Many in the genetic testing industry have viewed the Bilski decision as a harbinger of the Supreme Court's thinking for future patent cases, including the anti-gene patenting suit filed against Myriad Genetics.
Cancer Voices Australia, the law firm Maurice Blackburn, and breast cancer patient Yvonne D'Arcy this week took legal action in Australia's Federal Court against four biotech companies — Myriad Genetics, Genetic Technologies, Centre de Recherce de Chul in Canada, and the Cancer Institute in Japan — to challenge the legality of gene patents.
According to unofficial results, the Third Frontier extension passed by a 62-38 percent margin, benefiting from a consensus of support among life sciences leaders, business leaders, and government officials from both political parties.
The money is part of the $22 million committed by the state in return for the nonprofit research and technology development institute locating its recently-opened Center for Advanced Drug Research, or CADRE, in Harrisonburg, Va.
Restrictions in GINA could muddy payors' disease risk prediction models, though it remains to be seen the degree to which the law will "deteriorate" those predictions, Derek van Amerongen, chief medical officer of Humana Health Plans of Ohio, said last week at a conference.
The healthcare reform bill includes a section on comparative effectiveness research that creates the Patient-Centered Outcomes Research Institute. Seen as a victory for personalized medicine, the institute will study the utility of medical products in "various subpopulations," including groups differentiated by genetic and molecular subtypes.
The healthcare reform bill, expected to be signed into law by President Obama on March 23, includes a section on comparative effectiveness research that creates the Patient-Centered Outcomes Research Institute.
In an attempt to help guide healthcare stakeholders who wish to issue public comments to the interim final GINA rule, Johns Hopkins University's Genetics & Public Policy Center released a model document discussing GINA's underwriting restrictions and how they impact health risk assessments and wellness programs.
While DMAA and employer groups are urging for a moratorium on GINA fearing that the law's restrictions on "underwriting" activities will harm enrollment in wellness programs, personalized medicine advocates are concerned that any delay in implementing the law as is would harm adoption of personalized medicine and hinder participation in genetic research studies.
The Supreme Court Justices' comments imply they are looking for a way to uphold the lower court's "machine-or-transformation" test in Bilski v. Kappos while minimizing the impact on the technology and medical device industries.
A US district court decided this week that the lawsuit challenging the legality and constitutionality of BRCA gene patents owned by the University of Utah and exclusively licensed to Myriad has sufficient merit to be heard.