The Supreme Court shot down the Federal Circuit’s attempt to shift the burden of proof from patent holders to licensees when they seek a declaratory judgment in some patent disputes. To shift the burden would create post-litigation uncertainty about the scope of a patent, unnecessary complexity by forcing a licensee to prove a negative and a significant obstacle to seeking declaratory judgment, the court said in a unanimous ruling in Medtronic Inc. v. Mirowski Family Ventures LLC.

The FDA issued format and content guidelines for drugmakers to follow when sending dear health care provider (DHCP) letters by mass mail or electronically. Existing FDA regulations describe the process for mailing important new information about drug products to health care providers, but they don’t provide instructions on the format and content of the letters, nor do they discuss the use of electronic or other means of communication. The goal of the final guidance is to improve the effectiveness of DHCP communication.