Mylan v. Warner Chilcott: A Study in Pharmaceutical Product Hopping
Mylan v. Warner Chilcot : A Study in Pharmaceutical Product Hopping
Vikram Iyengar
Follow this and additional works at: http://scholarship.law.marquette.edu/iplr Part of the Intellectual Property Commons Repository Citation Vikram Iyengar, Mylan v. Warner Chilcott: A Study in Pharmaceutical Product Hopping, 19 Marq. Intellectual Property L. Rev. 245 (2015). Available at: http://scholarship.law.marquette.edu/iplr/vol19/iss2/5
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MYLAN V. WARNER CHILCOTT: A STUDY IN
PHARMACEUTICAL PRODUCT HOPPING
VIKRAM IYENGAR*
INTRODUCTION ..............................................................................................249
I. THE HATCH-WAXMAN REGULATORY FRAMEWORK AND PRODUCT
HOPPING..............................................................................................250
A. The Hatch-Waxman Act ................................................................251
1. Abbreviated New Drug Application Procedure.......................251
2. Patent Suits and ANDA Stays .................................................252
B. State Drug Substitution Laws.........................................................253
C. Pharmaceutical Product Hopping...................................................253
II. WARNER CHILCOTT’S MOTION TO DISMISS..............................................255
A. Mylan’s Complaint ........................................................................255
B. Defendant’s Motion to Dismiss......................................................255
C. The Court’s Order ..........................................................................256
III. LEGAL BACKGROUND FOR REGULATORY GAMING IN
PHARMACEUTICALS ............................................................................258
A. Patent Settlements ..........................................................................258
B. Product Hopping Caselaw..............................................................259
IV. MANIPULATION OF THE HATCH-WAXMAN REGULATORY
FRAMEWORK.......................................................................................260
A. Was Mylan’s Generic Entry Free-Riding?....................................261
B. The Effect of Product Hopping on the Hatch-Waxman
Compromise.................................................................................263
C. Withdrawal of Older Branded Versions in Mylan .........................264
CONCLUSION..................................................................................................266
* Dr. Vikram Iyengar is a JD candidate at Stanford Law School. The author thanks Professor
Phil Malone for supervising the amicus brief that led to this article. The author also thanks Professor
Mark Lemley and Professor Peter Menell for deepening his appreciation of IP and Antitrust Law, and
Professor Tim Iglesias for sharpening his understanding of Property Law. Finally, the author is
grateful to Professor Hank Greely for his helpful comments on this article.
MARQ. INTELL. PROP. L. REV.
Dr. Vikram Iyengar is a JD candidate at Stanford Law School, where he
conducts research in intellectual property and antitrust law. He holds a PhD in
Electrical & Computer Engineering from Duke University and a Masters in
Computer Engineering from Boston University. Before law school, he
conducted engineering research at IBM and designed circuits for the Watson
supercomputer, internet routers, and smartphones. Dr. Iyengar is an inventor
on eighteen U.S. patents.
MARQ. INTELL. PROP. L. REV.
INTRODUCTION
On June 11, 2013, a district court in the Eastern District of Pennsylvania
denied Defendant Warner Chilcott’s motion to dismiss in the ongoing
pharmaceutical litigation suit, Mylan Pharmaceuticals, Inc. v. Warner
Chilcott Public Limited Co.1 The Plaintiff in the suit, Mylan Pharmaceuticals,
alleged that when Warner Chilcott “switched the market” for their acne drug,
Doryx, from tablets to capsules, solely to avoid generic competition, it
engaged in “product hopping” and broke the antitrust laws.2 In its order,
denying Warner Chilcott’s motion-to-dismiss, the court stated that because
the defendant’s antitrust defense required it to consider facts that were well
outside the complaint, it could not address the defendant’s arguments
“without going beyond the pleadings.”3
However, although the court denied Warner Chilcott’s motion to dismiss,
its characterization of Mylan’s product hopping theory as “‘novel’ at best”
and failing to state “an antitrust injury”4 is troubling in light of the precedent.
While the “court’s dismissal decision” sends a “promising sign to those who
oppose antitrust scrutiny” of regulatory gaming in general and product
hopping in particular, it “does little to clarify the law.”5 Moreover, the court’s
stance on product hopping can have grave consequences for consumers,
health care plans, and the government if the court ultimately refuses to submit
Warner Chilcott’s conduct to antitrust scrutiny.
In this Note, I explain how product hopping—making non- (...truncated)