Bayh-Dole Act: Failing to Disclose Government Funding

Interesting filing from the folks at KEI. That alleges IONIS Pharma (formerly ISIS) and Cold Springs Harbor Labs failed to disclose Federal funding supported development of the inventions underlying their patents covering nusinersen and its for the treatment of spinal muscular atrophy (SMA).  See U.S. Patent Nos. 8,361,977 and 8,980,853.

The Bayh-Dole Act allows private entities to patent inventions developed through federal funding. However, the law requires that the federal funding be disclosed in order to allow the Government to understand and exercise its corresponding rights.

An entity that fails to disclose the funding is then subject to the penalty of title being awarded to the U.S. government – although the Government must demand title.  “The Federal Government may receive title to any subject invention not disclosed to it within such time.” 35 U.S.C. § 202(c)(1).

The KEI filing is in the form of a letter to Inspector General of HHS (parent of NIH) asking for an investigation and action.

Read the Filing: [18jan2017-oig-investigation-request-nusinersen-patents]

If the new Trump Administration is serious about high drug prices, this may be a place to start.  Nusinersen is priced at $750,000 for the first year of treatment and $375,000 for every year thereafter.