Full Text
HIGH COURT OF DELHI
Date of Decision: 10th July, 2023
PFIZER INC & ORS. ..... Plaintiffs
Through: Mr. Pravin Anand, Tusha Malhotra, and Aditya Kaushik, Advocates. (M:
8860276202)
Through: Mr. Vikas Khera, Mr. Vishal Sharan and Mr. Ved Prakash, Advocates.(M:
9456040966)
JUDGMENT
1. This hearing has been done through hybrid mode.
2. The present suit was filed for permanent injunction restraining infringement of patent numbers IN 218291, IN 249316, IN 243571 and IN
250050. The said patents as per the Plaintiff cover two products i.e., Palbociclib and Crizotinib in their different forms. The Plaintiffs are assignees to the said patents being asserted in the suit. The case of the Plaintiffs is that the patents are valid till 10th January, 2023 (Palbociclib) and 15th August, 2025 (Crizotinib) and are being infringed by the Defendant.
3. The details of the suit patents being asserted and the products they cover, as averred by the Plaintiffs are as follows: (a) IN 218291 is assigned to Plaintiff No. 2- Warner Lambert Company LLC and the said patent covers and claims the product, which is commercially sold under the trade name ‘Ibrance’ and in India as ‘Palbace’. The bibliographic details of IN 218291 are as follows: (b) IN 249316, IN 243571, and IN 250050 cover and claim the product of the Plaintiffs’, ‘Crizotinib’, which is commercially sold under the trade name Xalkori and in India as Crizalk. Plaintiff No. 1- Pfizer Inc is the assignee of IN ‘571 and IN ‘050 and Plaintiff No. 3- Sugen LLC is the assignee of IN ‘316. The bibliographic details of the three patents covering ‘Crizotinib’ are as follows
4. The allegation in the present suit was that the Defendant had listed these products as being available for manufacture and sale, on its website. Thus, the Plaintiffs sought an injunction against launch of any products which would be infringing of its suit patents. This suit was first listed before this Court on 9th February 2022 and on the said date, an ex-parte injunction was granted against the Defendants vide order dated 9th February, 2022 in the followings terms:
5. Thereafter, pleadings have been completed in the matter. The Defendants have challenged the territorial jurisdiction of this Court by way of an application filed under Order VII Rule 11 CPC but did not choose to file written statement. On 22nd August, 2022, an affidavit of Mr. Kamlesh Patel was filed by the Defendant. The relevant portions of the said affidavit reads as under:
7. Thus, the Defendant gave an undertaking not to launch any product which would be infringing of the suit patents. Subsequently, on 23rd September, 2023 a submission was made on behalf of the Defendant that the undertaking was subject to arguments before the Court on maintainability and jurisdiction. The same was not acceptable to the Plaintiff and hence a stalemate ensued despite the Defendant having giving an undertaking that the suit could be disposed of by recording its stand.
8. An application I.A., 3543/2023 was also filed under Order XXXIX Rule 2A in which notice was issued on 22nd February, 2023. On same date, the interim injunction was made absolute till the adjudication of the suit. Vide order dated 11th April, 2023, a Director of the Defendant was directed to appear before the Court as the explanation given by the Defendant for the continued listing of the impugned products was found to be unacceptable to the Court.
9. Today Mr. Dave Upendarkumar has appeared before the Court and has given a statement which has been recorded. As per the said statement, the Defendants’ stand is that the state Food and Drugs Control Administration (FDCA), State of Gujarat, approval for both products, has been surrendered. A copy of the said letter dated 10th August, 2022 written by the Defendant to the FDCA has also been handed over to the Court. The Defendant is also agreeable to stand by the undertaking given by Mr. Kamlesh Patel. It is stated that the listings of the patented products have also been removed from the website. The statement is set out below for the sake of ready reference: “Statement of Mr. Dave Upendarkumar S/o Mr. Vishnuprasad, Age: 56 years, R/o, A-10, Radheshyam Society, Kathavada Road Naroda Ahmadabad City, Gujarat-382330 On S.A. I, Dave Upendarkumar, Technical Director, am in charge of quality control, production and quality assurance in West-Coast Pharmaceutical Works Ltd. I have been working in this company for the last 32 years. I am a graduate by qualification, and have completed B.Sc. in Chemistry. I have also obtained the Food and Drugs Control Administration (FDCA) certification in tablet and liquid section. I state and submit that the company has not manufactured or sold a single product of Palbociclib or Crizotinib. The Defendant in the present suit West-Coast Pharmaceutical Works Ltd. had obtained a drug approval from the said drug department without being aware of the status of patents of the products. For the said purposes, the Defendant had prepared a raw label and had submitted the same for the approval. Whenever any new product is approved by the State FDA for the Defendant, the same is put up on the website for marketing and promotion. In the present case, after the suit was filed and injunction was granted, we had instructed the concerned IT personnel to remove the listings of these two products. However, the same appears to have not happened due to an inadvertent error by the IT Department. The said listings have now been removed. The Defendant has not even sourced or purchased the API for these two product formulations, from any procurement entity. I stand by the undertakings given by Mr. Kamlesh Patel who is one of the Directors of the Defendant. The Defendant shall be bound by the submissions made in the affidavit of Mr. Kamlesh Patel.”
10. One of the products i.e., Palbociclib, covered by IN 218291 has also become off-patent as the patent has completed its full term in January, 2023. The undertaking of the Defendant to the effect that it does not intend to manufacture, sell, or offer for sale Crizotinib products is accepted and taken on record.
11. The statement made on behalf of the Defendant today clearly suggests that there have been no steps taken by the Defendant towards manufacture or sale of the products which were subject matter of the suit patents.
12. Under such circumstances, no useful purpose is served in continuing the suit inasmuch as Defendant having not manufactured or sold any product of Palbociclib or Crizotinib, no rendition of accounts would also be liable to be directed. However, insofar as the non-removal of the listing on the website is concerned, the explanation that the instructions were given to the IT department which did not remove the listing is clearly unconvincing. However, since the listing of the infringing products have now been removed and no manufacture or sale of any infringing products has been done by the Defendants, the application under Order 39 Rule 2A is disposed of by cautioning the Defendant to be careful in future and ensure that orders passed by the Court are duly complied with.
13. Accordingly, accepting the undertakings on behalf of the Defendant the suit itself is liable to be decreed. Since the product patent in respect of ‘Palbociclib’ has already expired, a decree of permanent injunction is issued against the Defendant from manufacturing or selling any ‘Crizotinib’ pharmaceutical preparations till the expiry of the patents IN 249316, IN 243571 and IN 250050 i.e., 15th August, 2025.
14. Since the suit itself has been decreed, the contempt application is also disposed of. However, the Defendant shall pay a sum of Rs.3,00,000/- to the Plaintiff within six weeks, as costs.
15. Insofar as the product Palbociclib is concerned, the interim injunction already granted shall no longer be operational.
16. The suit is decreed in the above terms. All pending applications are disposed of.
PRATHIBA M. SINGH JUDGE JULY 10, 2023 dj/am