Is our legal commitment process an evidence-based model?

By Bryan Kozusko

The research methods used by the Policy Surveillance Program to develop datasets mapping health laws and policies include secondary research that provides context to the law, identifies the legal strategy it embodies, and uncovers any evidence to suggest whether it is improving health and well-being. While policy surveillance is meant to facilitate an evidence-building process by producing robust data for analysis, researchers attempt to uncover some indication that existing policies are evidence-based.

The Policy Surveillance Program has been mapping involuntary civil commitment laws at various levels: short-term inpatient commitment, long-term inpatient commitment, and outpatient civil commitment. So far, a literature review is inconclusive on the effectiveness of involuntary outpatient civil commitment.

Domestically, a handful of studies appear to exist. To date, only two systematic studies have been performed, both of which yield inconclusive or inconsistent results (see Kisely & Campbell, 2014, and Ridgely, Borum & Petrila, 2001). The Kisely and Campbell review shows an overall improvement in areas such as social functioning and quality of life; however, researchers acknowledge the sample size is very small and the quality of the trials range from low to medium. The Ridgely et al. review gathered similar unreliable data, inconsistent or conflicting results on quality of life after commitment. Read More

Sequenom vs. Ariosa and international approaches to the patent eligibility of biomedical innovation

By Timo Minssen

With a potential petition for writ of certiorari in the Sequenom v. Ariosa case approaching, it appears as if the US Supreme Court  will once again have to consider crucial patent eligibility questions with a great significance for biomedical innovation and diagnostic methods.

The claims at issue (see U.S. Patent No. 6,258,540 ) are directed to methods of genetic testing by detecting and amplifying paternally inherited fetal cell-free DNA (cffDNA) from maternal blood and plasma. Before the development of this non-invasive prenatal diagnostic test, patients were placed at much higher risk and maternal plasma was routinely discarded as waste.

In an earlier decision the district court ruled that the method claims were patent ineligible and an – apparently reluctant  – Federal Circuit agreed in Ariosa Diagnostics, Inc. v. Sequenom, Inc. 788 F.3d 1377 (Fed Cir. 2015). Judge Linn, for example, wrote that the innovation deserves patent protection, but also that the “sweeping language of the test” established in Mayo v. Prometheus requires a determination that the claims are patent ineligible. Read More

Stem cell patenting on the other side of the pond

By Timo Minssen

We are pleased to announce a new publication in the International Review of Intellectual Property and Competition Law (IIC). Our paper analyzes new case law in European stem cell patenting and compares these developments with the US situation and International treaties. Further information and an abstract is available below:

Authors: Ana Nordberg & Timo Minssen, University of Copenhagen, Centre for Information and Innovation Law (CIIR)

Title: A “Ray of Hope” for European Stem Cell Patents or “Out of the Smog into the Fog”? An Analysis of Recent European Case Law and How it Compares to the US
Journal: IIC – International Review of Intellectual Property and Competition Law, 47(2), 138-177
DOI: 10.1007/s40319-016-0449-x

ABSTRACT:  Read More