CHI CEO on Patent Reform and Follow-on Biologics Legislation

    By Donald Zuhn --

Earlier today, California Healthcare Institute president and CEO Dr. David Gollaher provided Patent Docs with an update regarding the status of patent reform and follow-on biologics legislation in the 111th Congress.  The California Healthcare Institute (CHI) is an independent organization comprising more than 250 biomedical companies and academic and research institutions involved in researching and advocating policy to forward the interests of California's biomedical community.

While in Washington, DC last week to host a workshop on comparative effectiveness research and participate in the CHI's quarterly board meeting, Dr. Gollaher and other representatives of CHI took the opportunity to meet with members of Congress to discuss pending patent reform and follow-on biologics legislation.  Dr. Gollaher was particularly interested in recent developments concerning H.R. 1260, the companion bill to the Senate patent reform bill (S. 515) voted out of Committee earlier this month, and H.R. 1548, the follow-on biologics bill introduced by Rep. Anna Eshoo (D-CA) on March 17.

With respect to patent reform legislation, Dr. Gollaher (at left) noted that the CHI had played an important role in securing the April 2 compromise that permitted S. 515 to be voted out of Committee (see "Senate 'Patent Reform' Bill (S. 515) Voted out of Judiciary Committee").  The organization accomplished this by working closely with Senator Dianne Feinstein (D-CA) to improve the bill originally introduced in the Senate on March 3 (see "Senate and House Introduce New Patent Reform Legislation").  Dr. Gollaher noted that the CHI was able to convince Senator Feinstein that the original version of the Senate bill would cause more problems for California's life sciences companies and universities than it would resolve problems with the U.S. patent system.  (Dr. Gollaher also noted that in making the argument for harm to California's universities, it probably did not hurt that Senator Feinstein's husband, Richard Blum, is the Chairman of the Board of Regents of the University of California.)  The CHI's work ultimately paid off when Senator Feinstein expressed concerns about the bill during the Senate Judiciary Committee's March 10 hearing on patent reform, and declared that absent a reworked damages provision, she would not be voting for the bill (see "Senate Judiciary Committee Holds Hearing on Patent Reform").

Despite the successful outcome in the Senate, however, Dr. Gollaher was worried about what might happen to the House version of the bill in the coming weeks.  Dr. Gollaher's fears had only been heightened by conversations he had last week with Rep. Zoe Lofgren (D-CA), who suggested that the pro-apportionment faction might be looking to torpedo the House bill altogether rather than allow it to pass with the same gatekeeper damages provision currently in S. 515.  In view of the House's passage of H.R. 1908 in September of 2007 (see "Patent 'Reform' Bill Passes House of Representatives"), it is hardly surprising that a portion of the House -- probably a good number of the Democrats that voted 160-58 in favor of the bill -- might have problems with the compromise provisions in S. 515.  Interestingly, Dr. Gollaher indicated that some House members had signed onto H.R. 1908 with the promise, subsequently broken, that more controversial provisions in the bill would be "fixed" before the legislation reached the floor for a vote.  Because it was unlikely that these House members would be duped again, Dr. Gollaher suggested that the pro-apportionment faction might fail in its attempts to put an apportionment of damages provision back into play.

As for the effort to enact follow-on biologics legislation, Dr. Gollaher noted that Rep. Eshoo's bill continued to maintain a sizeable advantage over Rep. Henry Waxman's competing bill (H.R. 1427) in terms of the number of co-sponsors (currently, H.R. 1548 has 66 co-sponsors and H.R. 1427 has 10).  Dr. Gollaher took this as a good indicator that Rep. Eshoo's bill, which the CHI supports, might prevail over Rep. Waxman's bill.  However, Dr. Gollaher conceded that Rep. Waxman, who chairs the House Committee on Energy and Commerce, still wielded much power, and as a result, could eventually swing support back to his own bill.  Dr. Gollaher also believed that the follow-on biologics debate could eventually be influenced by Senator Edward Kennedy (D-MA), who might introduce his own follow-on biologics bill in the Senate (as he did in the 110th Congress; see "Senate Committee Passes Biologics Legislation").  Dr. Gollaher concluded the discussion by noting that CHI member Deloitte recently released a study entitled "Avoiding No Man's Land: Potential Unintended Consequences of Follow-on Biologics," which examines the follow-on biologics bills introduced in Congress, and according to a CHI press release warns that "if responsible legislation is not carefully crafted specifically for today's industry, the industry may enter into a 'no man's land' which could significantly reduce our ability to continue to develop innovative treatments for the most dreaded diseases."  Patent Docs will provide a more comprehensive analysis of the study in a subsequent post.

Comments

[staff]

patent reform is a fraud on America...
please see http://truereform.piausa.org/ for a different/opposing view on patent reform