Posts Tagged: "labeling"

Seven IP Cases Slated on Supreme Court Oral Argument Calendar

The Court will hear oral argument as follows: on February 26, in two cases on granting (Octane Fitness) and reviewing (Highmark) attorneys’ fee awards; on March 31, in a case (Alice Corp.) on patent eligibility of system and computer-implemented method claims; on April 21, in a case (POM Wonderful) on claims under Section 43 of the Lanham Act challenging labels regulated by the Food and Drug Administration; on April 22, in a case (Aereo) on whether a provider of broadcast television programming over the Internet violates a copyright owner’s public performance right; on April 28, in a case (Nautilus) on the proper standard for finding indefiniteness invalidity for patents; and on April 30, in a case (Limelight) on joint liability for method claim infringement where all of the claimed steps are performed but not by a single entity.

AIPLA

February 25, 2014

Pharma Update July 2013: FDA, Preemption & SCOTUS

The FDA is following through on plans to issue a proposed rule to revise regulations to allow generic drugmakers to update labeling. The rule would update current regulations that prevent generic drugmakers from doing so, even if they become aware of a potential risk not mentioned in labeling. By contrast, brand-name drugamkers can update warnings and precautions on labeling before obtaining FDA approval. Additionally, Merck won an important court ruling for the entire pharmaceutical industry. A federal court decided that, under certain circumstances, drugmakers may defend themselves against product liability lawsuits by citing preemption.

Ed Silverman

July 24, 2013