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
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...more
There is no doubt that health care costs in the United States are rising. According to a recent study published by the U.S. Department of Health and Human Services, personal health care expenditures in the United States...more
6/22/2015
/ ACOs ,
Affordable Care Act ,
Alternative Payment Models (APM) ,
Bundled Payments ,
Cost-Containment ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Healthcare ,
Healthcare Costs ,
Patient Centered Medical Homes ,
Personalized Medicine
California sees opportunities in personalized medicine. Earlier this month, Governor Brown announced the creation of a two year initiative – California Initiative to Advance Precision Medicine to “begin building...more
President Obama’s “precision medicine initiative” earmarked over $200 million from his proposed 2016 budget to “bring us closer to curing diseases like cancer and diabetes – and to give all of us access to the personalized...more
23andMe is not a traditional diagnostics company. Rather than seeking to directly sell its services to health care professionals, 23andMe went straight to the consumer, offering genetic screening and analysis in a mail-order...more
Late last year, the USPTO issued its modified and revised 2014 Interim Guidance on Patent Subject Matter Eligibility (Interim Guidance) to assist patent examiners and the public in determining if a claim presented for...more
Personalized medicine has a friend in high places. President Obama recently announced an initiative to support “precision” or personalized medicine. In very general terms, the President stated during his 2015 State of the...more
President Obama announced during his 2015 State of the Union Address that he is launching a new “precision” or personalized medicine initiative to advance personalized, effective therapies for the American public. As reported...more
The Food and Drug Administration (“FDA”) announced a workshop to be held February 20th, 2015, entitled “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests” to obtain public input regarding...more
The Food and Drug Administration (“FDA”) announced a workshop to be held February 20th, 2015, entitled “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests” to obtain public input regarding...more
Just last week, the USPTO released its revised subject matter eligibility guidance (2014 Interim Guidance on Patent Subject Matter Eligibility “Interim Guidance” reviewed in my prior post of December 16th, 2014). The Interim...more
Post grant inter partes review proceedings have lowered the hurdle to invalidate U.S. patents. The “broadest reasonable construction” of the claims and the lower burden to prove invalidity (by a preponderance of the evidence)...more
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...more
The U.S. Supreme Court’s recent trilogy of patent-eligibility decisions (Prometheus, Myriad and Alice) have called into question the validity of many U.S. patents on diagnostic medical methods. Nevertheless, legal battles...more
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...more
The Federal Circuit in Ultramercial, Inc. v. WildTangent, Inc., held that an “entrepreneurial” multi-step process for distributing copyrighted media products over the Internet to consumers is not patent-eligible under 35...more
The Public Patent Foundation and Consumer Watchdog (collectively “CW”) petitioned the U.S. Supreme Court on October 31, 2014, seeking reversal of the Federal Circuit’s dismissal of its appeal from a decision of the USPTO that...more
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....more
On September 30th, 2014 the U.S. Food and Drug Administration published the draft guidance entitled ”Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (“Guidance”). The publication of the draft Guidance...more
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...more
The U.S. Food and Drug Administration (FDA) recently announced that the Agency is lifting its enforcement discretion over high-risk laboratory developed tests (LDTs). The FDA’s “LDT Guidance” was reviewed in detail in my...more
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...more
Personalized medicine relies on diagnostics to analyze a patient for individualized therapy and for monitoring a patient’s health status. Some diagnostic tests use natural products, for example gene sequences, either as the...more
Personalized medicine may use devices and assays that identify sex-related differences. For example, a device or an assay may determine if a cancer patient harboring a particular genetic variance will or will not respond to a...more