§ 271(g) held not to be limited by single-entity requirement; label-related copyright claims remanded

Syngenta Crop Protection, LLC v. Willowood, LLC et al.
Docket Nos. 2018-1614, -2044
December 18, 2019

Brief Summary: DC dismissal of copyright claims relating to Syngenta’s label remanded as premature. DC erred by imposing single-entity requirement on § 271(g).

Summary: Syngenta appealed DC dismissal of copyright claims relating to its product labels and findings of no infringement of its “Compound Patents” (US 5,602,076; 5,633,256 directed to fungicides including azoxystrobin) as well as US 5,847,138 directed processes including an “etherfication step” and US 8,124,761 using “between 0.1 and 2 mol % of” the chemical catalyst DABCO, respectively.
Syngenta asserted that Willowood infringed Syngenta’s registered copyrights by copying the Quadris® and Quilt Xcel® labels for Willowood’s products. The DC agreed with Willowood and the United States that, e.g., “the Federal Insecticide, Fungicide, and Rodenticide Act (‘FIFRA’) precludes copyright protection for Syngenta’s labels”, “FIFRA ‘endorses’ copying by generic applicants”, “Syngenta granted Willowood an implied license to copy its labels by participating in FIFRA’s labeling scheme”, and Willowood’s use are protected under the doctrines of merger (“which permits copying of material that can only be expressed in a limited number of ways”) and fair use. The FC panel remanded the DC’s decision because “FIFRA does not, on its face, require a me-too registrant to copy the label of a registered product”, the DC was required to but did not consider whether “some protected element of Syngenta’s label is both protected under existing copyright doctrines and necessary for the expedited approval of Willowood’s genetic pesticide product” (SmithKline, 2d Cir. 2000 (“Hatch-Waxman Act ‘not only permit[s] but require[s] producers of generic drugs to use the same labeling”, “‘obvious’ that Congress intended for the Hatch-Waxman Act to ‘trump the copyright laws’”)).

The DC denied SJ as to infringement of the ‘138 patent due to a genuine dispute of material fact as to whether Willwood’s Chinese supplier Tai He “performed both steps of the process claimed…or whether Willwood directed Tai He and others to practice the claimed process.” In this “issue of first impression”, the FC panel concluded that the DC “erred by imposing a single-entity requirement under § 271(g)” (“whoever imports…or offers to sell, sells, or uses…a product made by a process patented in the” US, burden on “accused infringer to prove that the patented process was not used”), which is a requirement of § 271(a) (“makes, uses, offers to sell, or sells any patented invention”, “§ 271(a) covers all patented processes, whether or not they result in a product”). Here, the FC panel reversed the DC’s finding of no infringement by Willowood USA since it “imported into the United States an azoxystrobin compound that was manufactured abroad using the process patented by the ‘138 patent.” The FC panel also affirmed the DC finding of no infringement by Willowood China under § 271(g) since it did not import the product, and remanded its decision regarding Willowood LLC to determine its “role, if any”.

The FC panel affirmed the jury finding that Willowood China did not infringe the Compound Patents or the ‘761 patent because it sold the product in China and did not import it into the US.

Posted in Copyright, Importation, Infringement, Uncategorized | Leave a comment

USPTO’s “Informative” denial of IPR institution finds Petitioner did not “explain[] sufficiently why” combination would have been made with a reasonable expectation of success

Johns Manville Corp. et al. (Petitioner) v. Knauf Insulation et al. (Patent Owner)

IPR2018-00827 (US 9,828,287 B2)
Final Written Decision entered October 16, 2018
Designated as Informative by the USPTO on December 11, 2019

Brief Summary: Informative FWD concluded Petitioner did not meet its burden to show obviousness (e.g., did not “explain[] sufficiently why” combination of references would have been made with a reasonable expectation of success).

Summary: In this final written decision, designated as Informative by the USPTO, the Board denied institution of IPR after determining that Johns Manville (JM) did not establish a reasonable likelihood that it would prevail in its obviousness challenges to Knauf’s US 9,828,287 B2 relating to “thermal or acoustical fiberglass insulation material” including particular amounts of several components (e.g., “the total weight of reactants ranges from about 73% to about 96%”, 75-99% glass fibers, “density of from about 0.4 lbs/ft3 to about 6 lbs/ft3”). The Board did not construe any of the claim terms (Vivid Techs., Fed. Cir. 1999), and determined one skilled in the art would have had a Ph.D. in Chemistry and 3-5 years industry experience in developing binders for fiberglass insulation products. JM argued “that a skilled artisan would have had several reasons to combine the teachings” of two prior art references, but Knauf argued the suggested reasons were insufficient (e.g., “picks and chooses binding components without explanation”, “being the same field of endeavor or analogous does not establish obviousness”, failed to support “assertion that” the references “could have been predictably combined”, “compatibility does not mean obvious to combine”, “a need for formaldehyde-free bindings is not a reason to modify”). The Board that demonstrating that a reference is analogous art or relevant to the field of endeavor of the challenged patent is not sufficient to establish [a] reason to combine its teachings with other prior art” (citing Securus Tech., Fed. Cir. 1997) and that “[m]ere compatibility of [] references is likewise not sufficient” (Personal Web, Fed. Cir. 1997). The Board also found that JM did support its argument “that all thermoset binders are useful” or “in its claim-by-claim analysis, which elements of the cited references could be predictably combined” (e.g., expert testimony did not “explain[] sufficiently why” a particular prior art composition would have been selected as a binder). The Board also found JM did not sufficiently explain “the reasons for” the modifications of the prior art, “and whether there would be a reasonable expectation of success” (“An unsupported statement that combining the teachings of two references would have been ‘well within the skill of a POSA,’ because the results of reacting a reducing sugar with an amine reactant ‘were well-known and predictable’ does not meet Petitioner’s burden….Petitioner does not expressly discuss whether one of ordinary skill in the art would have had a reason to combine the cited teachings….”) (citing KSR, US 2007 (“Obviousness…requires a reason…to combine the elements”) and Intell. Biosys., Fed. Cir. 2016 (“reasonable expectation of success in doing so”)). The Board also found JM did not adequately explain why the claims of another patent claiming “[v]irtually all of the subject matter of the challenged claims” and found unpatentable after reexamination meant that the ‘287 claims were also unpatentable.

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

DC decision of infringement and no Safe Harbor (§ 271(e)(1)) for Hospira’s EPO affirmed

Amgen Inc. et al. v. Hospira, Inc.

Docket Nos. 2019-1067, -1102
December 16, 2019

Brief Summary: DC denial of JMOL and new trial after jury findings of infringement, no anticipation and no Safe Harbor for certain batches of EPO affirmed.

Summary: Hospira appealed DC denial of its motion for judgment as a matter of law (JMOL) or a new trial and the jury’s verdict that Amgen’s US 5,856,298 relating to erythropoietin (EPO) was infringed and not invalid, Hospira’s products were not covered by the § 271(e)(1) Safe Harbor provision, and Amgen was entitled to $70 million in damages. Claim 27 of the ’298 patent is directed to “[a] method for obtaining an erythropoietin composition having a predetermined in vivo specific activity comprising preparing a mixture of two of more isoforms of claim 1” (i.e., “[a]n isolated biologically active erythropoietin isoform having a single isoelectric point and having” 1-14 “sialic acids per molecule”, and that is “the product of expression of an exogenous DNA in a non-human eukaryotic host cell”). The DC construed “[a]n isolated biologically active” EPO as “a group of molecules” that also “appears as a single band on an isoelectric focusing gel (an example of which is shown in Figure 1 of the ‘298 patent)”, and that the “mixture” is “of two or more of the isolated erythropoietin isoforms of Claim 1.” In addition, the DC disagreed with Hospira and further added that “Claim 27 does not require the individual isoforms of Claim 1 to be separately prepared prior to making the mixture.” Hospira argued “that this construction contradicts the intrinsic evidence and the testimony of the inventor Dr. Strickland, who stated that the purpose of his invention ‘was to separate isoforms and then ‘recombine’ them or ‘mix those fractions back together’”, which Hospira argued it did not do (and did not therefore infringe). The FC panel disagreed with Hospira, writing that “[t]he specification clearly contemplates the preparation of mixtures of isoforms in more than one way” and it was “improper to limit claim 27 to one embodiment based on Dr. Strickland’s testimony” (Phillips, Fed. Cir. 2005). Hospira argued the DC erred since “Amgen’s evidence of infringement only demonstrates that Hospira’s product is biosimilar to Amgen’s Epogen” and “insufficient to establish” it “has a ‘predetermined in vivo specific activity’, as required by claim 27.” The FC panel concluded that “[s]ubstantial evidence supports the jury’s infringement verdict”, including inventor and expert testimony and Hospira’s BLA showing “Hospira’s EPO” meets the claim limitations. The FC panel therefore affirmed the DC’s denial of JMOL.

Hospira also argued “no reasonable jury could find claim 27 not invalid” for anticipation since it “disclosed exactly [the] process in [Amgen’s] Example 2” (i.e., “ion exchange chromatography to separate impurities and less biologically active EPO and more biologically active EPO”). The FC panel agreed with Amgen, however, and found that the prior art “does not refer to a composition with a predetermined in vivo activity” but only that “‘[b]iologically active’ EPO was eluted”, as well as expert testimony “that nothing in” it “would indicate one to think there’s a predetermined in vivo activity” and “the product of [the] method depends on what is present in the starting material.”

Regarding Safe Harbor defense ((§ 271(e)(1)), Hospira also argued “that no reasonable jury could have found that some, but not all, of Hospira’s drug substance batches were protected by the Safe Harbor defense” (the jury found 7/14 batches produced in 2013-2015 were protected). Hospira argued that “it only had to provide that the use of the patented invention was reasonably related to submission of information to the FDA, not the manufacture”, and that the jury instructions improperly focused on manufacture. The FC panel explained that “[h]ere, the patented inventions are Amgen’s claimed methods of manufacture”, “[t]he accused activity is Hospira’s use of Amgen’s claimed methods of manufacture”, and “[t]he relevant inquiry…is…whether each act of manufacture was for uses reasonably related to submitting information to the FDA” (Amgen, FC 2009), and found no error in the jury instructions. The FC panel also found substantial evidence supported the jury’s conclusion that not all the batches were protected since, e.g., expert testimony showed that “Hospira was not required to manufacture additional batches after it made its 2012 batches” (e.g., “stability testing of Hospira’s 2013 batches was not required”, much of it was “[to] serve as commercial inventory” (noting however that “some of the ‘commercial inventory’ batches” were protected) (citing Momenta, Fed. Cir. (2015)).

The FC panel also found no reversible error in the DC damages determination, which Hospira argued “does not reflect a ‘reasonable royalty’” (e.g., “[i]t was not unreasonable for the jury to choose a damages award within the amounts proposed by each expert”).

The FC panel also disagreed with Amgen on its cross-appeal of the DC’s denial of Amgen’s motion for JMOL and new trial regarding the jury’s finding of noninfringement of Amgen’s US 5,756,349 directed to “[v]ertebrate cells…producing [EPO]…in excess of 100 U [EPO]…as determined by radioimmunoassay” (e.g., Hospira’s expert testified that Amgen’s dot blot assay results could not be correlated to the required “radioimmunoassay” test).

Posted in Anticipation (35 USC 102), Claim Construction, Infringement, Safe Harbor, FDA exemptions (271(e)(1)), Uncategorized | Leave a comment

ITC decision reversed as Chamberlain disavowed openers lacking infrared detectors

Techtronic Industries Co. Ltd. et al. v. Int. Trade Comm., The Chamberlain Group, Inc.

Docket Nos. 2018-2191
December 12, 2019

Brief Summary: ITC claim construction and final determination of infringement reversed and vacated.

Summary: Techtronic et al. (“Appellants”) appealed final International Trade Commission (ITC) decision finding Appellants violated Section 337(a)(1)(B) through the importation of garage door opener products that infringe” certain claims of Chamberlain’s US 7,161,319 (see FN3 regarding US 7,196,611). FN1 of this opinion indicates litigation is pending in IL but stayed pending the result of the ITC’s investigation. The ITC entered limited exclusion orders against the Appellants and cease and desist orders against two of the Appellants (TTI and One World). The ‘319 patent discloses “a passive infrared detector for a garage door” and claims a garage door opener including “a wall console, said wall console having a microcontroller”. The ITC’s Administrative Law Judge (ALJ) “acknowledged Chamberlain’s argument that the plain and ordinary meaning of ‘wall console’ but decided that, under” the Federal Circuit’s 2016 Poly-America decision “Chamberlain had disavowed wall consoles lacking a passive infrared detector”. The ALJ construed the phrase to cover a “wall-mounted control unit including a passive infrared detector” since, e.g., “the ‘319 patent sets forth its invention as a passive infrared detector superior to those of the prior art” and “the only embodiment in the ‘319 patent” includes a passive infrared detector. Based on this construction, the ALJ made a summary determination of non-infringement. But the ITC subsequently reversed the ALJ’s decision since “a patentee is not required to recite in each claim all features described as important in the written description” (citing Golight, Fed. Cir. 2004), parent patent US 6,737,968 evidenced “the patentee’s intent to claim wall control units with and without [passive infrared dectectors]”), and the prosecution history “lacked ‘the clear prosecution history disclaimer’ present in” Poly-America. The ITC therefore vacated the ALJ’s summary determination. The FC panel, however, concluded that Chamberlain disavowed openers lacking a passive infrared detector “because the specification, in each of its sections, discloses as the invention” openers including it (e.g., in the problem to be solved in the background section, “even the abstract”, Brief Description of the Drawings (“illustrating the preferred embodiment”), Detailed Description (e.g., “as may be best seen in FIG. 4”), the figures (see FN4), and claim 1) (citing, e.g., Aventis (Fed. Cir. 2012 (“Disavowel ‘may be inferred from clear limiting descriptions’”), Ekchian (Fed. Cir. 1997 (“by distinguishing the claimed invention over the prior art”), Phillips (Fed. Cir. 2005) (“in the context of the particular patent”), Poly-America (“where the specification ‘describes ‘the present invention’ as having [a] feature’”), Cont’l Circuits (Fed. Cir. 2019 (“unlikely where the prosecution history contains contradictory statements…but there is also no requirement that [it] reiterate the specification’s disavowel”), and Retractable Techs. (Fed. Cir. 2011 (“more modest claims in its parent patent does not inoculate it from the specification’s disavowel”)). Thus, the FC panel reversed the ITC’s claim construction and final determination of infringement, and therefore vacated the orders.

Posted in Claim Construction, Infringement, Injunction, International Trade Commission, Uncategorized | Leave a comment

DC grant of SJ of no literal or DOE infringement affirmed

Plastic Omnium Advanced Innovation and Research v. Donghee America, Inc. et al.

Docket Nos. 2018-2087
December 3, 2019

Brief Summary: DC grant of SJ of no literal infringement or under the DOE affirmed based on DC claim construction.

Summary: PO appealed DC grant of summary judgment (SJ) of noninfringement of PO’s US 6,814,921 and 6,866,812 relating to processes for manufacturing plastic fuel tanks formed by blow molding and such that accessory components can be installed without cutting holes in the tanks. The claimed process requires “manufacturing plastic hollow bodies from two shells formed by molding, which are joined together”, including “cutting and opening an extruded parison of closed cross section.” The DC construed the claim term “parison” and agreed with PO that it “had acted as its own lexicographer” (i.e., not using “the term ‘parison’ [in] its conventional, plain and ordinary meaning”). Based on its claim construction, the DC found Donghee’s accused product does not literally infringe or the doctrine of equivalents (DOE), based in part on PO’s expert opinion. On appeal, PO argued the DC’s deviated from its claim construction and “improperly imposed a ‘cutting location requirement’” in its decision. The FC panel disagreed with PO regarding literal infringement, explaining that the DC “correctly determined in its claim construction-accepting [PO’s] arguments-that the patentee gave the term ‘parison’ a special definition, and the patents ‘do not use the term ‘parison’ [in] its conventional, plain and ordinary meaning” and that definition, “not Donghee’s product literature”, “controls whether the accused product falls within the scope of the claim” (citing Martek Biosciences, Fed. Cir. 2005 and Phillips, Fed. Cir. 2005). The FC panel explained that infringement under the DOE “requires a showing that the difference between the claimed invention and the accused product or method was insubstantial or that the accused product or method performs substantially the same function in substantially the same way with substantially the same result as each claim limitation of the patented product or method” and “focuses on the an examination of the claim and the explanation of it found in the written description of the patent” (citing AquaTex, Fed. Cir. 2007). “The question” here, the FC panel wrote, was whether PO “presented evidence that” Donghee’s “conceded advantage is an ‘insubstantial difference’” (citing AquaTex and Texas Instruments, Fed. Cir. 1996), and concluded PO did not. The FC panel therefore affirmed the DC grant of SJ of no infringement to Donghee. Judge Clevenger’s dissent argued that the dispute should have turned on the meaning of “the term ‘die’ and whether Donghee’s extrusion head contains one” (e.g., “The [D] took its eye off the ball.”)

Posted in Claim Construction, Doctrine of equivalents, Infringement, Uncategorized | Leave a comment

Appeal of IPR decision dismissed as litigation settled and “substantial risk of future infringement” not shown

Fisher & Paykel Healthcare Ltd. v. ResMed Ltd.

Docket Nos. 2018-2262 (IPR2017-00504)
November 27, 2019
Non-Precedential Order

Brief Summary: ResMed’s motion to dismiss appeal of IPR decision after underlying litigation was settled granted because Fisher did “not provide[] any, let alone sufficient, detail regarding features of its future products to enable us to determine that its activities create a substantial risk of future infringement”.

Summary: ResMed moved to dismiss Fisher’s appeal of the Board IPR decision that the claims of ResMed’s US 9,027,556 relating to sleep disorder masks are not unpatentable. ResMed and Fisher settled the underlying litigation after Fisher appealed the Board’s decision to the FC. ResMed’s motion to dismiss argued Fisher lacks standing since the litigation was settled. In this order, the FC explained that “an appellant that is not facing a suit for infringement or immediate threat of suit for infringement may nonetheless have standing to appeal…if it is currently using claimed features of a patent or nonspeculatively planning to do so” (citing AVX, Fed. Cir. 2019), but also that “such plans must create a ‘substantial risk of future infringement’ or be likely to ‘cause the patentee to assert a claim of infringement’” (citing JTEKT, Fed. Cir. 2018). “Here”, the court wrote, “Fisher has not met this standard” as it did “not provide[] any, let alone sufficient, detail regarding features of its future products to enable us to determine that its activities create a substantial risk of future infringement”. ResMed’s motion to dismiss was therefore granted.

Posted in Appeal, Inter Parties Review (IPR), IPR, Uncategorized | Leave a comment

DC section 101 ineligibility decision reversed since the “the claimed invention is also directed to a non-abstract improvement”

Koninkijke KPN N.V. v. Gemalto, et al. and LG Electronics, Inc.

Docket Nos. 2018-1863-65
November 15, 2019

Brief Summary: DC finding of invalidity under § 101 reversed (claims “employs a new way of generating check data”).

Summary: KPN appealed DC finding that claims 2-4 of US 6,212,662 were invalid under § 101 since “the claims recite no more than mere abstract data manipulation operations, such as ‘reordering data and generating additional data.’” The FC panel opinion explains that “[c]onventional prior art systems detected errors in data transmissions by generating something called ‘check data’ (or ‘supplementary data’)” that is “attached to the original data” so that a receiver can detect errors. Errors are detected by the receiver by comparing the original data (“d1”) with the check data (“d2”). The system described in the ‘662 patent is designed to reduce “systematic error” by varying “the way check data is generated from time to time” (“a variable checking system”) and “different ways” of doing so (e.g., “varying the generating function”, “vary the original data before it is fed into the generating device”, varying it by “permutation” (the embodiment to which the disputed claims relate)). Under step one of Alice (US 2014), the DC found the claims to be “directed to the ‘abstract idea of reordering data and generating additional data’” as in Two-Way Media (FC 2017), RecogniCorp (FC 2017), Intell. Ventures (FC 2017), and Digitech (FC 2014) (e.g., “they do ‘not say how data is reordered”, how to use it, or “even that any data is transmitted”). Under step two of Alice, the DC “concluded that the claims are ineligible because KPN’s ‘purported inventive concept [was] not captured in the claims”. The FC panel explained that “[s]ince Alice”, it has “found software inventions to be patent-eligible where they have made non-abstract improvements to existing technological processes and computer technology” and that “[a]n improved result, without more stated in the claim, is not enough to confer eligibility” (“the claims must recite a specific means or method that solves a problem in an existing technological process”) (citing McRO, FC 2016; Enfish, FC 2016; Finjan, FC 2018; Ancora, FC 2018). Here, the FC panel reversed the DC, finding the claims to be “directed to an improved check data generating device that enables a data transmission error detection system to detect a specific type of error that prior art systems could not.” “[A]s in Finjan”, the FC panel wrote, “the claimed invention is also directed to a non-abstract improvement because it employs a new way of generating check data that enables the detection of persistent systematic errors in data transmissions that prior art systems were not previously equipped to detect” (“sufficiently capture the inventors’ asserted technical contribution”). The FC panel also explained that “[a] claim that is directed to improving the functionality of one tool…that is part of an existing system…does not necessarily need to recite how that tool is applied in the overall system” and that “the more relevant inquiry” is “whether the claims…focus on a specific means or method…or are instead directed to a result or effect” (McRO; Electric Power Group, FC 2016). The DC decision was therefore reversed.

Posted in Patent Eligibility (101), Software, Uncategorized | Leave a comment