Specificity Sometimes Key; Sometimes Not

By Robert M. Wolin on June 1, 2017 Posted in Uncategorized

Time spent drafting and negotiating an agreement often pays dividends in assuring that each party gets the benefits they desire through the agreement and incurs obligations no greater than they intended. Two recent cases, discussed below, demonstrate how small drafting oversights resulted in significant litigation costs to the parties and in one case, the party’s … Continue Reading

Pharmaceutical Life Cycle Management: Navigating the New IP, FDA, and Antitrust Terrain

By BakerHostetler on February 24, 2016 Posted in Uncategorized

Efforts to extend the life cycle of pharmaceutical products frequently involve innovations and improvements in product design, formulation, route of administration and treatment indications. In addition, negotiation of agreements with competitors, including generic and biosimilar manufacturers, is frequently employed as part of a life cycle management strategy. However, recent changes in patent, regulatory, and antitrust … Continue Reading

FDA Clarifies Orphan Drug Exclusivity Policy Following Court Defeat

By Lee H. Rosebush and Dena Kessler on January 26, 2015 Posted in Uncategorized

On the heels of a loss in federal court last fall, the FDA recently announced a clarification of its policy concerning orphan drug exclusivity. In short, despite a court ruling requiring the FDA to grant orphan drug exclusivity to a drug over the FDA’s objections, the agency announced it will not deviate from the same … Continue Reading