Ropes & Gray LLP

FDA Issues Draft Guidance for Dissemination of 'Off-Label' Information Regarding Approved Medical Products
April 15, 2008
On February 15, 2008, the U.S. Food and Drug Administration ("FDA") issued draft guidance on industry dissemination of medical or scientific journal articles and reference publications (hereafter "reprints") that discuss unapproved uses -- or "off-label" uses -- of...

Full Federal Circuit to Review Business Method Patents
April 15, 2008
On February 15, 2008, the U.S. Court of Appeals for the Federal Circuit issued an order that calls into question the continued viability of "business method" patents, and indeed invites new scrutiny as to what constitutes patentable subject matter in general.

IRS Denies 162(m) Performance-Based Compensation Exemption for Awards with Severance Protection
April 15, 2008
In a dramatic reversal of prior positions, the IRS in newly released Private Letter Ruling (PLR) 200804004 has ruled that a performance award providing for payout at target on a mid-period involuntary termination or "good reason" quit does not qualify for the performance-based...