Takeaway: Institution denied where the challenged claim language “without loss of efficacy” was found to be a claim limitation, which was not an inherent property of a known prior art method.

In its Decision, the Board did not institute inter partes review because Petitioner had not established that there is a reasonable likelihood that it would prevail with respect to claim 4 of the ‘149 patent under 35 U.S.C. § 103(a). The ‘149 patent “is directed to the topical ophthalmic use of brimonidine in combination with timolol for the treatment of glaucoma or ocular hypertension.”

The specification of the ‘149 patent noted that “both brimonidine and timolol previously were commercially available, and had been combined for serial application in the treatment of glaucoma.” However, according to the ‘149 patent, “[u]nexpectedly it has been discovered” that brimonidine in combination with timolol meets the criteria of “increased stability” and “increased efficacy to reduce side effects.” Claim 4 of the ‘149 patent had previously been found not invalid as obvious by the Federal Circuit. See Allergan v. Sandoz, 726 F.3d 1286 (Fed. Cir. 2013).

The Board first turned to claim construction under the “broadest reasonable interpretation in light of the patent specification” of which the claim terms of the unexpired patent are a part. Petitioner asserted that the term “without loss of efficacy” is not a limitation “because our broadest reasonable interpretation is broader than the ‘narrower Phillips standard’” that the Federal Circuit had applied. Petitioner further asserted that the term “recites an intended result of practicing the method as claimed, not a step of the claimed method, and, therefore, should not be given patentable weight.” The Board analyzed the Federal Circuit’s decision and was not persuaded that the term “is not a limitation in claim 4, regardless of whether we apply the broadest reasonable interpretation of the Phillips standard of claim construction.” Thus, the recited result required in claim 4 “is a limitation.”

The Board next turned to the asserted obviousness of claim 4, specifically based on DeSantis in view of Timmermans and further in view of Larsson and/or Stewart. Notably, “the Federal Circuit considered all of [the] references except Stewart.” However, “Petitioner’s contentions in this case suffer from the same failures discussed in the majority decision in Allergan.”

Even assuming Petitioner persuaded us that Stewart disclosed that reducing a dose of 0.2% brimonidine from three times to twice daily resulted in “no difference in intraocular pressure effects” in some fashion, as Petitioner and its expert witness contend in a conclusory manner (Pet. 26; Ex. 1005 ¶ 47), that disclosure would not establish sufficiently that reducing the number of doses of a single composition comprising 0.2% brimonidine and 0.5% timolol from three to two times daily would have resulted necessarily in no loss of efficacy in the treatment of glaucoma or ocular hypertension. Considering Petitioner’s arguments and cited evidence of record before us, Petitioner does not establish sufficiently that the “without loss of efficacy” limitation is an inherent property or a necessary result of administering the composition as recited in claim 4.

As such, “the information presented in the Petition and accompanying evidence does not establish a reasonable likelihood that Petitioner would prevail in showing the unpatentability of claim 4 of the ‘149 patent. Therefore, the Petition was denied.

Ferrum Ferro Capital, LLC v. Allergan Sales, LL.C, IPR2015-00858
Paper 10: Decision Denying Institution of Inter Partes Review
Dated: September 21, 2015
Patent: 7,030,149 B2
Before: Jacqueline Wright Bonilla, Sheridan K. Snedden, and Susan L. C. Mitchell
Written by: Bonilla
Related proceedings: Allergan, Inc. v. Sandoz Inc., C.A. No. 09-97 (E.D. Tex.); Allergan, Inc. v. Alcon Labs., Inc., C.A. No. 09-348 (E.D. Tex.); Allergan Inc. v. High-Tech Pharmacal Co., C.A. No. 09-182 (E.D. Tex.); Allergan, Inc. v. Apotex Inc., C.A. No. 10-200 (E.D. Tex.); Allergan, Inc. v. Watson Labs., Inc., 10-344 (E.D. Tex.).