In Ariosa Diagnostics, Inc. v. Sequenom, Inc., Slip Op. 2014-1139, 2014-114 (Fed. Cir. June 12, 2015), the U.S. Court of Appeals for the Federal Circuit held that Sequenom’s U.S. Patent No. 6,258,540 (the ‘540 Patent) was invalid under 35 U.S.C. § 101, for failing to claim patent-eligible subject matter. The Court’s decision is yet another application of the U.S. Supreme Court’s recent interpretation of patent-eligibility and confirms the raised bar for patents claiming diagnostic methods – even for “ground-breaking” inventions.
There is no doubt that health care costs in the United States are rising. According to a recent study published by the U.S. Department of Health and Human Services, personal health care expenditures in the United States totaled $2.5 trillion, a 3.8% increase from 2012. The per capita personal health care expenditure for the total U.S. population was $7,826 in 2013, up from $7,597 in 2012 and expenditures for hospital care accounted for 38.0% of all personal health care expenditures in 2013. National Center for Health Statistics. Health, United States, 2014: With Special Feature on Adults Aged 55–64. Hyattsville, MD. 2015.
Several alternative payment models (APMs) to the traditional fee-for-service (FFS) paradigm have been proposed to control rising health care costs. The Personalized Medicine Coalition commissioned a study to determine if the benefits of personalized medicine diagnostics and therapies are supported by the current proposed APM models. Paying for Personalized Medicine: How Alternative Payment Models Could Help of Hinder the Field (Study, attached here). The Study finds that several factors may limit access to the benefits of personalized medicine should the proposed APMs become the payment standard for health care in the United States, namely: the lack of a clear benchmarks to assess quality of care; a focus on cost-containment in the short term; and the failure to account for ongoing innovation in the delivery of health care. Continue reading this entry
Guest Post By: Jennifer F. Walsh , Director of Public Affairs, Foley & Lardner, LLP
Last week the Personalized Medicine Coalition held its 11th Annual State of Personalized Medicine luncheon in Washington, D.C. U.S. Representative Michael Burgess, a member of the House Energy and Commerce Committee (Committee) which oversees many health care issues, was the featured speaker, substituting for Representative Fred Upton, Chairman of the Committee, who was in the midst of a congressional hearing on the 21st Century Cures legislation. Representative Burgess described his commitment to furthering personalized medicine, in part through the Committee’s development of the 21st Century Cures legislation. He also shared his personal experiences as a consumer of our health care system and as a practicing physician prior to being elected to Congress. The legislation, which is currently being marked up before the full committee this week, has been described by Chairman Upton’s staff as his first, second and third priorities. Over the past several months significant progress has been made on developing a more bipartisan bill than what was originally unveiled at the beginning of the year. However, the bill has experienced several delays this week as lawmakers have wrestled with how to offset the cost of the legislation and whether to include provisions related to the 340B Drug Pricing Program. Meanwhile, the Senate has held a series of hearings related to issues that will likely be included in a measure similar to the House’s 21st Century Cures legislation. Congressional desire to advance a bill that furthers research and funding into the development of personalized medicine and other health care advancements is significant, and may serve as the most significant health care legislation developed by Congress since the Affordable Care Act. Stakeholders interested in this legislation should be actively communicating with Members of Congress, particularly in the Senate, as development of that chamber’s legislation evolves. As with any piece of congressional legislation that gains momentum, the possibilities of what issues could be added to the legislation – controversial or benign – are endless.
Stakeholders interested in the 21st Century Cures Act and related health care issues are welcome to contact Jennifer Walsh of Foley & Lardner regarding assistance with congressional and administration advocacy. Jennifer’s contact information is:
- Jennifer F. Walsh , Director of Public Affairs, Foley & Lardner, LLP
- Phone: (202) 295-4762
California sees opportunities in personalized medicine. Earlier this month, Governor Brown announced the creation of a two year initiative – California Initiative to Advance Precision Medicine to “begin building infrastructure and assembling resources necessary to advance precision medicine-orientated data, tools and applications.” See California Launches Initiative to Advance Precision Medicine. Continue reading this entry
President Obama’s “precision medicine initiative” earmarked over $200 million from his proposed 2016 budget to “bring us closer to curing diseases like cancer and diabetes – and to give all of us access to the personalized information we need to keep ourselves and our families healthier.” The National Institutes of Health (“NIH”) and the National Cancer Institute (“NCI”) will be the major benefactors if the proposed budget for this initiative is approved. A recent article co-authored by Drs. Francis S. Collins and Harold Varmus, directors of the NIH and NCI, respectively, identifies precision medicine’s critical needs and discusses how the President’s initiative will help “accelerate progress toward a new era of precision medicine.” Continue reading this entry