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.

Posted in Appeal, Negative Limitations, U.S. Supreme Court, Written description | Leave a comment

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)).

Posted in Equitable estoppel, Laches, Prosecution History Estoppel, Uncategorized | Leave a comment

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”)).

Posted in Generics / ANDA, Infringement, Method claims, Obviousness, Obviousness (Secondary Considerations) | Leave a comment

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.

Posted in Appeal, Claim Construction, Inter Parties Review (IPR), IPR, Obviousness | Leave a comment

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).

Posted in Generics / ANDA, Obviousness, Obviousness (Secondary Considerations), Prosecution History Estoppel | Leave a comment

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, 1st 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., 1st 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.

Posted in Trade Dress, Trademarks | Leave a comment

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”.

Posted in Anticipation (35 USC 102), Double Patenting, Enablement, Generics / ANDA, Incorporation by Reference, Infringement, Method claims, Obviousness, Obviousness (Secondary Considerations), Priority, Public Accessibility, Written description | Leave a comment

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.

Posted in Claim Construction, Inter Parties Review (IPR), IPR, Obviousness, Patent Prosecution, Prosecution History Estoppel | Leave a comment

SCOTUS denies Juno’s petition for certiorari regarding written description

Juno Therapeutics, Inc., Sloan Kettering v. Kite Pharma, Inc.

Docket No. 2020-1758 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1758.OPINION.8-26-2021_1825257.pdf)

MOORE, PROST, O’MALLEY

August 26, 2021 (updated November 9, 2022)

Update (Nov. 9, 2022):  SCOTUS denied Juno’s petition for certiorari (21-1566).  As summarized below, the FC reversed the DC’s original finding that Juno’s ‘190 patent provided sufficient written description (WD), the FC panel concluding “[t]he target” of the scFV “can be any target of clinical interest to which it would be desirable to induce a T cell response” (in the FC panel’s words “any scFv for binding any target”) and that the ‘190 WD “fails to provide a representative sample of species within, or defining characteristics for, that expansive genus” and “no details about these scFv species beyond the alphanumeric designations J591 and SJ25C1 for a skilled artisan to determine how or whether they are representative of the entire claimed genus.”

Brief Summary:  DC decision that Juno’s claimed “binding element that specifically interacts with a selected target” (e.g., scFv that binds CD19) was properly described reversed.

Summary:  Kite appealed DC decision finding Juno’s US 7,446,190 directed to nucleic acids encoding chimeric T cell receptors (chimeric antigen receptors, CARs) not invalid for lack of written description, the certificate of correction is not invalid, and awarding Juno over $1.2 billion in damages for infringement by Kite’s YESCARTA® product.  The FC panel found the claims invalid for lacking a proper written description (WD; under pre-AIA section 112) and reversed the DC’s decision without reaching the other issues.  Independent claim 1 of the ‘190 patent claims “a nucleic acid polymer encoding” a CAR “comprising…a zeta chain portion…a costimulatory signaling region [SEQ ID NO:6]…and…a binding element that specifically interacts with a selected target” and dependent claims 3 and 9 limiting “the claimed ‘binding element’ to ‘a single chain antibody,’ i.e., an scFv.”  Kite’s product includes “an scFv that binds the CD19 antigen”.  The FC panel explained the basic WD requirements (“reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date” (Ariad, FC 2010), not a “mere wish or plan” (Centocor, FC 2011)) and that those vary “with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence” (Capon, FC 2005).  Further, the FC panel explained, “[f]or genus claims using functional language, like the binding function of the scFvs claimed here, the written description ‘must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus’” (“either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus” (Ariad)) and that “a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials” (Lilly, 1997).  Here, the FC panel found that the ‘190 patent explains that “[t]he target” of the scFV “can be any target of clinical interest to which it would be desirable to induce a T cell response” (in the FC panel’s words “any scFv for binding any target”) and that the ‘190 WD “fails to provide a representative sample of species within, or defining characteristics for, that expansive genus” and “no details about these scFv species beyond the alphanumeric designations J591 and SJ25C1 for a skilled artisan to determine how or whether they are representative of the entire claimed genus.”  The FC panel wrote that “[t]o satisfy the written description requirement, the patent needed to demonstrate to a skilled artisan that the inventors possessed and disclosed in their filing the particular species of scFvs that would bind to a representative number of targets”, which is not satisfied by “[t]he disclosure of one scFv that binds to CD19 and one scFv that binds to a PSMA antigen on prostate cancer cells”.   The FC panel added that it is not saying “that a patentee must in all circumstances disclose the nucleotide or amino acid sequence of the claimed scFvs to satisfy the written description requirement when such sequences are already known in the prior art” and that “[i]t is not fatal that the amino acid sequences of these two scFvs were not disclosed as long as the patent provided other means of identifying which scFvs would bind to which targets, such as common structural characteristics or shared traits.”  Juno argued “that because scFvs, in general, were known, the two scFvs in the ’190 patent are representative” but the FC panel responded that “the specification provides no means of distinguishing which scFvs will bind to which targets” (citing Lilly and distinguishing Capon in which “more was known in the prior art”; see FN2:  “We agree with Juno that a patent specification need not redescribe known prior art concepts.”  Immunex, FC 2020).  The FC panel also found Juno’s expert testimony insufficient even though “[i]t is undisputed that scFvs generally have a common structure” given that “an scFv with the same general common structure but with a different amino acid sequence would recognize a different antigen” (citing Idenix, FC 2019 (“the patent merely provided ‘lists or examples of supposedly effective nucleosides, but [did] not explain what makes them effective, or why’”) and Abbvie, FC 2014 (“the patents described one species of structurally similar antibodies derived from only one lead antibody”); distinguishing Erfindergemeinschaft, FC 2018 (“there were hundreds of known PDE5 inhibitors, the type of compound at issue, and the patent identified the compounds by chemical name and structural drawings”)).  Claims 5 and 11, “limited to scFvs that bind CD19 (a specific target)”, were also found to lack WD even though Kite itself argued “that there were ‘four or five’ CD19-specific scFvs ‘arguably known in the art’ at the priority date” (including as argued by Juno “the one used in YESCARTA®”).  Thus, the FC panel reversed the DC decision.

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SCOTUS grants Amgen’s request for certiorari of lack of enablement of its anti-PCSK9 antibody claims; petition for FC en banc hearing previously denied (June 21, 2021)

Amgen Inc. v. Sanofi, et al.

SCOTUS Docket No. 21-757; FC Docket No. 2020-1074 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1074.OPINION.2-11-2021_1731739.pdf)

PROST, LOURIE, HUGHES

November 7, 2022 Update (original FC Panel decision on February 11, 2021)

Third Update (November 7, 2022):  SCOTUS granted certiorari regarding the second question raised in Amgen’s request regarding it functional anti-PCSK9 antibody-related claims and the District Court (DC) (Amgen Inc., et al. v. Sanofi, et al., Civ. No. 14-1317- SLR (D. Del.), judgment entered on January 3, 2017; Amgen Inc., et al. v. Sanofi, et al., Civ. No. 14-1317- RGA (D. Del.), judgment entered on October 3, 2019) and Federal Circuit (FC) (Amgen Inc., et al. v. Sanofi, et al., No. 2017-1480 (Fed. Cir.), judgment entered on October 5, 2017; Amgen Inc., et al. v. Sanofi, et al., No. 2020-1074 (Fed. Cir.), judgment entered on February 11, 2021) findings that those claims were invalid for lack of enablement.  SCOTUS will consider Question 2:  “Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to ‘make and use’ the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art ‘to reach the full scope of claimed embodiments’ without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “‘time and effort’”.  The DC’s finding of a lack of enablement of Amgen’s anti-PCSK9 antibody claims 19 (“binds to at least two of the following residues…listed in SEQ ID NO:3) and 29 (“binds to at least two of the following residues…listed in SEQ ID NO:3 and blocks the binding of PCSK9 to LDLR by at least 80%”) of US 8,829,165 and claim 7 (“wherein the epitope is a functional epitope”) of US 8,859,741 was affirmed by the FC in February 2021, and Amgen’s request for rehearing en banc was denied in June 2021.  Amgen’s petition for certiorari to SCOTUS on Nov. 18, 2021 asked for review of two questions:  1)  “Whether enablement is aa question of fact to be determined by the jury,’ Wood v. Underhill, 46 U.S. (5 How.) 1, 4 (1846), as this Court has held, or ‘a question of law that [the court] review[s] without deference’…as the Federal Circuit holds”; and, 2) “Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to ‘make and use’ the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art ‘to reach the full scope of claimed embodiments’ without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “‘time and effort’”.  Amicus curiae supporting Amgen’s position were filed on Dec. 22, 2021 by the Assoc. Univ. Tech. Managers (e.g., “the decision below cannot be reconciled with the language of the Patent Act and this Court’s precedent”), GSK (e.g., “Genus claims are critical to protect innovations of companies like GSK, as well as smaller entities and academic institutions, and to encourage investment and collaboration”), and Intellectual Property Professors (e.g., “The central feature of patent law in the life sciences industries is the genus claim.”)  Sanofi filed a brief in opposition on March 14, 2022.  In April, SCOTUS invited the Solicitor General (SG) of the United States to file a brief expressing its view, which was filed on Sept. 21, 2022.  Regarding Amgen’s first question, the SG argued that “[t]he lower courts’ finding of no enablement followed naturally from their conclusions as to the Wands factors, including that ‘no reasonable factfinder could conclude that there was adequate guidance beyond the narrow scope of the working examples’ or ‘that anything but ‘substantial time and effort’ would be required to reach the full scope of claimed embodiments”, and “Petitioners do not contend that they could prevail on enablement despite the individual Wands factors having been resolved against them.”  As to Amgen’s second question, the SG argued that SCOTUS’ previous “decisions confirm that the full scope of the claims must be considered in assessing enablement” (citing n Consolidated Electric Light Co. v. McKeesport Light Co., 159 U.S. 465 (1895); Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245 (1928)), Amgen’s “case-specific argument[s]” do “not warrant this Court’s review”, “disclosing how to produce some antibodies that perform a specified function is not equivalent to disclosing how to produce all such antibodies—and it is the latter that petitioners claim as their invention”, Amgen’s concern that “that the court of appeals’ standard is “‘impossible’ to satisfy any time a genus claim covers a ‘nontrivial’ number of embodiments’…is overstated”  (citing McRO, Inc. v. Bandai Namco Games Am. Inc., 959 F.3d 1091, 1099 (2020); Erfindergemeinschaft UroPep GbR v. Eli Lilly & Co., 276 F. Supp. 3d 629, 662-663 (E.D. Tex. 2017), aff’d, 739 Fed. Appx. 643 (Fed. Cir. 2018), cert. denied, 140 S. Ct. 449 (2019); and Wyeth & Cordis Corp. v. Abbott Labs., 720 F.3d 1380, 1386 (Fed. Cir. 2013) (“[e]ven ‘a considerable amount of experimentation is permissible”)), and the Federal Circuit does not “apply ‘a different,’ more stringent ‘enablement test for genus claims’ than for other types of claims” as its position here “simply reflect the fact that a disclosure must be ‘commensurate with the scope of the claims’” (citing National Recovery Techs., Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1196 (Fed. Cir. 1999)).  The SG therefore requested denial of Amgen’s require for a writ of certiorari.  As for the written description issues highlighted previously in our discussion of the Juno and Biogen cases, this case has been and will continue to be of great interest to those in the biotechnology and pharmaceutical industries.

Update (June 21, 2021):  Petition for rehearing en banc denied.  Judges Lourie, Prost and Hughes authored an opinion issued with the order.  In it, the judges explained that Amgen incorrectly argued that the FC has “created a new test for enablement” as “[g]enus claims, to any type of invention, when properly supported, are alive and well” (referring to “[c]hemical patent specifications”).  However, the opinion explained that “as with genus claims to chemical compounds, if” biological composition claims “encompass more subject matter than just a few species, they need to be enabled accordingly” (“Biological compositions not actually prepared need to be described constructively, if required to enable the full scope of the claims, with procedures and names of resultant compositions, as with chemical compositions…If the genus had been invented by the time of filing, it would have been fully enabled in the patent.”)  In this case, the judges wrote, “the narrow and limited guidance in the specification made far corners of the claimed landscape that were particularly inaccessible or uncertain to make unenabled” and given that “Amgen in fact has separate patent protection on the PCSK9 antibody” (U.S. 8,030,457), “the failure to obtain unsupported, unenabled claims has not deprived it of patent protection on the fruits of its investment.”  The opinion also states that the innovator can rely on the doctrine of equivalents to protect compounds “so close to species disclosed and claimed by a first entrant as to be an equivalent” and that the “second comer may encounter the expensive hurdle of having to meet its own regulatory requirements, if it does not qualify for ANDA or biosimilar status.”  Regarding functional claims generally, the opinion states that the analysis “is circular; enablement comes only with success, which depends upon enablement”, “one cannot claim everything that works”, “single means claims claim too much” (citing In re Hyatt, FC 1983), and “[m]ultiple means claims simply compound the problem.”  The opinion also refers to many earlier enablement decisions, noting that “[t]he much-cited Wands case is the signature authority on the issue” (In re Wands, FC 1988).

Brief Summary of Original FC Panel Opinion:  DC lack of enablement of Amgen’s anti-PCSK9 antibody claims affirmed.

Summary of Original FC Panel Opinion:  Amgen appealed DC grant of JMOL for lack of enablement of claims 19 and 29 of US 8,829,165 and claim 7 of US 8,859,741 directed to antibodies against PCSK9.  In a prior appeal related to this suit, the FC remanded the DC decision with respect to “its evidentiary rulings and jury instructions regarding Sanofi’s defenses that the patents lack written description and enablement” and vacated the permanent injunction (Amgen, FC 2017).  Relevant to this appeal, “[t]he jury again found that Sanofi failed to prove that the asserted claims were invalid for lack of written description and enablement”, but the DC “granted Sanofi’s Motion for JMOL for lack of enablement and denied the motion for lack of written description.”  The FC panel explained that it reviewed enablement decision without deference and the underlying factual findings for clear error, and the requirements of an enablement determination (e.g., undue experimentation, Wands factors (Alcon, FC 2014; In re Wands, FC 1988 (“‘go to’ precedent for guidance on enablement”, “disclosure adequately taught using hybridoma technology to produce the needed claims antibodies”)).  It also explained that “[a]lthough a specification does not need to ‘describe how to make and use every possible variant of the claimed invention, when a range is claimed, there must be reasonable enablement of the scope of the range’” (McRO, FC 2020, citing AK Steel, FC 2003).  Amgen argued that “no undue experimentation is required to obtain antibodies fully within the scope of the claims” by, e.g., “following a roadmap using anchor antibodies and well-known screening techniques described in the specification or by making conservative amino acid substitutions in the twenty-six examples” (e.g., “binds to at least one of the following residues” on PCSK9, “an epitope on PCSK9 comprising at least one of residues 237 or 238 of SEQ ID NO:3, and…blocks the binding of PCSK9 to LDLR” (low-density lipoprotein receptor)).  Sanofi argued “that there are millions of antibody candidates within the scope of the claims” the specification lacks sufficient guidance, and “antibody generation is unpredictable”.  The FC panel reviewed the Wands decision as well as its Wyeth (FC 2013 (no enablement of “methods of preventing restenosis with compounds having certain functionality requirements”), Enzo (FC 2019 (claims requiring “particular structure and functionality” not enabled), and Identix (FC 2019 (no enablement due to “lack of guidance across…full scope”, “needle in a haystack”) decisions.  The FC panel also wrote that “functional claim limitations…pose high hurdles in fulfilling the enablement requirement for claims with broad functional language”.  And it concluded that “[t]he binding limitation is…require[s] undue experimentation” since, e.g., “the claims are far broader in functional diversity than the disclosed examples” (AbbVie, FC 2014), “this invention is in an unpredictable field of science”, and the “required experimentation ‘would take a substantial amount of time effort’”.  The FC panel therefore affirmed the DC decision.

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