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Your search for “patent exclusivity” returned the following results.
…for the District of Columbia questioning whether modifications to labeling as a result of patent protections—beyond the mere omission of language—are permissible under the section viii carve-out requirements. In other…
…to the NDA holder or patent owner. In some cases, however, it is not known whether there is an application pending at FDA, because, for example, there are no patents…
Join members of the Judiciary and leading pharmaceutical patent litigators from brand name and generic drug companies at the American Conference Institute’s 8th Annual Paragraph IV Disputes Master Symposium taking…
…agreement resolving or settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a drug product.” In such a proceeding, “an agreement shall…
…stay provisions of the Hatch-Waxman Amendments apply to a pending ANDA for a generic version of an old antibiotic drug, which ANDA contains a Paragraph IV certification to a patent…
…as well as the Precise with Multiwave system. Nevro sued Boston Scientific for patent infringement in 2016 asserting that Boston Scientific infringed its patents covering methods for delivering spinal cord…
…or through a wholesale distributor, pharmacy, or similar intermediary, on the sale of any generic or off-patent drug sold or dispensed to any consumer in the state. A price increase…
Following the recent trend of state intervention where federal legislative action has failed, California passed a bill last week discouraging patent infringement settlements that delay drug competition. Pay-for-delay settlements or…
…management; Patent exchanges in biosimilar litigation; Patent term extension applications; FDA’s product name reviews for proprietary names protected by trademarks; and Use of patent information in FDA regulatory filings. The…
…pricing on patent prosecution in the session, Drug Price Regulation: What’s Patent Law Got to Do With It? She will set the stage for the discussion by tracing the landscape…
By Kurt R. Karst – September 24, 2009 is the 25th anniversary of the enactment of the Drug Price Competition and Patent Term Restoration Act (Public Law No. 98-417) –…
…first ever rescission of orphan drug exclusivity – for Octapharma USA, Inc.’s WILATE (von Willebrand Factor/Coagulation Factor VIII Complex (Human)) for von Willebrand disease (see our previous post here). The…
…can be approved notwithstanding a period of orphan drug exclusivity applicable to the previous drug and may obtain its own period of 7-year orphan drug exclusivity. On August 20, 2012,…
…initial determination on 180-day exclusivity eligibility . . . right? Not so fast! That was the case . . . until recently. As our friend Bob Pollock over at Lachman…
…Century Cures Act would have extended 180-day generic drug exclusivity and interchangeable biosimilar exclusivity by an undefined amount of time for “American-manufactured” products – see our previous post here.) There…