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 [...]
EPO practice on patenting plants knows two exclusions that are defined in Art. 53(b) EPC: the exclusion of “plant varieties”, and the exclusion of “essentially biological processes for the production of plants”.
The recent referral G2/12 may change this practice and may lead to the exclusion of plants depending on how they were made. The referring Board questions the patentability of product claims for plants obtained by classical breeding methods, even if the claims are not directed to plant varieties.
The exclusions of Art. 53(b) EPC have been subject to Enlarged Board of Appeal decisions G1/98 and G1/08, respectively. The extent of plant variety exclusion was discussed in G1/98. [...]
The UK IPO has applied the decision of the CJEU in Brüstle on stem cells in a recent case that is likely to lead to more judicial comment on the patentability of stem cell inventions. In International Stem Cell Corporation*, the applicant appealed the Examiner’s rejection of two patents, relating to methods of producing human stem cells and corneal tissues derived from such stems cells, where those stem cells are produced using parthenogenesis (i.e. the development of an embryo without fertilisation) to activate a human oocyte.
The Hearing Officer (who hears internal appeals at the UK IPO) therefore had to apply the CJEU’s decision in Brüstle, where the CJEU had sought to define “hum [...]
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 [...]
On Friday, July 20, 2012, the U.S. Court of Appeals for the Federal Circuit heard oral arguments in Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case), which is on remand in view of the U.S. Supreme Court decision in Mayo v. Prometheus. Reading the tea leaves from the judges’ questions and comments, I think the panel decision will depend on whether Judge Moore again concurs with Judge Lourie on the patent-eligibility of isolated DNA, or whether she feels compelled by Mayo to join Judge Bryson, who would invalidate the claims. You can listen to the recording of the oral arguments here, and you can read my full recap of the oral arguments on [...]
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 [...]