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Delayed Disclaimer: Patent Owner Arguments Made during IPR Not a Claim Limiting Disclaimer in That Proceeding

Repeating a conclusion from an earlier non-precedential opinion in VirnetX, the US Court of Appeals for the Federal Circuit held that the Patent Trial & Appeal Board (Board) need not accept a patent owner’s arguments as a disclaimer in the very same inter partes review (IPR) proceeding in which those arguments are made. CUPP Computing AS v. Trend Micro Inc., Case Nos. 2020-2262, 2020-2263, 2020-2264, at *11 (Fed. Cir. Nov. 16, 2022) (Dyk, Taranto, Stark, JJ.)

CUPP Computing is the owner of three related patents each entitled “systems and methods for providing security services during power management mode.” After CUPP sued Trend Micro for patent infringement, Trend Micro filed petitions for IPR against all three patents, asserting that several claims of CUPP’s patents were obvious over two prior art references. The Board instituted all three IPR and found all challenged claims unpatentable as obvious. CUPP appealed.

The Federal Circuit affirmed the Board’s conclusions. The principal issue concerned CUPP’s argument that the Board erred in claim construction. In CUPP’s view, all of the evidence required the claimed “security system processor” be remote from a “mobile device processor.” The Court rejected CUPP’s arguments. Starting with the claims, the Court found that they simply required that the two processors be different. Although some claims required the security system to send a wake signal to or communicate with the mobile device, that language did not support CUPP’s remoteness construction. As the Court explained, just as an individual can send a note to oneself via email, a unit of the mobile device can send signals to and communicate with the same device. Indeed, some of the claims teach communication via an internal port of the mobile device, which was consistent with a preferred embodiment disclosed in the specification in which the two processors could be within the same mobile device.

The Federal Circuit then addressed CUPP’s disclaimer arguments. The Court agreed with the Board that CUPP’s statements made during the original prosecution were far from clear and unmistakable, being susceptible to several reasonable interpretations that are contrary to CUPP’s construction. The Court also agreed with the Board that CUPP’s arguments during the Trend Micro IPRs do not qualify as a disclaimer for purposes of claim construction. While a disclaimer made during an IPR proceeding is binding in subsequent proceedings, the “Board is not required to accept a patent owner’s arguments as disclaimer when deciding the merits of those arguments.”

As the Federal Circuit explained, expanding the application of disclaimers to the proceedings in which they are made—as CUPP proposed—is rife with problems. IPR proceedings are more similar to district court litigation than they are to initial examination, and it is well established that disclaimers in litigation are not binding in the proceeding in which they are made. Further, CUPP’s proposal would effectively render IPR claim amendments unnecessary, as patent owners would be free to change the scope of their claims retrospectively without regard to the protections provided by the IPR claim amendment process, such as [...]

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Sleep Better: Amendments Proposed during IPR Deemed Proper and Valid

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s (Board) finding that proposed amendments made during an inter partes review (IPR) are valid and proper despite the inclusion of changes not related to patentability issues raised in the petition. Nat’l Mfg., Inc. v. Sleep No. Corp., Case No. 21-1321 (Fed. Cir. Nov. 14, 2022) (Stoll, Schall, Cunningham, JJ.)

We’ve likely all seen the commercials promising a proven quality of sleep. Sleep Number is the owner of numerous patents, including several directed to methods for adjusting “the pressure in an air mattress ‘in less time and with greater accuracy’ than previously known.” The patents state this is achieved by taking pressure measurements at the valve enclosure and applying a pressure adjustment factor that is iteratively revised using an “adjustment factor error.” The patent states that this method allows for monitoring the pressure of the air mattress without the need to turn off the pumps.

American National Manufacturing challenged the validity of the patents in an IPR proceeding, claiming that most were rendered obvious by the prior art of Gifft in view of Mittal and Pillsbury and that six of the dependent claims requiring a “multiplicative pressure adjustment factor” would have been obvious in further view of Ebel. Gifft disclosed an air-bed system using valve assembly pressure to approximate the air chamber pressure and Mittal and Pillsbury both disclosed using additive offsets to improve accuracy. Ebel disclosed using both additive and multiplicative components to accurately measure the actual pressure in an inflating or deflating air bag.

The Board agreed with American National that it would have been obvious to combine Gifft, Mittal and Pillsbury and that the resulting combination rendered most of the claims obvious, but it also noted that the combination failed to show that a “skilled artisan would have applied Ebel’s multiplicative factors” to the prior art. However, in each proceeding Sleep Number filed a motion to amend the claims contingent on a finding that the challenged claims were unpatentable. The proposed claims included the “multiplicative pressure adjustment factor” that the Board had determined was not unpatentable along with other non-substantive changes.

American National took issue with these amendments, arguing they were legally inappropriate, non-enabled because of an error in the specification and lacked written description support. The Board disagreed. American National appealed. Sleep Number cross-appealed the Board’s finding of obviousness.

The Federal Circuit found that the proposed amendments were not improper even though some of the changes were non-substantive changes to address consistency issues. The Court pointed out that “once a proposed claim includes amendments to address a prior art ground in the trial, a patent owner also may include additional limitations to address potential § 101 or § 112 issues, if necessary.” The Court rejected American National’s argument that permitting such amendments creates an “asymmetrical” and “unfair” proceeding “by allowing the patent owner and the Board to address concerns that may be proper for [an] examination or reexamination proceeding, but that [...]

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Ordinary Observer Conducts Product-by-Product Analysis in View of Prior Art

In one of two concurrent opinions concerning the same design patent case, the US Court of Appeals for the Federal Circuit vacated a district court’s entry of a preliminary injunction after concluding that the court had failed to properly consider the accused products separately and in view of the prior art when determining the plaintiffs’ likelihood of success. ABC Corp. I v. P’ship & Unincorporated Ass’ns Identified on Schedule “A”, Case No. 22-1071 (Fed. Cir. Oct. 28, 2022) (Dyk, Taranto, Stoll, JJ.)

Hangzhou Chic Intelligent Technology and Unicorn Global (collectively, the plaintiffs) own four patents claiming designs for handle-less, two-wheeled, motorized, stand-on vehicles commonly referred to as “hoverboards.” Urbanmax, GaodeshangUS, Gyroor-US, Fengchi-US, Jiangyou-US, Gyroshoes and HGSM (collectively, the appellants) sell Gyroor-branded hoverboards. In 2020, the plaintiffs sued the appellants for patent infringement and sought a temporary restraining order and a preliminary injunction. As explained here, the district court granted the preliminary injunction in 2020, but thereafter invited the plaintiffs to file a second motion for a preliminary injunction in light of unsuccessful motions by Fengchi-US, Urbanmax and Gyroor-US to dissolve the 2020 preliminary injunction for lack of notice under Fed. R. Civ. P. 65(a). Heeding the court’s advice, the plaintiffs filed a motion for a second preliminary injunction on August 24, 2021.

The primary issue before the district court concerning the 2021 preliminary injunction was whether the plaintiffs had demonstrated a likelihood of success on the merits that the accused products infringed the plaintiffs’ patents in light of certain prior art hoverboards. The prior art included a hoverboard with an hourglass-shaped body, which was a significant feature of the patented designs and the majority of the accused products. Despite the similarities between the prior art board and the claimed designs, the plaintiffs generally disregarded the prior art in their analysis. After comparing the four accused products as a group to the claimed designs, the plaintiffs’ expert opined that the accused products infringed the asserted patents based in large part on their similar hourglass bodies, in addition to other features.

The appellants’ expert countered that “the attention of the hypothetical ordinary observer will be drawn to those aspects of the claimed design that differ from the prior art,” rather than the hourglass shape, and that the additional ornamental features of the accused products were not substantially similar to the claimed designs. While the district court acknowledged that “resolving this expert dispute will likely require a trial,” it nonetheless concluded that the plaintiffs had demonstrated likelihood of success and entered the preliminary injunction order. The appellants filed a notice of appeal.

On appeal, the Federal Circuit concluded that the lower court had erred in four material respects:

  • Applying the wrong legal standard
  • Failing to conduct the ordinary observer analysis in view of the prior art
  • Failing to apply the ordinary observer analysis on a product-by-product basis
  • Crafting an overbroad injunction.

First, the Federal Circuit took issue with the district court’s entry of a preliminary injunction despite its [...]

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For Inherent Anticipation, How Many Is Too Many?

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) decision that prior art disclosing a class of 957 salts could not inherently anticipate claims to a salt within the class because a skilled artisan could not “at once envisage” every class member. Mylan Pharms. Inc. v. Merck Sharp & Dohme Corp., Case No. 21-2121 (Fed. Cir. Sept. 29, 2022) (Lourie, Reyna, Stoll, JJ.)

In the underlying inter partes review, Mylan alleged that Merck’s patent claims to sitagliptin dihydrogen phosphate (DHP) with 1:1 stoichiometry were anticipated by two similar Merck publications (collectively, Edmondson). Edmondson listed 33 enzyme inhibitors (including sitagliptin) and eight preferred acids for forming salts with the inhibitors. Mylan argued that the 1:1 stoichiometry between sitagliptin and DHP (which was required by the claims) was the only possible result when sitagliptin and phosphate were reacted.

In response, Merck experts declared that Edmondson did not expressly disclose any 1:1 sitagliptin DHP salts. They also declared that non-1:1 sitagliptin phosphate salts existed and had been created using conventional protocols, and that Edmondson encompassed approximately 957 predicted salts of DP-IV inhibitors.

The Board held that Edmondson did not expressly anticipate because it did not literally disclose the 1:1 sitagliptin DHP salt and Mylan could not attempt to fill in the missing claim limitation by arguing that a person of ordinary skill in the art (POSA) could “at once envisage” the “950+” salts. Merck’s evidence convinced the Board that non-1:1 sitagliptin phosphate salts “do exist and can form.”

Mylan tried to circumvent Merck’s antedation of Edmondson by asserting that it disclosed hydrates of 1:1 sitagliptin DHP, which Merck had not synthesized until months after Edmondson was published. The Board rejected this argument, noting that Edmondson only generically referred to hydrates. Since Mylan had not contested Merck’s common ownership of Edmondson’s subject matter, § 103(c)(1) applied and Edmondson became unavailable as an obviousness reference. The remaining claims to specific enantiomers and hydrates of sitagliptin DHP were deemed nonobvious because Mylan had not presented sufficient evidence to show motivation to make or reasonable expectation of success.

On appeal, the Federal Circuit found that substantial evidence supported the Board’s determinations with respect to explicit and inherent anticipation and obviousness. Mylan’s own expert had admitted that nothing in Edmondson directed a POSA to sitagliptin or to any phosphate salt. Edmondson’s disclosure of 957 potential salts was “a far cry” from the facts in the 1962 Court of Customs and Patents Appeals case In re Peterson, where a reference disclosing only 20 compounds was deemed inherently anticipatory. The Federal Circuit rejected Mylan’s antedation argument, noting that if Edmondson did not explicitly disclose 1:1 sitagliptin DHP, it could not disclose any hydrates of that compound either.

Finally, the Federal Circuit agreed with the Board that the claims to specific enantiomers or hydrates of sitagliptin DHP were nonobvious because Mylan had not shown any expected benefit to making the specific enantiomers claimed, the literature and experts for both sides reported many downsides [...]

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Sliced and Diced: PTAB Decision Remanded for Further Analysis

In an appeal from a Patent Trial & Appeal Board final written decision, the US Court of Appeals for the Federal Circuit affirmed the Board’s decision to include certain evidence first presented in the petitioner’s Reply but vacated the Board’s obviousness decision for a failure to fully and particularly set out the bases for its decision. Provisur Technologies, Inc. v. Weber, Inc., Case Nos. 21-1942; -1975 (Fed. Cir. Sept. 27, 2022) (Prost, Reyna, Stark, JJ.)

Provisur Technologies owns a patent directed to classifying slices or portions cut from a food product according to an optical image of the slice. The patent explains that certain meat products, such as bacon or cold cuts, are sold in groups of slices according to particular weight requirements. The specification also teaches that the arrangement of the slices according to quality is desirable. The independent claims are directed to an image processing system arranged above a weigh conveyor that is capable of categorizing slices by determining the surface area and fat-to-lean ratios of the slices based on pixel-by-pixel image data.

Weber petitioned for inter partes review of the patent, alleging that the claims were obvious over various prior art references. Provisur, in its Patent Owner Response, disputed Weber’s assertion that the prior art references disclosed the claimed digital imaging receiving device capable of determining a surface area from pixel-by-pixel image data. During deposition of Weber’s expert, Provisur probed the expert’s knowledge of various camera models available as of the priority date. This prompted Weber to introduce a data sheet on redirect showing various models of cameras, including a comparison between those disclosed in the prior art references and those disclosed as exemplary in the patent. Provisur moved to exclude the datasheet, but the Board concluded that the evidence was highly probative and allowable because it was submitted in response to an argument that Provisur advanced in its Patent Owner Response. The Board also found that the independent claims and various dependent claims were invalid as obvious over the references cited by Weber.

Provisur appealed the admission of the datasheet and the Board’s determination on obviousness. Regarding the evidentiary issue, the Federal Circuit found that the Board did not abuse its discretion by considering the datasheet, noting that it was reply evidence responsive to Provisur’s arguments that the prior art did not disclose a digital camera: “Importantly, Weber’s invalidity theories did not change, nor did the reply fill any holes in Weber’s petition.” Furthermore, the Court observed that Provisur had an opportunity to respond both by cross-examining Weber’s expert and in a sur-reply to the Board.

Regarding the Board’s obviousness determination, Provisur argued that the Board erred by failing to explain its rationale for how the prior art combinations specifically taught the claim element of “determining a surface area of the top slice from the [pixel-by-pixel image] data [of a top slice of the stack].” Under the Administrative Procedure Act (APA), the Board must fully and particularly set out the basis upon which it reached its [...]

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Not a Well-Crafted Housing: Product-by-Process Claim Element Isn’t Limiting

The US Court of Appeals for the Federal Circuit affirmed a ruling that certain claims reciting a “housing . . . being cast in one piece” should be construed as a product-by-process claim element and affirmed the subsequent finding of invalidity of all challenged claims. Kamstrup A/S v. Axioma Metering UAB, Case No. 21-1923 (Aug. 12, 2022) (Reyna, Mayer, Cunningham, JJ.)

Kamstrup owns a patent directed to an ultrasonic flow meter housing in the form of a monolithic polymer structure that is cast in one piece. The patent specification explains that the invention can be fabricated with fewer steps compared to existing meters, since only a single step is used to form the monolithic polymer structure. Axioma petitioned for inter partes review of all claims of the patent, and the Patent Trial & Appeal Board (Board) found each claim unpatentable as either obvious or anticipated.

The Board construed the claim term “being cast in one piece” to be a product-by-process claim element. Kamstrup did not present any evidence showing that this claim element provided structural or functional differences distinguishing the housing itself from the prior art, and therefore the Board determined that the housing element was not entitled to patentable weight. The Board subsequently invalidated the independent claim and various dependent claims based on a prior art meter having a housing. The Board also found the remaining dependent claims to be invalid based on two additional references, which the Board determined were sufficiently analogous to flow meter technology to merit consideration in its obviousness analysis.

On appeal, Kamstrup challenged the Board’s product-by-process construction. The Federal Circuit explained that product-by-process claiming is designed to enable an applicant to claim an otherwise patentable product that resists definition other than by the process by which it is made. Where a product-by-process claim element is implicated, structural and functional differences distinguishing the claimed product from the prior art must be shown in order for that claim element to be relevant (limiting) to the anticipation or obviousness inquiry. If no structural or functional differences are shown, the element is given no patentable weight. Turning to the claim element at issue, the Court found that the plain meaning of the term “housing . . . being cast in one piece” implicated a product-by-process interpretation since it described the structure “being” cast in a particular way. The Court also affirmed the Board’s finding of invalidity because Kamstrup failed to identify any disclosure in the specification, prosecution history or extrinsic evidence of any structural or functional differences between the housing element as claimed and the prior art.

Kamstrup also argued that the two secondary prior art references were not analogous prior art because they fell within the field of “medical devices for thermodilution,” and therefore they should not be included in an obviousness analysis. The Federal Circuit disagreed, finding that the references were directed to “sensing or measuring fluid flow and fluid flow characteristics such as temperature,” which is related to “flow meters that include different types of sensors.”




Prior Art Citation to Inventors’ Report Not “By Another” for § 102(e)

The US Court of Appeals for the Federal Circuit found that a prior art patent’s summarization of a report authored by the inventors of a patent challenged under inter partes review (IPR) did not constitute a disclosure “by another” under pre-America Invents Act § 102(e). LSI Corp. v. Regents of Univ. of Minnesota, Case No. 21-2057 (Fed. Cir. Aug. 11, 2022) (Dyk, Reyna, Hughes, JJ.)

The Regents of the University of Minnesota (UMN) sued LSI Corporation and Avago Technologies (collectively, LSI) for infringement of a patent related to methods for reducing errors in binary data sequences. LSI petitioned for IPR, challenging several claims of the asserted patent and arguing that they were anticipated by two prior art references, Okada and Tsang. Tsang made reference to a “Seagate Annual Report” that was published by the inventors of the asserted patent, and which was later embodied in the patent’s application.

The Patent Trial & Appeal Board (Board) found that one of the challenged claims was anticipated by Okada. The Board also found that LSI had not shown that the other challenged claims were rendered unpatentable by either Okada or Tsang and further rejected an invalidity (anticipation) theory first raised by LSI during oral arguments as untimely (while noting that the argument failed even if timely raised). The Board determined that the Tsang reference was not “by another” under § 102(e) because LSI’s petition relied solely on material that was originally disclosed in the inventor’s Seagate Annual Report. LSI appealed the Board’s determinations relating to invalidity based on Okada or Tsang.

The Federal Circuit noted that LSI did not challenge the Board’s untimeliness determination and rejected LSI’s argument that it did not need to because the Board nevertheless reached a merits decision on the argument. The Court cited to its 2016 decision in Intelligent Bio-Systems v. Illumina Cambridge, which held that “the Board’s rejection of arguments on the ground that they were newly raised in a reply brief was not an abuse of discretion even though the Board went on to address the merits.”

Turning to the § 102(e) issue, the Federal Circuit first explained that an invention is anticipated under § 102(e) if the invention is described in a patent application filed “by another,” but a patent owner may overcome such anticipation by establishing that the relevant prior art disclosure describes the owner’s invention. Describing the history of the Tsang reference and the patent under review, the Court explained that the inventors originally submitted a Seagate Annual Report to Seagate, a UMN collaborator. Tsang, a Seagate employee, received the report and quickly filed a patent application for an improvement on the methods described in the report. This application listed only Tsang as inventor and made direct reference to the Seagate Annual Report.

The Federal Circuit then addressed whether LSI’s IPR petition relied on Tsang’s improvement to the inventors’ report or simply on Tsang’s summary of the inventors’ report. The Court explained that while LSI’s petition relied on both Tsang’s summary of the [...]

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Federal Circuit Won’t Rescue Parachute Patent

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) decision that claims to a ballistic parachute were obvious over the prior art based on knowledge attributable to artisans and denying the patentee’s motion to substitute proposed amended claims, finding that they lacked written description. Fleming v. Cirrus Design Corp., Case No. 21-1561 (Fed. Cir. Mar. 10, 2022) (Lourie, Hughes, Stoll, JJ.)

Cirrus Design filed a petition for inter partes review on certain claims of Fleming’s patent related to ballistic parachute systems on an aircraft. The challenged claims relate to an autopilot system that increases the aircraft’s pitch, reduces the aircraft’s roll or changes the aircraft’s altitude when a ballistic parachute deployment request is made. Fleming moved to amend some of the challenged claims, effectively cancelling those claims. In its final written decision, the Board found the remaining original claims obvious over the prior art and found that the amended claims lacked written description and were indefinite. Fleming appealed both the obviousness determination and the denial of the motion to amend.

Fleming argued that the Board’s obviousness determination was incorrect because the prior art did not disclose the commands to the autopilot to alter the aircraft’s pitch, roll or altitude. The Board acknowledged that neither of the primary prior references included the claimed commands upon the receipt of a deployment request, but nevertheless, concluded that a person of ordinary skill in the art would have had the motivation to combine the prior art disclosures to arrive at the claimed invention. The Federal Circuit concluded that the Board’s findings were supported by substantial evidence, citing to the Supreme Court’s 2007 KSR decision for the proposition that it is appropriate to consider a person of ordinary skill in the art’s knowledge, creativity and common sense, so long as they do not replace reasoned analysis and evidentiary support. Here the Court noted with approval the Board’s finding that aircraft autopilots are programmable and can perform flight maneuvers and deploy a parachute. The Court also noted that an artisan would have understood that certain maneuvers, such as stabilizing at an appropriate altitude, should be performed prior to deploying a whole-aircraft parachute. The Board concluded that a person of ordinary skill in the art would be motivated to reprogram the autopilot to take Fleming’s proposed actions prior to releasing the parachute to improve safety outcomes.

Fleming also appealed the Board’s rejection of his argument that the prior art taught away from claimed invention because a person of ordinary skill in the art would deem the combination unsafe. He argued that the prior art taught that autopilot systems should not be used in the sort of emergency situations that would lead to the deployment of a ballistic parachute. The Board rejected that argument, and the Federal Circuit found that the substantial evidence supported the Board’s determination that the prior art did not teach that a person of ordinary skill in the art would never use an autopilot system during [...]

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Apply That Formulation: Presumption of Obviousness Based on Overlapping Ranges

The US Court of Appeals for the Federal Circuit found a method of treatment claims pertaining to topical formulations to be obvious, applying the presumption of obviousness of overlapping ranges theory. Almirall, LLC v. Amneal Pharmaceuticals LLC & Amneal Pharmaceuticals of New York, LLC, Case No. 020-2331 (Fed. Cir. Mar. 14, 2022) (Lourie, Chen, Cunningham, JJ.)

Almirall’s patent generally claims methods of treating acne or rosacea with formulations containing certain concentrations or concentration ranges of dapsone and acryloyldimethyl taurate (a type of thickening agent known as A/SA). The claims also contain a negative claim limitation of “wherein the topical composition does not comprise adapalene.”

In a final written decision, the Patent Trial & Appeal Board (Board) relied on three main references in its finding that the challenged claims would have been obvious. One reference (Garrett) disclosed dapsone formulations with a different type of thickening agent (Carbopol®). Garrett did not disclose any formulations that contained adapalene. Another reference (Nadau-Fourcade) described formulations containing exemplary types of thickeners, including both Carbopol® and A/SA agents. The last reference (Bonacucina) disclosed dispersions containing sodium acryloyldimethyl taurate that can be used for topical administration. All three references disclosed formulations with thickening agents within the claimed ranges.

The Board applied a presumption of obviousness based on the overlapping ranges of the thickening agents and ultimately concluded that it would have been obvious to a person of ordinary skill in the art (POISTA) to substitute the A/SA agents taught in either Nadau-Fourcade or Bonacucina for the Carbopol® agent disclosed in Garrett. The Board found that the claimed range of thickening agents overlapped with Garrett, Nadau-Fourcade and Bonacucina. The Board also relied on an expert presented by Amneal who testified that a POSITA would have appreciated that the different gelling agents are interchangeable to find a reasonable expectation of success in terms of a rationale for combing the prior art.

Almirall appealed, contending that the Board erred in presuming obviousness based on the overlapping ranges found in the prior art references. Almirall argued that the presumption of obviousness only applies when a single reference discloses all the claimed ranges, whereas the Board relied on different references to create the presumption (Garrett with either Nadau-Fourcade or Bonacucina). Citing the evidence showing the interchangeability of the two different types of thickeners, the Federal Circuit found that the Board did not err in applying the presumption, citing to its 2018 case of E.I. du Pont de Nemours & Co. v. Synvina: “[t]he point of our overlapping range cases is that, in the absence of evidence indicating that there is something special or critical about the claimed range, an overlap suffices to show that the claimed range was disclosed in—and therefore obvious in light of—the prior art.” The Court also noted that this case did not turn on the presumption, since the combination of prior art was simply involved the substitution of one known thickening agent for another as there was no evidence to challenge the substitutability.

The Federal Circuit [...]

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Long-Felt Need Not Felt Long Enough to Overcome Obviousness

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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