Tag Archives: Supreme Court

Liability Looms for Generic Drug Safety Labeling Changes

FDA is proposing to revise its rules to permit generic drug manufacturers to initiate safety labeling changes, and not wait until the brand company takes that action. The aim of the new policy is to inform consumers more quickly of emerging safety concerns – but it also could create confusion by allowing prescribing information to […]
Posted in FDA, Legal, Regulatory, Safety | Also tagged , , , , , , | 1 Comment

Mutual v. Bartlett: A Line in the Sand on Side Effects

The Supreme Court ruled last Monday in the case of Mutual Pharmaceuticals v. Bartlett that generic drug makers cannot change labeling or the formula of a drug after it has been approved by the FDA. The majority, which included Justices Alito, Roberts, Scalia, Kennedy, and Thomas, concluded that federal regulation trumps state tort liability law, […]
Posted in FDA, Legal, Market Access, Marketing, Regulatory, Safety | Also tagged , , , , , , , , , , , , , , , , | Leave a comment

Myriad Decision: Praise and Perils for Biotechnology Patent Policy

The Supreme Court decision blocking patents on naturally-occurring genes has generated predictions of doom for biotech innovation, along with expectations of more healthy competition in discovering new treatments and diagnostics. Although some commentators regarded the decision, Association for Molecular Pathology v. Myriad Genetics, as a “major reversal” in longstanding patent policy, many leaders of the […]
Posted in Biotech, Gene therapy, IP, Legal, Technology | Also tagged , , , | 2 Comments

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

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:
Posted in Emerging Markets, Global, IP, Legal, Manufacturing, Market Access, pricing, Strategy | Also tagged , , , , , , , | 6 Comments

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

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 […]
Posted in IP, Legal, Market Access, Regulatory | Also tagged , , , | 1 Comment
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