Mylan v. Warner Chilcott: A Study in Pharmaceutical Product Hopping

Marquette Intellectual Property Law Review, Jul 2015

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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 - 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)


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Vikram Iyengar. Mylan v. Warner Chilcott: A Study in Pharmaceutical Product Hopping, Marquette Intellectual Property Law Review, 2015, pp. 245, Volume 19, Issue 2,