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

Journal of Intellectual Property Law, Dec 2011

By Sarah Renee Craig, Published on 03/21/16

A PDF file should load here. If you do not see its contents the file may be temporarily unavailable at the journal website or you do not have a PDF plug-in installed and enabled in your browser.

Alternatively, you can download the file locally and open with any standalone PDF reader:

https://digitalcommons.law.uga.edu/cgi/viewcontent.cgi?article=1064&context=jipl

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

Journal of Intellectual Property Law Placebo Patents: Creating Stronger Intellectual Property Protection for Pharmaceuticals Approved by the U.S. Food & Drug Administration Jurisprudence Commons 0 0 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 Recommended Citation Part of theIntellectual Property Law Commons; Marketing Law Commons; and theMedical - PLACEBO PATENTS: CREATING STRONGER INTELLECTUAL PROPERTY PROTECTION FOR PHARMACEUTICALS APPROVED BY THE U.S. FOOD & DRUG ADMINISTRATION Sarah Rende Craig* II. III. TABLE OF CONTENTS INTRODUCTION ................................... ............. 144 BACKGROUND .................................... ............. 146 A. NUTS AND BOLTS OF SEEKING PATENT PROTECTION AND THE VALUE OF FDA APPROVAL ................................................................. 146 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 ANALYSIS ................................................. 162 A. ECONOMICS AND THE DISINCENTIVE CREATED BY ELILLLY.. 162 B. OVERTURNING EL ULLY.................................................................. 164 C. CREATING AN INCONTESTABILITY STANDARD IN PATENT LAW ........................................................................................................ 16 6 IV . CON 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 J.INTELL PROP.L 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 himself3. 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 wa s not 2011 ] 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 ill (...truncated)


This is a preview of a remote PDF: https://digitalcommons.law.uga.edu/cgi/viewcontent.cgi?article=1064&context=jipl

Sarah Renee Craig. Placebo Patents: Creating Stronger Intellectual Property Protection for Pharmaceuticals Approved by the U.S. Food & Drug Administration, Journal of Intellectual Property Law, 2011, Volume 19, Issue 1,