A proposed rule — pending comments by May 28, 2013 — from the U.S. Food and Drug Administration could place significant burdens on sponsors who conduct foreign clinical studies and applicants who plan to use data from such studies to support investigational device exemption applications and premarket submissions, say attorneys with King & Spalding LLP.
Given Justice Elena Kagan’s remark that this case is within the four corners of Mensing and the discomfort demonstrated by the other justices with Bartlett’s position, it seems unlikely that the First Circuit decision in Mutual Pharmaceuticals v. Bartlett will stand, say attorneys with Morrison & Foerster LLP.
Justice Stephen Breyer had put the legal field on notice that the U.S. Supreme Court was paying attention to patent eligibility in Lab. Corp. in 2006 — well before seemingly eliminating medical diagnostic patents with Prometheus. With Myriad V to be heard this term, the Supreme Court may further impact the future of patents supporting this field, as it addresses the patentability of isolated DNA sequences, say John Cox and Joseph Vandegrift of Alston & Bird LLP.
Following the Second Circuit’s ruling in U.S. v. Caronia, two recent developments, the Par Pharmaceutical Companies Inc. settlement and the Ninth Circuit's affirmation of Scott Harkonen's conviction, demonstrate a shift in the battleground for First Amendment challenges to the prohibition on off-label promotion under the federal Food, Drug and Cosmetic Act, say attorneys with King & Spalding LLP.
On March 25, the U.S. Supreme Court heard oral argument in Federal Trade Commission v. Actavis Inc. The justices appeared likely to issue a narrow ruling, not a broad one that would satisfy the FTC or fully resolve all the issues in the "pay-for-delay" area, say Thane Scott and Hill Wellford of Bingham McCutchen LLP.
Despite recession-driven cost pressures that have resulted in the downsizing of nonlawyer personnel at law firms, many litigation support departments are growing. In a recent survey, half of respondents indicated that their function has grown in size in the past three years, and more than half of respondents indicated that current staffing levels are inadequate for the projected needs of the coming year, say experts at Epiq Systems and Georgetown University Law Center.
This term marks a continuation of the Roberts court trend of close attention to business issues. From affirmative action and class actions to tort litigation, government enforcement and intellectual property, almost one half of this term’s argued cases are of interest to the business community, say Cliff Sloan and David Foster of Skadden Arps Slate Meagher & Flom LLP.
As of late, two big stories have made headlines in the food industry: the horse meat scandal in Europe and the indictment against the Peanut Corp. of America on a salmonella outbreak. Both cases warrant close examination to understand how quickly a company can become ensnared in a public relations nightmare and how to handle an investigation once it starts, say attorneys with Davis Wright Tremaine LLP.
The unanimous U.S. Supreme Court decision in Standard Fire Insurance Co. v. Knowles will be praised by class action defense counsel as comporting with the congressional intent of the Class Action Fairness Act and ramifying the pleading strategies used by putative class representatives to maximize the litigation leverage of the "Frankenstein's monster" created by class actions, say attorneys with Fulbright & Jaworski LLP.
Meso Scale Diagnostics v. Roche Diagnostics, a case of first impression in Delaware, will likely be viewed with relief by corporate practitioners because it both resolves the ambiguity created by an earlier ruling in this same case and because it sits in stark conflict with two previous federal district court opinions in California and New Jersey, say attorneys with Ropes & Gray LLP.