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Uncertainty In Patent Term Extension For Biologics

USA - May 22 2017 When Congress enacted the Biologics Price Competition and Innovation Act of 2009, it created an artificial act of infringement for the submission of a…

Biologic Patents Are Under Attack

USA - June 30 2016 A bedrock principle of U.S. health care is that a strong patent system is critical to new drug development. Tufts University, which has tracked drug…

The First Amendment Does Not Protect All Off-Label Drug Promotion

USA - December 23 2016 FDA is considering making off-label promotion easier, consistent with recent case law. The drug and biologics industry is also proposing an ease up…

Gina Nellesen.

FCC releases Notice of Proposed Rulemaking on approval procedures for radiofrequency devices

USA - August 10 2015 The Federal Communications Commission (FCC) recently released a Notice of Proposed Rulemaking (NPRM) to update the rules that govern the evaluation…

Jay S. Newman.

Predictions for the outcome of Amgen v. Sandoz

USA - June 25 2015 On June 3rd, 2015, the Federal Circuit heard oral arguments in Amgen Inc. v. Sandoz Inc. case, 2015-1499 involving the BPCIA provisions related to…