Federal judge in Myriad patent case says invalidation of gene patents does not violate TRIPS

In today’s court ruling in Association for Molecular Pathology, et al. v. USPTO, et al., Judge Robert Sweet rejected claims by Myriad that invaliding the patents would be an unconstitutional taking, or violate the WTO TRIPS Agreement. In discussing the TRIPS, Judge Sweet mentioned Article 8.1 and 27.3 of the TRIPS.

Finally, Myriad’s suggestion that invalidating the patents-in-suit would constitute an unconstitutional taking in violation of the Fifth Amendment of the Constitution or a violation of the United States’ obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) is unpersuasive. Myriad’s novel taking argument runs counter to a long history of invalidation of patent claims by the courts and is unsupported by legal precedent. Similarly, Articles 8.1 and 27.3 of TRIPS permit governments to incorporate public health concerns into their intellectual property law and to exclude from patentability diagnostic, therapeutic, or surgical methods as well as particular inventions on the grounds of public interest. As a result, invalidation of the patents-in-suit would constitution neither a constitutional violation nor a conflict with the Untied States’ treaty obligations. Pages 106-107

These are the two sections of the TRIPS that Judge Sweet cites.

Article 8

1. Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement.

Article 27
Patentable Subject Matter

3. Members may also exclude from patentability:

(a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals;

(b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.

The Public Patent Foundation played a very important role in this litigation. Their press release is here.

The ACLU page on the decision is here.

The Myriad release says: Federal District Court Rules Isolated DNA Claims are Not Patentable, Myriad to Appeal Decision to the Federal Circuit Court of Appeals.

The New York Times reports here.

John Conley and Dan Vorhaus has this report in the Genomics Law Report: Pigs Fly: Federal Court Invalidates Myriad’s Patent Claims

Duke’s Institute for Genome Sciences & Policy issued this statement by Robert Cook-Deegan:

“This is the first time a judge has ruled on gene patents in a conflict about diagnosis,” says Robert Cook-Deegan, the director of the Center for Genome Ethics, Law & Policy at Duke’s Institute for Genome Sciences and Policy. “This completely changes the game, at least for now. Judge Sweet reached a decision the opposite of prior cases. One big difference is that this case is about diagnostics, getting information about DNA in a person’s cells, and not about using DNA to make drugs.”

In 2006 Anja von der Ropp of WIPO and Tony Taubman, now head of intellectual property for the WTO wrote the: Bioethics and Patent Law: The Case of Myriad, for the WIPO Magazine.

Also of interest is the related story of the Federal Circuit court busting the NF-kB gene patent: Federal Circuit Invalidates Harvard and MIT’s Patent For NF-kB Gene Expression