Draft Guidelines for Examination of Biotechnology Related Inventions Published by the Indian Patent Office.

In one of my earlier post on gene patents, I had stressed need for adequate guidelines on dealing with application for biotechnology related inventions. The Controller General of Patent Design and Trademarks has now published draft guidelines detailing the manner in which application for biotech related inventions are to be examined.

Some important points to be noted from the guidelines are as follows:

Under the new guidelines, it has been clarified that claim to a polynucleotide or protein sequence, that was available as part of a library before the priority date, shall be interpreted to have lacked novelty. The reason given to support this interpretation is that the earlier (library) sequence inherently possesses the activity of the claimed sequence. The guidelines further clarify that product such as nucleic acid sequences, proteins, enzymes, etc which are directly isolated from nature are not patentable subject matter under section 3(c) of the Patent Act. This essentially precludes patent on genes which are identified, purified and made available in an isolated from, since genomes of practically every species including human genome have been sequenced and are now available in online searchable libraries.

Claim to an isolated sequence of nucleic acids or protein which is not hit by the above mentioned hurdle, shall require identification of its usefulness (to prove industrial applicability) and provide enabling disclosure on a practical way of using it, in the specification.

Methods in which human embryos are used for commercial exploitation will be termed as invention contrary to public order and morality and hence unpatentable under section 3(b). The explanation to this guideline however renders method in which even human embryonic cell lines are used, unpatentable. Embryonic cell lines are used in a variety of research areas especially screening of chemicals and compounds that can affect a fetus during gestation. Thus inventions not directed towards cloning or germ line modification may also be included under the ambit of section 3(b) if they happen to use embryonic stem cell lines.

Though the above are draft guidelines, I would not be surprised if the same are finalised without any modfications as it happend with guidelines issued for dealing with inventions related to traditional knowledge. Nevertheless, comments and suggestions, if any, can be sent to the Controller General of Patent Design and Trademark by 11th January 2013. The publication notice and the draft guidelines can be accessed here and here.


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