2 April 2013Asia

India publishes final biotech patent guidelines

India’s patent office has published final guidelines for examining biotechnology patents, after accepting comments on a draft version published in December.

The guidelines provide illustrative examples of obviousness, industrial applicability, extent of disclosure and clarity in claims, and advice for examiners on the patentability of genetic engineering inventions such as gene sequences and stem cells.

They were designed to address a need for greater clarity on how India’s patent law should be interpreted in relation to biotech inventions.

A draft version published on December 19, 2013 was criticised by organisations including India’s Biotechnology Industry Organization (BIO) and the Organisation of Pharmaceuticals Producers of India (OPPI), which described the guidelines as unclear and at odds with both international trade agreements and national patent law.

BIO, OPPI and law firms Kan and Krishme, DePenning and DePenning and Krishna and Saurastri criticised the assertion that microorganisms, compounds and other products isolated from nature are not patentable subject matter, while nearly all of the 21 organisations that submitted comments said the illustrative examples used in the draft guidelines lacked clarity.

Law firm Anand and Anand said these examples should be removed “unless supported by patent office decisions or case laws”.

The patent office held a meeting with industry stakeholders to discuss possible revisions to the draft guidelines and published a final version on March 25.

The guidelines now include a disclaimer that they “do not constitute rule making” and that “in case of any conflict between these guidelines and the provisions of the Patents Act, 1970, and the Patents Rules, 2003, the said provisions of the act will prevail”.

But Sharad Vadhera, a patent attorney at Kan and Krishme in New Delhi, said the office has ignored other concerns raised by stakeholders in the meeting – in particular, objections to the decision to exclude microorganisms from the patentability criteria and the assertion that a polynucleotide sequence whose genetic material has been sequenced as a library is not novel.

Vadhera also said stakeholders had suggested that no such guidelines should be issued in relation to section 3(d) of India’s Patent Act, which lists inventions that are not patentable, before the Supreme Court delivered its decision on the patentability of an updated version of Novartis’s cancer drug Glivec.

It’s unclear what impact these guidelines will have on the filing and patenting of biotech inventions in India, as they will not be implemented for several months, said Vadhera. But they will certainly "strengthen the grip of screening and prohibiting inventions under Indian patent law," he said.

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