Indian patent office have issued some new guidelines for processing patent related to traditional knowledge (TK) and biological materials (BM). It has been done by the patent office in wake of revocation of Avesthagen patent. Patent office said that Indian patent offices are not taking TKDL seriously whereas other international patent offices are processing patents only after checking TKDL database. Patent office also stated that they have played an important role in safeguarding TK by making this database and they are the only country who has made such database. This database is shared with many international patent offices, which have signed TKDL access agreements.
Patent office gave some laws that should be kept in mind while examining patent application, these are as follows:
According to these sections of Patents Act, 1970 TK and BM are safeguarded in India:
o Section 2 (1) (j) says “invention means a new product or process involving an inventive step and capable of industrial application”. Patents on TK require fulfilling this criterion.
o Section 3 (e) says “a substance obtained by a mere admixture resulting only in the aggregation of the components thereof or process for producing such substances” is not an invention.
o Section 3 (p) says “an invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components” is not an invention.
o Also sections 3 (b), (c), (d), (f), (h), (i) and (j) are of relevance with respect to patent applications related to TK or BM.
A patent application related to TK or BM is received by the patent office than it has to first see that it meets above criteria.
· Next point is regarding Biological resources, section 6 (1) of the Biological Diversity Act, 2002 states “no person shall apply for any intellectual property right, by whatever name called, in or outside India for any invention based on any research or information on a biological resource obtained from India without obtaining the previous approval of National Biodiversity Authority before making such application; provided that, if a person applies for a patent, permission of the National Biodiversity Authority (NBA) may be obtained after the acceptance of the patent but before the sealing of the patent by the patent authority concerned; provided further that the National Biodiversity Authority shall dispose of the application for permission made to it within a period of ninety days from the date of receipt thereof.”
· For this, while applying for a patent in India, the applicant have to submit a declaration under Form-1 (Grant of Patent form). The declaration should state that, “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.”
· Section 55 (1) of The Biological Diversity Act, 2002 has a provision for penalizing which states “whoever contravenes or attempts to contravene or abets the contravention of the provisions of the section 3 or section 4 or section 6 shall be punishable with imprisonment for a term which may extend to five years, or with fine which may extend to ten lakh rupees and where the damage caused exceeds ten lakh rupees such fine may commensurate with the damage caused, or with both.”
Thus, it is mandatory for the applicant to take approval from NBA before the examination step up patent filing procedure; else his application can be cancelled by the examiner.
· This provision deal with the opposition and refusal of patent application related to TK and BM. The Patent applications which does not follows above stated guidelines can be refused under section 15 or in pre-grant opposition under section 25 (2) (d), (f) and (k). Patents can be refused on non-disclosure or wrong mention of the source or geographical origin of BM used. Post grant oppositions can be filed under section 25 (1) (j) and section 25 (2) of the Patents Act, 1970.
The above stated provisions are required to be examined properly by the examiners who are processing patents related to TK. Now let us discus the new guidelines that have been asserted by the Indian Patent office now:
Screening
· Patent office said that all patent applications related to TK should be properly identified, screened and classified as “TK” by RECS Section. The RECS in-charge has to take proper care and no case related to TK should be wrongly screened or classified.
· If patent applications are found inappropriate (i.e. screening or classification not done properly) than during allotment/examination, this should be brought to notice of Group Leader by the concerned Examiner/Controller and rescreening and reclassification should be done by the Group Leader.
· Only the technical head will be competent for rescreening or reclassification of wrongly screened or classified patent applications and that too only on the recommendation of Group Leader.
· System Administrator is required to create separate screening fields in the Module namely, TK-Chemical, TK-Biotechnology and TK-Mechanical
Allotment
· The Group Leader will act himself as the Controller for all the applications related to TK and will ensure that the provisions are fully complied with. The Group Leader should choose one Examiner from his group for dealing with all applications related to TK. Group Leader and Examiner should upgrade their knowledge about TK and BM regularly.
· All application/cases under process including pre-grant opposition relating to TK will be re-allotted to new Group. Whenever any Examiner/Controller comes across a case related to TK, he has to bring it to the notice of Group Leader for re-allotment.
Examination
· The Examiner has to carry out thorough search for checking anticipation from TK and other databases. If any citation is made from TKDL database, then copy of the citation translated into English have to be sent along with the examination report
Next guideline is regarding assessment of novelty and inventive step and that has to be done under section 2 (1) (j) of the Patents Act, 1970.
Novelty
The Patents Act warrants that the subject-matter claimed in a patent application must be novel and while assessing the novelty of claimed subject-matter which relates to a traditional knowledge based invention following guiding principle must be followed:
Guiding Principle:If the subject-matter as claimed relates to extracts/alkaloids and/or isolation of active ingredients of plants, which are naturally/inherently present in plants, such claims cannot be considered as novel when use of such plants is pre-known as part of teachings of Traditional Knowledge.
Inventive step
The following guiding principles must be followed in assessing the inventive step:
Guiding Principle 1: Combination of plants with known-therapeutic effect with further plants with the same known-therapeutic agents wherein all plants are previously known for treating the same disease is considered to be an obvious combination.
Guiding Principle 2:In case an ingredient is already known for the treatment of a disease, then it creates a presumption of obviousness that a combination product comprising this known active ingredient would be effective for the treatment of same disease.
Guiding Principle 3:Discovering the Optimum or Workable Ranges of Traditionally known ingredients by Routine experimentation is not inventive.
Guiding Principle 4:In case multiple ingredients are known to have the same therapeutic activity as per traditional knowledge, taking out one single component out of them cannot be considered as inventive.
Guiding Principle 5:In case individual ingredients are already known for the treatment of a disease as a part of Traditional Knowledge, then it is obvious that a combination product comprising these known ingredients with further plants with the same known therapeutic effect would be more effective than each of the medicinal plants when applied separately (additive effect).
Patent office further said that directions given in the circular No. 1 of 2012 should be followed strictly. Directions were:
{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.”}
Publication
In the end it was stated that System Administrator will publish the list of all pending applications related to TK, under section 11 (A) of the Patents Act, 1970, in a separate link on the official site of CGPDTM. This list will be updated on real time basis. The list will display at least these fields:
· Application number
· Date of filing
· Title of the invention
· Name of applicant (indexed in the order of date of filing)
List of patents granted will also be published on the website for all patents granted (related to TK) from 1st July, 2012. This list will also be updated on real time basis. This list will be displaying these fields:
· Application number
· Patent number
· Date of filing
· Date of grant
· Title of the invention
Name of patentee (indexed in the order of date of grant).
