In this judgement, the Himachal Pradesh HC made the ad-interim protection granted to the plaintiffs for alleged patent infringement by the defendant, absolute, during the pendency of the civil suit
The Plaintiff for this case: Boehringer Ing. Pharma
The Defendant for this case: Macleods Pharma
Judgement given by : Himachal Pradesh HC
Coram: Justice Ajay Mohan Goel
Date of Pronunciation: 21st April, 2022
OVERVIEW OF THE CASE
The plaintiff is the proprietor of Indian Patent No. 243301 titled “8 (3-AMINOPIPERDIN-1YL)-XANTHINE COMPOUNDS” that was granted on 5th October, 2010. The international filing date of the patent is 18th August, 2003 and the patent is anticipated to expire on 18th October, 2023. The medicinal product “Linagliptin Tablet and Lenagliptin + Metformin Hydrochloride Tablets” covered by the patent were introduced and launched in the Indian market under the brand name “Trajenta/Trajenta Duo” on 27.05.2012 and 21.06.2014, respectively.
The defendant had purportedly made preparation to launch and thereafter had launched infringing product Linagliptin 5 mg tablets under the brand names “LINAMAC” and “LINAONE”.
An ad-interim protection was previously granted by the Court to the plaintiff till next date of hearing (the application being listed before the Court on 25.02.2022) owing to the establishment of a prima-facie case of patent infringement. The defendant was restrained from manufacturing and selling medicinal product ‘Linagliptin’ in any form under the brand name of LINAMAC and LINAONE.
SUBMISSIONS ON BEHALF OF THE PLAINTIFF
The plaintiff argued that the product Linagliptin 5 mg tablets are covered by the subject patent and manufacturing of the product by the defendant is an act of infringement of the exclusive rights of the subject patent. They further argued that the defendant has neither any patent nor has got a licence to manufacture and sell the products covered by the subject patent from the applicant nor the respondents have applied for or have been granted compulsory licence to manufacture and sell the product. According to the plaintiffs, the following points demonstrate that there exists a good case in their favour for confirmation of the interim order:
- ‘subject patent’ is old and well established;
- ‘subject patent’ is commercially highly successful and extensively useful;
- admittedly, no party, including the defendant, raised any pre-grant opposition, post-grant opposition, including against the quality and strength of the ‘subject patent’;
- the patent was granted in favour of the plaintiffs after following the substantive provisions of the The Patents Act, 1970;
- the patent has had a successful commercial run in India for more than eleven years, without any challenge, including that from the defendant;
- the Central Government has not filed any revocation for the ‘subject patent’ in terms of Section 64 of the Patents Act, 1970;
- the Central Government has not made any declaration for revocation of the ‘subject patent’ in public interest in terms of Section 67 of the Patents Act;
- none, including the defendant, applied under Section 84 of the Patents Act for grant of compulsory licence of the ‘subject patent’ on the grounds as mentioned therein;
- no challenge was ever put forth by the defendants to the ‘subject patent’ except immediately before the commercial launch of its infringing product in the month of February 2022, when a revocation petition was filed by the defendants under Section 64 of the Patents Act.
SUBMISSIONS ON BEHALF OF THE DEFENDANT
On the other hand, the defendant submitted that as the defendant has laid a credible challenge to the ‘subject patent’ therefore, ad-interim injunction granted on 25.02.2022 be vacated. In particular, the defendants had obtained two patents, i.e. Patent No. 227719 for the “Markush” formula being the ‘genus’ patent, which expired on 21st February, 2022 and subject patent 243301, which is a ‘species’ patent and both patents were granted for the same invention as it is nowhere disclosed either in the plaint or in the application as to what was the inventive step capable of industrial application, which distinguished patent 227719 from 243301.
As per the defendants, it is settled law that mere grant of patent does not lend a presumption of validity to the patent. The scheme of the Patents Act is to provide multi-layer challenges, which are available to a non-patentee to challenge and question the validity of a patent at any time and such validity has to be tested on the anvil of the provisions of the Patents Act, 1970. It was argued that the provisions of Section 13(4) of the The Patents Act expressly set out the absence of any presumption of validity due to mere grant. It was also argued that in the case of pharmaceutical patents, which have been recognized as a specific species of patent infringement litigation, the overwhelming factor is that of public interest-namely the need to provide for affordable and accessible healthcare products.
COURT’S OPINION AND JUDGEMENT
Citing the SC’s decision in the case of M/s Bishwanath Prasad Radhey Shyam vs. Hindustan Metal Industries, the HC held that grant and sealing of the patent, or the decision rendered by the Controller in the case of opposition, does not guarantee the validity of the patent, which can be challenged before the High Court on various grounds in revocation or infringement proceedings. Moreover, the HC cited the objective laid by the SC in case of Dalpat Kumar and Another vs. Prahlad Singh and Others that the burden lies on the plaintiff by evidence aliunde by affidavit or otherwise that there is “a prima facie case” in his favour which needs adjudication at the trial.
The HC opined that the subject patent is an old patent and it has not been granted recently to the plaintiffs. Therefore, these facts do create a prima facie case and balance of convenience in favour of the plaintiffs vis-a-vis the defendant, who admittedly does not have any patent qua the infringing product. In light of all the observations made, the HC pronounced that the ad-interim protection granted to the plaintiffs, vide order dated 25.02.2022, is made absolute during the pendency of the civil suit, subject to any further order(s) which may be passed by the Court.