The Pharmaceutical Research and Manufacturers of America (PhRMA) today released statements in that were critical of bills in the House and Senate aimed at curbing abusive patent litigation.
In reference to the 21st Century Cures draft moving through the House, PhRMA “look[s] forward to reviewing the draft legislation released today, and stand ready to work with the Committee to advance proposals that will better utilize 21st century science in the design and conduct of clinical trials, modernize regulatory tools and pathways, and enhance the Food and Drug Administration (FDA)’s access to scientific expertise.”
PhRMA states that, “While the Senate legislation is an improvement over the House version, there continue to be issues of concern that intellectual property holders have raised, and we look forward to working with Senators to address those concerns.”
On the Senate version of the Bill, PhRMA elaborated that “the legislation as introduced unfortunately contains no provisions to address significant shortcomings in the implementation of the post-grant proceedings at the Patent and Trademark Office (PTO), which have directly led to abusive practices. We appreciate the commitment the Senators have made to address this critical issue in the pending legislation and look forward to working with them to improve this process. The pro-challenger bias exhibited through these proceedings has come to be known as a “death squad” for legitimate patents and patent holders. Ultimately, PhRMA would have to oppose patent legislation that does not include changes to more fairly balance post-grant proceedings at the PTO.”
While they prefer the Senate version of the legislation, PhRMA stated that overall, “We continue to support more effective collaborative efforts within the institutes and centers of the National Institutes of Health (NIH) to ensure the groundbreaking basic research done by NIH is shared and translated into practical applications for the ongoing medical research, discovery, and development done in the private sector. We share the Committee’s interest in modernizing the FDA’s regulation of health care communication to ensure health care providers have access to scientifically accurate and up-to-date information in order to achieve the best possible outcomes for patients. We remain committed to patients having access to the medicines they need, and look to ensure delivery reforms enhance quality of care without limiting access to the newest and most innovative treatments.”