Pharma cos filing multiple patents for same drug

In September 2009, a patent application for AIDS drug darunavir was rejected as it did not meet patentability criteria laid down in the Indian Patent Act.

Had the patent been granted, no generic version of the drug could have been introduced and, with the innovator drug by Johnson &Johnson yet to hit Indian shores, patients would have had to suffer.

But one patent rejection is not the end of the story for J&J… Darunavir still has six other patent applications for various forms floating in patent offices across India.

Similarly, the diabetes drug, rosiglitazone, which has for some time been in the eye of a controversy over its heart risks, has four patent applications in India.

Companies have been filing applications for patenting different forms of the same drug, including the salt, polymorph form, analogue form, crystalline form, solid dosage form, combination of the drug with other drugs, etc.

This enables them to cover a broader scope of protection to commercially and therapeutically significant forms of the same compound, and also for extending the term of protection, also referred to as evergreening, said Rahul Chaudhry, partner, IP law firm Lall Lahiri&Salhotra.

Although it is within the legal framework to make multiple patent claims for various forms of the same drug, legal activists argue that doing so is morally incorrect as it implies trying to get from one patent office what could not be garnered from another office.

Moreover, multiple patents burden the patent offices, which have been crying hoarse about manpower shortage. There are four patent offices in India (at Delhi, Mumbai, Kolkata, Chennai) with about 150 officers.

Amit Sengupta, general secretary of All India Peoples Science Network, said, “multiple applications would toughen the work of the patent offices and there could be chances of applications getting wrongly granted.”

Industry estimates suggest, that by 2015, when the Indian pharmaceutical market would be worth $20 billion, about 15% of total drugs would be patented molecules.

The increased growth of patenting in India is due to the introduction of the product patent regime in 2005 after India signed the trade related aspects of intellectual property rights (Trips) agreement of the World Trade Organisation (WTO) in 1995.

About 70,000 patent applications are in the pipeline for process and examination in the country, P H Kurian, controller general of Patents, Design, &Trademarks, said in Mumbai recently.    Turn to Page 20

“Currently we have 150 officers, and about 260 officers will be recruited in a year”.

“From 2005, when the product patent regime came into being, till date, about 13,000 patents have been issued in both chemicals and pharmaceuticals,” he added.

The lack of co-ordination between the patent offices makes matters worse. “India is the only country with 4 Patent Offices in Delhi, Mumbai, Kolkata, Chennai and is no proper coordination between the offices,” says Gopakumar Nair, founder of intellectual property and legal advisory firm Gopakumar Nair Associates.

Kurian says the four patent offices have to be brought together so that they work in a similar fashion. “We are addressing this issue.”