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Intellectual Property

Set Alert for Intellectual Property

Takeda Prevacid Suit Was Not A ‘Sham,’ US Court Tells Zydus Cadila

A US district court has denied Zydus Cadila’s motion for summary judgment on Sherman Act antitrust counterclaims against Takeda over a branded formulation of lansoprazole, finding that the originator did have basis to sue the ANDA sponsor again in 2018.

Intellectual Property Legal Issues

Teva Launches First-Ever CREATES Act Suit

Amicus should to be forced to sell samples of Galafold (migalastat) for bioequivalence and other testing, Teva argues in what appears to be the initial case brought under the 2019 law intended to smooth the development of ANDAs.

Legal Issues Generic Drugs

AAM Strengthens Calls For Reforms To Stop Anticompetitive Tactics

The US Association for Accessible Medicines discussed six areas for reform during a recent US Senate Judiciary Committee hearing “shining a spotlight on the anti-competitive tactics used by some brand name pharmaceutical companies to delay patient access” to generics and biosimilars.

Policy Regulation

German Ruling Opens The Way To European Patent Court

The long-running process of setting up a new European patent court and unitary patent system should shortly be moving into its final phase following a ruling by a German constitutional court.

Intellectual Property Europe

Roche Tocilizumab IP Relaxation Does Not Go Far Enough

After the WHO recommended the use of IL-6 receptor blockers to treat patients hospitalized with severe or critical COVID-19, Actemra/RoActemra originator Roche pledged not to enforce IP covering the tocilizumab brand in low- and middle-income countries during the pandemic. But humanitarian organization MSF says this does not go far enough.

Intellectual Property Biosimilars

BGMA Chief Samuels Sees Boost From UK Biosimilars Pathway

In the second part of an exclusive interview with Generics Bulletin, BGMA chief executive Mark Samuels talks about the UK’s new biosimilars licensing pathway, future trade deals and IP, and efforts around repurposing generics, as well as looking ahead to how the UK’s vaccination program could reshape the COVID-19 pandemic.

United Kingdom Biosimilars

Purple Book Changes May Not Go Far Enough

Despite new requirements to include details of biologic exclusivity and intellectual property in the FDA’s Purple Book that come into effect on 25 June, experts believe information gaps for biosimilars developers may still exist.

Biosimilars Regulation

Sun Settles On Revlimid As Natco Scoops First ANDA Approval

Sun Pharma has become the latest ANDA sponsor to settle litigation with Celgene over Revlimid, shortly after Natco and partner Teva picked up the first ANDA approval for the blockbuster treatment for multiple myeloma.

Generic Drugs Deals

Dr Reddy’s Launches Second US Vascepa Rival As Supreme Court Rejects Amarin

Dr Reddy’s has shaken up the market for generic Vascepa in the US by launching its own icosapent ethyl capsules to compete with Hikma’s generic and the Amarin brand, hot on the heels of the Supreme Court’s rejection of the originator’s attempt to overturn a Federal Circuit decision invalidating six Vascepa patents.

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