Board post-grant decision finding GM’s design patent not anticipated or obvious affirmed

LKQ Corporation, et al. v. GM Global Technology Operations LLC

Docket No. 2022-00055 (PGR2020-00055) (https://cafc.uscourts.gov/opinions-orders/22-1253.OPINION.1-20-2023_2066551.pdf) (Non-Precedential)

LOURIE, CLEVENGER, STARK

January 20, 2023

Brief Summary:   Board post-grant decision finding GM’s design patent not anticipated or obvious affirmed.

Summary:  LKQ appealed USPTO final written decision (FWD) holding it failed to show by a preponderance of the evidence that GM’s design patent U.S. Patent D855,508 (the ‘’508 patent’) directed to an “ornamental design for the vehicle front skid bar” shown in Figs. 1-4 was anticipated or would have been obvious over the cited prior art.  LKQ sells automotive body repair parts and was a party to a license with GM but that expired in 2022, “after which GM sent letters to LKQ’s business partners alleging that the now unlicensed LKQ parts infringe its patents.”  LKQ petitioned the USPTO for post-grant review of the ‘508 patent, arguing that “it was anticipated by the design of the 2015 Changfeng Leopaard CS1020 (“Leopaard”) and would have been obvious over the Leopaard alone or in combination with the design of the 2012 Chevrolet Equinox (‘Equinox’).”  The Board disagreed, determining “that the ordinary observer would include both retail consumers who purchase replacement skid bars and commercial replacement part buyers”, emphasizing “that the “’508 design claims a ‘vehicle front skid bar,’ not a vehicle in total.’”  The Board also “concluded that, although there were some similarities, the references produced depicting the Leopaard design did not show certain aspects of the claimed design (e.g., the bottom or the sides) and what was visible from the provided images created a different overall impression” (e.g., “a ‘rugged, chiseled, three-dimensional overall appearance’ that the Leopaard’s sloping design did not have.”)  The Board also established the Rosen (In re Rosen, 673 F.2d 388 (C.C.P.A. 1982)) and Durling (Durling v. Spectrum Furniture Co., Inc., 101 F.3d 100 (Fed. Cir. 1996)) tests and found that “the Leopaard did not qualify as a proper primary reference under Rosen” and therefore “did not turn to Durling step two and look beyond the Leopaard to the Equinox”.  LKQ argued in this appeal that the Board erred in its finding regarding the ordinary observer, that the Rosen and Durling tests were “implicitly overruled” by KSR (KSR International Co. v. Telflex, Inc., 550 U.S. 398 (2007)), and placed “undue emphasis on allegedly trivial differences between the” ‘508 patent and the prior art (“would not have mattered to the correct ordinary observer,…failed to properly compare the designs as a whole”).  The FC panel agreed with GM regarding who the ordinary observer would be (“the lens of the ordinary observer that the anticipation inquiry is viewed. Gorham Co. v. White, 81 U.S. 511, 528 (1871)”, “there is a market for the claimed skid bar alone”, “the claimed design of the ’508 patent is not the design of a whole vehicle, but rather a design of a specific part of a vehicle”; KeyStone Retaining Wall Sys., Inc. v. Westrock, Inc., 997 F.2d 1444, 1451 (Fed. Cir. 1993); “the Leopaard design do not sufficiently show certain aspects of its design”, “different overall impressions”; “it is not clear the Supreme Court has overruled Rosen or Durling”).  The Board decision was therefore affirmed.

DC indefiniteness finding vacated and remanded, while “means”-related claim construction finding affirmed, each based on the intrinsic evidence

Grace Instrument Industries, LLC v. Chandler Instruments Co., LLC and Ametek, Inc.

Docket No. 2021-2370 (https://cafc.uscourts.gov/opinions-orders/21-2370.OPINION.1-12-2023_2062188.pdf)

CHEN, CUNNINGHAM, STARK

January 12, 2023

Brief Summary:   DC indefiniteness determination of “enlarged chamber” vacated and remanded while construction of “means for driving” a rotor limitation affirmed.

Summary:  Grace appealed a DC claim construction order the found the term “enlarged chamber” indefinite and its construction of “means for driving said rotor to rotate located in at least one bottom section” of US 7,412,877 relating to pressurized devices and viscometers for oil well drilling rigs.  As a result of the DC findings, the parties stipulated to the invalidity of certain asserted claims and non-infringement of certain others. 

The DC found “that ‘enlarged’ is a ‘term of degree’ that ‘necessarily calls for some comparison against some baseline’” (quoting Liberty Ammunition, Inc. v. United States, 835 F.3d 1388, 1395 (Fed. Cir. 2016)), and that “the ’877 patent ‘does not provide the requisite objective boundaries’ for a skilled artisan” (disagreeing with Grace “that ‘enlarged chamber’ could be defined by its purpose, finding that ‘explaining that something is large enough to do a certain task does not answer the question: larger than what?’” and “that the baseline for ‘enlarged’ is the prior art, explaining that ‘this is not evident from the ’877 Patent itself’”).  The FC panel explained that “[t]he ’877 patent’s specification guides us to the term’s meaning” and found that “a skilled artisan would ascertain [from] the intrinsic record” that the chamber “must be large enough to accomplish a particular function” (Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc); Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) (“the specification is the ‘single best guide to the meaning of a disputed term’”); Cont’l Cirs. LLC v. Intel Corp., 915 F.3d 788, 795 (Fed. Cir. 2019) (“claims, specification, and prosecution history”); Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901 (2014) (“reasonable certainty”); Aventis Pharma S.A. v. Hospira, Inc., 675 F.3d 1324, 1330 (Fed. Cir. 2012) (“inferred from clear limiting descriptions of the invention in the specification or prosecution history”); Biosig Instruments, Inc. v. Nautilus, Inc., 783 F.3d 1374 (Fed. Cir. 2015) (“a skilled artisan would understand the inherent parameters” from “the intrinsic evidence”)).

The DC also construed the “means for” limitation to be a “means for driving said rotor to rotate located in at least one bottom section.”  The parties agreed with the “driving said rotor to rotate” portion but “disputed the means and whether the phrase ‘located in at least one bottom section’ modifies ‘rotor,’ as Grace contended, or ‘means for driving,’ as Chandler argued.”  The DC agreed with Chandler since Grace’s proposal “(1) was ‘not broad enough to include magnetic coupling’ as it must because of dependent claim 14 and (2) would exclude other terms described in the patent as causing the rotor to rotate” and “‘located in at least one bottom section’ modifies ‘means for driving,’ not ‘rotor’” (“‘conform[s] with [the] usual rules of grammar and sentence structure’ and is confirmed by limitation 4(b)”).  The FC panel found the DC’s construction to be “consistent with the specification” (citing NOMOS Corp. v. BrainLAB USA, Inc., 357 F.3d 1364, 1367–68 (Fed. Cir. 2004)) and therefore affirmed its determination.

Novartis appeals to SCOTUS rehearing of FC panel decision reversing negative limitation written description finding of prior FC panel

Novartis Pharm. Corp. v. Accord Healthcare, et al. and HEC Pharm Co., Ltd. et al.

Docket No. 2021-1070 (https://cafc.uscourts.gov/opinions-orders/21-1070.OPINION.1-3-2022_1887614.pdf)

MOORE (D), LINN, O’MALLEY

January 24, 2022

Second Update (January 24, 2023): Novartis petitioned SCOTUS with two questions presented:  1) Whether 28 U.S.C. § 46 and principles of sound judicial administration preclude a court of appeals from adding a new judge to form a new panel and redecide a case after an original three-judge panel has already decided the case and entered its judgment; and, 2)  Whether 35 U.S.C. § 112 should be interpreted consistent with its plain text as requiring that a patent specification contain a “written description of the invention” in a form that need only be understandable to “any person skilled in the art,” or whether the court of appeals properly read in a heightened requirement that allows it to deem the specification inadequate on de novo review and displaces the perspective of a person skilled in the art.

DC prosecution laches finding affirmed (unreasonable and inexcusable delay by PMC and prejudice to Apple)

Personalized Media Communications, LLC v. Apple Inc.

Docket No. 2021-2275 (https://cafc.uscourts.gov/opinions-orders/21-2275.OPINION.1-20-2023_2066571.pdf)

REYNA, CHEN, STARK

January 20, 2023

Brief Summary:   DC decision of prosecution laches (unreasonable and inexcusable delay by PMC and prejudice to Apple) affirmed.

Summary:  Personalized Media Communications (“PMC”) appealed DC finding that US 8,191,091 is unenforceable based on prosecution laches (“an equitable affirmative defense dating back to the early 1900s”), finding PMC “successfully employed an inequitable scheme to extend its patent rights.”  PMC alleged that Apple’s FairPlay digital rights management software that uses decryption keys to prevent copying songs from iTunes.  The DC jury initially returned a unanimous verdict finding Apple infringed the patent and awarding PMC over $308 million in damages.  The DC then held a bench trial and rendered its unenforceability judgment relying on the FC’s 2021 Hyatt decision regarding “GATT-Bubble applications” (applications filed before the change in patent term from 17 years from issuance to 20 years from filing) (Hyatt v. Hirshfeld, 998 F.3d 1347, 1359–62 (Fed. Cir. 2021)).  Like Hyatt (which filed 381 GATT-Bubble applications “where each application was a photocopy of one of 11 earlier patent applications”), PMC filed 328 GATT-Bubble applications that derive from two earlier applications that, “[s]imilar to Hyatt”, “were ‘atypically long and complex,’” included a single claim that was later amended to “the range of 6,000 to 20,000 claims.”  The DC also found PMC’s prosecution delay to be similar to Hyatt as PMC waited 8-14 years to file its applications and at least 16 years “to present the asserted claims for examination”, making “it virtually impossible for the PTO to conduct double patenting, priority, or written description analyses”, and made “vast prior art disclosure[s], which included references having little-to-no relevance”.  The PTO did suspend prosecution of PMC’s applications but only after “prosecution had been pending for ‘nearly ten years’”.  Unlike in Hyatt, “PMC developed the ‘Consolidation Agreement’ with the PTO” with “A” and “B” applications, where A applications were prioritized, which the DC found not to “operate to shift the blame on the PTO” and to be a “business-driven, unreasonable prosecution strategy”.  The DC also considered prejudice against Apple which “had already begun developing the accused FairPlay system by 2003, the year that PMC first added the asserted technology to the ’091 patent’s predecessor”, and that “the ’091 patent issued in 2012—seven years after FairPlay had already matured into the version accused of infringement” (e.g., PMC “conceal[ed] its inventions until infringement was deeply embedded into the industry”).  The FC panel found the DC did not abuse its discretion in its determination.  The FC panel explained that “[l]aches is an equitable and flexible doctrine that requires considering the totality of the circumstances”, that this case “involves even more egregious facts” than Hyatt, the Consolidation Agreement led to a “drawn-out prosecution”, “a delay by the PTO cannot excuse the appellant’s own delay”, the number of applications is relevant, PMCs amendments were unreasonably delayed, and the DC’s factual findings were not an abuse of discretion.  The FC panel also concluded the DC correctly found PMC’s strategy was in place “well after 2003” when FairPlay was being developed by Apple and that this prejudiced Apple (citing Victor Talking Mach. Co. v. Thomas A. Edison, Inc., 229 F. 999, 1000–01 (2d Cir. 1916)).  Judge Stark dissented, agreeing that PMC’s delay in prosecution was unreasonable and inexcusable, but disagreeing that Apple did not have “to show that is suffered prejudice” (citing, e.g., Cancer Rsch. Tech. Ltd. v. Barr Labs., Inc., 625 F.3d 724, 728-29 (Fed. Cir. 2010); the 2021 Hyatt decision; PPC Broadband, Inc. v. Corning Optical Commc’ns RF, LLC, 815 F.3d 734, 740 (Fed. Cir. 2016); and In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989)).

FC panel affirms DC obviousness and non-infringement findings regarding Genentech’s Esbriet® patents

Genentech, Inc., Intermune, Inc. v. Sandoz Inc., LEK Pharmaceuticals, D.D.

Docket No. 2022-1595 (https://cafc.uscourts.gov/opinions-orders/22-1595.OPINION.12-22-2022_2052253.pdf)

NEWMAN, LOURIE, PROST

December 22, 2022

Brief Summary:   DC findings that Genetech’s disputed Esbriet^® patents are invalid for obviousness and not infringed by Sandoz’s ANDA affirmed.

Summary:  Genentech (“GT”) appealed DC decision holding that: (1) GT’s Liver Function Test (“LFT”) claims are invalid for obviousness (US 7,566,729; 7,635,707; 8,592,462; and 8,609,701) (2) “Sandoz’s” generic product sales would not induce infringement of the LFT patents, and (3) Sandoz’s generic product sales would not directly infringe GT’s Drug-Drug Interaction (“DDI”) patents (US 7,816,383 and 8,013,002 directed to avoiding adverse interactions between pirfenidone and fluvoxamine).  Sandoz’s ANDAs sought approval to market a generic version of pirfenidone that is sold by Genentech (as Esbriet^® with 17 and 19 patents listed on the Orange Book for the capsule and tablet forms, respectively) to treat about half of all idiopathic pulmonary fibrosis (IPF) patients.  The FC panel opinion explains that “[t]he major differences between the [available] drugs center on side effects and metabolism” and that pirfenidone was first studied as an IND in 1973, granted orphan drug status in the US in 2004, and that Esbriet^® was approved to treat IPF in 2014.  The FC panel opinion also explains that “[t]he LFT patents are directed to methods for administering pirfenidone to a patient who has exhibited abnormal biomarkers of liver function in response to pirfenidone administration” (e.g., “a grade 2 abnormality” indicated by alanine transaminase (ALT) or aspartate transaminase (AST) levels) “by reducing, maintaining, or discontinuing then returning to the full or a reduced dose (e.g., “2400 mg/day for a time period, followed by…2400 mg/day or 2403 mg/day”, “administering…1600…or 1602 mg/day”).  Sandoz’s proposed ANDA label includes instructions to modify the dosage if “liver enzyme and bilirubin elevations are exhibited”, including “ALT and/or AST”.  The DC agreed with Sandoz’s obviousness arguments regarding the LFT patents based on the Azuma reference (a pirfenidone clinical trial suggesting reduced dosages with “an adverse event of Grade 2 or worse”), the Pirespa^® label (suggesting discontinuing pirfenidone administration with increased AST or ALT), “and known, standard medical practices” and its argument that “there was no specific intent for induced infringement” as only “four of the five dose modification options provided in the label were covered by the asserted claims” and “the portion of the label that referred to infringing uses did not recommend any of the infringing uses, but rather, merely described them.”   The FC panel agreed with the DC on obviousness (e.g., no clear error in DC’s conclusion that “claiming” “varying doses in response to the occurrence of side effects [is] a well-established, hence obvious, practice” (Adapt, FC 2022); “weak secondary considerations” (W. Union, FC 2010)), and therefore did not review the DC’s infringement findings.

The DC agreed with Sandoz “that there was insufficient evidence of direct infringement” of the DDI patents (e.g., “the language in Sandoz’s label that encourages, recommends, or promotes an infringing use without any additional evidence showing such an infringing use will in fact occur, is insufficient for a finding of direct infringement”).  The FC panel also agreed with Sandoz, explaining that while “[i]t is true that although the Hatch-Waxman Act provides that the filing of an ANDA before a patent covering a compound or a use expires meets the technical jurisdictional requirement of infringement, that is not the same as the direct infringement that serves as a predicate for finding induced infringement” (35 USC 271(e)(2)(A); Glaxo, FC 1997).  “Here,” the FC panel wrote, “as in Eli Lilly and Takeda, the district court did not clearly err by considering all the relevant evidence, including Sandoz’s proposed label and physician practice” (e.g., “testimony from physicians that, in their decades of treating IPF patients, they had never prescribed pirfenidone to an IPF patient taking fluvoxamine; and were they to find themselves in that position, they would choose a noninfringing response—i.e., prescribing nintedanib instead”; Glaxo, FC 1997; Vanda, FC 2018 (“specific intent to encourage another’s infringement”); Takeda, FC 2015 (label “recommends, encourages, or promotes”; “evidence outside the label” showing direct infringement); Ferring, FC 2014; Lilly, FC 2017 (“product labeling, combined with…physicians’ general practices”)).

FC panel affirms Board IPR decisions finding P Tech’s robotic surgical instrument claims obvious

P Tech, LLC v. Intuitive Surgical, Inc.

Docket No. 2022-1102, -1115 (IPR-2020-00649-50) (https://cafc.uscourts.gov/opinions-orders/22-1102.OPINION.12-15-2022_2048477.pdf) (Non-Precedential)

LOURIE, DYK, CUNNINGHAM

December 15, 2022

Brief Summary:   Board IPR decisions of obviousness of P Tech’s robotic surgical instrument claims affirmed. Summary:  P Tech appealed two IPR final written decisions (FWDs) finding claims 1 and 4 of US 9,192,395 and claims 1-20 of US 9,149,281 directed to robotic tissue fastening systems unpatentable for obviousness.  This opinion explained that “[t]he differences between these claims have not been argued as significant to this appeal” and “[t]herefore, they all stand or fall together.”  The ‘281 patent requires a “position sensor configured to indicate a distance moved by the fastener or staple” that “[f]or the purposes of this appeal, only the position sensor recited in the ’281 patent is relevant.”  Intuitive’s petitions alleged obviousness over US 6,331,181 (“Tierney”) “in view of other prior art references” including US 5,518,163 (“Hooven”).  P Tech argued only that the prior art did not teach the position sensor but “did not dispute that the asserted prior art separately teaches the limitations of the challenged claims” and “[i]nstead” focused “on an asserted lack of motivation to combine Tierney with Hooven.”  P Tech argued “that although the challenged claims did not require an articulable joint near the head of the stapling device, the cited art described benefits of such articulation” and that there was not motivation to combine because “the proposed combination seemingly lacked this articulable joint” and “would lack other beneficial features, including providing force-feedback to the surgeon operating the device.”  The USPTO Board disagreed, including “P Tech’s challenges to Hooven’s alleged disclosure of a position sensor”, and held Intuitive “met its burden to show” obviousness “by a preponderance of the evidence”.  The FC panel reviewed the Board’s legal determinations de novo (In re Elsner, FC 2004) and factual findings for substantial evidence (In re Gartside, FC 2000; Consol. Edison, US 1938).  P Tech argued that “by improperly ignoring or excluding the prior arts’ disclosures describing the benefit of this articulating joint, the Board erred in conducting its motivation to combine analyses”.  The FC panel agreed with PT “that a motivation to combine analysis must account for ‘reasons not to combine,’ which are facts relevant to the overall consideration of obviousness” (Arctic Cat, FC 2017 (“unlikely to be productive of the result sought by the applicant”); In re Urbanski, FC 2016 (“the combination would be inoperable, present undesirable qualities”)), but found “the Board did not exclude or ignore the evidence to which P Tech now points on appeal” (e.g., “found it insufficient to rebut Intuitive’s showing”; Medichem, FC 2006 (“a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate a motivation to combine.”)).  The FC panel also found no error with the Board’s decision to cite little weight to P Tech’s expert testimony as no corroborating evidence to his opinion was presented (In re Am. Acad. Sci. Tech Ctr., FC 2004).  P Tech also asserted the Board “inappropriately relied on figures from an unasserted reference” (“Tovey”) but the FC panel found no error as “the Board simply considered Tierney and Tovey as part of the totality of evidence.”  P Tech also asserted the Board incorrectly construed the position sensor limitation but the FC panel agreed with Intuitive that since this was not argued in front of the Board, P Tech forfeited it.  The Board decisions were therefore affirmed.

DC findings of obviousness of certain claims affirmed and others vacated based on secondary considerations

Arius Two, Inc., Biodelivery Sci. Int., Inc. v. Alvogen PB Res. & Develop. LLC, et al.

Docket No. 2022-1394, -1449 (https://cafc.uscourts.gov/opinions-orders/22-1394.OPINION.12-21-2022_2051391.pdf) (Non-Precedential)

CHEN, CLEVENGER, CUNNINGHAM

December 21, 2022

Brief Summary:   DC obviousness findings for two patents affirmed; obviousness of certain claims vacated as DC applied “clear and convincing” to secondary considerations while only “preponderance of the evidence” standard required.

Summary:  This Hatch-Waxman case involves US 8,147,866; 9,655,843; and 9,901,539 regarding a bi-layer film containing a bioerodable mucoadhesive (BEMA) layer comprising  buprenorphine and a backing layer between the BEMA layer and the oral cavity.  BDSI sued Alvogen with respect to Alvogen’s ANDA for a generic version of BDMI’s Belbuca^® product.  Alvogen appealed the DC’s evidentiary and procedural findings against it for the asserted claims found not to be invalid, while BDMI/Arius appealed with respect to the burden of proof of long-felt needs and unexpected results.  The disputed claims include 4 and 5 of the ‘866 patent that claim pharmacokinetic properties (“PK” claims); claims 9 and 20 of the ‘539 patent claiming a certain pH of the BEMA and backing layers (“Backing Layer” claims); and claims 3 and 10 of the ‘866 patent and claims 8, 9 and 20 of the ‘843 patent that claim a certain pH of the BEMA layer (“BEMA layer” claims). 

The DC held the PK claims “not invalid because Alvogen failed to show a skilled artisan would have been motivated to combine the prior art references and waived its inherency argument by failing to raise the argument in the pre-trial order.”  The FC panel found no error with the DC’s conclusions, citing Stryker (FC 1996 (no motivation to combine)).

The DC held the Backing Layer claims not invalid “because Alvogen failed to show the pH of the backing layer was inherently present in the prior art and because secondary considerations supported a finding of nonobviousness.”  Alvogen’s expert testified that the backing layer pH of BDMI’s product is the same as that of the prior art (“‘identical ingredients present in materially identical amounts,’ and because the formulations are nearly the same, one would expect both formulations to have the same pH”) and it also pointed to an inventor declaration submitted during prosecution, but the DC found it showed that on average that the prior art pH was different.  The FC panel found no clear error in the DC’s decision of no invalidity (e.g., “incompatible representations in the record”).

The DC held the BEMA layer claims “invalid as obvious because a skilled artisan would have been motivated to combine certain prior art references with a reasonable expectation of success to arrive at the claimed invention” (“BDSI had not: (1) “clearly and convincingly” shown evidence of a long-felt need, (2) shown the prior art taught away, or (3) shown unexpected results.”)  The FC panel remanded this part of the DC’s decision as it applied a “clear and convincing standard” while “[s]econdary considerations must be established by a preponderance of the evidence” (Apple, FC 2016).

DC preliminary injunction regarding trademark / trade dress registration affirmed

SoClean, Inc. v. Sunset Healthcare Solutions, Inc.

Docket No. 2021-2311 (https://cafc.uscourts.gov/opinions-orders/21-2311.OPINION.11-9-2022_2031039.pdf)

NEWMAN, LOURIE, PROST

November 9, 2022

Brief Summary:   DC grant of injunctive relief to SoClean regarding its trade dress registration affirmed. Summary:  Sunset appealed DC order granting a “narrow” preliminary injunctive (PI) relief to SoClean relating to its trade dress registration (the ‘195 registration).  The DC concluded that “that SoClean’s request to enjoin all sales of Sunset’s filters would “go[] much further than necessary” to ‘end any possible statutory violation’” and required “Sunset to clearly associate its online marketing and sales . . . with the Sunset brand” to broaden it.  The injunction “‘prohibits Sunset from engaging in those practices that result in consumer confusion’ and enjoined Sunset from marketing its filters ‘using images of the filter cartridge alone’; ‘[a]ny image, drawings, or other depictions of Sunset’s filter cartridge used for the purposes of promotion, marketing and/or sales shall prominently display the Sunset brand name in a manner that leaves no reasonable confusion that what is being sold is a Sunset brand filter.’”  The FC panel reviewed the PI under the law of the regional circuit and for an abuse of discretion, and the “underlying questions of law de novo and questions of fact for clear error” (Koninklijke, FC 2022; Am. Inst. for Foreign Study, 1^st Cir. 2021).  The FC panel explained that “[a] party seeking a preliminary injunction must establish (1) a likelihood of success on the merits of its claim; (2) a likelihood of irreparable harm in the absence of preliminary relief; (3) that the balance of equities tips in its favor; and (4) that the injunction is in the public interest” and that “[t]he first two factors are the most important” (Together Emps., 1^st Cir. 2022).  It also stated that “[t]here is no dispute that SoClean’s trade dress is a product-configuration trade dress, so it is only protectable ‘upon a showing of secondary meaning’” (Wal-Mart, US 2000; 15 USC 1057(b) (“where, as here, the trade dress is federally registered, that registration ‘shall be prima facie evidence of the validity of the registered mark and of the registration of the mark’”)).  Sunset acknowledged that “it bears the burden of showing that SoClean’s registration lacks secondary meaning” (as “a product-configuration trade dress…it is only protectable ‘upon a showing of secondary meaning’”) but also argued that under 15 USC section 1119 the DC “should have ‘decide[d] whether the evidence that was before the [trademark] examiner, in view of Sunset’s arguments and additional evidence, is sufficient to support SoClean’s Section 2(f) registration.’”  The FC panel disagreed because “[t]he presumption of validity is not conditional; the statute provides that a certificate of registration ‘shall’ result in the presumption, without specifying any exceptions” (15 USC section 1507(b)), noting Sunset “may still invoke § 1119 and ask the district court to rectify the register if SoClean’s trade dress is deficient”.  And while the FC panel agreed the DC opinion includes a misstatement regarding the evidentiary requirements, the DC’s ultimate judgment was correct (Omega Pats., FC 2021; Vanderbilt, FC 2010 (“harmless error”); Environ, FC 2000).  The FC panel also found the DC “never concluded that the filter’s design is functional”.  It also noted that “under the Trademark Modernization Act of 2020, SoClean is entitled to a rebuttable presumption of irreparable harm once the court has found that SoClean is entitled to a likelihood of success on the merits” and “Sunset did not attempt to rebut that presumption.”  The DC decision was therefore affirmed.

DC decision of infringement and no invalidity of Pharmacyclic’s BTK inhibitor-related patents affirmed

Pharmacyclics LLC, Jannsen Biotech, Inc. v. Alvogen, Inc., Natco Pharma Limited

Docket No. 2021-2270 (https://cafc.uscourts.gov/opinions-orders/21-2270.OPINION.11-15-2022_2033497.pdf) (Non-Precedential)

CHEN, BRYSON, HUGHES

November 15, 2022

Brief Summary:   DC decisions that Pharmacyclic’s patents were infringed and not invalid for lack of written description, enablement, obviousness, or obviousness-type double patenting affirmed.

Summary:  Pharmacyclics and Jannsen (“Pharmacyclics”) appealed DC finding that Alvogen and Natco’s (“Alvogen’s”) ANDA to market a generic version of Pharmacyclic’s Bruton’s tyrosine kinase (BTK) inhibitor Imbruvica (ibrutinib) for cancer treatment infringed several Pharmacyclic patents.  Pharmacyclic originally asserted many claims of 17 of its patents, but during the DC trial reduced the asserted claims to claim 10 of US 8,008,309 directed to the compound; claim 2 of US 8,754,090 directed to a method for treating mantle cell lymphoma; claim 5 of US 9,725,455 directed to a crystalline form of ibrutinib; and claims 30 and 37 of US 9,655,857 directed to tablet formulations of ibrutinib.  At the DC, Alvogen stipulated it infringed the asserted claims of the ‘309, ‘090, and ‘455 patents, and the DC found it infringed the asserted claims of the ‘857 patent.  The DC also rejected Alvogen’s invalidity arguments. 

Regarding the ‘309 patent, Alvogen argued that Pharmacyclics’ provisional applications did not satisfy the written description (WD) or enablement requirements by failing to “disclose how to synthesize Intermediate 2” and was therefore anticipated by a prior art reference.  But the DC found that the “bracketed citation” to a PCT publication of the provisionals would have led “[a]n artisan of ordinary skill” to undertsand “that the inventors cited [WO ’829] to explain how to synthesize Intermediate 2” used in the preparation of ibrutinib, or “could also have synthesized without the teachings” of the cited PCT “based on the structure of Intermediate 2 disclosed in the diagram…by working backwards from its structure to known starting compounds.”  The FC panel found no error with the DC reliance on expert testimony and, further, “it is clear that Intermediate 2 was not novel because it was disclosed in the WO ’829 publication” and “Intermediate 2 was not a ‘novel aspect[]’ of claim 10 of the ’309 patent” (Genentech, FC 1997; Falko-Gunter, FC 2006 (“formal incorporation by reference is not necessary if the material being incorporated is background art”, “information readily accessible in journals need not be incorporated by reference in order to enable the patent claims at issue”)).

Regarding the ‘090 patent, Alvogen argued the method of treatment claims were not adequately described or enabled, obvious, or invalid for obviousness-type double patenting over Pharmacyclic’s ‘015 patent.  The DC found the ‘090 specification made clear that the preferred BTK inhibitor was ibrutinib (WD and enablement), there was no motivation to combine the alleged obviousness references (e.g., “given the ‘unpredictable nature of oncology’”, no motivation “to use a once-daily dose or about 560 mg”, “safety concerns would have discouraged an artisan”).  On double-patenting, the DC found, e.g., “the breadth of ranges…in the ‘015 patent weighed against applying the presumption of obviousness” and the 560 mg dose would not have been found by “routine experimentation”.  The FC panel found the DC decision not to be clearly erroneous, and distinguished this case from its Biogen decision (FC 2021 (“claimed dosage of 480 mg was “listed only once”)) while here the 560 mg daily dose “is expressly recited by itself (rather than as part of a range”, “appears again in….Example 13”, and “the summary of the invention explicitly discloses a dose of ‘about 560 mg/day.’”  The FC panel also found no clear error with the DC’s finding of no motivation to use 560 mg/day.  The FC also found no clear error in the DC’s double-patenting decision since “a presumption of obviousness may be invoked ‘when the only difference from the prior art is a difference in the range or value of a particular variable’” (In re Kumar, FC 2005) and here “there are additional differences between the prior art and claim 2 of the ’090 patent” (e.g., “the prior art did not disclose that ibrutinib was effective at treating R/R MCL”).

Alvogen also argued claim 5 of the ‘455 patent directed to crystalline forms “was inherently anticipated” by a clinical study, but the DC concluded “a skilled artisan…would not have necessarily recognized” the “authors used crystalline Form A” (citing Endo, FC 2018).  On obviousness of the ‘455 claim, the DC found none of Alvogen’s references “suggested that [Form A (‘with the claimed 2-Theta peaks’)] would be more desirable than any other crystalline form”, as well as Pharmacyclic’s secondary considerations of unexpected benefits and copying.  The DC also disagreed with Alvogen’s invalidity arguments based on WD and enablement of the ‘857 claims (e.g., “recites verbatim the formulations” and dosages).  The FC panel found no clear error with the DC’s conclusions (e.g., “[t]he question is what is “necessarily” inherent in the anticipating reference” (Schering, FC 2003); Endo (FC  (“no evidence ‘that only one vehicle formulation—the claimed vehicle formulation” could be used to achieve the results of the clinical study’”); Grunenthal, FC 2019 (upholding a [DC’s] finding that a skilled artisan would not have expected success in producing a particular crystalline form of a compound when a skilled artisan would not have had ‘reason to know[] how the multiple variables involved in conducting a polymorph screen would affect the recrystallization’ of the compound”)).

Alvogen’s arguments that the ‘857 tablet claims were not supported by WD were also rejected by the DC.  The FC panel found no clear error with that decision because, e.g., “the precise ranges recited in the claims are found in formulations disclosed in the specification”.

Board IPR claim construction and obviousness conclusions affirmed, disclaimer made during IPR not binding “in the very IPR proceeding in which it is made”

CUPP Computer AS v. Trend Micro Inc. (USPTO as Intervenor)

Docket No. 2020-2262-4 (IPR2-19-00764, -00765, -00767 (https://cafc.uscourts.gov/opinions-orders/20-2262.OPINION.11-16-2022_2034079.pdf)

DYK, TARANTO, STARK

November 16, 2022

Brief Summary:   Board claim construction and obviousness findings affirmed.  FC panel explains that “a disclaimer in an IPR proceeding is binding in later proceedings, whether before the PTO or in court” but not “in the very IPR proceeding in which it is made”.

Summary:  CUPP appealed three IPR decision finding Trend Micro (TM) had shown the challenged claims of CUPP’s US 8,631,488; 9,106,683; and 9,843,595 (all pre-AIA) relating to methods for waking a mobile device from a power-saving mode and then performing security operations on the device unpatentable as obvious in view of a US patent (“Gordon”) and a US patent publication (“Joseph”).  CUPP appealed the Board’s claim construction of the claim term “security system processor” relating to all three patents and its finding that either Gordon or Joseph renders the ‘595 patent obvious.  CUPP did request rehearing by the USPTO but was denied (Arthrex, US 2021).  The FC panel explained that in IPR proceedings the Board applies the Phillips “ordinary meaning” claim construction standard (37 CFR section 42.100(b); Phillips, FC 2005; Polaris, FC 2022).  Relying “on the language of the claims, the specification, and disclaimers made during the original examination and IPR proceedings”, CUPP argued “that the claims require that the security system processor be separate and remote from the mobile device.”  The Board concluded “that the security system processor is ‘different’ than the mobile device processor” but that this “does not suggest that the two processors are remote from one another” since “[i]n ordinary usage, ‘different’ simply means “dissimilar’” (“quoting general-purpose dictionaries”).  The FC panel explained that CUPP did not provide any “reason to apply a more specialized meaning to the word here” and a “preferred embodiment” showed that “the mobile security system…may be incorporated within the mobile device” (Vitronics, FC 1996 (“‘highly persuasive’ evidence” required to exclude a preferred embodiment); Accent Pkg., FC 2013; Columbia Univ., FC 2016 (“in the context of the patent”)); thus, the FC panel agreed with the Board that “two processors may be different from one another and yet both be embedded in a single device” (“The Board properly construed the security system processor limitation in line with the specification.”)  CUPP also argued that the Board’s construction is erroneous “because it disclaimed a non-remote security system processor during the initial examination of one of the patents at issue”, an argument the Board rejected.  The FC panel explained that a prosecution disclaimer must be a “disavowal [that was] both clear and unmistakable” (Mass. Inst. Tech., FC 2016; Avid Tech., FC 2016 (not if “disavowal is ambiguous, or even amenable to multiple reasonable interpretations”)).  And it did not find CUPP’s “purported disclaimer” to “unmistakably renounce security system processors embedded in a mobile device”.  CUPP also argued “the Board erred by rejecting CUPP’s disclaimer in the IPRs themselves”, citing Aylus Networks (FC 2017).  The FC panel found the Aylus decision to be “of no help to CUPP” as the decision “says only that a patentee’s disclaimer during an IPR can bind the patentee to a narrower claim interpretation in a subsequent proceeding” to “‘ensure that claims are not argued’ by the patentee ‘one way in order to maintain [the claims’] patentability and in a different way against accused infringers’” and “nothing about whether a patentee’s disavowal is binding in the very proceeding in which it is made” (VirnetX, FC 2019; Oil States, US 2018).  The FC panel explained that “a disclaimer in an IPR proceeding is binding in later proceedings, whether before the PTO or in court” but not “in the very IPR proceeding in which it is made”, and “Congress created a specialized process for patentees to amend their claims in an IPR” (35 USC section 316(d)).  The FC panel also found the Board’s ‘595 patent obviousness conclusions to be supported by substantial evidence.  The Board decision was therefore affirmed.