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"PATENT RIGHTS V. PUBLIC ACCESS:
INTERPRETING THE PUBLIC INTEREST FACTOR
IN PHARMACEUTICAL PATENT INFRINGEMENT
CASES
Camille Sizemore Halterman*

I. INTRODUCTION

“Patents have long been the crown jewels of the pharma industry. They
protect pioneer therapies from generic competition and underwrite the
enormous investment required for new drug research and development.”1
The estimated average cost per new prescription drug approval from the U.S.
Food and Drug Administration is over $2.5 billion.2 For this reason, the
pharmaceutical industry depends strongly on patent rights to recover from
their investments and fund further research and development.3
Brand name drugs have been developed and tested over a course of
many years to show that they meet safety and efficacy requirements by the
Food and Drug Administration.4 Pharmaceutical companies developing
brand name drugs rely on the exclusivity provided by patents in order to
charge a premium price while under protection.5 Absent patent protection,
other companies are free to make generic versions, causing the price to
significantly drop.6 A generic drug requires no discovery process because

* Camille Halterman is a third-year law student at Southern Illinois University School of Law,
expecting her Juris Doctor in May of 2018. She thanks her Note editor Amber Sanges for her all
of her edits and feedback. She would also like to thank her friends and family for their substantial
support and encouragement, especially her parents Aaron and Sarah Sizemore, and husband
Zachary Halterman.
1. Terry G. Mahn, Generics Behaving Badly: Carve Outs, Off-Label Uses, LAW360 (Mar. 24, 2009,
12:00 A.M.), http://www.law360.com/articles/93495/generics-behaving-badly-%20carve-outs-offlabel-uses.
2. Joseph A. DeMasi, Innovation in the Pharmaceutical Industry: New Estimates of R&D Costs,
TUFTS CTR. FOR THE STUDY OF DRUG DEV. (Nov. 18, 2014),
http://csdd.tufts.edu/files/uploads/Tufts_CSDD_briefing_on_RD_cost_study_-
_Nov_18,_2014.pdf.
3. Vernon Winters, Let’s Fix the Patent-Specific Preliminary Injunction Test, LAW360 (Apr. 05, 2013,
11:47 AM), https://www.law360.com/articles/424868/let-s-fix-the-patent-specific-preliminaryinjunction-test.
4. Cynthia M. Ho, Drugged Out: How Cognitive Bias Hurts Drug Innovation, 51 SAN DIEGO L. REV.
419, 431 (2014) (The developmental stages can take years because the entity not only must find a
chemical compound but there are several stages of clinical trials to prove safety).
5. Id.
6. Id. (“After a term of less than twenty years, companies can make generic versions, and when there
are multiple generic versions, the price drops substantially”).
500 Southern Illinois University Law Journal [Vol. 42

generics essentially copy successful brand name drugs that have already been
approved, meaning the costs to enter into the market are significantly lower
than costs brand name drug companies face.7
Courts use injunctions as a remedy against patent infringement because
calculating monetary damages for future harm by an infringer is extremely
difficult, if not impossible, to determine.8 Traditionally, courts granted
permanent injunctions to patent holders who had a valid patent that was
infringed.9 This method of patent protection was ideal for the pharmaceutical
companies investing hundreds of millions of dollars into research because
the patent holder would be able to practice its exclusivity in the marketplace
and recoup for damages made in the developmental stages.
However, in 2006, the Supreme Court significantly changed the
structure of the patent system for obtaining permanent injunctions.10 The
holding in eBay v. MercExchange reduced the frequency in which courts
were granting injunctive relief,11 and required that the traditional four-factor
test for equitable relief be used when considering permanent injunctions.12
The traditional test is stated as follows:
According to well-established principles of equity, a plaintiff
seeking a permanent injunction must satisfy a four-factor test
before a court may grant such relief. A plaintiff must demonstrate:
(1) that it has suffered an irreparable injury; (2) that remedies
available at law, such as monetary damages, are inadequate to
compensate for that injury; (3) that, considering the balance of
hardships between the plaintiff and defendant, a remedy in equity
is warranted; and (4) that the public interest would not be disserved
by a permanent injunction.13

7. Id. at 432 (“[T]he FDA refers to applications to sell generic drugs as abbreviated applications
because much less is required. First, there is no discovery process . . . In addition, although a generic
still needs FDA approval, it only needs minimal testing to be approved”).
8. David. B. Conrad, Mining the Patent Thicket: The Supreme Court’s Rejection of the Automatic
Injunction Rule in eBay v. MerchExchange, 26 REV. LITIG. 119, 123 (Winter 2007) (“placing a
dollar sign upon future harm from the continued actions of the defendant is usually very complex,
and often, an uncertain and impossible task”).
9. See infra Part II, Section A; Mark P. Gergen et al., The Supreme Court’s Accidental Revolution?
The Test for Permanent Injunctions, 112 COLUM. L. REV. 203, 204 (2012) (“a permanent injunction
will issue once infringement and validity have been adjudged”).
10. Id. at 205 (describing the eBay decision as having a “cataclysmic effect”).
11. Douglas Ellis et al., The Economic Implications (And Uncertainties) of Obtaining Permanent
Injunctive Relief After eBay v. MercExchange, 17 FED. CIRCUIT B.J. 437, 437 (2008) (“Since the
May 2006 decision, thirty-six district court decisions, including the remand in the eBay case, have
applied the Court's decision. The net result has been diminished power for patent holders and
increased uncertainties for licensing parties and litigants.”).
12. eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388, 391 (2006).
13. Id.


https://law.siu.edu/_common/documents/law-journal/articles-2018/spring-2018/9%20-%20Halterman%20-%20sm.pdf