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

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Federal Circuit reversed and remanded to the ITC to decide, in the first instance, whether the civil penalty should be rescinded or modified.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

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

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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Seeing Eye to Eye: Preliminary Injunction Affirmed for Patent Filed After Accused Product Was Sold

The US Court of Appeals for the Federal Circuit affirmed the grant of a preliminary injunction, finding that the district court did not abuse its discretion, clearly err in its underlying factual findings or abuse its discretion in setting the scope of the preliminary injunction. BlephEx, LLC v. Myco Indus., Inc., Case Nos. 2021-1149; -1365 (Fed. Cir. Feb. 3, 2022) (Moore, Schall, O’Malley, JJ.)

Myco sells AB Max, a mechanical device with an attached swab used for treating an eye condition known as blepharitis. Myco began marketing AB Max at a trade show in February 2019. One month later, BlephEx filed an application that later issued as a patent. The patent is directed toward cleaning debris from an eye during treatment of ocular disorders, including blepharitis. According to the patent, prior art treatment for blepharitis included at-home treatment where the patient would use a cotton swab, fingertip or scrubbing pad to scrub the eyelid margin in order to remove debris. Patients would often fail to adequately cleanse the eyelid margin, however. The patent’s solution is an electromechanical device with an attached swab for use by an eyecare professional to clean the patient’s eyelid margins.

The day the patent issued, BlephEx sued Myco and its chairman, John R. Choate, alleging that Myco’s AB Max infringed BlephEx’s newly issued patent. BlephEx moved the district court for a preliminary injunction prohibiting Myco from selling, distributing or offering the AB Max for sale. Myco opposed, arguing that a prior art reference (Nichamin) raised a substantial question of invalidity. The district court disagreed with Myco and granted the injunction. The district court noted that to anticipate, a prior art reference must disclose all elements of a claim arranged as in the claim, and Nichamin did not disclose combining the electromechanical applicator device depicted in one embodiment with a swab disclosed in another. The district court also rejected Myco’s argument that the patent examiner failed to consider Nichamin because he did not substantively discuss it during prosecution. The district court further rejected Myco’s obviousness argument as unsupported by expert evidence, finding Myco failed to overcome “the safety concerns of attaching a swab that is soaked in an abrasive to the Nichamin hand-held device.”

After the district court granted the preliminary injunction, Myco moved for reconsideration and argued that the preliminary injunction was overbroad because the AB Max had noninfringing uses. The district court rejected Myco’s argument, finding it was untimely and presented hypothetical noninfringing uses that were “outweighed by evidence that the only actual use of the AB Max was to treat anterior blepharitis,” which would likely infringe the asserted patent. Myco appealed.

The Federal Circuit affirmed the preliminary injunction grant. With respect to Myco’s anticipation argument, the Court found “Myco offers nothing other than attorney argument as to what the highly skilled artisan would do,” and this was insufficient to raise a substantial question of validity. The Court also noted that Myco had “put all of its eggs in the anticipation basket” and fatally failed [...]

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IPR Petition Cannot Be Based on Applicant Admitted Prior Art

Addressing the type of prior art that may form the basis of an inter partes review (IPR) proceeding, the US Court of Appeals for the Federal Circuit vacated an unpatentability finding based on “applicant admitted prior art” in the challenged patent. Qualcomm Inc. v. Apple Inc., Case Nos. 20-1558, -1559 (Fed. Cir. Feb. 1, 2022) (Taranto, Bryson, Chen, JJ.)

Qualcomm owns a patent directed to integrated circuit devices having power detection circuits for systems with multiple supply voltages. The patent seeks to solve problems associated with stray currents causing level shifters in integrated circuits to trigger input/output devices for transmission, which results in erroneous output signals from the circuit. The patent describes various prior art methods for solving the stray current problem.

Apple filed IPR petitions based on two grounds. The first was based on the combination of four prior art references. In its final written decision, the Patent Trial & Appeal Board (Board) found that the combination of these four references did not render the challenged claims invalid. The second ground relied on the applicant admitted prior art disclosed in the specification of the challenged patent in combination with another prior art reference (Majcherczak). During the IPR proceedings, Qualcomm admitted that the combination of the applicant admitted prior art and Majcherczak taught every element of the challenged claims but argued that Apple’s use of the applicant admitted prior art as the basis for an invalidity ground is barred in an IPR proceeding. The Board disagreed with Qualcomm and found the challenged claims unpatentable based on Apple’s second ground. Qualcomm appealed.

Qualcomm argued on appeal that IPR proceedings may only be based on “prior art patents or prior art printed publications” and that 35 U.S.C. § 311(b), which governs IPR proceedings, does not allow for the use of “a patent owner’s admissions” that is contained in non-prior art documents. Apple countered, arguing that any prior art that is contained in “any patent or printed publication, regardless of whether the document itself is prior art, can be used as a basis for [an invalidity] challenge.”

The Federal Circuit agreed with Qualcomm, finding that applicant admitted prior art in a challenged patent may not form the “basis” for an invalidity claim in an IPR proceeding. The Court explained that invalidity grounds advanced in an IPR must be based on patents or printed publications that are themselves prior art to the challenged patent. In reaching this conclusion, the Court relied on the 2019 Supreme Court opinion in Return Mail, Inc. v. U.S. Postal Serv., which referred to “patents and printed publications” in the context of § 311(b) as “existing at the time of the patent application.” The Court also looked to its own interpretations of “prior art consisting of patents or printed publications” in the context of ex parte reexamination proceedings under 35 U.S.C. §§ 301 and 303, which “permits the Director to institute a reexamination after ‘consideration of other patents or printed publications.’” Accordingly, the Court vacated the unpatentability [...]

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Federal Circuit Finds Interlocutory Appeal Untimely

Addressing the time limits for filing an interlocutory appeal in patent cases, the US Court of Appeals for the Federal Circuit dismissed such an appeal as untimely, finding that the appellant did not file within 30 days of all liability issues except for a determination of damages being resolved. Mondis Technology Ltd. v. LG Electronics Inc., Case No. 20-1812 (Fed. Cir. Aug. 3, 2021) (Hughes, J.)

Mondis Technology sued LG Electronics for infringement of a patent related to display technology. In a consolidated district court case joining other parties to dispute with LG, a jury found that (1) LG infringed certain claims of the patent owned by Mondis, (2) the patent claims were not invalid and (3) LG’s infringement was willful. The jury awarded $45 million in damages. LG filed multiple post-trial motions relating to infringement, invalidity, willfulness and damages. In September 2019, the district court denied LG’s motions regarding infringement, invalidity and willfulness. Then, in April 2020, the district court granted LG’s motion for a new trial on damages.

Within 30 days of the April 2020 order, LG filed a notice of interlocutory appeal with the Federal Circuit, seeking to challenge the denial of its three post-trial motions.

The Federal Circuit first discussed its jurisdiction to hear interlocutory appeals under 28 U.S.C. § 1292(c)(2), which provides the Court with exclusive jurisdiction over “an appeal from a judgment in a civil action for patent infringement which would otherwise be appealable to the . . . Federal Circuit and is final except for an accounting.” The Court explained that appeals under this section are subject to the time limits of § 2107(a), which in this case would give LG 30 days from the date the judgment became “final except for an accounting.” The Court cited to a previous case in which it held that a judgment is “final except for an accounting” under § 1292(c)(2) when all liability issues have been resolved and only a damages determination remains. The Court further supported its position by citing the Supreme Court of the United States’ 1988 decision in Budinich v. Becton Dickinson in which it found that the merits decision was final after the first post-trial order that resolved all issues except for attorneys’ fees. The Court thus found that all such liability issues were resolved as of the district court’s September 2019 order and that the 30-day clock started at that time.

LG also argued that Rule 4 of the Federal Rules of Appellate Procedure tolled the time to file its appeal. Rule 4(a)(4) provides that “the time to file an appeal runs for all parties from the entry of the order disposing of the last such remaining motion.” The Court disagreed with LG’s characterization, citing a Third Circuit opinion which found that a motion only tolls the time to file interlocutory appeals if the motion relates to the interlocutory judgment. The Court found that Rule 4(a)(4) did toll the time to file the interlocutory appeal but only until motions concerning liability [...]

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