1. The FDA adopted the term “follow-on protein product” in August 2004 to refer to a protein that is intended to be a similar version of an already approved or licensed protein pharmaceutical product. SeeFederal Register69, no. 50386 (16 August 2004 ): 50386 –50388. Inasmuch as biologic products from different manufacturers cannot be identical, we use the FDA’s term throughout this paper rather than the more oft-quoted term “generic biologics.”
2. See “Follow-Ons Off? FDA Shelves Near-Term Plans for Biologics Documents,”Pink Sheet67, no. 41 ( 2005 ): 14 . To date, the FDA has approved several complex protein products under the FDCA.
3. See, for example, AA. Naini , “Convergent Technologies and Divergent Patent Validity Doctrines: Obviousness and Disclosure Analyses in Software and Biotechnology,”Journal of the Patent and Trademark Office Society86, no. 7 ( 2004 ): 541 –567
4. ; and J.A. Kopczynski , “A New Era for §112? Exploring Recent Developments in the Written Description Requirement as Applied to Biotechnology Inventions,”Harvard Journal of Law and Technology16, no. 1 ( 2002 ): 229 –264.
5. The court has continued to apply rigorous written description requirements in recent cases involving bio-technology and chemical patents. See, for example,Inre Wallach, 378 F.3d 1330 (Fed. Cir. 2004 )