[Ip-health] KEI general statement to the 15th Standing Committee on the Law of Patents (SCP)

[Thiru Balasubramaniam]

http://keionline.org/node/975

SCP 15
General Statement of Knowledge Ecology International
12 October 2010

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.


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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru at keionline.org


Tel: +41 22 791 6727
Mobile: +41 76 508 0997