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Your search for “patent exclusivity” returned the following results.
…– Reference Product Sponsor’s Paragraph 3(A) Patent List; Step 3 – Biosimilar Applicant’s Paragraph 3(B) Patent List; Step 4 – Reference Product Sponsor’s Response; Step 5 – Patent Resolution Negotiations;…
…to include a Paragraph IV Certification to the ‘727 patent (and presumably to the ‘343 patent as well), and the Medicines Company has initiated patent infringement litigation. Because the ‘727…
Those familiar with the Hatch-Waxman Act and its various incentives to stimulate drug innovation know that New Chemical Entity (“NCE”) exclusivity is the holy grail of small molecule exclusivity. Though…
…Book with the appropriate “PC” (Patent Challenge) exclusivity expiration date. (Failure to notify has not been an issue with CGT 180-day exclusivity, but it’s worth noting that notice timing is…
…Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 360cc) generally grants orphan exclusivity to designated drugs upon approval, but does not address eligibility for exclusivity when the…
…statute also defines in general terms the scope of 3-year exclusivity, stating with respect to an original NDA that the exclusivity applies to the “conditions of approval,” and with respect…
…drug exclusivity. In some cases, particularly where drugs were designated and approved prior to this case, orphan drug exclusivity may now extend significantly farther than the approved indication for a…
…That saying applies well to ANDA 180-day exclusivity, because you don’t necessarily know whether or not a first applicant has forfeited eligibility for exclusivity – even though a statutory deadline…
…under 35 U.S.C. § 156, subject to the requirements for obtaining such patent or non-patent exclusivity. AIPLA’s letter notes that: The use of the conjunctive “and” in FDC Act §…
…a patent: IPR and PGR. Both procedures allow for administrative patent challenge proceedings at the U.S. Patent and Trademark Office (“PTO”) before the Patent Trial and Appeal Board that serve…
…for patent infringement to expire without bringing an action for patent infringement or invalidity; and (2) if the generic applicant’s notice to the NDA holder or patent owner relates to…
…that “the ‘267 patent covering Metvixia satisfies § 156(a)(5)(A) . . . .” Wyeth concerns a PTE request for U.S. Patent #4,916,154 (“the ‘154 patent”) covering Wyeth’s new animal drug…
…Act – when Bayer settled patent infringement litigation (concerning U.S. Patent No. 4,670,444, which expired in December 2003) with respect to generic versions of its antibiotic drug CIPRO (cirprofloxacin HCl). …
…the Hatch-Waxman provisions, the Court determined that a patent listed in the Orange Book must not only be a patent that claims a drug, but “it must be a patent…
…long line of lawsuits concerns U.S. Patent No. 5,206,248 (“the ‘248 patent”), which is listed in FDA’s Orange Book as a method-of-use patent covering Avanir Pharmaceuticals Inc.’s (“Avanir’s”) NUEDEXTA (dextromethorphan…