Generics

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.

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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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.
7 December 2023   Case dismissed with settlement between Novartis and Daiichi Sankyo unit | Melanoma therapy at centre of feud after Novartis faced infringement claims over Tafinlar.
5 December 2023   Emcure fends off COVID-19 trade secrets suit in Washington | A US biotech had inked a short-lived deal with Indian generic pharma company’s subsidiary.
30 November 2023   Final award follows and incorporates the August 2022 decision by the arbitrator denying all claims levied at the Japanese company | Dispute involves antibody drug conjugate technology.
23 November 2023   Judge encourages lawyers and public to make their voices heard over transparency concerns | Awkward access to public hearings ‘causing problems’ says Regeneron counsel | Plea for public virtual hearings as judge notes that requests have been ‘coming in by the dozen’ | Panellists discuss at LSPN Europe.
16 November 2023   Big pharma company relies on procedural arguments to fend off a complaint alleging that it engaged in excessive pricing | Feud centres on one of the most successful blockbuster drugs of all time.
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