Spinraza: KEI asks DHHS Office of the Inspector General (OIG) to investigate a failure to disclose federal funding in patents

KEI has asked the DHHS Office of Inspector General (OIG) to investigate a failure to disclose federal funding of patents on nusinersen, a drug developed by Ionis Pharmaceuticals (formerly known as Isis Pharmacetuicals) with BioGen, and sold under the trade name Spinraza.

A copy of the 22 page letter to OIG is available here.

As has been widely reported, Spinraza is an effective drug for the treatment of Spinal Muscular Atrophy (SMA), a terrible disease. BioGen is asking $750,000 for the 1st year of treatment and $375,000 per year for maintenance. The drug requires 4 injections per year.

Earlier KEI was asked by the staff of a Member of Congress about the potential for march-in rights on this drug. Ionis Pharmaceuticals reports to shareholders that five patents are related to nusinersen, including one that expires in 2018. KEI reviewed the remaining four patents. Two patents were assigned to the University of Massachusetts, and reported NIH funding in the patents. The other two patents reported multiple inventors, including Adrian R. Krainer and Yimin Hua, both working for Cold Spring Harbor Laboratory. Krainer was a principal investigator of several NIH grants, and Krainer and Hua both reported the NIH funding in research papers, but not on the patent. Ionis (when known as Isis), also received several million dollars in federal grants.

Dr. Diane Singhroy reviewed the relevant science and NIH grants that lead to the federally-funded subject inventions related to the composition and methods of use of nusinersen, an antisense oligonucleotide (ASO), for the treatment of spinal muscular atrophy (SMA), embodied in U.S. Patent Nos. 8,361,977 (hereinafter the “’977 patent”) and 8,980,853 (hereinafter the “’853 patent”).

The remedy for non-disclosure of the federal funding and rights in the patent can include a loss of patent rights.

Dennis Crouch has written about the issue here: