Menu
Your search for “patent exclusivity” returned the following results.
…their labeling certain information protected by patent or non-patent exclusivity. In an April 2015 FDA Letter Decision, which AstraZeneca refers to as the “2015 Interpretation,” FDA laid out a rationale…
…in which FDA has determined that a first ANDA applicant is eligible for 180-day exclusivity on the basis that there was not a forfeiture of such exclusivity because of a…
…to the labeling of the listed drug has been approved by the Secretary within 60 days of the expiration of the patent or exclusivity period that otherwise prohibited the approval…
…patent covering an enantiomer of a previously approved racemate. The court’s decision relied heavily on previous FDA and U.S. Patent and Trademark Office (“PTO”) PTE decisions concerning patents covering an…
…sponsors of new, original ANDAs may lose out on 180-day exclusivity eligibility. Consider, for example, the following scenario, where no patent information is yet listed in the Orange Book for…
…delisting of Orange Book-listed patents. We suspect that other counterclaims have been filed in Hatch-Waxman patent infringement litigation, but that they may be under seal or buried in dockets we…
…Cir. 2012), the so-called “scope of the patent test” when considering whether drug patent settlement agreements involving cash payments and early entry dates violate the antitrust laws, and instead applied…
…in a patented prescription drug being sold in the District of Columbia for an “excessive price.” If the wholesale price of a patented prescription drug in the District exceeded the…
…Section 1 of the federal Sherman Act – when Bayer settled patent infringement litigation with respect to generic versions of its antibiotic drug CIPRO (cirprofloxacin HCl). The case, In re:…
…contingent, prior to the expiration of— (A) any patent that is the basis for the patent infringement claim; or (B) any patent right or other statutory exclusivity that would prevent…
…containing a Paragraph IV certification to U.S. Patent No. 5,698,558 (“the ‘558 patent”), which is listed in the Orange Book for XYZAL as a method-of-use patent with a U-812 patent…
…To that end, FDA has attempted to limit exclusivity awards in an effort to facilitate generic access, by, for example, requiring proof of clinical superiority for Orphan Drug Exclusivity (Depomed)…
…the exclusivity provisions of the Orphan Drug Act requires the FDA to recognize exclusivity for any drug that the FDA has designated and granting marketing approval” (emphasis added), would have…
…180-day exclusivity. (FDA’s approval of ANDA 078003 also appears to indicate that before approving the application, AstraZeneca waived successive and overlapping periods of pediatric exclusivity expiring on May 25, 2015 and August…
…and exclusivity for biological products, but not on 180-day exclusivity (or orphan drug exclusivity), and that is intended to bring clarity and consistency to exclusivity decisions, a division or group…