In this case, however, our two industries principally disagree on the appropriate length of exclusivity. We believe that the
proven successful Hatch–Waxman exclusivity model provides an appropriate length of exclusivity to ensure appropriate return
on BIO's investment in innovation; allows for the appropriate incentive for the development of new treatments; and creates
savings from generic-drug competition.
This model seems especially appropriate when one considers that there is a minimal difference (less than eight months) between
the development of a biopharmaceutical product and the development of a traditional pharmaceutical product.
Accordingly, there is little justification for excessively expanding exclusivity beyond the Hatch–Waxman model. Excessive
exclusivity means that it will be decades before patients have access to affordable biogeneric medicines. For the countless
patients who are choosing between paying for their medicines and putting food on their tables, waiting decades is simply not
In November 2008, former House Ways and Means Committee Chief Economist and American Enterprise Institute Research Fellow
Alex Brill released a white paper that demonstrated that BIO's argument for a long period of exclusivity is invalid. He argued
that a period similar to Hatch–Waxman's five years of market exclusivity provides the necessary incentives to promote innovation
in novel biologics while opening the doors for timely patient access to less costly biogenerics.
What policymakers and consumers should know is that market exclusivity protection is separate and distinct from the patent
protection and corresponding patent extensions afforded to brand biopharmaceuticals today.
Yet, as BIO knows, market exclusivity acts as an absolute shield to their patents. Thus, from a practical perspective, considering
the time it takes to develop a drug, extending market exclusivity beyond the Hatch–Waxman period would block the introduction
of generic competition for nearly 20 years, derailing any potential cost savings to Americans and our healthcare system.
Kathleen Jaeger is president and CEO of the Generic Pharmaceutical Association, tel. 703.647.2480,