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Hit the Brakes: Experimental Use, Enhanced Damages Determinations Require Redo

by Paul Devinsky | May 12, 2022 | Patents

The US Court of Appeals for the Federal Circuit reversed and remanded a district court decision regarding experimental use under 35 U.S.C. § 102(b) and the application of enhanced damages based on an allegedly flawed noninfringement and invalidity opinion. Sunoco Partners Mktg. & Terminals L.P. v. U.S. Venture, Inc., Case Nos. 20-1640; -1641. (Fed. Cir. Apr. 29, 2022) (Prost, Reyna, Stoll, JJ.)

Sunoco sued Venture for infringement of four patents related to blending butane into gasoline. Venture argued that certain patent claims were invalid because they were subject to the on-sale bar of 35 U.S.C. § 102(b). The district court found that the sale at issue was primarily for experimentation and that the on-sale bar did not apply. Venture also argued that certain claim terms required measuring the actual vapor pressure of the butane and gasoline, but the district court rejected this argument. The district court found infringement and awarded Sunoco $2 million in damages, which it trebled to $6 million after finding that Venture lacked a good faith belief of invalidity or noninfringement because the legal opinion Venture relied upon was flawed. Venture appealed.

On appeal, Venture challenged numerous issues, including the district court’s rejection of its on-sale bar defense, construction of two claim terms and decision to enhance damages.

The Federal Circuit first addressed the district court’s finding that the on-sale bar did not apply to certain claims of two of the asserted patents. Reviewing de novo, the Court applied the Supreme Court’s 2019 Helsinn v. Teva decision, which requires that the on-sale bar applies if the invention was the subject of a commercial sale and ready for patenting. Analyzing the first prong, the Court looked to the contract language of the sale at issue. The inventor’s company offered to sell and install its butane blending technology at a customer’s fuel terminal more than one year before filing the patent application. The terms of the agreement required that the customer commit to purchasing at least 500,000 barrels of butane as consideration for the installation of the fuel mixing system. The Court noted that this agreement expressly described the transaction as a “sale” and did not reference any experimental purpose.

The Federal Circuit was not swayed by the lower court’s view that the contract did not require the customer to pay for the system directly, finding that a commitment to buy product in the future constituted a sale. The Court also gave little weight to the preinstallation testing terms of the agreement, finding that those tests were not experiments, but rather tests to confirm that the equipment was operating as contractually promised. Additional contract terms further cemented the Court’s view that this transaction was a sale, including language that the technology had already been “developed” and that title to the equipment transferred to the customer. The Court concluded that the sale of the system to the customer was not primarily for experimentation. The Court reversed the district court’s experimental-use determination and vacated its infringement determination, directing [...]

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Wild and Untamed Trademarks: Madrid Protocol Grants Right of Priority as of Constructive Use Date

by Katherine Pappas | Apr 28, 2022 | Trademarks

Addressing for the first time the question of enforceability of a priority of right in a trademark granted pursuant to the Madrid Protocol where the registrant’s actual use in commerce began after the allegedly infringing use, the US Court of Appeals for the Ninth Circuit found that the Madrid Protocol grants priority as of the constructive use date, but to prevail on an infringement action based on that superior right of priority, the registrant must still establish the requisite likelihood of confusion under the Lanham Act. Lodestar Anstalt v. Bacardi & Co., Case No. 19-55864 (9th Cir. Apr. 21, 2022) (Baldock, Berzon, Collins, JJ.)

Under the Madrid Protocol, applicants with trademarks in another country may obtain an “extension of protection” (generally equivalent to trademark registration) in the United States without needing to first use the mark in US commerce. Instead, the grant may be based on an applicant’s declaration of bona fide intent to use its mark in the United States.

In 2000 and 2001, Lichtenstein-based company Lodestar developed a brand of Irish whiskey called “The Wild Geese,” which was marketed in the US as “The Wild Geese Soldiers & Heroes.” Around 2008 and 2009, Lodestar developed the idea for the “Untamed” word marks, and in 2009 the US Patent & Trademark Office (PTO) accepted for filing two applications on behalf of Lodestar seeking extension of protection under the Madrid Protocol for the internationally registered “Untamed” word marks. The PTO published the marks for opposition, then granted the extensions of protection in 2011. In 2013, Lodestar developed a rum under The Wild Geese Soldiers and Heroes brand that used the Untamed word mark on the label. The rum was shown at the April 2013 Rum Renaissance Trade Show in Florida, where consumers sampled the rum. The rum was also featured in print advertisements associated with the trade show. But by June 2013, Lodestar had “decided to park the USA rum project as [it was] getting better returns in other markets.”

In 2012, Bacardi began developing the ad campaign “Bacardi Untameable.” Before launching the campaign, Bacardi ran a trademark clearance search that turned up Lodestar’s “Untamed” trademarks. From 2013 to 2017, Bacardi ran its “Bacardi Untameable” campaign. In response, Lodestar began promoting a then-nonexistent product “Untamed Revolutionary Rum” in an effort “to complement the Wild Geese Rum and also to combat Bacardi’s attempts to take over our Untamed mark.” In January 2015, the first Untamed Revolutionary Rum was sold to US retailers. In August 2016, Lodestar sued Bacardi for trademark infringement, arguing injury based on reverse confusion, as well as associated claims for unfair competition. The district court granted summary judgment in favor of Bacardi. Lodestar appealed.

The Ninth Circuit found that the district court erred on the threshold question of whether Lodestar’s Revolutionary Rum should be considered in the analysis of likelihood of confusion. The district court had found that the relevant products were those existing prior to launch of Bacardi’s campaign (excluding the later-created Revolutionary Rum). The Court found [...]

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Terms of Degree Not Always Indefinite

by Tim Dunker | Apr 21, 2022 | Patents

The US Court of Appeals for the Federal Circuit overturned a district court determination that the claim terms “resilient” and “pliable” were indefinite. The Federal Circuit found that the claims, while broad, were sufficiently definite in view of both intrinsic and extrinsic evidence. The Federal Circuit also upheld the district court’s findings of no induced infringement, finding zero evidence of predicate direct infringement of the properly construed method claims. Niazi Licensing Corp. v. St. Jude Medical S.C., Inc., Case No. 21-1864 (Fed. Cir. Apr. 11, 2022) (Taranto, Bryson, Stoll, JJ.) The Federal Circuit also affirmed entry of sanctions excluding portions of the plaintiff’s technical and damages expert reports for failing to disclose predicate facts during discovery and also affirmed exclusion of portions of plaintiff’s damages expert report as unreliable for being conclusory and legally insufficient.

In reaching its decision on indefiniteness, the Federal Circuit focused on the terms “resilient” and “pliable” as used in a claim directed to a double catheter structure. Citing the 2014 Supreme Court decision in Nautilus v. Biosig Instruments, the Federal Circuit explained that language has “inherent limitations,” and stated that a “delicate balance” must be struck to provide “clear notice of what is claimed” and avoid the “zone of uncertainty” relating to infringement. The Court noted that under Nautilus, claims must provide “objective boundaries,” but the Court distinguished the present case from those in which “subjective boundaries” created uncertainty and rendered the claim indefinite. The Court pointed to its 2005 decision in Datamize v. Plumtree Software as a “classic example” of subjectivity where the term “aesthetically pleasing” was deemed indefinite because the patent provided no way to provide “some standard for measuring the scope of the phrase.” The Court also noted that a patent’s claims, written description and prosecution history—along with any relevant extrinsic evidence—can provide or help identify the necessary objective boundaries for claim scope

The Federal Circuit concluded that there was sufficient support in the intrinsic evidence, both in the claims themselves and the written description, to allow a skilled artisan to determine the scope of the claims with reasonable certainty. The Court explained that the claim at issue recited “an outer, resilient catheter having shape memory” that “itself provides guidance on what this term means—the outer catheter must have ‘shape memory,’ and ‘sufficient stiffness.’” The Court also cited to “[n]umerous dependent claims [that] further inform the meaning of this term by providing exemplary resilient materials of which the outer catheter could be made. . . . The written description provides similar guidance . . . . Thus, a person of ordinary skill reading the claims and written description would know of exemplary materials that can be used to make a resilient outer catheter, i.e., one that has shape memory and stiffness such that it can return to its original shape.”

The Federal Circuit distinguished this case from Datamize, where the claim scope depended on the eye of each observer, finding it more akin to its 2017 decision in Sonix Technologies. In that [...]

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Missed Connection: Avoid Claim Construction Rendering Independent Claim Narrower Than Dependent Claim

by Tessa Kroll | Apr 14, 2022 | Patents

The US Court of Appeals for the Federal Circuit vacated a district court’s claim constructions concerning generic independent claims that were amended after a species restriction requirement, because the district court disregarded the doctrine of claim differentiation after incorrectly concluding that the examiner had mistakenly rejoined withdrawn claims. Littelfuse, Inc. v. Mersen USA EP Corp., Case No. 21-2013 (Fed. Cir. Apr. 4, 2022) (Prost, Bryson, Stoll, JJ.)

Littelfuse owns a patent directed to a fuse end cap for providing an electrical connection between a fuse and an electrical conductor. The specification teaches three embodiments of the invention:

A single-piece machined end cap comprising a mounting cuff and a terminal
A single-piece stamped end cap comprising a mounting cuff and a terminal
A two-piece assembled end cap comprising a mounting cuff, a terminal and a fastening stem attaching the mounting cuff to the terminal.

The originally filed claims included independent claims covering an end cap with a mounting cuff and a terminal, and dependent claims directed to the three embodiments. The claims directed to the two-piece assembled end cap embodiment contained the limitation that the terminal is press-fit onto the fastening stem.

During prosecution, the examiner issued a restriction requirement, asserting that the independent claims were generic to the three species in the dependent claims. Littelfuse elected to prosecute the assembled end cap species and the examiner withdrew the claims directed to the other embodiments. In response to a novelty rejection, Littelfuse amended the independent claims by adding the fastening stem element without specifying that the terminal is press-fit onto the stem. After allowing the amended independent claims, the examiner concluded that the previously withdrawn claims “require all the limitations of the . . . allowable claims,” and thus rejoined them.

Littelfuse sued Mersen for selling allegedly infringing fuses. The parties asked the district court to determine whether the fastening stem element in the independent claims limited Littelfuse’s patent to multi-piece end caps, despite the rejoined dependent claims being directed to one-piece embodiments. The district court found that the claim language, the specification and the prosecution history required the invention to have a multi-piece construction. First, the district court determined that the plain meaning of “fastening stem” was “a stem that attached or joins the other two components of the apparatus.” The district court then noted that the fastening stem was only mentioned in the specification in relation to the multi-piece embodiment in which the terminal is joined to the mounting cuff by the fastening stem. While Littelfuse argued that the US Patent & Trademark Office’s rejoining of the withdrawn claims meant that the independent claims covered unitary and multi-piece embodiments, the district court reasoned that the claims were rejoined based on a “misunderstanding” because they referred to the original independent claim, which did not include a fastening stem. In light of the district court’s finding that the independent claims covered only a multi-piece apparatus, the parties stipulated to non-infringement. Littelfuse appealed.

Applying the doctrine of claim differentiation, the [...]

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Game Reset: Extrinsic Evidence Can’t Limit Claim Scope Beyond Scope Based on Unambiguous Intrinsic Evidence

by McDermott Will & Schulte | Apr 7, 2022 | Patents

The US Court of Appeals for the Federal Circuit reversed a district court’s grant of summary judgment of noninfringement after concluding that the district court erred by relying on expert testimony to construe a claim term in a manner not contemplated by the intrinsic evidence. Genuine Enabling Tech. LLC v. Nintendo Co., Ltd., et al., Case No. 20-2167 (Fed. Cir. Apr. 1, 2022) (Newman, Reyna, Stoll, JJ.)

Genuine owns a patent directed to a user interface device (UID) that, in the process of synchronizing and merging data streams into a combined data stream, directly receives microphone speech input and transmits speech output via a speaker. During prosecution, the inventor distinguished “slow varying” physiological response signals discussed in a prior art reference from the “signals containing audio or higher frequencies” in his invention, arguing that the latter posed a signal “collision” problem that his invention solved. In distinguishing the prior art, the inventor explained that his invention “describes, in its representative embodiments, how to combine the data from a UID (mouse) and from a high-frequency signal, via a framer, which is unique and novel.”

Genuine subsequently filed a lawsuit against Nintendo, accusing Nintendo’s Wii Remote, Wii Remote Plus, Nunchuk, WiiU GamePad, Switch Joy-Con Controller and Switch Pro Controller of infringing the patent. During claim construction, the parties asked the district court to construe the term “input signal.” Genuine proposed the construction of the disputed claim term to be “a signal having an audio or higher frequency,” whereas Nintendo proposed the narrower construction of “[a] signal containing audio or higher frequencies.” Relying on expert testimony, Nintendo also argued that the inventor “disclaimed signals that are 500 [Hz] or less . . . generated from positional change information, user selection information, physiological response information, and other slow-varying information.”

The district court found that the inventor’s arguments amounted to a disclaimer. Crediting Nintendo’s expert testimony, the district court construed “input signal” as “signals above 500 Hz and excluding signals generated from positional change information, user selection information, physiological response information, and other slow-varying information.” The district court subsequently granted summary judgment of noninfringement, finding that the accused controllers produced the types of slow-varying signals that the inventor had disclaimed during prosecution. Genuine appealed.

Genuine argued that the district court erred in construing “input signal” by improperly relying on extrinsic evidence and improperly finding that the inventor disclaimed certain claim scope during prosecution. The Federal Circuit agreed, reiterating that although extrinsic evidence can be helpful in claim construction, “the intrinsic record ‘must be considered and where clear must be followed,’” such that “where the patent documents are unambiguous, expert testimony regarding the meaning of a claim is entitled to no weight.” In this case, although the parties agreed that the inventor had disavowed claim scope during prosecution, there was a dispute as to the scope of the disclaimer beyond signals below the audio frequency spectrum.

The Federal Circuit explained that for a statement made during prosecution to qualify as a disavowal of claim scope, it [...]

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Not a Bullseye: Defendant Must Rebut Presumption That Claims Lacking “Means” Language Don’t Fall Under § 112 ¶ 6

by Paul Devinsky | Mar 31, 2022 | Patents

Reversing a district court finding of indefiniteness under 35 U.S.C. § 112 ¶ 6, the US Court of Appeals for the Federal Circuit found that the district court erred by ignoring unrebutted evidence that the challenged claim terms would have been understood to connote sufficiently definite structure to avoid means-plus-function construction. Dyfan, LLC v. Target Corp., Case No. 21-1725 (Fed. Cir. Mar. 24, 2022) (Lourie, Dyk, Stoll, JJ.)

Dyfan sued Target for infringement of two patents directed to location-based message delivery. During claim construction proceedings, Target argued that certain claim limitations should be construed as means-plus-function limitations and that the specification failed to disclose the requisite corresponding structure. The district court found that three claim terms were subject to § 112 ¶ 6. For the terms “code” and “application,” the court assigned a “special-purpose computer function” as the corresponding structure and found that the specification did not disclose a requisite algorithm for the functions of the computer. The district court also found that the claim term “system” was subject to § 112 ¶ 6 because it recited purely functional language without disclosing sufficient corresponding structure, and that it was unclear which of the recited components performed the recited function. The district court concluded that all three terms were indefinite under § 112 ¶ 2 for lack of corresponding structure. Dyfan appealed.

Reviewing de novo, the Federal Circuit first addressed whether the claim language invoked § 112 ¶ 6. As the Court had stated previously, there is a rebuttable presumption that a claim limitation is not drafted in a means-plus-function format if it does not contain the term “means.” However, that presumption can be overcome if a challenger demonstrates that the term fails to recite sufficiently definite structure. The Court also explained that for purposes of § 112 ¶ 6, certain “nonce words that reflect nothing more than verbal constructs” are tantamount to using the word “means.”

Turning to the case merits, the Federal Circuit first considered the terms “code” and “application.” Given the absence of “means” language, Target was required to show by a preponderance of the evidence that persons of ordinary skill in the art would not have understood those terms to connote structure considering the claim as a whole. The Court found that the district court erred in concluding that Target overcame the presumption that § 112 ¶ 6 did not apply. The Court relied on unrebutted testimony from Target’s expert witness that the district court ignored. The expert testified that both terms would have connoted structure, such as off-the-shelf software. The Court found that this unrebutted testimony demonstrated that neither claim limitation recited purely functional language.

The Federal Circuit explained that the district court failed to follow its 2018 decision in Zeroclick v. Apple. In that case, the Court reversed a district court’s finding that the claim terms “program” and “user interface” invoked § 112 ¶ 6, finding that both terms were references to conventional program code existing in the prior [...]

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Outlier? Split Federal Circuit Denies En Banc Review of Written Description Requirement

by Jenny Chen, Ph.D. | Mar 31, 2022 | Patents

The US Court of Appeals for the Federal Circuit denied a patent owner’s request for en banc rehearing of a panel decision that invalidated a patent for lack of written description on the basis that a person of skill in the art would not be able to recognize the clinical efficacy of the claimed dose and thus would not recognize that the inventors were in possession of the claimed invention at filing. Biogen International GMBH, Biogen MA, Inc. v. Mylan Pharmaceuticals Inc., Case No. 20-1933 (Fed. Cir. March 16, 2022) (per curiam) (Moore, C.J., Lourie, Newman, JJ., dissenting).

Biogen owns a patent relating to the drug Tecfidera®. The patent claims a method of treating multiple sclerosis with dimethyl fumarate (DMF) at a specific dose of 480 mg per day via oral administration (DMF480). In the written description, the patent describes a method for treating a neurological disease using DMF and states that the neurological disease can be multiple sclerosis. The patent discloses that an effective dose of DMF for oral administration can be “from about 0.1 g to 1 g per day, 200 mg to about 800 mg per day (e.g., from about 240 mg to about 720 mg per day, or from about 480 mg to about 720 mg per day; or about 720 mg per day).”

Biogen sued Mylan for infringement after Mylan submitted an abbreviated new drug application (ANDA) for a generic version of Tecfidera®. Mylan challenged the validity of the patent based on lack of written description. The district court invalidated the patent, finding that the claimed method lacked written description support because the DMF480 dose was listed only once in the specification and finding that the specification’s focus on basic research and broad DMF-dosage ranges showed that the inventors did not possess a therapeutically effective DMF480 dose at the time of filing. Biogen appealed.

In a 2–1 panel decision, the Federal Circuit affirmed the district court finding, explaining that “a skilled artisan would not have recognized, based on the single passing reference to a DMF480 dose in the disclosure, that DMF480 would have been efficacious in the treatment of MS, particularly because the specification’s only reference to DMF480 was part of a wide DMF-dosage range and not listed as an independent therapeutically efficacious dose.”

Judge O’Malley issued a dissenting opinion, questioning whether the district court erred in requesting clinical data showing efficacy of the claimed DMF480 dose under the written description context.

Biogen timely petitioned for en banc review, raising two questions:

Must a “written description” prove the invention’s efficacy?
Is there a need to repeatedly emphasize elements of the invention in order to satisfy the written description requirement?

The Federal Circuit issued a 6–3 decision denying the en banc petition. Judge Lourie wrote in dissent, joined by Chief Judge Moore and Judge Newman, calling this case “an outlier” at “the farthest end of the spectrum of cases where written description has not been found” given that every claim limitation was expressly described [...]

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Dude, Where’s My Venue? Texas Car Dealerships Aren’t Distributor Agents

by Paul Devinsky | Mar 17, 2022 | Patents

The US Court of Appeals for the Federal Circuit vacated a district court’s denial of motions made by two car distributors to transfer cases out of the Western District of Texas for improper venue, finding that the patent owner failed to establish that franchised car dealerships in the judicial district were agents of the manufacturers for venue purposes under § 1400(b). In re Volkswagen Grp. of Am., Inc., Case Nos. 22-108; -109 (Fed. Cir. Mar. 9, 2022) (Dyk, Reyna, Chen, JJ.) (per curiam).

StratosAudio filed complaints in the Western District of Texas against Volkswagen and Hyundai, asserting infringement of infotainment-related patents. Volkswagen and Hyundai are car distributors incorporated in New Jersey and California, respectively. Both distributors moved to dismiss or transfer their cases for improper venue under § 1406(a). The district court denied the motions, concluding that venue was proper because independently owned Volkswagen and Hyundai car dealerships operated in the district. The district court found that franchise agreements gave the car distributors sufficient control over their respective dealerships such that they constituted regular and established places of business in the district. The district court reached this finding despite the fact that Texas law prohibited direct or indirect operation or control of a franchise by a car manufacturer or distributor. Volkswagen and Hyundai petitioned the Federal Circuit for writ of mandamus to vacate the district court’s order or transfer for improper venue.

The Federal Circuit first considered whether mandamus review was appropriate. The Court explained that it may only issue a writ if the petitioner has no other means adequate to attain the desired relief. In contrast to a motion to transfer to a more convenient venue under § 1404(a), denial of a motion to dismiss or transfer for improper venue under § 1406(a) can be remedied on appeal from final judgment. The Court explained that mandamus relief is therefore only available for a ruling on a § 1406(a) motion where the issue presented doing so is important to “proper judicial administration.” Citing to its ruling in In re. Google LLC, the Court explained that this condition may be met when there are a significant number of district court decisions that adopt conflicting views on a basic legal issue. The Court described the disagreement among district courts over whether independent car dealerships establish venue over vehicle manufacturer and distributors and determined that the situation warranted immediate review.

The Federal Circuit turned to the merits to analyze the factors for determining whether a defendant has a “regular and established place of business” for the purposes of establishing proper venue under 28 U.S.C. § 1400(b). There was no dispute that the car dealerships were physically located in the Western District of Texas, and that the defendants did not have any employees at these locations. The Court thus identified the three operative statutory requirements that StratosAudio had the burden of establishing:

Whether the dealerships were the agents of the defendants
Whether the dealerships conducted the defendants’ [...]

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Multiple Purchasing Options Overpower Use of “Quotation” in Finding Offer for Sale

by Joshua Revilla | Feb 24, 2022 | Patents

The US Court of Appeals for the Federal Circuit reversed a district court’s summary judgment of no invalidity under the on-sale bar, finding that the completeness of relevant commercial sale terms, including multiple purchase options, was not an invitation to further negotiate but rather was multiple offers for sale. Junker v. Medical Components, Inc., Case No. 21-1649 (Fed. Cir. Feb. 10, 2022) (Dyk, Reyna, Stoll, JJ.)

Larry Junker designed a sheath that makes it easier for doctors to grasp the sheath during catheter insertion. After designing the sheath, Junker inquired about manufacturing and eventually began a business relationship with James Eddings and his company, Galt Medical, to manufacture the product. Eddings also started a new company, Xentek Medical, to help with the development, manufacture and sale of the product. In January 1999, Eddings, through Xentek, communicated with Boston Scientific Corporation about the sheath products and sent a letter detailing bulk pricing information for the products. The letter concluded by noting Eddings’ appreciation for “the opportunity to provide this quotation.” In February 2000, Junker filed a design patent directed to an “ornamental design for a handle for introducer sheath.”

Junker sued MedComp in 2013 for infringement of the claimed design. In response, MedComp asserted invalidity, unenforceability and noninfringement defenses, as well as counterclaims. The parties filed cross-motions for summary judgment for several issues, including invalidity under the on-sale bar. The primary dispute regarding the on-sale bar was whether the January 1999 letter to Boston Scientific was considered an offer for sale of a product embodying the claimed design. The district court found that it was not an offer for sale because it was a preliminary negotiation and not a definite offer. The district court reasoned that although the letter included many specific commercial terms, the repeated use of the word “quotation” and the invitation to discuss specifics rendered the letter a preliminary negotiation. The district court proceeded with a bench trial, ultimately finding in favor of Junker and awarding damages. MedComp appealed.

A patent claim is invalid under § 102(b) if the invention was on sale more than a year before the application date and the claimed invention was the subject of a commercial offer for sale and was ready for patenting. There was no dispute that the January 1999 letter was sent more than one year before the patent’s filing and that the claimed design was also ready for patenting. As a result, the only issue on appeal was whether the letter was a commercial offer for sale of the claimed design.

The Federal Circuit determined that the letter was a commercial offer for sale. The Court found that the statement that Xentek was responding to a “request for quotation” signaled that the letter was more than just an unsolicited price quote and was instead a specific offer to take further action. The Court found that the letter contained many necessary terms typical in a commercial contract, including prices for bulk shipments, specific delivery conditions and payment terms. The Court [...]

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Long-Felt Need Not Felt Long Enough to Overcome Obviousness

by Tessa Kroll | Feb 24, 2022 | Patents

The US Court of Appeals for the Federal Circuit upheld a finding that patents covering Narcan, a naloxone-based intranasal opioid overdose treatment, were obvious despite evidence of long-felt need. Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., Case No. 20-2106 (Fed. Cir. Feb. 10, 2022) (Prost, Stoll, JJ.) (Newman, J., dissenting).

In 2012, during the growing opioid crisis, the US Food & Drug Administration (FDA) identified a need for an improved intranasal naloxone treatment that could be FDA-approved and deliver the same amount of naloxone to the blood as an injectable formulation. In 2015, Adapt filed a patent application for Narcan, a method of nasally administering naloxone using about 4 mg of naloxone, benzalkonium chloride (BZK) and three other excipients. After Teva submitted an abbreviated new drug application (ANDA) to sell a generic version of Narcan, Adapt sued Teva for infringement. After a two-week bench trial, the district court determined that Adapt’s patents were obvious in view of prior art. Adapt appealed.

The Federal Circuit found no error in the district court’s conclusions that a skilled artisan would have been motivated to combine the prior art, that the prior art did not teach away from the claimed combination and that Adapt’s evidence regarding unexpected results, copying and industry skepticism was not probative of nonobviousness. The Court noted that a skilled artisan would have been motivated to improve on existing treatments because their shortcomings were well known, and the FDA had explicitly identified a need for an improved intranasal product. The claimed excipients also were separately taught in the prior art within the claimed concentration ranges. The Court agreed that a skilled artisan would have been motivated to combine these components to achieve the tonicity and pH required for a drug to be tolerable in the nose and to preserve and stabilize the formulation. While the prior art suggested that BZK causes naloxone degradation, the Court found that this did not teach away from its use because BZK was commonly used in intranasal formulations.

Turning to secondary considerations of nonobviousness, the Federal Circuit affirmed the following:

Narcan’s 56% increase in bioavailability was not “evidence of unexpected results” because BZK was a known permeation enhancer expected to increase bioavailability.
“[C]opying in the ANDA context is not probative of nonobviousness because . . . bioequivalence is required for FDA approval.”
The FDA’s recommendation to increase naloxone dosage in intranasal formulations negated any alleged industry skepticism regarding the higher dosage.

While the Federal Circuit found that the district court erred in finding there was no long-felt but unmet need for an effective intranasal naloxone product, the Court concluded that this error was harmless because the long-felt need began just three years before the patents’ priority date, which was not long enough to overcome the “strong case of obviousness . . . in view of the plethora of prior art.” The Court further agreed that competitors’ alleged failure to obtain FDA approval was not probative of nonobviousness and ultimately affirmed the district [...]

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