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)

PROST, REYNA, TARANTO

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)

PROST, REYNA, TARANTO

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.

Posted in Claim Construction, Inter Parties Review (IPR), IPR, Terminal Disclaimers | Leave a comment

Teva’s ANDA carve-out does not save it from induced infringement (“when the provider of an identical product knows of and markets the same product for intended direct infringing activity, the criteria of induced infringement are met”)

GlaxoSmithKline LLC, et al. v. Teva Pharmaceuticals USA, Inc.

Docket No. 2018-1976, -2023

PROST, NEWMAN, MOORE

October 2, 2020

Brief Summary:  GSK appealed DC judgment of a matter of law (JMOL) finding no induced infringement of RE40,000 by Teva’s Coreg® (carvedilol) ANDA.  GSK’s RE40,000 issued on Jan. 8, 2008 following reexamination of US 5,760,069 (issued in 1998) directed to “[a] method of decreasing mortality caused by congestive heart failure”, RE’000 adding the limitation “wherein the administering comprises administering to said patient daily maintenance dosages for a maintenance period to decrease a risk of mortality caused by congestive heart failure, and said maintenance period is greater than six months.”  Teva’s original 2007 ANDA label (“full label”) did not mention congestive heart failure (a “carve-out”, “skinny label”) but revised its label in 2011 to include the CHF indication as directed by the FDA.  The DC instructed the jury that “GSK must prove that Teva’s actions led physicians to directly infringe a claim of the ’000 patent” and “proof…may be based on circumstantial evidence.”  The jury found that Teva induced infringement of certain claims starting January 8, 2008 (the date the RE‘000 patent issued) to April 30, 2011 (the last day before Teva amended its label) and some during the amended label period starting May 1, 2011 and ending June 7, 2015 (the date of expiration of the ’000 patent).  The DC, however, granted Teva’s JMOL of no induced infringement by either the skinny or full labels.  The FC panel disagreed, explaining that “[p]recedent has recognized that the content of the product label is evidence of inducement to infringe” (Vanda, FC 2018) and that the DC “applied an incorrect legal standard, for precedent makes clear that when the provider of an identical product knows of and markets the same product for intended direct infringing activity, the criteria of induced infringement are met” (e.g., “There was ample record evidence of promotional materials, press releases, product catalogs, the FDA labels, and testimony of witnesses from both sides, to support the jury verdict of inducement to infringe the designated claims for the period of the ’000 reissue patent.”)  The jury-calculated damages award was sustained, the FC panel writing that the DC “correctly instructed the jury that the availability of carvedilol from other generic producers is not a ‘non-infringing substitute’” (Micro Motion, FC 1990 (“There is precedent for finding causation despite an alternative source of supply if that source is an infringer….”)   The DC grant of JMOL was vacated and remanded for “consideration of GSK’s post-trial motion based on the verdict of willful infringement”.  Judge Prost dissented, writing, e.g., “Congress provided for skinny labels for exactly these circumstances…[a]nd Teva acted exactly as Congress intended” (“Teva’s skinny label did not even suggest using its product according to the patented method”, “there was still no inducement via the full label”).

Posted in Damages, Generics / ANDA, Inducement to Infringe, Willfullness | Leave a comment

DC claim construction reversed; joined party in IPR can raise new obviousness arguments; no improper broadening during reissue

Network-1 Techs., Inc. v. Hewlett-Packard Co. et al.

Docket No. 2018-2338-39, -2395-96

PROST, NEWMAN, BRYSON

September 24, 2020

Brief Summary:  DC claim construction affirmed and reversed (“ordinary meaning”); joinder rule did not prevent HP from raising new obviousness arguments that could have been raised during IPR; no improper broadening during reissue.

Summary:   Network-1 appealed DC finding that HP does not infringe US 6,218,030 relating to methods for “remotely powering access equipment in a data network” and the DC’s construction of the claim terms “low level current” and “main power source”.  HP cross-appealed the DC’s finding that Network-1 did not improperly broaden the ‘030 claim term “secondary power source” during reexamination (two reexaminations of the ‘030 patent).  In a previous IPR proceedings filed by Avaya and joined by HP (after being denied its own IPR as time-barred (“§ 315(b) creates an exception from the time bar for joinder under 35 U.S.C. § 315(c)”), ‘030 claims 6 and 9 were not held to be unpatentable.  The DC also granted JMOL to Network-1 regarding some of HP’s obviousness arguments that were not but “‘reasonably could have been raised’ in the Avaya IPR.”

The FC panel agreed with the DC’s construction of “low level current” but not “main power source”.  “Low level current” was found to include a “lower bound” of the current indicated “by use of the word ‘low’” in order “to give meaning to the term ‘current’” (“the delivered ‘low level current’ is current that is sufficient to begin start-up”; e.g., “[e]ven Network-1 admits that the term ‘current’ necessarily requires some flow of electric charge because ‘[i]f there is no flow, there is no ‘current’”).  Relying on expert testimony and Talbert Fuel (FC 2002 (“[a] construction that renders the claimed invention inoperable should be viewed with extreme skepticism”)), the DC “construed ‘main power source’ as ‘a DC power source,’ and thereby excluded AC power sources from its construction”.  But the FC panel disagreed, finding that “the correct construction…include[s] AC and DC power sources” as consistent with the ordinary meaning but “neither the claims nor the specification…require a departure from this ordinary meaning” (Starhome, FC 2014 (“In the absence of an express intent to impart a novel meaning to claim terms, an inventor’s claim terms take on their ordinary meaning.”)), “[t]he specification likewise never expresses a preference for DC power sources, much less a suggestion that DC power is an ‘essential’ feature of the main power source” (GE Lighting, FC 2014), and “the ‘930 patent’s disclosure of a preferred embodiment” (MBO Labs., FC 2007 (“A claim interpretation that excludes a preferred embodiment from the scope of the claim is rarely, if ever, correct.”)).  The FC panel also found the DC erred “by adding a limitation to the claims to carve out certain inoperable embodiments” but also “excluded operable embodiments” (Cordis, FC 2008). 

The DC also found HP to be estopped under § 315(e) from raising obviousness arguments that “‘reasonably could have been raised’ in the IPR”.  The FC panel explained that under Facebook (FC 2020) joined party HP could not “bring into the proceeding new grounds that were not already instituted” and was therefore “not statutorily estopped”.  The DC decision was therefore vacated and remanded on this ground. HP also argued that certain claims are invalid due to improper broadening during reissue (§ 305; Creo Prods., FC 2002; Predicate Logic, FC 2008 (“broader in scope…if it contains within its scope any conceivable apparatus or process which would not have infringed the original patent”)).  The FC panel disagreed that the scope of the disputed claim was changed during reexamination (Creo; Enzo, FC 2017 (“dependent claims cannot broaden an independent claim”); ArcelorMittal, FC 2015 (AK Steel) (rejecting “the argument that a defective reissue application invalidates…[the] original claims carried over from the original application”)).

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

Grant of JMOL reversed as “an old method of administration of an old product made by a new process is not novel and cannot be patented”

Biogen MA Inc. v. EMD Serono, Inc. et al. (Pfizer Inc., Bayer, Novartis)

Docket No. 2019-1133

NEWMAN, LINN, HUGHES

September 28, 2020

Brief Summary:  DC instructed to reinstate jury verdict of invalidity for anticipation of Biogen’s IFN-b method of treatment claims that include product-by-process limitations (e.g., “an old method of administration of an old product made by a new process is not novel and cannot be patented”). Summary:   Serono appealed DC judgment as a matter of law (“JMOL”) ruling Biogen’s claims (US 7,588,755) directed to methods of treatment using recombinant interferon b (“IFN- b”, sold as Rebif for multiple sclerosis (MS)) not anticipated and not invalid based on written description or enablement, overturning the jury verdict of no induced infringement and sustaining the verdict of contributory infringement, and that the claims were not patent ineligible.  The only issue addressed in this opinion is anticipation.   The claims include “the step of administering to a patient” recombinant IFN-b “produced by a non-human host transformed by a recombinant DNA molecule…capable of hybridizing to” specified DNA sequences.  The DC, “focusing on the process of making IFN-b, concluded it need not analyze whether native IFN-b and recombinantly produced IFN-b were identical” because the prior art did not teach “a method of treatment using recombinant IFN-b” and “categorized the ‘produced’ and ‘transformed’ limitations as meaningful ‘source limitations.’”  The DC also concluded that a product-by-process analysis “did not apply to the claims here because the ‘product’ itself was sufficiently described”.  The FC panel disagreed and explained that “the recombinant IFN-b composition that is administered…is claimed in terms of the process by which it is manufactured” which is a “product-by-process limitation within a method of treatment claim” that does not “change how novelty of that limitation is evaluated” (Purdue Pharma, FC 2016 (“conversion of oxycodone free base” a product-by-process limitation)).   It agreed with Serono “that a source limitation alone cannot confer novelty unless the product itself is novel” since “an old product is not patentable even if it is made by a new process” (Amgen, FC 2009 (“simply because prior art urinary EPO was not made recombinantly was not enough to avoid anticipation”).  “The key question” here, the FC panel wrote, “as in Amgen, is…whether the recombinant product is identical to the prior art product-not whether the prior art product was made recombinantly.”  Addressing Biogen’s arguments, the FC panel stated that “an old method of administration of an old product made by a new process is not novel and cannot be patented.”  Biogen was also found to have defined IFN-b as a linear amino acid sequence in the specification and that “the claimed antiviral activity limitation” is not defined in the claim by “any specific three-dimensional structure that gives rise to that activity.”  The FC panel found the DC “erred in concluding the mere absence of recombinantly produced IFN-b in the prior art was sufficient to grant JMOL of no anticipation.”  The FC panel also disagreed with the DC’s “conditional grant of a new trial” on anticipation and reversed and remanded the decision “with instructions to reinstate the jury verdict” of invalidity for anticipation.

Posted in Anticipation (35 USC 102), Product-by-Process, Uncategorized | Leave a comment

IPR claim construction and obviousness findings affirmed (insufficient evidence of nexus between claims and license agreements)


Siemens Mobility, Inc. v. USPTO

Docket No. 2019-1732, -1752 (IPR2017-01669, -02044
LOURIE, MOORE, O’MALLEY
September 8, 2020
Non-precedential

Brief Summary: Board IPR claim construction and obviousness conclusions affirmed (e.g., insufficient evidence nexus between claims and secondary considerations (license agreements)).

Summary: Siemens appealed two IPR final written decisions (FWDs) holding certain claims of US 6,609,049 and US 6,824,110 directed to methods and systems for automatically activating a train warning device unpatentable for obviousness. The method claims included “maintaining a database of locations…and corresponding regulations”, “obtaining a position of the train” (and speed in ‘049 claims), “select[ing] a next upcoming location”, “determining a point at which to activate the warning device”, “and activating the warning device at the point.” The system claims include a “control unit” that carries out the method steps and “further require that the database receive wireless updates.” Westinghouse challenged the claims as obvious in view of the Byers and Michalek US patents. Siemens argued the Board misconstrued “corresponding regulations”. The FC panel explained that “[t]he Board…declined to import from the specification that would require multiple regulations for individual locations” and relied on the “plain language of the claims” (“nothing in the claim language restricting the form or nature of correspondence between regulations and locations”) which it concluded the Byers patent “discloses, teaches, or suggests”. The FC panel agreed with the Board’s claim construction since, e.g., requiring “multiple regulations per location would eliminate the option of one regulation encompassed by the use of the article ‘a’” (N. Am. Vaccine, FC 1993 (“explaining that ‘a’ has a ‘normal singular meaning’ but can mean one or more”)) and is supported by the specification (e.g., “Figure 2 clearly contemplates locations for which only one regulation is stored and applied.”) Siemens also argued “the Board misinterpreted the law regarding secondary considerations”. The FC panel explained that effective evidence of secondary considerations must show a “nexus…between the merits of the claimed invention and the evidence offered” (Stratoflex, FC 1983) and “[t]he patentee bears the burden of establishing” that nexus (WMS Gaming, FC 1999). Siemens submitted evidence of licensing which the FC panel explained “is not an ‘infallible guide to patentability’” (EWP, FC 1985) and that here “the licenses are of little evidentiary value” (DyStar, FC 2006; Agrizap, FC 2008) (e.g., “employee testimony…related to…a ‘horn sequencing patent’ or addressed ‘automatic horn activation,’ without any connection to the language of the claims”). The FC panel also agreed with the Board’s conclusions of invalidity for obviousness.

Posted in Inter Parties Review (IPR), IPR, Obviousness, Obviousness (Secondary Considerations) | Leave a comment

DC claim construction affirmed; refusal to correct inventorship vacated/remanded (“AIA did not narrow the meaning of ‘error’”)


Egenera, Inc. v. Cisco Systems, Inc.

Docket No. 2019-2015, -2387
PROST, REYNA, STOLL
August 28, 2020

Brief Summary: DC claim construction affirmed; refusal to allow Egenera to correct inventorship vacated/remanded (“AIA did not narrow the meaning of ‘error’”).

Summary: Egenera appealed DC claim construction of the claims of US 7,231,430 relating to enterprise server systems and application of judicial estoppel to prevent Egenera from relisting an inventor delisted during a copending IPR proceeding, leading to its holding of invalidity for failing to name all inventors. Egenera argued the DC misconstrued the “logic to modify” limitation (“at least one control node including logic to modify said received messages to transmit said modified messages”) as a means-plus-function limitation (section 112, para. 6; Williamson, FC 2015 (“presumption against means-plus-function” without the word “means”, “challenger need not show that the limitation is ‘essentially…devoid of anything that can be construed as structure” but “need only show that the structure is not ‘sufficient’”, “[g]eneric terms such as ‘mechanism,’ ‘element,’ ‘device,’ and other…verbal constructs may be used…in a manner that is tantamount to using the word ‘means’ because they ‘typically do not connote sufficiently definite structure’”; TEK, FC 2019; MTD Prods., FC 2019 (may be invoked by “generic terms or black box recitations of structure or abstractions”)). The DC found “that, in the claim language, each ‘logic’ term was ‘described by a specific function’…unaccompanied by ‘structural components’” and “the specification was…‘consistent with an understanding of logic as an abstraction’” (“a generic black box”), thereby “rebut[ing] the presumption against means-plus-function claiming.” The FC panel agreed with the DC that “[a]s used, ‘logic’ is no more than a ‘black box recitation of structure’ that is simply a generic substituted for ‘means’”. The FC panel also concluded the DC identified the correct structure “as corresponding to the claimed functions of the ‘logic to modify’ limitation”, explaining that Egenera agreed with that determination and “cannot now seek a much narrower construction on appeal.” The FC panel therefore affirmed the claim construction order. Egenera also appealed the DC’s refusal to allow it to correct the ‘430 patent inventorship. During the IPR proceeding, Egenera removed one inventor that it argued to the DC was an error under section 256(a)/(b) (“The error of omitting inventors or naming persons who are not inventors shall not invalidate the patent…if it can be corrected as provided in this section.”) The FC panel explained that “ ‘error’ in [section] 256 includes ‘all varieties of mistakes-honest and dishonest’-rather than only unintentional inaccuracy” (Stark, FC 1997; same for reissue under section 251) and that this applied to amended section 256 (amended in the AIA to remove “without ‘deceptive intention’ on the inventor’s part” (“AIA did not narrow the meaning of ‘error’”; “the inequitable-conduct rules…provide a safety valve in the event of deceit”). The FC panel also explained that “[j]udicial estoppel is an equitable doctrine that prevents a litigant from taking a litigation position inconsistent with one successfully asserted in an earlier court proceeding” (New Hampshire, 1st Cir. 2010) which the DC incorrectly applied (e.g., “Egenera advanced no ‘clearly inconsistent’ position” and “would gain no unfair advantage”) and vacated/remanded that part of the decision.

Posted in America Invents Act, Claim Construction, Inventorship | Leave a comment

DC erroneously constructed “antibody” and “antibody fragment”, FC panel finds

Baxalta, Inc. et al. v. Genentech, Inc. et al.

Docket No. 2019-1527MOORE, PLAGER, WALLACH

August 27, 2020

Brief Summary:  DC non-infringement finding vacated and remanded due to erroneous construction of “antibody” and “antibody fragment”.

Summary:    Baxalta appealed DC judgment based on its construction of “antibody” and “antibody fragment” for US 7,033,590.  Baxalta alleged Genetech’s Helibra (emicizub-kxwh) bispecific antibody for treating hemolphilia infringed the ‘590 claims.  Claim 1 of the ‘590 patent is directed to “[a]n isolated antibody or antibody fragment thereof that binds Factor IX or Factor IXa and increased the procoagulant activity of Factor IXa” while dependent claims 4 and 19 are directed antibodies or antibody fragments (monoclonal, chimeric, humanized (claims 4 and 19, single chain, bispecifici, diabody, di-/oligo-/multimers).  The DC agreed with Genentech that the ‘590 patent requires an “antibody” to include “two identical heavy chains (H chains) and two identical light chains (L chains)” (e.g., “the patentee ‘chose [Genentech’s] narrower definition’ by expressly defining antibodies in column 5 of the patent”).  The DC did “recognize[] that the ‘590 patent claims and discloses ‘bispecific antibodies, which do not have identical heavy and light chains’ and IgM and IgA antibodies, which ‘can have more than two heavy chains and more than two light chains,’ it determined that these claimed embodiments were ‘antibody derivatives’ rather than ‘antibodies’”, citing “an amendment Baxalta made during prosecution” changing the term “derivative” to “fragment” to overcome an enablement rejection (“a disclaimer of antibody derivatives ‘including bispecific antibodies, except antibody fragments”).  The DC also agreed with Genentech that a “fragment” “partially or completely lacks the constant region” and that “the term ‘antibody fragment’ excludes bispecific antibodies.”  The FC panel disagreed because, e.g. “[t]he dependent claims confirm that ‘antibody’ is not so limited” given that each of the chimeric, humanized and bispecific antibodies of dependent claim 4 (and humanized of claim 19) “fall[] outside the [DC’s] construction because each does not ‘only bind[] to the antigen that induced its synthesis or very similar antigens” (see FN3; DC construction…excludes these explicitly claimed embodiments” (Intel. Vent. I, FC 2018; Ortho, FC 2008 (“rejecting a construction that would ‘render several dependent claims meaningless’”); Budde, FC 2001 (“plausible reading of the excerpt in isolation” but “claim construction requires that we ‘consider the specification as a whole, and [] read all portions of the written description, if possible, in a manner that renders the patent internally consistent”); “we read the excerpt in column 5 as a generalized introduction to antibodies rather than a definitional statement” (Luminara, FC 2016)).  The FC panel also disagreed that the prosecution history “confirms the specification’s definition of antibody” because it rejected “the excerpt in column 5” as “definitional” (Phillips, FC 2005; Avid Tech., FC 2016 (no disclaimer “where the alleged disavowel is less than clear”); 3M (FC 2013 (“must be both clear and unmistakable”)).  The FC panel also found that the DC misconstrued “antibody fragment” as the patentee did not “‘clearly express an intent’ to redefine” that term (Thorner, FC 2012).  The DC decision was therefore vacated and remanded.

Posted in Claim Construction, Claim Differentiation, Uncategorized | Leave a comment

DC grant of SJ affirmed due to “an unenforceable agreement to agree”

Phytelligence, Inc. v. Washington State University
Docket No. 2019-2216
PROST, REYNA, STOLL
August 27, 2020

Brief Summary: DC grant of SJ to WSU affirmed since option agreement was “an unenforceable agreement to agree”, not an “agreement with open terms” that could be deciphered by the court.

Summary: Phytelligence (“PT”; in receivership) appealed DC grant of summary judgment (SJ) in favor of WSU regarding sale and delivery of a specific type of apple tree (WA 38) and infringement of its COSMIC CRISP trademark. In 2012, PT and WSU entered into a Propagation Agreement that “forbid [PT] from selling WA 38 trees ‘unless [PT] ha[d] authorization to do so under a separate contract with [WSU], or an agent of [WSU], in accordance with Section 4 of this Agreement.” Section 4 describes an “option to participate as a provider and/or seller in [WSU] licensing programs” including the provision that “if the Cultivar is officially released by WSU and becomes available for licensing…[PT] will need to sign a separate contract with [WSU], or an agent of [WSU], to exercise this option.” In 2013, “WSU issued an ‘Announcement of Opportunity’…to companies interested in commercializing WA38”, including PT which did not submit a proposal. In 2014, WSU accepted Proprietary Variety Management’s (PVM’s) proposal and granted PVM and exclusive license that required any industry participant to be a member of the Northwest Nursery Improvement Institute (“NNII”). In 2017, PT notified WSU of its desire to “exercise its option under the Propagation Agreement”. WSU directed PT to contact PVM for a license, which it did, but then “rejected PVM’s requirement to become a NNII member.” WSU then offered PT three new options for exercising its option, including two that did not require NNII membership, which PT rejected. WSU then revoked its offer to PT. WSU was granted SJ after the DC agreed with it “that Section 4 was an unenforceable ‘agreement to agree’ pursuant to Washington state law” (“it required ‘a further meeting of the minds of the parties before a complete and enforceable agreement’” exists) and not “an enforceable ‘agreement with open terms’” as PT argued. The FC panel agreed with the DC that “the plain terms of the agreement provide that [PT’s] options turns on a future contract between the parties” which “renders Section 4 an unenforceable agreement to agree”. The FC panel also explained that Section 4 is not an “agreement with open terms” as in P.E. Systems (Wash. 2012) since the court has “no objective method for determining the terms of the ‘separate contract’”. The FC panel also disagreed that PT’s extrinsic evidence supports its “open terms” argument since, e.g., “the email communications…indisputably indicate that that the time the parties executed the Propagation Agreement, WSU did not commit to any definite terms of a future license” or that there was any agreement as to a “Form License”. Thus, the DC’s grant to SJ to WSU was affirmed.

Posted in Licensing, Uncategorized | Leave a comment

IPR decision finding Anacor’s KERYDIN® patents invalid for obviousness affirmed


Anacor Pharmaceuticals, Inc. v. Flatwing Pharmaceuticals, LLC

Docket No. 2019-2264-2267 (IPR2018-00168-00171, -01358-01361)
PROST, NEWMAN (D), HUGHES
August 27, 2020 (Non-precedential)

Brief Summary: IPR decisions finding Anacor’s tavaborole (5%) (KERYDIN®) patents invalid for obviousness affirmed (e.g., “concentration is a result-effective variable”).

Summary: Anacor appealed four IPR final written decisions (FWDs) holding all the claims of Orang Book patents US 9,549,938; 9,566,289; 9,566,290; and 9,572,823 (shared specifications; previously invalidated US 7,582,621 also listed on OB (FC 2018)) relating to the treatment of fungal infections using the boron-containing compound tavaborole (5%) (KERYDIN®) invalid for obviousness in view of Austin (WO publication), Brehove (US publication), and Samour (US 6,224,887). The ‘621 patent was previously invalidated in view of Austin and Brehove which were found to disclose topical compositions of boron-containing compounds like tavaborole for treating fungal infections (e.g., “structural and functional similarities” to tavaborole). In the FWDs leading to this appeal, the Board “rejected Anacor’s argument that Samour teaches away from a 5% concentration” (“in favor a 10%-econazole composition”) and found that “Samour does not ‘criticize or otherwise discourage the use of 5% w/w of antifungal agent’”. The FC panel also rejected Anacor’s argument because “Samour’s teachings barely even suggest a ‘preference for an alternative’ approach…let alone discourage a skilled artisan from pursuing a 5%-antifungal composition, as is required for a reference to teach away” (DePuy, FC 2009; Adams, US 1966). The FC panel also found that “[t]he Board reasonably credited testimony from Flatwing’s expert that the claimed composition could have been made according to well-known formulation techniques”, “the existence of the Brehove reference describing in vivo inhibition of a common fungus with organoboron compositions…is especially damaging to Anacor’s arguments”, “the inventors evidently did not consider formulating organoborons a great challenge”, and “there is no dispute that a skilled artisan would have appreciated that concentration is a result-effective variable” (In re Aller, CCPA 1955). Thus, the DC decision was affirmed.

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