IPR finding insufficient disclosure of range percentage and anticipation affirmed

Invidior UK Limited v. Dr. Reddy’s Laboratories S.A., et al.

Docket No. 2020-2073, -2142 (IPR2019-00329) (https://cafc.uscourts.gov/opinions-orders/20-2073.OPINION.11-24-2021_1870396.pdf)

DYK, O’MALLEY, HUGHES

November 24, 2021

Brief Summary:  IPR decision affirmed due to lack of written description of claimed range and affirmed as to claim to particular percentage shown in the examples. Summary:  Dr. Reddy’s (DRL) appealed USPTO Board final written decision (FWD) that claim 8 of Invidior’s US 9,687,454 directed to mucoadhesive films including “about 48.2 wt %” of a “water soluble polymeric matrix” was not anticipated by the 2009 Myers reference.  Invidior appealed the finding that ‘454 claims 1-5, 7 and 9-14 were found anticipated.  ‘454 claim 1 requires “about 40 wt% to about 60 wt % of a water-soluble polymeric matrix”, and claims 5, 7, and 9-14 require the same amount or amounts falling within the 40-60% range.  The anticipation question turned on whether Invidior’s claims “can get the benefit of [the] 2009 filing date for the claims at issue” from Invidior’s 2009 priority application (the ‘571 application), which DRL argued does not describe the claimed limitations.  “[T]he Board found that Tables 1 and 5 in the ’571 application disclose formulations from which a polymer weight of 48.2% could be calculated by a person of ordinary skill in the art” and, therefore, no anticipation by Myers.  The Board did find, however, “that the ’571 application does not ‘discuss or refer to bounded or closed ranges of polymer weight percentages.’”  Invidior argued the ‘571 application discloses “at least 25%” and examples showing 48.2 and 58.6 wt % polymer while DRL argued “that a skilled artisan would not have discerned the claimed ranges because the ’571 application does not disclose any bounded range, only a lower endpoint and some exemplary formulations” and “that a skilled artisan would not have discerned any upper range endpoint.”  The FC panel agreed “with the Board that there is no written description support in the ’571 application for the range of “about 40 wt % to about 60 wt %” as “the range was not expressly claimed”, “the values of ‘40 wt %’ and ‘60 wt %’ are not stated in the ’571 application” and “[m]ost importantly, neither is a range of 40 wt % to 60 wt %” (citing Ariad, FC 2010).  The FC panel explained that while “it is not necessary that the limitations of a claim be set forth in haec verba” but that “the specification must indicate with some clarity what the claim recites” (“various other indications of the polymeric content of the film are present in the ’571 application, rendering it even less clear that an invention of ‘about 40 wt % to about 60 wt %’ was contemplated as an aspect of the invention.””).  “In the case of a claimed range,” the FC panel wrote, “a skilled artisan must be able to reasonably discern a disclosure of that range” as “the law requires a statement of an invention, not an invitation to go on a hunting expedition to patch together after the fact a synthetic definition of an invention” (Brenner, US 1966 (“not a hunting license”)).  The FC panel therefore affirmed the Board’s invalidity decision as to claims 1-5, 7, and 9-14 (Judge Linn dissented (“overly demanding standard…for ranges”, citing Werthein, CCPA 1976 and Nalpropion, FC 2019).  The FC panel found the ‘571 application discloses the 48.2 wt % limitation, “a specific amount, which can be derived by selection and addition of the amounts of selected, but identified, components” and affirmed the Board decision that claim 8 was not shown to be anticipated by Myers.

Posted in Anticipation (35 USC 102), Written description | Leave a comment

DC finding that Horizon’s OB patents are obvious and/or not infringed affirmed

Horizon Medicines LLC v. Alkem Laboratories Ltd.

Docket No. 2021-1480 (https://cafc.uscourts.gov/opinions-orders/21-1480.OPINION.11-16-2021_1865455.pdf) (Non-precedential)

DYK, O’MALLEY, HUGHES

November 16, 2021

Brief Summary:  DC refusal to change inventorship, finding of obviousness and no infringement of Horizon’s patents affirmed.

Summary:  Horizon appealed DC finding claims 1, 8, 11 and 14 of US 8,067,033 invalid for obviousness and claims 1-3 and 8-10 of US 8,067,451 not infringed.  Horizon’s product is DUEXISTM (the ‘033 and ‘451 patents are two of six listed on the Orange Book) and Alkem filed a paragraph IV ANDA for a generic product.  Horizon’s patents are directed to combinations of ibuprofen and famotidine that “exhibit exceptional stability under forced degradation conditions” (detailed in the claims).  The ‘451 claims also refer to “the use of OpadryTM White YS-1-7003 as a barrier layer to further improve stability.”  The DC “found that Horizon narrowed the claim scope of the ’451 patent by specifying a barrier layer of YS-1-7003, describing it by listing the ingredients”, “construed the ‘barrier layer’ limitation in the ’451 patent to mean ‘consisting essentially of’ the ingredients in YS-1-7003” even though the claim recites “comprising”, found no infringement, and the FC panel did not disagree with the DC based on the prosecution history.  The DC found the ‘033 claims invalid in view of US Pat. Appln. Pub. 2007/0043096 A1, and the ‘033 patent claims the “combination dosage form disclosed in the ’096 publication”.  The ‘096 publication has a Feb. 22, 2007 priority date and lists inventors Golombick and Tidmarsh, while the ‘033 patent has a Nov. 30, 2007 priority date and lists Tidmarsh but not Golombick as an inventor.  Horizon argued the ‘096 publication is not prior art to the ‘033 patent under pre-AIA 102(a) (“known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent”) and unsuccessfully attempted “to correct the inventorship of the ’033 patent by adding Golombik as an inventor pursuant to 35 U.S.C. § 256 so that Golombik and Tidmarsh would be listed as inventors on both the ’033 patent and the ’096 publication” in front of the DC.   The FC panel explained that “[t]he court looks to “not merely the differences in the listed inventors, but whether the portions of the reference relied on as prior art, and the subject matter of the claims in question, represent the work of a common inventive entity” (Riverwood, FC 2003).  It also found no error in the DC’s decision as it must find “clear and convincing evidence” which cannot be inventor testimony alone (Caterpillar, FC 2004; EmeraChem, FC 2017 (must be evidence corroborating inventor testimony); Medichem, FC 2006) and its “cases are clear that inventing something in an earlier patent or patent application does not automatically make one an inventor of patents that incorporate the earlier invention” (Eli Lilly, FC 2004).  Horizon also unsuccessfully argued against the DC’s obviousness finding of “a reasonable expectation of success to achieve the claimed degree of stability”, but the FC panel found no error in the DC’s decision, citing Alkem’s expert testimony.  Given its invalidity finding, the FC panel did not reach the infringement issue.  The DC decision was therefore affirmed.

Posted in Anticipation (35 USC 102), Claim Construction, Conception and Reduction to Practice, Generics / ANDA, Inventorship, Obviousness | Leave a comment

DC Hatch-Waxman decision finding improper venue and failure to state a claim affirmed

Celgene Corp. v. Mylan Pharmaceuticals Inc., et al.

Docket No. 2021-1154 (https://cafc.uscourts.gov/opinions-orders/21-1154.OPINION.11-5-2021_1860406.pdf)

PROST, CHEN, HUGHES

November 5, 2021

Brief Summary:  DC finding of improper venue and failure to state a claim affirmed. Summary:  Celgene sued Mylan for infringement under the Hatch-Waxman Act (HW) following Mylan’s application to the FDA to bring generic pomalidomide (Celgene’s Pomalyst) to market.  The DC found that Celgene’s suit was improperly filed in New Jersey since the defendant Mylan companies are located in West Virginia (“MPI”) and the Netherlands (“NV”).  The FC panel agreed, finding that “Celgene did not show that those defendants committed acts of infringement in New Jersey and have a regular and established place of business there” and “Celgene’s pleadings failed to state a claim upon which relief could be granted.”  Mylan’s ANDA sought FDA approval under HW paragraph IV and Celgene’s multiple suits regarding six patents against Mylan were consolidated (“the first case”, filed in 2017).  In 2019, Celgene sued Mylan regarding three later-issued patents that led to this appeal.  Mylan’s motion to dismiss the first case for improper venue and failure to state a claim was denied by the DC “so that the parties could engage in venue-related discovery.”  Mylan then renewed its motion to dismiss for improper venue which was granted.  The DC also agreed with Mylan that “the ANDA that Celgene itself included with its complaint sought approval only on behalf of MPI…[a]nd Celgene’s pleadings with respect to the involvement of Mylan N.V. in that submission were simply too speculative and conclusory.”  The FC panel reviewed the venue issue de novo under 28 USC section 1400(b), explaining that “[t]he plaintiff has the burden of establishing proper venue under that provision” by “show[ing] either that the defendant ‘resides’ in a particular district or that it ‘has committed acts of infringement and has a regular and established place of business’ there”.  Celgene argued “that the ‘artificial act of infringement stemming from the ANDA submission extends nationwide’ (i.e., wherever the generic drug will be marketed and sold).”  The FC panel, however, explained that “[f]or Hatch-Waxman cases, this means venue is proper ‘where an ANDA-filer submits its ANDA to the FDA,’ not ‘wherever future distribution of the generic is contemplated’” and found that neither MPI nor Mylan Inc. “committed acts of infringement” in New Jersey.  Celgene also argued that Mylan’s act of sending its notice letter to Celgene in NJ was an act of infringement in NJ (“infringement for venue purposes includes all ‘acts that are ‘sufficiently related to the ANDA submission’”).  The FC panel disagreed, writing that “the relevant prong of § 1400(b) restricts venue to ‘where the defendant has committed acts of infringement’—not where the defendant has committed acts related to (but not part of) acts of infringement” (Valeant, FC 2020) (“the employee homes here are not places ‘of the defendant’”; insufficient evidence of “alter ego”).  It also found insufficient evidence that NV was involved in the ANDA filing and that Celgene did not timely amend its complaint.  The DC decision was therefore affirmed.

Posted in Generics / ANDA, Infringement, Jurisdiction, Venue | Leave a comment

Board IPR obviousness FWD reversed as “pure conjecture coupled with hindsight reliance”

University of Strathclyde v. Clear-Vu Lighting LLC

Docket No. 2020-2243 (IPR2019-00431) (https://cafc.uscourts.gov/opinions-orders/20-2243.OPINION.11-4-2021_1859852.pdf)

REYNA, CLEVENGER, STOLL

November 4, 2021

Brief Summary:  Board IPR obviousness FWD reversed as “pure conjecture coupled with hindsight reliance”.

Summary:  University of Strathclyde (US) appealed Board final written decision (FWD) finding claims 1-4 of US 9,839,706 relating to methods for disinfecting air from Gram-positive bacteria (e.g., MRSA) using visible light without a photosensitizer unpatentable as obvious.  The Board determined that ‘706 claims 1 and 3 would have been obvious over two non-patent prior art references (Ashkenazi in view of Nitzan) and claims 2 and 4 in view of Ashkenazi, Nitzan and a published US patent application (Jones).  This appeal is focused on the rejection of claims 1 and 3 over Ashkenazi and Nitzan.  The FC panel opinion explains that Ashkenazi describes the use of the photosensitizers gamma-aminolevulinic acid (ALA) or the vitamin riboflavin (without ALA) for photoeradication of the Gram-positive bacteria P. acnes (which causes acne), which were each found to increase the amount of intracellular porphyrin (e.g., “the greater the intracellular amount of the porphyrin the better are the eradication results.”)  Nitzan’ studies “focused on how exogenous porphyrins—i.e., a culture media supplemented with porphyrins—would affect inactivation” of Gram-positive MRSA and reported “no decrease in viability . . . after illumination”.  The Board found that “ ‘Ashkenazi and Nitzan teach or suggest all the limitations of claims 1 and 3,’ and that a person of ordinary skill in the art would have been motivated to combine these two references and ‘would have had a reasonable expectation of successfully doing so’”, relying “largely on Ashkenazi’s teachings that increasing the light doses, the number of illuminations, and the length of time the bacteria are cultured resulted in greater inactivation for both the ALA and non-ALA P. acnes to support its finding that a skilled artisan applying Ashkenazi’s teachings would expect at least ‘some’ inactivation for nonALA MRSA.”  The FC panel “review[ed] the Board’s legal conclusions de novo and its factual findings for substantial evidence” (Pers. Web, FC 2017; OSI, FC 2019) and explained that “[a]n obviousness determination generally requires a finding that ‘all claimed limitations are disclosed in the prior art’” (PAR, FC 2014; Koninklijke, FC 2020 (“common knowledge of a skilled artisan can be used to supply a missing limitation in some circumstances”)) and “that a person of ordinary skill in the art would have been motivated to combine or modify the teachings in the prior art and would have had a reasonable expectation of success in doing so” (OSI (hindsight)).  The FC panel found the Board erroneously found “that the prior art disclosed all claim limitations” (i.e., “inactivating one of the claimed Gram-positive bacteria without using a photosensitizer”) since Ashkenazi did not treat without a photosensitizer (ALA or riboflavin) and “there is no evidence that Nitzan successfully achieved inactivation” without a photosensitizer (“Given neither Ashkenazi nor Nitzan teaches or suggests inactivation of any bacteria without using a photosensitizer, we fail to see why a skilled artisan would opt to entirely omit a photosensitizer when combining these references.”; ATD FC 1998) (“hindsight combination of components selectively culled from the prior art to fit the parameters of the patented invention”); only support for reasonable expectation of success being “pure conjecture coupled with hindsight reliance on the teachings in the ’706 patent”; no reason given for discrediting expert testimony; “[t]he inventor’s own path itself never leads to a conclusion of obviousness; that is hindsight. What matters is the path that the person of ordinary skill in the art would have followed, as evidenced by the pertinent prior art.” Otsuka Pharm. Co., v. Sandoz, Inc., 678 F.3d 1280, 1296 (Fed. Cir. 2012)).  The Board IPR decision was therefore reversed.

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

DC section 101 ineligibility decision reversed as “the particular arrangement of steps in claim 1 provides a technical improvement” over conventional methods

CosmoKey Solutions Gmbh & Co. KG v. Duo Security LLC et al.

Docket No. 2020-2043 (https://cafc.uscourts.gov/opinions-orders/20-2043.OPINION.10-4-2021_1843694.pdf)

O’MALLEY, REYNA, STOLL

October 4, 2021

Brief Summary:  DC decision finding CosmoKey’s claims unpatentable under section 101 reversed (e.g., “the particular arrangement of steps in claim 1 provides a technical improvement”).

Summary:  CosmoKey appealed DC decision that the claims of US 9,246,903 “are directed to abstract ideas and fail to provide an inventive concept”.  The ‘903 patent claims methods of “authenticating a user to a transaction at a terminal”.  Under “step one of the Alice two-step framework for determining patent eligibility” (US, 2014), the DC concluded the ‘903 claims to be “directed to the abstract idea of authentication—that is, the verification of identity to permit access to transactions” as in Prism (FC 2017 (“where we determined that the patent claims were invalid because they were ‘directed to the abstract idea of ‘providing restricted access to resources’”).  Under Alice’s step two, the DC “concluded that ‘the [’]903 patent merely teaches generic computer functionality to perform the abstract concept of authentication’” (e.g., “the patent itself admits that ‘the detection of an authentication function’s activity and the activation by users of an authentication function within a pre-determined time relation were wellunderstood and routine, conventional activities previously known in the authentication technology field.’”)  The FC panel reviewed the decision de novo (Interval Licensing, FC 2018), finding “[t]he critical question” to be “whether this correct characterization of what the claims are directed to is either an abstract idea or a specific improvement in computer verification and authentication techniques” (Solutran, FC 2019 (“Under Alice step one, we consider ‘what the patent asserts to be the ‘focus of the claimed advance over the prior art.’”), citing Affinity Labs, FC 2016).  The FC panel was “not convinced” that the claims are “directed to the abstract idea of authentication” under Alice step one (are the claims directed to “a specific improvement in computer verification and authentication techniques”?) but did not answer that question as it found the claims satisfied Alice step two (Amdocs, FC 2016).  Under Alice step two, the FC panel “consider[s] the elements of each claim both individually and ‘as an ordered combination’ to determine whether the additional elements ‘transform the nature of the claim’ into a patent-eligible application”.  It explained that “[i]n computer-implemented inventions, the computer must perform more than ‘well-understood, routine, conventional activities previously known to the industry’… and cannot simply be an instruction to implement or apply the abstract idea on a computer” (BASCOM, FC 2016).  The FC panel disagreed with the DC, finding instead that “[t]he ’903 patent claims and specification recite a specific improvement to authentication that increases security, prevents unauthorized access by a third party, is easily implemented, and can advantageously be carried out with mobile devices of low complexity”, “discloses a technical solution to a security problem in networks and computers”, the prior art described in the ‘903 specification do not “teach the recited claim steps”, and “the patent specification describes how the particular arrangement of steps in claim 1 provides a technical improvement over conventional authentication methods” (Ancora, FC 2018 (claims patentable as “specific non-abstract computer-functionality improvement addressing the “vulnerability of license-authorization software to hacking.”)  The DC judgment was therefore reversed.

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

Board design patent anticipation decision reversed as prior art is to an art tool while design patent claim is “limited to lip implants”

In Re:  Surigisil, LLP et al.

Docket No. 2020-1940 (https://cafc.uscourts.gov/opinions-orders/20-1940.OPINION.10-4-2021_1843781.pdf)

MOORE, NEWMAN, O’MALLEY

October 4, 2021

Brief Summary:  Board decision finding design patent claim anticipated by art tool prior art reversed (e.g., “the claim is limited to lip implants and does not cover other articles of manufacture”). Summary:  Surgisil appealed USPTO Board decision affirming an examiner’s rejection of its design patent application (29/491,550) to a lip implant as anticipated by a Blick art tool “‘made of “tightly spiral-wound, soft gray paper’ and is used ‘for smoothing and blending large areas of pastel or charcoal.’”  Surgisil’s “claim language recites ‘a lip implant’” and it argued “that Blick could not anticipate because it disclosed a “very different” article of manufacture than a lip implant.”  The Board disagreed, finding it to be “appropriate to ignore the identification of the article of manufacture in the claim language” and explaining “that ‘whether a reference is analogous art is irrelevant to whether that reference anticipates.’”  The FC panel reviewed the Board’s legal conclusions “that the article of manufacture identified in the claim is not limiting” de novo (Redline, FC 2015), and found it to be erroneous.  The FC panel explained that “[a] design claim is limited to the article of manufacture identified in the claim; it does not broadly cover a design in the abstract”, and that “[h]ere, the claim identifies a lip implant”, “[t]he claim language recites ‘a lip implant’”, “the Board found that the application’s figure depicts a lip implant,” and “[a]s such, the claim is limited to lip implants and does not cover other articles of manufacture.”  In addition, the FC panel explained that “[t]here is no dispute that Blick discloses an art tool rather than a lip implant” and “[t]he Board’s anticipation finding therefore rests on an erroneous interpretation of the claim’s scope.”  The Board’s decision was therefore reversed.

Posted in Design Patents, Medical Devices | Leave a comment

FC panel finds PTO has the authority to reconsider ex parte reexamination under § 325(d)

In Re:  Vivint, Inc.

Docket No. 2020-1992 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1992.OPINION.9-29-2021_1841724.pdf)

MOORE, SCHALL, O’MALLEY

September 29, 2021

Brief Summary:  PTO has the authority to reconsider ex parte reexamination under § 325(d).

Summary:  Vivint appealed USPTO denial of its request to dismiss Alarm.com’s request for ex parte rexamination of U.S. 6,717,513 after Alarm’s multiple attempts to challenge the validity using the IPR system.  This FC panel opinion explained that “in the post-AIA world, a patent can be reexamined either in federal court during a defense to an infringement action, in an ex parte reexamination by the Patent Office, or in the suite of three postissuance review proceedings before the Patent Trial and Appeal Board” (Return Mail, US 2019; e.g., “an accused infringer may challenge validity both in district court and in an inter partes review (IPR)”).  It also explained that this case required it “to determine when one pathway, ex parte reexamination, is available to a requester who has repeatedly tried to use another pathway, IPR, to forward the same arguments” but that the PTO “may deny reexamination when ‘the same or substantially the same prior art or arguments previously were presented to the Office,’ 35 U.S.C. § 325(d)”.  Alarm filed three IPRs challenging the validity of the ‘513 patent.  The PTO declined institution “as an example of ‘undesirable, incremental petitioning’” (“Alarm.com had ‘used prior Board decisions as a roadmap to correct past deficiencies’”) and in denying institution of the ‘091 petition “reasoned that ‘allowing similar, serial challenges to the same patent, by the same petitioner, risks harassment of patent owners and frustration of Congress’s intent in enacting the’” AIA.   The FC panel explained that “[m]ore than a year later, Alarm.com requested ex parte reexamination of all claims of the ’513 patent” that “[l]argely…repackaged the arguments raised in the ’091 [IPR] petition” (e.g., “vast swaths of the ex parte reexamination request copied, almost word for word, the [IPR] ’091 petition”), but the PTO allowed reexamination based on arguments that include one reference that had been raised in three related IPRs because “the Shetty, Joao, and Garton references are now presented in a new light compared to the earlier examinations and proceedings in view of the material new argument and interpretation presented in the Request.”  The PTO dismissed Vivant’s petitions to dismiss the ex parte reeexamination based on the PTO’s position section “325(d) decisions are not reviewable” (e.g., Vivant argued the PTO “could not decline to institute IPR based on abusive filing practices, yet grant reexamination on essentially the same facts”, “acted arbitrarily and capriciously by applying the same law to the same facts and reaching a different conclusion”), after which an examiner issued a final rejection which was appealed and affirmed by the Board.   The FC panel found the PTO had the “authority to reconsider its decision ordering ex parte reexamination based on § 325(d)” (Tokyo, FC 2008; Medtronic, FC 2016 (IPRs)) and abused its discretion in not doing so (e.g., it was “arbitrary for the Patent Office to grant reexamination after denying institution of the ’091 IPR based on § 325(d)”).  The PTO’s decision, based on 325(d), was therefore vacated and remanded, the FC panel explaining that it is “not holding that the Director may never launch a reexamination even when a particular challenger has engaged in improper serial filing.”

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

DC’s finding of no willfulness reversed, enhanced damages and attorney fees affirmed

SRI International, Inc. v. Cisco Systems, Inc.

Docket No. 2020-1685, -1704 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1685.OPINION.9-28-2021_1841166.pdf)

DYK, PROST, HUGHES

September 28, 2021

Brief Summary:  DC finding of no willfulness reversed; grant of enhanced damages and attorney’s fee affirmed. Summary:  SRI appealed DC denial of its motion to reinstate the jury’s willfulness verdict and the enhanced damages award.  Cisco cross-appealed the DC award of attorney fees.  In a first appeal (SRI II), the FC “held that the jury’s verdict of willful infringement before May 8, 2012 was not supported by substantial evidence because it was undisputed that Cisco did not know of SRI’s patents until after that date.”  The DC then read the FC’s “opinion to require a more stringent standard for willful infringement than our other cases suggest—conduct rising to ‘the level of wanton, malicious, and bad-faith behavior’” and found “that substantial evidence did not support the jury verdict of willful infringement after May 8, 2012” (SRI III).  FN1 of this opinion explains that “[t]he jury was instructed under the Seagate willful infringement standard, which required both (1) ‘clear and convincing evidence that the infringer acted despite an objectively high likelihood that its actions constituted infringement of a valid patent’ and (2) that ‘this objectively-defined risk . . . was either known or so obvious that it should have been known’” (In re Seagate, FC 2007) and the SCOTUS Halo decision (US 2016) that “rejected the objective recklessness requirement” but “did not disturb the substantive standard for subjective willfulness” (Arctic Cat, FC 2017).  In this appeal, neither party challenged the DC’s jury instructions under which the FC panel “presume[d] that the jury found that Cisco knew of the patent, took action to encourage its customers to infringe, and knew that its customers actions (if taken) would infringe”.  This FC panel explained that “a finding of induced infringement does not compel a finding of willfulness” as “the standard required for willful infringement is different than that required for induced infringement” and concluded that “the jury’s unchallenged findings on induced infringement, when combined with Cisco’s lack of reasonable bases for its infringement and invalidity defenses, provide sufficient support for the jury’s finding of willful infringement for the period after May 8, 2012, when Cisco had notice of the patent.”  The FC panel explained that “[u]nder Halo, the concept of ‘willfulness’ requires a jury to find no more than deliberate or intentional infringement” (Eko Brands, FC 2020), which it found to be present in this case.  The FC panel also explained that “an award of enhanced damages does not necessarily flow from a willfulness finding” (Presidio, FC 2017) and that it reviews DC awards of enhanced damages for an abuse of discretion and did not find it here (Va. Panel, FC 1997; Halo quoting Octane, US 2014).  The FC panel also found no error in the DC’s finding the case to be “exceptional” and its award of attorney’s fees under section 285 (e.g., “Cisco crossed the line”).  Thus, the DC’s JMOL of no willfulness was reversed but the enhanced damages and attorney’s fee awards were affirmed.

Posted in Attorney's Fees, Damages, Infringement, Willfullness | Leave a comment

ITC claim construction and finding of infringement under the DOE affirmed

Jennewein Biotechnologie GmbH v. Int. Trade Comm. (Glycosyn LLC as Intervenor)

Docket No. 2020-2220 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-2220.OPINION.9-17-2021_1836421.pdf)

DYK, PROST, HUGHES

September 17, 2021

Non-precedential

Brief Summary:  ITC claim construction and finding of infringement under the DOE affirmed.

Summary:  Jennewein appealed ITC’s claim construction and finding of infringement of Glycosyn’s US 9,970,018 related to methods for using E. coli and lactose to produce fucosylated oligosaccharides (“2-FL”) found in human milk.  The E. coli of the ‘018 claims have an inactivated or deleted endogenous b-galactosidase (b-gal) gene and “an functional exogenous b-galactosidase gene” and a b-gal activity of “between 0.05 and 200 units.”  Glycosyn filed a complaint with the ITC, alleging “that Jennewein violated [section] 1337(a)(1)(B) by importing 2’-FL produced by a process covered by the ‘018 patent.”  The FC panel opinion explains that the three allegedly infringing E. coli strains lack an endogenous b-gal gene, “two of the strains, #1540 and #2410, comprise the gene fragments lacZα and lacZΩ, which when expressed together produce β-galactosidase, resulting in β-galactosidase activity”, the expression of which is controlled using temperature, and “[t]he third strain, TTFL12, lacks a functional β-galactosidase gene as it comprises the lacZα gene fragment but not the lacZΩ gene fragment” and “does not use lactose to produce 2’-FL”.  The #1540 and #2410 strains are FDA approved but the TTFL12 strain is not.  The ITC’s Administrative Law Judge (ALJ) construed the claims and found the 1540 and 2410 strains, but not TTFL12, infringed under the doctrine of equivalents (DOE).  The ITC “affirmed the ALJ’s finding of infringement under the doctrine of equivalents, agreeing that the combination of the lacZα and lacZΩ gene fragments in Jennewein’s #1540 and #2410 strains is equivalent to an ‘exogenous functional β-galactosidase gene’” (e.g., “the exogenous nature of lacZΩ” (not present in TTFL12), “any difference between the claim term ‘an exogenous functional β-galactosidase gene’ and the accused products is insubstantial”).  Jennewein unsuccessfully argued in this appeal that the ITC erred by not subtracting the activity of a negative b-gal expression control (e.g., “[t]he temperature regulator controlling expression of the lacZΩ gene fragment in Jennewein’s #1540 and #2410 strains can “leak,’”, “the two negative control strains selected by Jennewein had higher Miller unit values than the #1540 and #2410 strains”).  The FC panel also agreed with the ITC that “the combination of the lacZα and lacZΩ gene fragments in Jennewein’s #1540 and #2410 strains is equivalent to a ‘functional β-galactosidase gene’” and disagreed with Jennewein that the fragments were not exogenous (e.g., “the combination itself does not originate from within the organism”).  The FC panel also saw “nothing suggesting that the recited β-galactosidase activity must be present substantially throughout 2’-FL production and retrieval” in the claims. written description, or prosecution history (Primos, FC 2006 (cannot exclude preferred embodiments); MobileMedia, FC 2015; Schindler, FC 2010 (no “unequivocal disavowal”)).  The ITC decision was therefore affirmed.

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

DC denial of new infringement trial affirmed but jury damages award vacated due to improper apportionment

Omega Patents, LLC v. Calamp Corp.

Docket No. 2020-1793, -1794 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1793.OPINION.9-14-2021_1833974.pdf)

DYK, PROST, HUGHES

September 14, 2021

Brief Summary:  DC denial of CalAmp’s JMOL for a new trial on infringement affirmed but jury damages award vacated and remanded for improper apportionment.

Summary:  CalAmp appealed DC judgment of infringement and damages award regarding Omega’s US 8,032,278 relating to multi-vehicle-compatible systems that can remotely control various vehicle functions such as remote vehicle starting.  Omega appealed the DC’s post-verdict royalty rate.  The jury also found that CalAmp did not induce infringement of Omega’s US 6,756,885 (same subject matter at the ‘278 patent) but CalAmp appealed the jury’s underlying finding of direct infringement of the asserted claims by CalAmp’s customers, “specifically, the district court’s denial of JMOL that those customers did not directly infringe.”  The FC panel explained that “[t]he direct-infringement finding did not itself impose liability on CalAmp but instead was intended to serve as a predicate to Omega’s induced-infringement theory.”  However, as CalAmp was “the prevailing party as to Omega’s claim of induced infringement of the ’885 patent, we decline to review the merits of CalAmp’s appeal of the JMOL denial regarding direct infringement by its customers” but it did “agree with CalAmp that the jury’s direct-infringement finding should be vacated” (Camreta, US 2011).  The FC panel did consider the DC’s denial of CalAmp’s request for a judgment of a matter of law (JMOL) and a new trial as to infringement, with CalAmp alleging that Omega expert’s testimony was “beyond the scope of his expert report” and that “Omega failed to present evidence that two claim limitations were met.”  The FC panel disagreed as to the expert, finding the “disclosures provided enough notice to CalAmp ‘to prepare [its] case[] adequately and to prevent surprise’” (Guevara, 11th Cir. 2019).  The FC panel also found “there was sufficient evidence” in the expert’s reports “for the jury to find the ‘corresponding vehicle device code’ limitation met” and “the ‘enabling data’ limitation met” by CalAmp’s accused products.  It therefore affirmed the DC’s denial of JMOL on infringement.  The FC panel did find the DC abused its discretion by precluding CalAmp’s damages expert and that the jury’s damages award was unsupported by the record (e.g., “the $5.00 figure does not reflect apportionment and that Omega failed to show the incremental value of the ’278 patent (or that the patented improvement drove demand for the entire accused product)” (LaserDynamics, FC 2012; VirnetX, FC 2014; Ericsson, FC 2014; Exmark, FC 2018; “Omega still must ‘adequately and reliably apportion[] between the improved and conventional features of the accused [product]’ when using the LMUs ‘as a royalty base’… the jury could not reasonably have found that the multi-vehicle-compatibility feature of the LMUs drove demand for the entire LMU product.”)  The FC panel therefore vacated the jury’s damage award and remanded the case for a new trial on damages.  Judge Hughes’s dissent argued Omega’s royalty evidence was sufficient and certain expert testimony should not have been precluded.

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