Applied Filters
Skinny-label ruling will ‘decimate’ Hatch-Waxman, Fed Circuit told
One of the architects of the Hatch-Waxman Act has urged judges to reverse a decision which he says nullifies a key provision of the generic drug legislation.
Lawyers warn of Irish Sea split over SPCs
The UK is facing a divergence in supplementary protection certificate regulations across the Irish Sea post-Brexit.
Judge rejects Allergan challenge to FCA suit
A California judge has allowed a patent attorney to proceed with his claims against Allergan which allege the pharmaceutical company fraudulently obtained patents to monopolise pricing.
Tris blocks Actavis’ ADHD generic
New Jersey-based Tris Pharma has won a ruling blocking Teva-owned Actavis from launching a generic version of attention deficit and hyperactivity disorder drug Quillivant XR.
Number of pay-for-delay deals remains low, says FTC
The number of potentially anticompetitive patent infringement settlements between brand drugmakers and generic competitors remained low in 2017, according to the Federal Trade Commission.
Amgen, Teva to face Sensipar monopoly claims
Amgen and Teva will have to face a lawsuit accusing them of restricting competition by engineering a reverse payment designed to keep generic versions of Sensipar off the market.
Teva urges Fed Circuit to save skinny label law from ‘nullification’
Teva has urged the US Court of Appeals for the Federal Circuit to rehear its dispute with GlaxoSmithKline en banc, claiming that if the decision is upheld, “every skinny-labelled generic is at risk”.
MSF urges EU to rid market of ‘avoidable suffering’ from SPCs
Médecins Sans Frontières has warned that the European Commission’s commitment to the supplementary protection certificate system risks undermining its promise to improve drug accessibility.
EC fines Teva €60.5m over pay-for-delay deal
The European Commission has fined Teva and its subsidiary Cephalon €60.5 million for agreeing to delay a cheaper generic version of sleep disorder drug modafinil.
EC plans to lower barriers to generic drugs
The European Commission wants to increase access to generic medicines and crack down on anti-competitive behaviour in the pharmaceutical industry, a new plan has said.
