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ANDA sponsors targeting Neurocrine Biosciences’ Ingrezza (valbenazine) blockbuster are in position to launch – albeit with a 14-year wait that validates the strength of the originator’s IP.
Sanofi’s Orange Book listings for its insulin glargine product ‘can be viewed as one part of an overarching monopolistic scheme,’ FTC says in amicus brief.
In Swift Challenge To Orange Book Patent Listings, Federal Trade Commission Fills FDA Ministerial Gap
Agency sends letters to 10 companies saying they improperly listed patents in US FDA’s Orange Book covering drug-device combination products. FTC does not specify why it believes the patents were improperly listed.
Endo’s Par has moved on the first FDA-approved generic version of Hikma’s Mitigare prevention of gout flares – weeks after another ANDA sponsor, Micro Labs, sought to clear its own path to market via a lawsuit.
The US Court of Appeals for the Federal Circuit did not agree with the way a lower court adopted critical claim construction language in Viatris’ patent-litigation proceedings with Actelion over its Veletri injectable treatment for pulmonary arterial hypertension.
Amgen has thrown its hat in the ring to launch a US biosimilar to Regeneron’s Eylea eye-disease blockbuster, as all eyes remain on the outcome of a key patent-infringement trial between Biocon and the originator.
Biogen, Bio-Thera Solutions and Roche have announced a settlement has been reached allowing patent-infringement litigation over Actemra to be dismissed.
Months after signing off on claims from two other sets of plaintiffs, a US district court in Virginia has approved a settlement agreement with a third class to put to bed antitrust claims that Glenmark and Merck & Co conspired illegally to delay generic competition to Merck’s Zetia blockbuster.
Teva has failed in its attempt to overturn European fines totaling €60.5m in relation to a historical “pay-for-delay” arrangement covering Cephalon’s Provigil (modafinil).
Lupin may enjoy 180 days of market exclusivity for its proposed generic to Jazz’s next-generation Xywav treatment for sleep disorders.
The EU would benefit from the creation of a Medicines Security Act to enable equitable access to affordable medicines and active pharmaceutical ingredients across the bloc, Medicines for Europe has said.
The IGBA’s CEO advisory committee of top off-patent industry leaders has met with Daren Tang, director general of the WIPO, to discuss the importance of a balanced global intellectual property regime.
Medicines for Europe proposed several alterations to the European Commission’s planted alterations to market exclusivity incentives at its recent Regulatory and Pharmacovigilance Conference in Brussels, most prominently that various proposed extensions to data exclusivity should instead be used to extend market exclusivity.
A European Parliament committee says that some aspects of the EU’s proposed unitary supplementary protection certificate scheme could promote access to cheaper off-patent medicines while others could delay generic competition.
Viatris has failed in its attempt to begin proceedings to overturn two key semaglutide patents in the US, while succeeding on another, as part of its bid to gain early entry with its proposed generic version of Novo Nordisk’s renowned Wegovy. Generics Bulletin reviews the landscape.
Biocon’s ongoing legal battle with Regeneron over US patents shielding Eylea was discussed by the originator at a pair of recent healthcare conferences, with a decision due any day.
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