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

Personalized Medicine Today: PMC Issues Fourth State of the Industry Report

PersonalizedMedicine

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

USPTO Extends Deadline to Comment on Subject Matter Eligibility Analysis

PatentEligibility

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