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As Calls For Patent Sharing To Fight Pandemic Intensify, Manufacturing May Be Bigger Issue

 
• By Brenda Sandburg

Scientists and lawyers ask companies to temporarily license their IP for free, as others advocate compulsory licenses; real issue may be the ability to make a COVID-19 treatment or vaccine widely available.

Patent Health Care Pharmaceuticals Innovation concept.
Groups want biopharma companies to share their intellectual property for COVID-19 battle

Organizations, academicians and individuals continue to press companies to share their intellectual property for use in the battle against COVID-19. The call has gained traction, as drug and vaccine makers form collaborations and share their libraries of compounds. But a bigger issue may arise in assuring that products are widely available once they are approved.

Most recently, an international coalition of scientists and lawyers asked patent holders to commit to making their intellectual property available free of charge for use in ending the COVID-19 pandemic...

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How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

US FDA’s ‘Good Reputation’ For Science May Mean Loper Bright Not ‘Cataclysmic,’ Attorney Says

 
• By Malcolm Spicer

Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.

Europe’s UPC Issues Landmark Ruling On Second Medical Use Claims

 
• By Neena Brizmohun

The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.

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.

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How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
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If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.