Law Commons^™

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 …

The Rule Of Reason And The Scope Of The Patent, Herbert J. Hovenkamp

All Faculty Scholarship

For a century and a half the Supreme Court has described perceived patent abuses as conduct that reaches "beyond the scope of the patent." That phrase, which evokes an image of boundary lines in real property, has been applied to both government and private activity and has many different meanings. It has been used offensively to conclude that certain patent uses are unlawful because they extend beyond the scope of the patent. It is also used defensively to characterize activities as lawful if they do not extend beyond the patent's scope. In the first half of the twentieth century the …

Anticompetitive Patent Settlements And The Supreme Court's Actavis Decision, Herbert J. Hovenkamp

All Faculty Scholarship

In FTC v. Actavis the Supreme Court held that settlement of a patent infringement suit in which the patentee of a branded pharmaceutical drug pays a generic infringer to stay out of the market may be illegal under the antitrust laws. Justice Breyer's majority opinion was surprisingly broad, in two critical senses. First, he spoke with a generality that reached far beyond the pharmaceutical generic drug disputes that have provoked numerous pay-for-delay settlements.

Second was the aggressive approach that the Court chose. The obvious alternatives were the rule that prevailed in most Circuits, that any settlement is immune from antitrust …

Antitrust And Patent Law Analysis Of Pharmaceutical Reverse Payment Settlements, Herbert J. Hovenkamp

All Faculty Scholarship

Patent settlements in which the patentee pays the alleged infringer to stay out of the market are largely a consequence of the Hatch-Waxman Act, which was designed to facilitate the entry of generic drugs by providing the first generic producer to challenge a pioneer drug patent with a 180 day period of exclusivity. This period can be extended by a settlement even if the generic is not producing, and in any event all subsequent generic firms are denied the 180 day exclusivity period, significantly reducing their incentive to enter.

The Circuit Courts of Appeal are split three ways over such …

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 …

"Per Se Illegality For Reverse Payment Settlements?" Review Of "Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Daniel A. Crane

Reviews

Congratulations to Mike on a very fine book. I will confine my comments to Mike's chapter on patent settlements (Chapter 15), which I understand will also be coming out as an article in the Michigan Law Review. Patent settlements involving "reverse payments" are a huge topic on which I and many others have spilled much ink already. Representative Bobby Rush (President Obama's erstwhile nemesis from Chicago's South Side) has just introduced legislation that would ban reverse payments.' I will not regurgitate my entire spiel on patent settlements here, but instead just try to highlight my essential disagreement with Mike …

Antitrust Immunity, The First Amendment & Settlements: Defining The Boundaries Of The Right To Petition, Raymond Shih Ray Ku

Faculty Publications

Specifically, this Article examines whether settlement agreements and consent decrees resulting from what would otherwise be immunized litigation are protected from antitrust scrutiny and liability under Noerr. In order to conduct this analysis, this Article develops a methodology for determining immunity by focusing the immunity examination upon the means used to petition government and the source of the alleged injuries. Ultimately, private conduct is immune from antitrust scrutiny when it represents a valid attempt to persuade an independent governmental decision-maker in an effort to solicit government action, and the alleged injuries result from that persuasive effort. The validity of any …

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

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 …