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. In re BRCA1- and BRCA2- Based Hereditary Cancer Test Patent Litigation, Case Nos. 14-1361, -1366. If you missed oral argument, the parties’ Supplemental Briefs filed in late September set forth some of the key points raised during oral argument. My prior post of September 29, 2014 summarizes the status of the dispute and the parties’ positions on patent-eligibility.
On September 30th, 2014 the U.S. Food and Drug Administration published the draft guidance entitled ”Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (“Guidance“). The publication of the draft Guidance is the next step in FDA’s implementation of its risk based approach to oversight of LDTs. In addition to noting FDA’s intention for bringing under its review many devices or tests that previously were exempt under the FDA’s enforcement discretion, the FDA’s draft Guidance also imposes new requirements, such as registration and notice, for all LDTs. Continue reading this entry
Low cost sequencing of a patient’s genome and advances in the interpretation of a patient’s genetic information is promised to transform the delivery of health care. To date, much of personalized medicine has focused on the use of genetics and data analytics to match a patient to the best treatment, especially in the area of oncology. However the use of genetics and data analytics is moving into the design of clinical trials, the validation of biomarkers, and point of care diagnostics. Thus, there is a growing interest in the aggregation, analysis, and use of a patient’s genetic information for commercial and research purposes. However, in the United States, the use of such information depends on a variety of state and federal privacy laws. Continue reading this entry
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 most basic issues under patent law: should Myriad be able to enforce its patents to enjoy its remaining exclusivity or does section 101 of the Patent Act effectively say that Myriad can patent almost nothing related to its ground-breaking discovery?” Myriad Opening Brief (“Opening”) at page 4. In addition to responding to Myriad’s query regarding its patent estate, the Federal Circuit’s review has the potential to provide much needed clarity for diagnostic innovators and patent holders, as well as the U.S. Patent and Trademark Office, regarding the scope and reach of the U.S. Supreme Court’s recent patent-eligibility decisions. Continue reading this entry
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 prior post of August 4th, 2014. In brief, the LDT Guidance proposes a risk-based, phased-in framework for oversight of LDTs that is in accordance with FDAs current regulation of in vitro diagnostic devices (IVDs). The LDT Guidance creates uncertainty for diagnostic innovators and providers of LDTs. What tests will be subject to enhanced oversight? How will innovators adapt to increased regulation? What additional reporting requirements will be required by FDA? Continue reading this entry