Generics
20 February 2025 British pharma giant says that a Federal Circuit decision could stifle competition by lowering the bar for proving patent infringement | Earlier ruling ‘nullifies a statutory mechanism for expediting access to generic drugs and breaks sharply with precedent on inducement’ says UK pharma company.
13 February 2025
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8 October 2024
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.
More News
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.
22 August 2024 FTC backs FDA's proposals to streamline approval process for interchangeable biosimilars | Move aims to lower prescription drug costs and expand access to critical treatments | FTC emphasises the new guidance could create competition in the biologics market and save US healthcare billions of dollars.
15 August 2024 Amgen alleges infringement by proposed biosimilar versions of Prolia and XGEVA | Complaint accuses Samsung of failing to fully disclose biosimilar application and seeks injunction on bone-treatment products.
27 June 2024 Judges considered Hikma’s label and marketing material when overturning lower court’s decision | Court said Amarin had stated plausible claim for induced infringement of patents.
28 May 2024 US and Indian firms reach agreement to settle US litigation and UK arbitration | HDT had accused Emcure of trade secrets theft over COVID-19 vaccine technology.
9 April 2024 Annual global sales of Pfizer and Astella blockbuster drug reach roughly $5 billion |
Nonprofits argue the drug is sold at a price three to six times higher in the US than it’s priced in other similar high-income countries | Move to curb drug prices follows controversial march-in rights plan.
2 April 2024 Teva and co-appellant Mylan gain second chance at launching generics of Invega Sustenna, owned by J&J subsidiary Janssen | US Court of Appeals vacates a lower court’s decision to grant validity to the drug’s last remaining patent.
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