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REMS Patents

Foley & Lardner LLP

Revisiting FDA’s Original Guidance on Orange Book Listability in Light of Heightened FTC Scrutiny

Foley & Lardner LLP on

The listing of many types of patents in the FDA’s Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is fairly straightforward. Patents covering the approved drug product (active pharmaceutical...more

McDermott Will & Emery

Patent Law Principles Apply to Claim Scope: Orange Book Delisting and Listing and Regulations

The US Court of Appeals for the Federal Circuit ordered that the only Orange Book patent asserted in a lawsuit must be delisted since its claims were directed to the computer-implemented distribution system and not a method...more

Mintz - Intellectual Property Viewpoints

Federal Circuit Affirms Delisting of REMS System Patent from FDA Orange Book

On February 24, 2023, the U.S. Court of Appeals for the Federal Circuit, in Jazz Pharmaceuticals, Inc., v. Avadel CNS Pharmaceuticals, LLC, Case No. 23-1186, affirmed a decision from the District Court of Delaware directing...more

Tarter Krinsky & Drogin LLP

Protecting Against Big Pharma's Tactics for Delaying Market Entry of Generics

Branded companies make millions of dollars each day that a generic version of a drug is held from the market. Therefore, the branded companies are highly motivated to obstruct the path of generic pharma companies. For some...more

Robins Kaplan LLP

REMS and Antitrust: Latest Litigation Lessons

Robins Kaplan LLP on

Brand name pharmaceutical companies have long stood in the way of generic pharmaceuticals entering the market. To keep generics at bay, brands have used a variety tactics, including ultimately unlawful ones like fraudulently...more

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