Pink Sheet 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

UsernamePublicRestriction

FDA ‘Monster’ Patent Reg: Brands, Generics Each Want More Options To Pick Fights

Executive Summary

PhRMA is concerned about the agency giving deference to generic sponsors in patent use code disputes, while GPhA wants a mechanism to challenge refuse-to-receive letters.

You may also be interested in...



Patent Regulation Drops Deference To ANDA, 505(b)(2) Sponsors

FDA's final rule implementing provisions of Medicare Modernization Act ‘will fuel litigation,’ attorney predicts.

Patent Use Codes For Brands Can Be Challenged By Generics, Supreme Court Rules

The high court says the Hatch-Waxman Act did not intend for one patented use of a drug to prevent the marketing of a generic for unpatented uses; Justice Sotomayor criticizes FDA for not providing clearer direction to brand manufacturers about what to include in their use codes.

Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs

GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS056978

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

Cancel