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Genus Medical Technologies LLC v. FDA: D.C. Circuit Holds FDA Cannot Regulate Devices as Drugs | King & Spalding

FDA regulation of biomedical products can be like a very complex game theory decision tree. Choices made at each intersection impact the ultimate regulatory framework under which any.

Contrast Media Injectors Market likely to grow at over 4.9 % through 2030

Contrast Media Injectors Market likely to grow at over 4.9 % through 2030
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Bracco Diagnostics Inc. v. Maia Pharmaceuticals, Inc. (Fed. Cir. 2020) | McDonnell Boehnen Hulbert & Berghoff LLP

    (f) a buffer. [Wherein the italicized limitations were relevant to the District Court s claim construction and this appeal.] Maia s products contain amino acids in addition to the synthetic peptide hormone, which Bracco contended satisfy the buffer, surfactant and/or solubilizer limitations recited in the claims.  The issue thus resolved as whether these claim limitations encompassed amino acids.  One aspect of the District Court s construction was that dependent claims recited Markush groups for these limitations that contained amino acids for each.  Another aspect was that the specification recited particular definitions of these terms that encompassed amino acids within their scope.  These characteristics of the specification formed the basis for the District Court s construction of the terms buffer, surfactant, and solubilizer to include amino acids (among in each instance many other species).  Following claim construction, Maia stipulated infringemen

Last Week in the Federal Circuit (December 14-18): And/or confusion | Morrison & Foerster LLP - Federal Circuitry

You should read this case if: grammar gets you going Does “X/Y” mean “X and Y,” “X or Y,” or both?  The Federal Circuit took on the meaning of a slash in our case of the week. The case concerns drug patent claims referring to “a surfactant/solubilizer.”  Whether the defendant infringed the patent turns in part on the meaning of the slash.  According to the accused infringer, the slash means “and”:  To be “a surfactant/solubilizer,” a substance must be both a surfactant and a solubilizer.  According to the patentee, the slash captures both “and” and “or”:  To be “a surfactant/solubilizer,” a substance can be a surfactant

FDA Approves Bracco Diagnostic Inc.'s ProHance® (Gadoteridol) Injection, 279.3 mg/mL, for Pediatric Patients Younger than Two Years

FDA Approves Bracco Diagnostic Inc.'s ProHance® (Gadoteridol) Injection, 279.3 mg/mL, for Pediatric Patients Younger than Two Years
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