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The Department of Industrial Policy & Promotion (DIPP), Government of India has officially notified, in the Gazette of India, the revocation of the controversial Avesthagen patent that we had blogged about over here, here and here. As we initially guessed, the revocation did take place under Section 66 of the Patents Act, 1970. The notification by the DIPP is quite curt, only stating that the patent was revoked because it was “generally prejudicial to the public”. The notification can be accessed over here.
I hope that the DIPP has a separate more detailed order giving reasons for such revocation because there is no way this notification is going to stand by itself in a Court of Law. As I’ve stated earlier, I’ve repeatedly emailed the DIPP asking for a copy of the detailed order but they are not even replying to my emails.
In a simultaneous development, the Controller General of Patents Chaitanya Prasad, has announced draft “Guidelines for processing of patent applications relating to traditional knowledge and biological material” and has invited comments on the same. The public notice and the guidelines can be accessed over here and here.
Some of the important practices laid down by the new guidelines are as follows:
(i) The patent office examiners have to conduct an examination of patent applications using the Traditional Knowledge Digital Library (TKDL). In pertinent part the guidelines state "In every case related to TK and/or biological material, the Examiner shall carry out a thorough search for anticipation in TKDL and/or other databases. If any citation is made from TKDL database, then copy of the citation (English translated) should be sent along with the examination report";
(ii) Mandatory disclosure in Form 1 filings on the source of any biological material used in the invention. The declaration is as follows “"the invention as disclosed in the specification uses the biological material from India and the necessary permission from the competent authority shall be submitted by me/us before the grant of patent to me/us".
The guidelines further state “On the other hand, if the declaration in Form-1 regarding the use of biological material from India is cancelled out by the applicant and the specification also states that the source and geographical origin of the biological material is not from India, the specification should be amended by way of incorporation of a separate heading/paragraph at the beginning of the description that the biological material used in the invention is not from India and should clearly specify the country of source and geographical origin of the same.”
(iii) The above declarations will require patent applicants to get permission from the National Biological Authority (NBA) or its counterparts in different states, in order to secure patents before the IPO. In pertinent part the guidelines state “Therefore, no patent shall be granted without the necessary permission from the National Biodiversity Authority in cases where the invention uses biological material from India.”
Patent Examiners and Controllers have been warned against granting any exemptions for patent applications which have not sought prior approval from the NBA. In pertinent part the guidelines state:
“It has been observed that during the examination of applications pertaining to the Biological materials diverse yardsticks are adopted by different Patent Officer/Controller as regards the exemption from obtaining permission from NBA in r/o the claimed biological resource in the present application. In view of this, the following directions are issued for strict compliance of the concerned Controllers and Examiners:
“Exemption to medicinal plants from the provisions of the Biological Diversity Act, 2002 given by the notification issued by the Ministry of Environment and forests Notification dated 26th October 2009 is available only if they are traded as commodities and the said provisions are very much applicable if the biological resources are used as ingredients for medicine. As such, any interpretation by the Controllers/Examiners of the Office of CGPDTM to see this as an exemption from the Biological Diversity Act would be wrong.
Controllers/Examiners are directed to ensure strict compliance with the aforesaid order and approval of NBA should be sought for any biological resources derived from India and used in an invention for which patent application is filed.”
It appears that the Government is all set to crack down on TK-related patents.
My only fear is that strict implementation of the requirement of permission from the NBA, will seriously delay the grant of a number of patent applications.
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