In Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Laboratories, Inc., [2018-1804, 2018-1808, 2018-1809] (August 14, 2019), the Federal Circuit affirmed the determination that claims 1 and 2 of U.S. Patent No. 5,847,170 were not invalid for obviousness.

The Federal Circuit noted that in cases involving new chemical compounds, it remains necessary to identify some reason that would have led a chemist to modify a known compound in a particular manner to establish prima facie obviousness of a new claimed compound. The reason need not be the same as the patentee’s or expressly stated in the art, but charting a path to the claimed compound by hindsight is not enough to prove obviousness. The Federal Circuit observed that 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.

In its obviousness analysis, the district court considered the testimony of seven witnesses and seventeen prior art references and ultimately concluded that Defendants failed to prove that claims 1 and 2 of the ’170 patent would have been obvious. In addition, the district court found that some secondary considerations evidence supported nonobviousness and that there was a nexus between claims 1 and 2 and the marketed product Jevtana®. The Federal Circuit agreed with Sanofi and concluded that Fresenius’s “convoluted” obviousness theory lacks merit. The Federal Circuit concluded that the district court did not clearly err in its assessment of these references or in finding that they would not have motivated a skilled artisan to modify the lead compound to achieve the claimed compound.

In Novartis Pharmaceuticals Corp. v. West-Ward Pharmaceuticals Int’l Ltd., [2018-1434] (May 13, 2019), the Federal Circuit affirmed the district court’s determination that claims 1–3 of U.S. Patent No. 8,410,131 for treating treat advanced renal cell carcinoma would not have been obvious in view of the prior art.

The Federal Circuit held that the district court erred in finding no motivation to combine the prior art references, but found no clear error in the district court’s finding that a person of ordinary skill would not have reasonably expected success, and thus agreed with the district court’s ultimate determination that the challenged claims would not have been obvious.

As to motivation to combine, the Federal Circuit noted that its case law does not require that a particular combination must be the preferred, or the most desirable, combination described in the prior art in order to provide motivation for the current invention. Thus it was improper to have required defendants to prove that a person of ordinary skill would have selected the claimed compound over the other prior art treatment methods in the reference.

However on the issue of reasonable expectation of success, the Federal Circuit agreed with the district court. In particular the district court relied upon on the prior art and expert testimony to support subsidiary findings that (1) the phase I data for a related compound had diminished weight, (2) the claimed compound had different pharmacological properties than the prior art compound, and (3) the molecular biology of advanced RCC was not completely understood. The Federal Circuit affirm the district court’s conclusion that claims 1–3 of the ’131 patent would not have been obvious in view of the asserted prior art

In Neptune Generics, LLC v. Eli Lilly & Company, [2018-1257, 2018-1258](April 26, 2019), the Federal Circuit affirmed PTAB’s Final Written Decisions in multiple inter partes reviews holding Petitioners did not establish that claims 1–22 of U.S. Patent No. 7,772,209 are unpatentable for obviousness.

The Board found that it was known in the prior art that pretreatment with folic acid reduces the toxicity associated with administration of an antifolate, like pemetrexed, but there was not a reason to pretreat with vitamin B12 along with folic acid found that it was known in the prior art that pretreatment with folic acid reduces the toxicity associated with admin-istration of an antifolate, like pemetrexed, but there was not a reason to pretreat with vitamin B12 along with folic. The Board further found that skepticism of others, particularly the FDA, supported a conclusion of nonobviousness.

Although there was a reference that taught administration of folic acid and B12, it was not for the purpose of reducing toxicity of premetrexed, and the record including expert testimony persuasively established that one of skill in the art would not have understood that there was no observed correlation between vitamin B12 deficiency and pemetrexed-induced toxicity.

Petitioners argued that Lilly told the FDA that the FDA that the prior art suggested that pretreating with folic acid and B12 was a no-risk, predictable way to lower pemetrexed-induced fatalities by lowering pretreatment homocysteine levels. However, since these statements were all made post-critical date, the views Lilly expressed about the prior art references in its communications are made through the lens of what they had invented.

As to secondary considerations, the Board found that evidence of skepticism of others, particularly the FDA, supported a conclusion of nonobviousness. When during FDA trials Lilly recommended supplementation with folic acid and vitamin B12. The FDA responded that the “medical officer does not sup-port adding vitamins to the ongoing . . . trial,” and that in other communications with Lilly the FDA stated that the information provided to it “does not appear to support the addition of vitamins,” and that “the addition of vitamins . . . is risky.” Petitioners argued that skepticism must be premised on whether it is “technically infeasible,” “unworkable,” or “impossible” that the claimed subject matter would work for its intended purpose, but the Federal Circuit disagreed, point out that its caselaw recognizes a range of third-party opinion that can constitute skepticism. The Federal Circuit noted that while evidence that third parties thought the invention was impossible might be entitled to more weight, that does not mean the Board erred in giving weight to the skepticism evidence here.

While evidences of teaching away must specifically discourage the inventive course, the Federal Circuit reminds us in Neptune Generics that evidence that third parties were “worried” or “surprised” is sufficient to establish skepticism.

In Gruenthal GmbH v Alkem Laboratories Limited, [2017-1153, 2017-2048, 2017-2049, 2017-2050] (March 28, 2019), the Federal Circuit affirmed the district court’s judgment that U.S. Patent No. 7,994,364 is not invalid for obviousness or lack of utility, and that U.S. Patent No. 8,536,130 is not infringed.

With respect to infringement, because neither Hikma’s nor Actavis’s proposed label is indicated to treat polyneuropathic pain, and the case made by Grünenthal and Depomed for indirect infringement depended on the proposed label indications, the Federal Circuit agreed with the trial court that Hikma and Actavis do not induce infringement of or contributorily infringe claims 1 and 2 of the ’130 patent. The Federal Circuit said that the pertinent question is whether the proposed label instructs users to perform the patented method, and the Federal Circuit agreed that it did not.

On the obviousness question, the Federal Circuit found that defendants failed to show a reasonable expectation of success. The Federal Circuit said that the court did not clearly err in finding that a POSA would not have had a reasonable expectation of successfully producing Form A, as claimed in the ’364 patent, by using the methods outlined in Byrn on the compound disclosed in the ’737 patent (Form B). The Federal Circuit noted that because the record indicates that there was (1) no known or expected polymorphism of tapentadol; (2) no evidence that the synthesis of Example 25 results in any Form A; and (3) no guidance as to what particular solvents, temperatures, agitation rates, etc., were likely to result in Form A, Alkem failed to prove that a POSA would have reasonably expected a polymorph screening of the Form B disclosed in the ’737 patent to result in Form A.

The Federal Circuit also rejected the “obvious to try” arguments, noting that the patent owner identified many variables for screening, i.e., a “huge number of possible choices,” as opposed to a “finite number,” contemplated in KSR. The Federal Circuit reiterated that a conclusion of obviousness does not follow from merely varying all parameters or trying each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful.

Finally, on the issue of utility, the Federal Circuit noted that a patent must have specific and substantial utility. The substantial requirement, also known as “practical utility,” is satisfied when the claimed invention has a significant and presently available benefit to the public. The specific requirement is satisfied when the invention is shown to provide a well-defined and particular benefit to the public. In other words, the Federal Circuit said, a patent has utility if the alleged invention is capable of providing some identifiable benefit presently available to the public.

For pharmaceutical patents, practical utility may be shown by evidence of “any pharmacological activity.” The Federal Circuit found the disclosure sufficient. The patent stated that the crystalline Form A according to the invention is used for the treatment of pain or the treatment of urinary incontinence. This was confirmed by the prior art and by expert testimony. The Federal Circuit concluded that the ’364 patent concretely discloses the practical benefit of Form A of tapentadol hydrochloride as an analgesic.

The Federal Circuit also rejected the argument that substantial utility must be shown by test results. While test results often support claims of utility in patents concerning pharmacological arts, such testing is not always required. All that is required is that the tests be reasonably indicative of the desired pharmacological response. The Federal Circuit said that the patent owner need not prove that Form A has superior stability over Form B for purposes of determining utility — the patent statute does not require that a patentable invention be superior to all prior devices, it is sufficient that Form A is shown to be stable at room temperature and useful for pain relief.

In Personal Web Technologies, LLC v. Apple, Inc., [2018-1599] (March 8, 2019), the Federal Circuit reversed the PTAB determination that claims 24, 32, 81, 82, and 86 of U.S. Patent No. 7,802,310 are unpatentable.

The ’310 patent explains that in conventional data processing systems, data items such as files are typically identified by their user-created alphanumeric name and/or pathname or location. If one device transfers a data item to a second device using just the name associated with the data item, it is possible that the data item already exists on the second device, and a duplicate of the data item will be created.

The Board found the claims obvious relying on Woodhill inherently disclosing a claim element. The Federal Circuit found that because the element does not necessarily exist in Woodhill, the Board’s reliance on inherency for that element in its obviousness analysis was improper.

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.