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Pharma Pushes For Stronger ‘March In’ Rule Despite Changing Political Dynamics, COVID Complications

 
• By Sarah Karlin-Smith

With COVID-19 drawing new attention to the government’s investment in R&D and high drug prices, lower drug pricing advocates are optimistic the Biden team will a Trump-era attempt to carve out a medication’s price from patent breaking criteria. The drug industry isn’t just defending Trump’s plan – its trying to strengthen it.

patent license agreement
The Biden administration will have to review more than 80,000 comments on a proposed rule impacting patent rights • Source: Shutterstock

The brand pharmaceutical industry is asking the US government to tighten manufacturer’s patent rights on brand name drugs, pushing the new US political leadership under President Joe Biden to go even further than a proposed Trump rule, which would make it harder for the government to break patents due to the price of medicines funded with taxpayer resources.

It’s a bold tactic, given that Democrats have long been more open to the idea of using so called “march in” rights to break patents on high cost drugs, including...

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Life After Loper: Vaping Case Shows US FDA Retains Considerable Deference

 
• By Craig Bleifer, Royce DuBiner, Max Bogost, Michael Brody, and Allyson Maur

A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.

HHS Secretary Kennedy Says Trump Will Make Final Decision On Mifepristone Policy

 
• By Derrick Gingery

With an FDA review ongoing, Kennedy’s admission, made during a Senate hearing on the Health and Human Services Department’s budget request, suggests political officials could supersede scientific decisions.

Medicare Negotiation Does Not Violate Due Process, Appeals Court Rules, Other Suits At Risk

 
• By Cathy Kelly

Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

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ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Darzalex Faspro Gains US FDA AdComm Support For Smoldering Myeloma Claim

 
• By Bridget Silverman

The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.

STARGLO Dulled: Genentech’s Columvi Data Not Generalizable To US Patients, FDA Panel Says

 
• By Sue Sutter

The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.