Health Care and IP : International Law and Compulsory Licensing
The key provision in the TRIPS regarding compulsory licensing of patents is Article 31, Other Use Without Authorization of the Right Holder. However, many other Articles are also highly relevant. In particular, review at least Articles 1, 7, 8, 27.1, 30 and 44.
Article 31 of the TRIPS sets outs the framework for national laws on use without authorization of the patent owner. Contrary to some news reports, Article 31 gives countries broad discretion on government use of compulsory licensing. For example, there is no limitations on the grounds upon which a government can authorize use of a patent by third parties, only a set of procedures to follow. The general rules are that governments consider cases on their individual merits, that prior to authorizing third party use there should be an effort to negotiate a voluntary license on reasonable commercial terms, and that the government must provide for "adequate remuneration . . . taking into account the economic value of the authorization." Another important general rule is 31(f), which states "use shall be authorized predominantly for the supply of the domestic market."
There are many exceptions to the general rules. For example, the requirements for negotiation for a voluntary license on reasonable commercial terms may be waived:in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use.The United States is among the countries the does not require an attempt to acquire a voluntary license for public use, including cases where contractors act on behalf of the government. There are also special provisions that apply in cases of anticompetitive practices. For example, when use is a remedy for anticompetitive practices, there is no limitation on exports. There are special rules for follow on (second) patents. A so-called "Intel clause" in 31(c) limits the use of compulsory licensing for semi-conductor technology.
Article 1 says that countries are not obligated to provide more extensive protection than the TRIPS, and "shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice."
Article 7 says the TRIPS seeks to achieve the objectives of the transfer and dissemination of technology, in a manner in a manner conducive to social and economic welfare.
Article 8 says that members may adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development.
Article 27.1 says that"patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced."The so called "anti-discrimination" language of Article 27.1 has not been interpreted by the WTO on the issue of laws that single out the pharmaceutical sector.
Article 30 is the general clause on exceptions to patent rights, and will be relevant if countries provide production for export patent exceptions.
Article 44 on injunctions is an important clause. It says that in cases involving use by governments, or by third parties authorized by a government, without the authorization of the right holder, "Members may limit the remedies available against such use to payment of remuneration in accordance with subparagraph (h) of Article 31."
Other TRIPS provisions on compulsory licensing.
Article 21 of the TRIPS says that compulsory licensing of trademarks is not permitted.
A. Patents: Importation of Articles; Failure to Work or Insufficient Working; Compulsory Licenses.
This Paris Convention is administered by the World Intellectual Property Organization (WIPO). Here is the WIPO list of the 151 countries that are party to this treaty. Note also that Article 2.1 of the TRIPS accord requires compliance with Articles 1 through 12, and Article 19 of the Paris Convention.
(1) Importation by the patentee into the country where the patent has been granted of articles manufactured in any of the countries of the Union shall not entail forfeiture of the patent.
(2) Each country of the Union shall have the right to take legislative measures providing for the grant of compulsory licenses to prevent the abuses which might result from the exercise of the exclusive rights conferred by the patent, for example, failure to work.
(3) Forfeiture of the patent shall not be provided for except in cases where the grant of compulsory licenses would not have been sufficient to prevent the said abuses. No proceedings for the forfeiture or revocation of a patent may be instituted before the expiration of two years from the grant of the first compulsory license.
(4) A compulsory license may not be applied for on the ground of failure to work or insufficient working before the expiration of a period of four years from the date of filing of the patent application or three years from the date of the grant of the patent, whichever period expires last; it shall be refused if the patentee justifies his inaction by legitimate reasons. Such a compulsory license shall be non-exclusive and shall not be transferable, even in the form of the grant of a sub-license, except with that part of the enterprise or goodwill which exploits such license.
(5) The foregoing provisions shall be applicable, mutatis mutandis, to utility models.
|CPT||home page||IP and health care||compulsory licensing|