments qua the infringement of the then subsisting Species Patent. 
  • The claim of the plaintiffs in IN 241229 was very broad being the genus patent, disclosing the possibility of individual permutations and combinations of making 1.5 × 1020 (quintillion) compounds, making the claim a Markush claim. A Markush claim refers to a chemical structure by means of symbol indicating substituent groups and in such a claim one or more parts of the claimed compound comprise multiple functionally equivalent entities. Markush type claims allow important innovations to be patented. They are very complex and can cover a wide range of chemical structures including valuable compounds that may be used in drugs.
  • Claim 8 of the Genus patent disclosed specific compounds but did not name TICAGRELOR. However, under the leverage provided by the umbrella structure described in the Markush claim, Plaintiff continued to carry out research and development for a more stable, active and less toxic compound which would be most utilitarian as an effective platelet aggregation inhibitor resulting in developing the compound TICAGRELOR. 
  • According to the plaintiff TICAGRELOR falls within the scope of claim 1 of the Species patent. Further, TICAGRELOR is specifically claimed as the third compound in claim 5 of the said patent and the process for its making has also been specifically disclosed in example 3. 

Submission by Defendant

  • The defendants contended that the Species patent IN ‘907 is hit by Section 3(d) read with Section 64(1)(a) of the Patent Act and hence, liable to be rejected. Section 3 explains what is not an ‘invention’ and 3(d) states that mere discovery of a new form of a known substance is not an invention unless there is enhancement of the known efficacy of the substance. It was the contention of the Defendants that under the species patent TICAGRELOR was neither a known substance nor had any efficacy because prior to IN ‘229 no drug was manufactured and tested. 
  • Defendants also relied on the Novartis AG case. It was contended that as in Novartis AG since the plaintiffs have claimed that the present drug emanates from the Markush formula of IN ‘229, the teaching of IN ‘907 being available in IN ‘229, the plaintiff cannot claim extension of term of the patent. Reference was made to para 125 of the 2013 judgement, and the dichotomy between disclosure and coverage and state that since the product under IN ‘907 as claimed is covered under IN ‘229 and disclosed therein, IN ‘907 is not a valid patent.
  • It was also contended that TICAGRELOR was not an invention since it was anticipated by the Genus Patent IN ‘229 and the said patent having expired, does not grant the plaintiffs any subsisting rights. Reference was made to Section 13 which deals with search for anticipation by previous claim and by prior art. 

Held

The Court ruled that the Plaintiff’s claim was not hit by Section 3(d) read with Section 64(1)(a). TRICAGRELOR under species patent IN ’907 was neither a known substance or anticipated by the Genus Patent, at the time of it publication. No drug was manufactured or tested, there was no known efficacy of the substance. Referring to the issue of anticipation, the Court observed that though the priority date of Species Patent IN ‘229 was 22nd July, 1997, the same was published only on 4th February, 1999 whereas the priority date of IN ‘907 is 4th December, 1998. Hence before the publication of IN ‘229, IN ‘907 had its priority date which means that TICAGRELOR under species patent IN’907 was not anticipated by Genus patent IN ‘229. Further pursuant to the plaintiff’s patent IN ‘229 no commercially viable drug was manufactured or tested and the commercially viable manufactured drug was sold under patent IN ‘907, in accordance with the rights conferred. 

Discussing the dichotomy between coverage and disclosure the Court stated that the Indian law of patents regarding product patents is still nascent. The Court further elaborated the SC judgment in Novartis AG and stated that the law should not be developed in a manner that leaves vast gaps between  disclosure in patent claims and the coverage offered thereof. Scope of the claim should be determined by the intrinsic value of the invention and not artful drafting of the claim. Hence, in this case, even though the genus patent IN ‘229 consisted of a Markush claim that disclosed a possible quintillion of compounds and named some specific compounds, it did not cover TICAGRELOR. This compound came to be covered only by the species patent IN ‘907. At this juncture, the Court also discussed the principles of claim construction that was laid down by the SC in Hoffman La Roche v. CIPLA.

Copy of the Judgement

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