Alkermes, an innovative drug manufacturer, sought FDA approval to market an injectable drug used for the treatment of schizophrenia. A competitor filed a citizen protest asking FDA to not approve the drug, on the ground that the competitor’s drug had marketing exclusivity that barred approval of the new drug application….
In this case, Goodwin attorneys persuaded the Federal Circuit to reverse a district court decision and find a patent relating to an orally disintegrating tablet formulation of vardenafil (an erectile dysfunction treatment branded as Staxyn) invalid for obviousness. The unanimous Federal Circuit decision held that the district court’s purported credibility…
Goodwin filed a Fourth Circuit amicus brief on behalf of the Chamber of Commerce of the United States of America and American Benefits Council in this ERISA case. Goodwin attorneys argued that the Fourth Circuit’s erroneous loss causation standard created by its prior opinion in this dispute was no longer…
Donnie Johnson brought a petition for habeas relief, seeking to overturn his death sentence. After the district court denied his petition, the Supreme Court decided Martinez v. Ryan, 132 S. Ct. 1309 (2012), and Trevino v. Thaler, 133 S. Ct. 1911 (2013), which raised the possibility that Johnson could be…
Two university researchers accused of research misconduct filed suit against an internationally-renowned university, alleging that the misconduct investigation was conducted in a way that violated state contract and tort law. The Goodwin team obtained a dismissal of the case on the ground that the researchers failed to exhaust their administrative…
The Copyright Act provides protection to the artistic features of useful articles, provided the features can be identified separately from, and are capable of existing independently of, the articles on which they appear. For years, courts had struggled to provide a workable approach to “separability, and the federal courts of…
In the wake of the Supreme Court’s landmark decision in FTC v. Actavis, Goodwin attorneys have been at the forefront of litigating antitrust challenges to settlement agreements between brand and generic pharmaceutical companies. In this case, Goodwin filed an amicus brief on behalf of the Association for Accessible Medicines (formerly…
Goodwin filed an amicus brief on behalf of its client, the Generic Pharmaceutical Association, in this False Claims Act case. Goodwin lawyers argued that the First Circuit’s holding that mere regulatory violations could give rise to a False Claims Act claim could result in massive and disproportionate liability for compliance…
The City of Los Angeles brought a Fair Housing Act suit against a Fortune 50 bank, alleging that defendants violated the Fair Housing Act by originating purportedly predatory loans to minority borrowers since 2004. The Goodwin team won summary judgment on the ground that the City failed to prove an…
In this case, the Supreme Court granted review to reconsider the standard for awarding enhanced damages for patent infringement under 35 U.S.C. § 284. Goodwin attorneys filed an amicus brief in support of neither party, advocating that the Supreme Court retain a willfulness requirement but adopt a more flexible standard…