[Ip-health] KEI general statement to the 15th Standing Committee on the Law of Patents (SCP)
thiru at keionline.org
Tue Oct 12 03:53:59 PDT 2010
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
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
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
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
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.
Knowledge Ecology International (KEI)
thiru at keionline.org
Tel: +41 22 791 6727
Mobile: +41 76 508 0997
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