Delhi High Court
Date: November 27, 2015
Bench: Justice S Ravindra Bhat
Citation: [(2009) 40 PTC 125 (Del)]
Petitioner: CIPLA LTD.
Respondent: F HOFFMANN-LA ROCHE LTD. & PFIZER
Throughout the years, there have been numerous patent battles in India between foreign multinational pharmaceutical companies and Indian generic drug suppliers. When it comes to patent infringement charges, however, the case between Roche and Cipla has unquestionably set the standard, and this verdict will serve as a precedent for future instances. A historic disagreement erupted between Roche, a Swiss global healthcare company with operations all over the world, and Cipla, an Indian multinational pharmaceutical and biotechnology company. Roche’s patent on the anti-cancer treatment “Erlotinib,” which Roche distributes as TARCEVA, has been a source of contention between the two pharmaceutical companies in the Delhi High Court. This drug was initially made available in India in 2006. In late 2007, Cipla began marketing a polymorph of EH in India, causing Roche to sue the company in 2008, kicking off a series of legal disputes. Pfizer and Roche were also contenders in this case.
Facts of the Case
The dispute emerged in Delhi High Court over Roche’s medication ‘Erlotinib’ that was sold by Roche as TARCEVA. Both Roche and Cipla depend on the compound that goes by the name Erlotinib Hydrochloride. In February 2007, Roche in the wake of guaranteeing that it had been awarded a patent for ‘Erlotinib’ began selling the medication under the brand name TARCEVA. In January 2008, it was reported that Cipla is wanting to send off a nonexclusive form of ‘Erlotinib.’ This made Roche start encroachment procedures against Cipla. Roche asserted that Cipla had encroached on a Patent in 774 otherwise called ‘Erlotinib Hydrochloride’ which is authorized to Roche. On appeal, the Division Bench maintained the choice yet centered more around the disappointment of Roche to lay out an at first sight instance of encroachment. The SLP documented by Roche against the choice was also declined. The gatherings then, at that point, got back to the single appointed authority to the preliminary on principle help; the adjudicator conveyed judgment and Roche couldn’t adequately demonstrate that Cipla’s assembling of Erlocip encroached its patent IN774. The case was then taken to the Division Bench where the case went for Roche.
The plaintiffs, Roche and Pfizer, claimed that the medicine Erlotinib was created after years of research and significant investment and that the invention was protected by law. The defendant corporation had no authority to produce, market, or propose to sell any form of the medicine TARCEVA (Erlotinib) going forward, and that such action, as indicated by the defendant, would constitute a flagrant breach of the plaintiffs’ legal rights. They claimed to have received a patent in February 2007 for Erlotinib, a chemical recognised medically as a “Human Epidermal Growth Factor Type-1/Epidermal Growth Factor Receptor” (HER/EGFR) inhibitor. The medicine in question was a big advance in cancer therapy.
The medicine was available in tablet form and was marketed under the brand name TARCEVA. The US Food and Medicine Administration authorized the drug, which was then approved by the European Union. With a certificate dated February 23, 2007, the Controller General of Patents, New Delhi, has also given Erlotinib a patent. According to the 2005 revisions to the Patents Act, Erlotinib was patented. The patented substance was marketed under the brand name TARCEVA when Roche first launched it to the Indian market in 2006. On the 15th of January 2008, the plaintiff filed an action for infringement of rights, accompanied by an application for an ad-interim injunction.
At this time, two significant issues should be noted: it was said that the certificate carrying patent No. 196774 dated February 23, 2007, which was recorded in the Register of Patents on July 6, 2007, related to Erlotinib Hydrochloride, which was sold as TARCEVA. There were no references to the aforementioned patent’s specification or the x-ray diffraction of the product (tablet) TARCEVA or the defendant Erlocip in the plaint.
In response to Roche’s assertions, Cipla said, “Since October 2007, Cipla has been selling the generic form of Erlotinib under the name Erlocip.” Also, according to Section 5(2) of the Patents Act, the patentee’s entitlement only accrues from the date of the patent’s award. Though Roche Limited received a certificate in February 2007, the pre-grant opposition was settled in July 2007, hence the certificate issued was inaccurate.
Second, Cipla claimed that Erlotinib’s patent was invalid because it was a derivative of the patent ‘Quinazoline.’ Also, Erlotinib’s composition was identical to Quinazoline, with the exception of one substitution that was “clear to any knowledgeable person.”
Pharmaceutical was defined as containing one or more creative steps and something that had not been predicted by any document or publication in any nation under Section 2(1) (ta) of the Patents Act 1970. Having consideration to what was publicly known or publicly utilised in India, or what had been published in India or elsewhere before the priority date, Roche’s invention, as described in the full specification and claims, was apparent or did not entail any inventive step. Finally, they pointed out that in order for a drug to be considered patentable under Section 3(d), it must be demonstrated that it has “any increased efficacy of the said medication.”
Fourth, a judgement dated August 30, 2007 of an AstraZeneca application clearly stated that “the putative patented substance is nothing but a derivative from Gefitinib of AstraZeneca for which a patent was rejected in India.” Fifth, Cipla argued that it was in the public interest. It stated that when assessing whether or not to award an interim injunction, the large price differential between Roche’s medicine (Rs.4,800 pill (approx. US$ 100) and Cipla’s drug (Rs.1,600 (approx. US$ 33) should be considered.
Cipla stated that because the medicine in question was a life-saving treatment, the public interest problem should be taken into consideration. Finally, Cipla claimed that the plaintiff omitted critical facts about the medicine, claiming that it is actually a combination of polymorphs that is unfit for pharmaceutical usage.
Single Judge Judgement
The single judge, in his decision dated March 19, 2008, focused on two major concerns with Roche’s patent. The plaintiff’s contention that it was not obvious for a person skilled in the same art to replace methyl for ethynyl was outright denied by the single judge bench, who held that the requirement under section 3(d) of the Patents Act was unfulfilled because ‘Erlotinib’ was a derivative of a known compound and thus the requirement under section 3(d) of the Patents Act was unfulfilled as the ‘increased efficiency’ criteria were also not met forth.
Cipla’s second allegation, which was in the public interest and approved by the single judge bench, was that the generic form of Erlotinib that Cipla advertised and manufactured was genuinely available for one of their prices. Furthermore, this was a life-saving medicine, and Cipla’s products were made in India rather than being imported from outside. The court had to choose between guaranteeing life-saving medications at a low cost and issuing an injunction order while the case was pending. The single-judge bench chose the first option over the second and denied Cipla’s request for an injunction because many innocent persons who are not even parties to the lawsuit would be harmed unnecessarily.
Finally, the division bench determined that there was no infringement because the patent in question included a combination of Polymorphs A and B, but the medicine TARCEVA only contained Polymorph B. The important thing to notice here is that Roche sought for a patent on Polymorph B, but the Indian Patent Office refused it since it did not meet the conditions of Section 3(d) and the patentability test was not met. Furthermore, the court weighed the legislature’s objective in drafting Section 3(d) and anti-ever greening legislation, and prioritized the public interest. Because the court recognized that a life-saving treatment was at stake, Cipla’s drug was three times cheaper than Roche’s.
Roche asserted from the start of the case that Erlocip is Erlotinib Hydrochloride, whereas Cipla’s patent claim was for Polymorph B of the chemical Erlotinib Hydrochloride. “Any process involved in making Polymorph B of Erlotinib Hydrochloride would involve the preparation of Erlotinib Hydrochloride itself,” the Judge concluded. “A perusal of US ‘221 reveals that Erlotinib Hydrochloride in Polymorph B form results from re-crystallization of Erlotinib Hydrochloride using different solvents and temperature conditions.” As a result, if the suit was determined to disclose Erlotinib Hydrochloride, every polymorphic form of the same would infringe on the suit patent since Erlotinib Hydrochloride would be at the heart of every polymorphic version. “This compound may exist in various polymorphic forms,” the patent IN 774 noted, “but all such forms shall be subsumed under its patent.” As a polymorphic version of Erlotinib Hydrochloride, Cipla’s Erlocip will very probably infringe on Roche’s IN 774.” As a result, the case was decided in Roche’s favor.
The decision outlawed certain methods and rules that should be followed in every patent infringement case. They are: first, infringement is not shown by affirmative proof, which includes the defendant company’s medical and clinical study of a product. Second, an infringement assessment does not compare an allegedly infringing product to the marketed product; rather, it compares it to the patent’s claims. Finally, it was stated that in this circumstance, the right test is to map Cipla’s product against Roche’s patent claims. Finally, a 16-step test for developing patent claims in order to determine the patent’s breadth and determine if there has been any infringement was established. This may be used as a template for any patent infringement lawsuit.
The 2005 amendment demonstrated that India has implemented an IP policy that reflects the spirit of the WTO while also maintaining a clause barring ‘Evergreening,’ which is the practice of making pricey medications available at low prices to encourage market competition. The Indian judiciary has demonstrated through cases such as Novartis and Cipla that Section 3(d) is acting as a safeguard against Evergreening of patents, as pharmaceutical companies have a habit of simply changing one component that has no effect on the efficacy of the product and re-applying for the product. This effectively slows down research and development and contributes to the country’s decline.
Second, these decisions have demonstrated that the public benefit will be the most important factor to consider when granting and reviewing patent applications. If Roche had been given the patent by the Controller of Patents in New Delhi, the cancer therapy would have been out of reach for many patents because of the high cost of the drugs. In India, patent rules stimulate inventions but do not provide unlimited rights; instead, they grant a limited right that encourages greater research and development and the production of superior medicines on the market.
Edited by: Drishti Miglani