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Offit Kurman

Patents and the FDA: Four Critical Considerations Medical Device Companies Must Know to Successfully Introduce New Products into...

Offit Kurman on

The intersection of patent strategy and FDA regulatory strategy is a critical consideration for medical device companies. A well-integrated approach can create powerful barriers to entry, strengthen intellectual property (IP)...more

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

Patent Prosecution Tool Kit: Patenting the Product Label

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

When the U.S. Food and Drug Administration approves a new drug, it also approves a package insert of the drug, known as a “product label.” A pharmaceutical company marketing a generic product is required to package their...more

Knobbe Martens

Matching Claim Language with Label Language Ensnares Infringers

Knobbe Martens on

On January 12, 2017, the U.S. Court of Appeals for the Federal Circuit issued an opinion affirming the judgement that Eli Lilly’s U.S. Patent No. 7,772,209 (“the ’209 Patent”) was valid and infringed under the doctrine of...more

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