Today’s Federal Register includes a notice to the public inviting comments on independent second opinion genetic tests where patents and exclusive licenses exist that cover primary genetic diagnostic tests. The comments are collected for the purpose of preparing a report on the subject as required by Section 27 of the America Invents Act (“AIA”). In addition to soliciting comments, the USPTO will hold two public hearings in support of the genetic testing studies. Continue reading this entry
As most in the patent community know, last Friday, September 16, 2011, President Obama signed into law the long-awaited patent reform bill, known as the Leahy-Smith America Invents Act (“AIA”). There are many moving parts to this complicated piece of legislation—many consider it to implement the most sweeping changes to U.S. patent law since enactment of the 1952 Patent Act.
Yesterday, September 8, 2011, the Senate passed by a vote of 89-9 the House version of the patent reform bill H.R. 1249, also known as the Leahy-Smith America Invents Act, without amendment. Consequently, after many years of discussion, debate and hand-wringing, significant patent reform is imminent. In fact, at this point, the legislation only requires action by President Obama, who has already promised to sign the bill.
Most provisions in the bill impact U.S. patent practice generally, including moving towards a first-to-file system, expanding prior user rights as a defense to infringement, eliminating interference proceedings, and creating new USPTO proceedings for post-grant review. One aspect of the bill, however, in a section entitled “Study on Genetic Testing,” impacts the personalized medicine industry in particular. See previous discussion on this provision on our June 26 post and August 3 post.
The U.S. Patent and Trademark Office (USPTO) announced that it is proactively seeking public comments on the Leahy-Smith America Invents Act (AIA), H.R. 1249, passed by the U.S. House of Representatives on June 23, 2011, and currently pending before the U.S. Senate. The AIA requires the USPTO to undertake a series of rulemakings to implement the Act. Because several provisions of the AIA require implementation within a period of one year from enactment, the USPTO is anticipating that expeditious rulemaking proceedings will be required.
On June 23, 2011, the United States House of Representatives passed the “Leahy-Smith America Invents Act” (H.R. 1249) to amend title 35 of the United States Code, to provide for patent reform. Within the numerous provisions related to the examination, administration and enforcement of U.S. patents is a proposed amendment that may affect the value of genetic testing patents. Under Section 27 of H.R. 1249 the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent Office (Director) shall report to Committee of the Judiciary of the Senate and the Committee on the Judiciary of the House of Representatives on effective ways to conduct independent confirmatory genetic tests (second opinions) of genetic diagnostic tests covered by patents that are exclusively licensed.