As we come to the end of President Obama’s administration, it is time to look back on the past eight years and the administration’s impact on the delivery of the nation’s health care. While the Affordable Care Act (signed...more
The Cancer Moonshot Task Force has just released its 5 year plan for implementing President Obama’s “Cancer Moonshot” program (“Report”). The initiative, announced during President Obama’s 2016 State of the Union Address, is...more
In Yeda Research and Development Co., Ltd. v. Abbott GMBH & Co. KG, Slip Op. 2015-1662 (Fed. Cir. 2016), the Federal Circuit held that a claim to an isolated protein described by its partial amino acid sequence satisfies 35...more
Fetal diagnostic pioneer Ariosa Diagnostics lost its latest attempt to invalidate competitor Verinata Health’s U.S. Patent No. 8,318,430, “Methods of Fetal Abnormality Detection.” The USPTO’s Patent Trial and Appeal Board...more
Next Generation Sequencing (NGS) permits the analysis of millions of genetic variants at a time and has proven to be invaluable for the development of personalized or precision medicine. Analysis of whole genomes is providing...more
Personalized or Precision Medicine needs reliable and accurate diagnostic tests to guide clinical intervention and treatment decisions. Traditional testing of germline variants is site-specific and therefore only provides...more
A method of producing a desired population of multi-cryopreserved hepatocytes was held to be patent-eligible because the challenged claims did not recite a judicial exception. Rapid Litig. v. CellzDirect, Inc.., 2015-1570...more
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...more
The United States Supreme Court is set to render its decision on the grant or denial of Sequenom, Inc.’s (“Sequenom’s”) petition for writ of certiorari that posed the issue:
..Whether a novel method is patent-eligible...more
6/27/2016
/ Ariosa ,
CLS Bank v Alice Corp ,
Diagnostic Method ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Personalized Medicine ,
Petition for Writ of Certiorari ,
Pharmaceutical Patents ,
Section 101 ,
Sequenom ,
USPTO
Embracing personalized medicine, the European Medicines Agency (EMA) released a draft guidance document titled Draft Guideline on Good Pharmacogenomic Practice (“Guidance”) on good pharmacogenomic practice with the stated...more
Fueled by technological advances, scientific breakthroughs and significant financial investments, precision medicine (PM) has emerged as a promising approach to disease prevention and treatment. A multi-faceted solution to...more
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...more
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...more
Last week President Obama marked the one year anniversary of his Precision Medicine Initiative (“PMI”) by holding a web-accessible panel discussion where he and interested stakeholders discussed his PMI initiative, its...more
Health care analytics make use of patient data to inform treatment decisions and is increasingly moving front and center in personalized medicine. For example, the President’s Precision Medicine Initiative (see post of...more
Watching President Obama’s recent 2016 State of the Union Address reminded me that one year has passed since the President announced a new “precision” or personalized medicine initiative to advance personalized, effective...more
Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more
11/4/2015
/ AMP v Myriad ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratories ,
Complete Genomics ,
Diagnostic Method ,
Diagnostic Tests ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Genetic Testing ,
Health Insurance ,
Healthcare ,
Healthcare Costs ,
Healthcare Reform ,
Innovation ,
Insurance Industry ,
Intellectual Property Protection ,
Life Sciences ,
Medicaid ,
Medicare ,
Personalized Medicine ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Reimbursements ,
Research and Development ,
SCOTUS
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...more
10/13/2015
/ American Medical Association ,
Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Clinical Laboratories ,
Clinical Trials ,
Coding ,
Data Collection ,
Diagnostic Tests ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Manufacturers ,
Personalized Medicine ,
Physicians ,
Reimbursements
Diagnostic medicine is experiencing new challenges at the USPTO and the U.S. Food and Drug Administration (FDA). Under a new FDA proposal, laboratory developed test providers, previously exempt from FDA oversight, must now...more
9/24/2015
/ 510(k) RTA ,
Diagnostic Tests ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Personalized Medicine ,
Premarket Approval Applications ,
Proposed Regulation ,
Regulatory Oversight ,
USPTO
Personalized medicine relies on diagnostic technologies to accurately evaluate a patient’s clinical or genetic signature to guide treatment decisions. Protecting innovation by patenting the diagnostic methods and tools that...more
9/21/2015
/ Algorithms ,
AMP v Myriad ,
CLS Bank v Alice Corp ,
Diagnostic Method ,
Innovation Patent ,
Intellectual Property Protection ,
Mayo v. Prometheus ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Personalized Medicine ,
SCOTUS ,
Software ,
USPTO
Dow Chemical Company (“Dow”) lost a ruling that competitor NOVA Chemical Corporation and NOVA Chemicals Inc. (collectively “NOVA”) infringed claims of two Dow patents when the Federal Circuit applied the U.S. Supreme Court’s...more
9/1/2015
/ Best Practices ,
Definiteness ,
Dow Chemical ,
Indefiniteness ,
Issue Preclusion ,
Nautilus Inc. v. Biosig Instruments ,
Patent Applications ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Popular ,
SCOTUS ,
Stare Decisis ,
Teva v Sandoz
The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is...more
8/28/2015
/ Diagnostic Tests ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Medical Devices ,
Patients ,
Personalized Medicine ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reimbursements
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...more
8/25/2015
/ Akamai Technologies ,
CLS Bank v Alice Corp ,
Diagnostic Tests ,
Direct Infringement ,
En Banc Review ,
Induced Infringement ,
Limelight v Akamai ,
Mayo v. Prometheus ,
Myriad ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Personalized Medicine ,
SCOTUS ,
USPTO
On July 22, 2015, the U.S. District Court for the District of Maryland dismissed a long standing patent infringement suit brought by StemCells, Inc. against Neuralstem, Inc., on the ground that all those with an ownership...more
8/3/2015
/ Joint Inventors ,
Memorandum of Agreement ,
Oral Contracts ,
Patent Applications ,
Patent Infringement ,
Patent Litigation ,
Patent Ownership ,
Patent-in-Suit ,
Patents ,
Real Party in Interest ,
Standing ,
Stem cells ,
USPTO
In Amgen v. Sandoz, Fed. Cir., No. 15-1499 (July 21, 2015), a divided panel of the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that...more
7/23/2015
/ Amgen ,
Biosimilars ,
BPCIA ,
Generic Drugs ,
Marketing Exclusivity Periods ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs ,
Sandoz ,
Sandoz v Amgen