Case title: 

F. Hoffman-La Roche Ltd. & Anr. v. Cipla Ltd.

Date of Order: 

7th September 2012

Bench: 

Hon’ble Mr. Justice Manmohan Singh

Parties: 

Plaintiff(s): 1. F. Hoffman-La Roche Ltd.

              2. OSI Pharmaceuticals Inc.

              Defendant(s): Cipla Ltd.

SUBJECT:

The Hon’ble High Court of Delhi (hereinafter referred to as ‘the High Court’ or ‘the Court’) dealt with a case that revolves around a dispute concerning the patented Erlotinib compound, with the plaintiffs asserting its novelty and the defendant challenging its patentability under Section 3(d) of the Indian Patent Act. Central to the matter is the defendant's claim that the compound is a derivative of the known substance Quinazoline, lacking demonstrated enhanced efficacy. The court's judgment focused on the intricate evaluation of these contentions, ultimately rejecting the infringement claim and emphasizing the necessity for meeting stringent criteria in establishing the uniqueness and efficacy of pharmaceutical patents.

IMPORTANT PROVISIONS:

The Patent Act, 1970:

• Section 48
• Section 68
• Section 3(d)
• Section 8
• Section 2
• Section 35
• Section 39
• Section 58
• Section 57
• Section 26

The Code of Civil Procedure (CPC):

• Order 13 Rule 1
• Order 13 Rule 2
• Order 8 Rule 1A
• Order 7 Rule 14
• Order 18 Rule 17

OVERVIEW:

• A legal dispute emerged in the Delhi High Court between F. Hoffman-La Roche Ltd. (plaintiff no. 1) and Cipla (defendant) over the pharmaceutical drug 'Erlotinib,' commercially known as TARCEVA.
•  Central to the dispute is the compound Erlotinib hydrochloride, pivotal for both Roche and Cipla.
• In February 2007, the plaintiff claimed a patent for 'Erlotinib,' leading to the drug launch under the brand name TARCEVA.
• The primary objective was to secure exclusive rights for the production and sale of Erlotinib in the Indian market.
• In January 2008, the defendant announced its intentions to introduce a generic version of 'Erlotinib,' signaling impending competition with the plaintiff.
• The plaintiff initiated legal action against the defendant, asserting patent infringement concerning 'Erlocip,' Cipla's generic version.
• The court initially ruled against the plaintiff, justifying the decision based on the consideration that restraining the defendant's production would be contrary to the public interest.
• The court refrained from granting an injunction against Cipla, balancing pharmaceutical interests with the broader public welfare.

ISSUES RAISED:

• Whether the manufacture, marketing, and sale of ERLOCIP by the defendant is infringing the plaintiff’s Indian Patent?
• Whether the Indian Patent liable to be revoked on the grounds raised in a written statement and counter-claim of the defendant?
• Whether the plaintiffs are entitled to permanent injunction as prayed for?
• Whether the defendant/counter-claimant proves that the plaintiff's subsequent US Patent, is to the effect that the compound of claim No.1 of the suit patent is a mixture of the two, Polymorph A and B Compound and needs to be separated to perform and get the claimed compound for acceptable efficacy; and its effect on the plaintiff's patent?

ARGUMENTS ADVANCED BY THE PLAINTIFF(S):

• Erlotinib is an original compound that did not fall into categories like salts or polymorphs of any known substance.
• Section 3(d) of the Patents Act, 1970, which deals with the patentability of new forms of known substances, did not apply to their case.
• Defendant's 'Erlocip' is essentially 'Erlotinib Hydrochloride’ and the production of Polymorph B of this compound constitutes a clear infringement of the plaintiff’s patent.
• The Defendant's manufacturing of a specific form of the compound covered by the plaintiff's patent qualifies as a direct violation of their exclusive rights.
• If a patentee's rights were not upheld, it would be contrary to the public interest of promoting further research and development.
• Protecting patent rights encourages innovation and overlooking these rights could hinder progress in the field.
• In determining the balance of convenience, it is reasonable and appropriate to consider the use and availability of the innovation in the region.
• The manufacturing of the patented compound in India is not a prerequisite for considering the impact on the balance of convenience.

ARGUMENTS ADVANCED BY THE DEFENDANT:

• The plaintiff’s patent was susceptible to Section 3(d) of the Patents Act, 1970, as they claimed 'Erlotinib' was a derivative of the known compound 'Quinazoline.'
• The plaintiffs had failed to demonstrate any superior efficacy of their drug.
• The plaintiff’s product was priced significantly higher than theirs. Roche's tablets were priced at approximately Rs 4800, whereas the defendant's tablets cost around Rs 1600.
• The defendants emphasized that since these drugs were crucial for saving lives, they should be made available at a reasonable and affordable cost to benefit the general public.
• The plaintiff provided no evidence to support the claim that 'Erlotinib Hydrochloride' in the patent had superior therapeutic efficacy.
• Plaintiff's patented compound offered any notable advantage in terms of effectiveness.
• The Defendants defended that 'Erlotinib Hydrochloride' was a combination of two polymorphs, An and B.
• Obtaining the claimed compound involved the separation of both polymorphs, which constituted the inventive step of the alleged innovation.
• Plaintiff had not disclosed this crucial information, keeping it from the public domain.

JUDGEMENT ANALYSIS:

• Plaintiff No. 1 is a leading global healthcare organization dedicated to pharmaceuticals and diagnostics research and engages in research and development collaborations, investing approximately 7 billion Swiss Francs in such initiatives.
• According to the lawsuit, 'Erlotinib' is considered a novel compound, distinct from known substances.
•  Section 3(d) of the Patents Act 1970 was deemed irrelevant.
• The High Court acknowledged the defendant's argument on public benefit, highlighting the generic 'Erlotinib' as a life-saving, locally produced, and affordable medication.
• It denies the interim injunction, considering the implications on public access to life-saving medication.
• The Court ruled against the plaintiff, stating Cipla's production and introduction of the generic version did not violate Roche's patent on 'Erlotinib.'
• The defendant obtained a permanent injunction on manufacturing in March 2016.
•  Directions were given to provide accounts for 'Erlocip' production and sale.
• Plaintiff was awarded expenses of Rs. 5,000,000, but no long-term injunction against Cipla-manufactured goods.
• The Court noted discrepancies in the plaintiff’s claim, particularly regarding polymorph B.
• The Indian Patent Office rejected Roche's request for a patent on polymorph B, citing non-compliance with Section 3(d) and patentability criteria.
• The High Court ruled in favour of the defendant and against the plaintiff.

CONCLUSION

The High Court deliberated on the intricate arguments presented by both parties in the dispute over the patented Erlotinib compound. Notably, the Court sided with the defendant's assertion that the compound was a derivative of the known substance Quinazoline, thus challenging its patentability under Section 3(d) of the Indian Patent Act. The Court's decision, which rejected the infringement claim and underscored the significance of demonstrating enhanced efficacy for patentability, reflects the meticulous scrutiny applied to pharmaceutical patents. This case underscores the importance of meeting stringent criteria in establishing the distinctiveness and effectiveness of patented compounds, contributing to the evolving landscape of intellectual property law.