Category Archives: Prometheus

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Supreme Court Declines Sequenom Review

testtube
Last week the United States Supreme Court denied Sequenom’s petition to review the Federal Circuit’s holding in Sequenom Inc. v. Ariosa Diagnostic Inc., 788 F.3d 1371 (2015) that claims directed to detecting fetal DNA in maternal blood were invalid for failing to recite patent eligible subject matter. Therefore by default, the Court let stand the … Continue reading this entry

Protecting Diagnostic Innovation – Two Actor Infringement Liability

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In Akamai Techs. Inc. v. Limelight Networks, Inc., (August 13, 2015 Fed. Cir.) an en banc Federal Circuit unanimously held that direct infringement under Section 271(a) can occur: ”where all steps of a claimed method are performed by or attributed to a single entity…Where more than one actor is involved in practicing the steps, a … Continue reading this entry

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

PatentEligibility-Abstract-Light
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

PersonalizedMedicine
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

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

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

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

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

Federal Circuit - Non-Naturally DNA Patent-Eligible

Today, in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 2010-1406 (Fed. Cir. 2012), the Federal Circuit held that non-naturally occurring DNA is patent eligible as well as the use of a transformed, non-naturally occurring cell for screening drug candidates. Myriad’s method claims directed to “comparing” or “analyzing” DNA sequences were held to be patent-ineligible. A … 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

What's Patentable After Prometheus? USPTO Issues Interim Response

The USPTO has just issued guidelines for its patent examining corps to assist them in determining whether a process claim is patent-eligible in light of the U.S. Supreme Court’s Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __ (2012) (“Prometheus”) decision. A copy of the guidance document (“Guidance Document”) is attached. [2012_interim_guidance] The examiners are … Continue reading this entry

Lilly Urges “Poison Species” Test for Process Patents

June 15th, 2012 was the deadline for the parties and interested parties to file briefs in the controversial ACLU gene patenting case (see our post of March 26th, 2012), remanded to the Federal Circuit after the U.S. Supreme Court’s recent Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. __, 132 S.Ct. 1289 (2012) (“Prometheus”) … Continue reading this entry

Video Interview: Discussing Mayo v. Prometheus With LXBN TV

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 … Continue reading this entry