Full Text
HIGH COURT OF DELHI
Date of Decision: 13th December, 2024
PFIZER INC. & ORS. .....Plaintiffs
Through: Ms. Tusha Malhotra and Ms. Tanvi Bhatnagar, Advs.
Through: None.
JUDGMENT
1. The present suit has been filed seeking relief of permanent injunction restraining the defendants from infringement of Indian Patent No. 241773 titled “Pyrrolo [2, 3-d] Pyrimidine compounds” and Indian Patent NO. 218212 titled “crystalline 3-{(3R,4R)-4-methyl-3-[methyl-[7H-pyrrolo [2,3- D]pyrimidin-4-yl)amino]-piperidin-1yl}-3-oxo-propinitrile mono citrate salt and its method preparation” (hereinafter referred as ‘suit patents’) along with other ancillary reliefs.
CASE SETUP IN THE PLAINT
2. The plaintiff no 1, Pfizer Inc., is a corporation established under the laws of Delaware and serves under the Pfizer Group of companies which is renowned for its expertise in the research and development of innovative pharmaceutical and healthcare products.
3. The plaintiff no.2, Pfizer Products Inc., is a corporation organized under the laws of State of Connecticut, USA and is a wholly owned subsidiary of plaintiff no 1.
4. The plaintiff no 3, Pfizer Products India Private Limited is a subsidiary of plaintiff no[1], and is a private limited company duly incorporated under the Companies Act, 1956 having its registered office at Mumbai. The plaintiff no.3 markets various pharmaceutical and health care products in the Indian domestic market.
5. It is averred that the plaintiffs group of companies has legacy spanning over 150 years and the plaintiffs have consistently worked to ensure the availability of high-quality products at affordable prices for patients worldwide. As part of their Corporate Social Responsibility efforts, the plaintiffs actively support various programs and initiatives in areas such as cancer care, rural healthcare, and disaster relief. It is stated that the plaintiff no.3 extensively collaborates with the Government of India to provide education and training aimed at building the capacity of healthcare professionals. The plaintiffs also maintain partnerships with organizations like the Multiple Sclerosis Society, Bombay Leprosy Project, Naee Nigah Program, and Help Age India. The details of some of their key initiatives are provided in paragraph 9 of the plaint.
6. Additionally, the plaintiffs have received numerous awards and commendations in recognition of their innovative, ground-breaking products and their contributions to fulfilling corporate social responsibility.
7. The present action is in respect of the suit patents. The bibliographic details of the suit patents are mentioned below: Indian Patent NO. 241773 218212 Title “Pyrrolo [2, 3-d] Pyrimidine compounds” “crystalline 3- {(3R,4R)-4-methyl- 3-[methyl-[7Hpyrrolo [2,3- D]pyrimidin-4yl)amino]-piperidin- 1yl}-3-oxopropinitrile mono citrate salt and its method preparation” Patentee Plaintiff No.2 (Pfizer Products Inc.) Plaintiff No.2 (Pfizer Products Inc.) Application No. IN/PCT/2002/00588/DEL 1095/DELNP/2004 International Filing Date November 23, 2000 November 25, 2002 International Filing Number PCT/IB00/1742 PCT/IB02/04948 National Phase entry-filing date of India Application June 10, 1999 April 23, 2004 Priority Date (earliest) December 10, 1999 December 6, 2001 Publication Date under Section 11- A of Patents Act March 20, 2009 October 3, 2008 Grant Date July 24, 2010 March 31, 2008 Patent Valid upto November 23, 2020 November 25, 2022
8. Relevant details of the suit patents are mentioned in detail at paragraph 16 (a) and (b) of the plaint. The relevant documents with regard to the suit patents are filed with the suit.
9. The plaintiffs are owners of the suit patents, the claims of which cover Tofacitinib, its pharmaceutically acceptable salts and specific form of Tofacitinib mono-citrate.
10. It is averred that Tofacitinib is the active pharmaceutical ingredient of the product marketed under the name Xeljanz®. Xeljanz® was launched in India in the year 2016 and is marketed by an affiliate company of the plaintiffs in India. The details about XELJANZ are given in the document filed by the plaintiff along with the plaint.
11. It is further stated that Xeljanz® received approval from the United States Food and Drug Administration (FDA) in November 2012 for the treatment of adult patients with moderate to severe active rheumatoid arthritis. Furthermore, Xeljanz® has been approved for use in patients across 86 countries, including but not limited to the United States, Japan, Switzerland, Argentina, Kuwait, the United Arab Emirates, and Russia, where it is marketed under the trade name Jaqinus.
12. The plaintiffs have developed Xeljanz® following extensive research and development efforts, incurring millions of dollars in costs and expenses not only for its development but also for obtaining patents and marketing approvals globally. Xeljanz® addresses a long-standing need for a secondline oral treatment for Rheumatoid Arthritis, serving as an alternative to the injectable treatments currently available. The product has achieved significant commercial success in the United States and its net sales are detailed in paragraph 21 of the plaint.
13. It is contended that Xeljanz® has also achieved substantial commercial success in India since its launch in 2016. A copy of the Chartered Accountant’s certificate is filed along with the plaint. The plaintiff’s Tofacitinib uniqueness is reflected in paragraph 24 of the plaint.
14. It is averred that the plaintiffs have diligently protected their rights in the suit patents, initiating legal proceedings against third parties on multiple occasions. The plaintiffs' rights in the suit patents have been upheld and protected by this Court. The details of such proceedings are outlined in paragraph 25 of the plaint.
15. It is stated that no pre-grant or post-grant opposition was filed against the suit patents during their term. As a result of the grant of these patents, the plaintiffs held the exclusive right to prevent any third party from manufacturing, using, offering for sale, selling, or importing the subject matter of the suit patents for the duration of their validity.
16. The defendant no.1, Everest Pharmaceuticals Limited, is stated to be a pharmaceutical company with its head office in Bangladesh. As per its website, www.everestpharmabd.com, the defendant no.1 claims to manufacture a range of general and specialized pharmaceutical products, including those in the fields of oncology, nephrology, hematology, virology, and other biotic products. The defendant no.1 further claims to formulate newly invented molecules and make them accessible in Bangladesh and globally. The product list on the defendant no.1's website includes the generic version of the plaintiffs’ patented product under the name ‘Tofaxen’.
17. The defendant no.2, Kavya International, is an entity located in Chandni Chowk, Delhi. It claims to be a pharmaceutical distributor dealing in anti-cancer and specialty drugs. Mr. Ajay Kumar is stated to be the owner of the defendant no.2. The defendant no.2 has confirmed having a dealership arrangement with the defendant no.1 and has supplied the impugned ‘Tofaxen’ product, along with other products of the defendant no.1, to the investigator commissioned by the plaintiffs.
18. The defendant no.3, SG Overseas, is stated to be an entity based in Surat, Gujarat. The defendant no.3 has been operating as a trader of anti- HIV medicines, eye drops, and skincare medicines since 2020. As per its website, Mr. Sagar Gajera is identified as the owner of the defendant no.3, which has been confirmed by the independent investigator commissioned by the plaintiffs during a field investigation at the premises of defendant no.3. The defendant no.3 has been found offering for sale and advertising the generic ‘Tofaxen’ product of the defendant no.1 on the IndiaMart website. Additionally, the defendant no.3 was also willing to supply the impugned product for ₹5,000 and has confirmed exporting the same to countries outside India.
19. The defendant no.4, Life Care Medicos, is stated to be an entity based in Delhi. On its website, www.esuppliersindia.com, the defendant no.4 claims to be a supplier and trader of pharmaceutical medicines. Mr. Ankit Mangala has been identified as the proprietor of the defendant no.4. The defendant no.4 has been found willing to supply the impugned generic version of the plaintiffs’ product for ₹6,500.
20. The defendant no.5, Genius Remedies, is stated to be an entity located in Maharashtra, India. It is registered as a limited liability partnership (LLP) with the Ministry of Corporate Affairs, having an incorporation date of 8 June 2015. On the website www.Indiamart.com, the defendant no.5 claims to be a manufacturer, trader, importer, and exporter of pharmaceutical tablets and capsules, with an annual turnover between INR 5 to 10 crores. The defendant no.5 has been found advertising and offering for sale the generic version of the plaintiffs’ patented product on the Indiamart website. The defendant no.5 was also willing to supply the impugned product for ₹5,500 per bottle.
21. It is stated that defendant no.1. supplied the said impugned product to an investigator commissioned by the plaintiffs through defendant no[2]. Defendant no.1 is the common manufacturer and marketer of the generic versions of the drugs covered by the suit patents, which are being advertised, offered for sale, and being sold by defendants no.2 to 5.
22. In the third week of January 2020, the plaintiffs discovered a listing for the infringing product, “Tofaxen,” advertised by defendant no.5 on the website of IndiaMart Intermesh Ltd. The listing identified defendant no.1 as the manufacturer of the infringing product. Subsequently, the plaintiffs engaged an investigator to verify the availability of the infringing product in the Indian market.
23. Upon investigation, it was found that the defendant no.1 is the manufacturer of the impugned product ‘Tofaxen’, and has exported, marketed, and sold this impugned generic version of the patented product into India.
24. The actions of the defendants are stated to have arisen from the same transaction or a series of transactions, thereby giving rise to a cause of action in favour of the plaintiffs.
25. Being aggrieved by the aforesaid activities, the plaintiff filed the present suit seeking to restrain the defendants from carrying on their infringing activities.
PROCEEDINGS IN THE SUIT
26. On May 4, 2020, this court granted an ex-parte ad-interim injunction in favour of the plaintiffs and against the defendants restraining them from using, making, selling, distributing, advertising, exporting, importing and offering for sale, or in any other manner, directly or indirectly, dealing in any product including ‘Tofaxen’ that infringes the subject matter of Indian Patent Nos. 241773 and 218212.
27. On 12th November, 2020, this court noted that despite issuance of summons to the defendants, none had appeared on their behalf to contest the present suit.
28. On 22nd February, 2021, this court directed the defendant no.4 to be physically present in the court and ordered to freeze the accounts of one Shreeja Enterprises.
29. On 22nd March, 2021, the bailable warrants were issued against the defendant no.4 for flouting the orders passed by this court on 22nd February,
2021.
30. On 25th July, 2022, the defendant no.2 entered appearance before this court and time was granted to file a reply.
31. During the pendency of this suit, the Indian Patent No. 241773 expired on November 23, 2020 and Indian Patent No. 218212 expired on November 25, 2022.
32. On December 1, 2022, on account of the expiration of the suit patents, the injunction continuing in favour of the plaintiffs and against the defendants was vacated.
33. Vide Order dated October 18, 2024, all the defendants in the present suit were proceeded against ex-parte.
ANALYSIS AND FINDINGS
34. I have heard the submissions of learned counsel for the parties and also perused the material on record.
35. The plaint has been duly verified and is also supported by the affidavit of the plaintiff. In view of the fact that no written statement has been filed on behalf of the defendants, all the averments made in the plaint have to be taken to be admitted. Further, since no affidavit of admission/denial has been filed on behalf of the defendants in respect of the documents filed with the plaint, in terms of Rule 3 of the Delhi High Court (Original Side) Rules 2018, the same are deemed to have been admitted. Therefore, in my opinion, this suit does not merit trial and the suit is capable of being decreed in terms of Order VIII Rule 10 of CPC.
36. Based on the averments made in the plaint, it is clear that the defendant no.1, during the subsistence of the plaintiffs rights in the suit patents, had engaged in the unauthorized export, sale, supply, and distribution of the infringing product ‘Tofaxen’ within India. The defendant no.1, in collusion with other defendants, particularly defendant no 2, had actively facilitated these infringing activities in complete disregard of the plaintiffs’ exclusive rights.
37. During the patent duration, the defendants no.2 to 5 had violated the law by importing, offering for sale, and distributing the product ‘Tofaxen’ without adhering to the statutory requirements for Schedule H drugs. These actions, conducted clandestinely and without valid prescriptions, demonstrate a calculated disregard for public health and regulatory compliance. Moreover, defendants no.3 and 5 were unauthorizedly exporting the infringing product ‘Tofaxen’ to Saudi Arabia for commercial purposes.
38. The defendants’ business practices including the failure to issue invoices and the acceptance of only cash payments during the subsistence of the suit patents demonstrate a deliberate attempt to evade regulatory oversight.
39. The defendants’ unlawful manufacture, sale, distribution, and export of the infringing product ‘Tofaxen’, a generic version of the plaintiffs’ patented drug, posed a substantial and immediate threat to public health.
40. The defendant no. 1 has a pattern of repeated and brazen infringement of plaintiff’s rights in the suit patents. Despite being injuncted by this Court in prior cases (CS (Comm) No. 351/2024 and CS (Comm) No. 688/2024), the defendant no.1 had persisted in its infringing activities which compelled the plaintiffs to file a contempt application (IA No. 2595/2021).
41. The defendants’ activities during the term of the plaintiffs’ patents had caused irreparable harm to the plaintiffs, both in terms of financial losses and infringing the rights of the plaintiff in the suit patent. The market had been unlawfully flooded with infringing products by the defendants which undermined the plaintiffs’ rights in the suit patents.
42. In view of the discussion above, I am of the view that the defendants have collectively infringed the suit patents while the suit patents were valid and subsisting. However, in view of the fact that the suit patents have expired during the pendency of the suit, the plaintiffs do not press for relief of permanent injunction claimed under prayer clause 57 (a) of the plaint and the plaintiffs only press for a decree in respect of terms of prayer clauses 57 (e) of the plaint.
43. The plaintiff does not press for the reliefs claimed in clauses 57 (b) to
(d) of the plaint.
RELIEF
44. In view of the foregoing analysis, a decree is passed in favour of the plaintiff in terms of prayer clause 57 (e) of the plaint.
45. For the purposes of calculation of actual costs, the plaintiffs are directed to file their bill of costs in terms of Rule 5 of Chapter XXIII of the Delhi High Court (Original Side) Rules, 2018 within four weeks.
46. For this purpose, the representatives of the plaintiff shall appear before the taxation officer on 14th January 2025, who shall determine the actual costs incurred by the plaintiff in the present litigation.
47. Let the decree sheet be drawn up.
48. All pending applications stand disposed of AMIT BANSAL, J DECEMBER 13, 2024