IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
Specify the Steps of Information Manipulation or Lose under § 101 - In Mobile Acuity Ltd. v. Blippar Ltd. Appeal No. 22-2216, the Federal Circuit held that patent claims that merely recite result-orientated, functional...more
On August 13, 2024, the Federal Circuit issued its decision in Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 24-1061, which limits the scope of obviousness-type double patenting for patents in the same family. The...more
On July 24, in United Therapeutics Corporation v. Liquidia Technologies, Inc., the Federal Circuit addressed whether safety and efficacy are required for pharmaceutical method claims to be sufficiently enabled and supported...more
Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more
Last month, the Federal Circuit affirmed decisions from four separate trials in the District of Delaware involving seven different defendants regarding validity and infringement of patents directed to an opioid addiction...more
The Federal Circuit recently reversed a lower court’s ruling of validity under the § 112 written description requirement effectively opening the door for a number of generic drug manufacturers to enter the market with a...more
A Post-URAA Patent that Issues After but Expires Before a Related Pre-URAA Patent Is Not a Double-Patenting Reference Against the Pre-URAA Patent - In Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc.,...more
This month, we highlight significant developments in May 2018, including a stunning reverse payment decision at the FTC, draft guidance from the FDA intended to curb REMS “abuses,” and case law developments at the Federal...more
Federal Circuit Summary - Before NEWMAN, DYK, and STOLL. Appeal from the Northern District of California. Summary: A consumer of a patented product has no standing under the Declaratory Judgment Act to challenge the...more
On June 20, 2016, the full Federal Circuit denied Mylan’s petitions for rehearing en banc in Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 817 F.3d 755 (Fed. Cir. 2016), leaving intact the panel’s decision affirming two...more