Any patent offers a conditional monopoly for a limited period of time with a counterpart in the form of disclosure. The disclosure must enable a “person skilled in the art” or a “person of ordinary skill in the art” to arrive at the invention, however, without said disclosure it should never be possible for said person to come up with this particular invention. Therefore, the facets of the invention underlying a patent application must be disclosed categorically in the description to obtain a legal right not only to the disclosure, but in fact to the substantial invention that has been detailed in the description. disclosure.
On the other hand, publishing a result in the form of an “original peer-reviewed article” does not allow having a monopoly on said results, but the details are sometimes necessary, when the published research work must be verified. or when the published research work needs to be reproduced for a specific purpose or, last but not least, to develop a 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 the biological material used will be made in a later section of this article for clarity.
With regard to the requirement to disclose an invention comprising biological material(s), WIPO has even published a tabulated list (Annex) detailing the non-exhaustive selection of extracts from existing legislative texts. which, in one way or another, provide for a disclosure obligation 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, has inculcated some special requirements in the Indian Patents Act of 1970, in order to forge a working fair and controlled of its resources and human. distribution of benefits to be derived. In addition, India acceded to and ratified the Budapest Treaty in 2001, obliging Contracting States to deposit and recognize the deposit of biological material with certain specific international depositories under Article 7 of the Budapest Treaty, as well as than more than 80 countries and several international depositories notified. for the deposit of microbial cultures. In India, Microbial Type Culture Collection and Gene Bank (MTCC) at Institute of Microbial Technology (IMTECH), Chandigarh and Microbial Culture Collection (MCC), Pune, India are the two internationally recognized repositories 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 U/S 10(4)(d)(ii). )(A)(B) (C)(D), saying:
Each complete specification must:
10(4)(d)(ii) if the applicant mentions in the specification biological material which cannot be described so as to satisfy paragraphs (a) and (b), and if such material is not available to the public, the application is completed by filing [the material to an international depository authority under the Budapest Treaty] and fulfilling the following conditions, namely:
(A) the filing of the material must be made on or before the filing date of the patent application in India and a reference to it is made in the specification within the prescribed period;]
(B) all available characteristics of the material required for it to be properly identified or indicated are included in the specification, including the name, address of the depositary institution and the date and number of the deposit of the material with the institution;
(C) access to the material is only available in the depositary institution after the date of the patent application in India or if priority is claimed after the date of priority;
(D) disclose the source and geographical origin of the biological material in the specification, when used in an invention.
However, this requirement U/S 10(4)(d)(ii)(A) is made somewhat lenient by U/R 13(8) of Indian Patent Rules, 2003, stating:
13 (8) The time within which deposit is referred to in the specification under sub-paragraph (A) of sub-paragraph (ii) of sub-paragraph (4) of section 10 is three months from from the date of filing of the application.
Therefore, the filing must be made before the filing of the patent application, however, reference to said filing can be made within 3 months of the filing of the application, failure may result in the requirement of a request in the case where the deposition has been made but not notified, however, if the deposition has not yet been made, there may be an adverse decision upon consideration during the prosecution phase itself.
To underestimate the requirements of Indian jurisdiction, the above-mentioned section is analyzed in more detail. It should be noted that although the filing is mandated under Section A of Section 10(4)(d)(II) of the Act, it is only “if these elements are not accessible to the public, the request must be supplemented by filing [the material to an international depository authority under the Budapest Treaty]”, therefore, in the event that the material has already been deposited with another depositary, including but not limited to recognized depositories as specified in the Budapest Treaty, the patent application should never be refused when deposited in a jurisdiction, in this case, India, and deposited in a depositary, which may be considered accessible to residents of such jurisdiction, regardless of the status conferred by the Budapest Treaty. Following this logic, an Indian patent application citing the reference of a previous filing, that is to say a filing made well before the filing of the patent application with a valid depositary other than the 2 recognized by the Budapest Treaty, if considered in India, should not be objected to. under sufficiency, specifically under 10(4)(d)(ii)(A). However, for foreign-originated applications, pursued in the national phase in India, the filing should have been done long before reaching the national phase, and this aforementioned relief may never be applicable. For applications of foreign origin, but not coming from a PCT Contracting State, the filing must be made with a recognized depository, preferably before filing the priority application.
Clauses B and C basically mention what details are to be provided when, i.e. essential information including name and address of depositary institution, date and accession number obtained through said filing and the like, after the priority date and/or the date of filing in India.
Clause D is very important because the absence of such disclosure leads to the most common objection of the IPO, India. Even if the biological materials are detailed with accession numbers and dates or the like, the source and/or the geographical origin of the biological material must be categorically indicated in the complete specification at a particular part of the “Detailed description” it -same. However, failure to comply with this rule usually results in a request for information, which can easily be satisfied at any stage of the prosecution.
In India, Form 1 under 12(III) requires a statement as to whether or not biological material was used from India. Depending on the nature of the biological material, if there is no exemption from the list of exemptions of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), the necessary authorization from the National Biodiversity Authority must be requested before getting the patent application granted.
So, although the details are provided with an emphasis on India, similar procedures are followed in other jurisdictions as per the WIPO document in the appendix. As mentioned earlier, peer-reviewed articles also follow a dialectically similar protocol, in which disclosure requirements are usually mentioned in reporting standards or editorial policies. A reference may be cited for similar policies of reputable journals such as Nature, Science, Cell, Circulation or Springer or similar, where the difference usually lies in allowing deposit in many more repositories than prescribed by the Budapest Treaty . Even in practice, a researcher, ie a potential inventor, may even request certain biological materials from the authors of a published article.
In short, for an application using biological material originating from India, in order to comply with the provisions of the patent law, in this case the Indian patent law, the biological material must be filed before the filing of the patent application, unless said biological material has already been filed. and returned from it. However, where it is intended to file the same application in other jurisdictions through international arrangements, the filing should only succeed the filing of said material with one of the recognized international depositary authorities. In addition, the declaration in 12(III) of Form 1 must also be made accordingly. Last but not least, the accession number and associated details should be present in the specification, along with at least one line disclosing details of the source and geographical origin of the biological material used either at beginning or end of the description.