On April 15, 2013, the U.S. Supreme Court will hear oral arguments in one of the most controversial and publicized biotech patent cases, the “ACLU/Myriad” gene patenting case (formally, The Association For Molecular Pathology, et al. v. USPTO et al.). While it is nearly impossible to predict the outcome of a Supreme Court case from the oral arguments, the questions the Justices ask (or don’t ask) and the parties’ responses may at least provide an indication of the issues that the Court will focus on when it renders its decision.

Are Human Genes Patentable?

The Supreme Court granted certiorari to address the fundamental, threshold question of the patent-eligibility of human g [...]

On November 30, 2012, the U.S. Supreme Court granted certiorari in the “ACLU/Myriad” gene patenting case (Association for Molecular Pathology v. Genetics, Inc.), taking on the debate over the patent-eligibility of human genes. The Court will review the August 16, 2012 Federal Circuit decision that held for the second time that Myriad’s claims directed to isolated DNA sequences satisfy 35 USC § 101.

The Court’s order granting certiorari is limited to the following question:

Are human genes patentable?

However, in order to assess Myriad’s patents, it will have to decide whether Myriad’s claims, which are directed to “isolated DNA” that encompass genomic DNA const [...]

On August 16, 2012, just four weeks after it heard oral arguments, the U.S. Court of Appeals for the Federal Circuit issued its second decision in Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case). Once again, all judges on the three-judge panel agree that the diagnostic method claims based on “comparing” or “analyzing” DNA sequences are not patent-eligible and that the drug screening method claim is patent-eligible. The majority holds that all of the “isolated DNA” claims are patent-eligible, including those encompassing genomic DNA. Judge Bryson once again dissented with regard to the genomic DNA claims, but agreed with the maj [...]

Practitioners and applicants have been wondering how the USPTO would respond to the July 20, 2012, U.S. Supreme Court decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., which held that Prometheus’ personalized medicine method claims could not be patented because they were directed to a law of nature, and so excluded from patent-eligibility under 35 USC § 101.  Now the USPTO has issued internal guidance to the Examining Corps, in a memorandum entitled 2012 Interim Procedure for Subject Matter Eligibility Analysis 0f Process Claims Involving Laws of Nature.  The guidelines walk a careful line between following Supreme Court precedent without eviscerating the ability [...]