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| Image from here. |
The Patent Office has published the final version of the “Guidelines for Examination of Biotechnology Applications for Patents”, accessible over here, dated March 25, 2013. The draft version of these guidelines was published initially in December, 2012 and made available for public comment on the Patent Office website. The public comments received by the Patent Office, most of which were negative, were published on the patent office website and I’m told that the Patent Office did organize a meeting with the important stake-holders.
It is most important to note that in the final version of the guidelines, the Patent Office has itself conceded that it has no rule-making authority and that these guidelines do not have the force of law. The pertinent statement on page 1 reads as follows “However, these guidelines do not constitute rule making. 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 Act and Rules will prevail over these guidelines. The guidelines are subject to revision from time to time based on interpretations by a Court of Law, statutory amendments and valuable inputs from the stakeholders.” This is a vital point, which we had pointed out in our first post on the issue in December. The Controller General should clarify in adequate detail to his staff that any objection to a biotech patent will have to be based on the Patent Act and judicial precedents. If the Patent Office rejects a biotech patent application citing these guidelines as the controlling authority, the IPAB will most certainly reverse such an order since the guidelines do not have the force of the law. Controllers may thus cite only the reasoning contained in the guidelines provided that such reasoning itself is based on the Patent Act or judicial precedents.
These guidelines seems to be highly controversial. In spite of the feedback from various players, patent office doesn’t seem to have considered their views. The examiners will start rejecting biotech applications citing these guidelines which hardly seem to have any legal basis or judicial precedents. This might discourage development of biotech sector in India.
The guidelines are, and should be a welcome development in biotech patents landscape in India. At least now we have a set of guidelines to obtain guidance from. I, personally found them of immense help in learning and analyzing biotech claims. However, as for whether the guidelines “constitute rule making”, we do not have to re-invent the wheel. After all there are similar, publicly guidelines available for examining biotech patents in UK. We can learn from their experiences, and use the guidelines in our context. One more point, while going through the guidelines, I felt that the guidelines lack patents caselaw-based support. Of course, there are sporadic references made to them in the guidelines. We need more of them in order to provide “teeth” to them. Lastly and most importantly, it is a pity that despite having premier biotechnology-based research institutes like CCMB, IISc, and a host of other biotech research and academic institutes established back in the last century in the country, biotech patent regime is so neglected in India that it is only in 2013 that we could institute our guidelines for examining biotech patent applications. Could we please move faster?