Patent Legislation Debate Continues in the Senate
As the debate over patent reform legislation continues in Washington D.C., CHI has led efforts to address the concerns of California’s biomedical R&D community.  In meetings with the offices of Senators Dianne Feinstein and Barbara Boxer, CHI has explained the potential damage to life sciences investment and innovation resulting from certain provisions in the patent bill.  Unless amended, the new law would increase costs to obtain and maintain patents, undermine patent certainty, and make infringement easier.  Most recently, CHI organized more than 100 California-based biotechnology, medical device and diagnostics companies, venture capital firms, and private research institutes to sign onto letters opposing the legislation in its current form and urging the Senate not to schedule a vote on the measure until consensus is reached on a number of critical provisions.

Suit Filed to Block PTO Rules
On Oct. 9, GlaxoSmithKline (GSK) filed suit against the U.S. Patent and Trademark Office (PTO) in a bid to block new rules, issued in August and scheduled to take effect Nov. 1, which would restrict applications for continuations.  In its complaint, filed in the U.S. District Court for the Eastern District of Virginia in Alexandria, Virginia, GSK requests the court to enjoin the PTO from implementing the rules, arguing they were promulgated without proper legal authority and are “vague, arbitrary and capricious, and prevent GSK from fully prosecuting patent applications and obtaining patents on one or more of its inventions.”  In 2006, CHI filed formal comments with the PTO opposing the then-proposed restrictions.  We remain concerned about the final rules, and will closely monitor the legal proceedings against their implementation.  For more information, contact Todd Gillenwater, CHI vice president-public policy (gillenwater@chi.org or 202-974-6313).

NIH Funding Bill in Senate Moves Toward Passage
This week the Senate began work on its largest domestic spending package, the Labor-Health and Human Services appropriations bill, which includes funding for the National Institutes of Health (NIH).  Prior to consideration, Senate Labor-HHS Subcommittee Chairman Tom Harkin (D-IA) removed a controversial stem cell provision from the package as part of maneuvering with the administration.  The president had issued a veto threat in response to the original inclusion of the stem cell language and spending levels that were significantly higher than he requested.  Debate on the legislation is expected to continue, with additional amendment votes today, followed by a possible final passage vote tomorrow, Oct. 23.  The bill will then move to conference with the House, with the goal of reaching the president before the end of the month.  CHI is advocating for the higher NIH allocation contained in the Senate package.  Meanwhile, a proposal by Senator David Vitter (R-LA) that would prohibit HHS from using funds to prohibit the importation of drugs is among proposed amendments.  This amendment is similar to language that has been included in past years and CHI will advocate against it as a form of price controls.  For more information, contact David Burt, CHI legislative director (burt@chi.org or 858-551-6677).

NIH Director Challenges Administration on Stem Cell Policy
In the most recent edition of Medline Plus, a journal published jointly by the NIH and Friends of the National Library of Medicine, NIH director Elias A. Zerhouni voiced opposition to the administration’s current stem cell policy by calling for expanded research in the field.  President Bush has twice vetoed legislation that would have eased current restrictions to expand the number of embryonic stem cell lines eligible for federal funding.  As the leader of the nation’s primary biomedical research agency, Zerhouni defended his position stating it was his responsibility to the president and the American public to provide candid scientific expertise and perspective.  CHI supports a stronger, more robust federal initiative on embryonic stem cell research.

CHI to Engage on Education Issues; Request for Company Information
Since the August recess, congressional leaders have been discussing issues relating to the reauthorization of the No Child Left Behind Act. Given the leadership roles of key members of the California delegation on the House Education & Labor Committee (Chairman George Miller (D-Concord), Ranking Member Buck McKeon (R-Palmdale), as well as Representatives Lynn Woolsey (D-San Rafael), Susan Davis (D-San Diego), and Linda Sanchez (D-Cerritos)), and the desire among members, in general, to have the support and input of academic, business, and R&D leaders on education reform, CHI is well positioned to take a more visible leadership role in this debate.  CHI is currently collecting information from our member companies about their education outreach activities in the state, including internship programs, curriculum collaboration, teacher training, and more that are ensuring appropriately educated and trained workers in the life sciences field.  Please contact David Burt, CHI legislative director (burt@chi.org or 858-551-6677) with this information.