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Federal Affairs

Biocom Co-Hosts Washington Event on Federal Investment in Biomedical Innovation
On June 5, 2017, Biocom, along with 15 other state life science associations, hosted a Congressional briefing entitled Federal Investment in Biomedical Innovation. The event was held in cooperation with the Congressional Life Science Caucus, co-chaired by Representatives Scott Peters (CA-D-52) and Leonard Lance (NJ-R-7). 

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The event aimed at educating Congressional staff about the importance of funding for the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). Participants learned about how the agencies fuel biomedical innovation, work with private industry and academia to advance global human health, and give hope to patients in need. They also heard about the need for continued funding and the impact of budget cuts on health outcomes, the economy, and global leadership in medical research.
Speakers included Lizbet Boroughs, Associate Vice President for Federal Relations, Association of American Universities and President, United for Medical Research; Steven Grossman, Deputy Executive Director, Alliance for a Stronger FDA; and Eric Gascho, Vice President, Policy and Government Affairs, National Health Council. The event attracted more than 80 attendees.

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Supreme Court Limits Patent Venue
On May 22, the U.S. Supreme Court ruled on the TC Heartland v. Kraft Foods Group Brands case. In a unanimous decision delivered by Justice Thomas, the justices ruled that patent infringement lawsuits can only be filed in districts within states where the infringing defendant is incorporated. By doing so, the Supreme Court reversed a ruling by a federal appeals court which had ruled since 1990 that suits could be filed essentially anywhere a defendant sells allegedly infringing products. 

The patent venue statute, 28 U. S. C. §1400(b), provides that any "civil action for patent infringement may be brought in the judicial district where the defendant resides, or where the defendant has committed acts of infringement and has a regular and established place of business". In its decision, the Supreme Court construed the phrase "where the defendant resides" more narrowly than the Federal Circuit, concluding that a domestic corporation only resides in the state of incorporation.

This ruling could have troubling consequences for our industry, especially small biotech companies, by weakening the ability of patent owners to enforce their IP rights. Indeed, patent owners will have significantly fewer options for where they can file a suit. The ruling will also reduce the amount of lawsuits filed in the Eastern District of Texas.

House Committee Approves FDA User Fees Reauthorization Act 
On June 7, 2017, the Energy and Commerce Committee unanimously passed H.R. 2430 the Food and Drug Administration Reauthorization Act (FDARA) of 2017. FDARA reauthorizes the prescription drug, medical device, generic drug, and biosimilar user fee agreements, which are set to expire September 2017. The committee approved the following six amendments by voice vote:
  • Rep. Walden's Amendment (Manager’s Amendment) makes a number of changes to three of the amendments that were adopted at the Health Subcommittee hearing on May 18, related to hearing aids, counterfeit drugs, and generic competition. 
  • Rep. Peter's Amendment creates a clear regulatory pathway for new diagnostic imaging devices intended for use with contrast agents.
  • Rep. Costello's Amendment directs the FDA to issue a report addressing concerns about the quality and safety of medical devices serviced by third parties. 
  • Rep. Walter's Amendment enhances FDA’s ability to implement a provision of the 21st Century Cures Act that requires FDA to classify a medical device accessory based on its own risk rather than the risk of its parent device. 
  • Rep. Schakowsky's Amendment (1) creates a voluntary pilot program to develop post-market safety data on medical devices, with a focus on high-risk devices.
  • Rep. Schakowsky's Amendment (2) expresses the sense of Congress that the Administration should commit to working with Congress to enact legislative changes and take administrative actions to lower prescription drug prices. The amendment itself doesn’t mandate any legislative action.
After a thorough debate, Rep. Welch's amendment, which would allow the importation of drugs from Canada, was not agreed to. An amendment offered by Rep. Welch to prevent branded companies from using risk evaluation and mitigation strategies (REMS) and non-REMS restrictive programs to delay generic drug launches was withdrawn. Rep. Griffith's amendment on off-label communication and Rep. Guthrie's amendment to ensure communication of health care economic information and scientific information to payers and formulary and technology review committees were also withdrawn after Democrats threatened to opposed the bill altogether if the amendments passed. 

The bill now awaits floor consideration. The Senate version of the user fee legislation (S. 394) was approved on May 11 by the Senate HELP Committee and also awaits action by the full Senate. Biocom will continue to keep you informed of the progress of these bills.

Upcoming Public Policy Events
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Jun
27
Los Angeles Area Facilities/EH&S Committee Kickoff
Tuesday
June 27, 2017
12:00 PM
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Jul
18
Joint Biocom/IEA Meeting: Prop 65 Update
Tuesday
July 18, 2017
11:30 AM