Statement by India on Agenda Item 6 (iii) on the subject of Patents & Health, delivered by Dr. Dinesh P. Patil, Assistant Controller of Patents during the 22nd meeting of Standing Committee on the Law of Patents

Madam Chair,

The Delegation of India firmly reaffirms its support to the studies as proposed by the Delegation of South Africa on behalf of the African group and the Development Agenda Group on Patents and health(SCP/16/7). Further, we reaffirm our views expressed in the last SCP meeting on the issues related to the document SCP/21/9 concerning the feasibility study on the disclosure of International Nonproprietary Names (INN) in patent applications and/or patents and also, on the issues of a study related to Markush formulae.

The Delegation of India would like to reiterate its specific views with respect to the INN study (SCP/21/9) in which it refers that there is no primary legislation anywhere in the world in which the INN disclosure is a matter of compulsion, however, it says that in secondary legislation such as administrative guidelines at least indirectly indicate that the INN disclosure can be incorporated in the patent specification. Therefore, there is ample room for further discussion on said study. It is further reiterated that there are certain elements in said study, which need further amendments in the document:

-Negative bias with respect to the hardship cast upon the applicant for submitting the INN;

-Evading the question of usefulness or advantage of mandatory disclosure of INN in the patent specification, when the applicant is fully aware of said INN;

-Failure to acknowledge the tremendous hardship that an Examiner or any third party faces when the compound is buried in a Markush structure, whereas the compound could be easily recognized had it been identified by its INN; and

-Improvement of document by inclusion of the cost &benefit of INN disclosure, particularly when an important pharmaceutical compound remains buried within the billions of compounds covered by Markush structure.

The Delegation of India would also like to reiterate its specific views on the Markush formulae and their study concerned to be undertaken in the next session. The proposed study could be related to Markush formulae and the huge impediments, which they create in the healthcare industry by creating mysterious cobweb of unreal compounds to be discovered in future thus stifling the innovations in the field of technology. Particularly, the questions to be studied can be broadly divided into two vistas. One relating to the basic issues of patent law and other a set of questions arise from the barriers, which they create in respect of the availability of essential medicines to the public:

(i) An issue of actual enablement of compounds covered in a Markush formula. Do they meet the requirements of sufficiency and support?

(ii) Do all compounds under the coverage of such a broad Markush claim meet the requirement of usefulness or industrial applicability?

(iii) What are actual scopes of such claims?

(iv) To what extent they help to develop essential medicines?

With respect to the US proposals (SCP/17/11), Indian Delegation, in previous session, held the opinion that they appeared to be unrealistic in the absences any empirical data. We reaffirm the stand and hold the same view. However, in the 20thsession, certain programs were agreed by the SCP and consequently, a study SCP/21/8 was presented in the 21st session by the WIPO Secretariat. We reaffirm our stands in the last SCP meeting on said study and would like to draw attention on some observations in it:

-Empirical studies examining the relationship between patent systems and technology transfer to make medicines available in DCs and LDCs are very scarce;

-Broad Markush claims may cover a vast number of compounds, which had not been assessed by an applicant and supported by the disclosure in specification, and thus should not be allowed;

-WHO publication reported that the identification of the patent status of the particular pharmaceutical might prove difficult for a number of reasons: multiplicity of patents covering a pharmaceutical product; lack of reference to the INN in a patent application; and the technical language of the specification, among other reasons. As a result, specific expertise may be required to assess the patent status of medicines;

-Compulsory licenses might be most effective when the technology was already known and only access to it was required; and

-It acknowledges the incompleteness of sufficiency requirement in the context of transfer of technology and also, acknowledges the view expressed by some about the uncertainty brought in the patent disclosures by Markush formulas.

The Delegation of India fully endorses this view and also, endorses the view that for the sake of transfer of technology, further feasibility study on the disclosure of the INN and study related to Markush formulae be prepared. In essence, further studies can only reveal the real picture in DCs and LDCs. It would also be helpful if, the study focuses upon the real impediments, which the health care systems face in the wake of the product patent systems. As far as our experience is concerned, and as also admitted in the DOHA declaration, in the post-TRIPS regime, patented products are being sold, in certain areas of health care, at exorbitantly high price thereby making them unaffordable for the ordinary people. Therefore, further studies, as being insisted, would give us the opportunity to discuss how the DCs can utilize the Patent System for the betterment of its public health care system.

Thank you, Madam Chair.