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Federal Circuit Restores Induced Infringement Verdict Against Teva

by | Oct 15, 2020 |

Addressing the issue of whether a generic pharmaceutical company can be found to induce infringement even when all patented uses have been “carved out” of the label (resulting in a so-called “skinny label”), the US Court of Appeals for the Federal Circuit held that circumstantial evidence of inducement was sufficient. The Court relied on evidence that defendant stated its drug was a “complete replacement” for plaintiff’s drug covered by the asserted patent. GlaxoSmithKline LLC et al. v. Teva Pharmaceuticals USA Inc., Case Nos. 18-1976, -2023 (Fed. Cir. Oct. 2, 2020) (Newman, J.) (Prost, C.J., dissenting). The Court reinstated a jury verdict against Teva Pharmaceuticals, ordering it to pay GlaxoSmithKline (GSK) $235 million.

GSK brought suit against Teva in 2014 in response to Teva’s attempt to market a generic form of carvedilol, developed and marketed by GSK under the brand name Coreg®. Coreg® was US Food and Drug Administration (FDA) approved for three separate indications: hypertension, congestive heart failure (CHF), and left ventricular dysfunction following a myocardial infarction (post-MI LVD). After March 2007, however, no GSK Orange-Book-listed patent covered the hypertension or post-MI LVD indications. A reissue patent that issued in January 2008 remained in force for CHF.

In 2002, Teva filed an abbreviated new drug application (ANDA) with the FDA. Before Teva’s carvedilol product was finally approved in September 2007, Teva amended its ANDA and proposed label to “carve out” the CHF indication according to 21 USC § 355(j)(2)(A)(viii)—often referred to as a “section viii carve-out.” Thus, Teva’s carvedilol “skinny label” was only indicated for hypertension and post-MI LVD, neither of which was, at that time, covered by any GSK patent.

After a trial, the jury found that Teva had willfully induced infringement of GSK’s patent and awarded GSK $235 million in damages. The district court then granted Teva’s motion for judgment as a matter of law, concluding that the inducement verdict was not supported by substantial evidence. GSK, the district court reasoned, had failed to prove by a preponderance of the evidence that Teva’s alleged inducement (as opposed to other factors) had actually caused even at least one physician to prescribe generic carvedilol for CHF. GSK appealed.

On appeal, the Federal Circuit overturned the grant of judgment as a matter of law, reasoning that the “intent element” of inducement may be proven through circumstantial evidence. The Court noted that the jury had received evidence of, e.g., “Teva’s promotional materials [referring] to Teva’s carvedilol tablets as AB rated equivalents of the Coreg® tablets,” press releases identifying Teva’s product as “Generic Coreg® Tablets,” Teva’s Monthly Prescribing References, and testimony from GSK’s cardiologist witness that physicians are “completely reliant” on information provided by the generic companies. The majority concluded that this was “ample record evidence . . . to support the jury verdict of inducement.”

Chief Circuit Judge Prost authored a lengthy dissent warning of the broad implications of the majority’s ruling, including contravening the congressional design and intent of the generic approval system, and potentially stifling innovation by giving rise to [...]

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Non-Respondent’s Product Cannot Be Adjudicated for Infringement in Context of General Exclusion Order

by and | Oct 15, 2020 |

The US International Trade Commission issued a general exclusion order (GEO) excluding from entry into the United States products infringing patents directed to luxury vinyl tile, but vacated findings in the Initial Determination (ID) adjudicating infringement for products belonging to entities not named as respondents in the investigation. The Commission explained that a finding should not be made as to whether a non-respondent’s product infringes a patent in the context of a GEO, but instead the analysis should be limited to whether the “alleged” infringement supports a finding that there is a pattern of violation of Section 337. Certain Luxury Vinyl Tile and Components Thereof, USITC Inv. No. 337-TA-1155, Comm’n Op. (Oct. 5, 2020).

The ITC instituted an investigation against multiple respondents. The administrative law judge granted summary determination of violation by certain defaulting respondents and recommended a GEO. Unlike limited exclusion orders (LEO), which only prohibit infringing goods imported by a named respondent in an investigation, GEOs prohibit entry of the infringing products regardless of the source. GEOs are issued when necessary to prevent circumvention of an LEO or when there is a pattern of violation and it is difficult to identify the source of infringing products. In connection with the request for a GEO in this investigation, the complainants accused two additional products from non-respondents of infringement. In the ID, the administrative law judge analyzed the two products and determined that they infringed the asserted patents.

The Commission determined to review the ID in part. On review, the Commission determined that a GEO was appropriate, but vacated the findings of the ID that adjudicated infringement of the asserted patents by the two products belonging to the non-respondents. The Commission explained that in considering a GEO, a finding should not be made as to whether a non-respondent’s product infringes a patent and instead the analysis should be limited to whether there is a pattern of violation of Section 337. The Commission therefore vacated the infringement findings to avoid confusion and possible prejudice to the non-respondents in future proceedings.

Practice Note: A GEO is an attractive remedy for companies confronted by widespread infringement by imported products originating from sources that are difficult to identify or companies that dissolve and re-emerge as new entities and can therefore circumvent an LEO. The Commission has now made it easier to obtain a GEO because “alleged” infringement by products from a non-respondent can be used to show a pattern of violation warranting a GEO without a full adjudication of infringement for those products.



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One Claim Construction Error Is Enough to Trigger New Trial on Infringement

by | Oct 8, 2020 | ,

The US Court of Appeals for the Federal Circuit re-affirmed that incorrect construction of even a single claim element can be grounds for a new trial on infringement. Network-1 Technologies, Inc. v. Hewlett-Packard Company, Case Nos. 18-2338, -2339, -2395, -2396 (Fed. Cir. Sept. 24, 2020) (Prost, C.J.).

Network-1 Technologies sued Hewlett-Packard (HP) for patent infringement. HP defended on the grounds that the patent was invalid and that it did not infringe. The jury found the patent not infringed and invalid as obvious. Following post-trial motions, the district court denied Network-1’s request for a new trial on infringement but granted its motion for judgment as a matter of law (JMOL) on validity. The court found that HP should have been estopped from raising certain obviousness challenges as a consequence of certain obviousness challenges raised by a third party in a prior inter partes review (IPR) that were essentially the same as HP’s obviousness challenge here. Network-1 appealed the district court’s final judgment that HP did not infringe, arguing that the district court erred in its claim construction. HP cross-appealed on the issues of IPR estoppel under 35 USC § 315(e)(2) and invalidity because of a claim improperly broadened in re-examination.

On appeal, Network-1 contended that the district court erroneously construed the claim terms “main power source” and “low level current.” In order to prevail, Network-1 had to establish not only that at least one jury instruction on claim construction was legally erroneous, but that the error had prejudicial effect. Under Federal Circuit precedent, an incorrect claim construction that removes from the jury a basis on which it reasonably could have reached a different verdict can be an incorrect jury instruction. As the Court explained in Avid Tech. v. Harmonic (Fed. Cir. 2016), “[a]n erroneous claim construction on one element is harmless ‘only if a reasonable jury would have been required by the evidence to find non-infringement even without the error.’”

The Federal Circuit concluded that the district court correctly construed the term “low level current” but erred in its construction of “main power source” to exclude AC power sources on the basis of expert testimony that receipt of AC power by a network device would render it inoperable. The Court deemed this error for two reasons:

    • Even though the network device cannot receive AC power, the record established that “data nodes” or network switches were commonly used to convert AC power to DC power as needed to power the network device. Because nothing in the patent claims precluded the conversion of AC power to DC power, it was error for the district court to add such a limitation.
    • The district court erred by adding a limitation to the claims to carve out certain inoperable embodiments, in this case embodiments that do not convert AC to DC. The Federal Circuit has previously explained that it is improper to add limitations to a claim to exclude only certain inoperable embodiments (Cordis v. Medtronic (Fed. Cir. 2008)). Here, [...]

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No Refunds: Cancellation of Patent Claims in IPR Isn’t a Taking

by | Sep 3, 2020 |

The US Court of Appeals for the Federal Circuit found that cancellation of a patent in an inter partes review (IPR) proceeding is not a taking and does not grant the patentee any compensable claim against the United States. Christy, Inc. v. United States, Case No. 19-1738 (Fed. Cir. Aug. 24, 2020) (Hughes, J.).

After Christy sued two competitors for infringement of a patent directed to a vacuum, one of the competitors filed petitions for IPR. The Patent Trial and Appeal Board (PTAB) instituted the IPRs and ultimately found a majority of the patent claims unpatentable. Christy appealed to the Federal Circuit, which affirmed the PTAB’s invalidity decision.

Christy then filed a class action suit in the US Court of Federal Claims to recover from the government the issuance and maintenance fees Christy had paid for the patent, investments Christy had made in the patented technologies, attorneys’ fees from defending the IPR proceedings, the value of the patent claims, royalties and other payments for use of the patents. The government moved to dismiss all six claims for lack of subject matter jurisdiction and failure to state a claim. The court partially granted the motion to dismiss, but found that it had jurisdiction to consider Christy’s Fifth Amendment takings claim. The court found that Christy did not state a claim for relief on the merits, and reasoned that the cancellation of claims in an IPR did not amount to a compensable taking of Christy’s property interest. The court held that it did not have jurisdiction to consider Christy’s alternative illegal exaction claim, since a statute granting authority to the US Patent and Trademark Office (PTO) to refund mistakenly excessive patent-related fees displaced the court’s Tucker Act jurisdiction. In any case, the court found that on the merits, Christy’s issuance and maintenance fees were properly owed at the time they were paid, and were not paid by mistake. The government did not require Christy to pay any alleged damages on the government’s behalf, or at all, and so Christy’s theory that damages were illegally exacted was found “devoid of merit.” Christy appealed.

On appeal, Christy argued that the claims court erred in finding 1) that Christy failed to state a compensable taking claim based on the cancellation of patent claims, 2) that the claims court lacked subject matter jurisdiction over the illegal exaction claim, and 3) that Christy failed to state a plausible illegal exaction claim. The Federal Circuit disagreed, affirming the claims court and reiterating its finding in Golden v. United States that the AIA did not displace Tucker Act jurisdiction over IPR-based takings claims, and that cancellation of patent claims in an IPR cannot be a taking under the Fifth Amendment. Thus, the Court found that the claims court correctly found that it had jurisdiction over Christy’s takings claim, but that such cancellation was not a taking.

The Federal Circuit next considered Christy’s illegal exaction claim. Illegal exaction occurs when money is “improperly paid, exacted, or taken from the claimant [...]

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Standard Essential Patent Licensing Practices Do Not Violate Antitrust Laws

by and | Aug 26, 2020 |

The US Court of Appeals for the Ninth Circuit vacated a district court decision that found Qualcomm’s patent licensing practices violate antitrust laws and reversed a permanent, worldwide injunction against several of Qualcomm’s business practices. Fed. Trade Comm’n v. Qualcomm Inc., Case No. 19-16122 (9th Cir. Aug. 11, 2020) (C.J. Callahan).

Qualcomm sells modem chips that are incorporated into cellular handsets (i.e., smartphones) made by companies such as Samsung, Huawai, Apple and others. Qualcomm also holds a number of standard essential patents (SEPs) implemented by modem chips that are essential to cellular communication standards. A core part of Qualcomm’s business model is that it only licenses its SEPs to smartphone makers, i.e., its original equipment manufacturer (OEM) customers, not to rival modem chip suppliers—even though its rivals’ chips practice Qualcomm’s SEPs. Doing this allows Qualcomm to maximize its profits by charging royalty rates based on the value of the end-product smartphones rather than just the modem chip. In addition, Qualcomm will not supply modem chips to OEM customers unless they first pay to license Qualcomm’s SEPs (“no license, no chips”). OEMs must pay this licensing fee to Qualcomm even if they source chips from another supplier.

In January 2017, the FTC filed suit against Qualcomm in the Northern District of California, alleging that Qualcomm’s licensing practices violate the antitrust laws and unfairly protect its monopoly power as a modem chip supplier. Following a two-week bench trial, the district court issued a lengthy opinion ruling in favor of the FTC and ordering extensive injunctive relief requiring Qualcomm to change its business practices. The court made a number of findings, including: (1) Qualcomm’s refusal to license its SEPs to rival chipmakers violates both its FRAND commitments to standard-setting organizations (SSOs) and an antitrust duty to deal; (2) Qualcomm’s royalty rates for its SEPs are unreasonably high because they are based on the value of end products and (3) Qualcomm’s royalties, in conjunction with its “no license, no chips” policy, imposes an anticompetitive “surcharge” on the price of its rivals’ chips. Qualcomm appealed.

The Ninth Circuit reversed the district court’s decision in its entirety and vacated the injunctive relief which had been ordered, finding that Qualcomm’s licensing practices amount to “hypercompetitive,” not anticompetitive, behavior. The Court recognized that Qualcomm’s licensing practices are designed to maximize its profits, but concluded that they do not unfairly distort competition within the modem chip markets. According to the Court, the district court improperly extended the reach of the antitrust laws in issuing its injunction.

The Ninth Circuit addressed and rejected each of the district court’s findings. First, the Court concluded that Qualcomm does not have an antitrust “duty to deal” with its rival chipmakers. The Court emphasized that the Supreme Court has recognized only a narrow exception to the general rule that a business need not deal with its competitors, and concluded that the exception was not met here. The Court also concluded that whether Qualcomm breached a FRAND commitment to license its SEPs to rivals was [...]

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Glass Half Empty: Patent Reciting “Half Liquid” Is Indefinite

by | Aug 13, 2020 |

The US Court of Appeals for the Federal Circuit affirmed the district court’s finding that the asserted patent claims were invalid as indefinite because the meaning of the term “half-liquid” was not reasonably clear from the record. IBSA Institut Biochimique, S.A. v. Teva Pharms. USA, Inc., Case No. 19-2400 (Fed. Cir. July 31, 2020) (Prost, C.J.).

IBSA owns a patent directed to pharmaceutical formulations for thyroid hormones that enable a safe and stable oral administration. IBSA listed in the Orange Book the patent for Tirosint®, a soft gel capsule formulation containing the active ingredient levothyroxine sodium. Teva filed an abbreviated new drug application to market a generic version of Tirosint®, and IBSA responded by filing a lawsuit for patent infringement against Teva.

During claim construction, the parties disputed the construction of the term “half-liquid.” IBSA proposed that “half-liquid” should be construed to mean “semi-liquid,” while Teva argued that the term was indefinite or should be construed as “a non-solid, non-paste, non-gel, non-slurry, non-gas substance.” The district court began its analysis by acknowledging that the parties “agree that the intrinsic record does not define ‘half-liquid.’” IBSA argued that a priority Italian patent application’s use of the word “semiliquido” (translation: semi-liquid) in the same places where “half-liquid” was used in the patent at issue supported its position that the two terms were synonyms. The district court disagreed, noting several differences in the two patents that indicated that the different choice of terms was intentional. Further, the district court noted that the applicant originally used the term “semi-liquid” in a dependent claim during prosecution, but later removed this term, indicating that the applicant understood the terms to be different and intentionally chose not to use “semi-liquid” in the asserted claims. The district court also found IBSA’s extrinsic evidence (e.g., reliance on dictionary definitions, other patents and expert testimony) unpersuasive. The district court accordingly found the asserted patent claims invalid as indefinite because the meaning of “half-liquid” was not reasonably ascertainable from the record. IBSA appealed.

The Federal Circuit affirmed. The Court first found that the intrinsic record failed to establish the boundaries of the term “half-liquid.” The Court agreed with the district court’s analysis, finding that neither the claims nor the specification supported IBSA’s proposed construction. The Court also explained that the prosecution history reinforced the conclusion that the applicant understood “half-liquid” to be different from “semi-liquid,” because the applicant intentionally removed the term “semi-liquid” in a dependent claim during prosecution. The Court disagreed with IBSA’s suggestion that the district court refused to consider the foreign Italian priority document—rather, “when discrepancies between a foreign priority document and the U.S. filing exist, it may be proper to view the discrepancies as intentional.”

Turning to the extrinsic record, the Federal Circuit found that the district court did not clearly err in its analysis of the presented dictionary definitions, other patents and expert testimony. The Court noted that IBSA identified no scientific dictionaries containing the term despite IBSA’s argument that “half-liquid” would be a recognizable term [...]

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Patent Owners Beware: Serial Filings, Rent-Seeking May Be Grounds for Adverse Fee Award

by | Jul 15, 2020 |

The US Court of Appeals for the Federal Circuit vacated and remanded a district court’s denial of attorney’s fees to an accused infringer, finding the district court did not properly consider the Patent Owner’s manner of litigation, including the history of plaintiff’s actions in other jurisdictions and the broader context of its litigation practices. Elec. Commc’n Techs., LLC v. ShoppersChoice.com, LLC, Case No. 19-2087 (Fed. Cir. July 1, 2020) (Wallach, J.).

Following a finding by a Florida district court that a patent asserted by Electronic Communication Technologies (ECT) was ineligible under 35 U.S.C. § 101, ShoppersChoice filed a motion for attorney’s fees, citing ECT’s use of standardized demand letters and repeated infringement actions seeking nuisance-value settlements. ShoppersChoice also informed the district court of a recent award of attorney’s fees against ECT in the Central District of California (the True Grit decision) for conduct relating to the same asserted patent. The district court denied ShoppersChoice’s motion, finding that the case was not exceptional and that ECT’s litigation position was not so obviously weak. ShoppersChoice appealed.

The Federal Circuit reviewed the district court’s denial of attorney’s fees under the abuse of discretion standard, analyzing whether the district court made “a clear error of judgment in weighing relevant factors or in basing its decision on an error of law or on clearly erroneous factual findings” and whether it provided a “concise but clear explanation of its reason[ing].” The Court explained that “a pattern of litigation abuses characterized by the repeated filing of patent infringement actions for the sole purpose of forcing settlements, with no intention of testing the merits of one’s claims, is relevant to a district court’s exceptional case determination under § 285.” The Court found that the district court failed to conduct this analysis and erred by not considering ECT’s manner of litigation and the broader context of ECT’s litigation practices. Addressing the True Grit decision, the Federal Circuit noted that the California district court provided a detailed account of the nuisance value rent-seeking practices of ECT (and other affiliated shell companies), but ultimately found that the court failed to conduct an adequate inquiry into ECT’s litigation conduct.

The Federal Circuit thus vacated the attorney’s fee award and remanded the case, directing the district court to consider both ECT’s manner of litigation and the objective unreasonableness of its claims.

Practice note: While the California District Court’s decision is not binding in the Florida court, the Federal Circuit made clear that a court cannot ignore developments in other jurisdictions in connection with § 285 fee determinations.



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“All Substantial Rights” Test Informative in Obviousness-Type Double Patenting Context

by | Jul 15, 2020 |

The US Court of Appeals for the Federal Circuit endorsed for the first time the “all substantial rights” test to determine whether inventions are commonly owned for purposes of obviousness-type double patenting validity analysis of a later patent. Immunex Corp. v. Sandoz, Inc., Case No. 20-1037 (Fed. Cir. July 1, 2020) (O’Malley, J.) (Reyna, J., dissenting). The Court determined that patents were not commonly owned—and therefore a later patent was not invalid for obviousness-type double patenting—when the patentee retained a secondary right to sue for infringement and the right to “veto” further assignment of the patents by the grantee.

Roche licensed a family of patent applications to Immunex. Under the license agreement, Immunex agreed to pay a running royalty to Roche based on sales of products incorporating the patented technology. Non-party Amgen subsequently acquired Immunex. Amgen, Immunex and Roche entered into an agreement to eliminate the continuing royalties to Roche. The agreement granted to Immunex a paid-up, irrevocable, exclusive license to the US patent family for the patents-in-suit and gave Immunex the sole right to sublicense. It further granted Immunex the exclusive right to prosecute applications in the US patent family. Critically, Roche retained the secondary right to assert the patents if Immunex did not assert them in litigation after being informed of potential infringement, and the right to veto any downstream assignment by Immunex to a third party.

Immunex and Roche later sued Sandoz for infringing a patent included in the license agreement. At trial, Sandoz argued that the patents-in-suit were invalid for obviousness-type double patenting over several patents filed by Immunex.

The judicially created doctrine of obviousness-type double patenting prohibits claims in a second patent that, while not for the same invention, are so similar to the claims of a commonly owned earlier patent that granting both patents exclusive rights would “effectively extend the life of patent protection.” This doctrine rests primarily on two justifications: preventing unjustified extension of the time of the right to exclude, and preventing multiple infringement suits by different assignees. The doctrine applies to all commonly owned patents, including cases in which the obvious variant inventions have different inventors.

Urging a novel theory of common ownership, Sandoz argued that although the patents-in-suit were assigned to Roche, Immunex effectively owned both the Immunex patents and the patents-in-suit. Sandoz asserted that the agreement between Amgen, Immunex and Roche conveyed “all substantial rights” in the patents-in-suit, which was tantamount to an assignment of ownership. Thus, Sandoz argued that the “all substantial rights” test, which previously had only been used to determine who had standing to sue for infringement as a “patentee” under 35 USC § 281, should apply in the context of obviousness-type double patenting.

Immunex argued that the “common ownership” analysis should take into account ownership at the time of invention, such that common-ownership-based obviousness-type double patenting arises only where the relevant inventions were owned by the same entity.

The Federal Circuit agreed with Sandoz, endorsing for the first time the all substantial rights test to [...]

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“Seams” Like Activity Giving Rise to Infringement Risk Supports Appellate Jurisdiction

by | Jul 8, 2020 | ,

Adding to its body of jurisprudence on standing to challenge an adverse final written opinion in inter partes review (IPR) proceedings, the US Court of Appeals for the Federal Circuit found a petitioner had constitutional standing to appeal where it showed it engaged in activity that would give rise to a possible infringement suit. Adidas AG v. Nike, Inc., Case Nos. 19-1787; -1788 (Fed. Cir. June 25, 2020) (Newman, J.).

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Verdict Delivered: Shipment Notification Claims are Patent Ineligible—Even with Security Flair

by | May 28, 2020 |

The US Court of Appeals for the Federal Circuit affirmed a district court’s pleadings-stage determination that a patent claim directed to a delivery notification system was subject matter ineligible under 35 U.S.C. § 101. Elec. Commc’n Techs., LLC v. ShoppersChoice.com, LLC, Case No. 19-1587 (Fed. Cir. May 14, 2020) (Prost, C.J.).

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