Court Says Alzheimer's Doctor's Nerve Disorder Patent Invalid

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By John T. Aquino

Dec. 17 — A physician/inventor's patent application claims for methods of inhibiting a molecule called TNF-α to achieve therapeutic results in patients with nerve disorders are invalid, a federal appeals court affirmed Dec. 16.

Edward Tobinick is known for his promotion of Enbrel (etanercept), described in his application as a TNF-α inhibitor, for treating back problems, Alzheimer's disease, stroke and Parkinson's disease. His Institute for Neurological Recovery in Boca Raton, Fla., was the focus of an Australia 60 Minutes segment in 2010 for its approach to treating Alzheimer's.

The Patent and Trademark Office's Patent Trial and Appeals Board found his claims invalid, and he appealed that decision to the U.S. Court of Appeals for the Federal Circuit. The appeals court had previously reversed and remanded the case because, contrary to the PTAB's holding, the court found that Tobinick's application included adequate written description support under 35 U.S.C. §112 (8 LSLR 510, 5/30/14).

On remand, the PTAB still found Tobinick's patent claims invalid as lacking in novelty under 35 U.S.C. §102 and as obvious and anticipated under 35 U.S.C. §103 because of a prior patent application by Kjell Olmarker and an article on a research study Olmarker co-authored.

The Federal Circuit panel, comprising Judges Jimmie V. Reyna, Richard G. Taranto and Kara F. Stoll, affirmed the PTAB's ruling without issuing an opinion.

Appeal Attacked Witness's Testimony

Tobinick's U.S. Patent Application No. 12/714,205 is for “a method of treating a nerve disorder mediated by nucleus pulposus in a mammal in need thereof, comprising: administering to said mammal a TNF-α inhibitor that is a monoclonal antibody which blocks TNF-α activity, thereby inhibiting TNF-α and treating said disorder.” 

The claims relate to novel methods of using specific cytokine antagonists for treating neuropsychiatric and neurological disorders in humans that block, inhibit or antagonize the biologic effects of tumor necrosis factor-alpha (TNFα) or interleukin-1 (IL-1) and that can take the form of a fusion protein such as etanercept or a monoclonal antibody such as infliximab.

The application suggested that the method could be effective in treating Alzheimer's and Parkinson's.

The dispute before the patent board was an interference action—a determination as to which similar claims have priority—between Olmarker's patent claims and those in Tobinick's application.

In an unsuccessful request for a rehearing after the board's decision on remand, Tobinick had argued that the PTAB had relied on the testimony of Gunnar Bengt Andersson, who, Tobinick said, didn't understand how antibodies work or what a buffer is.

In his appellant brief, Tobinick continued his assertion that the PTAB had erred in relying on what Andersson said, criticizing his testimony and then quoting criticisms of Andersson's testimony by Allan Weinberger, Tobinick's expert witness.

Tobinick also asserted that the PTAB had abused its discretion and erred in denying his requests to file a motion for inequitable conduct and failing to consider credible allegations of inequitable conduct against Olmarker; in granting Olmarker the priority benefit of two Swedish patent applications, and in denying Tobinick's motion to exclude as evidence four affidavits by Andersson.

But the Federal Circuit affirmed the PTAB's ruling without comment.

Tobinick was represented before the Federal Circuit by Robert W. Hahl and Robert Mihail of Neifeld IP Law, PC, Alexandria, Va.

Other Tobinick Litigation

Tobinick was a party in another recent litigation in which he sued Steven Novella, a neurologist with Yale New Haven Hospital, for defamation arising from comments Novella made concerning Tobinick and the use of Enbrel for treating Alzheimer's.

On June 4, the U.S. District Court for the Southern District of Florida dismissed Tobinick's defamation, trade libel and unfair competition claims against Novella (9 LSLR 658, 6/12/15). On Sept. 30, the court granted Novella's motion for summary judgment on two remaining claims.

Tobinick has filed notice of appeal of the district court's ruling to the U.S. Court of Appeals for the Eleventh Circuit. Novella filed motions for recovery of attorneys' fees and for sanctions against Tobinick's attorneys (9 LSLR 658, 6/12/15).

To contact the reporter on this story: John T. Aquino in Washington at jaquino@bna.com

To contact the editor responsible for this story: Lee Barnes at lbarnes@bna.com