Drug Calibration Patents Under Scrutiny As Supreme Court Weighs How To Build On Law Of Nature

During oral arguments in Mayo v. Prometheus, justices question what standard to apply in assessing whether the correlation of a drug’s metabolites to proper dosage is patentable; ACLU petitions court to review Myriad gene patent case.

Supreme Court justices grappled with the standard to apply in determining whether a test that correlates a drug’s metabolites to proper dosage is patent-eligible during Dec. 7 oral arguments in Mayo Collaborative Services v. Prometheus Laboratories Inc.

The justices questioned Mayo’s contention that Prometheus’s patent simply covers a natural phenomenon. But they also asked whether the application...

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

More from Legal & IP

EU Pharma Overhaul May Reshape Aspects Of Drug Promotion And HCP Partnerships

 

Lawyers explain how changes to rules around drug advertising and promotional activities under the EU pharma reform package could impact companies operating in the bloc, with one legal expert advising companies to “monitor developments closely.”

US Supreme Court Wants Solicitor General Input On Hikma Skinny Label Case

 
• By 

The US Supreme Court is seeking the administration's view following the Federal Circuit decided to reopen Amarin’s case against the ‘skinny-label’ generic Vascepa (icosapent ethyl).

New EFPIA President Hopes ‘Sanity Will Prevail’ In EU Pharma Reform Dialogs

 

Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.

EU Pharma Reform: Council Wants Strengthened Member State Powers On Drug Supply

 

The Council of the EU’s vision for the pharma reform package includes a stronger role for member states regarding the supply of medicines and the prevention of indication-stacking for orphan drugs.

More from Pink Sheet

Industry Criticizes Dutch Decision To Slash PARP Inhibitor Reimbursement

 

ZIN, the Dutch health technology assessment body, estimates that the number of patients eligible for treatment with a PARP inhibitor will be halved following a reassessment of drugs in the class.

EU Biosimilar Filings, Opinions And Approvals

 

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

US FDA’s ADHD Drug Relabeling Advances A MAHA Priority, Reviving Data Dispute

 

Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.