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Your search for “patent exclusivity” returned the following results.
…when it denied the company three-year exclusivity for its NDA supplement (“sNDA”) (“exclusivity claim”); and (2) FDA violated its own regulations—and changed established policy without the procedure required by law—when…
…of 3-year exclusivity. (In that case, FDA ultimately issued a letter decision explaining how the Agency handled the exclusivity vis-à-vis generics.) And just last week, FDA denied without comment another…
…alleged eligibility for 180-day exclusivity. As the Citizen Petition describes in detail, Ranbaxy has a long history of data integrity and manufacturing issues that have resulted in countless recalls of…
…drug is different from a previously approved orphan drug, thus making the company’s product eligible for orphan drug designation and orphan drug exclusivity (and, where applicable, the ability to “break”…
…the first interchangeable high-concentration, citrate-free biosimilar to HUMIRA, and that qualifies for First Interchangeable Exclusivity (“FIE”)—FDA denied the Boehringer Petition. FDA responded to each of Boehringer’s arguments in turn. To…
…Q&A guidance, see our post here. After an introductory section, the questions and answers are grouped into three major categories: Biosimilarity and Interchangeability, What is a “Biological Product” and Exclusivity. …
Last week, we reported on several citizen petitions submitted to FDA by Mylan and Pfizer concerning the availability and applicability of 180-day exclusivity and pediatric exclusivity to amlodipine drug products. …
…Section 505(q). According to Teva, “FDA’s tactics make it virtually impossible for a court to provide aggrieved petitioners with meaningful relief before they are harmed irreparably.” Each patent listed in…
…FTC to help out. FDA posed several questions for stakeholder input: How have exclusivity periods, patents and patent listing procedures, innovator drug product labeling, post-approval changes to innovator products, and…
…a public list of off-patent and off-exclusivity NDA products without ANDA competition. Effective June 27, 2017, MAPP 5240.3 Rev. 3, Review Order of Original ANDAs, Amendments, and Supplements, updates FDA’s…
…against FDA challenging the Agency’s authority to compel patent certifications, it’s Jazz’s turn to sue FDA. This time, rather than use codes and patent certifications, the fight is over orphan…
…diminishes the effectiveness of the next, effectively destroying the usefulness of both the knowledge and the resulting product (rivalry). The fundamental reworking of patent law theory to account for this…
…presumption of intent to deceive under 35 U.S.C. § 292 is created when a manufacturer prints expired patent numbers on its products with knowledge that the patents are expired, that…
…notice” of commercial marketing can be given (see our previous posts here and here). (The Federal Circuit also ruled that the so-called “patent dance,” starting with the provisions at PHS Act…
…occupy the field of federal patent litigation,” states are precluded from regulating in the space. The government’s focus is on patent litigation (not the more general patent law), explaining that…