Pharmabiz
 

GUARD AGAINST EVERGREENING

P A FrancisWednesday, April 29, 2009, 08:00 Hrs  [IST]

A key provision in the amended Patent Act, notified in 2005, is pertaining to the patentability of a new drug molecule. The third amendment to the Act was brought to keep trivial and frivolous pharmaceutical inventions out of patent protection to avoid chances for evergreening. And section 3(d) precludes patent protection for mere discovery of new forms of a known substance, which lacks enhancement of the known efficacy of that substance. The objective of this Section is to prevent drug companies from unjustifiably prolonging the life of a patent by claiming new properties. The possibility of pharmaceutical companies approaching the patent offices for securing patents for such products was, thus, foreseen by the government while drafting the new Act. Yet, the Patent Offices in the country continue to receive hundreds of patent applications for products with no new therapeutic properties. As the global pharmaceutical industry is turning less and less innovative and is struggling to get new molecules, they tend to re-jigger the same old drugs with the hope of getting new product patents. The case of Glivec of Novartis is well known. The company wanted a patent for Glivec, which is regarded just an incremental innovation of a known molecule. The patent office rejected Novartis application for the product in January 2006 but the company approached the Madras High Court challenging the decision. Just a few weeks ago, the Patent Office rejected patent application of Pfizer for its drug, Caduet, a therapeutic combination of amlodipine and atorvastatin. The decision against Caduet, a combination Pfizer's Norvasc (amlodipine besylate) and Lipitor (atorvastatin calcium), is in favour of a pre-grant opposition filed by Torrent. The Delhi Patent Office also rejected the patent application of SmithKline Beecham PLC, for ethane sulphonate salt of its anti-diabetic drug rosiglitazone after finding that the company failed to establish that the rosiglitazone derivative has better efficacy than the known patent compound. In yet another case, the Delhi Patent Office rejected the patent application of Gilead Science Inc for its anti-influenza drug, Tamiflu (oseltamivir phosphate), in favour of a pre-grant opposition filed by Cipla Ltd. The Patent Office said that the description of the innovation provided by the company is ambiguous amounting to insufficiency and alleged that invention falls under section 3 (d) of the Patent Act. Desperation of the global pharmaceutical industry to somehow obtain patents for any product is evident from these failed attempts. It is quite possible that international pharmaceutical companies will continue to try to get patents for worthless products in future. Indian pharmaceutical industry and the patent controllers need to be, therefore, sufficiently alert so as to not to issue any frivolous patents by default. The global pharmaceutical industry should realize that it is basically the high pricing of so called patented products that has created a tide against the whole system of patents in the pharmaceutical industry.

 
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