In Amerigen Pharmaceuticals Limited v. UCB Pharma GmbH, [2017-2596] (January 11, 2019), the Federal Circuit claims affirmed the PTAB’s determination that claims 1–5 and 21–24 of U.S. Patent 6,858,650 on an antimuscarinic drug marketed as Toviaz® to treat urinary incontinence were not unpatentable as obvious.

The Federal Circuit noted that its review of a Board decision is limited. The Federal Circuit reviews the Board’s legal determinations de novo, and the Board’s factual findings underlying those determinations for substantial evidence.  The Federal Circuit explained that a finding is supported by substantial evidence if a reasonable mind might accept the evidence as adequate to support the finding.

The Federal Circuit agreed that the Board did not legally err and that substantial evidence supports the Board’s findings.  As to Amerigen’s argument that a person of ordinary skill would have been motivated to modify 5-HMT to increase its lipophilicity, the Federal Circuit said that a a reasonable fact finder could have weighed UCB’s expert testimony over Amerigen’s, and concluded that substantial evidence supported the Board’s finding that a person of ordinary skill would not have been motivated to modify 5-HMT to increase its lipophilicity.

As to Amerigen’s argument that increasing lipophilicity “in and of itself” (i.e., independent of bioavailability concerns) would have motivated a person of ordinary skill to modify 5-HMT, the Federal Circuit noted that Amerigen did not present this theory to the Board, and could point to no evidence in the record to support of it, and did not explain why a skilled artisan would modify a drug to increase its lipophilicity independent of bioavailability.

As to Amerigen’s argument that a skilled artisan would have been motivated to modify 5-HMT because 5-HMT was patented at the time of invention, the Federal Circuit noted that there was no indication that such a motivation was sufficient to prove that the claimed compounds would have been obvious.  The Federal Circuit said:

Any compound may look obvious once someone has made it and found it to be useful, but working backwards from that compound, with the benefit of hindsight, once one is aware of it does not render it obvious.

Any compound may look obvious once someone has made it and found it to be useful, but working backwards from that compound, with the benefit of hindsight, once one is aware of it does not render it obvious.

The Federal Circuit said it considered Amerigen’s remaining arguments, and not find them persuasive, and thus affirmed the Board’s decision.

In Realtime Data, LLC, v. Iancu, [2018-1154] (January 10, 2019), the Federal Circuit affirmed the PTAB’s determination that claims 1–4, 8, 14–17, 21, and 28 of U.S. Patent No. 6,597,812 on systems and methods for providing lossless data compression and decompression would have been obvious over the prior art.

Realtime made two primary arguments on appeal: (1) that the Board erred in its determination that a person of ordinary skill in the art would have been motivated to combine the teachings of O’Brien and Nelson; and (2) that the Board erred by failing to construe the “maintaining a dictionary” limitation and in finding that O’Brien disclosed the “maintaining a dictionary” limitation.

HP’s primary argument to the Board was that all of the elements of claims 1–4, 8, and 28 were disclosed in O’Brien, a single reference, and it relied on Nelson simply to demonstrate that a person of ordinary skill in the art would have understood that the string compression disclosed in O’Brien was, in fact, a type of dictionary encoder, the terminology used in the ’812 patent.  HP alternatively argued that that Nelson disclosed at least some of the elements in the claims at issue.  Because the Board agreed that all of the claim elements could be found in O’Brient alone, the the Board was not required to make any finding regarding a motivation to combine.  Had the Board relied upon HP’s alternative argument, it would have been required to demonstrate a sufficient motivation to combine the two references.

While Realtime argues that the use of O’Brien as a single anticipatory reference would have been more properly raised under §102, the Federal Circuit said that it is well settled that “a disclosure that anticipates under § 102 also renders the claim invalid under §103, for ‘anticipation is the epitome of obviousness.’”

The Federal Circuit said that in any event, even if the Board were required to make a finding regarding a motivation to combine O’Brien with Nelson, its finding in this case is supported by substantial evidence.  The Federal Circuit noted that a motivation to combine may be found “explicitly or implicitly in market forces; design incentives; the ‘interrelated teachings of multiple patents’; ‘any need or problem known in the field of endeavor at the time of invention and addressed by the patent’; and the background knowledge, creativity, and common sense of the person of ordinary skill.”

On the issue of whether the Board erred in finding that O’Brien disclosed the “maintaining a dictionary” limitation in independent claim 1, Realtime argued that the Board erroneously failed to construe the term “maintaining a dictionary” to include the requirement that the dictionary be retained during the entirety of the data compression unless and until the number of entries in the dictionary exceeds a predetermined threshold, in which case the dictionary is reset.  While the words of a claim are generally given their ordinary and customary meaning, a claim term is read not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification.  These claim construction principles are important even in an inter partes review proceeding like this one, in which the claims were properly given the “broadest reasonable interpretation” consistent with the specification.

The Federal Circuit said that the Board’s interpretation was supported by both the claim language itself and the specification. While the term “maintaining a dictionary” is not defined, claim 4 lends meaning to the phrase, and directly mimics the specification.  Realtime argued that because the claim recited “comprising” the Board erred by limiting the definition of “maintaining a dictionary.”  The Federal Circuit rejected, this argument pointing out that the word “comprising” does not mean that the claim can be read to require additional unstated elements, only that adding other elements to the device or method is not incompatible with the claim.

The Federal Circuit concluded that the Board did not err in concluding that the claims would have been obvious in view of a single reference, and that the Board did not err in finding that O’Brien disclosed the “maintaining a dictionary” limitation in independent claim 1, and therefore affirmed the Board.

In Hamilton Beach Brands, Inc. v. F’Real Foods, LLC, [2018-1274](November 16, 2018) the Federal Circuit affirmed the PTAB’s Final Written Decision upholding the validity of claim 21 of U.S. Patent No. 7,520,662, on a rinseable splash shield and method of use, covering a shield for the vessel of a mixing machine.

As a preliminary matter, the Federal Circuit ducked the question of whether the IPR was barred by Section 315(b) because F’Real failed to appeal the Board’s decision that the IPR was not time barred.  Hamilton Beach had actually been served with a complaint for infringement of the ‘662 patent more than a year before the IPR was filed, but at the time F’Real did not own the patent, and thus did not have standing.  Thus the Federal Circuit’s Click-to-Call decision was not necessarily controlling, but the Federal Circuit declined to decide whether 315(b) applies to a complaint served by a party without standing.

The Board concluded that the references did not teach a rinse nozzle at a fixed location relative to the shield, and that in any event objective evidence of non-obviousness outweighed the evidence of obviousness.  Hamilton Beach argued that the Board violated the Administrative Procedure Act by changing claim construction theories midstream without providing the parties an opportunity to respond, and additionally erred in construing the “nozzle” terms so as to require that the nozzles be pre-positioned.  The Federal Circuit found that Hamilton Beach received adequate notice of the claim construction adopted by the Board in F’Real’s post-institution response regarding the nozzle terms, as shown by the fact that Hamilton Beach argued against F’Real’s proposed constructions in its reply brief and during the oral hearing.  The Federal Circuit further found that the Board’s final adopted construction of the nozzle terms, while not identical to those proposed by F’Real, were similar enough to F’Real’s proposed constructions so as to not constitute changing theories midstream in violation of the APA.

Based on the claim language itself, the Federal Circuit rejected Hamilton Beach’s claim construction, noting that the claim required “a nozzle oriented” towards the splash shield. Based upon this construction the Federal Circuit affirmed the determination of non-obviousness.  In an unusual twist, Hamilton Beach, the patent challenger, argued that the Board improperly relied upon hindsight, in its finding that finding that there was no sufficiently proved motivation to combine the prior art references.  Although the prior art recites cleaning the mixing machine, the Federal Circuit found that substantial evidence supports the Board’s finding that Hamilton Beach did not prove that the prior art provides a motivation to clean components in place with a fixed nozzle directed towards the splash shield.  The Federal Circuit concluded that the Board did not err in its decision that the prior art did “not teach or suggest the nozzle limitations.”

Because the Federal Circuit affirmed the Board’s findings regarding the failure of the prior art to teach or suggest all limitations of claim 21, it did not address Hamilton Beach’s assertions of error in the Board’s consideration of the objective indicia of nonobviousness.

In Yeda Research and Development Co., Ltd. v. Mylan Pharmaceuticals Inc., [2017-1594, 2017-1595, 2017-1596] (October 12, 2018) the Federal Circuit affirmed the Board’s determination that U.S. Patent Nos. 8,232,250, 8,399,413, and 8,969,302 unpatentable as obvious.

Yeda contends that its due process rights and the APA were violated because it did not have notice of, and an opportunity to respond to, Khan 2009. The Board relied on Khan 2009 in deciding whether a POSITA would have had a reasonable expectation of  success of a thrice-weekly regimen.  Yeda received notice of Khan 2009 in Petitioners’ expert reply declaration, attached to Petitioners’ reply. Yeda deposed Dr. Green after receiving his reply declaration; he discussed Khan 2009 in that deposition and was questioned about it.  Yeda also moved to exclude Khan 2009 as irrelevant, which the Board denied. Yeda could have, but did not, address Khan 2009 at the oral hearing or
seek leave to file a surreply to substantively respond to Khan 2009.

Based on this record, the Federal Circuit received proper notice of and an opportunity to respond to Khan 2009—an opportunity Yeda took advantage of when it moved to  exclude the study. But Yeda contends that it had no notice that the Board “might rely extensively” on Khan 2009 and make it “an essential part of its obviousness analysis.” The Federal Circuit said that although Yeda framed its argument as being about due process, it really only challenges the Board’s use of Khan 2009.  The Board acknowledged that Khan 2009 does not qualify as statutory prior art, but because the study began two years before the priority date of the patents, the Board concluded that Khan 2009 is “probative of the fact that those skilled in the art were motivated to
investigate dosing regimens of GA with fewer injections to improve patient compliance.”

The real question before the Federal Circuit was whether the Board may consider non-prior art evidence, such as Khan 2009, in considering the knowledge, motivations, and
expectations of a POSITA regarding the prior art.  The Federal Circuit noted that the statute permits IPR petitioners to rely on evidence beyond the asserted prior art. Section 312(a)(3) of Title 35 specifies that a petition should include both “copies of
patents and printed publications that the petitioner relies upon,” and “affidavits or declarations of supporting evidence and opinions.” As do the regulations.  See 37 C.F.R. § 42.104(b).

The Federal Circuit said that the Board has recognized that non-prior art evidence of what was known “cannot be applied, independently, as teachings separately combinable” with other prior art, but “can be relied on for their proper supporting roles, e.g., indicating the level of ordinary skill in the art, what certain terms would mean to one with ordinary skill in the art, and how one with ordinary skill in the art would have understood a prior art disclosure.” The Federal Circuit said that the expert’s reliance on Khan 2009 is permissible, as it supports and explains his position that a POSITA would have thought less frequent dosing worthy of investigation as of the priority date. The Federal Circuit found the reliance proper, but to the extent that this reliance was error,
it concluded that it was harmless error, because substantial evidence otherwise
supports the Board’s conclusion.

In Teva Pharmaceuticals USA, Inc., v. Sandoz Inc., [2017-1575] (October 12, 2018), the Federal Circuit affirmed the district court decision invalidating for obviousness all asserted claims of patents directed to COPAXONE® 40mg/mL, a product marketed for treatment of patients with relapsing forms of multiple sclerosis.

On appeal, Teva argued the district court improperly discounted the “sufficiency” terms in its claims, construing these terms to be nonlimiting statements of intended effect.  The Federal Circuit said that “the regimen being sufficient to reduce the frequency of relapses in the patient” does not change the express dosing amount or method already disclosed in the claims, or otherwise result in a manipulative difference in the steps
of the claims.” The Federal Circuit further found that Teva’s argument that the  sufficiency terms were added during prosecution to overcome rejections overstated the intrinsic record. Accordingly the Federal Circuit found no error in the district court’s construction.

As to obviousness, Teva argued for the patentability of its claimed dosing regimen,  the improved tolerability, reduced frequency of adverse effects, and the reduced severity of injection site reactions.

The Federal Circuit rejected Teva’s argument that the district court engaged in an improper obvious to try analysis.  An “obvious to try” analysis is improper if it suggests varying all parameters or try every available option until one succeeds, where the prior art gave no indication of critical parameters and no direction as to which of many possibilities is likely to be successful.   An “obvious to try” analysis is involves a new technology or general approach in a seemingly promising field of experimentation, but the prior art gives only general guidance as to the particular form or method of
achieving the claimed invention. The Federal Circuit said that neither of these was what the district court did — the prior art focused on two critical variables, dose size and injection frequency, and provided clear direction as to choices likely to be successful in
reducing adverse side effects and increasing patient adherence.

Teva contends that the unpredictable nature of the compound categorically precludes the obvious-to-try analysis employed by the district court.  Again the Federal Circuit disagreed, noting obviousness was proven through human clinical studies establishing the safety, efficacy, and tolerability at doses and dose frequencies similar to the claimed regimen.

Regarding improved tolerability and reduced frequency, Teva argued that the prior art did not lead POSITAs to expect improved tolerability and reduced frequency of
injection reactions from the claimed regimen compared to the prior art, but the Federal Circuit disagreed.  Teva found fault with the district court’s reference to “common sense” in its reliance on expert testimony, and argued that the expert testimony was conclusory and unsupported by the prior art.  The Federal Circuit found no error in what is essentially a credibility determination.

On reduced severity, the Federal Circuit again agreed with the district court that the evidence provided a reasonable expectation to those skilled in the art that reducing the number of injections per week may also reduce the severity of injection site reactions.

In Endo Pharmaceutical Solutions, Inc. v. Custopharm Inc., [2017-1719] (July 13, 2018), the Federal Circuit affirmed the determination that the claims of U.S. Patent Nos. 7,718,640 and 8,338,395 on a long-acting injectable testosterone replacement therapy were not invalid for obviousness.

the district court found that the prior art did not disclose the 750 mg TU injection dosage, and that Custopharm had not shown, by clear and convincing evidence, that a skilled artisan would have been motivated to lower the dosage of TU from 1000 mg to 750 mg.  The district court
found that articles about studies do not inherently disclose the particular co-solvent or the particular ratio of solvent to co-solvent claimed by the patents-in-suit simply because this formulation was what had been used in the studies forming the basis of the articles.

The claims required a 750 mg dosage, which the parties agreed was not disclosed by the prior art.  However, Custompharm argued the district court erred in finding no motivation for a skilled artisan to lower the dose of TU from the 1000 mg disclosed in the prior art to 750 mg.   After discussing the evidence, the Federal Circuit said the district court
reasonably rejected Custopharm’s argument that a skilled artisan would consider 1000 mg of TU to be an overdose and would have been motivated to lower the dosage to the patented 750 mg.

Custopharm also argued that the district court erred in finding that the
claimed formulation was not inherently described by prior art articles Articles.  Although the formulation was not disclosed is the articles,  Custopharm argues that the vehicle formulation was “necessarily present” in the articles because it was later revealed to be the actual formulation the authors of the Articles used in their reported clinical studies, but the Federal Circuit disagreed.  The Federal Circuit noted that Custopharm has not demonstrated that a skilled artisan could extrapolate the vehicle formulation used in the Articles from pharmacokinetic performance data.  It was Custopharm’s burden to present clear and convincing evidence that the Articles necessarily disclosed the vehicle formulation to one of skill in the art, and  Custopharm’s expert’s testimony and briefing fall short of meeting this burden.  The Federal Circuit said that under the circumstances
of this case, the incomplete description of the injection composition elements denied skilled artisans from having access to that composition, thereby precluding use of the inherency doctrine to fill in disclosure about the product missing from the articles.

Regarding the motivation to combine, the Federal Circuit said that the district court thus did not err in considering the obviousness inquiry from the perspective of a skilled artisan “confronted with the same problems as the inventor,” which in the present case is developing a commercially
viable long-acting testosterone therapy.  Doing so, the district court properly found that Custopharm failed to meet its burden of showing that a skilled artisan would combine the lowered dose with the injection schedule in the manner claimed.