31 January 2013Asia

India publishes feedback on draft biotech guidelines

India’s patent office has released  comments submitted in response to draft examination guidelines for biotechnology patents published in December 2012.

21 organisations submitted comments, including the Biotechnology Industry Organization (BIO), Organisation of Pharmaceuticals Producers of India (OPPI) and the National Biodiversity Authority.

While all agreed there was a need for greater clarification on how India’s Patent Law should be interpreted, most of those commenting called for significant revisions before the guidelines are finalised.

BIO and OPPI said that India’s guidelines present a broader interpretation of obviousness than is found in other jurisdictions, and criticised the assertion in paragraph 11 that microorganisms, compounds and other products isolated from nature are not patentable subject matter.

“This is contrary to the laws of many jurisdictions…it denies patent claims for essentially all of the basic biotechnology inventions which are necessary to the further research and development of 8 innovative biotechnology products,” said BIO.

Law firm Kan & Krishme said paragraph 11 is at odds with section 3 of India’s patent Act, arguing: “it is very clear from the wordings of the Section 3(j) that microorganisms are patentable. Therefore, it is very surprising that the microorganisms have been included in the category of the non-patentable subject matter.”

DePenning & DePenning said this is contrary to European Parliament Directive 98/44/EC and last year’s Myriad ruling in the US, while Krishna and Saurastri suggested that the paragraph be amended to read:

“As per Section 3(c) [of India’s Patent Act] products directly isolated from nature are not patentable subject matter. The term 'directly' conveys without anyone or anything intervening.

“Hence, whenever a substance (living or non-living) is obtained or isolated from nature on account  of substantial human and technical intervention and if the substance is properly characterized either by its structure, or by other parameters and it meets the criteria of patentability i.e. it is `new' in the absolute sense of having no previously recognized  existence, it is not obvious to the person ordinarily skilled in the art and has industrial applicability, then such a substance per se is patentable.”

BIO also expressed “significant concerns” over a lack of clarity in paragraph 10 of the guidelines on whether certain types of cells are patentable subject matter, and recommended that this be amended to allow for the patenting of stem cells and other modified cells useful for therapeutic purposes, while law firm Remfry & Sagar criticised the recommendation included in the guidelines that gene sequences may be patented but only if patentees can disclose how it may be used in industry.

“ESTs give information that can in-turn be used to determine gene expression and further used in drug designing. EST can be valuable, inseparable and sometime even specific during the designing of a particular drug at a later stage. Keeping in mind all the aforesaid, it may not be possible at a particular stage at which the claim for an EST is being sought to mention the precise industrial use,” said the firm in its response.

The most common objection was to illustrative examples included in the guidelines to provide guidance on novelty, inventive step and industrial applicability. Nearly all those who commented said these examples lacked clarity, and law firm Anand and Anand said some were at odds with patent office practice and should be removed “unless supported by patent office decisions or case laws”.

Dr Ruchi Tiwari, deputy controller of patent and designs in India, said that a committee is now reviewing the feedback and that finalised guidelines are likely to be published later this month.

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