1. Pink Sheet
  2. >>Legal & IP

Are Regeneron And Pfizer/BioNTech COVID-19 Products Covered By Patent Safe Harbor?

 
• By Brenda Sandburg

Allele claims Regeneron’s monoclonal antibody cocktail and Pfizer/BioNTech’s COVID-19 vaccine infringe its fluorescent protein patent. Regeneron asks court to toss suit against it, arguing use of protein for FDA submission is protected. A different court denied Pfizer/BioNTech’s motion to dismiss similar suit.

safe harbor
Lawsuits claim patent safe harbor does not apply to Regeneron and Pfizer/BioNTech's use of patented invention • Source: Alamy

Allele Biotechnology and Pharmaceuticals Inc.’s lawsuits against Regeneron Pharmaceuticals, Inc. and Pfizer Inc./BioNTech SE are testing the scope of the safe harbor that allows patented inventions to be used in the submission of information to the US Food and Drug Administration.

At issue is whether Allele’s patented fluorescent protein used by Regeneron in developing its REGEN-COV antibody cocktail and by Pfizer and BioNTech in developing their COVID-19 vaccine is a research tool that is exempt from the safe

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Legal & IP

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.

More from Pink Sheet

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.

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

EU Moment Of Truth For Obe-Cel And 10 Other New Medicines

 
• By Neena Brizmohun

Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.