Do Not Pass Go, Do Not Stop for Summary Judgment: The U.S. District Court for the District of Delaware’s Seemingly Disjunctive Yet Efficient Procedures in Hatch-Waxman Litigation

With the multi-billion dollar generic pharmaceutical industry growing annually, litigation under the Hatch-Waxman Act—the legislation that expedited the Food & Drug Administration’s (“FDA”) approval process for generic drugs—can have substantial economic implications on American consumers. Under the Hatch-Waxman Act, a generic drug company can challenge a brand-name pharmaceutical company’s pioneer drug patent(s) in an Abbreviated New Drug Application (“ANDA”) by filing a Paragraph IV certification with the FDA, and the patentee can—and usually does—sue for infringement. The court may find the pioneer drug patent(s) invalid or not infringed by the generic drug, which results in savings to American consumers when the affordable generic drug is eventually brought to market. The United States District Court for the District of Delaware’s four Article III judges hear the majority of cases arising under the HatchWaxman Act. However, unlike other patent-heavy dockets, the District of Delaware does not have uniform local patent rules and very rarely entertains motions for summary judgment in Hatch-Waxman litigation. This article evaluated the District of Delaware’s procedures in handling Hatch-Waxman cases and presents an empirical study of the district’s summary judgment practice in these cases. The empirical study shows that the District of Delaware’s practice is efficient and predictable and not contrary to the purpose behind the Hatch-Waxman Act: to bring more low-cost generic drugs to consumers. Because the district has a bench experienced in patent litigation, the District of Delaware does not need to adopt local patent rules and should continue its current practice of rarely hearing summary judgment motions in ANDA cases. * J.D. candidate, Northwestern University Pritzker School of Law, 2016; B.S. Chemistry, Illinois Wesleyan University, 2012. The author wishes to thank Laura A. Lydigsen, a Shareholder at the firm of Brinks, Gilson & Lione and Northwestern Pritzker Law Professor David L. Schwartz for each of their helpful insights, comments, feedback, and guidance throughout the writing process and the staff and executive board of the Northwestern Journal of Technology & Intellectual Property for their amazing support and patience. N O R T H WE S T E R N J O U R N AL O F T E C H N O L O G Y A N D I N T E L L E C T U A L P R O P E R TY [ 2 0 1 6 82 TABLE OF CONTENTS INTRODUCTION 83 I. BACKGROUND OF THE HATCH-WAXMAN ACT 84 A. ANDA Approval Process 85 B. Purpose and Policy of the Hatch-Waxman Act 86 C. Paragraph IV Certifications 87 II. LOCAL RULES AND SUMMARY JUDGMENT PRACTICE IN THE DISTRICT OF DELAWARE 88 A. The Local Rules: Delaware vs. New Jersey 89 B. The District of Delaware’s Local Rules 89 1. Delaware’s ANDA Procedures and Its Judges’ Idiosyncrasies 90 III. EMPIRICAL STUDY: SUMMARY JUDGMENT PRACTICE IN DELAWARE VS. NEW JERSEY 92 A. Data Collection for the Empirical Study 92 B. The Results of the Study 93 C. Summary Judgment Is Rare in the District of Delaware 95 D. Delaware’s Practice: Disjunctive or Consistent and Predictable? 97 IV. NO NEED FOR DELAWARE TO CHANGE ITS PROCEDURES IN ANDA CASES 98 A. The Purpose and Benefit of Local Patent Rules 98 1. Local Patent Rules Are Not Necessary in Delaware 100 2. The Benefits of Early Disclosure in ANDA Cases 102 B. Is Summary Judgment Proper in ANDA Litigation? 103 1. Summary Judgment Motions Are Not Necessary in ANDA Cases 103 2. Delaware’s Practice Is Consistent with the Purpose of the Hatch-Waxman Act . 106 CONCLUSION 106 Vol. 14:1] Katherine Rhoades