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Full-Text Articles in Law
Antitrust Analysis After Actavis: Applying The Rule Of Reason To Reverse Payments, Benjamin Miller
Antitrust Analysis After Actavis: Applying The Rule Of Reason To Reverse Payments, Benjamin Miller
Benjamin Miller
Abstract In F.T.C. v. Actavis, Inc. the Supreme Court resolved a circuit split regarding the proper evaluation of reverse payment settlements under federal antitrust law, holding that they must be evaluated under a rule of reason analysis. However, the Court simultaneously created significant uncertainty by declaring that the lower courts were responsible for structuring the analysis. While a few cases are currently in the pre-trial phase, the only decisions relating to reverse payments since Actavis have been rulings on pre-trial motions—there have been no decisions on the merits. Given the intricate intersection between antitrust and intellectual property principles in these …
Pay-For-Delay Settlements In The Wake Of Actavis, Michael L. Fialkoff
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
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. …