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Your search for “patent exclusivity” returned the following results.
…deconstruct, in a step-by-step manner, a complex exclusivity dispute, analyzing the various (and sometimes evolving) positions on exclusivity presented. Relevant court decisions will also be analyzed and their practical and…
…application (if that application is blocked by another sponsor’s orphan drug exclusivity) and also to obtain orphan drug exclusivity. According to FDA’s orphan drug regulations, a drug is “different” from…
…concerned about how FDA might handle 180-day exclusivity forfeiture decisions under FDC Act § 505(j)(5)(D)(i)(IV) during a government or other emergency shutdown. That provision states that 180-day exclusivity eligibility is…
…revise and weaken the 180-day generic drug exclusivity incentive and framework first established with the passage of the 1984 Hatch-Waxman Amendments and amended with the passage of the 2003 Medicare…
…se illegal: they prevent any generic manufacturer with a legitimate challenge to a patent from potentially entering the market. . . . Expanding the exclusivity period is vitally important, since…
…aspect of labeling protected by patent or accorded exclusivity under [FDC Act § 505(j)(5)(D)]. However, FDA’s regulations at 21 C.F.R. § 314.127(a)(7) further provide that to approve an ANDA that…
…Amgen seeks to convert a “notice” provision for resolving patent disputes into an “exclusivity” provision. Adopting Amgen’s interpretation would defy Congress’s intent (as expressed in the statute’s plain language) by…
…contains three appendices (Product Name Index; Product Name Index Listed by Applicant; and Uniform Terms) and a Patent and Exclusivity Information Addendum (divided into Patent and Exclusivity Lists and Patent…
…Government’s brief puts a lot of faith in the existing regulatory system rather than the patent system. Because FDA cannot review patent claims, the Agency must rely on the brand-name…
…the “Preserve Access to Affordable Generics Act” in the report (Senate Report No. 111-238; pages 144-148 & 150-151) accompanying S. 3677. The legislation would make patent settlements (or what opponents…
By Kurt R. Karst – The long-running dispute over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin) may…
…Motion for Summary Judgment in a long-running dispute (involving all three branches of the federal government) over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”)…
…Nu-Pharm’s ANDA with a paragraph IV patent certification expired without a substantive ruling on patent validity or infringement. FDA nevertheless refused to approve ANDA #77-615 based on an order entered…
…reported, the case involves a generic version of LOVENOX (enoxaparin) and a method patent – U.S. Patent No. 7,575,866 (“the ‘866 patent”) – assigned to Momenta. Momenta sued Amphastar in…
As the breadth of the “patent safe harbor” continues to expand under the Federal Circuit’s growing body of relevant case law, some patent holders are looking to the Supreme Court…