Category Archives: Gene Patents

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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

Patent Pool Simplifies Development of Personalized Medicine

One argument often cited against patenting is that multiple patents can cover one product, its preparation and use, creating a so-called “patent thicket” that must be unwound like a bowl of spaghetti before a new technology is free of potential liability. Cooperation and collaboration among patent holders in the form of a patent pool is one means … Continue reading this entry

ACLU Petitions Supreme Court to Review Gene Patenting Case

The ACLU and PUBPAT issued a press release today announcing that they are petitioning the U.S. Supreme Court to review the U.S. Federal Circuit’s decision upholding the patent-eligibility of isolated DNA . The release announces in part: “The American Civil Liberties Union and the Public Patent Foundation today asked the U.S. Supreme Court to invalidate … 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

More on Myriad -- "Gene Patenting" Debate Continues

As promised in my earlier post, today our firm issued its review of the much anticipated decision regarding the “gene patenting” case (formally known as The Association For Molecular Pathology. et al. v. USPTO et al.) The case was before the Federal Circuit on remand from the U.S. Supreme Court’s March 20, 2012 decision in Mayo Collaborative Services … 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

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

Myriad Urges Dismissal of "Gene Patenting" Case

Yesterday Myriad urged the Federal Circuit to dismiss the “gene patenting” case on the ground that subject matter jurisdiction no longer exists. Myriad argued that in the alternative, the case should be remanded to the district court to address whether declaratory-judgment jurisdiction exists under the current facts of the dispute. … Continue reading this entry

Patent-Eligibility of Diagnostic Patents Reconsidered in Canada

The Canadian Patent Office released today practice guidelines regarding the patent-eligibility of medical diagnostic methods and medical methods. The practice guidance are in effect immediately and until further notice, and in place of any contrary guidance presently in the Canadian Manual of Patent Office Practice (MOPOP, the Canadian equivalent to the US MPEP, setting forth … 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

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

Dissecting Prometheus – My Wish List

In his March 23rd Patently-O blog, Dennis Crouch posted a U.S. Patent and Trademark Office memorandum to examiners setting forth the Office’s current thinking on application of the U.S. Supreme Court’s recent Mayo v. Prometheus holding to patent examination. The memorandum preliminarily advises examiners to reject a patent claim under 35 U.S.C. § 101 if the … Continue reading this entry

U.S. Supreme Court: Prometheus' Patents Set Forth Laws of Nature

The U.S. Supreme Court reversed the Federal Circuit and held that Prometheus’ patents claiming a method to optimize therapeutic efficacy for the treatment of immune-mediated gastrointestinal disorders were invalid. Mayo Collaborative Services v. Prometheus Laboratories, Inc., __ U.S. __ (2012). [Prometheus] Justice Breyer, writing for a unanimous Supreme Court, held that Prometheus’ patent claims set forth … Continue reading this entry

Gene Patenting Case – U.S. Supreme Court Postpones Decision on Review

The U.S. Supreme Court was expected to include the highly publicized case of Assn. Molec. Path. et al. v. USPTO et al. (“ACLU/Myriad“, a/k/a “the gene patenting case”) on its Orders List today thereby granting or denying certiorari. Unexpectedly, the case was absent thereby postponing the news whether or not the Supreme Court will weigh in on … Continue reading this entry

Mayo Reported To Start Pilot Study To Provide Whole Genome Sequencing

The Guardian reports that Mayo Clinic (“Mayo”) has announced that it is starting a pilot study to provide whole genome sequencing to patients. As reported, Mayo will launch the pilot study in early 2012 as part of an ambitious move towards an era of proactive genomics. Recall, Mayo Clinic is a named party in the legal challenge to Prometheus … Continue reading this entry

ACLU Petitions For Supreme Court Review in the "Gene Patent" Case

On the same day the U.S. Supreme Court entertained oral argument in Mayo Collaborative Services v. Prometheus Laboratories, Inc., (reported in our December 7th post) the American Civil Liberties Union Foundation (“ACLU”) and the Public Patent Foundation petitioned the U.S. Supreme Court on behalf of the plaintiffs (the Association for Molecular Pathology, et al.) for review of 1) … Continue reading this entry

Patent-Eligibility of Medical Methods Considered By U.S. Supreme Court

This post is co-authored by Antoinette F. Konski and Jacqueline D. Wright Bonilla The U.S. Supreme Court entertained oral argument today in Mayo Collaborative Services v. Prometheus Laboratories, Inc. The case is being closely monitored by the pharmaceutical and biotechnology industry, and in particular those in the industry that patent diagnostic methods and companion diagnostics.  … 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

Patent-Eligibility Trilogy: One of Three Reaches U.S. Supreme Court

As the U.S. Supreme Court starts its next term on Oct. 3, 2011, the biotechnology industry is awaiting resolution of at least one of three pending disputes addressing the extent to which diagnostic medical methods are patent-eligible. Per colleague Hal Wegner, respondent’s U.S. Supreme Court brief in Mayo Collaborative Services v. Prometheus Laboratories, Inc. is due Oct. 31, 2011 … Continue reading this entry

Fed. Cir. Denies Myriad's Petition for Rehearing in Gene Patenting Case

We previously reported that the ACLU and Myriad each filed a Petition for Panel Rehearing with the Federal Circuit for review of the July 29, 2011 decision, Assn. Molec. Path. et al. v. USPTO et al. This dispute, now known as the “gene patenting case,” reviewed whether isolated genetic material and diagnostic tests that rely on … 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

Subject Matter Jurisdiction Challenged in Supreme Court's Review of Mayo v. Prometheus

An international intellectual property association filed an amicus curie brief urging the U.S Supreme Court to dismiss the dispute and issue presented in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 131 S.Ct. 3027 (2011), arguing that the district court and Federal Circuit lacked subject matter jurisdiction. The amici argued that for reasons that are not … 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