Posts Tagged: "U.S. Department of Health and Human Services"

It’s Time for NIH to Uphold the Law, Once Again

As discussed previously, the critics are in full howl now that their attempts to enact legislation controlling drug prices has failed once again. They are applying unprecedented political pressure on Secretary Xavier Becerra at the Department of Health and Human Services (HHS) to misuse the march in provisions of the Bayh-Dole Act to accomplish their goal. Nearly 100 distinguished organizations and individuals endorsed the following letter from the Bayh-Dole Coalition, which I lead, warning HHS not to take this disastrous misstep. Here’s what we said.

U.S. Government Patent Enforcement: A Ripple or a Coming Tempest?

In most respects, the widely reported patent complaint recently filed against Gilead is perfectly ordinary. It was filed in the U.S. District Court for the District of Delaware, the most common venue for patent infringement lawsuits, and alleged that a pharmaceutical company’s drug sales infringed the plaintiff’s patents on uses of the sold drug. The defendant’s response has so far been similarly unexceptional:  Gilead has filed petitions for Inter Partes Review (IPR) of each asserted patent (see links below), arguing that those patents are invalid over the prior art, either as obvious or as entirely anticipated. What is remarkable about this lawsuit, however, is that the plaintiff is the government of the United States.