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Lawyers Scolded but Not Sanctioned for Violating Federal Circuit’s COVID-19 Rules

by Paul Devinsky | Mar 10, 2022 | Uncategorized

The US Court of Appeals for the Federal Circuit decided not to impose sanctions for violation of its COVID-19 restrictions on the number of counsel permitted to attend oral argument, citing the involved lawyers’ “earnest remorse.” In re Violation of the Revised Protocols for In-Person Arguments and Related Order, Case No. 22-9000 (Fed. Cir. Feb. 25, 2022) (per curiam).

When the Federal Circuit reopened for in-person oral arguments in September 2021, it continued to restrict public access to the National Courts Building and set out strict protocols governing appearances at oral argument. Under those protocols, only arguing counsel and up to one additional attendee whose presence was necessary to assist or supervise the arguing counsel could attend. All persons entering the building had to sign a form certifying that they were either arguing counsel or assisting or supervising arguing counsel. Arguing counsel had to sign an additional form taking personal responsibility for ensuring that all individuals attending argument with the arguing counsel had read and would comply with the COVID-19 protocols.

Several senior lawyers from one law firm wanted to attend a junior colleague’s oral argument. The junior lawyer moved for permission for two lawyers and two other individuals to attend the oral argument in addition to arguing counsel and the one permitted assistant/supervisor. The Federal Circuit denied the motion. Nonetheless, on the day of argument, four lawyers (each carrying the required form) went to the courthouse and entered the assigned courtroom. The two non-arguing, non-assisting/supervising lawyers sat in the back corner of the courtroom until they were summoned to the front by a deputy clerk and told to leave the courtroom. The lawyers returned to the lobby area and were subsequently escorted out of the building.

The matter was referred to the Federal Circuit’s standing panel on attorney discipline, which ordered all four lawyers to show cause why they should not be sanctioned. The lawyers stated that they had gone to the courthouse notwithstanding the denial of their motion for leave to attend the hearing merely to seek clarification on any potential changed circumstances that might permit their attendance. They also argued that the Court’s COVID-19 restrictions were ambiguous. Finally, they expressed remorse for having violated the rules.

The Federal Circuit criticized the lawyers for trying to attend the oral argument even though their motion for leave to attend was denied. The Court noted that the lawyers might have sought clarification or reconsideration of the denial in writing but stated that it was inappropriate for the lawyers to have sought such clarification or reconsideration in person at the time of the hearing. The Court also called the lawyers’ argument that the protocols were ambiguous “wholly without merit.” Nonetheless, on a finding that the lawyers’ remorse was earnest, the Court decided not to impose sanctions.

Practice Note: Anyone might make an occasional error in judgment. While remorse does not undo such an error, it can at least help prevent sanctions from being imposed. Then again, the Federal Circuit has now [...]

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California, I’m Coming Home: Transfer to Venue Where Products Were Designed Is Appropriate

by Paul Devinsky | Mar 10, 2022 | Patents

The US Court of Appeals for the Federal Circuit denied a patent owner’s petition for writ of mandamus, finding that the district court properly transferred a case from the Eastern District of Virginia to the Northern District of California because the center of the alleged infringing activities occurred in California. In re: SunStone Information Defense, Inc., Case No. 2022-121 (Fed. Cir. Feb. 11, 2022) (Moore, Dyk, Stoll, JJ). (non-precedential).

SunStone filed a patent infringement suit against F5 Networks and one of its customers in the Eastern District of Virginia. F5 Networks moved to transfer the case to the Northern District of California pursuant to 28 U.S.C. § 1404(a), arguing that at the time of filing, SunStone was headquartered in Northern California, and the F5 Networks subsidiary that designed and developed the accused products was also located in the area. F5 Networks also noted that essentially all of the relevant documents and knowledgeable employees were in Northern California.

The district court granted F5 Networks’ motion, explaining that F5 Networks satisfied its burden of proving that transfer was warranted based on convenience of the parties and witnesses and because California was the “center of the alleged infringing activities.” The district court also noted that neither party disputed that the action “might have been brought” in the Northern District of California. SunStone petitioned for writ of mandamus.

The Federal Circuit applied the law of the regional circuit (the Fourth Circuit), which requires finding a clear abuse of discretion in order to overturn a district court’s transfer decision. The Court found that SunStone failed to meet this “stringent standard.” The Court also found that SunStone’s choice of forum was not entitled to significant weight because it was not SunStone’s home forum and had no specific connection to the infringement claims. The Court therefore denied SunStone’s petition.

Practice Note: This is another decision in a long line of recent Federal Circuit rulings relating to venue, which are summarized in an article related to a string of transfer denials in the Western District of Texas and our 2022 IP Outlook Report: The Developments Shaping Patent Law.

What Preclusion? Post-IPR Reexam Moves Forward

by Tim Dunker | Mar 10, 2022 | Patents

The US Court of Appeals for the Federal Circuit revived a petitioner’s validity challenge seeking ex parte review at the US Patent & Trademark Office (PTO), reversing a district court decision dismissing its complaint seeking Administrative Procedures Act (APA) review of the PTO Director’s vacatur decision. The Federal Circuit concluded that the petitioner was not subject to inter partes review (IPR) estoppel from pursuing reexamination after receiving IPR final written decisions concerning the same claims of the same patents. Alarm.com Inc. v. Hirshfeld, Case No. 21-2102 (Fed Cir, Feb 24, 2022) (Taranto, Chen, Cunningham, JJ.)

This case explores the tension between the ex parte reexam statute and the IPR estoppel statute. Under 35 U.S.C. § 302, “any person at any time may file a request for reexamination . . . of any claim of a patent on the basis of any prior art cited under [§ 301].” If the PTO Director determines “pursuant to [§ 303(a)] that no substantial new question of patentability is raised,” that determination “will be final and nonappealable.” § 303(c). If a substantial new question is deemed to have been raised, “the determination will include an order for reexamination of the patent for resolution of the question.” § 304. Under § 315(e)(1), a petitioner in an IPR that results in a final written decision is estopped from requesting or maintaining a proceeding before the PTO “with respect to that claim on any ground that the petitioner raised or reasonably could have raised during that inter partes review.”

Alarm.com filed several IPR petitions that resulted in three final written decisions holding that Alarm.com had not carried its burden of proving that the challenged claims at issue were unpatentable. The Federal Circuit affirmed all three decisions in its 2018 ruling in Vivint, Inc. v. Alarm.com. Alarm.com subsequently filed three requests for ex parte reexamination of the same claims under 35 U.S.C. § 302 and 37 C.F.R. § 1.510, presenting different grounds than were presented in the IPRs. Instead of rendering a § 303(a) decision on the issue of whether petitioner presented a substantial new questions of patentability, the Director vacated the requests, finding that Alarm.com reasonably could have raised its reexamination grounds in the IPRs and, therefore, was estopped under § 315(e)(1) from submitting the requests. Alarm.com filed a complaint in the Eastern District of Virginia against the Director and the PTO under 5 U.S.C. § 702, stating that the Director’s actions were arbitrary and capricious. Following dismissal of the complaint, Alarm.com appealed.

The PTO argued that the overall ex parte reexamination scheme precluded judicial review of the Director’s vacatur decision based on § 315(e)(1) estoppel, which brought Alarm.com’s challenge within the exception to APA review, i.e., where “statutes preclude judicial review.” 5 U.S.C. § 701(a)(1). The PTO did not raise any other arguments as to why judicial review would not be available under the APA.

The Federal Circuit explained that “[t]he only portion of the ex parte reexamination statutory scheme that expressly precludes judicial review is § [...]

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“TRUMP TOO SMALL” Trademark Decision Leaves Big Questions

by Sarah Bro | Mar 10, 2022 | Trademarks

Revisiting jurisprudence touching on the Lanham Act and the First Amendment from the Supreme Court’s decisions in Matal v. Tam and Iancu v. Brunetti, the US Court of Appeals for the Federal Circuit held that applying Sec. 2(c) of the Lanham Act (which bars registration of a trademark that consists of or comprises a name of a particular living individual without their written consent) may, in certain instances, unconstitutionally restrict free speech in violation of the First Amendment. In this instance, the Federal Circuit found that the Trademark Trial & Appeal Board’s (Board) refusal to register the trademark “TRUMP TOO SMALL” for use on t-shirts involved content-based discrimination that was not justified by a compelling or substantial government interest. In re: Steve Elster, Case No. 20-2205 (Fed. Cir. Feb. 24, 2022) (Dyk, Taranto, Chen, JJ.)

Steve Elster filed a US trademark application in 2018 for the mark “TRUMP TOO SMALL” (a reference to a 2016 Republican presidential primary debate exchange between then- candidate Donald Trump and Senator Marco Rubio (R-FL)) for use on shirts. The US Patent & Trademark Office (PTO) examining attorney, and subsequently the Board, refused registration of the mark on grounds that it clearly referred to former President Trump, and that Elster did not have written consent to use former President Trump’s name in violation of Sec. 2(c) of the Lanham Act. Sec. 2(c) requires such consent when a trademark identifies a “particular living individual.” Elster argued that his trademark aimed to convey that some features of former President Trump and his policies were diminutive and appealed the Board’s holding that Sec. 2(c) is narrowly tailored to advance two compelling government interests, namely, protecting an individual’s rights of privacy and publicity and protecting consumers against source deception.

The Federal Circuit started with a brief primer on relatively recent decisions in which the Supreme Court found certain provisions of Sec. 2(a) to be improper viewpoint discrimination because they barred registration of trademarks that were disparaging or comprised of immoral or scandalous matter. The Federal Circuit found that while neither Tam nor Brunetti resolved Elster’s appeal pertaining to Sec. 2(c), the cases did establish that a trademark represents private, not government, speech entitled to some form of First Amendment protection, and that denying a trademark registration is akin to the government disfavoring the speech being regulated. The Court then examined whether Sec. 2(c) could legally disadvantage the specific “TRUMP TOO SMALL” speech at issue in Elster’s case, and whether the government has an interest in limiting speech on privacy or publicity grounds if that speech involves criticism of government officials.

The Federal Circuit did not decide the matter on whether a trademark is a government subsidy, avoiding the somewhat varying opinions of the Supreme Court on that issue. Instead, the Federal Circuit found that Elster’s mark constituted speech by a private party for which the registration restriction must be tested by the First Amendment. Regardless of whether strict or intermediate scrutiny is applied [...]

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

by Alexander P. Ott | Mar 10, 2022 | Patents

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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Third-Party Licensing Information May Be Exception to General Right of Public Access to Court Records

by Paul Devinsky | Feb 24, 2022 | Patents

In a second appeal relating to sealing third-party licensing information, the US Court of Appeals for the Federal Circuit vacated and remanded a district court’s order denying a motion to seal because the district court failed to follow the Federal Circuit’s previous instruction to make particularized determinations regarding the information. Uniloc USA, Inc. v. Apple Inc., Case No. 21-1568 (Fed. Cir. Feb. 9, 2022) (Lourie, Cunningham, JJ.) (Mayer, J., dissenting).

In a previous decision, the Federal Circuit affirmed the denial of a motion to seal with regard to information pertaining to Uniloc but vacated and remanded the denial of the motion to seal with regard to certain third-party licensing information. The Court instructed the district court to “make particularized determinations as to whether and, if so, to what extent, the materials of each of these [third] parties should be made public.”

On remand, the district court again denied the motion to seal the third-party licensing information. The district court made findings regarding the relative weight of the public’s interest in accessing judicial records, including patent licensing information. It also found that the particular licensing information at issue was relevant to a dispute over Uniloc’s standing to sue. With regard to one particular third party, Uniloc’s financier Fortress Credit Co. LLC, the district court denied the motion to seal because Fortress had not complied with Local Rule 79-5(e)(1) of the Northern District of California, which requires that a supporting declaration be filed. Uniloc appealed a second time.

The Federal Circuit found that the district court failed to follow its instructions to make particularized determinations regarding whether the third-party licensing information sought to be sealed should be made public. Accordingly, the Court remanded for the district court to carry out the inquiry it had previously ordered.

The Federal Circuit also noted its disagreement with certain statements the district court had made in its order denying the motion to seal. The district court had stated that “[t]he public has an interest in inspecting the valuation of patent rights . . . particularly given secrecy so often plays into the patentee’s advantage in forcing bloated royalties.” The Federal Circuit stated that the district court committed “an error of law in making a blanket ruling that the public has a broad right to licensing information relating to patents.” While the district court had stated that the public has a strong interest in knowing the full extent of the terms and conditions involved in the exercise of its patent rights and in seeing the extent to which the patentee’s exercise of the government grant affects commerce, the Federal Circuit wrote that “[a]bsent an issue raised by the parties concerning license rights and provisions, there is no public interest or entitlement to information concerning consideration for the grant of licenses.” And while the amount Uniloc received in royalties was relevant to the dispute regarding standing, the Court wrote that “that fact can be proved without opening up all the licenses that the court granted [...]

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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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Too Much to Say? Word Limits Don’t Prevent Estoppel

by Paul Devinsky | Feb 24, 2022 | Patents

The US Court of Appeals for the Federal Circuit found that the Patent Trial & Appeal Board (Board) did not err in finding that a petitioner was estopped from maintaining a third inter partes review (IPR) of a patent claim after a final determination of two other IPRs challenging the same claim on different grounds. The Federal Circuit also found that it did not have jurisdiction to review the merits decision of the third IPR because the petitioner lacked statutory authorization to appeal as of the issuance of the prior two final written decisions. Intuitive Surgical, Inc. v. Ethicon LLC, Case No. 20-1481 (Fed. Cir. Feb 11, 2022) (O’Malley, Clevenger, Stoll, JJ.)

Intuitive Surgical concurrently filed three separate IPR petitions for a patent owned by Ethicon relating to a robotically controlled endoscopic surgical instrument. All three petitions challenged a single claim of the patent, relying on different combinations of prior art references. The Board instituted on two of the petitions at the same time and on the third petition one month later. The Board issued simultaneous final written decisions in the first two IPRs, upholding the patentability of the challenged claim. As the third IPR remained ongoing, Ethicon filed a motion to terminate Intuitive as a party to the IPR, arguing that it was estopped from proceeding under 35 U.S.C. § 315(e)(1). The Board agreed, terminating Intuitive as a party and issuing a decision upholding the patentability of the challenged claim. Intuitive appealed.

Intuitive argued that § 315(e)(1) should not apply to simultaneously filed petitions. Section § 315(e)(1) precludes a petitioner from maintaining a proceeding before the Board on any ground that it “raised or reasonably could have raised during that inter partes review.” Intuitive argued that it could not have reasonably raised all of its grounds in one petition because of the 14,000-word limit, and that simultaneously filed petitions do not conflict with the purpose of § 315(e)(1)—to prevent abusive IPR conduct. The Federal Circuit disagreed, finding that § 315(e)(1) estops a petitioner as to grounds it reasonably could have raised in another IPR, even if the petitions are filed on the same day. The Court went on to note multiple ways around the word limit issue, none of which Intuitive attempted. Intuitive could have sought to consolidate the proceedings or divided its petitions on a claim-by-claim basis instead of by grounds (something which the Court noted is not prohibited by § 315(e)(1)). Intuitive also argued that, under the Court’s decision in Shaw, it was only estopped from raising instituted grounds, but the Court cited its recent decision in California Institute of Technology v. Broadcom Limited, which overruled Shaw, explaining that estoppel applies to all grounds that could have been reasonably included in the petition.

The Federal Circuit also considered whether Intuitive was authorized to pursue an appeal given the termination. Intuitive argued that it had the right to appeal the Board’s decision in the third IPR because it was once a party to the IPR. [...]

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Federal Circuit Divided on Whether Skinny Labeling Compliance Precludes Inducement or Supports Equitable Estoppel

by Paul Devinsky | Feb 24, 2022 | Patents

The US Court of Appeals for the Federal Circuit denied a generic drug manufacturer’s petition for en banc review of a panel opinion finding induced infringement liability despite the manufacturer’s adherence to skinny labeling rules, and suggested that equitable estoppel was the appropriate vehicle for considering whether the branded drug manufacturer’s representations to the US Food & Drug Administration (FDA) should prevent it from recovering. GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., Case Nos. 18-1976, -2023 (Fed. Cir. Feb. 11, 2022) (per curiam) (Moore, C.J., concurring) (Prost, J., dissenting) (Dyk, J., dissenting) (Reyna, J., dissenting).

GlaxoSmithKline (GSK) developed a drug called carvedilol, which it markets (with FDA approval) for three indications: hypertension, left ventricular dysfunction following myocardial infarction (post-MI LVD) and congestive heart failure (CHF). GSK indicated to the FDA that only the CHF indication was under patent. Teva developed a generic version of carvedilol. Commensurate with skinny labeling regulations, Teva carved out from its label the language that GSK indicated was related to the protected CHF indication. Nonetheless, GSK alleged that Teva’s label induced infringement of patents covering the CHF indication. After trial, the jury agreed that the remaining language on Teva’s label would encourage physicians to practice the patented method of treating CHF. Notwithstanding the jury’s verdict, the district court granted judgment as a matter of law that Teva did not induce infringement. GSK appealed, and a divided panel reinstated the verdict (GSK v. Teva). Teva sought panel rehearing, which was denied, and then sought en banc review.

Out of the nine judges who considered the petition for en banc review, six voted to deny it and three would have granted it. All nine judges expressed concern that Teva should be held liable for induced infringement notwithstanding its compliance with the skinny labeling regulations and GSK’s representation to the FDA that the carved-out language was the only language in the label that would implicate its patents on the CHF indication. The judges differed, however, as to why Teva should not be held liable.

Chief Judge Moore’s concurrence, in which Judges Newman, O’Malley, Taranto, Chen and Stoll joined, affirmed the panel majority’s opinion and endorsed its approach of considering all the evidence. According to Judge Moore, any concerns that the result was unfair to Teva, which had complied with the skinny labeling requirements, should be addressed in the district court’s resolution of the still-pending equitable estoppel defense. In Judge Moore’s view, the facts fit squarely within the doctrine of equitable estoppel: GSK’s representations to the FDA could be seen as misleading Teva into believing that GSK would not seek to enforce its patents against the skinny label (which would omit the language GSK identified as relating to the infringing use); Teva could be seen as having relied on GSK’s representations in obtaining its skinny label and bringing its generic carvedilol product to market; and Teva could be seen as having been greatly prejudiced by later being found liable for GSK’s lost profits, which were greatly in [...]

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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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