Any patent offers a conditional monopoly for a limited period of time with a consideration in the form of disclosure. The disclosure must enable a “person skilled in the art” or “person having ordinary skill in the art” to arrive at the invention, however, sans said disclosure, it should never be possible for said person of to arrive at that particular invention. Therefore, the facets of the underlying invention of a patent application must be disclosed categorically in the specification to obtain a legal right not merely on the disclosure but actually on the substantial invention that has been detailed vide the disclosure.

 

 

As against that, publication of a finding in the form of an “original peer-reviewed paper” doesn’t allow a monopoly of said findings, yet the details are required at times, when the published research work needs verification or when the published research work needs to be replicated for some purpose or last but not the least, to develop some research plan based on said published research work. A comparative account between a patent application and a peer reviewed publication in terms of disclosure requirements of biological material used will be made in a later section of this article for clarity.

 

 

Coming to the disclosure requirement for an invention comprising biological material(s), the WIPO has even published a tabulated list (Annexed) detailing the non-exhaustive selection of extracts from existing legislative texts which, in one way or another, provide for a specific disclosure requirement related to genetic resources and/ or traditional knowledge. India, with its rich biome, and vast traditional knowledge on the use of said biome both in written and unwritten formats, inculcated certain special requirements in the Indian Patent Act, 1970, in order to forge a just and controlled exploitation of its resources and humane distribution of benefits to be obtained out of the same. In addition, India acceded and ratified the Budapest Treaty in 2001, mandating the contracting states to deposit and recognize the deposition of biological materials at certain specific International depositories under Article 7 of the Budapest Treaty, along with more than 80 countries and several notified International depositories for deposition of microbial cultures. In India, Microbial Type Culture Collection and Gene Bank (MTCC) at the Institute of Microbial Technology (IMTECH), Chandigarh and Microbial Culture Collection (MCC), Pune, India, are the two recognized international depositories of microorganisms. Thus, after allowing “product” patents, and patents on specific biological materials and/ or materials of biological origin, specific requirements are specifically detailed in the Act U/S 10(4)(d)(ii)(A)(B)(C)(D), saying:

 

 

Every complete specification shall:

 

 

10 (4)(d)(ii) if the applicant mentions a biological material in the specification which may not be described in such a way as to satisfy clauses (a) and (b), and if such material is not available to the public, the application shall be completed by depositing [the material to an international depository authority under the Budapest Treaty] and by fulfilling the following conditions, namely:

 

 

 

 

However, this requirement U/S 10(4)(d)(ii)(A) is made a bit lenient U/R 13(8) of the Indian Patent Rules, 2003, stating:

 

 

13 (8) The period within which reference to the deposit shall be made in the specification under sub-clause (A) of clause (ii) of sub-section (4) of section 10 shall be three months from the date of filing of the application.

 

 

Therefore, the deposition must be made before filing of the patent application, however, reference to said deposition may be made within 3 months of filing of the application, a failure may result in the requirement of a petition in case the deposition has been made but not notified, however, in case the deposition is yet to be made, there may be an adverse decision upon examination during the prosecution phase itself.

 

 

For understating the requirements for the Indian jurisdiction, the aforesaid section is analysed further. It may be noted that although deposition is mandated under Clause A of Section 10(4)(d)(II) of the Act, this is only “if such material is not available to the public, the application shall be completed by depositing [the material to an international depository authority under the Budapest Treaty]”, therefore, in case the material has already been deposited in any other depository, including but not limited to the recognized depositories as specified under the Budapest Treaty, the patent application should never be refused when it is filed in a jurisdiction, in this case, India, and deposited in a depository, which may be considered accessible to the residents of said jurisdiction, irrespective of the status accrued by the Budapest Treaty. Going by this logic, an Indian patent application citing the reference of an earlier deposition i.e. deposition made well before filing of the patent application in any valid depository other than the 2 recognized under the Budapest Treaty, if examined in India, should not face any objection under sufficiency, more specifically under 10(4)(d)(ii)(A). However, for applications of foreign origin, prosecuted in the national phase in India, the deposition should have been made well before coming to the national phase, and this aforementioned relief may never be applicable. For applications of foreign origin, but not from a PCT contracting state, deposition should be made in a recognized depository, preferably before filing of the priority application.

 

 

The clause B and C basically mentions what details are needed to be provided at what point of time i.e. the essential information including name and address of the depository institution, date and accession number as obtained through said deposition and the likes, after the priority date and/ or the date of filing in India.

 

 

Clause D is very important as lack of such disclosure results in the commonest objection from the IPO, India. Even if the biological materials are detailed with accession numbers and dates or the likes, the source and/ or geographical origin of the biological material must be categorically stated in the complete specification at a particular part in the “detailed Description” itself. However, failure to comply with this generally results in a demand asking for the information, which may easily be addressed during any stage of prosecution.

 

 

In India, Form 1 under 12(III) demands a declaration regarding whether or not any biological material has been used from India. As per the nature of the biological material, if no relief is there from the exempted list of International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), necessary permission from the National Biodiversity Authority must be sought before getting the patent application granted.

 

 

Thus, although the details are furnished putting India on focus, similar procedures are followed across other jurisdictions as per the annexed WIPO document. As earlier mentioned, peer reviewed papers also follow similar protocol in dialectical ways, wherein the requirements of disclosure are generally mentioned under the reporting standards or the editorial policies. Reference may be cited for the like policies of renowned journals such as Nature, Science, Cell, Circulation or Springer or the like, wherein the difference generally lies in allowing deposition in many more depositories than prescribed under the Budapest Treaty. Even by practice, a researcher i.e. a potential inventor may even request certain biological material(s) from the authors of a published paper.

 

 

In sum, for an application using biological material from India, in order to comply with the provisions of the Patent Act, in this case Indian Patent Act, the biological material should be deposited prior filing the patent application unless said biological material has already been deposited and referred therefrom. However, in case there is a plan to file the same application in other jurisdictions through any international arrangements, filing should only succeed the deposit of said material before any of the recognized International Depository Authorities. In addition, the declaration in the 12(III) of Form 1 should also be made accordingly. Last but not the least, the accession number and allied details should be present in the specification, along with atleast a single line disclosure of the details of source and geographical origin of the biological material used either at the beginning or at the end of the description.