By Unmesh Shah, Ph.D. and Cary Miller, Ph.D.

Allergan is typically the patent holder in these types of disputes, however, it recently successfully played the role of petitioner in an IPR against 1474791 Ontario Ltd.’s U.S. Patent No. 6,806,251 covering the use of botulinum toxin to treat spinal compression.  Ontario had asserted the ’251 patent against Allergan in litigation, accusing Allergan of infringing the patent through its purported off-label use of Botox® for treating back pain.   (N.D. Ill. 1:15-cv-03372)  The court stayed the case pending the result of the IPR.  (Id.)  In Allergan, Inc. and Allergan Sales, LLC v. 1474791 Ontario, Ltd., IPR2016-00102 (March 28, 2017), the PTAB found that Allergan had successfully invalidated all the challenged claims of the ’251 patent as obvious.

Claim 1 of the ‘251 patent recites:

A method of treating a disorder associated with spinal compression comprising administering an effective dose of botulinum toxin directly and solely to the intrinsic muscles of a patient in need of such therapy.

Claims 1-4, 6, and 7 were held obvious over Travell, a prior art reference that generally disclosed myofascial pain syndromes referred from myofascial trigger points and treatment methods for releasing the trigger points using botulinum toxin such as botulinum toxin A (“BTA”).

The Board found that a preponderance of evidence supported Petitioner’s position that trigger points as described in Travell were a “disorder associated with spinal compression.”  In reaching its conclusion, the Board credited the testimony of Petitioner’s expert, who testified that Travell disclosed association of treating trigger points with treatment of nerve compression, radiculopathy, and other disorders, all of which are associated with spinal compression.

The PTAB construed the terms “directly” and “solely” to mean that botulinum toxin is delivered precisely to the intrinsic muscles.  While the patent owner argued that Travell did not expressly teach BT injection “directly” or “solely” into intrinsic muscles, the Board found that the combined teachings in Travell taught and/or suggested BT injection into trigger points, taught that those trigger points were located within the intrinsic muscle, and taught in detail how to locate those trigger points in particular intrinsic muscles.  The Board further found that trigger points cause myofascial pain and can be associated with disorders associated with spinal compression, and that injecting botulinum toxin into a trigger point can effectively treat myofascial pain.

Claim 5 requires injecting between 1 and 30 mouse units of botulinum toxin.  It was held invalid over Travell in view of Cheshire, which disclosed injecting specific amounts of botulinum injection of trigger points using “a total dose of mouse units of botulinum toxin in 4ml normal saline divided equally among 2 or 3 sites.”

Ontario further contended that Travell taught away from the claimed invention.  While Travell discussed the challenges in locating trigger points, the Board noted that Travell did not “criticize, discredit, or otherwise discourage” practicing the disclosed method.  Even though there was a need for care and skill in making these trigger point injections, a person of ordinary skill in the art would have had a reasonable expectation of success in injecting botulinum toxin into trigger points in the intrinsic muscles.

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Dr. Cary Miller’s practice focuses on assisting life sciences clients with their patent issues. She works with clients in patent prosecution, prelitigation analysis, PTAB proceedings, and patent litigation. Prior to joining Jones Day, Cary participated in numerous biotechnology and pharmaceutical patent lawsuits including representing companies in Hatch-Waxman litigation, biosimilars litigation, and in litigation relating to DNA sequencing.