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)

NEWMAN, O’MALLEY, WALLACH

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)

O’MALLEY, WALLACH, TARANTO

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)

LOURIE, REYNA, HUGHES

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)

PROST, BRYSON, STOLL

December 21, 2020

Non-precedential

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.

Posted in Doctrine of equivalents, Generics / ANDA, Indefiniteness, Prosecution History Estoppel | Leave a comment

FC panel affirmed DC claim construction based in part on Maia’s stipulation to infringement

Bracco Diagnostics Inc. v. Maia Pharmaceuticals, Inc.

Docket No. 2020-1387 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1387.OPINION.12-17-2020_1703604.pdf)

NEWMAN, O’MALLEY, TARANTO

December 17, 2020

Non-precedential

Brief Summary:  DC decision affirmed based on claim construction and Maia’s stipulation to infringement (e.g., technical construction errors “harmless”). Summary:  Maia appealed DC finding that its sincalide product (ANDA of Kinevac®) infringed Bracco’s US 6,803,046 based on the claim construction of the terms buffer, surfactant/solublizer, and surfactant.  The FC panel opinion explains that while “sincalide was originally introduced in 1976, the ‘046 patent purports to teach sincalide formulations that are ‘purer than prior art formulations, and have fewer degradants and more consistent potency’ in part through addition of excipients such as buffers, surfactants/solublizers, and surfactants”, which are required by the claims.  Regarding the claim term “buffer”, the DC “imported into its definition the list of exemplary buffering agents from the specification” including amino acids and “rejected Maia’s proposal to construe the term buffer to mean ‘[a] compound that stabilizes the pH of a sincalide formulation’”.  The DC also “imported a list of preferred surfactants/solubilizers from the specification into its definition of the term” and “rejected Maia’s proposal to construe” it “to mean ‘[a] surfactant is also a solubilizer’…that aids in solubilization” of sincalide.  And the DC construed the claim term “surfactant” as “[a]n excipient that may reduce the interfacial tension”, rejecting “Maia’s proposal to construe” it “to mean ‘[a] compound that reduces the tension of the air/liquid or liquid/solid interface’” and “Bracco’s proposal to import a list of exemplary surfactants/solubilizers from the specification into its definition.”  In view of these constructions, Maia stipulated to infringement.  In this appeal, Maia argued that the DC “erroneously included amino acids in its definitions of buffer and surfactant/solubilizer, erroneously constructed the backslash between surfactant/solubilizer to mean ‘and’ or ‘or,’ and erroneously included ‘may’ in its definition of surfactant.”  Maia argued that the amino acids in its product do not “have buffering effects” and its stipulation “is only an admission that” it “has amino acids”.  The FC panel agreed the DC “technically erred in importing” the specification’s list of buffers but that dependent “claim 3…recites…one or more amino acids” rendering that error “harmless.”  Maia also “argued that the claims are invalid as inoperable, because…amino acids are not buffers” but the FC panel found it “relinquished those arguments when it stipulated to infringement and dismissal of its counterclaims of invalidity” (Inventio, FC 2012).  The FC panel similarly found that the DC “technically erred in importing a list of excipients into its definition of surfactant/solubilizer” but was “harmless” because it was “essentially correct in its functional definition” and Maia is bound by its stipulation that it infringed “every limitation of the claims, not just to having amino acids”.  The FC panel also rejected Maia’s argument that the slash between the terms “describe[s] one excipient that has multiple functions”, finding the DC correctly construed it “to mean ‘and’ or ‘or’” based on the plain language of the claims (e.g., dependent claims) and the specification (Hill-Rom, FC 2014 (no “clear intention to limit the claim scope”)).  The FC panel also concluded the DC correctly construed surfactant and that its “use of the word ‘may’ in its construction does not render surfactant meaningless” (“standing alone, [it] presents some ambiguity”) and “the specification’s disclosure that one type of surfactant ‘may reduce the interfacial tension,’ supports the [DC’s] construction that surfactants need not necessarily reduce interfacial tension” (Imaginal Sys., FC 2015 (“cautioned against limiting the claimed invention to preferred embodiments or specific examples in the specification”); “supported by the extrinsic evidence”).  Thus, the DC decision was affirmed.

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

DC erred in denying ownership of foreign patents arising from non-disclosure agreement

SiOnyx LLC et al. v. Hamamatsu Photonics K.K. et al.

Docket No. 2019-2359, 2020-1217 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/19-2359.OPINION.12-7-2020_1697100.pdf)

LOURIE, REYNA, WALLACH

December 7, 2020

Brief Summary:  DC erred in failing to transfer ownership of foreign patents arising from confidential information disclosed under an NDA.

Summary:  Hamamatsu appealed from DC judgment after a jury verdict finding Hamamatsu breached a Non-Disclosure Agreement (NDA) with SiOnyx and willfully infringed US 8,080,467 relating to processes for creating “black silicon”; that SiOnyx is entitled to damages, pre-judgment interest and post-judgment interest; Dr. James Carey is a co-inventor of several US patents (the “Disputed U.S. Patents”) which SiOnyx is entitled to solely own; and, SiOnyx is entitled to an injunction preventing Hamamatsu from practicing the Disputed Patents for breach of the NDA and the ‘467 patent for infringement.  SiOnyx cross-appealed the DC decisions denying it sole ownership of the Japanese patent applications from which the Disputed Patents and other ex-US (foreign) patents (“Disputed Foreign Patents”) claim priority and its motion for fees under section 285 as an “exceptional case” (Octane Fitness, US 2014).  The FC panel opinion explains that the NDA requires confidentiality for seven years, “that a party receiving confidential information acknowledges that the disclosing party claims ownership of the information and all patent rights ‘in, or arising from’ the information”, and that the receiving party returns all confidential information (CI) to the disclosing party within 30 days of termination of the NDA.  During the term of the NDA, SiOnyx disclosed “architectures and a manufacturing process for a photodetector device, which were marked as confidential” and the parties worked together until “Hamamatsu represented that it wished to develop its products alone ‘without further reference to proprietary information of SiOnyx’”.  After expiration of the NDA on Jan. 12, 2008, SiOnyx did not request that Hamamatsu return its CI.  Hamamatsu then developed a product including black silicon, informed SiOnyx it did not believe infringed SiOnyx’s intellectual property or breached the NDA, and filed the Japanese patent applications that led to the Disputed U.S. and Foreign Patents.  SiOnyx learned of those patents from a customer in 2014 after launching its own products in 2013.  The FC panel first rejected Hamamatsu’s statute of limitations arguments, finding that a reasonable jury could have concluded that Hamamatsu’s failure to return CI to SiOnyx was “immaterial and did not cause SiOnyx’s claims to accrue”, and that Hamamatsu made “multiple statements” that its “products did not make use of SiOnyx’s” CI, such that “the running of a statute of limitations” was not triggered.  The FC panel also found the damages award for unjust enrichment and breach of contract, as well as granting of the injunction, to be proper (products are competitive, irreparable harm to SiOnyx, money damages inadequate; re post-NDA damages:  “Hamamatsu continued to benefit”).  The FC panel also agreed with the DC’s grant of sole ownership of the Disputed U.S. Patents to SiOnyx to be an “equitable remedy” under MA law, even though both parties have inventors named on those patents, since, e.g., Hamamatsu did not show it “contributed [CI] to the patents under the NDA” (Beech Aircraft, FC 1993 (“inventorship and ownership are separate issues”)).   The FC panel also concluded SiOnyx is entitled to sole ownership of the Disputed Foreign Patents because the DC “erroneously perceived it lacked authority to compel the transfer of ownership” (separate from authority over “the foreign patent office in which the assignment is made”) and that the evidence showed that the patent applications “must also have arisen from SiOnyx’s” CI.  The FC panel also agreed with the DC’s denial of fees under section 285 as an “exceptional case” (Octane Fitness, US 2014) since, e.g., SiOnyx did not “demonstrate[] that Hamamatsu’s defenses were so weak as to be exceptional” or that its litigation “conduct was unreasonable”.

Posted in Assignment / Ownership, Damages, Licensing, Unjust enrichment | Leave a comment

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 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1273.OPINION.11-23-2020_1689851.pdf)

DYK, TARANTO, STOLL

November 23, 2020

Non-precedential

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 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1054.OPINION.11-19-2020_1688174.pdf)

PROST, BRYSON, WALLACH

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 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/19-1756.OPINION.11-10-2020_1683097.pdf)

REYNA, SCHALL, STOLL

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)

O’MALLEY, REYNA, CHEN

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:  http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/18-1635.OPINION.11-17-2020_1686726.pdf)

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.

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