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12:00 AM
Apr 05, 2010
 |  BioCentury  |  Politics, Policy & Law

Bracketing the BRCA Appeal

Fate of Myriad gene patent ruling will hinge on case law used by appeals courts

Drug and diagnostic companies have been operating for decades under the principle that genes are eligible for patenting as long as they have been isolated and purified. That premise was turned on its head last week by a district court summary judgment that held Myriad Genetics Inc.'s BRCA gene patents invalid. The ultimate disposition of the case now will likely rest on whether appeals courts apply Supreme Court case law on natural products, or on case law created by the Court of Appeals for the Federal Circuit when it examined other gene patents.

Robert Sweet, district court judge for the Southern District of New York, ruled in his summary judgment that 15 claims in seven Myriad patents covering composition of matter of and methods for analyzing the breast cancer 1 early onset (BRCA1) and BRCA2 genes were invalid.

Specifically, he said neither isolated DNA sequences nor the act of analyzing and comparing genes are patentable subject matter under Section 101 of the Patent Act.

The short-term effects of the ruling will be very limited because it directly affects only those specific claims and is binding only in that district. Myriad said its BRCAnalysis test, which analyzes the two genes to assess risk for hereditary breast and ovarian cancers, is covered by 16 additional patents.

Still, biotech patent attorneys told BioCentury they are concerned that Sweet's logic could be used to invalidate the more than 50,000 patents that contain at least one claim to a nucleic acid sequence, ultimately harming molecular diagnostics companies and other sectors.

Myriad said it plans to appeal to the CAFC, where the majority of gene patent experts contacted by BioCentury predicted the appeals panel will use its own gene patent case law to overturn Sweet's ruling.

Whatever CAFC decides is likely to be appealed to the Supreme Court, which, based on its recent interest in patent cases and the high profile nature of the case, is likely to agree to hear it.

The methods claims in the case are more likely to be determined by the Supreme Court in Bilski v. Kappos or Prometheus Laboratories Inc. v. Mayo Collaborative Services. Bilski was heard last year and the high court could rule in any week, while the court has not yet decided whether to hear Prometheus.

Marked difference

The BRCA case is widely believed to be the first to challenge the eligibility of gene patents under Section 101 of the Patent Act.

Section 101 defines matter that is eligible for patenting as "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof."

Once a claim is determined to be eligible for patenting under Section 101, then the claim's patentability is determined under other sections of the statute that cover criteria such as anticipation, enablement and obviousness.

The BRCA case, Association for Molecular Pathology et...

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