“Rigidity Should Yield to Flexible, Sensible Interpretation;” Written Description Satisfied

In Nalpropion Pharmaceuticals, Inc. v. Actavis Laboratories FL, Inc., [2018-1221] (August 15, 2019), the Federal Circuit held that the district court did not err in finding claim 11 of the U.S. Patent 8,916,195 patent not invalid for lack of written description, but did err in finding that claim 1 of the ’111 patent and claims 26 and 31 of the U.S. Patent 7,462,626 patent would not have been obvious in view of the prior art.

The ’195 patent is also directed to methods of treating overweight or obesity, but the claims are drawn to specific dosages of sustained-release naltrexone and bupropion that achieve a specific dissolution profile. The Federal Circuit conclude that the district court did not clearly err in finding that the inventors had possession of the invention consisting of treating overweight and obesity with the stated amounts of bupropion. The district court found that irrespective of the method of measurement used, the specification shows that the inventors possessed the invention of treating overweight or obesity with naltrexone and bupropion in particular amounts and adequately described it. The Federal Circuit concluded that this finding did not present clear error.irrespective of the method of measurement used, the specification shows that the inventors possessed the invention of treating overweight or obesity with naltrexone and bupropion in particular amounts and adequately described it.

The test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. It is not necessary that the exact terms of a claim be used in haec verba in the specification, and equivalent language may be sufficient. The Federal Circuit noted that while as a general matter written description may not be satisfied by so-called equivalent disclosure, in the present case, buttressed by the district court’s fact-finding, and where the so-called equivalence relates only to resultant dissolution parameters rather than operative claim steps, the Federal Circuit affirmed the district court’s conclusion, noting “rigidity should yield to flexible, sensible interpretation.

The ’111 patent is directed to a composition of sustained-release bupropion and naltrexone for affecting weight loss, and the ’626 patent is drawn to a method for treating over-weight or obesity comprising. Although the district court found the claims non-obvious, in the Federal Circuit’s view, the prior art disclosed the claimed components of the composition claims and the steps of the method claims including the use claimed by the method.

Nalpropion argued that bupropion does not possess sufficient weight loss efficacy to obtain FDA approval by itself, but the Federal Circuit said that motivation to combine may be found in many different places and forms; it cannot be limited to those reasons the FDA sees fit to consider in approving drug applications. Instead, the court should consider a range of real-world facts to determine whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.

The Federal Circuit said that the inescapable, real-world fact here is that people of skill in the art did combine bupropion and naltrexone for reductions in weight gain and reduced cravings—goals closely relevant to weight loss. Contrary to Nalpropion’s view, persons of skill did combine the two drugs even without understanding bupropion’s mechanism of action but with an understanding that bupropion was well-tolerated and safe as an antidepressant. Thus, the Federal Circuit concluded that skilled artisans would have been motivated to combine the two drugs for weight loss with a reasonable expectation of success. The Federal Circuit examined the claims, and concluded that every limitation in the claims at issue was met by the prior art.

The Federal Circuit then examined objective indicia of nonobviousness. Nalpropion argues that many others tried and failed to find a combination effective for weight loss and that the claimed combination exhibited un-expected results, but the Federal Circuit found that a combination drug that affected weight loss—could not have been unexpected. The Federal Circuit said that the failure of others alone cannot overcome the clear record that the combination of the two drugs was known and that both drugs would have been understood to be useful for claimed purpose.

The Federal Circuit affirmed the district court’s decision on written description, but reversed the district court’s decision that the claims were not obvious.

“Any Compound May Look Obvious Once Someone Has Made it,” But Federal Circuit rejects “Convoluted” Obviousness Argument

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.

Lack of Reasonable Expectation of Success Meant Claims Weren’t Obvious

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

FDA Skepticism Supported Non-obviousness

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.

Great Expectations: An Expectation of Success is Needed to Make Invention Obvious

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.

Inventor Diligence Removed 102(e) Prior Art

In Arctic Cat Inc. v. GEP Power Products, Inc., [2018-1520, 2018-1521] (March 26, 2019), the Federal Circuit affirmed the PTAB’s invalidity determination as to U.S. Patent No. 7,420,822, but reversed as to U.S. Patent No. 7,072,188 because the Board improperly considered Boyd, U.S. Patent No. 6,850,421 as prior art.

The Board concluded that Boyd, whose filing date of April 1, 2002, is about seven months before the October 2002 filing date of the ’188 patent, was prior art to the ‘188 patent under 35 U.S.C. § 102(e). The Board rejected Arctic Cat’s argument of prior conception and diligence in reduction to practice. The Board also rejected the argument that the allegedly anticipatory portions of Boyd are not actually “by another,” as required by 35 U.S.C. § 102(e), even though the only named inventor on Boyd is Mr. Boyd himself, not Mr. Janisch, the inventor of the ‘188 patent.

The Federal Circuit agreed that Janisch had shown prior invention, in particular that the record established that Mr. Janisch was reasonably diligent during the critical period so as not to have abandoned his invention or unreasonably delayed its reduction to practice. While the Board concluded that the evidence did not establish diligence throughout the period from April 1, 2002, to October 29, 2002, the Board’s analysis rested on too rigid a standard, and the record establishes diligence under the correct standard.

The Federal Circuit found that the gaps in activity relied upon by the Board could be explained by third party testing activity and that lack of diligence cannot be inferred from putting the invention into someone else’s hands for needed testing and awaiting test results for a short period commensurate with the testing need, at least where oversight was diligent. That course of action, as a way of reducing an invention to practice, does not give rise to an inference of unreasonable delay or abandonment of the invention.

Obviousness Requires a Reason, Suggestion, or Motivation

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.

Element that is not Necessarily Present is not Inherent

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.

Working Backwards with the Benefit of Hindsight, Does not Render Compound Obvious

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.

Anticipation is the Epitome of Obviousness

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.