The U.S. Congress is currently considering a large number of bills that would attempt to bring down drug prices by a variety or means, including some aimed at reform of certain patent-related aspects of the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act of 2009 (BPCIA)....

Biologic patents are the basis of some of the most valuable technologies in the pharmaceutical industry. Biologic patents include patents to vaccines, antibodies as well as gene therapy and isolated blood products. This study focuses on the changing nature of a key biologic product, namely...

On June 8, 2005, Congressman Lamar Smith introduced H.R. 2795, the Patent Reform Act of 2005, aimed at improving the quality and certainty of issued patents, simplifying the patent procurement process, harmonizing U.S. law with international practice, and reining in abusive patent enforcement...

The term quot;reverse paymentquot; has been used as shorthand to characterize a variety of diverse agreements between patent owners and alleged infringers that involve a transfer of consideration from the patent owner to the alleged infringer. Reverse payment settlements are particularly...

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...

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...

In 2005, an article in the highly influential journal Science reported that roughly 20% of human genes are patented. This figure has been widely cited and at times over-interpreted. For example, a popular science fiction author warns the public that their bodies are "owned" by someone else. A...

Drawing an appropriate boundary between unpatentable natural phenomena and patentable inventions is critical in preventing the patent laws from unduly restricting access to fundamental scientific discoveries. Some would argue that, particularly in the U.S., patents are being issued which purport...

The fear that farmers could be found liable for patent infringement based on the inadvertent presence of patented genetically modified plants on the farmer’s fields has led to calls for limitations on the scope and enforceability of patents. These “reforms” would be especially problematic...

In the 1970s and early 1980s the US Supreme Court issued several landmark decisions establishing the contours of patent eligibility, a judicially created doctrine that serves as a gatekeeper to prevent the patenting of subject matter deemed so fundamental as to be better left unpatented. Over...