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Federal court limits FDA discretion in “drug” vs. “device” classification

The U.S. Court of Appeals for the D.C. Circuit recently decided in Genus Medical Technologies LLC v. U.S. Food and Drug Administration that, when classifying a biomedical product as either...


Biden signs bill limiting new drug exclusivity awards to innovations in active moiety

On April 23, U.S. President Biden signed into law two bills meant to lower prescription drug prices by limiting new drug exclusivity awards and promoting biosimilars. The Ensuring...

Hogan Lovells Publications

Life sciences and health care horizons 2021

Companies in the life sciences and health care industry navigated unparalleled challenges in 2020. The pandemic forced the development and adoption of new technologies and innovations...


New Orange & Purple Book laws increase transparency of patent information for drugs, biologics

On January 5, 2021, President Trump signed into law H.R. 1503, the "Orange Book Transparency Act of 2020," which amends provisions governing the types of patents and...


Labeling carve-out does not shield generic drug makers from induced infringement claims, CAFC rules

The U.S. Court of Appeals for the Federal Circuit (CAFC) recently decided (2-1) in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. that a labeling carve-out by a generic drug...


FDA quietly withdraws plans for a Devices Referencing Drugs regulatory approval pathway

The U.S. Food and Drug Administration recently withdrew its plans for a “Devices Referencing Drugs” (DRD) regulatory approval pathway, which it had proposed in September 2017....


HHS announces public meeting on ways to accelerate clinical innovation

Government seeks industry comment on expediting medical product development.


FDA guidance may ease path to biosimilar interchangeability Focus On Regulation

On 10 May 2019 the U.S. Food and Drug Administration (FDA) published the final guidance, "Considerations in Demonstrating Interchangeability With a Reference Product," which is intended to...

Hogan Lovells Publications

FDA to consider patent listing, therapeutic equivalence, and other Orange Book issues; agency will issue draft guidance documents, seek public comment Focus On Regulation

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will take to ensure that the Orange Book (FDA's publication of Approved Drug...

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