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Latest From Legal Issues

Delay Means New EU Clinical Trial Rules May Not Be Transferred To UK

With the implementation of the EU Clinical Trials Regulation now postponed to the second half of 2019, it is unlikely that its provisions will be taken over into UK legislation as part of the Brexit “Repeal Bill” that will convert all EU laws and regulations into domestic UK law.

Clinical Trials Brexit

Allergan May Rue Mohawk Tribe Deal As Court Invalidates Restasis Patents

District court questions legitimacy of Allergan's patent transfer tactic, saying it 'could spell the end of the PTO's IPR program.'

Intellectual Property Policy

FDA Objects To Amarin Trade Complaint Against Omega-3 Ingredients

FDA Chief Counsel Rebecca Wood says Amarin's request for an ITC investigation necessarily turns on questions of drug and supplements policy, where it is the expert and authorized agency. If successful, Amarin's move could encourage others to similarly seek alternative forums for action.

Consumer Legal Issues

Avastin Biosimilar Battle: Amgen, Genentech File Dueling Suits

Amgen seeks declaratory judgement that its biosimilar Mvasi does not infringe 27 Genentech patents, has Genentech suit put under seal; Amgen gave 180-day commercial marketing notice on Oct. 6.

Biosimilars Legal Issues

PCSK9 Patent Case: Praluent Injunction Vacated, But May Well Return

Appeals court vacates injunction that Repatha marketer Amgen had won against Sanofi/Regeneron's Praluent, but notes 'a reduction in choice of drugs cannot be the sole reason for a district court to deny an injunction.'

Intellectual Property Legal Issues

IPR Battles Could Become Easier For BioPharma Patent Owners

En banc Federal Circuit says patent owners do not have to prove patentability of amended claims in inter partes review proceedings; judges issue five opinions in fractured decision.

Intellectual Property Legal Issues
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