Personalized medicine is changing the paradigm of the research, development and delivery of health care. The Personalized Medicine Coalition (PMC), a consortium of interested stakeholders that seeks to promote the understanding and adoption of personalized medicine concepts, services and products, is a key driving force to removing roadblocks to the adoption of personalized medicine. Consistent with this mission, the PMC issues periodic reports on the state of the industry. Recently, the fourth edition of its industry report, titled “The Case for Personalized Medicine” (Report) was released. In this Report, the PMC noted significant progress in sectors such as technology, regulatory and reimbursement or payer issues that are moving this industry forward. This post will review some of the highlights of the PMC’s latest Report. Continue reading this entry
Yesterday at BIO’s session entitled “Patent-Eligibility from the Trenches: Practical Implications of the Supreme Court’s Prometheus (Mayo) and Myriad Decisions” a panel of experts and an engaged audience discussed the controversial USPTO “Guidance for Determining Subject Matter Eligibility of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products” (2014 Guidance) and its implications for the biotechnology and pharmaceutical industries. The USPTO’s Former Acting Director Terry Stanek Rea announced that based on information gleaned from a prior BIO panel, the USPTO is open to revising its 2014 Guidance that called into question the patent-eligibility of many biotechnology and pharmaceutical inventions and is accepting public comments until July 31, 2014. Continue reading this entry
Recently in Consumer Watchdog v. Wisconsin Alumni Research Foundation, No. 2013-1377 (Fed. Cir. 2014), the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) dismissed Appellant Consumer Watchdog’s appeal on the ground that as a party, it lacked Article III standing. While the court’s decision raises interesting issues regarding litigation strategy, dismissal of the appeal leaves unanswered the substantive issue of whether a claimed in vitro culture of human embryonic stem cells is patent-eligible under 35 U.S.C. § 101. A review of the issue would have provided the court an opportunity to apply the U.S. Supreme Court’s Myriad jurisprudence to a claimed product of nature and much needed judicial insight into the U.S. Patent and Trademark Office’s (USPTO) recent Section 101 Guidance (for a review of the Guidance and its application to stem cells, see my prior posts dated March 5, 2014; March 7, 2014; March 20, 2014 and April 27, 2014). Continue reading this entry
The U.S. Supreme Court reversed the U.S. Court of Appeal for the Federal Circuit holding that a defendant may not be liable for inducing infringement of a patent under 35 U.S.C. § 271(b) when no one has directly infringed the patent under 35 U.S.C. § 271(a) or any other statutory provision. Limelight Networks, Inc. v. Akamai Technologies, Inc., 572 U.S. __ (2014). The decision limits the ability of patent holders to protect technologies that are increasingly relevant in today’s economy. We are in an era of specialization and collaboration. Digital technology moves information among users. Patient samples may be taken in the home or in a physician’s office, analyzed and in a laboratory and transmitted to a treating physician who prescribes therapy. Thus, in many instances, more than one individual or entity can be involved in providing a digital service or medical method. Today’s decision dictates that these method patents are only enforceable if one party practices all steps of the method. Continue reading this entry
Personalized medicine relies on diagnostic medicine to identify the best therapy for the patient at the right time. Tests that match a therapy to the patient fall into one of two categories. In vitro diagnostic devices or IVDs are diagnostic tests developed and manufactured by device manufacturers. In the United States, IVDs are regulated by the U.S. Food and Drug Administration (FDA). IVDs that direct treatment decisions are considered by the FDA to be high risk and therefore require pre-market approval.
Diagnostic tests developed by a commercial laboratory, termed laboratory developed tests or LDTs are subject to oversight under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) administered by the Centers for Medicare & Medicaid Services (CMS). Continue reading this entry