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Intellectual Property

Set Alert for Intellectual Property

Lupin Looks To Be First Out Of The Blocks On US Ingrezza, With Zydus Second

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.

Generic Drugs Deals

FTC Campaign Against Orange Book Patent Listings Extends To Mylan’s Battle With Sanofi

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.

Intellectual Property Legal Issues

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.

Intellectual Property Legal Issues

Endo Launches First US Mitigare Generic Following Micro Labs Lawsuit

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.

Generic Drugs Launches

Viatris Handed Another Chance On US Epoprostenol Challenge

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.

Legal Issues Intellectual Property

Amgen Confirms US Aflibercept Filing As Regeneron Awaits Biocon Trial Fate

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.

Biosimilars Drug Review

Biogen, Bio-Thera Shake Hands On US Actemra Settlement

Biogen, Bio-Thera Solutions and Roche have announced a settlement has been reached allowing patent-infringement litigation over Actemra to be dismissed.

Intellectual Property Legal Issues

US Court Signs Off $70m Glenmark, Merck Settlement In Zetia ‘Pay-For-Delay’ Case

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.

Legal Issues Deals

Teva Fails To Overturn €60m EU Fine Over Provigil ‘Pay For Delay’

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).

Legal Issues Deals

Lupin Looks To Next Generation In Narcolepsy With Tentative US Xywav Nod

Lupin may enjoy 180 days of market exclusivity for its proposed generic to Jazz’s next-generation Xywav treatment for sleep disorders.

Approvals Generic Drugs

Medicines For Europe Calls For A Medicines Security Act

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.

Europe Generic Drugs

IGBA Leaders Open Up Talks With WIPO

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.

Intellectual Property Policy

Medicines For Europe Proposes Revised Remodulation To EU Exclusivity Proposals

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.

Legislation Intellectual Property

EU’s Unitary SPC System Must Maximize Access To Medicines And Not Block Generic Entry

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.

Europe EU Legislative Reform

What Does Viatris’ Trio Of Attacks On US Semaglutide Mean For Wegovy Generics?

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.

Intellectual Property Legal Issues

Questions Swirl Around US Aflibercept With Biocon Decision Imminent

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.

Biosimilars Intellectual Property