Generics Bulletin is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Biopharma, US FTC Portray Opposing Sides In Debate Over Patent ‘March-In’ Policy

Executive Summary

BIO and PhRMA describe the complexity of pricing biopharmaceuticals in arguing price should not be a factor in deciding whether to exercise march-in rights. The FTC suggests agencies consider a patent holder’s private investment and breadth of patent coverage, while KEI, AUTM, the American Bar Association, and former USPTO directors also weigh in on NIST's proposed framework.

You may also be interested in...

FTC, HHS Probe GPO Contracting Practices As Source Of Generic Drug Shortages

Contracting practices and lack of competition among large healthcare group purchasing organizations and drug wholesalers – and their impact on the generic pharmaceutical market – are among topics in request for public comments by the agency.

Patent ‘March-In’ Policy Shift Will Likely Drive Uncertainty More Than Price Drops

Biden administration’s new framework will consider whether a product’s price is reasonable in deciding whether to exercise march-in rights. Numerous other factors could limit provision’s impact, but industry is concerned it will discourage firms from licensing government-funded inventions.

FTC Suit Kills Sanofi/Maze Licensing Deal; Will It Doom The Pompe Candidate?

Faced with a lawsuit asserting it had acquired an asset because it was a potential threat, Sanofi bows out of agreement to develop Maze’s GYS1 inhibitor. A test for FTC’s competition theory will be whether MZE001 eventually makes it to the market through other means.

Related Content


Related Companies

Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts