Category Archives: Legal

The Patent Black Label: Six Side-Effects of India's Novartis Glivec Ruling

By William Looney | Published: April 3, 2013
Monday’s decision by India’s Supreme Court to deny a patent for the top-selling oncologic drug Glivec took nearly a decade of litigation to resolve – but the implications in and beyond India are both immediate and lasting.  Here’s a list of six that Pharm Exec thinks are most important:
Also posted in Emerging Markets, Global, IP, Manufacturing, Market Access, Strategy, pricing | Tagged , , , , , , , , | 6 Comments

The FTC's Beef with Pay For Delay: What's the Fuss?

By Clark Herman | Published: March 26, 2013
Yesterday, the Supreme Court heard arguments on the matter of pay-for-delay settlements between patent holders and generic firms. The Federal Trade Commission (FTC) hopes to overturn the 11th federal circuit’s ruling that such settlements are not anti-competitive on the grounds that these settlements amount to a restraint of trade under the commerce clause of the [...]
Also posted in IP, Market Access, Regulatory | Tagged , , , , | 1 Comment

FTC v. Actavis: The Wrong End of the Telescope

By Guest Blogger | Published: March 25, 2013
by Traci Medford-Rosow and Peter C. Richardson On December 8, 2012, the Supreme Court agreed to hear the Federal Trade Commission (FTC) v. Actavis, Inc. case. The court’s grant of certiorari marked the latest chapter in a decade-long effort by the FTC to have the court rule on the festering issue of whether pay-for-delay provisions in [...]
Also posted in IP, Market Access, Op-Ed, Regulatory, Strategy | Tagged , | 1 Comment

Are US and Canadian Rx Policies Converging?

By Guest Blogger | Published: March 19, 2013
by Tom Norton As the US pharmaceutical industry anxiously watches the rapid onset of Obamacare, certainly one of the more pressing issues is the debate over the number of drugs that will be reimbursed in each therapeutic class under the Essential Health Benefits (EHB) program.  To say that this is a critical concern for the future [...]
Also posted in Global, Guest Blog, Market Access, Strategy, healthcare | Tagged , , , , , , | Leave a comment

CDER Runs into Trouble with Generic Drug Reorg Plan

By Jill Wechsler | Published: March 15, 2013
After less than a year on the job, the head of FDA’s Office of Generic Drugs (OGD) has announced his departure, a sign that all is not well with plans for major organizational changes at the Center for Drug Evaluation and Research (CDER).
Also posted in FDA, leadership | Tagged , , , , , , , , , | Leave a comment