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Your search for “patent exclusivity” returned the following results.
…Inc., __ U.S. __, 133 S. Ct. 2223 (June 17, 2013), which dealt with drug patent settlement agreements (aka “reverse payment agreements” or “pay-for-delay agreements”) and the appropriate antitrust analysis…
…causes of action: field preemption, the Excessive Fines Clause, and procedural due process. Because AB 824 does not address the validity of patent law, the Court determined that federal patent…
…of anticompetitive effect on any Paragraph IV patent settlement in which the generic sponsor receives “anything of value,” including an exclusive marketing license or promise not to launch an authorized…
…the request for delay under the statute. Even a biosimilar manufacturer in the midst of invalidating patents in a patent litigation may not be able to make a request given…
…be unclear and may only be clear once a carve-out is challenged in patent litigation. Each patent carve-out, therefore, will be subject to a fact-specific inquiry as to infringement. Due…
…Watson Pharmaceuticals, Inc., and Synthon Holding B.V. notifying them that the Bureau believes the companies violated federal law by failing to inform antitrust authorities about patent agreements involving Sanofi’s insomnia…
…rejected the so-called “scope of the patent test” when considering whether patent settlement agreements violate the antitrust laws, and instead applied a “quick look rule of reason” under which “the…
…bioequivalence requirements for generic VANCOCIN, as well as FDA’s denial of 3-year exclusivity for a VANCOCIN Supplement NDA the Agency approved on December 14, 2011. (Our firm represented ANDA applicant…
…drug exclusivity post-Depomed. Post-Depomed, one issue is whether or not orphan drug exclusivity applies broadly, such that FDA is prohibited from approving any marketing application for a drug containing the…
…and induced infringement liability. First, FDA proposes to amend three-year exclusivity such that exclusivity is awarded only where the new drug applicant is actually seeking exclusivity and where the data…
…amendment proposed to terminate marketing exclusivity for drugs and biologics if the person to which such exclusivity was granted or any person to which such exclusivity is assigned commits certain…
…AstraZeneca later in the day on Tuesday in the form of a Letter Decision in which FDA also addressed labeling carve-out and three-year exclusivity issues, stating: AstraZeneca identified three portions…
…(or reward) new product development by offering an incentive different from the standard grants of patent and non-patent marketing exclusivities (including incentives that merely stack new exclusivity periods upon one…
…for biological products that will be deemed licensed under the PHS Act? Does that exclusivity simply disappear given the BPCIA’s pediatric exclusivity limitation and lack of a patent listing mechanism? …
…strength of an injectable drug product as both a function of concentration and container size (fill volume). Under the scenario above, and depending on the patent estate for Drug X,…