Experts Disagree On How Long Biologic Drugs Should Have Market Exclusivity

Main Category: Pharma Industry / Biotech Industry
Also Included In: Public Health
Article Date: 20 Mar 2009 - 6:00 PDT

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Settling the "debate over how long biotechnology drugmakers should retain exclusive rights to their patents" if done right "will save patients' lives and cut costs; if done incorrectly, however, it could cripple investment in products that cost billions to develop," Roll Call reports.

On Tuesday, Rep. Anna Eshoo (D-Calif.), House Energy and Commerce Committee ranking member Joe Barton (R-Texas) and Rep. Jay Inslee (D-Wash.) introduced legislation that would give brand-name biologic drugmakers 12 years of market exclusivity. Meanwhile, House Energy and Commerce Committee Chair Henry Waxman (D-Calif.) and House Energy and Commerce Health Subcommittee ranking member Nathan Deal (R-Ga.) last week introduced a bill that would provide five years of exclusivity with an optional three-year extension for new improvements and indications. President Obama's fiscal year 2010 budget calls for seven years of exclusivity. The Biotechnology Industry Organization maintains that there should be a minimum 14 years of exclusivity to account for a development process that on average takes 10 years and $1.2 billion for a product to reach market.

According to Roll Call, entities that support longer periods of exclusivity -- such as universities, biotech companies and venture capitalists -- are "fighting to protect inventors' rights and ensure more thorough clinical trials." On the other side, consumer groups, labor unions, insurers and generic drug manufacturers "see shorter exclusivity as the way to deliver safe, affordable and quality drugs to patients and open the marketplace to increased competition," Roll Call reports (Kindelan, Roll Call, 3/18).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

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