Tag Archives: Subject Matter Patent Eligibility

Myriad’s Continuing Patent Debate

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On October 6, 2014, the U.S. Court of Appeals for the Federal Circuit entertained oral argument in the interlocutory appeal of the district court’s denial of Myriad’s motion for preliminary injunction against Ambry Genetics. In re BRCA1- and BRCA2- Based Hereditary Cancer Test Patent Litigation, Case Nos. 14-1361, -1366. If you missed oral argument, the … Continue reading this entry

Myriad Set for Another Round

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On Monday, October 6th, the U.S. Court of Appeals for the Federal Circuit will entertain oral argument in another case involving Myriad’s BRCA1/BRCA2 diagnostic tests. In re BRCA1- and BRCA2- Based Hereditary Cancer Test Patent Litigation, Case Nos. 14-1361, -1366. In the words of Myriad “[t]his appeal … presents this Court with one of the … Continue reading this entry

Federal Circuit Frames Test for Patent-Eligibility

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Personalized medicine relies on diagnostics to analyze a patient for individualized therapy and for monitoring a patient’s health status. Some diagnostic tests use natural products, for example gene sequences, either as the target of the diagnostic test or as a tool to identify a genetic trait or anomaly. Personalized medicine also may rely on the … Continue reading this entry

Will the USPTO Respond to Public Feedback of Its Eligibility Guidance?

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Periodically, the USPTO holds open meetings with the public to discuss its thinking on current topics relating to the patent procurement process. Late last week, the Biotechnology, Chemical and Pharmaceutical Customer Partnership of the USPTO announced the first bi-coastal meeting to be held via webcast in Washington, D.C. and San Jose, California on September 17th, 2014. … Continue reading this entry

Managing IP Risk in the Age of Personalized Medicine

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As discussed on Foley’s Health Care Law Today blog, personalized medicine treatment trends and innovations are leading diagnostic and therapeutic companies to form complex arrangements and partnerships with the ultimate goal of delivering improved patient treatment. Diagnostics are married to a single or multiple treatments. Devices connect patients with providers. Health care systems may partner with … Continue reading this entry

USPTO Extends Deadline to Comment on Subject Matter Eligibility Analysis

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Yesterday at BIO’s session entitled “Patent-Eligibility from the Trenches: Practical Implications of the Supreme Court’s Prometheus (Mayo) and Myriad Decisions” a panel of experts and an engaged audience discussed the controversial USPTO “Guidance for Determining Subject Matter Eligibility of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products” (2014 Guidance) and its implications for … Continue reading this entry

Federal Circuit Dismisses WARF Stem Cell Case – A Missed Opportunity

Recently in Consumer Watchdog v. Wisconsin Alumni Research Foundation, No. 2013-1377 (Fed. Cir. 2014), the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) dismissed Appellant Consumer Watchdog’s appeal on the ground that as a party, it lacked Article III standing. While the court’s decision raises interesting issues regarding litigation strategy, dismissal of the appeal … Continue reading this entry

Federal Circuit Adds to Section 101 Jurisprudence

The U.S. Court of Appeals for the Federal Circuit, relying on U.S. Supreme Court patent-eligibility precedent, held that a claim to a live-born clone of a pre-existing, non-embryonic, donor mammal is not patent-eligible. The Court reasoned that because the clone is genetically identical to its donor parent, it is not markedly different from that found in nature and … Continue reading this entry

Patent-Eligibility of Stem Cells Under New USPTO "Myriad-Mayo" Guidance

In March, the U.S. Patent and Trademark Office (USPTO) implemented new procedures to address whether inventions that relate in whole or in part to laws of nature and naturally occurring products are patent-eligibility in light of recent U.S. Supreme Court decisions, notably Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013) … Continue reading this entry

USPTO Issues Guidance for Examining Process Patents

On March 4th, 2014, the U.S. Patent and Trademark Office (USPTO) issued “2014 Procedures For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products” Guidance, advising examiners and the public of the factors for determining whether an invention satisfies the U.S. Supreme Court’s interpretation of 35 U.S.C. §101, as … Continue reading this entry

USPTO to Apply Myriad Beyond Isolated DNA

On March 4th, 2014, the United States Patent and Trademark Office (“USPTO”)  issued a Guidance, advising examiners and the public of the factors for determining whether an invention satisfies the U.S. Supreme Court’s interpretation of 35 U.S.C. §101, as applied to patent-eligibility. See Assn. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. … Continue reading this entry

Computer-Aided Selection Method Fails Patent-Eligibility

In SmartGene, Inc. v. Advanced Biological Labs., S.A., No. 2013-1186 (Fed. Cir., Jan. 24, 2014), the Federal Circuit held that a patent claiming the use of a computer to implement routine mental information-comparison and rule-application processes to select a treatment for a patient fails patent-eligibility because the claims are directed to an abstract idea. The … Continue reading this entry

United States and PTO Invited to Stem Cell Party

Last week Consumer Watchdog (“CW”) and Wisconsin Alumni Research Foundation (“WARF”) squared off at the Federal Circuit over CW’s appeal of the  inter partes reexamination of WARF’s U.S. Patent No.  7,029,913 (the ’913 Patent, entitled “Primate Embryonic Stem Cells”). Consumer Watchdog v. Wisconsin Alumni Research Foundation, No. 13-1377 (Fed. Cir. 2013).  CW’s appeal challenges the patent-eligibility of in vitro cultured human embryonic stem cells (hESCs) … Continue reading this entry

WARF Could Avoid Federal Circuit Review

On November 25, 2013, Consumer Watchdog (“CW”) and Wisconsin Alumni Research Foundation (“WARF”) responded to the Federal Circuit’s Order directing each party to brief whether CW, as a third party requester, has standing to appeal the U.S. Patent and Trademark Office’s (“USPTO’s”) decision in the inter partes reexamination of WARF’s U.S. Patent No.  7,029,913 (the ’913 Patent, … Continue reading this entry

California Court Holds Diagnostic Claims Not Patent-Eligible

In one of the first district court decisions applying the U.S. Supreme Court’s new Myriad patent-eligibility standard, the Northern District of California held that diagnostic claims containing only conventional and existing detection steps do not make the use of a natural phenomenon patent-eligible. See Ariosa Diagnostics, Inc., v. Sequenom, Inc., No. C 11-06391 SI (N.D. … Continue reading this entry

Update on WARF Stem Cell Patent Challenge

As reported in my July 8, 2013 post, Consumer Watchdog (formerly known as The Foundation for Taxpayer and Consumer Rights) and the Public Patent Foundation (collectively “CW”) asked the Federal Circuit to determine if in vitro cultured human embryonic stem cells (hESCs) are patent-eligible. Consumer Watchdog v. Wisconsin Alumni Research Foundation, No. 13-1377 (Fed. Cir. … Continue reading this entry

Isolated DNA Is Not Patent-Eligible

Today the U.S. Supreme Court in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., __ U.S. __ (2013) (opinion here), held that genes and DNA fragments merely isolated from nature without alteration are not patent-eligible. Justice Thomas, who delivered the opinion of the Court, stated that claims to isolated DNA (in this case, isolated BRCA1 and BRCA2 … Continue reading this entry

Video Interview: Discussing the Supreme Court's Oral Arguments in Myriad Gene Patenting Case

Earlier this week, I had the opportunity to speak again with Colin O’Keefe of LXBN regarding last week’s oral arguments in Association for Molecular Pathology v. Myriad Genetics. In the interview, I share some quick observations on the oral arguments and offer my thoughts why I believe the Justices will “split the baby” with their ruling.… Continue reading this entry

Myriad Posts Gene Patenting Victory in Australia

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 – … Continue reading this entry

Petitioners File Supreme Court "Gene Patenting" Brief

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 … Continue reading this entry

Personalized Medicine Patenting Update

Patenting diagnostic methods is more challenging in the wake of the U.S. Supreme Court’s Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __ (2012) (Prometheus) and the USPTO’s application of the decision, as set forth in its Guidance Document distributed to patent examiners. Patent examiners are advised to follow the Guidance Document in examining … Continue reading this entry

Video Interview: Discussing Myriad & the Supreme Court with LXBN TV

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.  … Continue reading this entry

Are Human Genes Patentable?

As reported in my November 30th, 2012 post, the U.S. Supreme Court granted certiorari to review the issue “are human genes patentable?” The issue arises from the long-running dispute among a consortium of plaintiffs, led by the American Civil Liberties Union (collectively “ACLU”) who sued Myriad Genetics, Inc. and the Directors of the University of … Continue reading this entry

Amici Urge Reversal of “Gene Patenting” Decision

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. … Continue reading this entry