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New USPTO Patent Subject Matter Eligibility Guidelines Raise More Questions Than They Answer

The USPTO has issued new Guidance For Determining Subject Matter Eligibility to help examiners apply the principles of Myriad and Prometheus to any claim “reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products.” The guidelines focus on a “signficantly different” test, and include lists of factors that weigh towards and against patent eligibility. The guidelines also include several examples applying the new analytical framework to sample claims. The guidelines do not apply to claims that raise “abstract idea” issues, which are still to be examined under MPEP 2106(II).

This article delves into the details of the guidelines, and you can read a [...]

U.S. Supreme Court Holds Isolated Human Genes May Not Be Patented

On June 13, 2013, the U.S. Supreme Court issued its long-awaited decision in the “ACLU/Myriad” gene patents case (Association For Molecular Pathology v. Myriad Genetics, Inc.). In a unanimous opinion authored by Justice Thomas, the Court held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring.” Thus, the Court held that human genes may not be patented.

Background

This case stems from a declaratory judgment action brought to challenge certain claims in seven patents related to Myriad’s discovery of the BRCA1 and BRCA2 genes, and t [...]

U.S. Supreme Court Hears Oral Arguments in Myriad Gene Patent Case

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 [...]

U.S. Supreme Court To Decide If Human Genes Can Be Patented

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 [...]

U.S. Court Again Upholds Myriad Isolated DNA Claims

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 [...]

The USPTO Issues New Patent Eligibility Guidance Under Prometheus v. Mayo

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 [...]

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