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A Tale of Two Authors: Determining Ownership Rights of Novels Adapted for Theatre

by | Sep 30, 2021 |

The US Court of Appeals for the First Circuit vacated the district court’s opinion and order that Roberto Ramos Perea, the playwright who adapted the novels of prominent Puerto Rican author Enrique Laguerre for theatre, was not a proper copyright owner. Perea v. Editorial Cultural Inc., Case Nos. 19-2119, -2129 (1st Cir. Sept. 13, 2021) (Thompson J.) The issue before the Court was whether Editorial, a publishing company, was liable for copyright infringement after it printed and sold 20,000 copies of the theatrical adaptations of two novels (La Llamarada and La Resaca) written by Laguerre and adapted by Ramos.

In 2001, Laguerre contracted with Producciones Teatro Caribeño, authorizing Ramos to create the adaptation of La Resaca and retain the moral rights (protecting the link between Ramos and his work). The parties again contracted in 2003 for the adaptation of La Llamarada. Laguerre and Editorial entered into a contract in 2002 that gave Editorial the right to print “one edition” of the “dramatic adaptation of La Resaca” for seven consecutive years from the first printing date. Editorial received the right to print up to 25,000 copies of La Llamarada (the novel) in exchange for royalties.

During the district court action, both sides moved for partial summary judgment on the infringement claim. Editorial argued that, pursuant to the Laguerre-Caribeño contracts, Laguerre reserved the printing rights to the adaptations to himself exclusively, and Ramos therefore was not entitled to damages for infringement. Ramos argued that he owned the copyrights in the the adaptations and was entitled to recover for infringement because “(1) Laguerre authorized Ramos to create the Adaptations, therefore those creative works belong to him, or, alternatively, (2) La Resaca and La Llamarada were in the public domain when the Adaptations were written (meaning they were available for public use) and as such Laguerre’s authorization was not required.” The district court eliminated the playwright, Ramos, as the copyright owner and, following a jury trial, entered a judgment against Editorial Cultural awarding damages to Laguerre’s heirs. In dismissing Ramos’ claim, the district court exclusively relied on the language of the Laguerre-Caribeño contracts, under which Laguerre retained publishing rights. The issue on appeal involved which party owned the publishing rights to the adaptations when Editorial sold them in 2013.

The district court did not consider whether the novels were in the public domain when Ramos created his adaptations. Under the 1909 Copyright Act, works created before 1978 retained copyright protection for 28 years (plus an additional 28 years if renewed). The novels were written in 1935 (La Llamarada, not renewed) and 1949 (La Resaca, never registered in the Copyright Office). The First Circuit explained it is clear that both novels had passed into the public domain well before the contracts were signed.

Reviewing the summary judgment orders de novo, the First Circuit found that when Ramos adapted the novels into the play scripts in 2001 and 2003, Laguerre had no copyright interest in either of these novels (or any work derived from them) and [...]

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Fifth Circuit Affirms Jury Verdict on Willing Licensee FRAND Commitment

by and | Sep 30, 2021 |

The US Court of Appeals for the Fifth Circuit affirmed a jury verdict finding that a standard essential patent (SEP) owner did not breach its commitment to license its SEPs on fair, reasonable and non-discriminatory (FRAND) terms. The ruling establishes not only that willing licensee disputes can be subject to jury adjudication, but also that in willing licensee disputes, traditional patent damages factors such as apportionment are not required, since willing licensee disputes are based in contract law rather than patent law. HTC Corp. et al. v. Telefonaktiebolaget LM Ericsson et al., Case No. 19-40566 (5th Cir. Aug. 31, 2021) (Elrod, J.) The panel concluded that the district court properly instructed the jury on the meaning of FRAND and did not err in granting a post-trial declaratory judgment in the SEP owner’s favor.

Ericsson holds patents that are essential to the 2G, 3G, 4G and WLAN wireless communication standards and made a commitment to the European Telecommunications Standards Institute (ETSI) to license those SEPs on FRAND terms. In order to minimize the risk of anticompetitive behavior, standards setting organizations such as ETSI may exclude patented technology from their standards if an SEP holder does not commit to license the patent on FRAND terms.

HTC makes smartphones that implement Ericsson’s SEPs. In 2016, Ericsson and HTC were engaged in negotiations to renew their third licensing agreement. Negotiations broke down, and HTC filed a lawsuit alleging that Ericsson breached its commitment to provide a license on FRAND terms. HTC argued that Ericsson’s royalty rate should be based on the smallest salable patent-practicing unit (SSPPU) of HTC’s smartphones—specifically, the baseband processor component—rather than the net sales price of the entire end-user device. Ericsson counterclaimed for a declaration that it had complied with its FRAND obligation. Ericsson argued that its offer to HTC was fair and reasonable because its licenses to other similarly situated device makers were also based on the value of the end-user product, not just the smallest salable unit. After an earlier Fifth Circuit decision (applying French law) determined that the ETSI intellectual property rights policy contained no express language requiring SEP holders to base royalties on the SSPPU. The Court also noted that the prevailing industry standard has been to base FRAND licenses on the end-user device. Thus, a “reasonable person” would not interpret Ericsson’s FRAND commitment to mean that it must base its SEP royalties on the SSPPU.

The case proceeded to trial, and a Texas jury found that Ericsson did not breach its FRAND commitment. The district court also granted a declaratory judgment in Ericsson’s favor following trial, concluding that Ericsson’s offers were FRAND. HTC appealed to the Fifth Circuit, challenging the district court’s exclusion of several of its proposed jury instructions and the declaratory judgment in Ericsson’s favor. At trial, the district court had instructed the jury that whether a license is FRAND “will depend on the totality of the particular facts and circumstances,” and that “there is no fixed or required methodology for setting or calculating [...]

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Discretion to Authorize Hague Alternative Service on Foreign Defendant—it’s All About Time and Cost

by | Sep 23, 2021 |

The US Court of Appeals for the Federal Circuit denied a petition for a writ of mandamus, directing the US District Court for the Western District of Texas to dismiss multiple infringement actions for insufficient service of process and lack of personal jurisdiction where the plaintiff used alternative methods to effect service of process on a foreign defendant instead of the more conventional Hague Convention. Although the Court expressed reservations about the district court’s authorization of alternative service methods solely because of the Hague Convention’s slower and more expensive procedures, it found the decision to be within the district court’s discretion. In re: OnePlus Tech. (Shenzhen) Co., Ltd., Case No. 21-165 (Fed. Cir. Sept. 10, 2021) (non-precedential) (per curiam).

OnePlus is a Chinese consumer electronics manufacturing company. WSOU Investments d/b/a Brazos Licensing and Development is a non-practicing entity headquartered in Texas. Brazos filed five patent infringement actions against OnePlus and alleged that OnePlus had no place of business or employees in the United States. Although the People’s Republic of China is a signatory to the Hague Convention, Brazos decided not to attempt service on OnePlus by invoking the Hague Convention because of the burdens involved. Instead, Brazos requested that the district court grant leave under Fed. R. of Civ. Pro. 4(f)(3) to use alternative methods to effect service. Brazos made no showing that service under the Hague Convention had been tried and failed, would have been unlikely to succeed or was otherwise impracticable. The district court regarded the Hague Convention procedure as slow and expensive and granted the motion. Brazos served the complaint and summons on lawyers who represented OnePlus in the past and on OnePlus’s authorized agent for service in California.

OnePlus made a special appearance to challenge the sufficiency of the service and the district court’s jurisdiction over OnePlus. The district court rejected the challenge on the basis that Rule 4(f)(3) gave it discretion to order service on a foreign defendant by means other than those prescribed by the Hague Convention, and that the service was effective to grant the district court personal jurisdiction over OnePlus. OnePlus sought mandamus.

OnePlus’s mandamus petition requested that the Federal Circuit compel the district court to vacate its order authorizing alternative service and require that Brazos effect service pursuant to Hague Convention procedures. OnePlus argued that:

  • Brazos’s service was ineffective because it did not satisfy Texas state law.
  • As a result of the ineffective service, the district court lacked personal jurisdiction over OnePlus.
  • It was an abuse of discretion for the district court to authorize alternative service absent showing of a need to forego Hague Convention procedures.

OnePlus argued that the district court had jurisdiction over it only if OnePlus was subject to jurisdiction in Texas under the Texas long-arm statute. Because valid service under Texas law required the transmittal of documents abroad and triggered the Hague Convention (which Brazos did not use), OnePlus contended that there was no valid service and the district court therefore lacked personal jurisdiction over [...]

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Not on My Watch: Disclosure of Restored Goods’ Source Obviates Consumer Confusion

by | Sep 23, 2021 |

The US Court of Appeals for the Second Circuit affirmed a ruling that a defendant’s use of a mark in connection with the sale of used goods did not create consumer confusion, finding that the district court adequately analyzed the relevant Polaroid factors and did not erroneously apply the 1947 Champion Spark Plug case. Hamilton Int’l Ltd. v. Vortic, LLC, Case No. 20-3369 (2d Cir. Sept. 14. 2021) (Cronan, J.)

Vortic is a watchmaker that specializes in the restoration and conversion of antique pocket watches into wristwatches. Hamilton International brought a trademark infringement suit against Vortic based on a watch that Vortic sold called the “The Lancaster.” The Lancaster name pays homage to Lancaster, Pennsylvania, which is where the Hamilton Watch Company was originally located. The watch was made with restored “Railroad-Era” movements (the internal mechanism of the watch with the hands and face attached) that were originally produced by Hamilton. The Hamilton mark could be seen both on the antique face of the watch and through the see-through back on the internal workings. Vortic’s mark, as well as “The Lancaster” and a serial number, were located on a ring on the rear of the watch.

The district court focused on the Polaroid factors in its likelihood of consumer confusion analysis and on the issue of disclosure under Champion. The district court found that Vortic’s labeling and disclosure were compliant with Champion, that there was no evidence of actual confusion or bad faith and that the buyers of these antique watches were sophisticated purchasers. The district court found no likelihood of confusion and entered judgment for Vortic on all claims. Hamilton appealed.

The main issue on appeal was whether the district court erred in finding no likelihood of consumer confusion. To show a likelihood of consumer confusion, “[a] plaintiff must show ‘a probability of confusion, not a mere possibility’ affecting ‘numerous ordinary prudent purchasers.’”

The Second Circuit considered the district court’s application of Champion. In that case, the Supreme Court determined that keeping the “Champion” logo on refurbished spark plugs would not mislead consumers as the plugs were originally Champion plugs and had the terms “Repaired” or “Used” stamped on them, which provided full disclosure. The Court explained that the lesson from Champion is that when a refurbished “genuine product” is resold, “the seller’s disclosures and the extent of a product’s modifications are significant factors to consider” in any infringement analysis.

Hamilton argued that the repair of the Hamilton parts that went into The Lancaster was so extensive that Champion should not have been applied. The Second Circuit disagreed, noting that the only modification to the original movement was a replacement lever, and that it was clear to consumers that The Lancaster was an “antique pocket watch modified into a wristwatch rather than an entirely new product.”

Hamilton also unsuccessfully argued that the district court erred by not first using the Polaroid factors before turning to the Champion analysis. The Second Circuit explained that since the plaintiff bears the burden [...]

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De Minimis Defense Doesn’t Protect Minimal Use of Concededly Infringing Material

by | Sep 23, 2021 |

The US Court of Appeals for the Ninth Circuit reversed a district court’s grant of summary judgment in favor of the defendant in a copyright case based on a “minimal usage” or de minimis use defense. Richard N. Bell v. Wilmott Storage Services, LLC, et al., Case Nos. 19-55882, -56181 (9th Cir. July 26, 2021) (Wardlaw, J.) (Clifton, J., and Choe-Groves, J., concurring).

Richard Bell took a photo of the Indianapolis skyline and published it on various websites. Eleven years later, he registered the photo with the US Copyright Office. Bell later conducted an online reverse image search of his photo to identify potential infringers and subsequently filed more than 100 copyright infringement lawsuits. One of the sites on which Bell found the photo was VisitUSA.com. The image was only available to those who had conducted a reverse image search or knew the precise web address to the photo. Wilmott Storage Services purchased VisitUSA.com in 2012. In 2018, Bell notified Wilmott that it was displaying the photo without his permission. Wilmott removed the photo in response to Bell’s request. In 2019, Wilmott continued to display a copy of the photo, but at a slightly different address than before. Wilmott explained that its webmaster was supposed to remove the photo but instead only changed the file name. Wilmott subsequently removed the photo.

Bell sued Wilmott for copyright infringement in 2018, asserting that Wilmott infringed his right to “display the copyrighted work publicly” by making it accessible to the public on Wilmott’s server. Assuming infringement, Wilmott filed for summary judgment based on the affirmative defenses of de minimis use, fair use and the statute of limitations. The district court granted summary judgment to Wilmott on the de minimis use defense. Although Wilmott conceded that an identical copy of the photo was hosted on its server, the district court found no infringement. Bell appealed.

The Ninth Circuit noted that it had not previously addressed the issue of whether one “publicly displays” a work where it is accessible only to members of the public who either possess the specific pinpoint address or who perform a particular type of online search—here, a reverse image search. Applying Ninth Circuit precedent from Perfect 10, the Court concluded that Wilmott publicly displayed the photo.

The Ninth Circuit also found that there was no place for an inquiry into whether there was de minimis copying because the “degree of copying” was total since the infringing work was an identical copy of the copyrighted photo. The Court explained that it and a majority of other circuits do not view the de minimis doctrine as a defense to infringement but rather as an answer to the inquiry whether an infringing work and copyrighted work are substantially similar so as to make the copying actionable. The Court reiterated that the de minimis defense applies to the amount of copying, not to the extent of the defendant’s use of the infringing work. The Court also explained that the de minimis copying defense is [...]

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NDA Sunset Provision Means Trade Secret Use May Not Be Misappropriation

by | Sep 16, 2021 |

The US Court of Appeals for the Ninth Circuit reversed a district court ruling in a trade secret misappropriation case based on a non-disclosure agreement (NDA) that resulted in an award of more than $60 million, ruling that any disclosures that occurred after the termination date of the NDA were not subject to misappropriation claims. BladeRoom Group Ltd. v. Emerson Electric Co., Case No. 19-16583 (9th Cir. Aug. 30, 2021) (Murphy, J.) (Rawlinson, J., concurring).

BladeRoom and Emerson compete for contracts to design and build data centers. In August 2011, the companies explored a potential sale of BladeRoom to Emerson. BladeRoom drafted an NDA governed by English law, and the parties signed it. Critically, the 12th paragraph of the NDA provided that “this agreement shall terminate on the date 2 years from the date hereof.” The potential acquisition ultimately fell through.

Not long after, Facebook began plans to build a data center in northern Sweden. BladeRoom pitched a design in July 2012, and Emerson pitched a design several months later. In October 2012, Facebook verbally approved Emerson’s design although it was only 10% complete. Almost a year later, Facebook contacted BladeRoom asking about updates to its proposal. In November 2013, Facebook selected Emerson’s proposal. Facebook and Emerson signed a design-build contract in March 2014, at which point BladeRoom learned about the design Emerson had pitched. BladeRoom sued Facebook and Emerson, alleging that Emerson had breached the NDA and misappropriated BladeRoom’s trade secrets.

The case was tried to a jury. During trial, BladeRoom settled with Facebook but not Emerson. Before closing arguments, Emerson proposed a jury instruction excluding information disclosed or used after August 2013 (i.e., after the NDA allegedly expired). The district court denied the instruction. BladeRoom then moved in limine to prohibit Emerson from arguing that the NDA permitted it to use BladeRoom’s information after August 2013. The district court granted the motion. The jury found Emerson liable and awarded $10 million in lost profits and $20 million in unjust enrichment damages but did not distinguish between the breach and misappropriation claims in making its award. The district court awarded $30 million in punitive damages and further awarded pre-judgment interest beginning on October 30, 2012, and $18 million in attorney’s and expert witness’ fees. Emerson appealed.

The Ninth Circuit first considered whether the NDA expired after two years. Applying English law, the Court held that it did based on a primarily textual analysis. However, the Court could not determine from the record the date on which the alleged breach/misappropriation had occurred. Accordingly, it vacated the judgment and remanded for a new trial.

The Ninth Circuit also discussed several issues in the appeal that would be relevant if Emerson was found liable on remand. The Court stated that the punitive damages award was not supported by the record where the jury did not distinguish between the breach and misappropriation claims because punitive damages are not available for breach of contract under California law. The Court also discussed prejudgment interest, observing [...]

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TTAB Judicial Appointments are Determined Constitutionally Sound

by | Sep 16, 2021 |

Addressing for the first time whether the Supreme Court of the United States’ recent decision in United States v. Arthrex, Inc. also applied to the Trademark Trial and Appeal Board (TTAB), the US Court of Appeals for the Federal Circuit held that it did not, upholding the constitutionality of TTAB judicial appointments and affirming the TTAB’s cancellation of the SCHIEDMAYER trademark. Piano Factory Group, Inc. v Schiedmayer Celesta GMBH, Case No. 20-1196 (Fed. Cir. Sept. 1, 2021) (Bryson, J.)

Schiedmayer Celesta is the remaining corporate entity from a centuries-old line of German keyboard instrument manufacturers that uses the SCHIEDMAYER trademark in connection with the sale of its products. Sweet 16 Musical Properties and Piano Factory Group (collectively, Piano Factory) operated Hollywood Piano retail outlets where it sold “no-name” pianos purchased from China that were affixed with “Schiedmayer” labels. The owner of Piano Factory, believing the SCHIEDMAYER mark had been abandoned, applied to register the SCHIEDMAYER mark, and the registration issued in 2007.

In 2015, Schiedmayer filed a petition to cancel Piano Factory’s registration, alleging that it falsely suggested a connection with Schiedmayer and, thus, violated Section 2(a) of the Lanham Act. After the TTAB granted the petition to cancel, Piano Factory appealed.

Between the time that the parties filed their appeal briefs and the Federal Circuit issued its decision, the Supreme Court issued its decision in United States v. Arthrex, holding that the appointment of Patent Trial & Appeal Board (PTAB) administrative judges violated the Appointments Clause of Article II of the Constitution. On appeal, Piano Factory argued that the appointment of TTAB administrative judges (specifically, the administrative judges who issued the decision Piano Factory was appealing) was likewise unconstitutional. However, the Court disagreed, citing language from the Arthrex decision that “effectively confirmed that . . . the statutory scheme governing TTAB decision-making is not subject to the Appointments Clause problem the Court identified with regard to the PTAB.”

Additionally, Piano Factory cited the Trademark Modernization Act of 2020 (TMA)—which explicitly addressed this issue—for support. Piano Factory argued that since the TMA was not enacted until after the TTAB’s decision to cancel the SCHIEDMAYER registration, its enactment indicated that the TTAB was previously flawed. Again, the Federal Circuit disagreed, stating “the 2020 legislation itself makes clear that it merely confirmed, and did not alter” the framework that was in place prior to the TMA.

Piano Factory also challenged the merits of the TTAB’s decision, including its application of the four-factor test for false association, which considers:

  1. Whether the challenged mark is identical or nearly identical to a name previously used by another person;
  2. Whether the mark would be understood as a unique and unmistakable reference to that person;
  3. Whether the person referenced by the challenged mark was connected with the applicant’s activities and
  4. Whether the earlier user’s name has sufficient fame such that a connection with applicant would be presumed when the contested mark was used to identify the applicant’s goods.

Piano Factory disputed the [...]

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Federal Circuit: Contractual Arbitration Agreements Don’t Bind PTAB Institution Decisions

by | Sep 16, 2021 |

The US Court of Appeals for the Federal Circuit issued an order declining to intervene in inter partes review (IPR) institution decisions by the Patent Trial & Appeal Board (PTAB) and further denied a writ of mandamus to stay the PTAB’s IPR institution pending contractually required arbitration of the dispute between MaxPower and ROHM Japan. In re: MAXPOWER SEMICONDUCTOR, INC., Case No. 21-146 (Fed. Cir. Sept. 8, 2021) (Reyna, J.) (O’Malley, J., concurring in part and dissenting in part).

MaxPower owned patents directed to silicon transistor technology and licensed the patents to ROHM Japan. The license agreement contained an arbitration clause that applied to any disputes arising from or related to it—including patent validity. A dispute arose between the parties as to whether the patents covered certain silicon carbide transistor ROHM products. After MaxPower notified ROHM that it was initiating arbitration under the terms of their license agreement, ROHM challenged the validity of four MaxPower patents at the PTAB, which granted ROHM’s petitions to institute IPRs for the four challenged patents.

MaxPower appealed the PTAB’s institution decision to the Federal Circuit and sought a writ of mandamus to stay or terminate the IPR proceedings without prejudice to later institution if an arbitrator decided that IPR proceedings were appropriate.

The Federal Circuit held that the PTAB’s decision to institute IPR is non-appealable under 35 U.S.C. §314(d), which plainly “confirms the unavailability of jurisdiction” for the Court to hear direct appeals. The Court also found that MaxPower failed to meet the criteria necessary to invoke the collateral order doctrine, which allows appeals from interlocutory rulings if they decide an issue “separate from the merits of the case” that would not be reviewable after final judgment. The Court noted that MaxPower could still raise its arbitration-related challenges after the PTAB issued its final written decisions in these cases.

The Federal Circuit also rejected arguments that the appeals were authorized under 9 U.S.C. § 16(a)(1) and that MaxPower failed to show that its mandamus petition was not “merely a ‘means of avoiding the statutory prohibition on appellate review of agency institution decisions,’” citing the Court’s 2018 decision in In re Power Integrations.

Since the PTAB is not bound by private contracts enforcing arbitration agreements between parties, the Federal Circuit ruled that MaxPower had failed to show that the PTAB’s institution decisions in this case “clearly and indisputably exceeded its authority,” also stating that 35 U.S.C. § 294 does not authorize the PTAB to enforce private arbitration agreements.

In a partial dissent, Judge Kathleen O’Malley argued that the majority decision casts “a shadow over all agreements to arbitrate patent validity” and goes against strong federal policy in favor of enforcing arbitration agreements. While concurring with the majority that the PTAB’s IPR institution decisions are not appealable, Judge O’Malley stated that the case “provides exactly the sort of extraordinary circumstances under which mandamus review is appropriate” in what she called an important issue of first impression. The Supreme Court of the United States has held that [...]

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Notice Under § 287 Means Knowledge of Infringement, Not Knowledge of Patent

by | Sep 16, 2021 |

The US Court of Appeals for the Federal Circuit reversed a district court’s finding of liability for infringement that occurred prior to the filing of the action, explaining that notwithstanding the defendant’ admission that it was aware of the asserted patent, the actual notice requirement of § 287(a) is only satisfied when the recipient is informed of the identity of the patent and the activity that is believed to be an infringement. Lubby Holdings LLC v. Chung, Case No. 19-2286 (Fed. Cir. Sept. 1, 2021) (Dyk, J.) (Newman, J., dissenting in part).

Lubby Holdings sued Henry Chung for infringement of its patent relating to leak-resistant vaping products. Lubby sought damages for alleged pre-filing sales based on alleged compliance with the marking requirement of § 287. Chung raised the issue of whether Lubby’s products were properly marked as required by § 287(a), pointing to one of Lubby’s products as an example. At trial, Chung moved for judgment as a matter of law (JMOL) under Fed. R. Civ. Pro. 50(a), arguing that Lubby did not meet its burden to show that it complied with the § 287 marking requirement. The jury ultimately found Chung liable for direct infringement and awarded Lubby almost $900,000. Chung renewed his motion for JMOL under Rule 50(b) and moved for a new trial under Rule 59(a). After both motions were denied, Chung appealed.

Chung argued that there was no evidence that Lubby complied with the marking or notice requirements of § 287. Lubby argued that Chung did not meet his initial burden to point to products that were sold unmarked.

The Federal Circuit explained that under § 287(a), a patentee must properly mark its articles that practice its own invention, or the patentee is not entitled to damages for patent infringement that occurred before “actual notice” was given to an alleged infringer. The Court noted that once Chung met the “low bar” burden bar under Artic Cat to “articulate the products he believed were unmarked patented articles, the burden of proving compliance with the marking requirement is on the patentee.” The Court explained that Chung met this burden by specifically pointing to Lubby’s J-Pen Starter Kit. The Court continued that the burden shifted to Lubby, and Lubby failed to present any evidence that its products were properly marked or that its products did not practice its invention. As a result, Lubby could only recover damages for the period after Chung was provided with “actual notice.”

The Federal Circuit explained that actual notice under § 287(a) requires that the recipient be informed “of the identity of the patent and the activity that is believe to be an infringement, accompanied by a proposal to abate the infringement.” The Court further explained that it is irrelevant whether the defendant knew of the patent or knew of its own infringement. As applied to this case, the Court found that it was not relevant that Lubby told Chung that he could not use the patented technology, or that Chung [...]

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Material Information Submitted to FDA but Withheld from PTO Gives Rise to Inequitable Conduct

by | Sep 16, 2021 |

The US Court of Appeals for the Federal Circuit found prior art submitted to the US Food and Drug Administration (FDA), yet withheld from the US Patent & Trademark Office (PTO) during prosecution of an asserted patent, sufficient evidence for a finding of inequitable conduct. Belcher Pharmaceuticals, LLC v. Hospira, Inc., Case No. 20-1799 (Fed. Cir. Sept. 1, 2021) (Reyna, J.)

The patent in issue relates to injectable formulations of l-epinephrine. Epinephrine is a hormone that has been on the market since approximately 1938 and is used for a variety of medical purposes. It is also known that l-epinephrine degrades into a more potent isomer known as d-epinephrine. L-epinephrine also degrades into an impurity known as adrenalone through a process called oxidation.

In 2012, Belcher first submitted a New Drug Application (NDA) for a 1 mg/mL injectable l-epinephrine formulation. The NDA was literature-based, meaning that Belcher did not perform any clinical or non-clinical studies on its epinephrine formulation to support its application. Among the materials submitted to the FDA was an article by Stepensky et al to support its statement that “racemization of the enantiomerically pure L-Epinephrine isomer in injectable formulations of epinephrine is a well-known process.” It also submitted data from Swiss pharmaceutical company Sintetica SA’s formulation that had a pH range of 3.1 – 3.3 and undetectable levels of adrenalone. Ultimately, Belcher pursued a formulation with a similar pH range of 2.8 – 3.3.

In 2014, Belcher filed a patent application that was ultimately issued as the asserted patent. The patent taught that increasing the in-process pH to 2.8 – 3.3 unexpectedly reduced the racemization of l-epinephrine to d-epinephrine at release by approximately two thirds. The asserted claims covered pharmaceutical epinephrine formulations having a pH between 2.8 – 3.3 and certain concentrations of l-epinephrine, d-epinephrine and adrenalone at the time of release and 12 months later.

The prosecution of the application involved a single office action in which the pending claims were rejected in view of Helenek. The examiner explained that Helenek taught 1 mg/ml of epinephrine injection that, among other things, had a pH range of 2.2 – 5.0. Belcher overcame this rejection by arguing that Helenek did not render obvious the claimed range of 2.8 – 3.3 because the claimed range was unexpectedly found to be critical to reduce racemization of l-epinephrine.

Hospiria also submitted an NDA seeking approval of an injectable l-epinephrine formulation, which included a certification under 21 U.S.C. § 355(b)(2)(A)(iv)(Paragraph IV) that the asserted patent’s claims were invalid, unenforceable and/or not infringed by Hospira’s NDA product. Belcher subsequently sued Hospira for patent infringement.

During trial, Darren Rubin, Belcher’s Chief Science Officer, testified that in his role at Belcher, he was involved in the drafting and development of the NDA and in the prosecution of the asserted patent—including drafting the claims and specification and responding to the examiner’s office action. Darren admitted he knew of Stepensky before the application was filed and that he possessed a label for a 1 mg/mL epinephrine product marked [...]

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