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Friday, February 22, 2013

Gene Patent Outlook Now Clearer in Australia, U.S. Still Waits

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In Australia, things are clearer now for owners of gene patents than they were a week ago, while U.S. gene patent owners are still anxiously waiting for the April 15 oral arguments to begin before the Supreme Court in the celebrated case nicknamed as “Myriad,” after one of the defendants.

The Federal Court of Australia ruled Feb. 15 in Cancer Voices Australia v. Myriad Genetics Inc., FCA 65 (2013), that claims in patents exclusively licensed by Myriad Genetics on isolated DNA and complementary DNA related to the BRCA1 and BRCA2 genes associated with hereditary breast and ovarian cancer are eligible for patenting under Australia's Patent Act.  

The U.S. Court of Appeals for the Federal Circuit reached the same conclusion in litigation concerning U.S. versions of the same patents in its "Myriad" ruling in Association for Molecular Pathology v. U.S. Patent and Trademark Office. But the Supreme Court is reviewing that decision.  

Attorneys predicted to BNA for its Life Sciences Law & Industry Report’s 2013 Outlook that the court will find at least isolated DNA to be patent ineligible. Kevin E. Noonan, of McDonnell Boehnen Hulbert & Berghoff LLP, Chicago, told BNA, “The Supreme Court did not grant certiorari in Myriad to affirm the Federal Circuit’s ruling.”  

Parts of the Australian court’s analysis mirrored that of Judge Alan D.  Lourie of the Federal Circuit, who focused on the isolated nature of genetic material. But generally, the U.S. and Australia courts are working under different laws and court precedents.  

The Australian court ruling cited the fact that the Parliament in that country has rejected efforts to amend patent law to exclude claims directed to DNA. And while the Federal Circuit found that isolated DNA has “markedly different characteristics” from DNA in the human body, the Australian court found the characteristics to be the same and instead focused on whether, under Australian precedent, isolated DNA represents “an artificially created state of affairs, that has some discernible effect, and that is of utility in a field of economic endeavour.”  

Interestingly enough, the attorney representing the challenger to the Myriad patents in Australia said after the ruling that she will be watching what the U.S. Supreme Court does in weighing whether or not to appeal. Whether the Australian ruling will matter at all to the U.S. justices is, for now, unknown.  

   

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