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Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane
Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane
Michigan Telecommunications & Technology Law Review
Under the Hatch-Waxman Act, patent law and FDA regulation work together to determine the timing of generic entry in the market for drugs. But FDA has sought to avoid any responsibility for reading patents, insisting that its role in administering the patent provisions of the Hatch-Waxman Act is purely ministerial. This gap in regulatory oversight has allowed innovators to use irrelevant patents to defer generic competition. Meanwhile, patent litigation has set the stage for anticompetitive settlements rather than adjudication of the patent issues in the courts. As these settlements have provoked antitrust litigation, antitrust courts have proven no more willing …
Pharmaceutical Patent Litigation Settlements: Balancing Patent & Antitrust Policy Through Institutional Choice, Timothy A. Cook
Pharmaceutical Patent Litigation Settlements: Balancing Patent & Antitrust Policy Through Institutional Choice, Timothy A. Cook
Michigan Telecommunications & Technology Law Review
Should a branded pharmaceutical company be allowed to pay a generic competitor to stay out of the market for a drug? Antitrust policy implies that such a deal should be prohibited, but the answer becomes less clear when the transaction is packaged as a patent-litigation settlement. Since Congress passed the Hatch-Waxman Act, which encourages generic manufacturers to challenge pharmaceutical patent validity, settlements of this kind have been on the rise. Congress, the Department of Justice, and the Federal Trade Commission have condemned these agreements as anticompetitive and costly to American consumers, but none of these bodies has been able to …
The Applicability Of The Antitrust Procedures And Penalties Act Of 1974 To Voluntary Dismissals, Jon B. Jacobs
The Applicability Of The Antitrust Procedures And Penalties Act Of 1974 To Voluntary Dismissals, Jon B. Jacobs
University of Michigan Journal of Law Reform
This Note argues that Congress should amend the APPA to require a judicial public interest determination prior to the entry of a voluntary dismissal in government-initiated civil antitrust actions. Part I of this Note briefly describes the APPA and Federal Rule of Civil Procedure 41(a)(1). Part II asserts that APPA procedures do not currently apply to voluntary dismissals under Rule 41(a)(1). Part III concludes that the purposes underlying the APPA and general policy considerations support the legislative extension of the Act to dismissals. Part IV responds to objections to this proposal. Finally, Part V presents a specific amendment to the …
The Scope Of Judicial Review Of Consent Decrees Under The Antitrust Procedures And Penalties Act Of 1974, Michigan Law Review
The Scope Of Judicial Review Of Consent Decrees Under The Antitrust Procedures And Penalties Act Of 1974, Michigan Law Review
Michigan Law Review
In the wake of this uncertainty, this Note analyzes the proper scope of judicial review of consent decrees. The Note argues that to further the policies embodied in the APP A, courts should undertake intense review of proposed settlements before entering them as final judgments. Both the congressional intent in enacting the APP A and the public's interest in effective enforcement of the antitrust laws support intense judicial review. The Note then demonstrates that the deferential standard that some courts have applied is derived mainly from a case that is inapplicable to the review of consent decrees. Finally, the Note …