Category Archives: Companion Diagnostics

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More Than 25% of New Molecular Entities Approved in 2016 Are Personalized Medicines

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The Personalized Medicine Coalition (PMC) recently reported that for the third year in a row, personalized medicines accounted for more than 25% of all new molecular entities (NMEs) approved by the US Food & Drug Administration (FDA). Personalized Medicine at FDA, 2016 Progress Report (Report). Personalized medicines are new drugs, agents or therapeutic biologics where … Continue reading this entry

EMA’s New Draft Guideline On Good Pharmacogenomic Practice - Implications For Personalized Medicine

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Embracing personalized medicine, the European Medicines Agency (EMA) released a draft guidance document titled Draft Guideline on Good Pharmacogenomic Practice (“Guidance”) on good pharmacogenomic practice with the stated goal of developing and laying out appropriate genomic methodologies for use during the development and life-cycle of a drug. Past issues and problems that have been encountered … Continue reading this entry

USPTO RELEASES PATENT ELIGIBILITY UPDATE

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On May 4, 2016, the USPTO released a “May 2016 Subject Matter Eligibility Update” (“Update”) providing guidance to patent examiners on formulating a subject matter eligibility rejection and evaluating an applicant’s response to that rejection. The USPTO concurrently released new life science examples to assist examiners and applicants evaluate whether claimed discoveries satisfy 35 U.S.C. … Continue reading this entry

ANOTHER DIAGNOSTIC PATENT FALLS UNDER 101

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In Genetic Techs Ltd v Merial LLC (Fed. Cir., April 8, 2016), the Federal Circuit invalidated yet another diagnostic patent for failing to satisfy 35 U.S.C. § 101 on the ground that the claims recite nothing more than a law of nature. The claim’s recitation of the term “to detect the allele” was insufficient to … Continue reading this entry

Navigating the Diagnostic Commercialization Process

Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One key takeaway was that while diagnostics hold the promise of getting the right medicine to the right patient at the right time, much … 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

Federal Circuit Invalidates Another Diagnostic Patent

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In Ariosa Diagnostics, Inc. v. Sequenom, Inc., Slip Op. 2014-1139, 2014-114 (Fed. Cir. June 12, 2015), the U.S. Court of Appeals for the Federal Circuit held that Sequenom’s U.S. Patent No. 6,258,540 (the ‘540 Patent) was invalid under 35 U.S.C. § 101, for failing to claim patent-eligible subject matter. The Court’s decision is yet another application … 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

Unlocking the Promise of Personalized Medicine: Reimbursement, Coverage, and Clinical Utility

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AmerisourceBergen, in connection with the Business of Personalized Medicine Summit, released “Unlocking the Promise of Personalized Medicine: Perspectives on Reimbursement, Coverage, and Clinical Utility” (“Report“). The Report explores the role of personalized medicine in today’s health care system with an overview of payer perspectives and provides recommendations to innovators to navigate the path to commercialization of … Continue reading this entry

FDA Set to Regulate LDTs - Citing Safety Concerns and Advanced Technologies

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Advances in medical technology have increased the use of diagnostic tests to guide therapeutic decisions for many diseases and conditions, especially in the context of personalized medicine. Citing the need to ensure that certain tests used by health care professionals that diagnose and treat patients are accurate, consistent and reliable, the U.S. Food and Drug … Continue reading this entry

Is Next Generation Sequencing Ready for Personalized Medicine?

Next generation sequencing[1] (NGS) promises to transform the delivery of health care by providing in one test diagnostic and prognostic information that had previously only been available in multiple analyses. One application of the information obtained from NGS is as a companion diagnostic for a therapeutic.[2] A significant reduction in the overall cost to sequence the … Continue reading this entry

USPTO Releases Examiner Post-"Myriad" Training Slides – Points to Ponder

The United States Patent and Trademark Office (USPTO) published its examiner training materials (Training Materials) for applying “2014 Procedures For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products” (Guidance), that advised U.S. patent examiners and the public of the factors for determining whether a patent claim satisfies the … Continue reading this entry

Expanding Access to, and Development of, Personalized Medicine

In a July 8th, 2013 letter to the Centers for Medicare & Medicaid Services (CMS), the Personalized Medicine Coalition (PMC) advised that proposed reimbursement schedules for diagnostic medicine will  threaten the development of, and access to, personalized medicine and reduce the quality of patient care.… Continue reading this entry

Supreme Court Asked for Further Clarity on Patent-Eligibility of Diagnostic Claims

Did the Federal Circuit incorrectly interpret and apply the holding of the U.S. Supreme Court’s decision regarding patent-eligibility of medical methods as set forth in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012)(“Mayo“)? Intema Ltd. (“Intema”) asserts that yes, the Federal Circuit did err when it determined that Intema’s diagnostic patent claims are invalid for failing to … Continue reading this entry

FDA Regulation of Laboratory Developed Tests: Benefit or Unnecessary Burden?

The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the American Clinical Laboratory Association, the College of American Pathologists, and the Association for Molecular Pathology, have weighed in on whether the FDA can and should … Continue reading this entry

Personalized Multiplex Test on Market

A multiplex test that can analyze tumors for over 200 genes is now available from Foundation Medicine Inc., the Wall Street Journal reported today. The test will be used by Novartis, Sanofi SA, Johnson & Johnson and Celgene to analyze patients in early-stage clinical trials of new cancer drugs to identify patients most likely to benefit from the drug and to … 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

Personalized Medicine Market Growing Amid Challenges

On the same day that the personalized medicine testing market was reported to have exceeded $28 billion in 2011, the New England Journal of Medicine (NEJM) also reported a perceived stumble to the use of genomic tests that serve personalized medicine.… Continue reading this entry

Speak UP - USPTO Seeking Comments on Second Opinion Genetic Tests

Today’s Federal Register includes a notice to the public inviting comments on independent second opinion genetic tests where patents and exclusive licenses exist that cover primary genetic diagnostic tests. The comments are collected for the purpose of preparing a report on the subject as required by Section 27 of the America Invents Act (“AIA”).  In … Continue reading this entry

FDA To Issue Final Guidance For In Vitro Companion Diagnostics in Mid-2012

Elizabeth Mansfield, Ph.D., Director of Personalized Medicine, Office of In Vitro Diagnostics, Center for Devices and Radiological Health of the Food and Drug Administration (FDA) announced today at the 2012 Personalized Medicine World Conference that the FDA is targeting the second quarter of 2012 to release the FDA’s Final Guidance for In Vitro Companion Diagnostic … 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

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