Section 3 d of Patent Act 1970 and Evergreening of Patent
Introduction: The case represents a landmark decision in Indian patent law, addressing critical issues such as patent infringement, the public interest in life-saving drugs, and the interpretation of Section 3(d) of the Indian Patents Act. The ruling balanced intellectual property rights with access to affordable healthcare.
Background: This dispute arose over the patent rights of the anti-cancer drug Erlotinib, sold under the brand name Tarceva, owned by F. Hoffmann-La Roche and Pfizer. The plaintiffs alleged Cipla's generic version, marketed as Erlocip, infringed their patent. Cipla countered, citing invalidity and public interest considerations.
Brief Facts of the Case: The plaintiffs held an Indian patent for Erlotinib (Patent No. 196774) since 2007, asserting exclusive rights to manufacture, sell, and distribute the drug. Cipla announced its intention to sell a generic version, prompting Roche to seek an ad-interim injunction to restrain Cipla from manufacturing or selling Erlocip. Cipla argued the patent lacked novelty and inventive step under Section 3(d) and claimed the drug was priced exorbitantly, restricting accessibility to patients in India.
Issues Raised:Whether the plaintiffs’ patent was valid under Indian patent law. Whether Cipla’s manufacture and sale of Erlocip constituted patent infringement. Whether granting an injunction would serve public interest, especially concerning affordable access to life-saving drugs.
Plaintiffs submission: Argued the patent underwent thorough scrutiny before grant, making it presumptively valid. Highlighted Erlotinib's novelty and enhanced efficacy over prior compounds. Emphasized their financial investment in R&D and the potential irreparable harm caused by Cipla’s infringement.
Defendant's submission: Contended the patent was invalid, citing Section 3(d) of the Patents Act, asserting that Erlotinib was a derivative of a known compound lacking enhanced efficacy. Highlighted public interest, arguing that Cipla's generic version was significantly cheaper, thus ensuring access to cancer patients in India. Asserted the balance of convenience favored Cipla as the patent had not been commercially worked in India.
Judgments Referred:
Novartis v. Union of India (Madras High Court, 2007): Examined the scope of Section 3(d) and emphasized enhanced efficacy as a criterion for patentability.
American Cyanamid Co. v. Ethicon Ltd. (UK): Laid down principles for granting interlocutory injunctions, requiring courts to assess balance of convenience and irreparable harm.
Telemecanique v. Schneider Electric: Affirmed that patents confer statutory monopoly, protecting inventors from infringement.
Reasoning of the Judge:
Patent Validity: Recognized the legislative intent behind Section 3(d) to prevent "evergreening" of patents. Determined that Cipla's challenge raised prima facie doubts about Erlotinib's enhanced efficacy, warranting detailed examination.
Public Interest: Prioritized affordability of life-saving drugs. The court noted that Cipla’s version was priced substantially lower, making it accessible to a broader population.
Balance of Convenience: Concluded that denying the injunction served greater public good. The court emphasized that any harm to the plaintiffs could be compensated through damages, whereas public health implications were irreversible.
Decision:The court denied the ad-interim injunction sought by Roche, allowing Cipla to continue manufacturing and selling Erlocip. The judgment underscored the need for balancing patent protection with public health needs.
Case Title: F. Hoffmann-La Roche Ltd. and Anr. vs Cipla Limited
Date of Order: 19 March 2008
Case No.: IA 642/2008 in CS(OS) 89/2008
Neutral Citation: 148(2008)DLT598, MIPR2008(2)35
Court: High Court of Delhi
Judge: Justice S. Ravindra Bhat
Advocate Ajay Amitabh Suman
[Patent and Trademark Attorney]
High Court of Delhi
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