Considering Sex-Specific Variation for Personalized Medicine

FDA

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 particular cancer therapy. In some instances, the prediction of clinical outcome is related not only to the genetic variance but also to the sex of the patient.

The Food and Drug Administration (FDA) recently issued a new guidance for industry and FDA staff that may be relevant in the design and development of medical devices that serve personalized medicine, especially those that categorize patients into responders and non-responders. “Evaluation of Sex-Specific Data in Medical Device Clinical Studies” (Guidance) should be carefully reviewed by clinical device manufacturers, especially manufacturers of devices that separate individuals into two or more groups, such as those that respond to a particular treatment and those that do not respond. The Guidance is intended for devices that require clinical information in support of a marketing submission, whether a premarket notification (510(k)), premarket approval (PMA), a de novo request, or a humanitarian device exemption application. The recommendations reported in the Guidance also apply to post-approval study submissions and postmarket surveillance. Continue reading this entry

Will the USPTO Respond to Public Feedback of Its Eligibility Guidance?

PatentEligibility-Abstract-Light

Periodically, the USPTO holds open meetings with the public to discuss its thinking on current topics relating to the patent procurement process. Late last week, the Biotechnology, Chemical and Pharmaceutical Customer Partnership of the USPTO announced the first bi-coastal meeting to be held via webcast in Washington, D.C. and San Jose, California on September 17th, 2014. Included on the September 17th agenda is a panel discussion of the U.S. Supreme Court patent-eligibility decision, Assn. for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013) (“Myriad”). Continue reading this entry

Yamanaka iPSC Patent Challenged

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Dr. Shinya Yamanaka of Kyoto University shared the 2012 Nobel Prize in Physiology or Medicine with Dr. John B. Gurdon for their respective discoveries that mature, specialized cells can be reprogrammed to become immature cells capable of developing into all tissues of the body. In the 2012 Nobel announcement, the Nobel Assembly at Karolinka Institutet stated that the findings of Drs. Yamanaka and Gurdon “have revolutionized our understanding of how cells and organisms develop.”

Dr. Gurdon was recognized for his 1962 discovery that the specialization of cells is reversible when he replaced the immature cell nucleus in an egg cell of a frog with the nucleus from a mature intestinal cell. The modified egg developed into a normal tadpole. Dr. Yamanaka was recognized for his later discovery that intact mature cells in mice could be reprogrammed to become immature stem cells, now known as induced pluripotent stem cells (iPSCs). Continue reading this entry

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 data analytics companies. But do these partnerships that facilitate the creation and delivery of personalized health care adequately protect IP and/or foster potential IP liability for the innovations and their partners?

While the U.S. Supreme Court’s decisions in Prometheus, Myriad, and Limelight may have clouded how and what type of innovation is protected in the United States, there are steps companies can take before forming new contractual arrangements that mitigate IP risk and protect future innovations. Learn more here.

This and other business concerns that are unique to the personalized medicine industry will be discussed at the Business of Personalized Medicine Summit, September 9th, 2014 in South San Francisco. Find out more and register here.

FDA Set to Regulate LDTs - Citing Safety Concerns and Advanced Technologies

FDA

Advances in medical technology have increased the use of diagnostic tests to guide therapeutic decisions for many diseases and conditions, especially in the context of personalized medicine. Citing the need to ensure that certain tests used by health care professionals that diagnose and treat patients are accurate, consistent and reliable, the U.S. Food and Drug Administration (FDA) signaled that the Agency is lifting its enforcement discretion over certain laboratory developed tests (LDTs) that aid physicians in selecting appropriate therapies for patients. “LDTpacket Guidance” (Guidance) provides anticipated details of a draft guidance to be issued no earlier than 60 days from the July 31, 2014 publication of the Guidance, and fulfills the agency’s requirement to notify Congress of its intent to publish the draft guidance consistent with the Food and Drug Administration Safety and Innovation Act of 2012.

The 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). Continue reading this entry