Five industry executives argue for an overhaul of the current approval and reimbursement framework for diagnostic tests. In A Pay-For-Value, Data-Driven Approach for the Coverage of Innovative Genetic Tests a case is made for...more
As reported in my July 8, 2013 post, Consumer Watchdog (formerly known as The Foundation for Taxpayer and Consumer Rights) and the Public Patent Foundation (collectively “CW”) asked the Federal Circuit to determine if in...more
Earlier this year, the American Academy of Pediatrics (AAP) and the American College of Medical Genetics and Genomics (ACMG) issued recommendations and proposed best practices for genetic testing and screening of infants and...more
Personalized medicine offers something for everyone. Dell Corporation, most notably known for producing computers has recently become deeply involved in the health industry....more
Two separate clinical initiatives were recently announced that support the therapeutic use of regenerative medicine. The first utilzing induced pluripotent stem cells and the second, a state-wide network in support of...more
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...more
In a July 12, 2013 letter to Dr. Francis S. Collins of the National Institutes of Health (“NIH”), Senator Patrick J. Leahy urged the NIH to exercise its march-in rights under the Bayh-Dole Act to directly license the genetic...more
Now that the U.S. Supreme Court has determined that isolated, naturally-occurring genes are not patent-eligible (see, Ass’n. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __ (2013))(“Myriad”), Consumer Watchdog...more
On June 10, 2013, the U.S. Court of Appeals for the Federal Circuit held that Monsanto’s representation that it would not pursue farmers and seed sellers for patent infringement if they inadvertently use Monsanto’s patented...more
On June 13, 2013, the U.S. Supreme Court in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., __ U.S. __ (2013), held that genes and DNA fragments merely isolated from nature without alteration are not patent-eligible....more
In a remarkable move, the Food and Drug Administration recently indicated that it plans to take new steps to regulate laboratory-developed tests (“LDTs”). FDA Commissioner Margaret Hamburg made the significant announcement...more
On June 13, 2013, the U.S. Supreme Court issued its long-awaited decision in the “ACLU/Myriad” gene patenting case (formally, Association For Molecular Pathology. et al. v. Myriad Genetics, Inc., et al., Supreme Court No....more
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,...more
There are several emerging technology clusters in the induced pluripotent stem cell (iPSC) space. Simon Elliot and I conducted a patent landscape analysis focusing on issued U.S. patents and pending applications....more
At 10:00 A.M. on April 15th, the U.S. Supreme Court will entertain oral arguments in the dispute now known as the human “gene patenting” case. The Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398...more
When should a patent application be filed? Should it be filed prior to submission of a manuscript or abstract for peer-review or just prior to publication? In highly competitive technologies, it is prudent to file as soon as...more
The patenting of human genes in Australia remains under court review. As reported in the blog Patentology, an appeal of the Australian decision, Cancer Voices et al. v. Myriad Genetics Inc. et al., was filed on March 4, 2013...more
The application of medical technology in the pediatric setting must serve the best interest of the child. Genetic testing of children and infants presents unique challenges. In contrast to the testing of adult patients, most...more
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...more
In a companion case to the “gene patenting” dispute presently before the U.S. Supreme Court, Myriad Genetics, Inc. successfully defended the patent-eligibility of “gene patents” in Australia. In Cancer Voices et al. v. Myriad...more
Patenting diagnostic methods is more challenging in the wake of the U.S. Supreme Courts Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __ (2012) (Prometheus) and the USPTO’s application of the...more
The Food and Drug Administration (FDA) recently issued a guidance document related to the conduct of clinical trials to support approval of human drugs and biological products “Draft Guidance for Industry: Enrichment...more
Increasingly, the development of new pharmaceuticals utilize genetic information to stratify patient subpopulations and/or predict efficacy and adverse events – the development paradigm of personalized medicine....more
On December 3, 2012, Representative Mike Honda of California introduced The Healthcare Innovation and Marketplace Technologies Act (HIMTA), to foster more innovation in the health care industry by removing barriers in...more
As reported in my November 30th, 2012 post, the U.S. Supreme Court granted certiorari to review the issue “are human genes patentable?”...more