Biotech Values

[DewDiligence]

Teva Comments on the 'Biologics Price Competition and Innovation Act of 2007'

[The “Biologics Price Competition and Innovation Act of 2007” is the Senate bill described in #msg-20694180. A comparable bill has not yet been moved through the House. Thus, it’s too soon to say which features will survive a compromise between the two chambers—or even to say that a biogenerics bill will pass Congress this year. If a bill does get passed this year, I think it will likely specify a lower exclusivity period than 12 years.]

http://biz.yahoo.com/bw/070627/20070627005867.html?.v=1

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Wednesday June 27, 12:23 pm ET

JERUSALEM--(BUSINESS WIRE)--Today, the Senate Health, Education, Labor and Pensions committee will take a significant step forward to ensure that the Food and Drug Administration (FDA) has the regulatory pathway necessary to establish an approval process for generic biologics. Teva applauds the Committee, especially Senators Kennedy, Enzi, Clinton and Hatch for their leadership, as well as Senator Schumer, in taking these important steps. The fundamental approach of the Biologics Price Competition and Innovation Act of 2007 is to address the scientific, regulatory and legal issues involved in bringing affordable biologics to the marketplace. The bill will create a scientifically-rigorous, efficient, FDA-driven pathway for both biosimilar and biogeneric products and include a mechanism intended for timely resolution of patent disputes.
Unfortunately, there are two critical issues that undermine the promise of the bill for consumers, payers and employers who continue to face increasing health care costs. The first issue is the unprecedented twelve years of market exclusivity the bill provides to the innovator company for developing a compound. Teva, as a significant patent holder, supports strong incentives for innovation, however, twelve years of market exclusivity is four years beyond any other nation and seven years beyond the exclusivity period guaranteed for chemical drugs. Our hope is that the Congress will adopt a more constructive and balanced market exclusivity period that is closer to the Hatch Waxman Act. [The H-W exclusivity period for small-molecule drugs is five years for a new molecular entity and three years otherwise; these periods apply even if there is no patent on the compound.]

The second issue and the potentially fatal flaw that needs to be addressed before the bill moves forward is the loophole in the legislation that enables companies to secure multiple twelve year exclusivity periods for very minimal true innovation or improvement to an existing compound. Minor changes to a product would result in an additional 12 years of monopoly protection -- a practice commonly referred to as "evergreening." This issue could indefinitely delay consumer access to potentially life saving medicines. We do not believe it is the intent of the sponsors of this legislation to allow such evergreening. Teva looks forward to continuing to work with the bill's sponsors and other policymakers to rectify these concerns and fulfill the promise of true competition and access to affordable healthcare that this bill should offer.
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