Posts Tagged: "sacghs"

PTO Report on Confirmatory Genetic Testing: A Worthwhile Effort But Not Far Enough

The USPTO has released its ‘Report on Confirmatory Genetic Diagnostic Testing,’ which was prepared to fulfill the requirements of §27 of the Leahy-Smith America Invents Act. The USPTO did make an interesting observation that has been reflected in its patent examining guidelines. The USPTO Report concludes that ‘it is unlikely that exclusive provision of a diagnostic test, whether for an original diagnosis or to confirm the original result, will be possible based on patenting and licensing behavior.’ This statement reinforces the USPTO’s prior broad interpretations of the Court’s findings in Mayo and Myriad. Of note is that in the USPTO Report, the USPTO adopts the Supreme Court’s factually and scientifically unsupported distinction between genomic DNA and cDNA.

High Noon for Bayh-Dole

Senate Judiciary Committee Chairman Patrick Leahy (D-VT) asked NIH in a July 12 letter to force compulsory licensing of Myriad’s BRCA breast and ovarian cancer genetic test under the “march-in rights” provision of the Bayh-Dole Act. Myriad received an exclusive license to develop the test from universities operating under Bayh-Dole Act. The law allows nonprofit institutions receiving federal R&D funds to own and license resulting inventions so they can be commercialized for use by the public. Critics of Bayh-Dole have long sought to reinterpret its statutory standards under which the government can compel universities to issue compulsory licenses as a weapon to control prices. This was not the intent of the law.

Minority Report: Task Force on IP & Genetic Testing

Yesterday, the Task Force on IP and Genetic Testing submitted its Final Draft Report (titled Final Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests) to the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS). SACGHS, in turn, voted to accept the recommendations, which will be passed on to Secretary Sebelius,…

HHS Assault on Gene Patents and Diagnostic Methods

UPDATED: 7:19pm on 10/8/2009 Today the Task Force on IP and Genetic Testing submitted its Final Draft Report (titled Final Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests) to the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS). SACGHS, in turn, voted to accept the recommendations, which will be passed…