Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Legal & IP

Set Alert for Legal & IP

Latest From Legal Issues

Pharmacists To Get New Substitution Powers To Tackle Brexit Shortage Risk

In an effort to address possible serious drug shortages in the event of a no-deal Brexit, the UK government has formally proposed giving pharmacists wide powers to dispense alternative medicines such as different forms, generics, biosimilars, or “therapeutically equivalent” drugs.
Brexit United Kingdom

US Federal Courts Can Operate Until Jan. 25; Patent Office Faces Eminent Closure Under Shutdown

Federal courts and USPTO will soon run out of funds that have allowed them to continue normal operations; pending ANDAs to get same filing date, which could lead to FDA legal challenges.
Legal Issues Intellectual Property

Bristol-Celgene: Congressional Reps Want Assurance Merger Will Not Increase Prices

Reps. Welch and Rooney urge FTC and DOJ to condition their approval of the merger on inclusion of a pricing provision.

Pricing Debate M & A

Orange Book Policing May Increase, US FDA's Gottlieb Says

Commissioner says agency will modernize drug patent reference manual this year and consider potential changes to Orange Book administration policy. However, any transformative moves could trigger a court challenge.
Generic Drugs Legal Issues

ABPI Code “Tidy Up” Reflects Digital Developments

The Association of the British Pharmaceutical Industry’s revised code of practice reflects digital developments and replaces the 2016 version.

Europe United Kingdom

US Supreme Court Declines Review Of False Claims Act, PCSK9, Hep C Patents

Gilead disputed Campie FCA decision, Amgen challenged Repatha ruling, and Merck challenged "unclean hands" defense against damages. Patent and Trademark Office wants court to determine if its attorneys' fees should be covered by patent applicants challenging its decisions.

Legal Issues Intellectual Property
See All
UsernamePublicRestriction

Register