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2020 Supreme(Del) 922

IN THE HIGH COURT OF DELHI AT NEW DELHI
Mukta Gupta, J.
Astrazeneca Ab And Anr. - Appellant
Versus
Emcure Pharmaceuticals Limited & Ors. - Respondent
CS(COMM) 561 and 562 of 2019
Decided On : 15-01-2020

Advocates Appeared:
Mr. Pravin Anand, Ms. Vaishali Mittal, Mr. Siddhant Chamola, Ms. Ankita Sabharwal, Advocate, for the Appellant, Mr. J. Sai Deepak, Mr. G. Natraj, Mr. Abhishek Audhani, Advocate, for the Respondent.

The court considered the infringement of Indian Patents No. IN 209907, IN 247984, and IN 272674 by the defendants' product TICAGRELOR under the brand names TICAPLAT and TIARE, and the imminent expiry of the plaintiffs' patent IN 907, leading to the decision not to grant an ad-interim injunction.

Headnote:

Patent Infringement - TICAGRELOR - Indian Patents No. IN 209907, IN 247984, IN 272674 - The court discussed the infringement of Indian Patents No. IN 209907, IN 247984, and IN 272674 by the defendants' product TICAGRELOR under the brand names TICAPLAT and TIARE. The court found that the plaintiffs made a prima facie case in their favor, but due to the imminent expiry of the plaintiffs' patent IN 907, no ad-interim injunction was granted. The defendants were directed to maintain accounts of sales from the launch of their products till the expiry of the patent.

Fact of the Case:

The plaintiffs sought interim injunction to restrain the defendants from making, selling, and distributing products infringing Indian Patents No. IN 209907, IN 247984, and IN 272674, covering the pharmaceutical compound TICAGRELOR. The plaintiffs claimed that their product TICAGRELOR under the name BRILINTA was significantly more effective than existing medications in preventing cardiovascular events.

Finding of the Court:

The court found that the plaintiffs made a prima facie case in their favor, but due to the imminent expiry of the plaintiffs' patent IN 907, no ad-interim injunction was granted. The defendants were directed to maintain accounts of sales from the launch of their products till the expiry of the patent.

Issues: The issues included patent infringement, validity of the patents, anticipation by prior claiming, enhanced efficacy of the invention, and the applicability of Section 10 of the CPC.

Ratio Decidendi: The court found that the plaintiffs made a prima facie case in their favor, but due to the imminent expiry of the plaintiffs' patent IN 907, no ad-interim injunction was granted. The defendants were directed to maintain accounts of sales from the launch of their products till the expiry of the patent.

Final Decision: No ad-interim injunction was granted due to the imminent expiry of the plaintiffs' patent IN 907. The defendants were directed to maintain accounts of sales from the launch of their products till the expiry of the patent.

JUDGMENT

1. By these two applications the plaintiffs seek interim injunction restraining the defendants, its directors, agents, etc., from making, selling, distributing, exporting, offering for sale product comprising of the compound TICAGRELOR under the brand TICAPLAT by the defendant Emcure Pharmaceuticals Limited in CS(COMM) 561/2019 and under the brand name TIARE by MSN Laboratories Pvt. Ltd., the defendant in CS(COMM) 562/2019 or any other product that infringes the subject matter of Indian Patents No. IN 209907, IN 247984 and IN 272674 as also directions to withdraw the stock and render accounts for the same, besides damages and costs.

2. Case of the plaintiffs is that they are owners of Indian Patent Nos. IN 209907, IN 247984 and IN 272674 which cover the pharmaceutical compound TICAGRELOR. The said patents being valid and subsisting, the defendants in breach of the plaintiffs valid and subsisting patents have launched their generic version of TICAGRELOR under the brand names as aforesaid.

3. As per the plaintiffs, defendants claim that their products contain (1S, 2S, 3R, 5S)-3-[7-[(1R,2S)-2-(3,4-Difluorophenyl)cyclopropylamino]-5- (propylthio)-3H [1,2.3] triazolo [4,5-d]pyrimidin-3-yl]-5-(2- hydroxyethoxy)cyclopentane-1,2-diol which is the empirical formula of TICAGRELOR i.e. C23H28F2N604S and its molecular weight is 522.57 g/mol"

4. Case of the plaintiffs is that it has successfully started manufacturing the product TICAGRELOR under the trade name BRILINTA which is 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. The drug of the plaintiff is priced at very reasonable and affordable price. The drug BRILINTA was initially sold at Rs. 50 per tablet and to further increase the accessibility of the product to patients, in June 2015 plaintiffs entered into an agreement with Sun Pharmaceuticals Industries Limited, an Indian company to sell and market TICAGRELOR under a second brand name i.e. AXCER. The plaintiffs have further reduced the price of drug BRILINTA to Rs. 30 per tablet as its MRP to make it more accessible. It is the claim of the plaintiffs that in the year 2017 alone plaintiffs have generated revenue in excess of US$ 1 billion worldwide for BRILINTA and the sales figure of the Indian market for the year 2017 alone have been in excess of Rs. 29 crores for BRILINTA and Rs. 44 crores for AXCER.

5. According to the plaintiff its product TICAGRELOR under the name BRILINTA has since proven to be significantly more effective than the existing medications such as clopidogrel in preventing further cardiovascular events in ACS patients.

6. The plaintiff had an earlier patent being IN 241229 for the ''Markush'' formula being the ''genus'' patent and IN 209907 is the ''species'' patent thereof whereas IN 247984 is the ''crystalline'' form and IN 272674 the ''finished'' formulation. The plaintiffs genus patent IN 229 has since expired on 14 th July, 2018 and the present suit patent i.e. IN 209907 would expire on 2 n d December, 2019. While addressing arguments on the application learned counsel for the plaintiffs has confined his arguments qua the infringement of IN 907 and not IN 84 and IN 674.

7. 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 X 10 (quintillion) compounds. Learned counsel for the Plaintiffs states that a broad umbrella coverage is understood as a genus patent in the format of Markush claim/ formula and is well-known under the patent law. 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

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