Food and Drug Law Commons^™

The "Evergreening" Metaphor In Intellectual Property Scholarship, Erika Lietzan

Faculty Publications

This article is a plea for changes in the scholarly dialogue about "evergreening" by drug companies. Allegations that drug companies engage in "evergreening" are pervasive in legal scholarship, economic scholarship, medical and health policy scholarship, and policy writing, and they have prompted significant policymaking proposals. This Article was motivated by concern that the metaphor has not been fully explained and that policymaking in response might therefore be premature. It canvasses and assesses the scholarly literature-more than 300 articles discussing or mentioning "evergreening." It catalogues the definitions, the examples, and the empirical studies. Scholars use the term when describing certain actions …

Citizen Petitions: Long, Late-Filed, And At-Last Denied, Michael A. Carrier, Carl Minniti

American University Law Review

No abstract provided.

Permissible Product Hopping: Why A Per Se Legal Rule Barring Antitrust Liability Is Necessary To Protect Future Innovation In The Pharmaceutical Industry, Michelle L. Ethier

Akron Intellectual Property Journal

Pharmaceutical product hopping is a relatively new phenomenon in which a brand-name pharmaceutical company tactically reformulates a drug and patents the reformulation in an attempt to avoid competition by a generic competitor. When viewed in the context of the HatchWaxman framework, product hopping can effectively eliminate generic competitors from the market, thereby implicating § 2 of the Sherman Act. In addressing antitrust liability, this Note advocates a per se legal approach to product hopping so long as the hop is supported by a valid patent. Although some have argued that deference to the United States Patent and Trademark Office and …

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 …

Pay-For-Delay Settlements In The Wake Of Actavis, Michael L. Fialkoff

Michigan Telecommunications & Technology Law Review

“Pay-for-delay” settlements, also known as reverse payments, arise when a generic manufacturer pursues FDA approval of a generic version of a brand-name drug. If a patent protects the brand-name drug, the generic manufacturer has the option of contesting the validity of the patent or arguing that its product does not infringe the patent covering the brand-name drug. If the generic manufacturer prevails on either of these claims, the FDA will approve its generic version for sale. Approval of a generic version of a brand-name drug reduces the profitability of the brand-name drug by forcing the brand-name manufacturer to price its …

Actavis, The Reverse Payment Fallacy, And The Continuing Need For Regulatory Solutions, Daniel A. Crane

Articles

The Actavis decision punted more than it decided. Although narrowing the range of possible outcomes by rejecting the legal rules at the extremes and opting for a rule of reason middle ground, the opinion failed to grapple with the most challenging issues of regulatory policy raised by pharmaceutical patent settlements. In particular, it failed to clearly delineate the social costs of permitting and disallowing patent settlements, avoided grappling with the crucial issues of patent validity and infringement, and erroneously focused on “reverse payments” as a distinctive antitrust problem when equally or more anticompetitive settlements can be crafted without reverse payments. …

Mergers, Market Dominance And The Lundbeck Case, Herbert J. Hovenkamp

All Faculty Scholarship

In Lundbeck the Eighth Circuit affirmed a district court’s judgment that a merger involving the only two drugs approved for treating a serious heart condition in infants was lawful. Although the drugs treated the same condition they were not bioequivalents. The Eighth Circuit approved the district court’s conclusion that they had not been shown to be in the same relevant market.

Most mergers that are subject to challenge under the antitrust laws occur in markets that exhibit some degree of product differentiation. The Lundbeck case illustrates some of the problems that can arise when courts apply ideas derived from models …

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 …

Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Michael A. Carrier

Michigan Law Review

A tidal wave of high drug prices has recently crashed across the U.S. economy. One of the primary culprits has been the increase in agreements by which brand-name drug manufacturers and generic firms have settled patent litigation. The framework for such agreements has been the Hatch-Waxman Act, which Congress enacted in 1984. One of the Act's goals was to provide incentives for generics to challenge brand-name patents. But brand firms have recently paid generics millions of dollars to drop their lawsuits and refrain from entering the market. These reverse-payment settlements threaten significant harm. Courts nonetheless have recently blessed them, explaining …

A Complete Property Right Amendment, John H. Ryskamp

ExpressO

The trend of the eminent domain reform and "Kelo plus" initiatives is toward a comprehensive Constitutional property right incorporating the elements of level of review, nature of government action, and extent of compensation. This article contains a draft amendment which reflects these concerns.

Bond Repudiation, Tax Codes, The Appropriations Process And Restitution Post-Eminent Domain Reform, John H. Ryskamp

ExpressO

This brief comment suggests where the anti-eminent domain movement might be heading next.