Case Analysis of F. Hoffman-La Roche Ltd. v. Cipla Ltd. (2012) Delhi HC Aditi Bhardwaj Legal Article Fri, May 19, 2023, at ,06:32 PM IntroductionA patent is essentially a monopoly right that the creator receives as compensation for his toil and years of study. It is only granted when a valuable and original invention has been made by an inventor. In India, a patent may only be used for a period of 20 years before entering the public domain. A person who is an expert in that field should not find it obvious, according to the idea of non-obviousness.The current case concerns international corporations that were involved in the development of a life-saving medicine that was used to treat lung cancer. Two multinational corporations were involved in the case; the plaintiff, Cipla, is an Indian multinational corporation, and the defendant is a combined foreign multinational firm made up of Roche and Pfizer. The issue concerns the patenting of "Erlotinib," also known as "Human Epidermal Growth Factor Type-1/Epidermal Growth Factor Receptor," an inhibitor. The medication was marketed as "Tarceva" and was available as an oral tablet.Facts of the caseThe controversy arose in the Delhi High Court about the Roche medicine "Erlotinib," which Hoffman-La Roche Ltd. marketed as TARCEVA. The substance marketed under the name erlotinib hydrochloride is a key component for both Hoffman-La Roche Ltd. and Cipla. After confirming that it had been granted a patent for "Erlotinib," Hoffman-La Roche Ltd. started distributing the medication under the trade name TARCEVA in February 2007.It was noted in January 2008 that Cipla intends to release a nonexclusive variety of "Erlotinib." As a result, Hoffman-La Roche Ltd. filed an infringement claim against Cipla. Hoffman-La Roche Ltd. assured that Cipla had violated Patent No. 774, also known as "Erlotinib Hydrochloride," which he owns a license to.It was discovered that the Indian multinational corporation Cipla intended to introduce a generic version of the copyrighted medicine, "Erlotinib." After some time, the drug's generic form was released, and the news was reported in the renowned English daily mint. Knowing about the situation, Roche filed a lawsuit for infringement against Cipla on January 15th, 2008, alleging that Cipla was attempting to use their patent medicine "Erlotinib," which Roche obtained a patent for in 774 and called "Erlotinib Hydrochloride," without permission.Issue whether Cipla's sale of a generic version of Hoffman-La Roche Ltd drug Erlotinib Hydrochloride in India infringed its patent for the drug. whether Hoffman-La Roche Ltd. patent was valid and enforceable. AnalysisOne of the top healthcare organizations in the world that focuses on research in the areas of pharmaceuticals and diagnostics, according to the plaintiff No. 1 Company. According to the plaint, the named plaintiff, among other things, enters into cooperative agreements and alliances with multiple partners for the aim of research and development, investing around 7 billion Swiss Francs in such activities.The patented thing was brought into the Indian market by Hoffman-La Roche Ltd in the year 2006 under the brand name ‘Tarceva’. In the meantime, Cipla guaranteed selling a nonexclusive form of ‘Erlotinib’ under the brand name ‘Erlocip’.The historic case involved Cipla, an Indian multinational pharmaceutical and biotechnology corporation, and Hoffman-La Roche Ltd a Swiss global healthcare organization with operations generally over the globe.Erlotinib, according to the lawsuit, is a novel compound and unquestionably not a salt, polymorph, or other variation of any recognized substance. Section 3(d) of the Patents Act of 1970 is therefore irrelevant.They claimed that "Erlotinib Hydrochloride," sold under the brand name "Erlocip" by Cipla, is an adequate violation of Hoffman-La Roche’s patent, as is the creation of Polymorph B of this substance.On the other hand, defendant argued Citing the fact that "Erlotinib" is a subset of the well-known patent "Quinazoline," Cipla argued that the patent was infringed by Section 3(d) of the Patents Act, 1970. They acknowledged that Hoffman-La Roche Ltd. had not shown "any superior viability of the said drug".They continued by saying how highly regarded Roche's product was. Cipla tablets cost about Rs 1600, whilst Roche tablets were anticipated to cost roughly Rs 4800. They argued that since this contained life-saving medications, it should be produced at a fair and affordable cost to the entire people.Furthermore, they argued that Roche failed to provide any evidence to support the claim that the patent's 'Erlotinib Hydrochloride' had a better restorative potential.JudgementThe Court considered Cipla's argument about public welfare, stating that the generic form of "Erlotinib" was for the benefit of the public and that it was a life-saving medication that was exclusively produced and imported in India. When denying an interim injunction, the court observed that it was necessary for the court to consider the results of the requested relief in this case because the substance was a life-saving medication that was inexpensively available. The court ruled that although Cipla had claimed that Hoffman-La Roche Ltd 's patent on the drug "Erlotinib" had been violated, this claim was unfounded and that Cipla had done nothing illegal in producing and bringing the generic version of "Erlotinib" into India. Although Hoffman-La Roche Ltd. won the case in the end, Cipla was given a permanent injunction on manufacturing in March 2016. Cipla was ordered to provide accounts for the production and sale of Erlocip, and Hoffman-La Roche Ltd. was awarded expenses in the amount of Rs. 5,000,000. However, the Court declined to issue a long-term injunction against Cipla-manufactured goods.The Tarceva medicine solely included polymorph B, contrary to the division's ruling that there was no infringement because it was combined with polymorphs A and B. The pertinent fact is that the Indian Patent Office rejected Hoffman-La Roche Ltd request for a patent on polymorph B since it no longer satisfies the requirements of section 3(d) and passes the patentability test. Cipla Limited received a significant patent case for Hoffman-La Roche Ltd Limited in September 2012.ConclusionThe amendment of 2005 demonstrated that India had implemented an IP framework that exemplified the WTO's spirit while maintaining a provision for preventing "Evergreening," which involves making pricey medications available at low prices to spur market competition. The Indian judiciary has demonstrated through cases involving Novartis and Cipla that Section 3(d) is acting as a safeguard against Evergreening of patents because pharmacy companies have a habit of simply changing one component without altering the product's efficacy and reapplying for the product. This effectively slows down research and development and contributes to the collapse of the nation.