Published 25/03/2016 by Iris Kim, PhD
In September 2015, the Patent Trial and Appeal Board (“Board” or “PTAB”) denied institution of an inter partes review (IPR), in case IPR2015-00858, regarding patent 7,030,149. The IPR was requested by Ferrum Ferro Capital, LLC (the “Petitioner”) of claim 4 of the ‘149 patent, owned by Allergan Sales, LLC (the “Patent Owner”).
The Petitioner identified several related proceedings. In particular, the Petitioner cited the Federal Circuit decision, Allergan v. Sandoz, 726 F.3d 1286 (Allergan, Fed. Cir. 2013, Ex. 1012, 726 F.3d at 1293–96), in which claim 4 was not found to be invalid as obvious. Although this claim was upheld in the Federal Circuit decision, the Petitioner still attempted to challenge the validity of the claim. The Petitioner likely relied on there being differences between the broadest reasonable interpretation (BRI) claim construction used by the Board and the Phillips standard (which applies “ordinary and customary meaning”) used by the Federal Circuit. If the Board had proceeded with the IPR, then a much broader reading of the challenged claim would have been used than when it was looked at in the Federal Circuit. Many have cited this as one of the reasons why IPR has become a widely used for challenging patent validity, as applying BRI typically means that it is more likely to find a patent invalid than valid.
In the case of the ‘149 patent, however, the Board ultimately decided that the Petitioner did not establish a reasonable likelihood of prevailing with respect to claim 4, and denied the request. The ‘149 patent is directed to “topical ophthalmic use of brimonidine in combination with timolol for the treatment of glaucoma or ocular hypertension” (IPR2015-00858). The Petitioner contended that claim 4 would have been obvious over DeSantis in view of Timmerans and in further view of Larsson and Stewart, and supported their position with a declaration. Claim 4 “recites a ‘method of reducing the number of daily topical ophthalmic doses of brimondine… from 3 to 2 times a day without loss of efficacy’ in the treatment of glaucoma or ocular hypertension” (emphasis added). That is, the application of the medication two times a day is as effective as application of three times, if timolol is added.
“In Bristol-Myers Squibb, the Federal Circuit stated that ‘[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.’ In this context, the court stated that claim limitations that merely recite a newly discovered result of a known process ‘do not distinguish those claims over the prior art’” (IPR2015-00858). Citing this as well as the earlier Allergan Federal Circuit case in IPR2015-00858, the Petitioner contended that the phrase “without loss of efficacy” was not a claim limitation, due to the fact that the broadest reasonable interpretation standard used by the Board is broader than the Phillips standard used in the Federal Circuit. “Petitioner also asserts that ‘without loss of efficacy’ 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” (IPR2015-00858).
The Petitioner argued that, in the Federal Circuit Allergan case, the majority in the case considered “without loss of efficacy” to be a claim limitation while the dissent did not consider it to be so. The Petitioner considered this to mean that the majority and dissent applied different claim construction to claim 4. The dissent considered claim 4 to only include a single limitation, a step: “applying a fixed combination of 0.2% brimonidine and 0.5% timolol twice a day.” The dissent then stated that the “method of applying a fixed combination of 0.2% brimonidine and 0.5% timolol twice a day would therefore have been obvious over the prior art” (Allergan). The Petitioner argued that the dissent was applying BRI, and therefore, the claim should be found to be invalid when using BRI.
The Patent Owner responded by stating that the Petitioner wrongly argued that the dissent “adopted a different claim construction from the majority in which the language ‘without loss of efficacy’ appearing in the claim was not a limitation and could be ignored” (IPR2015-00858). The Patent Owner contended therefore that the majority and dissent had indeed both adopted the same claim construction. The Board agreed with the Patent Owner that result of “without loss of efficacy” is a limitation.
With respect to the Petitioner’s argument of Claim 4 being obvious, the Board stated in its decision, “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… 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” (IPR2015-00858).
The decision by the Board not to institute IPR concluded with, “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” (IPR2015-00858).
Although this request for inter partes review was denied, IPR still remains a popular strategy for petitioners challenging the validity of patents due to the claim construction being broader in the PTAB than in the Federal Circuit. There remains a debate regarding the differences between the BRI and Phillips standards, however. Another major discussion about these standards will be coming soon, with the Supreme Court accepting the review of the case of Cuozzo Speed Technologies v. Lee scheduled on April 25, 2016.
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