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)