Academic journal article Bulletin of the World Health Organization

Pharmaceutical R&D Needs New Financial Paradigms

Academic journal article Bulletin of the World Health Organization

Pharmaceutical R&D Needs New Financial Paradigms

Article excerpt

I endorse Professor Correa's sound recommendations on patent law. The patent system is at its most successful when it covers a significant discrete product or process. It is at its least successful when it covers something much broader or much narrower. Patents on broad scientific principles are generally bad, because in the words of the United States Supreme Court, they "may confer power to block off whole areas of scientific development, without compensating benefit to the public" (1). At the other end of the continuum, patents on very minor improvements create a monopoly out of proportion to the technological benefit of the improvement. Moreover, such patents may impose extensive and costly legal negotiations on those who wish to have the freedom to launch a new product. Thus, national patent offices should apply appropriate doctrines of utility or of the scope of patentable subject matter to avoid the problem of overly broad patents, and appropriate doctrines of inventive step to avoid the problem of overly incremental patents.

I want to emphasize that the patent law provisions that Correa describes are only part of a much larger body of issues affecting the balance between drug development incentives and drug access. In the United States, the 1984 Waxman--Hatch Act explicitly extends a drug's regulatory monopoly (with some very technical provisions that have been used to obtain longer exclusivity than was probably intended by Congress and have recently been revised). Relevant to middle-income countries with the ability to build a generic industry, the TRIPS Agreement and some other trade agreements restrict the right to use an original applicant's clinical trial data to obtain approval for a genetic product. …

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