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B. Federal Circuit Review of PTAB Decisions While the procedures instituted by the AIA could contribute significantly to the sound administration of patent law, enjoying the benefits will depend heavily [...]

Passage of the America Invents Act of 2011 (AIA) (1) inaugurated three new procedures for challenging patents in the U.S. Patent and Trademark Office (PTO). Inter partes review (IPR) supplements [...]

TABLE OF CONTENTS INTRODUCTION I. THE STATUTORY FRAMEWORK A. Pharmaceutical Patents and The Hatch-Waxman Act B. New Administrative Proceedings Created by the America Invents Act II. CURRENT STATUTORY FORFEITURE PROVISIONS [...], Congress created the unique Hatch-Waxman framework in 1984 to increase the availability of low-cost generic drugs while preserving patent incentives for new drug development. The Hatch-Waxman Act rewards generic drug companies that successfully challenge a pharmaceutical patent: 180 days of market exclusivity before any other generic firm can enter the market. When a generic firm obtains this reward, sometimes drug developers agree to pay generic firms to delay entering the market. These pay-for-delay agreements give rise to exclusivity parking and run counter to congressional intent by delaying full generic drug competition. The Medicare Prescription Drug, Improvement, and Modernization Act created several statutory forfeiture provisions that proved only marginally effective at curbing the practice of exclusivity parking. More recently, Congress created new quasi-judicial administrative proceedings that effectively replace certain kinds of district court patent litigation. This Note describes the complex statutory scheme that gave rise to exclusivity parking, explains why previous and current attempts to curtail exclusivity parking were and remain ineffective, and suggests amending the 'failure to market' provision to include these new administrative proceedings as a way to help curb exclusivity parking.

INTRODUCTION I. THE EVOLUTION OF THE FEDERAL CIRCUIT A. An Overview B. The Increasing Volume of Patent Appeals C. The Changing Character of Patent Litigation D. A Change in Who [...]

TABLE OF CONTENTS INTRODUCTION I. THE NPE OR "PATENT TROLL" II. THE COST OF LITIGATION III. LIKELIHOOD OF SUCCESS IV. FEDERAL RULE OF CIVIL PROCEDURE 20(A)(2): PERMISSIVE JOINDER OF PARTIES [...], To stem the rising tide of patent suits brought by non-practicing entities (NPEs), Congress enacted the anti-joinder provisions of the Leahy-Smith America Invents Act (AIA) while, at nearly the same time, the Federal Circuit issued a series of decisions making it easier for defendants to transfer multi-defendant cases filed by NPEs away from the Eastern District of Texas. The unexpected result of these initiatives, however, has been that NPEs have selected the District of Delaware as their new 'forum of choice,' making it the most popular forum for patent litigation in the country and displacing the Eastern District of Texas.

This Article examines the unique dialogic relationship that exists between the Supreme Court and Congress concerning patent law. In most areas of the law, Congress and the Supreme Court engage [...]

1. Judicial Dialogue: Grants and Denials of Certiorari The Federal Circuit is sufficiently interested in Supreme Court review of its cases that, at times, the court has attempted to influence [...]

I. INTRODUCTION II. GENERAL COMPARISON OF THE UNITED STATES AND CHINESE PATENT LAW A. Origin and History of Chinese Patent Law B. Basic Principles of United States Patent Law III. [...]

I. Introduction II. THE REGULATORY HISTORY OF BIOLOGICS IN THE UNITED STATES A. The Biologic Control Act of 1902 B. The Pure Food and Drug Act and the Federal Food, [...]

TABLE OF CONTENTS I. Introduction II. Inequitable Conduct and the Duty of Disclosure: Recent Developments A. The Law of Inequitable Conduct 1. Inequitable Conduct Doctrine before Therasense 2. Inequitable Conduct [...], The duty to disclose material information to the United States Patent and Trademark Office under 37 C.F.R. § 1.56 (Rule 56) is a critical requirement when prosecuting a patent application in the United States. The failure to disclose information can result in a later ruling of inequitable conduct rendering the patent unenforceable. The Federal Circuit's en banc decision in Therasense heightened the 'materiality' and 'intent' standards for finding inequitable conduct. However, there has been much uncertainty in the patent community regarding the future of the duty of disclosure under Rule 56. The majority in Therasense theorized that curing the 'plague' of inequitable conduct would solve the over-disclosure problem faced by the Patent Office. Others, including the dissent in Therasense, argue that without the threat of inequitable conduct, patent applicants and practitioners will ignore their duty to disclose and the information gap between the Patent Office and applicants will widen; this will result in further impaired patent quality. The supplemental examination provision in the America Invents Act (AIA), a legislative cure for the proliferation of inequitable conduct charges, has heightened the concern among critics that information submission to the Patent Office will dwindle. The Therasense Court's answer to the over-disclosure problem and the concerns raised by critics are premised on the notion that inequitable conduct and the duty of disclosure always go in tandem. However, inequitable conduct and the duty of disclosure are not inseparably tied; and, changes in the inequitable conduct landscape may not have a significant effect on information disclosure practice before the Patent Office. First, despite the tightening of the inequitable conduct standard, information submission to the Patent Office will likely not decrease from the pre-Therasense level. This is because there are many other incentives within the patent system for applicants and practitioners to continue to err on the side of overdisclosure. Second, supplemental examination will not sound the death knell for the duty of disclosure. This is because patentees are not likely to use this provision to purge willful omissions or misrepresentations from the examination record. And third, overdisclosure is likely to remain a problem for the Patent Office and needs to be addressed in other ways. This Article concludes with suggestions for the Patent Office to consider on how to rein in overdisclosure, while encouraging applicants and practitioners to be forthcoming with information relevant to patent examination.

B. Force-of-Law Prerequisite This Section examines whether the congressional conferral of formal adjudicatory powers to the PTO is sufficient to infer that the Agency has the ability to speak with [...]

Whereas Congress has increasingly turned to administrative agencies to regulate complex technical areas, the patent system has remarkably remained an outlier. In the patent arena, the judiciary--not a federal agency--is [...]