[Ip-health] The CoreValve compulsory license on patent for device to treat aortic stenosis

Jamie Love james.love at keionline.org
Thu Sep 1 14:05:33 PDT 2011


On February 7, 2011, a federal judge in Delaware rejected a request for an
injunction to prevent the continued infringement of United States Patent No.
5411552 [1], for "Valve prothesis for implantation in the body and a
catheter for implanting such valve prothesis." The patent in question
relates to the CoreValve device, which is used to treat Aortic valve
stenosis  [2], a disease of the heart valves in which the opening of the
aortic valve is narrowed.

This case, Edwards Lifesciences v CoreValve, was notable for several

1.  The compulsory licensing of the patent involves a medical technology --
at a time when the Obama Administration is trying to block mention of
compulsory licensing of medical patents at a UN high level meeting on
non-communicable diseases.

2.  At least for now, the compulsory license will be used exclusively for
manufacturing and exporting the infringing medical device. This is an
example of how a compulsory license issued under Part III of the TRIPS is
not bound by the restrictions on exports under a compulsory license granted
under Article 31 of the TRIPS (31.f), or even the 30 August 2003 Decision of
the WTO to implement Para 6 of the Doha Declaration on TRIPS and Public

3.  The decision to order the compulsory licensing of the invention was in
part to avoid the relocation of the manufacturing from the United States to
Mexico. That is, the compulsory licensing of the patent saved U.S.
manufacturing jobs that would have otherwise gone to a country with no
patent for the invention.


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