Protecting Diagnostic Innovation – Two Actor Infringement Liability


In Akamai Techs. Inc. v. Limelight Networks, Inc., (August 13, 2015 Fed. Cir.) an en banc Federal Circuit unanimously held that direct infringement under Section 271(a) can occur:

”where all steps of a claimed method are performed by or attributed to a single entity…Where more than one actor is involved in practicing the steps, a court must determine whether the acts of one are attributable to the other such that a single entity is responsible for the infringement. We will hold an entity is responsible for others’ performance or method steps in two sets of circumstances: (1) where that entity directs or controls others’ performance, and (2) where the actors form a joint enterprise.” Slip Op. at 4. Continue reading this entry

Inventorship, Ownership Issues Cause Dismissal of Suit


On July 22, 2015, the U.S. District Court for the District of Maryland dismissed a long standing patent infringement suit brought by StemCells, Inc. against Neuralstem, Inc., on the ground that all those with an ownership interest in the patents-in-suit did not voluntarily join as plaintiffs in the action. StemCells, Inc v. Neuralstem, Inc., Case No. 06-cv-187-RWT (D. Md. July 22, 2015). The decision highlights that even informal agreements among collaborators can be construed as assignments of inventions and that there is often a difference of opinion, even among experts, as to who made an inventive contribution to a patent filing. Continue reading this entry

Federal Circuit Invalidates Another Diagnostic Patent


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.

Continue reading this entry

Will Personalized Medicine Survive Alternative Payment Models?


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

An Update on 21st Century Cures Legislation

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