Diagnostic developers and legal experts have been keeping a close watch on Prometheus since the Federal Circuit Court of Appeals' handling of diagnostic method patents in that case may impact the AMP v. USPTO gene-patenting lawsuit that is pending review by the same court.
In a filing with the federal appeals court, the DoJ attempted to strike a balance between rewarding inventions that result from genomic discoveries and ensuring that discoveries of natural phenomena remain in the "storehouse of knowledge of all men." Meanwhile, it's business as usual at the USPTO until the appeals court rules on Myriad's challenged BRCA patents.
Although the company is embroiled in a high-profile patent lawsuit involving its flagship BRACAnalysis test, and the FDA's plan to regulate laboratory-developed tests may impact all of its marketed products, Myriad officials maintain a positive outlook.
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.