Category Archives: Secondary Considerations

Broad, Functional Claims Made it Hard to Presume Nexus for Commerical Succes

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In Teva Pharmaceuticals International GmbH v. Eli Lilly and Company, [2020-1747, 2020-1748, 2020-1750] (August 16, 2021), the Federal Circuit affirmed that Board’s determination that the claims of U.S. Patent Nos. 9,340,614, 9,266,951, and 9,890,210 are unpatentable because they would have been obvious over the cited prior art. The patents are directed to humanized antagonist antibodies that target calcitonin gene-related peptide (“CGRP”), that has been shown to be a potent vasodilator in the periphery.

Teva raised three challenges to the Board’s decision. First, Teva contended that the Board erred as a matter of law in its motivation to combine analysis by deviating from the motivation asserted by Lilly in its petitions for inter partes review. Second, Teva contended that even under the motivation to combine that the Board did analyze, substantial evidence does not support the Board’s factual findings. And third, Teva contended that the Board erred in its analysis of secondary considerations of nonobviousness.

Lilly asserted that a skilled artisan would have been motivated to combine the teachings of the references to make a humanized anti-CGRP monoclonal antibody for therapeutic use in humans, but the Board instead considered whether a skilled artisan would have been motivated to make the antibody merely to study or use it. Teva insists that by not requiring Lilly to support its therapeutic motivation, the Board incorrectly discounted important safety and efficacy concerns that would have been demotivating factors—i.e., reasons why a skilled artisan would have been motivated not to make a humanized anti-CGRP monoclonal antibody. The Federal Circuit held that the Board did apply the motiviation that Lilly asserted. The Federal Circuit said that “common sense and scientific reality dictate that scientists do not “study or use” humanized anti-bodies with an end goal of treating diseases in test tubes or in rats. At bottom, the prior art supports a motivation to humanize antibodies with the goal of treating human disease.”

Teva also argued that the substantial evidence did not support the Board’s factual findings. The Federal Circuit agreed with Lilly that substantial evidence supports a motivation to make a humanized anti-CGRP antibody to study its therapeutic potential for use in treatment of human disease, noting that Lilly identified evidence that supports the Board’s reasonable readings of each reference. Under the deferential standard of review, the Federal Circuit could not replace the Board’s reasonable interpretation of references with Teva’s interpretation.

Finally, with respect to secondary considerations, the Board found that the commercial products and the license lacked sufficient nexus to the challenged claims. Teva argued that the Board made two legal errors: first, in finding no presumption of nexus between the claims and the secondary considerations based on the commercial products; and second, with regard to the asserted licenses, Teva argued that the Board erred by focusing on the licensee’s products rather than the scope of the license.

The Federal Circuit found that the Board erred in its articulation of the standard for presuming nexus, but nonetheless conducting the necessary factual analysis of the unclaimed features of the commercial products, and reached the correct conclusion that no presumption of nexus applied. The Federal Circuit noted that the claims at issue used functional language, and that a claim to “anything that works” hardly has a nexus to any particular product. Because the claims in this case have a broad scope due to their lack of structural limitations, the unclaimed features in the commercial products cited here are of particular importance to the coextensiveness analysis. The Federal Circuit thus found that the Board’s factual findings regarding unclaimed features are thus supported by substantial evidence, and Teva has not shown otherwise.

Teva also argued that the Board erred by requiring a direct nexus between the challenged claims and the licensee’s products. The Federal Circuit found that the Board’s conclusion that the license lacked nexus to the challenged claims was supported by substantial evidence. The significance of licensing a patent as a secondary consideration in enhancing the nonobviousness of an invention is that an independent party with an interest in being free of the patent has chosen to respect it and pay a royalty under it rather than litigate and invalidate it. Such action tends to support its validity. The Federal Circuit said that given that 188 patents were licensed, the nexus between the license and the validity of any particular claim is rather tenuous to say the least. The Federal Circuit noted that Teva failed to show anything more than the existence of the license. Teva did not present direct evidence that the licensee’s motivation for entering into the license was related to the validity or enforceability of the patents at issue.

It is not Obvious to Ignore the Teachings of the Prior Art

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In Chemours Company FC, LLC v. Daikin Industries, LTD., [2020-1289, 2020-1290] (July 22, 2021), the Federal Circuit concluded that the Board’s decision on obviousness is not supported by substantial evidence and that the Board erred in its analysis of objective indicia of nonobviousness, and reversed.

U.S. Patent No. 7,122,609 relates to a unique polymer for insulating communication cables formed by pulling wires through melted polymer to coat and insulate the wires, a process
known as “extrusion.”

Chemours argues that the Board’s final written decision on obviousness is erroneous because its factual findings on motivation to combine were unsupported by substantial evidence, and specifically that Daikin did not meet its burden of proof because it failed to show that a person of ordinary skill in the art would modify the polymer of the prior art reference to achieve the claimed invention. However the reference also taught that a narrow distribution of molecular weights was important, while the claimed invention did not use the narrow distribution of molecular weights.

The Federal CIrcuit found that Board’s obviousness findings are not supported by substantial evidence. The Federal Circuit said the Board appears to have ignored the express disclosure in the reference that teaches away from the claimed invention and relied on teachings from other references that were not concerned with the particular problems the reference sought to solve. More specifically, the Board did not explain why one would be motivated to increase the melt flow rate to the claimed range, when doing so would necessarily involve altering the inventive concept of a narrow molecular weight distribution polymer. The Federal Circuit cited Trivascular, Inc. v. Samuels, 812 F.3d 1056, 1068 (Fed. Cir. 2016) where it found no motivation to modify the prior art where doing so “would destroy the basic objective” of the prior art).

The Federal Circuit found that this was particularly true in light of the fact that the reference appears to teach away from broadening molecular weight distribution and the known methods for increasing melt flow rate. The Federal Circuit said that the Board relied on an inadequate evidentiary basis and failed to articulate a satisfactory explanation that is based on substantial evidence for why one would have been motivated to modify the reference.

The Federal Circuit also agreed that the Board erred in its analysis of objective indicia. The Board found no nexus between the claimed invention and the alleged commercial success because all the features were disclosed in the prior art. The Federal Circuit instructed that contrary to the Board’s decision, the separate disclosure of individual limitations, where the invention is a unique combination of three interdependent properties, does not negate a nexus, explaining that concluding otherwise would mean that nexus could never exist where the claimed invention is a unique combination of known elements from the prior art.

The Federal Circuit also agreed that the Board erred in its demand that market share evidence is necessary to sustain a finding of commercial success. Chemours contended that sales data
alone should be enough for commercial success, and the Federal Circuit agreed. The Federal Circuit said that market share data, though potentially useful, is not required to show commercial success. While the Board was entitled to weigh evidence and find, if appropriate, that Chemours’s gross sales data were insufficient to show commercial success without market
share data, the Board, erred in its analysis that gross sales figures, absent market share data, “are inadequate to establish commercial success.”

Lastly, the Federal Circuit agreed that the Board erred when it found that the patents in suit were blocking patents. A blocking patent is an earlier patent that prevents practice of a later invention—the invention of the patent-in-dispute. The Board concluded that the evidence proffered to establish commercial success was weak because the patent-in-suit blocked others
from entering the market. The Federal Circuit said that the challenged patent, which covers the claimed invention at issue, cannot act as a blocking patent.

Obviousness Requires a Reason, Suggestion, or Motivation

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In Forest Laboratories, LLC v, Sigmapharm Laboratories LLC, [2017-2369, 2017-2370, 2017-2372, 2017-2373, 2017-2374, 2017-2375, 2017-2376, 2017-2389, 2017-2412, 2017-2436, 2017-2438, 2017-2440, 2017-2441]( March 14, 2019) the Federal Circuit vacated and remanded the district court’s validity determination, and we vacated and remanded the question of infringement under a corrected claim construction.

The district court construed claim 1 to be limited to buccal and sublingual formulations. Although claim 1 does not expressly refer to buccal or sublingual administration, the Federal Circuit noted that claims “must be read in view of the specification, of which they are a part.” The Federal Circuit held the district court properly construed claim 1 to be limited to buccal and sublingual formulations.

As to obviousness, the district court found Appellants had not established that there was a motivation to combine asenapine maleate into a sublingual or buccal form, and even if there were a motivation to combine, a skilled artisan would not have had a reasonable expectation that it would work. The Federal Circuit noted that an invention is not obvious simply because all of the claimed limitations were known in the prior art at the time of the invention. Instead, the question is whether there is a reason, suggestion, or motivation in the prior art that would lead one of ordinary skill in the art to combine the references, and that would also suggest a reasonable likelihood of success. The motivation can be found explicitly or implicitly in the prior art references themselves, in market forces, in design incentives, or in any need or problem known in the field of endeavor at the time of invention and addressed by the patent.

The Federal Circuit noted that the district court failed to make an express finding as to whether compliance concerns for patients with trouble swallowing would provide a motivation to combine, and remanded for the district court to address this question.

As to secondary considerations, the Federal Circuit found that the district court did not err in finding long felt need weighs in favor or non-obviousness. However, the Federal Circuit found that the district court did err in finding unexpected results, finding that the results were not surprising and unexpected, since one of ordinary skill in the art would not have expected differently.

On the issue of written description, the Federal Circuit held that the district court’s finding that the specification contains sufficient written description support for the claims was not clearly erroneous.

On the issue of infringement, the district court construed claim 4 to not cover the treatment of bipolar disorders. Because the district court erred in treating “excitation” as being limited to “excitation disorders,” we vacate its finding of non-infringement. We construe “excitation” to refer to a symptom and remand for the district court to assess infringement in light of this construction.

What’s Zup? Water Board Patent Obvious; Secondary Considerations Too Weak to Show Otherwise

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In Zup, LLC v. Nash Manufacturing, Inc., [2017-1601] (July 25, 2018), the Federal Circuit affirmed the district court’s judgment that claims 1 and 9 of U.S. Patent No. 8,292,681 on a water recreational board and a method of riding such a board were invalid for obviousness.

Zup and Nash had discussions about a potential joint manufacturing venture for the ZUP Board, and when they fell through, and Nash
brought the accused product to market.  Zup sued Nash, and the district court granted Nash’s motion for summary judgment of invalidity.  The parties agreed on the content of the prior art, and level of skill, but disagreed on whether a person of ordinary skill in the art would have been motivated to combine the prior art references in the way claimed in the patent, and whether the district court properly evaluated Zup’s
evidence of secondary considerations.

The Federal Circuit said 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.”  The district court explained that the ’681 patent identified known elements in the prior art that aided in rider stability while engaging a water recreational device and simply combined them in one apparatus and method.  The district court said that one of ordinary skill in the art would have been motivated to combine the various elements from the prior art references, noting that such motivation would have stemmed from a desire to aid in rider stability, to allow a wide variety of users to enjoy the device, and to aid users in maneuvering between positions on a water board — all
motivations that were “a driving force throughout the prior art and have been shared by many inventors in the water recreational device industry.

The Federal Circuit found that the record supported the district court’s analysis.  The Federal Circuit observed that helping riders switch between riding positions had long been a goal of the prior art, citing various portions of the references of record.  The Federal Circuit pointed out that Zup admitted that achieving rider stability is an “age-old motivation in this field,” and found that such stability was enhanced in the prior art through the same components employed in the ’681 patent: tow hooks, handles, foot bindings, and other similar features.

In the face of significant evidence regarding the consistent desire for riders to change positions while riding water recreational boards (and the need to maintain stability while doing so), and given that the elements of the ’681 patent were used in the prior art for this very purpose, the Federal Circuit said there was no genuine dispute as to the existence of a motivation to combine the references.

The Federal Circuit further found that Zup’s minimal evidence of secondary considerations does not create a genuine dispute of fact
sufficient to withstand summary judgment on the question of obviousness.  The Federal Circuit rejected ZUP’s contention that the district court improperly shifted the burden to prove non-obviousness to Zup because Nash introduced no evidence as to secondary
considerations, yet Zup still lost, noting that “any concerns regarding improper burden allocation can be quickly dismissed. The Federal Circuit said that the burden of persuasion remains with the challenger during litigation because every issued patent is entitled to a  presumption of validity. However, while the burden of persuasion remains with the challenger, a patentee bears the burden of production with respect to evidence of secondary considerations of nonobviousness.  The Federal Circuit said that it is clear that the district
court kept the ultimate burden of persuasion on the patent challenger throughout the obviousness analysis. Any argument that the district court improperly shifted the burden is therefore without merit.

On the issue of secondary considerations the Federal Circuit said that where the differences between the prior art and the claimed invention are minimal, it cannot be said that any long-felt need was unsolved.  The Federal Circuit further found that the record evidence indicates that the claimed invention was not the first to achieve the goal of helping users maneuver between positions on a water recreational board.

The Federal Circuit rejected the arguments of copying, noting that Nash’s instructions suggest a configuration that is different from Zup’s product, dispelling any inference of copying.

The Federal Circuit concluded that the weak evidence of secondary
considerations presented here simply cannot overcome the strong showing of obviousness, quoting “a claimed invention represents no more than the predictable use of prior art elements according to
established functions, as here, evidence of secondary indicia are frequently deemed inadequate to establish non-obviousness.”

Patent Owner Has Burden to Prove Marking Once Infringer Identifies Unmarked Products

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In Arctic Cat Inc. v. Bombardier Recreational Products Inc., [2017-1475] (December 8, 2017), the Federal Circuit affirme the district court’s denial
of judgment as a matter of law as to obviousness, the
jury’s royalty rate, willfulness, treble damages, and award of an ongoing
royalty to Arctic Cat, but vacated the court’s denial of judgment as a matter of law as to marking and remand for further consideration limited to that issue.

The case involved U.S. Patent Nos. 6,568,969 and 6,793,545 directed to thrust steering systems for personal watercraft.  At trial, the jury found both patents not invalid, awarded a royalty for past infringement of $102.54 per unit, and based upon the jury’s finding of willful infringement, the district court trebled damages.  The district court also awarded an ongoing royalty of $205.08 per unit.

On the obviousness finding the Federal Circuit said that it presumes the jury found that an ordinarily skilled artisan would not have been motivated to combine the prior art as appellant proposed, and that if
such a fact finding is supported by substantial evidence, it cannot not reverse it. The Federal Circuit noted that appellant devoted much of its argument to re-litigating its case and its evidence rather than addressing the evidence that could have supported the jury’s finding of no motivation to combine. The Federal Circuit said that it does not reweigh the evidence and reach its own factual determination regarding motivation. The question on appeal is only whether substantial
evidence supports the jury’s presumed finding, and the Federal Circuit found substantial evidence did support the finding.

As to objective indicia of non-obviousness, the patent owner argued the claimed invention received industry praise and satisfied a long-felt need. The Federal Circuit again presumed the jury found in favor of patentee, and the Federal Circuit cannot reverse these presumed findings if they are supported by substantial evidence, which the Federal Circuit found they were.

As to the marking issue,  the Federal Circuit said that the patent owner patentee bears the burden of pleading and proving it complied with § 287(a)’s marking requirement, because if a patentee who makes, sells, offers for sale, or imports the patented articles has not given notice of its right”by marking the articles pursuant to the marking statute, it is not entitled to damages before the date of actual notice.  A patentee’s licensees must also comply with §287, because the statute extends to persons making or selling any patented article for or under the patentee.  The Federal Circuit add that recognizing that it may be difficult for a patentee to ensure his licensees’ compliance with the
marking provisions, its has held that where third parties are involved, courts may consider whether the patentee made reasonable efforts to ensure compliance with the marking requirements.

In the present case, the patent owner Arctic Cat licensed patents to Honda, and the agreement specifically stated Honda “shall have no obligation or requirement to mark” its licensed products.  However, While Honda sold products in the U.S. without marking them, Arctic Cat contended they were not covered by the patent and thus should not have been marked.

Arctic Cat and Bombardier disputed whether the products Honda sold were patented articles that were required to be marked, as well as who had the burden of proof.  There was a split in the Circuits on the burden of proof, which the Federal Circuit resolved by holding that an alleged infringer who challenges the patentee’s compliance with § 287 bears an initial burden of production to articulate the products it believes are unmarked “patented articles” subject to § 287. The Federal Circuit said that this was a low bar, and that the alleged infringer need only put the
patentee on notice that it or its authorized licensees sold specific unmarked products which the alleged infringer believes practice the patent. The Federal Circuit said that the alleged infringer’s burden is a burden of production, not one of persuasion or proof.  The Federal Circuit said that  once the alleged infringer meets its burden of production, however, the patentee bears the burden to prove the products identified do not practice the patented invention.

The Federal Circuit declined to determine the minimum showing
needed to meet the initial burden of production, but found that it was satisfied.  The Federal Circuit did say that alleged infringer need not produce claim charts to meet its initial burden of identifying products, because it is the patentee who bears the burden of proving that it satisfied the marking requirements and thus the patentee who would have to prove that the unmarked products identified by the infringer do not fall within the patent claims. The Federal Circuit concluded that the district court erred in placing this burden upon BRP and vacated and remanded on the issue of marking.

On the pre-judgment and post-judgment royalty rates, the Federal Circuit found no error, noting that a difference in the rates may be justified by the change in the parties’ legal relationship and other factors.  Finally the Federal Circuit affirmed the district court on the issue of willfulness and enhanced damages.

 

 

Not Every Instance of an Agency Reaching Inconsistent Outcomes in Similar, Related Cases will Necessarily be Erroneous

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In Vicor Corp. v. Synqor, Inc., [2016-2283] (August 30, 2017) the Federal Circuit affirmed in part, vacated in part, and remanded the Board’s decisions in two reexaminations, one in which the Board found that certain claims of U.S. Patent No. 8,023,290 are patentable; and one in which the Board found certain claims of U.S. Patent No. 7,272,021 unpatentable as anticipated or obvious.

The Federal Circuit found that despite sharing a common panel and having opinions issued on the same date, the decisions in the respective reexaminations contain inconsistent findings on identical issues and on essentially the same record. With respect to the ‘290 patent reexamination, the Federal Circuit said that the
Board improperly analyzed the obviousness arguments under only one of the four Graham factors when it looked exclusively at the objective evidence, without considering the remaining factors and the relative strength of the factors. The Federal Circuit further said that the Board reached inconsistent conclusions as to the evidentiary weight to be given to the secondary considerations evidence presented in the respective reexaminations of the ’290 and ’021 patents, without any explanation to justify such inconsistency.

The Federal Circuit said that the Board’s legal error with respect to the ‘290 patent is underscored by its opinion issued on the same day in the related reexamination of the ’021 patent, where the Board applied all four Graham factors in the ’021’s reexamination and stated that “[t]he Federal Circuit has determined that only after considering the four Graham criteria together can the decision maker make the legal determination of whether the invention is nonobvious.”

The Federal Circuit said that in the ’290’s reexamination, the Board found the objective
evidence to be so persuasive that it approved of the examiner’s decision to withdraw rejections without analyzing the remaining Graham factors and without considering
Federal Circuit decisions on related claims.  In the ’021’s reexamination, however, the Board determined that the objective evidence principally related to features of the
claims that were found to be anticipated in other cases and, therefore, found that there was no nexus between the objective evidence and the claims of the ’021 patent. The Federal Circuit concluded that Board’s decisions do not evince any explanation or justification for these inconsistent findings, given the similarity between the claims at issue in the respective reexaminations.

The Federal Circuit said that not every instance of an agency reaching inconsistent outcomes in similar, related cases will necessarily be erroneous, but concluded that the inconsistent application of the Graham factors in two cases reaching different results, required that the cases be vacated and remanded,

It was Error Not to Consider Secondary Considerations, But They Wouldn’t Have Made a Difference

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In ClassCo, Inc. v. Apple, Inc., [2015-1853] (September 22, 2016), the Federal Circuit affirmed a PTAB decision affirming an Examiner’s rejection of claims to a call-screening
system that verbally announces a caller’s identity before the call is connected.as obvious under 35 USC 103.

The Federal Circuit rejected the reexam applicant’s that the combination of references was inconsistent with KSR, noting:

Contrary to ClassCo’s argument, KSR does not require that a combination only unite old elements without changing their respective functions. KSR, 550 U.S. at 416. Instead, KSR teaches that “[a] person of ordinary skill is also a person of ordinary creativity, not an automaton.” Id. at 421. And it explains that the ordinary artisan recognizes “that familiar items may have obvious uses beyond their primary purposes, and in many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. at 420. The rationale of KSR does not support ClassCo’s theory that a person of ordinary skill can only perform combinations of a puzzle element A with a perfectly fitting puzzle element B.

The Federal Circuit concluded that the Board properly applied a flexible approach mandated by KSR.

The Federal Circuit did find that the Board erred in dismissing some of the objective evidence of non-obviousness, noting that it has previously explained that “when secondary considerations are present, though they are not always dispositive,
it is error not to consider them.”  The Federal Circuit said that a determination of whether a patent claim is invalid as obvious under § 103 requires consideration of all four Graham factors, and it is error to reach a conclusion of obviousness until all those factors are considered.

However, the Federal Circuit found that the Board correctly determined that much of the evidence deserved no weight because it did not have a nexus to the merits of the claimed invention.  However as to some of the evidence there was a nexus.  The Federal Circuit explained that nexus depends on whether the claims are commensurate in scope with the secondary considerations.  The Federal Circuit noted that dependent claims contained the touted features, and that it was reasonable to assume that the underlying independent claim includes these features.  Even though the indepdent claims encompassed other embodiments as well, the Federal Circuit further noted that it has not required a patentee to produce objective evidence of nonobviousness for every potential embodiment of the claim. A patent applicant ‘need not sell every conceivable embodiment of the claims in order to rely upon objective
indicia of nonobviousness.

However, despite finding error in the Board’s according no weight to the evidence of secondary considerations, the Federal Circuit found no error in the Board’s ultimate conclusion of obviousness.  The Federal Circuit said that the value that the evidence of secondary consideratons possesses in establishing nonobviousness is “not strong” in comparison to the findings and evidence regarding the prior art under the first three
Graham factors.