KEI general statement to the 15th Standing Committee on the Law of Patents (SCP)

Thank you Mr. Chair, and I would like to take this opportunity to congratulate you and the vice-chairs upon your re-election.

1. Knowledge Ecology International welcomes the reports by experts, thanks the Secretariat for its work on this topic.

As a general matter, KEI suggests the WIPO Secretariat provide standardized disclosure of the professional consulting that various experts do, as is the practice for other UN bodies and some academic journals.

2. With regard to the studies on limitations and exceptions to patent rights, and to the enforcement of those rights, KEI suggests WIPO provide an opportunity for the general public to make online submissions on these topics, and to offer comments on the expert reports.

This is a complex topic, and the experts have offered a considerable amount of information that we have found useful. However, in some areas, the reports could be more complete.

In particular, the discussion of compulsory licensing of patents in the United States does not address the several areas where compulsory licenses are available or mandatory to address certain public interest objectives.

While the United States does not have a general compulsory licensing statute of the type that is found in most countries, it does have statutory authority for granting compulsory licenses for patents on nuclear energy, or for patented inventions used to implement government standards in the clean air act.

In 2006, the United States Supreme Court, in a decision involving eBay, the online auction service, held that injunctions on patents can only be issued if other remedies for infringement are rejected, including granting compulsory licenses on infringed patent. Since 2006, the courts in the United States have issued a number of compulsory licenses on patents, including compulsory licenses that have benefited Microsoft, Toyota, DirectTV, Johnson and Johnson, Abbott Laboratories and other leading technology and manufacturing firms. Compulsory licenses were granted at least four times in the past four years on various medical technologies, including for purposes of exporting the compulsory licensed products to Europe.

In the field of clean energy, the United States Energy Storage Competitiveness Act of 2007 created a system of compulsory licenses for energy storage technologies.

In March of 2010, the U.S enacted the Affordable Health Care Act, which among other things, created a mandatory compulsory license on patents for biologic drugs, when the patent holder fails to make timely disclosures to generic competitors.

The United States also makes frequent use of compulsory licenses to remedy anticompetitive practices, including for example, those relating to undisclosed patents on standards for gasoline or computer technologies.

3. Finally, KEI notes that the experts failed to distinguish between compulsory licenses that are granted under the procedures of Part II of the TRIPS, concerning patent rights, and those granted under Part III of the TRIPS, concerning the remedies for infringement of those rights. The most commonly used mechanisms for obtaining a compulsory license in the United States are those associated with Part III of the TRIPS, including in particular Article 44 of the TRIPS. Under the structure of the TRIPS agreement, Article 44 compulsory licenses are not subject to the restrictions that exist for Article 30 and 31 of the TRIPS, an issue not explored in the experts reports.

KEI is completing an updated review of the experiences with compulsory licensing of patents, which should be completed in November of 2010.

Thank you.