Written by: Lex Protector|March 27, 2015
Written By: Rosalin Dhal
Historic Recurrence is a Natural Phenomenon. When Supreme Court cancelled Novartis’ Patent on Glivec, it was clearly a tragedy for the latter and was expected to create a farse for the other branded drug-makers. But no one would have thought that a small hail-ball will groom into a full-fledged snowball so quickly. A patent granted to the German pharmaceutical company “Boehringer Ingelheim” on Spiriva, an asthma drug by the Controller General of Patent, Design and Trademarks has been revoked on an opposition filed by Cipla, the old player of “generic” arena. The Indian patent office on the application by Cipla, revoked the granted patent on the ground that it failed to demonstrate therapeutic efficacy and is not an invention as per section 3(d) of the Indian patent Act 1970.
Indian patent law prohibits grant of patent to new forms of known substance, unless the new form results in enhanced efficacy of that known substance. The efficacy is therapeutic efficacy that can be proved with the help of conducting clinical trials. Under the brand Spiriva, BI (Boehringer Ingelheim) sells the crystalline salt form of tiotropium bromide monohydrate, which is effective for treatment of pulmonary diseases.
Two years ago, the outcome of the Novartis case had determined the position of patenting new forms of known drugs in India. Novartis appeal petition on patent application of the beta crystalline form of imatinib mesylate, was rejected by the Supreme Court. The court had then contended that section 3(d) of the patent act is a safeguard introduced by the parliament in 2005 to prevent Evergreening. Evergreening is a practice adopted by pharmaceutical companies to extend their monopolies over a drug by patenting new forms of existing substance.
Cipla, India’s fourth largest drug maker who opposed the patent Spiriva has been marketing tiotropium bromide monohydrate under the brand Tiova since year 2003. Cipla must have breathe a sigh of relief on the revocation of BI’s Spiriva patent as it paved way for it to continue selling its brand in the Indian market. The contention of BI that the crystalline salt of tiotropium bromide monohydrate is more stable was questioned by Cipla on the ground that it didn’t demonstrate any significant change in the therapeutic efficacy to which the Patent Office has agreed. Apart from Novartis, this January, even Abbot found itself in a fix when its drug Humira was revoked by the Patent Office after Glenmark objected to the patent Grant before the Delhi High Court. To further substantiate the observation made with respect to this trend, our readers must be familiar with Cipla’s request for revocation of five patents owned by Novartis and the grant of compulsory license to Natco, ordered against Bayer Pharma.
This trend sets a clear message to the world that the US’s axiom of “anything under the sun can be patented” is not acceptable in India. Most importantly, even grant of a patent doesn’t guarantees that the protection will remain unhindered throughout the next twenty years. But what is important is to make sure that in a bid to prevent “evergreening” of Patents, the government doesn’t ends up setting the threshold so high that it starts acting as a deterrence to the major drugmakers from selling drugs in India. A balance has to be struck between the needs of the people vis-a-vis the market interests of branded drugmakers to allay the concerns raised by such decisions.
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