Statement by India on Agenda Item 7 on the Patents and Health delivered by Dr. S. P. Subramaniyan, Deputy Controller of Patents during the 24th meeting of Standing Committee on the Law of Patents on 28 June 2016

Madam Chair,

The public health is paramount importance to the developing countries and least developing countries.  India is very concerned about the issues relating to public health. The delegation appreciates the Secretariat in compiling the documents.

Any scientific and technological developments should reach all the mankinds irrespective of geographical boundaries.  At the same time, the innovator also to be benefitted with the effective patent administration.  Necessary efforts shall be taken for the availability and affordability of medicines to the neediest, but the Patent system should not be the barrier for outreach of medicines. The system should balance between the innovator and public health.  It is indeed one of the foremost responsibilities of the patent system to ensure the accessibility of medicines for the public at affordable prices.  Even though many other factors affect the availability and affordability of medicines, patent protection is also directly affecting the DCs and LDCs. 

Madam Chair, India fully supports the proposal submitted by the Delegation of South Africa on behalf of the African Group and the Development Agenda Group on patents and health to work out the balance of rights between patent rights and caring for the public health by way of restricting the Patentee to sell their pharmaceutical products for an affordable price.

The delegation reiterate its stand on inclusion of INN in the patent specification which will facilitate in granting of quality patents. The term of the patent according to TRIPS is 20years, but in reality the life of pharmaceutical ingredient in almost all the cases is more than term mandated in TRIPS by filing second level applications.  The delegation would like to emphasize the importance of disclosing INN in the patent application.

Madam Chair,
INN is a given chemical name by WHO for a single, well-defined substance, but not for mixtures of substances, herbal substances or for homoeopathic products. During substantial Examination the Examiner can easily access the details such as IUPAC name, structural formula, molecular formula, Chemical Abstract Service (CAS) number, therapeutic use and pharmacological action of the molecule if INN is known. As a result granting patent for the molecule with trivial modification can be minimized to some extent.  Therefore the delegation of India emphasize the Secretariat to conduct feasibility study for inclusion of INN in the patent specification.

Madam Chair,
Markush type of claim is generally found in pharmaceutical and biotechnology related inventions. Several group of compounds are taking shelter under single Markush claim, which will later be filed as a separate application so that the term of the patent legitimately extended. Even though the molecule is disclosed in the first application, it is still difficulty for the examiner in the well established patent offices to distinguish the molecule from Markush structure. As a result the molecules disclosed in the Markush claim enjoys the monopoly beyond the period specified in TRIPS. Having good number of Examiners also familiar in the respective IPC with all necessary infrastructure still facing problem to conduct a search and examining the patent applications with a broad or speculative Markush claims.

We may also recall the Objective of the TRIPS agreement in Article 8, and
Doha declaration of TRIPS and Public health and their calls for empowering
states to take appropriate measures to protect public health and nutrition.
We re-iterate our appreciation to the Secretariat for their work related to
patent and health.
Delegation of India has requested previously and we still continue to do so, that a study be conducted on cost and benefit of Patenting overbroad markush formulae. That study can broadly be divided into two areas (a) one relating to such issues of the Patent law like inventive steps and the
other is the relationship of overbroad markush formulae with the sufficiency of disclosure.

The study would fall under the scope of not only the quality of Patents but also under other areas which the present committee is pursuing namely Patents and Health and Transfer of Technology vis a vis sufficiency of disclosure.

Thank you Madam Chair