News & Analysis as of

FDA Approval Generic Drugs Federal Food Drug and Cosmetic Act (FFDCA)

Axinn, Veltrop & Harkrider LLP

FTC Peeling Back the Layers of the Orange Book

The Federal Trade Commission (FTC) is continuing to pursue pharmaceutical manufacturers for allegedly improperly listing patents in the “Orange Book,” delaying the entry of generic drug competitors. On May 21, the FTC...more

Nutter McClennen & Fish LLP

Product Liability 2018 Year in Review

Massachusetts state and federal courts issued a number of important product liability decisions in 2018. The Product Liability practice group at Nutter recently reviewed these cases. Highlighted below are some of the key...more

Jones Day

ITC Institutes Investigation Based on Allegation of Drug Sales Without FDA Approval

Jones Day on

Normally, it is the FDA that monitors the improper distribution of drugs. But, as it turns out, the International Trade Commission (“ITC”) might be able to enter the fray too. On April 18, 2018, the ITC issued a notice...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Patent Term Extension Considerations for BioPharma Patents

Time spent on securing marketing approval for regulated products, such as pharmaceuticals, medical devices and agrochemicals effectively shortens the term of patent protection during which an innovator can recover its...more

Foley & Lardner LLP

Can FDA Implement The BPCIA As The CAFC Suggested?

Foley & Lardner LLP on

In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more

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