Browsing by Subject "Hatch-Waxman Act"

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    Biologics Price Competition and Innovation Act: Striking a Delicate Balance Between Innovation and Accessibility
    (Minnesota Journal of Law, Science and Technology, 2014-02-20) Lu, Ude
    The Biologics Price Competition and Innovation Act of 2009 (BPCIA, also known as the Biosimilar Act) was signed into law in 2010 by President Barack Obama as part of the healthcare reform bill. The central mission of the BPCIA is two-fold: (1) providing sufficient incentives for continuous innovations in biologic therapies (i.e., promoting innovation); and (2) lowering the price of biologic therapies (i.e., promoting accessibility). To promote innovation, the BPCIA provides twelve-year Food and Drug Administration (FDA) exclusivity to innovator biologics. This twelve-year FDA exclusivity prevents generic biologics, also known as follow-on biologics (FOBs), from being approved. To promote accessibility, the BPCIA provides an abbreviated pathway for FOBs—the abbreviated biologic license application (ABLA). The ABLA allows FOB manufacturers to cut short the time and the expensive cost of clinical testing by referring to innovator biologics’ clinical data to establish safety and efficacy. The goal of this Note is to discuss the advantages and drawbacks of the mechanisms established in the BPCIA and to suggest modifications to strike a better balance between innovation and accessibility. Part I of this Note introduces the legal and scientific background of the BPCIA and Hatch-Waxman Act in order to engage in further analyses. Part II of this Note analyzes the competing interests of innovation and accessibility and suggests a novel six-year data exclusivity and a six-to-twelve-year market exclusivity regulatory scheme. This Note concludes that the current design of the BPCIA tips too favorably toward innovation and compromises accessibility. The suggested six-year data exclusivity and six-to-twelve-year market exclusivity regulatory scheme potentially strike a better balance between innovation and accessibility.
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    The Preemptive Power of Federal Patent Law: A Framework for Analyzing State Antitrust Challenges to Pay-for-Delay Settlements
    (Minnesota Journal of Law, Science and Technology, 2013-07-01) Marsili, Caroline
    Since the passage of the Hatch-Waxman Act (the Act) in 1984, patent litigation in the pharmaceutical industry has generated a troubling breed of settlement agreements wherein the payment goes from patentee plaintiffs to allegedly infringing defendants, resulting in anticompetitive effects. The provisions of the Act, though intended to promote innovation and lower drug prices while expediting infringement litigation, tend to incentivize reverse payments, or pay-for-delay settlements. The settlements are often challenged by the Federal Trade Commission (FTC) and by private parties for violation of antitrust law. Thus, pay-for-delay settlements illustrate a tension between patent law and antitrust law. Since the adoption of the Act, courts have struggled to harmonize the two bodies of law with regard to pay-for-delay settlements, as evidenced by the widely divergent rulings on the legality of these settlements among regional circuit courts. In December 2012, the Supreme Court granted a writ of certiorari to review Federal Trade Commission v. Watson Pharmaceuticals, Inc., an Eleventh Circuit case favoring the pharmaceutical companies, and should enunciate the proper legal standard to apply to pay-for-delay settlements.