News & Analysis as of

GPhA Issues Statement Regarding Proposed IP Provisions of Trans-Pacific Partnership Agreement

The Generic Pharmaceutical Association (GPhA) issued a statement today regarding ongoing talks between major Pacific Rim countries (including the U.S.) related to the proposed Trans-Pacific Partnership Agreement. This trade...more

Supreme Court Rejects ‘Stop-Selling’ Argument in Conflict Preemption Cases

In a 5-4 decision, the U.S. Supreme Court rejected the notion that a manufacturer’s option to stop selling its product resolves preemption concerns raised by conflicting state and federal laws....more

Supreme Court Rules That “Pay for Delay” Generic Drug Patent Settlements Are Not Shielded From Antitrust Liability

The Supreme Court has held that the antitrust laws may forbid patent settlements that delay the market entry of generic drugs in return for large payments from manufacturers of competing branded drugs....more

Key Recommendations From The Australian Pharmaceutical Patents Review

The Australian Government has continued with the trend of reviewing Australian patent law by commissioning a review of laws relating to patents for medicines ie pharmaceutical patents. The Pharmaceutical Patents Review Panel...more

A Narrow Exception To The Mensing Preemption Defense

The Sixth Circuit recently held that a failure-to-warn claim could proceed against a generic manufacturer that had failed to timely follow the brand-name label. Fulgenzi v. Pliva Inc., Case No. 12-3504 (6th Cir. March 13,...more

Breaking Down The Bartlett Oral Argument

The U.S. Supreme Court has heard oral argument in the much-anticipated Mutual Pharmaceuticals v. Bartlett case, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). The...more

Supreme Court Oral Argument in FTC v. Actavis

The Supreme Court heard oral argument in Federal Trade Commission v. Actavis (the caption for what was Federal Trade Commission v. Watson Pharmaceuticals, Inc. in the 11th Circuit opinion below) last Monday, with Deputy...more

Driving on Both Sides of the Road: Supreme Court Hears Bartlett Oral Argument

The Supreme Court heard oral argument yesterday in the much-anticipated Mutual Pharmaceuticals v. Bartlett case, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). The...more

In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation (Fed. Cir. 2013)

On the first day of February, the Federal Circuit rejected Impax's efforts to get out from under a preliminary injunction in a case captioned In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation. ...more

Weeks Defies Years of Jurisprudence, Allowing Innovator Liability for Generic Drugs

Last week the Alabama Supreme Court adopted brand-name manufacturer liability for a generic drug sold by another company, becoming the first state supreme court to do so. Wyeth, Inc. v. Weeks, No. 1101397 (Ala. Jan. 11,...more

Stengel Tangles MDA Preemption: Ninth Circuit Decision Creates Split on Buckman Preemption of Post-Market Reporting Requirements

Last week the Ninth Circuit created a new state-law cause of action against medical device manufacturers: “failure to warn the FDA.” The en banc opinion in Stengel v. Medtronic Inc., __ F.3d __, 2013 WL 106144, 13 C.D.O.S....more

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