Tag Archives: Diagnostic Test

Managing IP Risk in the Age of Personalized Medicine

PersonalizedMedicine
As discussed on Foley’s Health Care Law Today blog, personalized medicine treatment trends and innovations are leading diagnostic and therapeutic companies to form complex arrangements and partnerships with the ultimate goal of delivering improved patient treatment. Diagnostics are married to a single or multiple treatments. Devices connect patients with providers. Health care systems may partner with … Continue reading this entry

Task Force Recommendation for BRCA-Related Genetic Testing

The U.S. Preventive Services Task Force (“USPSTF”) recently issued a report regarding the effectiveness of BRCA1/BRCA2 genetic tests for women and within the report, issued recommendations for preventive screening for women with and without confirmed familial history of breast, ovarian, tubal, or peritoneal cancer (“BRCA-related cancers”). Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related … Continue reading this entry

Clinical Adoption of Personalized Medicine

A recent study published in the American Journal of Medical Genetics, “Barriers for Integrating Personalized Medicine into Clinical Practice:  A Qualitative Analysis” investigated physicians’ perceptions about the future of personalized medicine and identified factors that would influence their decisions in using genetic testing in their practice. The study is an interesting read for any innovator … Continue reading this entry

Risk-Sharing and Reimbursement of Diagnostic Tests

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 a move from a Fee-For-Service (FFS) system to a Pay-For-Value (PFV) model based on risk sharing among innovators, payors, physicians and … Continue reading this entry

Expanding Access to, and Development of, Personalized Medicine

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 of, and access to, personalized medicine and reduce the quality of patient care.… Continue reading this entry

Supreme Court Asked for Further Clarity on Patent-Eligibility of Diagnostic Claims

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, Inc., 132 S.Ct. 1289 (2012)(“Mayo“)? Intema Ltd. (“Intema”) asserts that yes, the Federal Circuit did err when it determined that Intema’s diagnostic patent claims are invalid for failing to … Continue reading this entry

FDA Regulation of Laboratory Developed Tests: Benefit or Unnecessary Burden?

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 American Clinical Laboratory Association, the College of American Pathologists, and the Association for Molecular Pathology, have weighed in on whether the FDA can and should … Continue reading this entry

What's Patentable After Prometheus? USPTO Issues Interim Response

The USPTO has just issued guidelines for its patent examining corps to assist them in determining whether a process claim is patent-eligible in light of the U.S. Supreme Court’s Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __ (2012) (“Prometheus”) decision. A copy of the guidance document (“Guidance Document”) is attached. [2012_interim_guidance] The examiners are … Continue reading this entry

Personalized Multiplex Test on Market

A multiplex test that can analyze tumors for over 200 genes is now available from Foundation Medicine Inc., the Wall Street Journal reported today. The test will be used by Novartis, Sanofi SA, Johnson & Johnson and Celgene to analyze patients in early-stage clinical trials of new cancer drugs to identify patients most likely to benefit from the drug and to … Continue reading this entry

Video Interview: Discussing Mayo v. Prometheus With LXBN TV

The other day I had the opportunity to speak with Colin O’Keefe of LXBN TV on the subject of Mayo Collaborative Services v. Prometheus Laboratories, Inc. In the short interview, I explain the background of the case, offer my thoughts on why Prometheus’ patent wouldn’t have a detrimental impact on medical research and give my thoughts … Continue reading this entry

Personalized Medicine Market Growing Amid Challenges

On the same day that the personalized medicine testing market was reported to have exceeded $28 billion in 2011, the New England Journal of Medicine (NEJM) also reported a perceived stumble to the use of genomic tests that serve personalized medicine.… Continue reading this entry

Mayo Reported To Start Pilot Study To Provide Whole Genome Sequencing

The Guardian reports that Mayo Clinic (“Mayo”) has announced that it is starting a pilot study to provide whole genome sequencing to patients. As reported, Mayo will launch the pilot study in early 2012 as part of an ambitious move towards an era of proactive genomics. Recall, Mayo Clinic is a named party in the legal challenge to Prometheus … Continue reading this entry

Patent-Eligibility of Medical Methods Considered By U.S. Supreme Court

This post is co-authored by Antoinette F. Konski and Jacqueline D. Wright Bonilla The U.S. Supreme Court entertained oral argument today in Mayo Collaborative Services v. Prometheus Laboratories, Inc. The case is being closely monitored by the pharmaceutical and biotechnology industry, and in particular those in the industry that patent diagnostic methods and companion diagnostics.  … Continue reading this entry

U.S. Patent Reform - USPTO Solicits Public Comment Regarding Genetic Testing Study

As most in the patent community know, last Friday, September 16, 2011, President Obama signed into law the long-awaited patent reform bill, known as the Leahy-Smith America Invents Act (“AIA”). There are many moving parts to this complicated piece of legislation—many consider it to implement the most sweeping changes to U.S. patent law since enactment … Continue reading this entry

U.S. Patent Reform - What Does It Mean To Personalized Medicine?

Yesterday, September 8, 2011, the Senate passed by a vote of 89-9 the House version of the patent reform bill H.R. 1249, also known as the Leahy-Smith America Invents Act, without amendment. Consequently, after many years of discussion, debate and hand-wringing, significant patent reform is imminent. In fact, at this point, the legislation only requires action … Continue reading this entry

Top Twelve Practice Tips Following Myriad and Prometheus

*  Written by Kristel Schorr and Jackie Wright Bonilla, both partners in the Washington, DC office of Foley & Lardner LLP As most in the biotech industry know by now, the Federal Circuit recently issued its decision in Assn. Molec. Path. et al. v. USPTO et al., a case otherwise known as Myriad or the … Continue reading this entry

Patent Eligibility of Diagnostic Method Claims - What Have Courts Considered So Far?

Even for patent attorneys who specialize in personalized medicine, confusion still exists as to the best way to pursue and enforce diagnostic method patent claims in light of patent eligibility considerations under 35 U.S.C. §101.  While the Supreme Court and Federal Circuit have provided some guidance regarding patent eligibility of certain method claims, details of … Continue reading this entry

Diagnostic Method Claims Invalid for Lack of Written Description and Anticipation

In Billups-Rothenberg, Inc. v. Associated Regional and University Pathologists, Inc. (ARUP) and Bio-Rad Labs., Inc., the Federal Circuit affirmed a district court summary judgment that diagnostic method claims in two patents were invalid as either failing the written description requirement under 35 U.S.C. §112, or being anticipated under 35 U.S.C. §102 by a patent owned … Continue reading this entry