The Leahy-Smith America Invents Act (AIA) and the Biologics Price Competition and Innovation Act (BPCIA) are dramatically reshaping business strategies designed to protect intellectual property and regulatory exclusivity rights granted by the United States Patent and Trademark Office (PTO) and the Federal Drug Administration (FDA) to the sponsors of new and follow-on versions of many biopharmaceutical products. The AIA alters many provisions in the U.S. patent statutes, most notably long-standing policies and practices relating to the conditions for patentability of an invention, particularly 35 USC §§ 102 and 103 relating to novelty and non-obviousness, respectively, and introduces new provisions relating to post-grant review proceedings and prioritized examination that will affect the business plans of academic and corporate institutions seeking to discover and develop health care products that serve unmet medical needs or provide consumers with safe sources of drug products at a low cost. The BPCIA implements many new provisions relating to the abbreviated review and approval of follow-on biopharmaceutical products. Important aspects of the BPCIA, particularly issues identified in draft guidance documents that were released by the FDA in February 2012 concerning the characterization, comparison, and evaluation of reference and follow-on macromolecules, will be discussed in this article. Political issues that may jeopardize the BPCIA, economic considerations faced by drug product sponsors, and public reaction to the guidance documents are also discussed in this final article of a three-part series describing key provisions of the AIA and the BPCIA that affect intellectual property and regulatory exclusivity rights of institutions having an interest in developing novel or follow-on versions of biopharmaceutical drug products…
Tag: <span>intellectual property</span>
The Patient Protection and Affordable Care Act (PPACA), which was passed in 2010, included the Biologics Price Competition and Innovation Act (BPCIA) authorizing the United States Food and Drug Administration (FDA) to establish an abbreviated regulatory approval pathway for complex macromolecules produced in living cells or organisms. The BPCIA implements many new provisions relating to the abbreviated review and approval of follow-on biopharmaceutical products. These include: (1) evaluating the biochemical properties of reference and follow-on macromolecules; (2) establishing procedures for the exchange of information between product sponsors, regulatory agencies, and the federal court system; and (3) establishing periods of regulatory exclusivity which complement patent rights typically awarded to the sponsor of a reference molecule. Important aspects of the BPCIA, particularly issues relating to the exchange of information between product sponsors and the establishment of periods of regulatory exclusivity protecting a novel or follow-on macromolecule are discussed in this article. This is the second in a series of three articles describing key provisions of the Leahy-Smith America Invents Act (AIA) and the BPCIA that affect intellectual property rights of academic and corporate institutions having an interest in the life sciences…
A patent permits the patent holder to keep others out. That is, a patent holder can prevent others from making, using, selling, offering to sell, or importing an invention within the United States and its territories and possessions. In the United States, these exclusionary rights generally last for 20 years from the date on which the patent application was filed. What the patent holder can keep others out of is defined by the “claims” of the patent. Patent claims describe the boundaries of the patent, much like a real property deed outlines the borders of a parcel of land. However, having a patent does not guarantee that the patent holder is free to use the claimed invention…
From an intellectual property (IP) standpoint, probably the two biggest problems I encounter in my practice for early-to-middle stage technology companies are: (1) their failure to fully understand and keep abreast of the competitive intellectual property environment , and (2) their failure to institute procedures that will permit and encourage development of a strategic intellectual property portfolio. By “strategic,” I mean an intellectual property portfolio that focuses on both an offensive and defensive position — a portfolio that not only covers the product and all aspects of its manufacture, production, and applications (defensive portfolio development), but also provides significant blocking positions with respect to competitors’ efforts…