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Friday, May 23, 2014

Weekly Opinion Summaries Drugs & Biotech

Tobinick v. Olmarker

Court: U.S. Federal Circuit Court of Appeals
Docket: 13-1499Opinion Date: May 19, 2014
Judge: Reyna
Areas of Law: Drugs & Biotech, Patents
The related patents claim priority from a 1998 application and concern drugs for treatment of spinal nerve injuries, often associated with herniated discs. Between spinal vertebrae are soft “spinal discs,” that permit the spine to flex and move by absorbing and distributing compressive forces. A spinal disc becomes herniated when tissue surrounding it tears and nucleus pulposus, normally inside the disc, leaks into the epidural space of the spine. Nucleus pulposus secretes TNF-α, a powerful signaler of inflammation and other injuries. The nerve roots that extend from the spinal cord pass through the epidural space; if they come into contact with TNF-a, back pain or numbness may result. Nerve root injuries may be reduced or eliminated by “inhibiting” the TNF-α. Tobinick brought an interference proceeding. The Patent Trial and Appeal Board dismissed, construing “administered locally” as administering the claimed therapeutic compound “directly to the site where it is intended to act, that is, to the location where the nucleus pulposus is causing the symptoms of the nerve disorder.” The Board found that Tobinick’s patent application did not contain written description support so that he lacked standing to bring the interference. The Federal Circuit reversed, finding that Tobinick’s application contained sufficient written description support for local administration; it describes administering the therapeutic compound to the epidural space adjacent to a herniated spinal disc, which is the site where it is intended to act and the location where the nucleus pulposus is causing symptoms of the nerve disorder.
http://j.st/Z3ezView Case
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