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16 January 2013Patents

Comment period extended for India's draft biotech guidelines

The period for accepting comments on draft guidelines for the examination of biotech patent applications in India has been extended until Friday, 18 January.

The draft guidelines were published by the Indian Patent Office (IPO) on 19 December 2012, and include illustrative examples of obviousness, industrial applicability, extent of disclosure and clarity in claims, and advice on the patentability of genetic engineering inventions such as gene sequences, cloning, stem cells and gene diagnostics — issues which the IPO says are of “serious concern” to users of the patent system in India.

The guidelines are intended to provide clarification for examiners on how India’s patent law should be interpreted.

“There is an urgent need to put in place guidelines to establish uniform and consistent practice in the examination of patent applications in the field of biotechnology and allied subjects under the Patents Act 1970,” said the Patent Office in its introduction.

But Archana Shanker, partner at Anand and Anand in New Delhi, said there should be serious revisions before the guidelines are finalised.

“The illustrative examples included in the guidelines are not based on legal precedence or foreign jurisprudence – they have no basis in law. These should be removed, and the interpretation of the provisions of the Patents Act should be left to the courts,” she said.

Shanker also said that advice on the patentability of gene sequences and stem cells, including the recommendation that gene sequences may be patented but only if the patentee can disclose how it can be used in industry, requires further discussion and clarification.

“Every expressed sequence tag (EST) has the potential to be used as diagnostic, so the guidelines are a little impractical. Guidelines shouldn’t be too broad, and ESTs have to be considered very carefully.”

“We are keen to see if suggested amendments to the guidelines are incorporated. If they are not, the fallout is that the patent office, namely controllers and examiners, will strictly follow those guidelines, and may refuse cases based on the interpretation of that guidance,” she added.

Anyone wishing to comment on the draft should contact a.chakaraborti@nic.in by Friday.

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