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Abstract

Over the past decade or so, the United States has been the arena of a boisterous debate regarding the creation of a new regulatory framework for the approval of generic versions of biologics-based pharmaceutical products (also known as "biological products" and "biologics")--an important and increasingly growing class of drugs. The basic purpose of such a framework is to create a fast and less-costly route to FDA approval for biologics that would be similar or identical to already-approved biological products--typically ones that are sold on the market at monopoly rates--thereby allowing cheaper versions of such medicines to enter the market. One of the main points of contention in creating the framework for the approval of generic biologics has been the length of the exclusivity period granted to developers of original biologics during which generic competitors are not allowed to enter the market. On March 21, 2010, as part of the healthcare reform act, Congress settled this debate by enacting the Biologics Price Competition and Innovation Act of 2009 ("BPCIA"), which provides statutory exclusivity periods of 12 to 12.5 years for original biologics from the date of FDA approval. This 12- to 12.5-year statutory exclusivity period predominantly overlaps with patent protection on the underlying biological product and is about 5 to 11 months shorter than the average remaining period of such patent protection on the original product. This redundancy raises questions regarding the need for and purpose of having patents in inventions related to biologics in addition to statutory exclusivities. What justification is there, if any, for such double-layered protection in biologics? Assuming that such justification or need for double protection does exist, why should biologics be the only kind of technology to benefit from it? Could the statutory exclusivity regime in biologics mark the dawn of a new era in the protection and incentivizing of innovation and the beginning of a gradual replacement of the old patent system with modern schemes of statutory exclusivities; or is it just a peculiar case of a legal regime shaped by an unusually powerful industry? In this Article I will seek to address these questions and propose some answers. Part I of this Article will review fundamental patent theory concepts necessary for the discussion and compare them with statutory exclusivities, with emphasis on the statutory exclusivity scheme created under the Hatch-Waxman Act. Part II will describe the current regulation of biologics in the United States and review the framework for the approval of generic biologics under BPCIA. Comparing statutory exclusivities and patent protection in the context of biologics, Part III will discuss the merits of these two regimes from a public policy perspective, address the possible ramifications of having both statutory exclusivities and patent protection in biologics, and culminate in a call for the suspension of patent enforcement rights with relation to biological products that benefit from statutory exclusivities afforded under BPCIA for the duration of such exclusivities.

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