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Beware Equitable Doctrine of Issue Preclusion in Multiparty, Multivenue Patent Campaigns

by | Aug 1, 2024 |

Addressing for the first time whether an invalidity order merges with a voluntary dismissal for purposes of finality, the US Court of Appeals for the Federal Circuit held that an interlocutory order merges with the final dismissal, rendering the interlocutory order final for purposes of issue preclusion. Koss Corp. v. Bose Corp., Case No. 22-2090 (Fed. Cir. July 19, 2024) (Hughes, Stoll, Cunningham, JJ.). As a consequence, the Federal Circuit found that the patent owner’s appeal from an adverse decision in an inter partes review (IPR) was moot under the doctrine of nonmutual collateral estoppel.

In July 2020, Koss filed a patent infringement lawsuit against Bose in the Western District of Texas, asserting three patents whose common specification discloses a “wireless earphone that communicates with a digital-audio source, such as an iPod, over an ad hoc wireless network like Bluetooth.” The same day, Koss asserted the same patents against Plantronics. Bose filed a motion challenging venue and also petitioned for inter partes review (IPR) of the three patents. Later in 2020, Bose filed a declaratory judgment action seeking a declaration of noninfringement in the District of Massachusetts on the three patents Koss asserted against Bose in the Texas litigation. The Massachusetts litigation was stayed pending the resolution of the venue motions in the Texas case.

In 2021, the Texas court dismissed Koss’s complaint against Bose for improper venue. Koss then asserted a counterclaim of infringement of the same three patents in the Massachusetts litigation. The Massachusetts court again stayed the litigation pending the resolution of the IPRs, which (by that time) the Patent Trial & Appeal Board had instituted. Meanwhile, Koss’s case against Plantronics was transferred to the Northern District of California, and Plantronics moved to dismiss the complaint on the ground that all the asserted claims (which included all the claims asserted against Bose) were invalid under 35 U.S.C. § 101. The California court granted Plantronics’s motion, rendering all the asserted claims invalid. However, that order did not finally dispose of the case.

Koss then moved for leave to amend its complaint, which the California district court granted. In the amended complaint, Koss asserted two additional patents. Plantronics moved to dismiss the asserted claims in those patents as invalid under § 101. The parties fully briefed Plantronics’s motion, but before the district court issued a decision on the merits of that motion, Koss voluntarily stipulated to dismissal with prejudice, disposing of the lawsuit in its entirety. Koss did not ask the district court to vacate its earlier order finding certain claims invalid under § 101. The California district court then issued an order dismissing the case with prejudice. The deadline for Koss to appeal the judgment came and went – Koss did not appeal.

Arguing that the patents had been finally adjudicated invalid in the Plantronics litigation, Bose moved to dismiss Koss’s appeal from the Board in the IPR proceedings as moot. Koss opposed the motion, arguing that its amended complaint rendered the invalidity decision on the prior complaint non-final because the [...]

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Patenting Web Advertising? Ask Alice, I Think She’ll Know

by | Mar 14, 2024 |

In a wide-ranging opinion, the US Court of Appeals for the Federal Circuit affirmed the district court’s grant of summary judgment of invalidity for lack of patent eligible subject matter under 35 U.S.C. § 101 with respect to claims directed to web-based advertising. Chewy, Inc. v. International Business Machines, Corp., Case No. 22-1756 (Fed. Cir. March 5, 2024) (Moore, Stoll, Cunningham, JJ.)

Chewy filed suit against International Business Machines (IBM) seeking a declaration that Chewy’s website did not infringe multiple patents related to web-based advertising. IBM responded by filing infringement counterclaims. After claim construction and discovery, the district court granted Chewy’s motions for summary judgment of invalidity for lack of patent eligible subject matter with regard to the asserted claims of one patent and noninfringement of the asserted claims of a second patent.

The claims of the first patent relate to providing a targeted advertisement from an “information repository” to a user based on the user’s internet search. In affirming the district court, the Federal Circuit first determined that, under Alice step 1, “[t]he claims broadly recite correlating advertisements with search results using a generic process.” The Court noted that the claims “merely recite the concept of identifying advertisements based on search results, without any specificity as to how this is accomplished,” and are directed to “the abstract idea of identifying advertisements based on search results.”

Turning to Alice step 2, the Federal Circuit found that the claims used a generic database and conventional processing steps, and “claimed use of a conventional repository for storing advertisements and associated search results in a well-known way.” Because “the claims recite the generic process for obtaining search results from a search query and using the search results to identify advertisements,” they failed under Alice step 2 and did not claim patent eligible subject matter under § 101.

Regarding the second asserted patent, the district court construed the claim term “selectively storing advertising objects at a store established at the reception system” as requiring the “advertising objects” to be “pre-fetched” and retrieved before the user requested a page on a website. Because it was undisputed that “Chewy retrieves advertisements in response to a user requesting a page” and not before, the district court ruled that Chewy’s website did not meet this claim limitation. Looking to the intrinsic claim construction evidence, the Federal Circuit held that the district court’s claim construction was amply supported by the specification and prosecution history and affirmed the district court’s grant of summary judgment of noninfringement. Of note, the Court explained that the specification made multiple references to pre-fetching as being part “of the present invention” and therefore limited the scope of the claims.

With respect to one asserted claim of the second patent, which did not include the limitation at issue, the district court found that Chewy’s website did not practice the limitation of “establishing characterizations for respective users based on the compiled data” because “the record undisputedly showed they deliver advertisements based on the page the user is currently viewing, [...]

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District Court Finding Doesn’t Preclude PTAB Proceeding

by | Jun 15, 2023 | ,

The Patent Trial & Appeal Board refused to terminate an inter partes review (IPR) proceeding, finding that collateral estoppel and claim preclusion do not apply to previous findings from a district court proceeding. Patent Quality Assurance, LLC v. VLSI Technology LLC, IPR2021-01229, Paper No. 128 (PTAB June 3, 2023) (Melvin, Giannetti, McNamara, APJs).

Patent Quality Assurance filed a petition for IPR on July 7, 2021, against a patent owned by VLSI. The Board granted institution. The Board later instituted on a substantively identical petition filed by Intel and granted Intel’s motion for joinder to add Intel to the Patent Quality Assurance IPR proceeding. Prior to the July 7, 2021, petition, litigation between VLSI and Intel resulted in a jury verdict that Intel infringed certain claims of the challenged patent. Invalidity was not presented to the jury. On May 10, 2022, the district court entered final judgment, including a finding that Intel had not proven invalidity. Based on the district court’s judgment, VLSI asserted that claim preclusion barred Intel from challenging validity of the asserted patent in IPR and sought termination of the IPR as to Intel.

VLSI argued that the elements of claim preclusion were met because both VLSI and Intel were parties to both cases, the district court entered a final judgment for infringement and no finding of invalidity, and the effect of Intel’s IPR was to collaterally attack the final judgment in the first case. Intel responded, arguing that claim preclusion does not apply to IPRs from the district court under the America Invents Act (AIA).

The Board agreed with Intel that estoppel did not apply. Intel argued that if Congress had intended for IPRs to be precluded by claims in a parallel district court, it would have identified that as one of the estoppel circumstances in the AIA. VLSI argued that the Supreme Court’s 1991 decision in Astoria Federal sav. & Loan Ass’n v. Solimino applies only when an agency decision precludes a later court decision and, therefore, common-law claim preclusion would apply to the IPR proceeding barring a plain statement from Congress showing intent to overcome preclusion.

The Board disagreed, noting that the cited case law related to statutes where a later statute superseded the earlier one and required a clear and manifest intent to repeal the earlier statute. The Board found that there was no express intent to repeal the earlier statute regarding estoppel, and the jurisprudence constantly counsels against repeal “by implication.” The Board also crucially noted that there was no statutory conflict between the earlier and later statutes, and the question, therefore, was whether (under Astoria) the AIA showed congressional intent that common-law claim preclusion should apply to IPRs.

Reading 35 U.S.C. § 315(e), the codification of the AIA’s estoppel provision, the Board noted that the statute clearly imposes estoppel on future agency and district proceedings but says nothing about applying adjudications in district court proceedings at the Board. As the Board explained, there would be no reason for § 315(e) to spell [...]

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No Extra Life: Harmless Claim Construction Error Does Not Restart Invalidity Challenge

by | May 18, 2023 | ,

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board decision, finding that under the harmless error rule, the challenged claims were invalid as obvious even if the Board erred in claim construction. Bot M8 LLC v. Sony Interactive Entertainment LLC, Case Nos. 22-1291 (Fed. Cir. May 9, 2023) (Prost, Reyna, Cunningham, JJ.).

Bot M8 owns a patent related to a gaming machine that authenticates certain data and includes both a board and a motherboard. The independent claims require that a “game program” is stored in memory on the board and written to the motherboard only after the game program has been authenticated by a central processing unit (CPU) on the motherboard (the Write Limitation). Sony Interactive Entertainment petitioned for inter partes review (IPR). Ultimately, the Board determined that the challenged claims were unpatentable as obvious. Bot M8 appealed.

The issue presented to the Federal Circuit was what data the Write Limitation precludes from being written to the motherboard prior to authentication: (1) the entire game program, (2) any portion of the game program and/or (3) any data (including data not related to the game program). It was undisputed that the claims at minimum preclude writing the entire game program to the motherboard before authentication (option 1). Both the Board and the Court rejected Bot M8’s argument that would preclude writing any data whatsoever before authentication (option 3). The question thus resolved into whether the Write Limitation also precluded writing any portion of the game program prior to authentication (option 2). Bot M8 argued that it did.

Bot M8 focused on a statement made by the Board as indicative that the Board applied an erroneous claim construction that would allow a portion of the game program to be written prior to authentication (rejecting option 2): “[Bot M8] seeks to read into claim 1 a requirement that nothing related to, or any portion of, the gaming information be read into [the motherboard’s] RAM … prior to authenticating the game program.”

The Federal Circuit rejected Bot M8’s argument, finding that even if the Board erred in construing the claim, Bot M8 failed to demonstrate that the alleged error was harmful. Specifically, the Court found that any such error was harmless because the Board never needed to apply an improper construction since it found the prior art disclosed writing only non­­-game program data prior to authentication, a protocol that both the Board and the Court found was not precluded by the Write Limitation. Deeming the Board’s potential claim construction error harmless, the Court affirmed the Board’s invalidity determination.

Practice Note: Parties seeking to appeal a Board decision based on an improper claim construction theory should demonstrate how the Board’s error resulted in harm.



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Pending Appeal Does Not Divest Board of Statutory Authority to Institute IPRs

by | May 18, 2023 | ,

In a case involving sua sponte review, the Director of the US Patent & Trademark Office (PTO) vacated an inter partes review (IPR) decision denying institution, found that the Patent Trial & Appeal Board had statutory authority to institute IPR review of a claim that had been previously found invalid by a district court under 35 U.S.C. § 101 (but under appeal), and remanded the proceeding for the Board to consider whether discretionary denial was appropriate. Volvo Penta of the Americas, LLC v. Brunswick Corp., IPR2022-01366, -01367, -01368, -01369, -01424 (PTO May 2, 2023) (Vidal, Dir.).

Brunswick owns several patents related to marine vessels. Volvo filed IPR petitions challenging the patents, which the Board ultimately denied. Prior to the Board’s decision, the District Court for the Eastern District of Virginia determined that claim 1 in each of the challenged patents was directed to patent-ineligible subject matter and thus was invalid under § 101. In denying institution, the Board concluded that it lacked authority to institute the IPRs because the challenged claims were no longer in effect and the America Invents Act (AIA) only permits a petitioner to challenge a claim, noting that “when given its plain and ordinary meaning, § 311(b) provides that only claims that are in effect may be annulled.” Although Brunswick appealed the district court’s decision, the Board determined that the challenged claims were finally adjudicated. Thus, the Board lacked authority to institute the requested IPR. The Board also determined that the multi-factor Fintiv analysis for discretionary denial under 35 U.S.C. § 214(a) was inapplicable here in view of the district court’s invalidity finding.

The Director reviewed the Board’s decision sua sponte and vacated the Board’s institution decision with instructions to analyze Fintiv factors 1 through 5 in view of the parallel district court proceeding.

The Director first addressed the Board’s § 311(b) analysis. The Director concluded that in finding the district court’s invalidity determination to be a final adjudication, the Board appeared to have borrowed from collateral estoppel principles. The Director found, however, that these principles do not apply to § 311(b) nor was there any assertion that Volvo was collaterally estopped from pursuing IPRs. The Director also determined that the challenged claims were not fully adjudicated since the district court’s decision was subject to further judicial review. Thus, the Director found that the Board had statutory authority to institute the IPRs.

Next, the Director addressed the Board’s Fintiv analysis, finding that the Board improperly interpreted Fintiv as limited to its exercise of discretion in the context of ongoing parallel district court litigation where final judgment has not yet been entered. The Director explained that the Fintiv analysis applied where, as here, the claims remain subject to further review on appeal. The Director instructed the Board to evaluate the Fintiv factors on remand and instructed that if the Board determines that these factors favor discretion to deny institution, the Board should then consider whether the case on the merits is compelling (consistent with the
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Console Yourself: Patent Owner Bears IPR Estoppel Burden

by | Apr 13, 2023 |

Addressing for the first time the standard and burden of proof for the “reasonably could have raised” requirement for inter partes review (IPR) estoppel to apply, the US Court of Appeals for the Federal Circuit concluded that a patent owner bears the burden of proving that an IPR petitioner is estopped from using invalidity grounds that a skilled searcher conducting a diligent search reasonably could have been expected to discover. Ironburg Inventions Ltd. v. Valve Corp., Case Nos. 21-2296; -2297; 22-1070 (Fed. Cir. Apr. 3, 2023) (Lourie, Stark, JJ.) (Clevenger, J., dissenting).

Ironburg sued Valve for infringing Ironburg’s video game controller patent. Valve responded by filing an IPR petition in 2016. The Patent Trial & Appeal Board partially instituted on three grounds but declined to institute on two other grounds (the Non-Instituted Grounds), as was permitted prior to the Supreme Court’s 2018 decision in SAS Institute Inc. v. Iancu. Valve did not seek remand pursuant to SAS, which would have allowed the Board to consider the Non-Instituted Grounds. In the district court litigation, Valve alleged invalidity based on the Non-Instituted Grounds and grounds Valve learned of from a third party’s IPR filed after Valve filed its IPR (the Non-Petitioned Grounds). Ironburg filed a motion asserting that Valve was estopped, pursuant to 35 U.S.C. § 315(e)(2), from asserting both the Non-Instituted Grounds and the Non-Petitioned Grounds. The district court granted Ironburg’s motion in full, removing all of Valve’s invalidity defenses. After trial, the jury returned a verdict finding that Valve willfully infringed the patent. Valve appealed.

35 U.S.C. § 315(e)(2) precludes an IPR petitioner from asserting invalidity during a district court proceeding based on “any ground that the petitioner raised or reasonably could have raised during that [IPR].” The Federal Circuit first addressed the legal standard needed to meet the “reasonably could have raised” requirement for IPR estoppel. The Court found that the “skilled searcher” standard used by several district courts is appropriate, as opposed to a higher “scorched earth” search standard. The “skilled searcher” standard is consistent with the § 315(e)(2) statutory requirement of discovering prior art references that “reasonably could have been raised.”

The Federal Circuit next addressed which party has the burden to prove what prior art references a skilled searcher reasonably would, or would not, have been expected to discover. The district court placed the burden on Valve, the party challenging the patent’s validity, and determined that Valve did not show how difficult it was to find the Non-Petitioned Grounds that Valve did not initially uncover. The Court noted that the third party that did find the Non-Petitioned Grounds may have used a “scorched earth” search, which would make its discovery of the Non-Petitioned Grounds irrelevant to estoppel. The Court concluded that the patent owner has the burden of proving what a skilled searcher reasonably would have found because the patent holder is looking to benefit from estoppel. The Court explained that this conclusion is consistent with the practice of placing the burden on the party asserting [...]

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Challenging Inventorship on Summary Judgment? Put a Cap on It

by | Jan 5, 2023 |

The US Court of Appeals for the Federal Circuit, citing a dispute as to material facts, held that a factfinder could reasonably conclude that an alleged joint inventor failed to sufficiently contribute to inventing the claimed technologies and thus reversed a district court order granting summary judgment of invalidity based on failure to join an inventor. Plastipak Packaging, Inc. v. Premium Waters, Inc., Case No. 21-2244 (Fed. Cir. Dec. 19, 2022) (Newman, Stoll, Stark, JJ.)

Plastipak sued Premium Waters, asserting 12 patents directed in part to the neck portions of lightweight plastic containers and preforms. These neck portions include a dispensing opening, a tamper-evident formation (TEF) that indicates if the container has been opened and a support flange/ring to facilitate manufacturing handling:

The patents list Richard Darr and Edward Morgan as inventors. Premium Waters countered that the patents should have included a third co-inventor, Alessandro Falzoni, an employee of another company with whom Darr and Morgan had collaborated on a project involving a design that included a neck portion, a specialty closure and a discontinuous TEF. Premium Waters moved for summary judgment of invalidity on the theory that the failure to include Falzoni as a joint inventor rendered the patent invalid, contending that Falzoni contributed the following to the invention:

  • A discontinuous (as opposed to continuous) TEF that is claimed by five of the asserted patents
  • A neck portion with only 0.580 inches or less separating its dispensing opening from its support flange/ring’s lower surface (the X dimension, as shown in the diagram above) that is claimed by the other asserted patents.

Plastipak contended that the asserted inventors were the sole inventors and that discontinuous TEFs (Falzoni’s alleged contribution) were merely state-of-the-art.

In granting the motion for summary judgment, the district court observed that Falzoni was “at least” a joint inventor because he had disclosed to one of the named inventors a neck finish measuring less than 0.580 inches with a discontinuous TEF in the form of an image of a 3D model that “constituted clear and convincing evidence of Falzoni’s disclosure, leaving ‘no doubt’ that the image ‘contributed significantly to the conception of a complete neck finish.’”

That model’s support ring lacked a lower surface, however, and Plastipak argued that without a lower surface the 3D model’s X dimension was undeterminable.

Plastipak also argued that Falzoni’s email circulating the 3D model stated that “[t]he area below the neck support ring has been left undefined” and seemingly invited the named inventor (Darr) to finalize it. Darr did so and, on the same day, emailed Falzoni a schematic depicting a support ring with a lower surface and a 0.591-inch X dimension.

Falzoni testified that while he calculated that the model had a ~0.563-inch X dimension, that calculation was based on “a reasonable indication” of where the support ring’s lower surface should be, and that the absence of an [...]

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Patent Invalidity Doesn’t Demonstrate Good Faith for Consent Order Violation

by | Mar 10, 2022 |

The US Court of Appeals for the Federal Circuit affirmed a US International Trade Commission (ITC) decision upholding a civil penalty for violating a consent order based on a patent that was later found to be invalid. The Court agreed with the ITC that a belief that a patent is invalid does not support a finding of good faith for violating a consent order, even if that belief is later vindicated by invalidation of the patent. DBN Holding, Inc. v. ITC, Case No. 20-2342 (Fed. Cir. March 1, 2022) (Moore, C.J.; Newman, Reyna, JJ.)

In 2012, BriarTek IP instigated a Section 337 investigation at the ITC against DBN based on allegations of infringement of a single patent related to two-way satellite notification devices. That investigation was terminated in early 2013 after DBN agreed by a consent order to not import any infringing devices. Only a month later, however, BriarTek filed a complaint seeking an enforcement action against DBN and asserting that DBN had continued selling its infringing devices in violation of the consent order. A month after that, DBN filed a declaratory judgment action in the Eastern District of Virginia alleging that BriarTek’s asserted patent was invalid. In June 2014, the ITC found that DBN had violated the consent order and imposed a civil penalty of $6.2 million against DBN. Later, in November 2014, the district court granted summary judgment of invalidity of BriarTek’s patent. DBN appealed the ITC’s civil penalty finding and BriarTek appealed the district court’s invalidity finding. On appeal, the Federal Circuit affirmed the invalidity finding but also affirmed the ITC’s imposition of a civil penalty for violating the consent order even though the patent was later found invalid.

Undeterred, DBN filed a petition in early 2016 asking the ITC to rescind or modify the civil penalty in view of the finding that the asserted patent was invalid. The ITC denied DBN’s petition based on its view that the Federal Circuit’s previous decision constituted res judicata that barred the ITC from reconsidering the civil penalty. DBN again appealed, and the Federal Circuit reversed and remanded to the ITC to decide, in the first instance, whether the civil penalty should be rescinded or modified. On remand, in August 2020, the ITC again denied DBN’s petition. The ITC first rejected DBN’s argument that civil penalties had been modified in similar circumstances, finding that the only identified case where a civil penalty (as opposed to a remedial order) was rescinded was distinguishable because the civil penalty had been negated by a retroactive license while the appeal was still pending. The ITC next analyzed the EPROM factors and concluded that they did not favor rescission or modification. With regard to the first EPROM factor (whether DBN acted in good or bad faith), the ITC held that the invalidity finding had no effect because a belief in invalidity is not one of the factors considered for good faith.

DBN appealed again to the Federal Circuit. The Court agreed with the ITC that [...]

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

by | Feb 24, 2022 |

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 | Feb 24, 2022 |

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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