The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is for you.” The promise of personalized medicine holds allure for patients, providers, and payers alike by improving quality of care by targeting therapy, predicting disease course, mitigating risk, and reducing waste of scarce resources. However, several barriers remain that hinder adoption of PM across the globe, including industry incentive, regulatory pathways, reimbursement policies, and physician habits. In the U.S. market, there are challenges related to reimbursement, but manufacturers can take steps to overcome these barriers working with fellow stakeholders to unlock the full potential of personalized medicine. Continue reading this entry
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
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
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