WIPO patent committee (SCP21) to discuss International Nonproprietary Names and Exceptions and Limitations to Patent Rights

In the words of the International Bureau of the World Intellectual Property Organization (WIPO), the WIPO Standing Committee on the Law of Patents (SCP) was created,

created in 1998 to serve as a forum to discuss issues, facilitate coordination and provide guidance concerning the progressive international development of patent law.

At its 21st session (3 November 2014 to 7 November 2014), the SCP will tackle five subjects: a) Exceptions and Limitations to Patent Rights, b) Quality of Patents, Including Opposition Systems, c) Patents and Health, d) Confidentiality of Communications between Clients and their Patent Advisors and e) Transfer of Technology.

For the discussion on patents and health, the WIPO secretariat prepared a paper, “Feasibility Study on the Disclosure of International Nonproprietary Names (INN) in Patent Applications and/or Patents“. At SCP 20 in January 2014, the Committee agreed that the Secretariat, in collaboration with WHO and WTO, would carry out a feasibility study on INNs (despite heavy opposition by the United States of America). In the cost benefit analysis of requiring the disclosure of INN in patent applications, the WIPO paper noted,

48. Ministries of Health, procurement agencies and humanitarian organizations may be interested in knowing the patent status of medicines in order to check the validity of patents, negotiate price or license with the patent holder or to consider the possible use of compulsory licenses or governmental use. A comprehensive INN keyword search function would facilitate a search for relevant patents and their legal status without the need for specialized skills for searching pharmaceutical substances. Similarly, the possibility of a more thorough patent search for particular pharmaceutical substances through an INN keyword search may aid health policy advocates and patent landscape service providers. (Source: SCP/21/9, Feasibility Study on the Disclosure of International Nonproprietary Names (INN) in Patent Applications and/or Patents)

In terms of WHO’s guidelines on the use INNs for pharmaceutical substances, WHO notes that an,

INN is usually designated for the active part of the molecule only, to avoid the multiplication of entries in cases where several salts, esters, etc. are actually used. In such cases, the user of the INN has to create a modified INN (INNM) himself ; mepyramine maleate (a salt of mepyramine with maleic acid) is an example of an INNM. When the creation of an INNM would require the use of a long or inconvenient name for the radical part of the INNM, the INN programme will select a short name for such a radical (for example, mesilate for methanesulfonate). (Source: Guidance on INN)

WIPO’s INN study, prepared in collaboration with WHO and WTO, does not dwell on modified INN in the context of the pharmaceutical industry’s frequent practice of seeking extension of patent terms through evergreening including for new uses or new formulations (including Novartis’s litigation before the Indian Supreme Court in which an INNM, imatinib mesylate, existed).

For WIPO’s discussions on Exceptions and Limitations to Patent Rights, the Secretariat prepared four papers on the following themes:

(i) acts for obtaining regulatory approval from authorities, (ii) exhaustion of patent rights, (iii) compulsory licensing and/or government use and (iv) farmers’ and/or breeders’ use of patented inventions.

In the study on exhaustion, the WIPO secretariat had this following nugget on regional exhaustion:

25. The response from the Netherlands indicated that whether a product had been “put on the market lawfully” or not was decisive for the determination of exhaustion of the rights. The Supreme Court of the Netherlands ruled that products put on the market under a compulsory license or prior use were deemed to be lawfully put on the market. In contrast, for the European Union, products put on the market in another country under a compulsory license are deemed not to be put lawfully on the market, and thus these products may only be imported with the consent of the patentee.

The Secretariat noted that Argentina, China, Costa Rica and Georgia have adopted a regime of international exhaustion.

In terms of mixed exhaustion regimes, WIPO provided the following overview of South Africa.

The judge held that “provided the patentee of a South African patent is able and prepared to place limitations in a country of origin upon the sale in South Africa of his patented good imported into South Africa from that country of origin, purchasers in South Africa, from the likes of unauthorized jobbers, for resale in South Africa can be interdicted from so reselling on the basis of the protection afforded by South African patent”. Therefore, in principle, South Africa adopts the national exhaustion regime. However, the response of South Africa also noted that “the Minister of Health is empowered […] to prescribe the conditions on which any patented medicine may be parallel imported into South Africa, regardless of the provisions of the Patents Act. A parallel imported medicine must have the same formulation, meet the same quality standards and is intended to have the same proprietary name as the medicine already available and registered in South Africa. A potential parallel importer shall obtain a permit to parallel import a medicine and a registration of a relevant medicine, and comply with other regulatory requirements with respect to parallel-imported medicines.