When people think of risks associated with artificial intelligence (AI), Hollywood looms large. Movies have long conjured the worst case scenarios: from Hal refusing to open the pod bay doors in 2001, to a murderous Arnold Schwarzenegger travelling back through time. If there is a robot...

On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act of 2009 (‘BPCIA’) to create an abbreviated approval pathway for generic ‘biological products’ that are demonstrated to be highly similar (i.e., biosimilar) to or interchangeable with an...

The year has been framed by the emergence of concerted state-sponsored terrorism designed to undermine national elections and state infrastructure. Even state-sponsored cyber warfare may take second place to massive criminal attacks on financial credit bureau Equifax. The year also featured a...

In Merck KGaA v. Integra LifeSciences I Ltd., the U.S. Supreme Court adopted a broad construction of the regulatory approval exception to patent law infringement, 35 U.S.C. § 271(e)(1), for experiments conducted at early stages of the pharmaceutical development process. But the Court refused to...

A 2005 Science article by Jensen and Murray is widely cited for the proposition that 20% of human genes are patented, and has led to a pervasive assumption that thousands of human genes cannot be used, studied or even 'looked at' by researchers and healthcare providers without infringing a gene...

Judge Bryson recently asserted in Association for Molecular Pathology v. US Patent and Trademark Office (dissenting-in-part) that human gene patents "present a significant obstacle to the next generation of innovation in genetic medicine — multiplex tests and whole-genome sequencing." His...

Individual citizens have been found to be a major source of new product and service innovations of value both to themselves and to the economy at large. These citizen innovators operate in a little understood legal environment that we call the innovation wetlands. We show via a review of...

In 2005, the Food and Drug Administration required the use of CFC-free propellants in albuterol inhalers. But 3M held patents on the only U.S.-approved CFC-free inhaler. The FDA's regulations forced multiple generic albuterol manufacturers to choose between infringing 3M's patents and exiting...

Planet earth is host to a dazzling variety of living organisms. This diversity of life, or – biodiversity, is vital to the survival and prosperity of humanity, supplying such vital amenities as food, clothing, shelter, natural biochemicals useful in medicine, industry, and agriculture, and...

Because it must rely on imperfect information, the patent system will inevitably make mistakes. To determine how the system ought to err in cases of uncertainty—and whether a given mistake is worth correcting—scholars have composed a simple picture of the consequences of error in either...