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 ...

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 ...

AbbVie, AstraZeneca, and GSK are among the 10 companies now under scrutiny by the Federal Trade Commission, which is cracking down on businesses it says improperly or inaccurately placed items on a ...

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 ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

“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 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 ...

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 ...

CHICAGO--(BUSINESS WIRE)--Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...