Infringement by Hospira’s ANDA of Par’s epinephrin injection-related claims affirmed

Par Pharmaceutical, Inc. et al. v. Hospira, Inc.

Docket No. 2020-1273 (


November 23, 2020


Brief Summary:  DC finding that Hospira’s ANDA infringed Par’s claims affirmed (e.g., “[w]hat a generic asks for an receives approval to market, if within the scope of a valid claim, is an infringement”).

Summary:  Hospira appealed DC finding that its generic (ANDA) of Par’s Adrenalin® epinephrin injection infringed Par’s US Pat. Nos. 9,119,876 and 9,295,657 directed to compositions and methods of treatment, respectively.  The DC construed several claim terms and “determined that the sodium chloride permitted by Hospira’s ANDA comes within the claim limitation requiring ‘about 6 to 8 mg/mL’ of a tonicity regulating agent”, “the ANDA covered a product having citric acid that would serve as a transition metal complexing agent” (“about 0.01 to 0.4 mg/mL”) and “covered a product having citric acid that served as a pH lowering agent in an amount that comes within the claim-required range” (“about 0.001 to 0.010 mg/mL”).  The FC panel explained that “whether an ANDA is ‘for’ a patent-claimed drug or patent-claimed use of a drug under 35 U.S.C. § 271(e)(2), is an issue of fact…reviewed for clear error.”  Referring to its Cohesive (FC 2008) and Monsanto (FC 2018) decisions, the FC panel wrote that “[t]he authorized extension” of the term “about” “beyond the stated numbers in the range is cabined to what ‘a person having ordinary skill in the art…would reasonably consider ‘about…’ to encompass”, “[t]he extension effected by ‘about’ must be tied to ‘the purpose of the limitation in the claimed invention-not the purpose of the invention itself”, and “requires examination of whether the extension is by a ‘modest amount,’…considering the ‘criticality of the [numerical limitation] to the invention’”.  In front of the DC, Par and Hospira “agreed that ‘about’ should be construed to have its ‘plain and ordinary meaning’ of ‘approximately’”, and the FC panel found that the DC “reasonably concluded” (e.g., based on expert testimony) that “‘about 8’ encompasses 9, considering the purpose of the upper limit”, without considering “statements suggesting that 8.5 mg/ml might be too high to be ‘about 6 to 8’” made “years after the ‘876 and ‘657 patents issued” during prosecution of “a continuation-in-part application that named a different inventor group, that had different claims, and that Par eventually abandoned”.  Regarding the “transition metal complexing agent” limitation, which the DC found the citric acid of Hospira’s product meets, Hospira argued that the DC’s “analysis should have focused entirely on the characteristics of the composition that Hospira was likely to sell, not on what compositions the ANDA, if approved, would allow Hospira to market.”  The FC panel disagreed with Hospira, explaining that “[i]t is not necessary that Hospira intended the citric acid to function as a chelating agent if, as the [DC] could readily find, the citric acid actually does so” (Global-Tech, US 2011) and that “[w]hat a generic asks for an receives approval to market, if within the scope of a valid claim, is an infringement” (“representations about the ANDA’s scope control the infringement analysis”) (Sunovion, FC 2013; Glaxo, FC 1997; Ferring B.V., FC 2014 (“When an ANDA is silent with respect to a claim limitation, Sunovion does not govern; it is the product that the generic company is likely to sell that guides the infringement analysis.”))  The FC panel also concluded the DC correctly found Hospira’s ANDA product included the claimed pH lowering agent.  The DC decision was therefore affirmed.

Posted in Claim Construction, Generics / ANDA, Infringement | Leave a comment

Infringement by GSK’s inhalers and damages determination affirmed

Vectura Limited v. GlaxoSmithKline LLC et al.

Docket No. 2020-1054 (


November 19, 2020

Brief Summary:  DC finding that GSK’s inhaler composition infringe Vectura’s patent and the ~$90 million damages award affirmed. Summary:  GSK appealed jury finding it infringed Vectura’s US 8,303,991 directed to “[c]omposite active particles for use in a pharmaceutical composition for pulmonary administration” that include magnesium stearate, and the damages award.  Vectura alleged infringement by GSK’s Ellipta-brand inhalers (the Breo, Anoro, and Incruse devices) and awarded almost $90 million in damages (3% royalty on $2.99 billion in sales).  GSK’s “accused inhalers feature[] one or more ‘blisters,’ which are sealed receptacles containing a single active ingredient, an excipient, and, optionally, additive material” (vilanterol, umeclidinium, or fluticasone deposited onto magnesium stearate-coated lactose particles).  The DC construed the claim phrases “promotes the dispersion of the composite active particles” as being “compared to the same composition” but including “unmodified active particles”, and “composite active particles” as being those in which “the active and additive particles do not separate in the airstream”.  GSK argued that Vectura did not present substantial evidence that “the accused inhalers use additive material that ‘promotes the dispersion’ of the active material” and that “composite active particles” was misconstrued.  The FC panel opinion reviewed Vectura’s evidence and concluded that the jury’s finding was supported by substantial evidence.  The DC’s construction of “composite active particles” was based only on intrinsic evidence and the FC panel therefore applied de novo review (Teva, US 2015).  GSK argued that the term “should be construed to include a process limitation” which the panel explained “falls between two prior cases from this court:”  Continental Circuits (FC 2019) and Anderson (FC 2007) (e.g., Continental “merely indicated a preference” for the process while Anderson’s “specification made it clear that a process was an essential part of the apparatus claim” (“language of requirement, not preference”), confirmed by the prosecution history).  The FC panel found the ‘991 patent specification to be “more like the specification in Continental Circuits than the specification in Andersen” (e.g., “few statements suggesting that its high-energy milling is required”, “outweighed by the numerous statements indicating that high-energy milling is merely a preferred process”, criticism of other methods “not dispositive” (AstraZeneca, FC 2013)).  The FC panel also found that GSK’s prosecution arguments distinguishing the prior art were “based on the unique structure of the claimed composite particles, not the disclosed milling method”.  The FC panel also found that the DC “did not abuse its discretion in denying GSK’s motion for a new trial on damages” based on, e.g., properly considered expert testimony regarding a “hypothetical negotiation”. 

Posted in Claim Construction, Damages, Licensing | Leave a comment

DC ineligibility decision erroneous as claims not “solely directed to the printed matter”

C. R. Bard, et al. v. AngioDynamics, Inc.

Docket No. 2019-1756, -1934 (


November 10, 2020

Brief Summary:  DC erroneously granted JMOL based on expert mistake and conclusion that printed matter made claims patent ineligible under section 101.

Summary:  Bard appealed DC grant of judgment as a matter of law (JMOL) that the claims of three patents related to assemblies “for identifying a power injectable vascular access port” using “identifiable features” including a “radiographic marker perceivable via x-ray” were not infringed and invalid under section 101 for being directed to printed matter.  Dependent claims require the “radiographic marker” to “be in the form of radiographic letters or other symbols, patterns, or characters” and an “extrinsic identifier” in the form of “a key chain, a bracelet, a wrist band, a sticker provided on a patient’s chart, a patient ID card, or a label provided on the product packaging.”  AngioDynamics was granted JMOL of non-infringement, no willfulness and ineligibility under section 101 based on the “printed matter doctrine” after presenting its case which included (for both sides) expert testimony on infringement and damages.  The FC panel agreed with Bard that the DC erred in granting JMOL because a mistake made by Bard’s expert “undermine[d] his credibility, it does not make his testimony legally insufficient to support an infringement verdict” (distinguishing Wiener (FC 1996) and Cordis (FC 2011)), “Bard was entitled to rely on AngioDynamic’s representations to its customers and to the FDA” (“[n]either the [DC] not AngioDynamics provide any reason why direct testing evidence is required…under these circumstances”), and “there was sufficient circumstantial evidence” that “AngioDynamics induced infringement of the method claims” (Toshiba, FC 2012 (sufficient evidence to “reasonably conclude that, sometime during the relevant period[,] more likely than not one [entity] somewhere in the [US]’ performed each of the claim steps, even when there is no direct evidence of a specific person doing so”)).  The FC panel also found the DC’s finding of no willful infringement because “Bard had failed to show infringement” or AD “had obtained written opinions of counsel regarding the invalidity, and Bard had failed to show that the opinions were ‘drafted by a bad law firm’ or put forth other evidence of willfulness” to be erroneous (e.g., Bard introduced evidence that AD was “aware of the applications that issue as the patents-in-suit prior to their issuance”, “intentionally copied Bard’s CT radiographic marker” (Eko Brands (FC 2020); Polara (FC 2018), leaving “question[s] of fact for the jury”).  The FC panel also found the DC’s patent ineligibility finding “procedurally improper” since the issue was not “fully heard” but also “conclude[d] that although the asserted claims contain printed matter that is not functionally related to the remaining elements of the claim, each claim as a whole is patent eligible because none are solely directed to the printed matter” (“no patentable weight” assigned “to the claimed printed matter”; AstraZeneca, FC 2010; In re Chatfield, CCPA 1976; Praxair, FC 2018; In re Marco, FC 2018 (“markings did not cause dice to become a ‘manufacture with new functionality”)) and “material disputes of fact remain as to whether other elements of the claim are novel of the prior art.”

Posted in Inducement to Infringe, Infringement, Patent Eligibility (101), Patentability | Leave a comment

SCOTUS’ 2020 Thryv decision “makes clear that the threshold determination” of CBM review eligibility “non-appealable under 35 U.S.C. 324(e)”

SIPCO, LLC v. Emerson Electric Co.

Docket No. 2018-1635 (CBM2016-00095)


September 25, 2019

Update (11/17/20):  FC panel explained that SCOTUS’ 2020 Thryv decision “makes clear that the threshold determination that SIPCO’s ‘842 patent qualifies for CBM review is a decision that is non-appealable under 35 U.S.C. 324(e)” and affirmed the Board’s unpatentability decision without reaching the Board’s decision of patent ineligibility (section 101) decision. (Decision:

Brief Summary:  PTAB determination of CBM eligibility reversed since, e.g., “SIPCO’s claims combine certain communication elements in a particular way to address a specific technical problem” (not a CBM case under the “technological invention” exception). Summary:   SIPCO appealed the PTAB’s covered business method (CBM) review final written decision (FWD) regarding US 8,908,842.  The FC panel opinion explained that a patent does not qualify for CBM review if “the claimed subject matter as a whole recites a technological feature that is novel and unobvious over the prior art; and solves a technical problem using a technical solution” (the “technological invention” exception (AIA § 18(d); 37 CFR § 42.301(b); FN4:  “the AIA does not define what is or is not a technological invention”).  Emerson requested CBM review “on, inter alia, §§ 101 and 103 grounds,”, arguing “that the challenged claims were directed to the patent-ineligible abstract idea of ‘establishing a communication route between two points to relay information’” and unpatentable over a US patent (“Tymes”).  The PTAB found that the ‘842 patent “recited apparatuses ‘used in the practice, administration, or management of a financial product or service’ under § 18(d)(1)” (“the features of claim 1, as incorporated in dependent claims 3 and 4” that refer to an ATM or vending machine), and “contained no technical solution to a technical problem”, based in part on its construction of the claim element “low power transreceiver configured to wirelessly transmit a signal” (Versata, FC 2015 (“general computer system components” not a technological feature)).  After institution, SIPCO filed a statutory disclaimer of claims 3 and 4 (§ 253) and argued that those claims could not “form the basis” of finding the ‘842 patent a CBM patent (Guinn, FC 1996 (“treated as though the disclaimed claims never existed”)), but the PTAB disagreed since institution is based on “what the patent claims at the time of the institution decision”.  The PTAB also agreed with Emerson’s patent-ineligiblity and obviousness arguments.  The FC panel disagreed with the PTAB’s construction of “low power” as not correlated with a “limited transmission range”, finding instead that “a skilled artisan would understand” from the ‘842 specification that “low power” corresponds to “limited transmission range” (Phillips, FC 2005).  The FC panel first explained that the PTAB’s conclusion of CBM eligibility was “not arbitrary and capricious” (SightSound, FC 2015; Apple, FC 2016 (“only one claim must meet the requirements”)).  However, it also found that the PTAB “misread and mischaracterized the features of claim 1 in its analysis of dependent claims 3 and 4”, “did not appreciate that the claims provide a technical solution to a technical problem” (“how to extend the reach of an existing communication system from a central location to a remote, unconnected device” using the “low power, i.e., limited transmission range”; “SIPCO’s claimed invention does not simply use ‘well understood,’ off-the-shelf wireless technology for its intended purpose of communicating information” (unlike Champerlain, FC 2019 (see FN3)), and therefore found its ruling to be arbitrary and capricious.  The FC panel explained that even if the ‘842 patent uses conventional components as argued by Emerson, this case is similar to Bascom (FC 2016) (e.g., “SIPCO’s claims combine certain communication elements in a particular way to address a specific technical problem”).  The FC panel therefore remanded the case to the PTAB.  Judge Reyna’s dissent argued that the PTAB’s claim construction should have been afforded deference.

Posted in Covered Business Method Reviews, Patent Eligibility (101), Software | Leave a comment

IPR decision vacated and remanded for failure to compare “purposes or problems” of patent and alleged analogous art

Donner Technology, LLC v. Pro Stage Gear, LLC

Docket No. 2020-1104 (IPR2018-00708) (


November 9, 2020

Brief Summary:  Board IPR decision vacated and remanded as it “failed to properly identify and compare the purposes or problems” of the patent and the alleged analogous prior art.

Summary:  Donner appealed USPTO (“Board”) rejecting its IPR challenge of Pro Stage’s US 6,459,023 relating to guitar effects pedalboards, finding the alleged prior art US patent (“Mullen”) not to be analogous art.  The FC panel opinion explains that the ‘023 patent “explained that there was…a need for ‘an improved pedal effects board which allows easy positioning and changing of the individual guitar effects while providing a confined and secure area for cable routing and placement” and that it “describes a guitar effects pedalboard that purportedly solves these problems.”  The Mullen reference, upon which each of Donner’s alleged grounds for invalidity depends, is described in this opinion as providing “an improved support for supporting one or more relay structures and for providing wiring-channel space” which Donner “contends…depicts a structure that is analogous to the structure claimed by the ‘023 patent”.  The FC panel agreed with Donner that the Board erred in finding it “failed because Donner had not shown that Mullen falls within the scope of the prior art”.  The FC panel explained that “[i]t is undisputed that the ‘023 patent and Mullen are not from the same field of endeavor” and “[t]herefore, the question is whether Mullen is reasonably pertinent to one or more of the particular problems to which the ‘023 patent relates” (“the problems to which both relate must be identified and compared”;  Princeton Bio., FC 2005 (“The scope of the prior art includes all analogous art.”); In re Bigio (FC 2004) (“Two separate tests define the scope of analogous prior art:  (1) whether the art is from the same field of endeavor, regardless of the problem addressed and”, if not, “(2)…whether the reference is still reasonably pertinent to the particular problem.”); Wyers, FC 2010 (“dividing line…ultimately rests on the extent to which the reference of interest and the claimed invention relate to a similar problem or purpose”)).  The FC panel found that while “the Board did consider all relevant arguments and evidence”, it “failed to properly identify and compare the purposes or problems to which Mullen and the ‘023 patent relate”, “the relevant purposes of an invention” being “those relating to solving a problem” (In re Clay, FC 1992).  It found “the Board’s articulation of the purpose of or problem to be solved” to be “so intertwined with the patent’s field of endeavor that it would effectively exclude consideration of any references outside that field”, while the “analysis must be carried out from the vantage point of a PHOSITA who is considering turning to the teachings of references outside her field of endeavor” (Sci. Plastic, FC 2014; FN1 acknowledging that there can be specific problems that “rules out all art outside that field”; Heidelberger, FC 1994 (“The relevant question is whether a PHOSITA ‘would reasonably have consulted’ the reference in solving the relevant problem.”)  The Board was found to have “failed to apply the proper standard” and remanded the decision.

Posted in Analgous Art, Inter Parties Review (IPR), IPR | Leave a comment

Board interference decision finding UW to be senior party affirmed based on proper claim construction

Chevron U.S.A. Inc. v. University of Wyoming Corp. et al.

Docket No. 2019-1530 (


November 4, 2020

Brief Summary:  Board interference decision finding UW to be senior party affirmed based on proper claim construction.

Summary:  Chevron appealed USPTO (“Board”) interference decision finding UW to be the senior party regarding the claimed subject matter of US 8,367,425 since Chevron was unable to show a sufficiently early “corroborated conception coupled with diligence”.  The FC panel explained that Chevron presented it “only one, narrow issue:  whether the Board erred in its construction of the limitation ‘gradually and continuously changing the alkane mobile phase solvent to a final mobile phase solvent’” and that “the parties concur that if we agree with the Board’s construction of ‘gradually,’ we must affirm”.  The FC panel reviewed the Board’s construction de novo since “the intrinsic record fully governs the proper construction” of the term” (In re Power Int., FC 2018; ULF Bamberg, FC 2016 (broadest reasonable construction “[b]ecause Wyoming copies claim 1 of Chevron’s ‘814 application to provoke the interference”, “in the context of the ‘814 application”)).  Chevron argued “the specification discloses that the solvent is ‘gradually and continuously’ changed at the inlet of the column” while UW argued “that…the ‘814 application itself specifically and unambiguously provides a definition”.  The FC panel agreed with UW because, “[f]irst and most significantly, [para.] 37 of the ‘814 application…provides an express definition of ‘gradually’” that “requires ‘incremental[] remov[al]’ and ‘continuous[] adding’” and other examples did not require “the claimed ‘chang[ing]’ be limited to occurring at the column’s inlet” (“‘gradually’ ‘shall be understood to mean’”; distinguished from In re Suitco (FC 2010)).  The FC panel also found no error with the Board’s reliance solely on the specification after accepting expert testimony from both sides as it, e.g., “simply…confirm[ed] its understanding…that Wyoming’s ‘425 patent had adequate written description”, or its consideration of “ ‘gradually’ and ‘continuously’ separately” since “the ‘814 application defined ‘gradually,’ an adverb generally used to describe the pace at which something is performed, ‘[to] be understood to mean…continuously adding a final mobile phase solvent” (also distinguishing Haemonetics (D. Mass. 2007) and Bicon, both “correct[ing] claim constructions that were inconsistent with the patent’s specification”)).  The FC panel therefore affirmed the Board decision.  Judge Newman’s dissent argued that “[t]he Wyoming specification does not describe and does not support the claims copied from Chevron” (“only mention of the Chevron method is in the claims that Wyoming copied from Chevron” (Ariad, FC 2010 (written description); extensive analysis provided in the dissent).

Posted in Claim Construction, Interference | Leave a comment

SFM correctly found to have standing to bring trademark cancellation request (e.g., “reasonable belief of damage”)

Corcamore, LLC v. SFM LLC

Docket No. 2019-1526 (


October 27, 2020

Brief Summary:  SFM found to have standing to bring trademark cancellation request against Corcamore’s SPROUTS registration in connection with vending machines in view of SFM’s registration for retail grocery stores (e.g., “reasonable believe of damage”).

Summary:  Corcamore appealed USPTO Board decision granting SFM’s request to cancel Corcamore’s SPROUTS registration in connection with vending machines in view of SFM’s registration of SPROUTS regarding retail grocery stores.  Corcamore argued the Board erred in applying the FC’s “analysis in Empresa Cubana, instead of the analytical framework established by the Supreme Court in Lexmark” (Empresa, FC 2014; Lexmark, US 2014).  The FC panel reviewed the Board’s decision “de novo whether SFM pleaded sufficient facts to establish entitlement to challenge Corcamore’s registered trademark under [section] 1064” (which “does not involve the traditional legal notions of Article III standing”).  The FC panel found that “[t]he Board failed to apply the Lexmark analytical framework” (its “interpretation…is unduly narrow”; “zone-of-interests and proximate-causation requirements control the statutory cause of action analysis”; “if that person ‘believes that he is or will be damaged…by the registration of a mark on the principal register”; “distinguish [parties demonstrating a real interest] from mere intermeddlers”) “but it reached the correct result”, explaining that it “see[s] no meaningful, substantive difference in the analysis used in Lexmark and Empresa Cubana” (e.g., “a party that can demonstrate a reasonable believe of damage by the registration of a mark also demonstrates damage proximately caused by the registered mark”).  And it agreed with the Board’s conclusion that “SFM pleaded allegations sufficient to demonstrate a right to challenge Corcamore’s registered mark” (e.g., “goods sold are substantially similar…an interest falling within the zone of interests protected by [section] 1064”, “purchasers will be led to the mistaken belief that SFM’s goods and [Corcarmore’s] goods originate from the same source, or that [Corcamore’s] useof SPROUT has been sponsored, authorized, or warranted by SFM”).  The Board granted a default judgment “as a discovery sanction”, which Corcamore unsuccessfully argued was an abuse of discretion (e.g., “Corcamore failed to follow Rule 2.119 and provided no explanation for why it failed to effect email service”).  The Board decision was therefore affirmed.

Posted in Trademarks | Leave a comment

Induced infringement decision reversed (“subjective bad faith”); eligibility decision affirmed (“improving a basic function of a computer”)

TecSec, Inc. v. Adobe Inc., et al.

Docket No. 2019-2192, -2258


October 23, 2020

Brief Summary:  DC incorrectly excluded evidence of induced infringement (“subjective bad faith”) but correctly found patent eligibility (“directed to improving a basic function of a computer”).

Summary:  TecSec appealed DC finding direct infringement of its US 5,369,702; 5,680,452; 5,717,755; and 5,898,781 (“DCOM patents”, expired in October 2013) relating to multi-level security systems and its reduction of the jury’s damages award ($1.75 million) “to zero on the ground that there was no proof of any damages from direct infringement and the jury had rejected induced infringement” (section 271(b)) relating to the use of PDF document, including the exclusion of certain deposition testimony regarding induced infringement after March 3, 2011 (the date the DC stayed the case as to all defendants except IBM which was found not to infringe (affirmed by FC in 2012)).  Adobe cross-appealed the DC’s ruling that the asserted claims are patent eligible under section 101.  It is noted that in TecSec I (TecSec, FC 2013), an earlier DC decision was reversed and remanded due to its erroneous construction of “multimedia”, and another reversed for an erroneous grant of summary judgment (SJ) of noninfringement (TecSec II, FC 2016).

Regarding induced infringement, the DC “explained that the March 3, 2011 claim construction and stipulation of noninfringement made it legally impossible for Adobe to have had, after that date, the knowledge-of the infringing character of the allegedly induced customer actions-required for inducement” (Global-Tech, US 2011 (“intent element…can be established by…‘willful blindness’”); Power Int., FC 2016) and “allowing either party to present evidence would substantially prejudice the other party and would confuse the jury.”  The FC panel reversed the DC’s decision to exclude evidence of inducement of infringement after March 3, 2011, explaining that “Adobe may have had the requisite knowledge of infringement if it believed (as we ultimately held in 2013) that the March 3, 2011 claim construction was incorrect, even if that construction was objectively reasonable” (Halo, US 2016 (“finding of willfulness may rest on the subjective bad faith of the infringer”); Smith & Nephew, FC 2015 (non-precedential, subject intent proven in view of DC’s prior “objectively weak” decision); Sanofi, FC 2017; AstraZeneca, FC 2010; Cheek, US 1991 (“legally unreasonable view that no tax was due”); “The Global-Tech inducement standard…can be met by proof of what Adobe in fact subjectively believed.”)  The FC panel also reversed the DC’s decision precluding “TecSec from introducing its evidence of post-March 3, 2011 inducement of infringement”.  The FC panel also found no error with the DC’s reduction of damages to zero since “TecSec presented no evidence of damages caused by Adobe’s direct infringement, which was the only form of infringement that the jury found Adobe to have committed.”

Regarding patentability (section 101), the FC panel concluded “that the claims are directed to improving a basic function of a computer data-distribution network, namely, network security” and affirmed the DC decision of patent eligibility (SRI, FC 2019; Solutran, FC 2019 (Alice Step 1 focuses on “the claimed advance over the prior art”)).

Posted in Inducement to Infringe, Patent Eligibility (101), Section 101 (see also Patentability), Software, Uncategorized | Leave a comment

IPR anticipation findings reversed due to erroneous claim construction

St. Jude Medical, LLC v. Snyders Heart Valve LLC (USPTO as Intervenor)

Docket No. 2019-2108-9, -2140 (IPR2018-00105-00106)


October 15, 2020

Brief Summary:  Board anticipation finding of certain claims reversed based on FC panel’s revised claim construction (claims “interpreted with an eye toward giving effect to all terms in the claim”).

Summary:  St. Jude appealed Board IPR-105 and IPR-106 final written decisions (FWDs) finding St. Jude had not established unpatentability (anticipation) of some of the challenged claims of SHV’s US 6,540,782 directed to an artificial hear valve and system for inserting the valve. 

In IPR-105, “the Board essentially adopted St. Jude’s proposed claim construction of ‘band’” (“a band attached to the frame limiting spacing between adjacent anchors”, broadest reasonable construction (BRC)) as “a structure generally in the shape of a closed strip or ring,’ which slightly broadened St. Jude’s language by replacing St. Jude’s ‘circular’ with ‘closed’ (thereby including ovals, for example)” and found the prior art reference (Leonhardt) did not anticipate the claims because it disclosed “a ‘sleeve’…not a ‘strip’ or ‘ring’.”  The FC panel found no error with the Board’s anticipation conclusion, rejecting St. Jude’s claim construction arguments that “a dictionary definition of ‘band’” as “[a] thin strip of flexible material” and the “explicit[] disclaim[er]” of “any restriction on the length of the band” (e.g., “dictionary definition does not exclude any width constraint from being part of the relevant understanding”, “the specification does not affirmatively specify any particular limit on a band’s width”, St. Jude did “not address the terms ‘srip’ or ‘ring’”).

In IPR-106, the Board found anticipation of ‘782 claims 1, 2, 6, and 8 but not claim 28 (“St. Jude did not prove that Bessler discloses the ‘manipulation’ required by the claim”).  SHV appealed the anticipation finding, successfully arguing the Board erroneously construed the claim term “sized and shaped” limitation (“a flexibly resilient frame sized and shaped for insertion in a position between the upstream region and the downstream region”).  The FC panel agreed with SHV due to the claim language that “provides some support for the reading advanced by Snyders in preference to the Board’s construction” (Wasica, FC 2017 (“highly disfavored to construe terms in a way that renders them void, meaningless, or superfluous”); Bicon, FC 2006 (“[C]laims are interpreted with an eye toward giving effect to all terms in the claim.”))  The FC panel also found support in the specification which includes “passages” that “make it unreasonable” to read it another way (BRC “in light of the specification” (37 CFR 42.100(b); Phillips, FC 2005 (“specification ‘is the single best guide’”)).  The FC panel also found that during the IPR St. Jude “relied only on its claim-construction argument that the ‘782 claims cover the situation of a removed native valve” and “did not dispute the express assertion by Snyders that Bessler ‘requires removal of the native heart valve” and did not “preserve[] any” other argument (Novartis, FC 2017; In re Baxter, FC 2012).  Based on its claim construction, the FC panel reversed the Board’s conclusion of anticipation of claims 1, 2, 6 and 8 and affirmed the finding of no anticipation of claim 28. The FC panel also rejected St. Jude’s challenge of the Board’s conclusion that certain claims were not shown to be obvious because it “failed to prove that a relevant artisan would have made the particular combination St. Jude proposed”, finding the Board “did not lack substantial-evidence support” (Arctic Cat, FC 2017; 35 USC 316(e); In re Magnum Oil, FC 2016).

Posted in Anticipation (35 USC 102), Claim Construction | Leave a comment

IPR FWD invalidating Immunex’s “human antibody” claims invalidated (“nothing in the claim’s language restricts ‘human antibodies’ to those that are fully human”)

Immunex Corp. v. Sanofi-Aventis U.S. LLC et al. (USPTO as Intervenor)

Docket No. 2019-1749, -1777 (IPR2017-01879, -01884)


October 13, 2020

Brief Summary:  Immunex appealed two IPR final written decisions (FWDs) invalidating the challenged claims of US 8,679,487 directed to human anti-IL4R antibodies (“”[a]n isolated human antibody…wherein the light chain…comprises the amino acid sequence of SEQ ID NO:10 and the heavy chain…comprises the amino acid sequence of SEQ ID NO:12”).  The FC panel opinion explains that “[t]his appeal concerns what ‘human antibody’ means in this patent…must a ‘human antibody’ be entirely human?  Or may it also be ‘partially human,’ including ‘humanized’?”  In the ‘884 FWD, the USPTO (“Board”) invalidated the ‘487 claims for obviousness in view of the Hart, Schering-Plough and Hoogenboom references disclosing “fully murine” antibodies, “‘grafting’…CDRs onto an otherwise fully human antibody”, and closing the “gap between ‘humanized’ and ‘fully human’”, respectively, concluding “that the ‘humanized’ antibody met its construction of ‘human antibody.’”  Immunex argued the Board’s construction was erroneous.  In the ‘879 IPR, the Board “concluded that Sanofi had not shown by a preponderance of the evidence that claims 1-14, 16, and 17 were anticipated by one of Immunex’s own publications”.  Sanofi’s appeal argued the Board erred in determining that “the disclosure was not § 102(e) prior art ‘by another.’”

Immunex filed a terminal disclaimer (TD) “[a]fter appellant briefing was complete” and the ‘487 patent “therefore expired on May 26, 2020, just over two months before oral argument.”  The Board applied the Broadest Reasonable Interpretation (BRI) standard to these IPRs, while “in all newly filed IPRs, the Board applies the Phillips district-court claim construction standard” (37 CFR 42.100(b), Phillips (FC 2005) (“ordinary meaning”)).  Immunex argued the Phillips standard should apply but the FC panel disagreed since “when Sanofi filed its IPRs, the Board applied” the ordinary meaning “standard only to expired patents” (In re CBS-Sys., FC 2016; Wasica, FC 2017; Andrea Elecs., FC 2020 (does not “mean that whenever a patent expires on appeal, at any time and for any reason, Phillips applies”)) and “the patentee shortened the term abruptly after the parties had already fully briefed claim construction under the BRI standard” (In re Thorington, CCPA 1969 (“Our predecessor court has refused to consider terminal disclaimers filed after the Board’s decision.”)) 

The FC panel reviewed the “Board’s evaluation of the intrinsic record de novo” (Kaken, FC 2020; Teva, FC 2015) and found it to support “the correctness of the Board’s construction” (e.g., “the language of the claim itself” (Allergan Sales, FC 2019), “nothing in the claim’s language restricts ‘human antibodies’ to those that are fully human”, no “express definition” of “human antibody” in the ‘487 specification (“makes clear that ‘human antibodies’ is a broad category encompassing both partially and completely human antibodies”), and the prosecution history shows the “two terms…are not interchangeable” (the claims of a related patent, “strong presumption against a claim construction that excludes a disclosed embodiment” (Nobel Biocare, FC 2018), claim amendments, “examiner expressly wrote that the amended ‘human’ antibodies encompassed ‘humanized’ antibodies”).  The FC panel was unpersuaded by Immunex’s proposed extrinsic evidence including expert testimony since “the intrinsic evidence here decides the issue” (Helmsderfer, FC 2008).  The FC panel also explained that the Board did not err in departing from a DC interpretation of “human antibody” from “litigation that prompted this IPR” (Power Integrations, FC 2015 (“the Board ‘is not generally bound by a previous judicial construction of a claim term”); Board required “to provide ‘reasoning in sufficient detail to permit meaningful appellate review”).  The Board decision was therefore affirmed.

Sanofi’s cross-appeal regarding the ‘879 IPR was dismissed since the Board’s ‘884 IPR FWD was affirmed.

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