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.
As just a small sampling, the AIA institutes significant changes to 35 U.S.C. §102, involving a shift to a “first to file” system and expansion of prior art, as well as new USPTO procedures and proceedings, including pre-grant submissions, post-grant review, inter partes review, derivation proceedings and supplemental examination. The AIA also provides provisions relevant to litigation, such as limits on false marking suits, restrictions on joinder of defendants, elimination of best mode as a ground for invalidation, and a prior commercial use defense to infringement. Different provisions of AIA kick in at different times, i.e., immediately (or nearly immediately), or 12 or 18 months after the date of enactment.
For a substantial review of the timing of effective dates for the different provisions please see “Pressing The Patent Reform Panic Button” (posted on PharmaPatents on Sept. 5). For additional up-to-date information on patent reform generally, including links to useful information at the USPTO (also including timing of effective dates of different AIA provisions), please see foley.com/patentreform.
The USPTO is just starting its process of drafting regulations that will eventually implement many of the upcoming changes. As discussed in previous posts, one aspect of the AIA, a section entitled “Study on Genetic Testing,” impacts the personalized medicine industry in particular. See previous discussion in our September 9, August 3 and June 26 posts.
In a recent webinar on September 14, 2011, Robert Stoll (Commissioner for Patents at the USPTO), Sharon Barner (former Deputy Under Secretary for IP and Deputy Director of the USPTO) and Hal Wegner spoke about the impending patent reform. See Foley & Lardner’s webinar event summary and pdf copy of the slides. Mr. Stoll presented a slide (slide 6) showing a USPTO time line for providing comments to several provisions, including Section 27, Study on Genetic Testing.
As seen in Mr. Stoll’s time line, the USPTO will immediately prepare a Federal Register notice relating to the genetic testing study, and will publish its notice at some point in the next 2-3 months, i.e., between November 16 and December 16, 2011. After publishing its notice (and likely even beforehand), the USPTO will accept public comments relating to the genetic testing study for 60-90 days, i.e., until at least February 16, 2012. After that time, the USPTO will prepare its genetic testing study. The USPTO will complete and provide its final report to Congress’s Judiciary Committees by the deadline (9 months after enactment) mandated in the AIA, June 16, 2012.
In other words, for companies, institutions and groups that care about this study and what the USPTO may report (and any resulting impact on Congress), the time to think about providing comment to the USPTO is coming up fast. Keep in mind, the USPTO must report on items such as (a) the impact of a lack of independent second opinion testing on medical care, (b) the impact of relevant exclusive licenses/patents on the practice of medicine, and (c) the role of cost and insurance coverage on access to genetic diagnostic tests. To do so, undoubtedly the USPTO will need to consult outside experts regarding health care law, reimbursement and insurance issues, and other aspects of medicine impacted by genetic tests.
The USPTO has made it abundantly clear, as stated several times by Mr. Stoll in the webinar, that it welcomes, encourages, and in fact needs, comments from those impacted by the new law. Because of the speed in which the USPTO must take action, it eagerly seeks input from anyone with views regarding the best course of action going forward. The USPTO provides contact information for public comment on its AIA Implementation webpage. Those in the personalized medicine industry will not want to miss this opportunity to have their voices heard.