Boehringer Ingelheim Pharma Gmbh & Co. Kg Vs Vee Excel Drugs And Pharmaceuticals Private Ltd. & Ors. (Delhi High Court)
Delhi High Court held that filing of multiple patent claims in respect of the same invention amounts to evergreening or layering of patent protection, which is impermissible under the Indian Patent Law.
Facts- The present six suits have been filed on behalf of the plaintiff no.1, Boehringer Ingelheim Pharma Gmbh And Co. Kg and its group company, plaintiff no.2, Boehringer Ingelheim (India) Pvt. Ltd, against various defendants, who are Indian Pharmaceutical Companies, seeking permanent injunction restraining the defendants from infringing Indian Patent No. IN 243301 titled ―8 – (3 AMINOPIPERIDIN–1–YL)-XANTHINE COMPOUNDS‖. All the aforesaid six suits were accompanied by applications for grant of interim injunction under Order XXXIX Rules 1 and 2 of Code of Civil Procedure, 1908 (CPC).
Conclusion- In the present case also, the plaintiffs by filing multiple patents for different aspects of the same product are seeking to extend the term of the patent beyond twenty years, granted in respect of the genus patent, which expired on 21st February 2022. In my considered view, the action of attempting to patent both the genus and species patent would amount to evergreening or layering of patent protection, which is impermissible under the Indian Patent Law. Section 3(d) of the Patents Act has been incorporated in the statute to ensure that such action of evergreening and layering is prevented.
Held that by filing multiple patent claims in respect of the same invention, the plaintiffs have made an attempt towards evergreening the invention and re-monopolizing the same. These attempts on behalf of the patentees strike at the root of patent law in India. The aforesaid conduct of the plaintiffs defeats the rights of the manufacturers of generic drugs such as the defendant companies and is also detrimental towards the public interest.
In view of the discussion above, the plaintiffs have failed to make out a prima facie case for grant of interim injunction. Balance of convenience is in favour of the defendants and against the plaintiffs. Irreparable injury would be caused not only to the defendants but also to the public, if the interim injunction is granted in favour of the plaintiffs.
FULL TEXT OF THE JUDGMENT/ORDER OF DELHI HIGH COURT
I.A. 6797/2019 (O-XXXIX R-1 & 2 of CPC) in CS(COMM)239/2019 I.A. 6802/2019 (O-XXXIX R-1 & 2 of CPC) in CS(COMM) 240/2019 I.A. 5801/2022 (O-XXXIX R-1 & 2 of CPC) in CS(COMM) 236/2022 I.A. 5806/2022 (O-XXXIX R-1 & 2 of CPC) in CS(COMM) 237/2022 I.A. 5811/2022 (O-XXXIX R-1 & 2 of CPC) in CS(COMM) 238/2022 I.A. 7109/2022 (O-XXXIX R-1 & 2 of CPC) in CS(COMM) 296/2022
1. The present six suits have been filed on behalf of the plaintiff no.1, Boehringer Ingelheim Pharma Gmbh And Co. Kg and its group company, plaintiff no.2, Boehringer Ingelheim (India) Pvt. Ltd, against various defendants, who are Indian Pharmaceutical Companies, seeking permanent injunction restraining the defendants from infringing Indian Patent No. IN 243301 titled ―8 – (3 AMINOPIPERIDIN–1–YL)-XANTHINE COMPOUNDS‖. All the aforesaid six suits were accompanied by applications for grant of interim injunction under Order XXXIX Rules 1 and 2 of Code of Civil Procedure, 1908 (CPC).
Proceedings in the suits
2. Summons in CS(COMM) 239/2019 and CS(COMM) 240/2019 were issued on 10th May, 2019 and an ad interim injunction was granted in favour of the plaintiffs restraining the defendants from manufacturing LINAGLIPTIN tablets and the said interim order has continued till date.
3. Summons in CS(COMM) 236/2022, CS(COMM)237/2022 and CS(COMM) 238/2022 were issued on 19th April, 2022 and the following interim/pro tem arrangement was arrived at between the parties and the said arrangement has continued till date:
“15. After some hearing, learned Senior Counsel appearing on behalf of the Plaintiffs and learned counsels appearing on behalf of the Defendants, on instructions, agree that, as a pro-tem arrangement between the parties, Defendants shall not manufacture, sell, offer for sale and/or use LINAGLIPTIN or LINAGLIPTIN tablets, or any other pharmaceutical preparations or formulations containing LINAGLIPTIN as the active pharmaceutical ingredient, till the next date of hearing.
16. It is further agreed that Defendants shall be at liberty to sell the existing stock, already manufactured and the Defendants shall disclose the existing stocks and packaging, which they have already manufactured along with details of batch numbers, dates of manufacturing as well as the value of the stock, within a period of one week from today, on an affidavit.
17. It is made clear that this is purely a pro-tem arrangement between the parties for expeditious disposal of the applications and will not be treated as a precedent in any other case.”
4. Similar interim/pro tem arrangement was arrived at between the parties in CS(COMM) 296/2022.
5. Since the issues involved in all the aforesaid suits and applications for grant of interim injunction are broadly similar, they are being decided by way of this common judgment. As noted in the order dated 4th January, 2023, it was agreed between the parties that CS COMM (236/2022) shall be taken as the lead matter. Accordingly, for the sake of convenience, detailed facts of CS(COMM) 236/2022 have been recorded in the judgment. However, submissions on behalf of the counsels in all the aforesaid suits have been noted.
6. Submissions were heard on behalf of the counsels on 4th January, 2023, 5th January, 2023, 9th January, 2023, 11th January, 2023, 18th January, 2023 and 27th January, 2023 and the judgment was reserved on 27th January, 2023. Counsels for the parties have also placed on record various written submissions along with judgments relied by them.
Factual Background
7. Case set up by the plaintiffs in CS(COMM)236/2022 has been summarised below.
7.1 The plaintiff no.1 is engaged in the business of developing, manufacturing and marketing pharmaceuticals in India through the plaintiff no.2.
7.2 The plaintiff no. 1 was granted Patent IN 243301 (hereinafter also referred to as ―suit patent” or ―IN‘301″) on 5th October, 2010 under Section 43 of the Patents Act, 1970 (hereinafter ―Patents Act”) for the invention titled “8- (3 AMINOPIPERIDIN–1–YL)-XANTHINE COMPOUNDS” for a term of 20 years with effect from 18th August, 2003. The bibliographic details of the suit patent are set out hereunder:
