FC panel affirms DC decision that Torrent did not show obviousness of Takeda’s algoliptin claims

Takeda Pharm. Co. et al. v. Torrent Pharm. Ltd., et al.

Docket No. 2020-1552, -1598 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1552.OPINION.2-16-2021_1733600.pdf) (Non-Precedential)


February 16, 2021

Brief Summary:  DC holding that Torrent did not show Takeda’s claims related to algoliptin obvious affirmed. Summary:  Torrent appealed DC final judgment that Takeda’s US 7,807,689 “directed to alogliptin, a uracil-containing DPP-IV inhibitor useful for treating type II diabetes” was not proven by clear and convincing evidence to be invalid for obviousness or non-statutory obviousness-type double patenting.  The DC determined “a skilled artisan would not have been motivated to make Appellants’ proposed scaffold and isoteric replacements with a reasonable expectation of success.”  The FC panel wrote that it was undisputed that “very small changes in molecular structure can have dramatic effects on the properties of the molecule” and “the more distantly related two chemical structures are, the less probable it will be that they have the same biological effect.”  Regarding double patenting holding, the FC panel found no clear error in the DC’s holding that “a skilled artisan would not have been motivated to replace F162’s pyrimidinone scaffold with a uracil scaffold with a reasonable expectation of success” (F162 being Torrent’s proposed lead compound) (e.g., “Torrent has not identified anything in the prior art that would have motivated a skilled artisan to dispose of F162’s fluoro-olefin unit, let alone replace it with an amide, given myriad more conservative and predictable modifications that were available for transforming F162 into a ‘novel’ compound.”)  The FC panel also agreed with the DC that Torrent did not show invalidity for statutory obviousness since, e.g., “Indoco ‘failed to show that a [skilled artisan] who did so would have [had] a reasonable expectation of success’ with ‘this particular scaffold replacement’” (e.g., “[t]he interchangeability references on which Indoco relies do not pertain to DPP-IV inhibitors or diabetes, nor do they, or any other prior art of record, teach substituting an existing xanthine scaffold for uracil”, “Indoco’s expert, as the district court observed, did not present any testimony or evidence as to the predictability of the resulting properties from replacing DCAX’s scaffold with uracil.”)  Torrent also argued that the DC “materially erred with respect to the level of ordinary skill in the art” (e.g., “improperly ignored the parties’ dispute over whether a skilled artisan must have specific experience developing DPP-IV inhibitors and/or type II diabetes drugs—experience Takeda’s expert did not have”), but the FC panel disagreed, finding the DC “considered the prior art from both perspectives” (e.g., “even if [Appellants] are correct in this, they still fail to provide invalidity by clear and convincing evidence”, “While motivation and reasonable expectation of success need not be expressly disclosed by the prior art itself and may instead come from the background knowledge of the skilled artisan, merely asserting that a given modification would have been obvious to a skilled artisan does not make it so.”)  The DC decision was therefore affirmed.

Posted in Double Patenting, Generics / ANDA, Obviousness | Leave a comment

DC claim construction and indefiniteness findings affirmed; ineligibility conclusions not reached by FC panel

Synchronoss Techs., Inc. v. Dropbox, Inc., Funambol, Inc.

Docket No. 2020-2196, -2199 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/19-2196.OPINION.2-12-2021_1732513.pdf)


February 12, 2021

Brief Summary:  DC claim construction, invalidity for indefiniteness, and grant of SJ affirmed. Summary:  Synchronoss appealed DC claim constructions and grant of summary judgment (SJ) finding all claims of US 6,671,757; 6,757,696; and 7,587,446 relating to systems for synchronizing data invalid under section 112, second paragraph (indefiniteness, “functional terms that do not impart any particular structure”) or not infringed.  Dropbox cross-appealed the DC’s decision that “the challenged claims, viewed as an ordered combination, impose sufficient limitations sufficient under Enfish and McRO to survive at the motion to dismiss stage” (i.e., the claims are patent eligible under section 101, “improving the manner in which computers synchronize data between devices connected to a network”; decision not reviewed here).   The FC panel first explained that it had jurisdiction for this appeal of the SJ as it “deem[ed] the [DC’s] judgment final” because “Dropbox agreed to give up its invalidity counterclaims with respect to the ‘757 patent” (Amgen, FC 2020).  Regarding indefiniteness, the FC panel explained that the indefiniteness question is whether the claims can be understood with “reasonable certainty” (Nautilus, US 2014; Biosig, FC 2015; Allen Eng’g, FC 2002; Columbia Univ., FC 2016).  “Here,” it determined, “the asserted claims of the ‘446 patent are nonsensical and require an impossibility” and “[a]dopting Synchronoss’s proposal would require rewriting the claims, but ‘it is not our function to rewrite claims to preserve their validity”, therefore finding the claims indefinite.  The FC panel also determined that the ‘696 claims are indefinite because the means-plus-function terms do not “correspond to ‘adequate’ structure in the specification that a person of ordinary skill in the art would be able to recognize and associate with the corresponding function in the claim” (Willamson, FC 2015 (two-step process:  identify the claimed function and determine whether sufficient corresponding structure is disclosed)).  Synchronoss argued that the DC “erred in concluding that the asserted claims require hardware”, “that the asserted claims-as construed by Synchronoss-recited hardware not as a claim limitation, but merely as a reference to the ‘location for the software’”, and that the DC “misinterpreted” its statements as “a concession that the claims require hardware”.  “The evidence”, the FC panel wrote, “Dropbox provides its customers with software for download but no corresponding hardware” and therefore “does not make, sell, or offer for sale the complete invention” (Rotec, FC 2000 (“[O]ne may not be held liable under section 271(a) for ‘making’ or ‘selling’ less than a complete invention.”)), or “directly infringe by ‘using’ the entire systems” (Centillion, FC 2011 (“requires use of each and every element of the system”, “[s]upplying the software for the customer to use…is not the same as using the system”), NTP, FC 2005 (“a party must put the invention into service, i.e., control the system as a whole and obtain benefit from it”)).  As the FC panel found the disputed claims invalid or not infringed, it did not reach the patent eligibility questions.  The DC decision was therefore affirmed.

Posted in Claim Construction, Indefiniteness, Means-plus-function, Patent Eligibility (101), Section 101 (see also Patentability), Software | Leave a comment

DC lack of enablement of Amgen’s anti-PCSK9 antibody claims affirmed

Amgen Inc. v. Sanofi, et al.

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


February 11, 2021

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

Summary:  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.

Posted in Enablement | Leave a comment

Board correctly determined references on website were publicly accessible; improper change of grounds vacated and remanded

M&K Holdings, Inc. v. Samsung Electronics Co., Ltd.

Docket No. 2020-1160 (IPR2018-00696) (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1160.OPINION.2-1-2021_1726200.pdf)


February 1, 2021

Brief Summary:  Board public accessibility finding affirmed; anticipation determination vacated and remanded for improper change in grounds from obviousness. Summary:  M&K appealed IPR final written decision (FWD) finding all claims of US 9,113,163 directed to methods for compressing video files.  M&K unsuccessfully argued to the Board that “none of the three references” used in Samsung’s arguments (WD4-v3, Park and Zhou) “were publicly accessibly, i.e., that interested parties could not have accessed any of those references by exercising reasonable diligence” before the critical date (Dec. 13, 2011).  The Board disagreed because “those references were discussed at JCT-VC meetings and were posted to the organizations’ public website” (JCT-VC being “a prominent standards-setting organization”).  In this appeal, M&K argued “that a person of ordinary skill could not have located the Park and Zhou references by exercising reasonable diligence”.  The FC panel explained that “[a] reference will be considered publicly accessibly if it was ‘disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it” (Blue Calypso, FC 2016; Kyocera, FC 2008; In re Klopfenstein, FC 2004 (conference, trade show, group meeting); Acceleration Bay, FC 2018; SRI Int., FC 2008 (internet, brick-and-mortar location such as a library); MIT, FC 1985 (conference with attendees, copies made available without restriction)).  The Board found that the Park and Zhou references were presented at the JCT-VC meetings that “were attended by between 200 and 300 interested persons and that the conferees had discussed Park and Zhou at the meetings”, “meeting reports summarized the Park and Zhou discussions…without any expectation of confidentiality”, at least one trade journal cited the report, and skilled artisans “would have been motivated to track the JCT-VC website”, based in part on expert testimony.  The FC panel disagreed with M&K’s argument “that although the record established the prominence of JCT-VS’s working-draft documents, it did not show that input documents such as Park and Zhou were equally prominent” because “[t]he relevant inquiry is whether the channel through which the references were publicized is prominent or well-known among persons of ordinary skill in the art” (Samsung v. Infobridge, FC 2019 (“no requirement to show that particular members of the public actually received the information”); Voter Verified, FC 2012) and “the JCT-VC organization as a whole was prominent among the community of skilled artisans” (Board conclusion supported by substantial evidence).  The FC panel agreed with M&K that the Board relied on anticipation grounds rather than obviousness relied on for institution of the IPR (EmeraChem, FC 2017; unlike Wasica, FC 2017), and vacated that part of the decision.

Posted in Anticipation (35 USC 102), Inter Parties Review (IPR), IPR, Public Accessibility | Leave a comment

Board IPR FWD obviousness findings affirmed (e.g., no teaching away)

Columbia University v. Illumina, Inc.

Docket No. 2019-2302-5, -2452 (IPR2019-00291, -00318, -00322, -00385, -00797) (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/19-2302.OPINION.2-1-2021_1726127.pdf)


February 1, 2021 (Non-Precedential)

Brief Summary:  IPR obviousness decisions affirmed (e.g., no teaching away). Summary:  Columbia appealed two IPR final written decisions (FWDs) holding claims 1 of US 9,718,852; 9,719,139; 9,708,358; 9,725,480; and claims 1-2 of US 9,868,985 directed to nucleotide analogs and methods for using those for DNA sequencing (“sequencing-by-synthesis” (SBS)) unpatentable as obvious in view of combinations of the Tsien, Prober, Metzker, and Dower references.  “This appeal centers on one aspect of the claims:  the use of a capping group that is ‘small,’ and not a ‘ketone group,’ ‘a methoxy group, or an ester group’”, which Columbia is required “in order to ‘work for SBS’” (“an ‘allyl capping group’ is small, and is not ketone, methoxy, or ester”).  The FWDs “found that Tsien discloses the use of allyl capping groups” that is not “negated” by “Metzker’s experiment” which “a person of ordinary skill would have understood…could be further improved by ‘increasing [nucleotide] concentration or reaction time’”.  Administrative Patent Judge Worth dissented, “believing that ‘Metzker’s experiment would have discouraged a person from pursuing an allyl nucleotide.”  The FC panel reviewed the Board’s legal determinations de novo (obviousness conclusions) and the underlying factual findings for substantial evidence (“[w]hat the prior art teaches”, motivation, teaching away, reasonable expectation of success) (In re Elsner, FC 2004; In re Gartside, FC 2000; Consol. Edison, US 1938).  Columbia argued the Board erred in finding a motivation “to pursue an allyl capping group for use with SBS” and a reasonable expectation of success (e.g., “the Board’s error stemmed from is ‘misapprehension’ of Metzker’s experiment”, POSA would have been “discouraged…from using an allyl capping group because SBS requires efficient incorporation of nucleotides”).  The FC panel disagreed, concluding that “Columbia has not demonstrated that there was any…clear discouragement” from the allyl capping group (“it confirms rather than negates Tsien’s teachings”) (Univ. of Md. Biotech. Inst., FC 2017 (“Teaching away requires ‘clear discouragement’ from implementing a technical feature.”); In re Ethicon, FC 2017).  The FC panel explained that “while it may be true that Metzker and other scientists ultimately chose to research alternative capping group, ‘just because alternatives exist…does not mean that an inferior alternative ‘is inapt for obviousness purposes’” (In re Mouttet, FC 2012).  The FC panel also agreed with the Board’s finding of a reasonable expectation of success (e.g., POSA “would have understood how to improve incorporation efficiency”, “Columbia’s patents provide further evidence” and “cite Metzker without mentioning concerns regarding the use of allyl capping groups” (PharmaStem, FC 2007 (“Admissions in the specification regarding the prior art are binding on the patentee for purposes of a later inquiry into obviousness.”)) and that Columbia’s argument regarding priority dates considered in a previous reexamination unconvincing.  The FC panel also explained that the Board “was not obliged to discuss every argument that Columbia raised.”  The Board’s obviousness decisions were therefore affirmed.

Posted in Inter Parties Review (IPR), IPR, Obviousness, Obviousness-Teaching Away | Leave a comment

Board IPR FWD remanded regarding reasonable expectation of success

KeyNetik, Inc. v. Samsung Electronics Co., Ltd.

Docket No. 2020-1271 (IPR2018-00986) (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1271.OPINION.1-27-2021_1723945.pdf)


January 27, 2021 (Non-Precedential)

Brief Summary:  IPR final written decision remanded for finding on reasonable expectation of success (“The Board erred in assigning no burden to Samsung and making no finding as to a reasonable expectation of success in combining the contested references.”) Summary:  KEYnetic appealed IPR final written decision (FWD) holding claims 1-20 of US 8,370,106 relating to motion detection systems unpatentable as obvious.  The FC panel affirmed the Board’s finding of a motivation to combine the prior art but remanded the question of a reasonable expectation of success.  KEYnetik challenged the Board’s construction (broadest reasonable construction) of the “orientation detector limitation” and the “sequence limitation”, but the FC panel found no error with it (“use of the word ‘orientation’ without an article does not suggest that the reference is limited to a single orientation”, “Board’s construction is consistent with the ordinary English usage of the term ‘each’…made clear by the more general definitions in the Oxford English Dictionary”, the claims “use the signal ‘comprising’…which means that the named elements are essential, but other elements may be added” (Genentech, FC 1997), prosecution history does not show “clear disclaimer of claim scope”).  KEYnetik also argued that the Board erred in finding a motivation to combine two of the prior art references (Tosaki and Linjama) as “the references teach away from each other”, but the FC panel disagreed because KEYnetik provided “no rationale as to why a [POSA] would be discouraged from applying” the references “or that the combination of the two would result in a direction divergent from that taken by the patentee” (In re Gurley, FC 1994).   KEYnetik also argued the Board erred in finding a reasonable expectation of success in combining the references in stating “Petitioner has no such ‘burden’ to show that a POSITA would have a reasonable expectation of success in combining the references.”  The FC panel agreed with KEYnetik, explaining that “[i]t was Samsung’s ‘burden’ to demonstrate” the reasonable expectation of success and remanded the decision on this point (Artic Cat, FC 2017; Intell. BioSys., FC 2016) (“The Board erred in assigning no burden to Samsung and making no finding as to reasonable expectation of success in combining the contested references.”)  Judge O’Malley’s dissent did not dispute the majority’s reasonable expectation of success finding but disagreed with the claim construction findings (e.g., “the claim language supports KEYnetik’s view that a single orientation is detected for each slow motion phase” (Harari, FC 2011 (“use of both singular and plural language in the claims suggests the single use carried only a singular meaning”)).

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

Board IPR FWD finding Sanofi’s amended claims not unpatentable affirmed

Mylan Laboratories Limited v. Aventis Pharma S.A.

Docket No. 2020-1302 (IPR2016-00712) (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1302.RULE_36_JUDGMENT.1-15-2021_1718184.pdf)


January 15, 2020

Brief Summary:  FC panel affirmed Board IPR FWD finding Sanofi’s amended claims not to be unpatentable for obviousness, public use and section 101. Summary:  FC panel affirmed Board final written decision (FWD) on remand that was entered on Oct. 22, 2019 (Sanofi Mature IP v. Mylan Labs., FC 2019 (vacating denial of Sanofi’s Motion to Amend (MTA) by introducing new replacement claims 31-34 and remanding)).  The FWD relates to US 8,927,592 directed to “[a] method of increasing survival comprising administering” (new claim 31) a cabazitaxel formulation to a patient having “castration resistant or hormone refractory, metastatic prostate cancer that has progressed during or after treatment with docetaxel.”  The Board construed the ‘592 claims according to their broadest reasonable construction in light of the specification…‘to the extent necessary to resolve the controversy’” (37 CFR 42.100(b), Cuozzo Speed Techs., US 2016; Wellman, FC 2011).  On remand, the Board was “instructed to treat the preamble of claim 31 ‘as an additional limitation of’ the claim that ‘require[s] ‘increasing survival’ as the ‘intentional purpose…for which the [recited] method must be performed’” and found the MTA to meet the requirements of section 316(d).  The Board explained that “[a]n invention is not obvious ‘just because all of the elements that comprise the invention were known in the prior art’” and that finding obviousness “requires a ‘plausible rational[e] as to why the prior art references would have worked together” as well as “a reasonable expectation of achieving what is claimed in the patent-at-issue” (Broadcom, FC 2013; Intelligent Bio-Systems, FC 2016).  The reasonable expectation of success arguments regarded the “intentional purpose” of claim 31, which the Board found “would be shown only if the evidence of record proves that a person of ordinary skill in the art [POSA] would have expected carrying out the recited method steps to result in increased survival” (agreeing with Sanofi, citing Sanofi v. Glenmark (D. Del. 2016); Sanofi v. Watson, FC 2017 (“reasonable expectation” is not “known certainty”)).  The Board explained that “the mere fact that the” phase III cabazitaxel TROPIC study “investigating overall survival” “does not prove that a POSA would have expected…increase[d] survival.”  Expert testimony, the Board determined, showed that a POSA “would have hoped” for increased survival but did not “support a conclusion that the person would have expected such a result” (OSI, FC 2019; Coalition, PTAB 2015).  The Board also wrote that “[t]he existence of a phase III study to determine whether the claimed treatment method would achieve the intended purpose is strong evidence that the inventor had not yet determined that the invention would work for its intended purpose” (In re Omeprazole, FC 2008), and concluded the TROPIC study is not constitute a public-use bar under section 102(b).  The Board also concluded that the claims (the “intentional purpose” limitation, “performed in the human mind”) are patent eligible under section 101 because it “integrates a mental process into a method of treatment” (Vanda, FC 2018).  The Board therefore found new claims 31-34 not to be unpatentable and granted Sanofi’s MTA.

Posted in Anticipation (35 USC 102), Claim Construction, Inter Parties Review (IPR), IPR, Obviousness, Patent Eligibility (101), Public Use | Leave a comment

DC grant of SJ to SIMO reversed without remand due to improper construction of preamble

SIMO Holdings Inc. v. Hong Kong uCloudlink et al.

Docket No. 2019-2411 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/19-2411.OPINION.1-5-2021_1711937.pdf)


January 5, 2021

Brief Summary:  DC claim construction and grant of SJ to SIMO reversed due to improper interpretation of preamble language. Summary:  uCloud appealed DC claim construction, grant of summary judgment (SJ) of infringement, permanent injunction, and award of $8+ million in damages to SIMO.  The disputed patent, SIMO’s US 9,736,689, relates to systems for avoiding roaming charges of cellular networks.  uCloudlink’s accused products are devices that can act as WiFi hotspots.  The DC found the preamble of ‘689 claim 8 to be limiting (“the only part that identifies the physical components of the apparatus…supplies the necessary structure”), relying on the FC’s Oatey decision (FC 2008 (“normally we do not interpret claim terms in a way that excludes embodiments disclosed in the specification…absent probative evidence [to] the contrary”)).  The FC panel reviewed the claim construction de novo as it was decided on intrinsic evidence only (Arctic Cat, FC 2019), giving the “words of the claim their ordinary meaning in the context of the claim and the whole patent document” and the prosecution history (World Class, FC 2014).  The FC panel agreed with the DC that the initial language of claim 8 is limiting but explained that the structural language was not preamble because it “follows, rather than precedes, the word ‘comprising,’ which is one of the transition words that typically make the end of the preamble, with what follows constituting the body of the claim” (CIAS, FC 2007; Gillette, FC 2005; In re Fought, FC 2019 (“preamble limiting when it serves as antecedent basis”); Bio-Rad, FC 2020 (claim “body’s reliance on preamble for antecedent basis”); Cochlear, FC 2020 (preamble statement of intended use not limiting)).  However, the FC panel noted that “[t]he parties…treated the language at issue as part of the preamble” but maintained it was nonetheless limiting.  The FC panel reviewed its SuperGuide decision (FC 2004) for the “general grammatical principle” that “[w]hen there is a straightforward, parallel construction that involves all nouns or verbs in a series, a prepositive or postpositive modifier normally applies to the entire series”, a principle with “particular force when the term joining the items in a series is ‘and’”.  The disputed portion of claim 8 refers to “a plurality of” (i.e., “at least two” (August Tech., FC 2011)) which the FC panel concluded applies “to each item in the list following that phrase”.  And it found this construction did not “contradict the specification” but “simply leaves out some alternative embodiments of what SIMO’s specification describes as inventive, while capturing one embodiment expressly described.”  The FC panel therefore reversed the grant of SJ to SIMO and found “that uCloudlink is entitled to a judgment of noninfringement” without remand.

Posted in Claim Construction, Infringement, Preamble | Leave a comment

“Substantial risk of future infringement” provides standing for IPR appeal; non-obviousness conclusion vacated and remanded

General Electric Company v. Raytheon Technologies Corporation

Docket No. 2019-1319 (IPR2017-00428) (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/19-1319.OPINION.12-28-2020_1707556.pdf)


December 23, 2020

Brief Summary:  GE found to have standing due to a substantial risk of future infringement”; Board finding of no obviousness vacated and remanded (no teaching away; motivation to combine present).

Summary:  GE appealed PTAB IPR decision finding the claims of Raytheon’s US 8,695,920 relating to methods “of designing a gas turbine engine” not invalid for obviousness.  The FC panel first found that GE had standing to appeal because it “alleged facts establishing that it is currently engaged in conduct creating a substantial risk of infringement”.  Raytheon argued GE does not have standing “because it has never ‘sued or threatened to sue GE”, but the FC panel explained that to appeal an IPR final written decision “[a]n appellant need not face ‘a specific threat of infringement litigation by the patentee” and “it is generally sufficient for the appellant to show that it has engaged in, is engaging in, or will likely engage in activity that would give rise to a possible infringement suit” (Adidas, FC 2020; Grit Energy, FC 2020; JTEKT, FC 2018; Phigenix, FC 2017; AVX, FC 2019).  The FC panel also explained that in a prior dispute, GE failed to show “a substantial risk of future infringement” since it “allegations of fact…left a great deal to the imagination” (“shaky allegations”) but that “here, GE has alleged that it has conceived a…design that Raytheon would likely argue falls within the scope of” the disputed claims and remedied “the problems we identified in the prior appeal.” The PTAB found the disputed claims not to be invalid for obviousness even though “the prior art disclosed all limitations” because the primary reference (Wendus) “taught away from combination with” the secondary reference (Moxon) (e.g., “GE did not ‘provide a persuasive motivation or justification for why a person of ordinary skill in the art” would have combined the prior art disclosures.)  The FC panel found the PTAB lacked substantial evidence for its teaching away conclusion, even though it “correctly set forth the standard” (Polaris, FC 2018 (“[a] reference does not teach away ‘if it merely expresses a general preference…but does not ‘criticize, discredit, or otherwise discourage’ investigation into the invention claimed”)).  The FC panel found that while “Wendus was moving away from” the claimed design, “this is not a repudiation-or even discouragement” (e.g., “Wendus does not make a single negative statement”, “does not criticize, credit, or discourage”; In re Gurley, FC 1994 (not patentable “simply because it has been described as somewhat inferior”)).  For similar reasons, the FC panel also found the PTAB lacked substantial evidence that GE did not show a motivation to combine the prior art (e.g., “An artisan seeking to improve upon or otherwise modify the Wendus advanced engine…because of the known advantages provided by” it.) (KSR, US 2007 (“any need or problem…can provide a reason for combining elements”)).  The FC panel also found the PTAB lacked substantial evidence for finding GE did not establish obviousness for the claims “as a whole”, a requirement that prevents “a patent challenger from merely showing that all elements of the claim exist, without showin why an artisan might combine the elements” (Princeton Bioch., FC 2005; Unigene, FC 2011).  The PTAB’s decision was therefore vacated and remanded.

Posted in Appeal, Obviousness, Obviousness-Teaching Away, Uncategorized | Leave a comment

DC grant of SJ of infringement to Lilly under DOE affirmed

Eli Lilly And Company v. Apotex, Inc.

Docket No. 2020-1328 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1328.OPINION.12-21-2020_1705369.pdf)


December 21, 2020


Brief Summary:  DC grant of SJ of infringement under DOE affirmed. Summary:  Apotex appealed DC grant of Lilly’s motion for summary judgment (SJ) of infringement of US 7,772,209 claiming methods of administering an antifolate, a particular methylmalonic acid lowering agent, and “an effective amount of pemetrexed disodium” (as in Lilly’s ALIMTA® product for mesothelioma and lung cancer) by Apotex’s ANDA, and that prosecution history estoppel (PHE) does not bar Lilly from asserting infringement under the doctrine of equivalents (DOE).  During prosecution of a parental ‘821 application, Lilly “sought dependent claims limiting the antifolate to ‘ALTIMA’” that were rejected by the Examiner for indefiniteness, which Lilly subsequently canceled “and instead prosecuted only claims reciting ‘pemetrexed disodium’.”  Lilly took the same steps in a Preliminary Amendment of the ‘329 application that led to the disputed ‘209 patent.  The proposed product of Apotex’s ANDA contains pemetrexed dipotassium, not the claimed pemetrexed disodium.  This FC panel opinion reviewed its decision in Eli Lilly & Co. v. Hospira (FC 2019, cert. denied 2020) in which it agreed with the DC “that Lilly’s amendment narrowing the ‘821 application’s claims from administration of “an antifolate’ to ‘pemetrexed disodium’ did not give rise to” PHE as it “was merely tangential to pemetrexed ditromethamine because the prosecution history, in view of the ‘209 patent itself, strongly indicates that the reason for the amendment was not to cede other, functionally identical, pemetrexed salts.”  Similarly, in this case, the DC found that Lilly’s amendment from ALTIMA to pemetrexed disodium “was not a narrowing amendment and, thus,” PHE “does not apply”.  The FC panel agreed since, e.g., “Lilly’s patent applications from the ’209 patent claims priority equate ‘ALIMTA’ with ‘pemetrexed disodium’” (e.g., “Pemetrexed Disodium (ALIMTA)”) and “the prosecution history confirms that the inventors used ‘ALIMTA’ in the original claims-and the Examiner understood the term-as Lilly’s trade name for pemetrexed disodium”; “[t]he Examiner did not…reject the original claims as ‘indefinite’ because there was ambiguity about whether ‘ALIMTA’ has multiple meanings” but “because ALIMTA is a trade name”).  Apotex argued Lilly’s European prosecution supported its arguments but the FC panel disagreed as that evidence supports the DC’s conclusion (also noting its “caution[] against relying on the prosecution of foreign applications in interpreting claim terms of U.S. patents and patent applications” (AIA Eng’g, FC 2011).  The FC therefore affirmed the DC decision.

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