Placebo Patents: Creating Stronger Intellectual Property Protection for Pharmaceuticals Approved by the U.S. Food & Drug Administration

Journal of Intellectual Property Law Volume 19 | Issue 1 Article 6 October 2011 Placebo Patents: Creating Stronger Intellectual Property Protection for Pharmaceuticals Approved by the U.S. Food & Drug Administration Sarah Renee Craig Follow this and additional works at: https://digitalcommons.law.uga.edu/jipl Part of the Intellectual Property Law Commons, Marketing Law Commons, and the Medical Jurisprudence Commons Recommended Citation Sarah R. Craig, Placebo Patents: Creating Stronger Intellectual Property Protection for Pharmaceuticals Approved by the U.S. Food & Drug Administration, 19 J. Intell. Prop. L. 143 (2011). Available at: https://digitalcommons.law.uga.edu/jipl/vol19/iss1/6 This Notes is brought to you for free and open access by Digital Commons @ Georgia Law. It has been accepted for inclusion in Journal of Intellectual Property Law by an authorized editor of Digital Commons @ Georgia Law. Please share how you have benefited from this access For more information, please contact . Craig: Placebo Patents: Creating Stronger Intellectual Property Protecti PLACEBO PATENTS: CREATING STRONGER INTELLECTUAL PROPERTY PROTECTION FOR PHARMACEUTICALS APPROVED BY THE U.S. FOOD & DRUG ADMINISTRATION Sarah Rende Craig* TABLE OF CONTENTS ................................... ............. 144 1. INTRODUCTION II. BACKGROUND .................................... ............. 146 A. NUTS AND BOLTS OF SEEKING PATENT PROTECTION AND THE 146 VALUE OF FDA APPROVAL ................................................................. B. PHARMACEUTICAL PATENT UTILITY STANDARD........................... 151 C. ELI LLLY V. ACIA I/S AND ITS PROBLEMATIC PRECEDENT....... 153 D. EXPLOITATION THROUGH OFF-LABEL MARKETING.................... 157 E. EFFECTS OF THE HATCH-WAXMAN ACT.......................................... 160 F. INCONTESTABILITY DOCTRINE IN TRADEMARK........................... 161 III. ANALYSIS ................................................. 162 A. ECONOMICS AND THE DISINCENTIVE CREATED BY ELILLLY.. 162 B. OVERTURNING EL ULL Y.................................................................. 164 C. CREATING AN INCONTESTABILITY STANDARD IN PATENT L AW ........................................................................................................ 16 6 IV . C O N CLU SION ............................................................................................... 170 * J.D. Candidate 2012, University of Georgia School of Law. The author would like to thank Anne Marie Pippin for her wonderful feedback and encouragement. She would also like to thank her family and friends for their support. 143 Published by Digital Commons @ Georgia Law, 2011 1 Journal of Intellectual Property Law, Vol. 19, Iss. 1 [2011], Art. 6 144 J. INTELL PROP.L [Vol. 19:143 I. INTRODUCTION Desperate to end a lengthy cycle of chronic pain, seventy-nine-year-old Richard Smith decided to try the prescription medication Neurontin after multiple doctors recommended he use the drug "off-label" (in a way not approved by the U.S. Food & Drug Administration (FDA)).' Two months later, Smith committed suicide. 2 His widow blames the Neurontin and its manufacturer, Pfizer Inc., for promoting the drug for the treatment of neuropathic pain, an off-label use. She claims the medication changed his personality and led to his uncharacteristic decision to shoot himself.3 Neurontin had not been approved by the FDA for neuropathic pain. But patent law frequently provides monopoly protection for pharmaceuticals that have not been approved by the FDA.4 However, a new and alarming trend has developed where patent law undermines the strength of patents for FDAapproved drugs for various reasons, including lack of utility.5 Thus, patent law appears to be operating contrary to public health and safety in its protection of pharmaceutical inventions. One recent federal district court decision provides an example of unnecessary, expensive litigation over the patent of an FDA-approved drug. In Eli Lilly v. Actatis Eli.Zabeth LLC, recently overturned by the U.S. Court of Appeals for the Federal Circuit (Federal Circuit),6 the U.S. District Court of New Jersey invalidated a patent for an FDA-approved drug for lack of data showing the utility of the drug at the time the patent was filed.7 Although the drug is currently approved and marketed for the use cited in the patent, the court found that the plaintiff had not adequately proven the usefulness of the drug when the patent was filed.8 The district court relied on precedent from the Federal Circuit, which had also invalidated a patent on the grounds of lack of utility in spite of FDA approval for the patented use.9 Overturning the lower court's decision, the Federal Circuit distinguished between the precedent and the new case, arguing the precedent was an example where utility was not 1 Smith v. Pfizer Inc., 688 F. Supp. 2d 735, 738-39 (M.D. Tenn. 2010). 2 Id 3 Id 4 In re Krimmel, 292 F.2d 948, 954 (C.C.P.A. 1961). s See, e.g., Eli Lilly & Co. v. Actavis Elizabeth LLC, 731 F. Supp. 2d 348, 348-50 (D.N.J. 2010), afd in part, r'evd in part ly Eli Lilly & Co. v. Actavis Elizabeth LLC, No. 2010-1500, 2011 WL 3235718 (Fed. Cir. July 29, 2011). 6 Eli Lilly & Co. v. Actavis Elizabeth LLC, No. 2010-1500, 2011 WL 3235718 (Fed. Cir. July 29, 2011). 7 Id at *36. 8 Id. 9 In r '318 Patent Infringement Litig., 583 F.3d 1317, 1327 (Fed. Cir. 2009). https://digitalcommons.law.uga.edu/jipl/vol19/iss1/6 2 Craig: Placebo Patents: Creating Stronger Intellectual Property Protecti 2011] PLACEBO PATENTS 145 adequately demonstrated in the patent. 0 The Federal Circuit sidestepped the key common factor, however: both cases involved challenges to patents covering an FDA-approved use of an FDA-approved drug. These decisions threaten future research and development of pharmaceutical drugs. A drug manufacturer is not required to seek FDA approval in order to acquire patent protection of a drug." Rather, patent protection establishes a monopoly on which drug manufacturers rely while they develop a new drug and conduct the research necessary to acquire FDA approval.12 Once a manufacturer acquires FDA approval for a certain indication, it frequently seeks to exploit that approval for the duration of the patent term through off-label marketing.' 3 Off-label marketing is illegal due to the safety risks involved with using drugs for an untested or unproven use.14 Such marketing is a common technique pharmaceutical companies employ to maximize profits during their patent terms. 5 In recent years, federal officials have focused intensive efforts on reducing off-label marketing of pharmaceuticals.16 These efforts could potentially be bolstered by stronger patent protection of FDA-approved uses of drugs, but have instead been undermined by decisions invalidating patents for FDA-approved drugs. In light of the prevalence of off-label marketing and the recent decisions creating disinc (...truncated)