Patent statute court interpretation

District Court for the District of Columbia found the FDA s interpretation of court to be ineonsistent with the statute s plain meaning the FDA was directed to approve an ANDA upon a decision of a district court finding a patent invalid, unenforceable, or not infringed. 

One district court explicitly has held that a brand-name company may not list a metabolite patent in the Orange Book, because the metabolite patent does not claim the drug, as required by the listing statute. " The court looked to the precedent, Hoechst-Roussel Pharms., Inc. v. Lehman, which interpreted the term claims in the Patent Term Restoration portion of the Hatch-Waxman Amendments at 35 U.S.C. 156(a) and concluded that a metabolite patent does not claim the approved dmg product. 

Due to the peculiar wording of the statute, 256 has been interpreted as applying a different standard of correction depending on whether the situation is one of misjoinder or nonjoinder. In the case of misjoinder ( through error a person is named in an issued patent ), the correction may be made even when there was deceptive intent on the part of the misjoined party (the improperly listed inventor).15 In its statutory construction of 256, the Court in Stark v. Advanced Magnetics, Inc. held ... 

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