Patented and Generic Drugs: Overview

Pages189-191

Page 189

The Issue

Many World Bank-supported projects finance antiretroviral medicines (ARVs) and other drugs for HIV-related treatment. ARVs are expensive drugs, although competition from generics has helped to drive prices down. In countries where ARVs (and other relevant drugs) are patented, can generic drugs be manufactured or imported legally?

Legal and Policy Considerations

A patent is an exclusive right granted for an invention. It provides the patent owner with the legal means to prevent others from making, using, selling or importing the new invention for a limited period of time (usually 20 years). Patents are intended to provide incentives for innovative activity and are granted under national law. There are no "worldwide patents." For the 150 member countries of the World Trade Organization (WTO), the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and WTO decisions with respect to that agreement provides a common set of requirements.

The World Health Organization (WHO) favors the term "multisource pharmaceutical product" over the term "generic product" because the latter can have different meanings depending on context and jurisdiction. Under the WHO's definition, a generic drug is a "pharmaceutical product, usually intended to be interchangeable with the innovator product, which is usually manufactured without a license from the innovator company and marketed after expiry of the patent or other exclusivity rights." Further, "[g]eneric products may be marketed either under the approved nonproprietary name or under a brand (proprietary) name. They may be marketed in dosage forms and/or strengths different from those of the innovator products." (See References, Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products at 35.)

Whether a generic ARV can be manufactured or imported legally depends on the patent situation in the country. If there is a patent law that allows for the patenting of pharmaceutical products and if a given ARV is under patent, a generic version may only be manufactured or imported legally if: (a) there is an exception that can be invoked under national law, or (b) if the patent holder has voluntarily entered into a licensing agreement or has agreed not to enforce a patent.

A compulsory license is an authorization by the government to...

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