November 4, 2013:

U.S. patent 6,419,944 (inventor Edward Tobinick M.D., filed April 5, 2001) contained the first clinical report of rapid improvement in disc-related pain following the administration of perispinal etanercept. Now, more than a decade later, there are four favorable clinical trials that provide randomized, controlled trial (RCT) data supporting the efficacy of etanercept for treating disc-related pain. In 2013, data from two of these RCTs have been presented: the Nov 1 study by Freeman published in Spine; and the study conducted at Chiba University in Japan(Sainoh, T., et al., Intradiscal Administration of Tumor Necrosis Factor-Alpha Inhibitor, Etanercept, Clinically Improves Intractable Discogenic Low Back Pain: A Prospective Randomized Study, in International Society for the Study of the Lumbar Spine 40th Annual Meeting, May 2013). In 2012 the RCT by Ohtori reported positive etanercept data (Ohtori, S., et al., Epidural administration of spinal nerves with the tumor necrosis factor-alpha inhibitor, etanercept, compared with dexamethasone for treatment of sciatica in patients with lumbar spinal stenosis: a prospective randomized study. Spine (Phila Pa 1976), 2012. 37(6): p. 439-44). In 2009 the RCT performed at Walter Reed Army Medical Center provided favorable efficacy and human and animal safety data (Cohen, S.P., et al., Randomized, double-blind, placebo-controlled, dose-response, and preclinical safety study of transforaminal epidural etanercept for the treatment of sciatica. Anesthesiology, 2009. 110(5): p. 1116-26).

August 5, 2013:

On August 5, 2013, in the United States District Court for the Eastern District of Virginia, Alexandria Division, judgment in favor of TACT IP, LLC, holding patents of Edward Tobinick, M.D., was entered:

” Case No. 1:12cv909

JUDGMENT ORDER

Upon consideration of the July 19, 2013 Report and Recommendation of the United States Magistrate Judge designated to conduct a hearing in this matter, no objections having been filed, and upon an independent de novo review of the record, it is hereby ORDERED that the Court adopts as its own the findings of fact and recommendation of the United States Magistrate Judge, as set forth in the June 19, 2013 Report and Recommendation.

Accordingly, it is hereby ORDERED that judgment is ENTERED by default in favor of plaintiff TACT IP LLC and against defendants Janssen Biotech, Inc. and New York University…..”

Edward Tobinick’s issued patents, assigned to TACT IP LLC, include, but are not limited to the following U.S. patents: 6419944, 6537549, 6982089, 7214658, 7629311, 8119127, and 8236306. The patents at issue in the entered judgment in favor of TACT IP LLC included those involving epidural administration of etanercept for treatment of symptomatic lumbar disc herniation.