Petitioner Allowed to Supplement Evidence that Reference was Available

In Telefonaktiebolaget LM Ericsson v. TCL Corp., [2017-2381, 2017-2385] (November 7, 2019) the Federal Circuit affirmed the Board’s decision that the specified publication is an available reference, and based on this publication in combination with other prior art it affirmed the Board’s decision of invalidity of the challenged claims.

Ericsson argued that the Jentschel article is not prior art because it was not publicly available more than one year before Ericsson’s earliest asserted filing date, and thus is subject to antedating by Ericsson’s invention date. During the trial TCL sought to provide evidence of the date of availability of this journal issue in university libraries in Germany.

TCL first submitted to the PTAB a letter from a librarian from the “Periodicals Team” at the Technische Informationsbibliothek and Universitätsbibliothek in Hannover, Germany. Ericsson objected to the letter as inadmissible hearsay, and the statement was withdrawn when the librarian declined to provide a sworn statement and declined to testify in the United States. TCL then moved to submit the sworn Declaration of Doris Michel, a librarian at the Technische Universität Darmstadt in Germany. Ericsson again objected, stating that the submission was not in compliance with the Board’s Rules, which required a petitioner to present sufficient evidence, at the petition stage, and requires that a party who seeks to submit new or supplemental information more than one month after the date an IPR is instituted must show why the supplemental information rea-sonably could not have been obtained earlier, and that consideration of the supplemental information would be in the interests-of-justice.

TCL responds that Regulation § 42.123(b) gives the Board discretion to accept a tardy submission and to consider the interest of justice. TCL argues that the Jentschel article is very close prior art and that Ericsson was allowed to file supplemental briefing and to depose Ms. Michel.

The Federal Circuit concluded that the Board did not abuse its discretion in admitting the Michel Declaration, for when the challenged evidence is reasonably viewed as material, and the opponent has adequate opportunity to respond and to produce contrary evidence, the interest of justice weighs on the side of admitting the evidence.

Ericsson argues that the date of availability to the public of the Jentschel reference was not established by the Michel Declaration, even if that Declaration were deemed admissible. The Federal Circuit explained that a reference is deemed publicly available if it has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it. The Federal Circuit noted that Ericsson provided no evidence to counter the Michel Declaration, the date on the face of the journal, and the Library’s records showing receipt of the journal and its shelving. The Federal Circuit found that substantial evidence supports the Board’s ruling that Jentschel was accessible to the public in the May/June 1996 period, and that the Board did not abuse its discretion in receiving the Jentschel article as a reference.

The Federal Circuit further concluded that substantial evidence supports the Board’s finding that Jentschel renders obvious the claims.

Federal Circuit Loosens the Iron Grip on Evidence of Copying

In Liqwd v L’Oreal USA Inc., [2018-2152](October 17/30, 2019), the Federal Circuit vacated and remanded the PTAB’s final written decision that cetain claims of U.S. Patent No. 9,498,419 directed to forulations and methods of keratin treatment are unpatentable as obvious.

During the PGR Liqwd presented evidence that L’Oreal had used Liqwd’s confidential information and copied Liqwd’s patented invention as an objective indicia of non-obviousness. However, the Board concluded that the copying involved was legally irrelevant, because it was not evidence of copying a specific product, citing Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1325 (Fed. Cir. 2004), and thus was not “copying of the type that is relevant to the question of obviousness.”

Objective indicia are essential safeguards that protect against hindsight bias, and thus are a fundamental part of the overall § 103 obviousness inquiry. The Federal Circuit said that It is well established that copying by a competitor is a relevant consideration in the objective indicia analysis, as such copying may be evidence that the patented invention is nonobvious. However copying requires duplication of features of the patentee’s work based on access to that work, lest all infringement be mistakenly treated as copying. Evidence of copying may include internal documents, direct evidence such as photos of patented features or disassembly of products, or access and similarity to a patented product.

The Federal Circuit conceded that in Iron Grip Barbell, it stated that “copying requires the replication of a specific product,” but explained that it was simply stating that something more than showing similarity between the accused product and the patent was needed. The Federal Circuit pointed that that access to the patent, or access to articles about a patented invention have been sufficient to establish copying, in the absence of a specific product to be copied. What the Federal Circuit meant was “copying requires duplication of features of the patentee’s work based on access to that work, lest all infringement be mistakenly treated as copying” and that the relevant inquiry was whether there was evidence of copying efforts.

The Federal Circuit concluded that the evidence presented by Liqwd shows more than merely a competing product that arguably falls within the scope of a patent. Determining that this evidence is relevant does not implicate the concern with avoiding every infringement suit turning into a confirmation of the nonobviousness of a patent. The Federal Circuit said that because this evidence of actual copying efforts was relevant, the Board erred by disregarding it. The Federal Circuit vacated the Board’s obviousness determination and remanded the case for the Board to consider this evidence in its obviousness analysis.

Hope is not Enough to Create a Reasonable Expectation of Success

In OSI Pharmaceuticals, LLC v. Apotex Inc., [2018-1925] (October 4, 2019), the Federal Circuit reversed the PTAB’s determination that claims 44-46 and 53 of U.S. Patent No. 6,900,221 on the use of erlotinib on non smallcell lung cancer (NSCLC) would have been obvious because the Board’s finding of a reasonable expectation for success was not supported by substantial evidence.

The Board found that the disclosures in OSI’s own 10-K that erlotinib targeted a variety of cancers including NSCLC, and that erlotinib had entered Phase II clinical trials, would have provided a person of ordinary skill with a reasonable expectation of success in light of the other prior art references. The Board concluded that an ordinary artisan would under-stand from the commencement of Phase I studies referenced in the 10-K that “pre-clinical animal efficacy data” had been submitted to the FDA.

The Federal Circuit said that an obviousness determination requires finding that a person of ordinary skill in the art would have been motivated to combine or modify the teachings in the prior art and would have had a reasonable expectation of success in doing so. The Federal Cicuit said that when the references are properly read, the Board’s finding that the asserted references provide a reasonable expectation of success also is not supported by substantial evidence.

The Federal Circuit noted that the record does not contain any clinical (human) data or pre-clinical (animal) data. It did not even include in vitro (test tube) data regarding erlotinib’s effect on NSCLC. The Federal Circuit added that at the same time, it is undisputed that NSCLC treatment was highly unpredictable with an over 99.5% rate of failure for drugs entering Phase II clinical studies. On this record, the Federal Circuit was not persuaded that a reasonable fact finder could conclude that a person of ordinary skill would have reasonably expected success based on the combination of the references and OSI’s 10-K.

The Federal Circuit examined one reference (Gibbs) that said “these compounds appear to have good anti-cancer activity in preclinical models, with an acceptable therapeutic index, particularly in patients with non-small cell lung cancer. The Federal Circuit consulted the footnotes and conclude that the reference as a whole would not be understood by a person of ordinary skill in the art to refer to erlotinib, because the supporting article did not refer to erlotinib. The Federal Circuit said that the Board’s finding that there is a “clear inference” in Gibbs that “erlotinib has anti-cancer activity against non-small cell lung cancer” is thus not supported by substantial evidence.

On the specific issue of reasonable expectation of success the Federal Circuit found that the asserted references do not disclose any information about erlotinib’s efficacy in treating NSCLC in a mammal (in Scnhur and Gibbs). These references contained no data or other promising information regarding erlotinib’s efficacy in treating NSCLC, just cancer generally and this was not enough “because of the highly unpredictable nature of treating NSCLC.” With respet to OSI’s own 10-K the Board emphasized the 10-K’s statement that erlotinib had completed Phase I clinical trials, which require preclinical animal efficacy data. However, the Federal Circuit noted, there was nothing in OSI’s 10-K suggesting the existence of erlotinib preclinical efficacy data that is specific to NSCLC.

The Federal Circuit concluded that “[t]hese references provide no more than hope—and hope that a potentially promising drug will treat a particular cancer is not enough to create a reasonable expectation of success in a highly unpredictable art such as this.”

Campbell’s Primary Reference in Design Patent Challenge was Mmm Mmm Good

In Campbell Soup Company v. Gamon Plus, Inc., [2018-2029, 2018-2030] (September 26, 2019) the Federal Circuit affirmed in part, vacated in part, and remanded, Board determinations that U.S. Patent Nos. D612,646 and D621,645 were nonobvious from the cited prior art.

The ‘645 and ‘646 patents are directed to ornamental design for a gravity feed dispenser display.

The Figures from U.S. Patent Nos. D612646 and D621645

The figures are identical except that the edges at the top and bottom of the cylindrical object lying on its side and the stops at the bottom of the dispenser are shown in broken lines in the ‘645 patent, and there is a small circle shown in broken lines near the middle of the label area.

Campbells filed IPR against both designs, arguing that the designs were obvious in view of (1) Linz in view of Samways, (2) Samways, or (3) Samways in view of Linz.

Linz (left) and Samways (right)

The Board held that Campbells did not establish unpatentability by a preponderance of the evidence because it found that neither Linz nor Samways was similar enough to the claimed designs to constitute a proper primary reference.

In the design patent context, the ultimate inquiry under section 103 is whether the claimed design would have been obvious to a designer of ordinary skill who designs articles of the type involved. To determine whether one of ordinary skill would have combined teachings of the prior art to create the same overall visual appearance as the claimed design, the fact finder must first find a single reference, a something in existence, the design characteristics of which are basically the same as the claimed design. To identify a primary reference, one must: (1) discern the correct visual impression created by the patented design as a whole; and (2) determine whether there is a single reference that creates “basically the same” visual impression. If a primary reference exists, related secondary references may be used to modify it.

The Board found that Linz was not a proper primary reference because it does not disclose any object, including the size, shape, and placement of the object in its display area and fails to disclose a cylindrical object below the label area in a similar spatial relationship to the claimed design. The Federal Circuit reversed for lack of substantial evidence support. Accepting the Board’s description of the claimed designs as correct, the Federal Circuit found that the ever-so-slight differences in design, in light of the overall similarities, do not properly lead to the result that Linz is not “a single reference that creates ‘basically the same’ visual impression” as the claimed designs.

The Board also found that Samways was not a proper primary reference. The Board found that significant modifications would first need to be made to Samways’ design, such as combining two distinct embodiments of the utility patent, which was “not a design in existence.” The Board found that considering the designs as a whole, the design characteristics of Samways are not basically the same as the claimed design. The Federal Circuit agreed, saying accepting the Board’s description of the claimed designs as correct, substantial evidence supports the Board’s finding that Samways is not a proper primary reference. The Federal Circuit noted numerous differences, and concluded that given these differences, substantial evidence supports the Board’s finding that Samways does not create basically the same visual impression as the claimed designs.

The Federal Circuit remanded the case to the Board to consider obviousness with Linz as a primary reference.

Objective Indicia Supported PTAB’s Finding of Non-Obviousness

In Henny Penny Corporation v. Frymaster LLC, [2018-1596] (September 12, 2019), the Federal Circuit affirmed the PTAB determination that claims 1–3, 5–12, 17–21, and 23 of U.S. Patent 8,497,691 were not unpatentable as obvious.

The ‘691 Patent relates to deep fryers, and in particular to TPM sensors that detect accumulating impurities in the cooking oil, and alert the operator when to change oil.

Henny Penny originally argued the claims were the obvious result of replacing the Kauffman analyzer with the Iwaguchi sensor. However, Henny Penny changed its position arguing that Kauffman’s analyzer could simply be modified. The Board refused to consider this impermissible new theory of unpatentability raised for the first time on reply.

As to Henny Penny’s original argument the Board found that the disadvantages from the proposed modification out-weighed the uncertain benefits of the modification. The Board further found that evidence of secondary considerations supported nonobviousness. Frymaster sub-mitted evidence that it marketed a product called the “Oil Quality Sensor” (“OQS”) that won praise from two industry organizations and one customer. The Board also determined that each award specifically praised the TPM sensor in the OQS. While the Board recognized that the individual claim elements were in the prior art, it found that the praise was directed to the claimed combination as a whole. Accordingly, the Board found that the two industry awards weighed in favor of patentability, as did, to a lesser extent, the customer award.

The Federal Circuit found that the Board did not abuse its discretion by holding Henny penny to the obviousness theory in its petition. Because of the expedited nature of IPR proceedings, it is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify “with particularity” the ‘evidence that supports the grounds for the challenge to each claim. Accordingly, an IPR petitioner may not raise in reply an entirely new rationale for why a claim would have been obvious.

As to the original obviousness contention, the Federal Circuit noted that the benefits, both lost and gained, should be weighed against one another, and found that the Board’s analysis was consistent with these principles. As to the secondary considerations supporting non-obviousness, the Federal Circuit rejected Henny Penny’s argument that there was no nexus between the evidence and the claimed invention. The Federal Circuit agreed that the identified objective indicia must be directed to what was not known in the prior art, and what was not known in the prior art may well be the novel combination or arrangement of known individual elements.

The Federal Circuit concluded that substantial evidence supported the Board’s determination of non-obviousness.

“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.