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 has been revoked on an opposition filed by Cipla, the old player of 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.
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 has been revoked on an opposition filed by Cipla, the old player of 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.
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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