Generics

22 August 2024   Judges will not rehear safe harbour case between Edwards and Meril | Medtech company said court’s precedent ‘distorts the market’ for patented products.

Latest Features

Generics
While President Biden’s desire to reduce costs at the pharmacy counter is commendable, it is too blunt an instrument that would threaten innovation beyond the life sciences, argue former USPTO directors Andrei Iancu and David Kappos.
Asia
Five cases in which preliminary injunctions were granted are examined by Takanori Abe of Abe & Partners.
Biotechnology
The Australian government has made numerous claims for damages against patentees for savings forgone when an interlocutory/preliminary injunction delays a generic's launch but the patent is invalidated or there is a finding of non-infringement.
Generics
Generic drug makers are watching two cases that will determine whether pharmaceutical firms can deduct—rather than capitalise—legal fees for defending against patent infringement suits, say Carina Federico and Anne Li of Crowell & Moring.
Americas
Certain problems with the patent opposition process need to be addressed in order to protect patent owners, say Alejandro Luna and Luz Elena Elias of Olivares.
Africa
Government-led schemes to incentivise patents are leading to delays and prejudice against legitimate applicants. Tyron Grant of Spoor and Fisher explains how South Africa is tackling the problem.
Big Pharma
The long-running legal saga between the pharma giant and the NHS as well as generic drug makers has developed further, as Darren Smyth of EIP explains.
Big Pharma
The pharma company’s arguments focusing on ‘inventive step’ failed to convince a London court that the Israeli generic drug maker had infringed, explains Azadeh Vahdat of EIP.
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28 March 2024   Judge disagrees that barrier against generic drug makers should be longer | Pharma company argues that ‘window should be shut’ on copycat versions due to potential for irreparable harm.
13 February 2024   Appeals court sides with GSK unit in licensing dispute over ovarian cancer drug | Judges find fault with previous decision ordering the pharma firm to pay royalties on all sales of an ovarian cancer treatment.
16 January 2024   US biotech has launched multiple suits over alleged infringement of Eylea patents | Regeneron asks US court to block Amgen’s biosimilar before potential approval.
9 January 2024   Judge says Bayer racked up high costs ‘in pursuit of vague point of principle’ | Teva and others wanted presentation slides as part of patent invalidity suit.
4 January 2024   California-based drugmaker lost Hatch-Waxman Act case after judge ruled it had failed to show patent infringement | Corcept CEO ‘confident’ decision will be reversed on appeal.
2 January 2024   District judge ruled in favour of Regeneron confirming patent infringement by Mylan | Court recognised Mylan's success in challenging the validity of certain patents | Ruling happened while Regeneron filed a separate case against another competitor alleging the infringement of 51 patents.
14 December 2023   Court rules that patent must be later-filed to be available as OTDP reference | MSN had submitted ANDA for generic version of Parkinson’s treatment Nuplazid.
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