Tagged: FDA

Federal Appeals Court Directs FDA to Treat Reissue Patents as Separate and Distinct When Determining Eligibility for Pre-MMA 180-Day Exclusivity 0

Federal Appeals Court Directs FDA to Treat Reissue Patents as Separate and Distinct When Determining Eligibility for Pre-MMA 180-Day Exclusivity

In Mylan Pharm., Inc. v. FDA, generic drug manufacturer Mylan Pharmaceuticals, Inc. (“Mylan”) challenged an FDA letter decision describing the agency’s treatment of original and reissue patents as “a single bundle of patent rights” when determining eligibility for 180-day exclusivity under the Hatch Waxman Act (pre-MMA). The United States District Court for the Northern District of West Virginia deferred to the FDA’s interpretation of the statute under step 2 of Chevron U.S.A. Inc. v. Natural Res. Def. Council, Inc..

The FDA Releases New Draft Guidance for Demonstrating Biosimilarity 0

The FDA Releases New Draft Guidance for Demonstrating Biosimilarity

On May 13, the Food and Drug Administration released a new draft guidance on the data needed to establish that a proposed therapeutic biological product is biosimilar to an approved reference product. This new guidance gives sponsors a roadmap, detailing the procedures needed to demonstrate biosimilarity between a proposed drug candidate and a reference product, and highlighting the types of data needed to support such a demonstration.

Mutual Pharmaceutical Co., Inc. v. Bartlett 0

Mutual Pharmaceutical Co., Inc. v. Bartlett

The generic pharmaceutical industry faced a Catch-22 when a serious adverse reaction arose from use of a generic drug product, and the manufacturer was restrained from unilaterally amending the product label to conform to state requirements, due to the Supreme Court’s decision in PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011). PLIVA held that state requirements to change a label are pre-empted by the Federal Food, Drug and Cosmetic Act’s prohibition of changing labeling without authorization by the FDA.