In a companion case to the “gene patenting” dispute presently before the U.S. Supreme Court, Myriad Genetics, Inc. successfully defended the patent-eligibility of “gene patents” in Australia. In Cancer Voices et al. v. Myriad Genetics Inc. et al. [Myriad] the Federal Court of Australia held that a claim that covers an isolated naturally occurring nucleic acid – either deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) – is patentable provided that the other requirements for patentability have been met.
The Challenged Claims
The challenged patent entitled “In vivo mutations and polymorphisms in the 17q-linked breast and ovarian cancer susceptibility gene” claims isolated polynucleotides comprising all, or a portion of the BRCA1 locus or of a mutated BRCA1 locus. The polynucleotides can be RNA, DNA, cDNA and synthetic forms. The invention also includes detection methods, isolated antibodies, and screening methods.
In reaching its holding, the Australian court reviewed the relevant case law in Australia and the United States and its application to the patenting of products of nature. The court highlighted prior decisions where the technology may depend on the operation of natural laws or the natural properties of the materials involved. Similar to Judge Lourie’s reasoning in the companion U.S. case [see prior post of August 16, 2012], the Australian court focused on the isolated nature of genetic material. Isolated or purified nucleic acids, the court reasoned, is the product of human intervention. Moreover, the court placed importance on the long standing practice of patenting isolated DNA in Australia and other countries. The court also determined that it would be difficult, on any rational basis, to confine the holding of this case to patenting in other fields, such as the patenting of pure and isolated chemicals that occur in nature; where the consequences of such are unknown.
Myriad and the biotechnology community now wait for the U.S. Supreme Court’s review of the patent-eligibility of human genes. Oral argument is expected in April. Stay tuned.
Petitioners (The Association for Molecular Pathology et al., represented by the American Civil Liberties Union or ”Petitioner” or “ACLU”) filed their brief with the U.S. Supreme Court yesterday urging the Court to reverse the Federal Circuit’s decision and the USPTO’s decades long practice of granting patents on isolated DNA. Similar to their arguments in all prior briefings, the Petitioners argue that the patents issued to Respondent Myriad Genetics, Inc. et al. (“Myriad”) were erroneously issued because they claims products of nature. Petitioner also applied the Supreme Court’s Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012)(“Mayo”). A copy of the brief is attached [MyriadPetitionersMeritsBrief].Continue reading this entry
Following up on my post examining the Myriad gene patenting case, which is heading to the Supreme Court, I had the chance to discuss the subject with Colin O’Keefe of LXBN. In the interview, I discuss the legal and commercial issues at the core of the controversy, and whether or not genes are indeed patented.
On November 30th, 2012, the U.S. Supreme Court will conference and consider whether to review the patent-eligibility of isolated DNA sequences. Our prior post of September 25, 2012 addressed Petitioners’ brief and request for review of the Federal Circuit’s decision that upheld the patent-eligibility of isolated DNA. On October 31st, 2012, Myriad Genetics, Inc. et al. responded and filed its brief in opposition to Supreme Court review (see our post of November 14, 2012). Seven “friend of the court” briefs were filed in support of Petitioners’ request for review and reversal of the Federal Circuit’s decision.
On October 31, 2012, Myriad Genetics, Inc. etal. (“Respondent” or “Myriad”) filed its brief in opposition to Petitioners’ (The Association for Molecular Pathology etal., represented by the American Civil Liberties Union or “ACLU”) quest for U.S. Supreme Court review in the ongoing legal battle over whether isolated DNA is patent-eligible subject matter. Myriad argued that U.S. Supreme Court review is not warranted, and that if it is, the question for the Supreme Court is not whether human genes are patentable, but whether isolated DNA molecules that were identified and defined by human inventors are patent-eligible subject matter in the United States. Continue reading this entry
The biotechnology industry, including those investing in personalized medicine, have been waiting for the Federal Circuit’s decision that answers the questions whether isolated DNA and use of the isolated material are patent-eligible under 35 U.S.C. § 101. As reported in our August 16th post, the same three judges (Lourie, Bryson and Moore) held that isolated DNA and cells transformed with the DNA are patent-eligible. Claims that broadly claim detecting alterations in a gene, in this case the BRCA1 gene, were held to be patent-ineligible. The Ass’n for Molecular Pathology et al. v. USPTO, et al., No. 2010-1406 (Fed. Cir. 2012). In addition, the court determined that the plaintiffs had standing to maintain the action. This decision validates that the tools (DNA and isolated naturally occurring materials) underlying personalized medicine are still patent-eligible. Moreover, the court’s evaluation of the claimed methods are informative to those seeking to patent medical diagnostic tests because the court compared and contrasted a patent-ineligible claimed method to a patent eligible one.Continue reading this entry
On July 20th, 2012, the parties in the Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 10-1406 (Fed. Cir. 2011)(also known as the “ACLU gene patenting” case) argued (again) before the Federal Circuit. Recall, the U.S. Supreme Court had asked the court to reconsider its prior ruling as to the patent-eligibility of claims to isolated DNA, in light of its unanimous decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (S. Ct. 2012) (“Mayo”). In Mayo, the U.S. Supreme Court held that that certain diagnostic inventions cannot be patented under 35 USC Secion 101 because they effectively claim a law of nature.Continue reading this entry
The other day I had the opportunity to speak with Colin O’Keefe of LXBN TV on the subject of Mayo Collaborative Services v. Prometheus Laboratories, Inc. In the short interview, I explain the background of the case, offer my thoughts on why Prometheus’ patent wouldn’t have a detrimental impact on medical research and give my thoughts on what this means for the Myriad “gene patenting” case.
On November 2, 2011, England’s highest court issued an important decision, Human Genome Sciences v. Eli Lilly, relating to biotechnology and claims directed to genes in particular, and consequently personalized medicine. Interestingly, claims at issue in this U.K. case are very similar to the type of compositions claims at issue in the U.S. Myriad “gene patenting” case. See our previous posts on Myriad, such as our August 9, 2011 post. Specifically, in both cases, claims relate to “isolated DNA” encoding a particular amino acid sequence.
That said, the U.K. case resolves around whether the patent is valid under the requirement that an invention be “susceptible of industrial application” under Articles 52 and 57 of the European Patent Convention (the EPC). This EPC requirement mirrors the U.S. “utility” requirement under 35 U.S.C. §101, rather than subject matter eligibility under §101 at issue in Myriad. The U.K court reversed the lower court to find that HGS’s patent satisfied the industrial application requirement.
For those of you closely following Assn. Molec. Path. et al. v. USPTO et al., otherwise known as the Myriad “gene patenting” case, you already know that both sides petitioned the Federal Circuit for a rehearing by the three-judge panel (not en banc), albeit for different reasons. Specifically, on August 25, 2011, on behalf of Plaintiffs/Appellees, the ACLU filed a Petition for Panel Rehearing on the merits, while Myriad/Appellant filed its own Petition for Panel Rehearing on the standing issue four days later. Both parties filed petitions in response to the precedential decision by the Federal Circuit on July 29, 2011. The latest update is that yesterday, September 13, 2011, the Federal Circuit denied ACLU’s petition, although we still await word on Myriad’s petition.
On August 25, 2011, on behalf of Plaintiffs, the ACLU filed a Petition for Panel Rehearing with the Federal Circuit in Assn. Molec. Path. et al. v. USPTO et al., known as the Myriad “gene patenting” case. Four days later, on August 29, 2011, Myriad likewise filed its own Petition for Panel Rehearing. Both parties filed their Petitions in response to a precedential decision by the Federal Circuit a month earlier. In that decision, a three-judge panel held, among other things, that all “isolated DNA” claims at issue are patent-eligible, contrary to Plaintiffs’ position. All three judges wrote detailed opinions, with Judge Lourie writing the majority opinion, Judge Moore concurring-in-part, and Judge Bryson concurring-in-part but dissenting-in-part regarding claims encompassing isolated genomic DNA. For background details of the case, see August 9 post, July 31 post and July 29 post. (Many thanks to Kevin Noonan at Patent Docs for first providing the Petitions.)
ACLU/Plaintiffs Petition for Panel Rehearing
In their recent petition, Plaintiffs ask the same three judges rehear the case again. Notably, they do not ask for a rehearing en banc, which would entail reconsideration by all active Federal Circuit judges.
Subject Matter Patent-Eligibility of Isolated DNA and Diagnostic Methods Addressed Head-on
On Friday, July 29, 2011, in one of the most controversial and publicized biotech patent cases in recent years, the Federal Circuit decided the “ACLU/Myriad” gene patenting case, formally known as Assn. Molec. Path. et al. v. USPTO et al. In a majority opinion by Judge Lourie, the court addressed the case on the merits, after finding that at least one plaintiff had standing to sue. The court held all “isolated DNA” claims at issue patent-eligible, but held as patent-ineligible diagnostic method claims that in effect recited only “comparing” or “analyzing” DNA sequences. While this ruling could ultimately be subject to en banc review before all judges at the Federal Circuit and/or find its way to the Supreme Court, this decision now and its impact will undoubtedly be of great interest to everyone working in the biotechnology and diagnostic medicine fields.