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Full-Text Articles in Law
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. …
Patent Infringement As Criminal Conduct, Jacob S. Sherkow
Patent Infringement As Criminal Conduct, Jacob S. Sherkow
Michigan Telecommunications & Technology Law Review
Criminal and civil law differ greatly in their use of the element of intent. The purposes of intent in each legal system are tailored to effectuate very different goals. The Supreme Court's recent decision in Global-Tech Appliances, Inc. v. SEB S.A., 131 S. Ct. 2060 (2011), however, imported a criminal concept of intent--willful blindness--into the statute for patent infringement, a civil offense. This importation of a criminal law concept of intent into the patent statute is novel and calls for examination. This Article compares the purposes behind intent in criminal law with the purposes behind intent in patent law to …
The Accession Insight And Patent Infringement Remedies, Peter Lee
The Accession Insight And Patent Infringement Remedies, Peter Lee
Michigan Law Review
What is the appropriate allocation of rights and obligations when one party, without authorization, substantially improves the property of another? According to the doctrine of accession, a good faith improver may take title to such improved property, subject to compensating the original owner for the value of the source materials. While shifting title to a converter seems like a remarkable remedy, this outcome merely underscores the equitable nature of accession, which aims for fair allocation of property rights and compensation between two parties who both have plausible claims to an improved asset. This Article draws upon accession-a physical property doctrine …
Teva V. Eisai: What's The Real Controversy, Grace Wang
Teva V. Eisai: What's The Real Controversy, Grace Wang
Michigan Telecommunications & Technology Law Review
This Note examines the changing role of declaratory judgment actions in challenging patents upon generic entry and evaluates alternative regulatory schemes to the FDA's current system of patent enforcement in the drug approval setting. Part I reviews the Federal Circuit's recent decisions regarding generic drug entry, focusing on how the courts justify declaratory judgments in the current system and when a "controversy" exists to create Article III jurisdiction. Part II examines the complex system of regulating generic drug entry and how attempts to stop the exploitation of loopholes have resulted in a patchwork of regulation by various parties. It challenges …
Pharma's Nonobvious Problem, Rebecca S. Eisenberg
Pharma's Nonobvious Problem, Rebecca S. Eisenberg
Articles
This Article considers the effect of the recent decision of the U.S. Supreme Court in KSR International Co. v. Teleflex, Inc. on the nonobviousness standard for patentability as applied to pharmaceutical patents. By calling for an expansive and flexible analysis and disapproving of the use of rigid formulas in evaluating an invention for obviousness, KSR may appear to make it easier for generic competitors to challenge the validity of drug patents. But an examination of the Federal Circuit's nonobviousness jurisprudence in the context of such challenges reveals that the Federal Circuit has been employing all along the sort of flexible …
Why Pharmaceutical Firms Support Patent Trolls: The Disparate Impact Of Ebay V. Mercexchange On Innovation, Jeremiah S. Helm
Why Pharmaceutical Firms Support Patent Trolls: The Disparate Impact Of Ebay V. Mercexchange On Innovation, Jeremiah S. Helm
Michigan Telecommunications & Technology Law Review
Before the unanimous decision in eBay v. MercExchange, patent holders were almost always granted an injunction against an infringer. In fact, the Federal Circuit, in deciding eBay, noted that, upon a finding of infringement, an injunction would issue unless there were extraordinary circumstances. The Court, in a brief opinion, disagreed with the Federal Circuit and explained that the injunction issue in a patent case must be analyzed under the traditional four-factor test.[...] Is the four-factor test fairer or better than the Federal Circuit's near-automatic injunction rule? It is certainly more difficult to administer a factor test as compared to a …
Arising Under Jurisdiction And Uniformity In Patent Law, Christopher A. Cotropia
Arising Under Jurisdiction And Uniformity In Patent Law, Christopher A. Cotropia
Michigan Telecommunications & Technology Law Review
The law governing the Federal Circuit's appellate jurisdiction was brought into question in Holmes Group, Inc. v. Vornado Circulation Systems, Inc. The Federal Circuit's appellate jurisdiction over Vornado's appeal rested solely on Vornado's counterclaim alleging patent infringement by Holmes. Holmes's complaint sought a declaratory judgment of no trade dress infringement and did not include any patent law claims. While the Federal Circuit found appellate jurisdiction over Vornado's appeal based on the counterclaim of patent infringement, the Supreme Court disagreed. The Court focused on the language in 35 U.S.C. § 1338(a), which defines the Federal Circuit's appellate jurisdiction by the statute's …
The Patentability Of A Principle Of Nature, John B. Waite
The Patentability Of A Principle Of Nature, John B. Waite
Articles
The extent to which courts will go in conceding patentability to a natural law, or principle of nature, is evidenced in the case of Minerals Separation Co. v. Hyde, 37 Sup. Ct. -, decided by the Supreme Court, December 11, 1916. It has always been more or less an axiom of patent law that the discovery of a principle of nature does not entitle the discoverer to a patent for it. The case usually thought of first as authority therefor, is that of Morton v. New York Eye Infirmary, 5 Blatch. 116, 2 Fisher 320. The patentees in that case …