Statement by India on Agenda Item 6 (i) on the sufficiency of disclosure, delivered by Dr. S. P. Subramaniyan, Assistant Controller of Patents during the 22nd meeting of Standing Committee on the Law of Patents

Madam Chair,

The Delegation of India would like to thank Chair, the member countries for providing the information and the WIPO Secretariat for compiling those information. India has formulated a multipronged strategy to develop an Intellectual Property regime in the country to promote creativity entitled "Intellectual Property Initiatives to Drive 'Make in India'”. In that, several measures have been taken to create a strong and vibrant IP regime in India such as transparency, quality of issuing patents, capacity building and certain concession to the small entities, etc.

Madam Chair,

India firmly believes that the Quality of Patents is very important for the development of any patent system. The patent specification plays a major role in the patent prosecution, opposition, revocation, infringement, technology transfer and public health. According to Indian Patents Act, the applicant shall fully and particularly describe the invention and best method of performing the invention at that time of filing the application.

Madam Chair,

The document covered many areas on the sufficiency of disclosure under: (i) the enabling disclosure; (ii) the support requirement; and (iii) the written description requirement, but Indian delegation would like to make statement on the issue:

The High Court of Mumbai in AIR1969Bom255, paragraph 14 commented that that insufficiency of description has two branches, (1) the complete specification must describe an embodiment" of the invention claimed in each of the claims and that the description must be sufficient to enable those in the industry concerned to carry it into effect "without their making further inventions"; and (2) that the description must be fair i.e. it must not be unnecessarily difficult to follow”.

The Delegation disagrees with single method of preparing compound in the description as a support where the application claims substantial number of compounds. The Delegation further disagrees with the amendment to the specification after the filing date based on the further study in the laboratory or clinical trial results, because it is later acquired knowledge. The present study although focuses on the fundamental issues of the different patent system with respect to the sufficiency, however, is still deficient in answering the problems of the correspondence of the claimed inventions and sufficiency of description in the areas of Markush claims. Therefore it is proposed:  Special study can be escalated further to survey the problems of Markush type of claims which is invariably found in most of the pharmaceutical and biotechnological patent applications. Claims encompassing innumerable compounds using single Markush formula, hardly find support for those compounds in the description, which posing several problems during examination, more particularly  meaningful search could not be conducted for assessing novelty, inventive step and also difficult to assess the unity of invention.

In India's experience of following are the reasons for the above said study:

(i). The Markush claim is a platform for protecting multiple inventions in a single application and paving way to many further selection patent applications.

(ii). Most of the time, it is difficult for a person skilled in the art to reach the invention without undue burden.

(iii). Number of examples required, particularly in the context of broad Markush formulas, is yet again a matter of debate.

(iv). Finally, the questions to be asked:

a). Is there enabling disclosure is provided for all the molecules claimed in the application?

b). Is all the compounds are prepared by the applicant before the date of filing?

c). Can the skilled man prepare all compounds without undue burden?

d). Is all the compounds are useful to the society?

Therefore, it is a submission of the Delegation to the WIPO Secretariat to make survey for ascertaining common sufficiency requirement for Markush claims among the member countries before concluding the Quality of patents w.r.t. sufficiency of disclosure. We hope that most of the member countries agree with Indian delegation and they may also be facing the similar problems in processing patent applications claimed in Markush type of claims.

We strongly feel that the claim shall be supported by the enabling disclosure (emphasis added). The sufficiency requirement for Markush type of claims in the description may be further studied and consensus among the members in this matter also to be considered.

India’s one of the major concerns is to prevent the trivial inventions. The burden on the prosecution can be facilitated by introducing INN in the specification for known molecules filed as a modified form.  India reiterates its stand that further study on the mandatory disclosure of INN in the specification can facilitate quality of patent.

Thank you, Madam Chair.

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