Tag Archives: Gene Patenting

USPTO Releases Revised Subject Matter Eligibility Guidance

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On December 15th, 2014, the USPTO released its much anticipated revised subject matter eligibility examination guidance to assist patent examiners evaluate inventions that may be related to any one of the three judicial exceptions to subject matter eligibility under 35 U.S.C. § 101 – law of nature, natural phenomena, and/or an abstract idea. 2014 Interim … Continue reading this entry

Canada Joins the Gene Patenting Debate

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Canada has joined the gene patenting debate. Children’s Hospital of Eastern Ontario (“Children’s”) sued the University of Utah Research Foundation, Genzyme Genetics, and Yale University (“Defendants”) in Canada’s Federal Court asserting that 5 patents[1] assigned to Defendants (collectively the “Long QT Patents”) for compositions and methods useful in the diagnosis and/or assessment of Long QT syndrome … Continue reading this entry

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

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

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

Patents, Genetic Testing and Federal Funding

In a July 12, 2013 letter to Dr. Francis S. Collins of the National Institutes of Health (“NIH”), Senator Patrick J. Leahy urged the NIH to exercise its march-in rights under the Bayh-Dole Act to directly license the genetic testing patents held by Myriad Genetics, Inc. (“Myriad”) that have been the subject of on-going litigation. … 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

Personalized Medicine and the Gene Patenting Debate

The transcript for today’s Supreme Court oral argument in The Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (2013) has been released, and the importance of the gene patenting debate to personalized medicine was discussed. The Court was well briefed on the issues and questioned the parties and U.S. government regarding why isolated genes should or should not be patent-eligible, the … Continue reading this entry

Australian "Gene Patenting" Case to be Appealed

The patenting of human genes in Australia remains under court review. As reported in the blog Patentology, an appeal of the Australian decision, Cancer Voices et al. v. Myriad Genetics Inc. et al., was filed on March 4, 2013 to a Full Bench of the Federal Court of Australia by the law firm of Maurice … 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

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

Myriad Responds: ACLU Asks The Wrong Question

On October 31, 2012, Myriad Genetics, Inc. et al. (“Respondent” or “Myriad”) filed its brief in opposition to Petitioners’ (The Association for Molecular Pathology et al., 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 … Continue reading this entry

Genetic Data, Patents, and Trade Secrets

Patents protect proprietary information but are of limited duration. After expiration, the patented technology becomes part of the public domain. Trade secrets, in contrast, never expire and therefore are not accessible to the public as long as the information remains secret. Thus, the authors of “The Next Controversy in Genetic Testing: Clinical Data as Trade Secrets?“  … Continue reading this entry

Personalized Medicine After the ACLU “Gene Patenting” Decision

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 … Continue reading this entry

ACLU "Gene Patenting" Case Argued at Federal Circuit

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 … Continue reading this entry

Gene Patents and Diagnostics: The Economics of Innovation

The increasing importance of genetic markers and diagnostic tests in the drug approval process and the delivery of health care requires consideration of who will underwrite the necessary research and development, Michael Hopkins and Stuart Hogarth argue in the recent issue of Nature Biotechnology. “Biomarker patents for diagnostics: problem or solution?” Nature Biotechnology, Vol. 30(6): … Continue reading this entry

Gene Patenting Case Heads Back to Federal Circuit

The U.S. Supreme Court has sent the ACLU “gene patenting” case back to the Federal Circuit for reconsideration in light of its unanimous decision in  Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (S. Ct. 2012). For a review of the issues, please see Foley & Lardner’s client alert “Supreme Court Tells Federal Circuit to … Continue reading this entry

U.K. Supreme Court in HGS v. Eli Lilly Determines “Gene Patent” Meets European “Industrial Application” Requirement

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 … Continue reading this entry

U.S. Patent Reform - USPTO Solicits Public Comment Regarding Genetic Testing Study

As most in the patent community know, last Friday, September 16, 2011, President Obama signed into law the long-awaited patent reform bill, known as the Leahy-Smith America Invents Act (“AIA”). There are many moving parts to this complicated piece of legislation—many consider it to implement the most sweeping changes to U.S. patent law since enactment … Continue reading this entry

Federal Circuit Denies ACLU's Petition for Panel Rehearing in Myriad "Gene Patenting" Case

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 … Continue reading this entry

U.S. Patent Reform - What Does It Mean To Personalized Medicine?

Yesterday, September 8, 2011, the Senate passed by a vote of 89-9 the House version of the patent reform bill H.R. 1249, also known as the Leahy-Smith America Invents Act, without amendment. Consequently, after many years of discussion, debate and hand-wringing, significant patent reform is imminent. In fact, at this point, the legislation only requires action … Continue reading this entry