Robert Cerwinski: Current Infliximab Litigation
Robert Cerwinski, JD, Partner at Goodwin, discusses current infliximab litigation.
Transcript:
Janssen is currently involved in litigation over infliximab. Where does the case stand?
Right now, the parties are actively litigating potential infringement of 1 patent. The parties were scheduled for a trial, and that trial has been suspended while the parties litigate issues concerning standing and damages. Right now, there is a pending motion to dismiss Janssen’s complaint for patent infringement for lack of standing. The allegation that has been announced publicly is that Janssen doesn’t have all the rights it needs to assert the ‘083 patent against the defendants, and therefore the suit should be dismissed. That’s where things stand right now. There are some pending damages issues as well, that the court is considering, but it’s really that motion to dismiss that the court is hearing briefing and arguing on.
HHS Praises Biosimilars Savings but Opportunities to Reduce Part B Spending Remain
November 28th 2023Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.
Dr Fran Gregory Sizes Up the US Adalimumab Market: Will Biosimilars See Success?
September 17th 2023On this episode of Not So Different, Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, analyzes the adalimumab market so far in the United States and provides insight into how the market needs to adapt to accept these products and ensure lower drug costs for patients.
BioRationality: FDA Launches a New Opportunity to Remove Redundant Trials of Biosimilars
November 6th 2023The FDA introduced a plan to improve clinical trials, including a provision to possibly eliminate clinical efficacy testing for biologic products, which evidence has suggested may not be necessary, according to Sarfaraz K. Niazi, PhD.
