“Out of the 230 Orange Book patents challenged in IPR proceedings, 90.4% (208) of these patents were also challenged in Hatch-Waxman litigation…” More than three decades ago, Congress enacted the ...
The modern regime for balancing innovation and competition in pharmaceuticals was established through the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman ...
After a clutch of lawmakers last month challenged “sham patents” registered with the FDA’s Orange Book—the registry for patents of approved drugs—the Federal Trade Commission (FTC) is getting in on ...
Earlier this year, two new laws were enacted that impact patent listings in the Orange Book (drugs) and Purple Book (biologics). The Orange Book Transparency Act primarily codifies current FDA ...
Inter partes review has changed the patent dispute landscape and strategy, and important insights can be gained from the data, explain Corinne Atton of Venable and consultant April Breyer Menon Inter ...
Expansion to FTC’s Orange Book Campaign Leads to Calls for More Clarity from Pharmaceutical Industry
“The FTC acts as if the agency is being perfectly clear on what it’s subjecting companies to, but there’s never been a conversation around what it means for a patent to claim a drug product.” – Hans ...
The tension between regulatory compliance and antitrust exposure in Orange Book patent listings reached a dramatic inflection point this fall. In late October, Teva Pharmaceuticals agreed to pay $35 ...
The FTC’s plans to scrutinise improperly listed Orange Book patents could make these listings more important in litigation, but firms should be looking at this anyway A recent policy statement from ...
CHICAGO--(BUSINESS WIRE)--Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative ...
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