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File Like an Eagle: ANDA pH Specification Rules Infringement Inquiry

by Nitya Anand | Sep 1, 2022 | Patents

The US Court of Appeals for the Federal Circuit affirmed a district court’s finding of noninfringement in a Hatch-Waxman case under 35 U.S.C. § 271(e)(2) and § 271(a)-(b). The Court found that the alleged infringer’s abbreviated new drug application (ANDA) specification controlled the § 271(e)(2) infringement inquiry, and that there were no clear errors by the district court that would warrant reconsideration of the § 271(a)-(b) ruling. Par Pharmaceutical, Inc. et al. v. Eagle Pharmaceuticals, Inc., Case No. 21-2342 (Fed. Cir. Aug. 18, 2022) (Moore, Prost, Hughes, JJ.)

Par is the maker of Vasostrict®, a vasopressin injection product used to treat patients with critically low blood pressure. Par sued Eagle, an ANDA filer seeking to market a generic version of Vasostrict®, asserting infringement of two Orange Book-listed patents. The claims of both asserted patents required a vasopressin composition with a rounded pH between 3.7 and 3.9 (i.e., a pH between 3.65 and 3.94 before rounding). Par argued that Eagle infringed because Eagle’s ANDA sought approval for a product with a pH of 3.64, just 0.01 beneath the claimed range, and because “real-world” evidence purportedly showed that the pH of Eagle’s product drifts up over time. Accordingly, Par asserted infringement under § 271(e)(2), based on the filing of Eagle’s ANDA, and also sought a declaratory judgment that Eagle’s planned generic product would infringe under § 271(a)-(b). The district court disagreed. Par appealed.

Turning first to the issue of infringement under § 271(e)(2), the Federal Circuit explained that because drug manufacturers are bound by strict statutory provisions to sell only those products that comport with their ANDAs, if an ANDA defines a proposed generic drug in a manner that directly addresses the issue of infringement, the ANDA controls the infringement inquiry. The Court stated, however, that if an ANDA specification does not speak clearly and directly to the question of infringement, courts may look to other relevant evidence, such as data or samples the ANDA filer has submitted to the US Food & Drug Administration (FDA), to assess whether a proposed product will infringe.

The Federal Circuit found that in Eagle’s case, “the inquiry begins and ends with Eagle’s ANDA specification.” Eagle’s ANDA contained both a release specification, requiring the generic product to have a pH range of 3.4–3.6 (i.e., up to 3.64 before rounding) at the time of distribution, and a stability specification, requiring that same pH range throughout the entirety of the product’s shelf life. Par argued that the stability specification was irrelevant to the infringement inquiry because the FDA cannot ensure that every product Eagle sells complies with the stability specification. The Court disagreed, finding that the district court did not clearly err in ruling that Eagle’s ANDA defined a product outside the scope of Par’s claims.

As to Par’s declaratory judgment claim under § 271(a)-(b), the Federal Circuit found that the district court did not commit clear error in its consideration of Par’s infringement arguments. The district court considered but did not find compelling Par’s evidence of an upward pH drift in Eagle’s post-release pH data [...]

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Seal of Disapproval: TTAB Refuses Registration of County Logos

by Sarah Bro | Aug 18, 2022 | Trademarks

The Trademark Trial & Appeal Board (Board) issued a precedential decision affirming the US Patent & Trademark Office (PTO) Examining Attorney’s refusal to register two different logo marks filed by southern California’s County of Orange because the marks consisted of and comprised, respectively, an insignia of a municipality. The Board found that a logo adopted by a government entity does not have to be “official” to constitute an insignia for which trademark registration is prohibited under Section 2(b) of the Trademark Act, 15 U.S.C. §1052(b). In re County of Orange, Ser. Nos. 87419378; 87639750 (TTAB, Aug. 4, 2022) (Shaw, Coggins, Allard, Administrative Trademark Judges).

The County applied to register two logo marks. The US trademark applications described one mark as “a circle with the image of three oranges in front of an orange grove and . . . mountains with the words ‘COUNTY OF ORANGE’ . . . and . . . ‘CALIFORNIA’ . . . [around] the circle” (Circle Mark). The second logo mark featured a park ranger badge design that encompassed the Circle Mark in its entirety.

The PTO examining attorney refused registration of both logo marks under Section 2(b), which imposes an absolute bar on registration on either the Principal or Supplemental Register of a mark that “[c]onsists of or comprises the flag or coat of arms or other insignia of the United States, or of any State or municipality, or of any foreign nation, or any simulation thereof.”. This section reflects the sentiment that such symbols are indicia of government authority that ought to be reserved solely for signifying the government, and which should not be registered as symbols of origin for commercial goods and services.

On appeal to the Board, the County argued that the logo marks did not constitute “insignia” because they were not an “official” seal of the County, and, even if they were, registration should not be precluded because the County is not a “municipality.” Considering both of these arguments in turn, the Board provided analysis specific to both the circle and badge iterations of the applied-for logos.

The County argued first that the proposed marks could not constitute an insignia of Orange County, California, because the County created and adopted an official seal (a design of an orange having a stem with three leaves) more than a century ago, in accordance with the applicable state government code requiring a two-step process for adopting an official seal.

The Board found this argument unpersuasive, noting that although the Circle Mark had not undergone the state’s two-step process to become an “official” seal, Section 2(b) does not distinguish between “official” and “unofficial” insignia. Therefore, formal adoption of an “official” seal is not required for an insignia to otherwise fall under the Section 2(b) bar to registration.

The Board explained that the County uses the Circle Mark for a plethora of official government business [...]

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PTO Issues Notice on Duties of Disclosure and Reasonable Inquiry

by Amol Parikh | Aug 11, 2022 | Patents

The US Patent & Trademark Office (PTO) issued a notice on July 29, 2022, titled “Duties of Disclosure and Reasonable Inquiry During Examination, Reexamination, and Reissue, and for Proceedings Before the Patent Trial and Appeal Board.” The notice comes in response to US President Joe Biden’s July 9, 2021, executive order on Promoting Competition in the American Economy, and to a September 9, 2021, letter from Senators Patrick Leahy (D-VT) and Thom Tillis (R-NC), who requested that the PTO “take steps to reduce patent applicants’ making inappropriate conflicting statements in submissions to the [PTO] and other federal agencies.”

PTO Director Vidal explained in the notice that parties involved in proceedings before the PTO should not take a position about the patentability of the claims that is inconsistent with positions taken in submissions to other government agencies regarding the same subject matter. If a party to a PTO proceeding discovers that an earlier position taken in a submission to the PTO or another government agency was incorrect or inconsistent with other statements made by the party, the party must promptly correct the record.

When an examiner has a reasonable basis to conclude that an individual identified under 37 CFR 1.56(c) or any assignee has information that would aid in the examination of the application or treatment of some matter, the examiner may require submission of information that is not necessarily material to patentability. This requirement could include statements made or information submitted to other government agencies, such as the US Food & Drug Administration (FDA).

Any party presenting a paper to the PTO has a duty to perform an inquiry that is reasonable under the circumstances. This reasonable inquiry may comprise a review of documents that are submitted to or received from other government agencies, including the FDA. If any reviewed document is material to the patentability of a pending matter before the PTO, the party has a duty to submit the information to the PTO.

Each individual with a duty to disclose, or each party with a duty of reasonable inquiry, should ensure that statements made to the PTO and other government agencies, or any statements made on their behalf to other government agencies regarding the claimed subject matter, are consistent. Providing material information to other government agencies, including the FDA, while simultaneously withholding the same information from the PTO violates those duties.

Further, any individual with a duty to disclose, or any party with a duty of reasonable inquiry, should review documents it receives from other government agencies to determine whether the information should be submitted to the PTO. For example, a party receiving a paragraph IV certification related to a generic drug application (e.g., an Abbreviated New Drug Application (ANDA)) should review such documents to determine whether they are material to the patentability of any pending matters before the PTO. If any information that is part of the ANDA process is deemed material to patentability in a pending PTO matter, then such [...]

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Claim Construction Error Fuels Remand

by Paul Devinsky | Aug 4, 2022 | Patents

The US Court of Appeals for the Federal Circuit vacated and remanded a district court’s noninfringement decision, finding that the district court improperly construed the asserted claims as requiring a dual-fuel system. Ethanol Boosting Sys., LLC v. Ford Motor Co., Case No. 21-1949 (Fed. Cir. July 18, 2022) (Moore, Hughes, JJ.) (Newman, J., dissenting) (non-precedential).

Ethanol Boosting Systems (EBS) filed suit against Ford for infringement of three patents relating to fuel management systems for spark ignition engines that include both a direct injection and a port fuel injection fueling system. During claim construction, Ford argued that the direct injection fuel system required “a fuel that contains an anti-knock agent . . . that is different from the fuel used for port injection.” The district court agreed with Ford, relying on the patents’ titles, figures and background sections. The district court noted that no figures depicted a single fuel engine, and that the specification repeatedly referenced direct injection of a non-gasoline fuel, such as ethanol, into a gasoline engine. The district court acknowledged that the specification made a singular reference to a 100% ethanol embodiment but found that this disclosure did not teach a single fuel engine and that it was in the context of a dual-fuel engine. In view of this construction, the parties stipulated to judgment of noninfringement. EBS appealed.

Reviewing claim construction de novo, the Federal Circuit found that nothing in the asserted claim language required the use of different fuels in the direct-injection and port-injection systems. The Court also found that the specification imposed no such requirement, relying on one embodiment that disclosed “100% of the fuel . . . come[s] from ethanol with a smaller fraction being port injected.” The Court rejected Ford’s citation to multiple passages requiring the use of two fuels, finding that those statements could not describe the invention as a whole because they did not describe all embodiments (namely, the aforementioned 100% ethanol embodiment). Ford also cited to an earlier Federal Circuit decision in which family members of the asserted patents were construed to require dual fuels. The Court disagreed, concluding that those patents had different specifications that did not disclose the 100% ethanol embodiment. The Court finally turned to the prosecution history of a different patent family member that has the same specification as the asserted patents. In that application’s prosecution history, the patent holder distinguished a prior art reference on the ground that it only used a single fuel type. The Court declined to import such a limitation from a statement made in that prosecution history because it did not reflect the claim language. The Court concluded that the district court erred in construing the claims to require a dual-fuel system and remanded the case for further proceedings.

Judge Newman issued a stinging dissent, taking the panel majority to task for departing from what she regarded as settled claim construction law. She agreed with the district court that the 100% ethanol example, considered in context, was “merely discussing how this [...]

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Clearly, the Disclosure Was an Error

by Vincent Li, PhD | Jul 21, 2022 | Patents

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) finding that claimed subject matter was not disclosed in asserted prior art where the prior art reference contained an “obvious error of a typographical or similar nature that would be apparent to one of ordinary skill in the art,” even though the error went unrecognized and uncorrected for 20 years until an expert conducted an extensive analysis. LG Electronics Inc. v. ImmerVision, Inc., Case Nos. 21-2037; -2038 (Fed. Cir. Jul. 11, 2022) (Stoll, Newman, Cunningham, JJ.) (Newman, J., dissenting)

The issue before the Federal Circuit was whether an error in the prior art that remained uncorrected in the public domain for 20 years and took an expert many hours of analysis to uncover, was an obvious error that would meet the standard set in the 1970 Court of Customs and Patent Appeals (CCPA) case In re Yale. Since the CCPA is a predecessor court to the Federal Circuit, its decisions are mandatory authority. Under the Yale standard, “where a prior art reference includes an obvious error of a typographical or similar nature that would be apparent to one of ordinary skill in the art who would mentally disregard the errant information as a misprint or mentally substitute it for the correct information, the errant information cannot be said to disclose subject matter. . . . The remainder of the reference would remain pertinent prior art disclosure.”

The patent at issue pertains to capturing and displaying panoramic images using an objective lens. The claims require a certain image point distribution function and that the objective lens “compresses the center of the image and the edges of the image and expands an intermediate zone of the image located between the center and the edges of the image.”

LG’s expert reconstructed a lens depicted in an embodiment of the asserted prior art using information found in Table 5 of the reference. Based on this reconstruction, LG argued that certain limitations of the claims at issue were found in a prior art patent to Tada, and thus the claims at issue were obvious.

ImmerVision had its own expert attempt to create the same lens model based on the same information. However, ImmerVision’s expert noticed something was wrong, as the resulting output image from the lens was distorted. Upon further investigation, ImmerVision’s expert discovered that the disclosure in Tada Table 5, on which LG’s expert relied, was intended to correspond to a different embodiment. The inconsistency was caused by a transcription error from the Japanese priority application in terms of the embodiment associated with Table 5. It was undisputed that when the correct values were used, the subject matter was not disclosed.

The question on appeal was whether the Board correctly held that the error in Tada would have been apparent to a person of ordinary skill in the art such that the person would have disregarded the disclosure or corrected the error to meet the Yale standard. [...]

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Heightened Written Description Standard for Negative Limitations?

by Mandy H. Kim | Jun 30, 2022 | Patents

Addressing the issue of negative claim limitations, the US Court of Appeals for the Federal Circuit granted a petition for panel rehearing, vacated its prior decision (authored by now-retired Judge O’Malley) and reversed the district court’s finding that the patent was not invalid for inadequate written description. Novartis Pharms. v. Accord Healthcare Inc., Case No. 21-1070 (Fed. Cir. June 21, 2022) (Moore, C.J.; Hughes, J.) (Linn, J., dissenting).

This is the second time this Hatch-Waxman case has been before the Federal Circuit. Novartis sued HEC, alleging that HEC’s abbreviated new drug application infringed a patent directed to methods of treating remitting multiple sclerosis (RRMS) with fingolimod or a fingolimod salt at a daily dose of 0.5 mg without an immediately preceding loading dose. The district court found sufficient written description for the claimed 0.5 mg daily dose and no-loading dose negative limitation. In January 2022, the Federal Circuit affirmed the district court’s decision finding adequate written description.

HEC petitioned for panel rehearing. The Federal Circuit granted the petition, vacated its January 2022 decision and reversed the district court’s judgment finding adequate written description for the no-loading dose negative limitation. The majority explained that “silence is generally not disclosure” because “[i]f it were, then every later-added negative limitation would be supported so long as the patent makes no mention of it.” The majority also explained that implicit disclosure cannot satisfy the written description requirement if it would render the limitation obvious to a skilled artisan. The majority emphasized that while a negative limitation need not be recited in the specification in haec verba, there generally must be something in the specification that conveys to a skilled artisan that the inventor intended the exclusion—for example, a description of a reason to exclude the relevant element. Here, the majority found that the specification made no mention of the presence or absence of a loading dose. This silence cannot support a later-added claim limitation that precludes loading doses, particularly where there was no evidence that the patentee precluded the use of a loading dose and skilled artisans agreed that loading doses are sometimes given to RRMS patients.

Judge Linn (a member of the majority in the January 2022 opinion) dissented, arguing that the majority applied a heightened written description standard requiring not only a “reason to exclude” but a showing that the negative limitation was also “necessarily excluded.” He stated that the question was not whether the patentee precluded the use of a loading dose, but whether the claim limitation that precluded a loading dose was supported by the specification’s written description that disclosed only a daily dose. Judge Linn argued that disclosure along with the testimony of Novartis’s experts implied an absence of a loading dose to a skilled artisan, and that is all that is required for adequate written description. Citing precedent and the US Patent & Trademark Office’s guidance in the Manual of Patent Examining Procedure, he argued that newly added claims or claim limitations may be supported [...]

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Claim Construction and Jurisdictional Discovery Are More Than Skin Deep

by Mike Baldwin | Jun 23, 2022 | Patents

Referencing the use of antecedents from a “wherein” clause, the US Court of Appeals for the Federal Circuit reversed a district court’s claim construction and vacated its summary judgment ruling of indefiniteness that relied on that construction. University of Massachusetts v. L’Oréal S.A., Case No. 21-1969 (Fed. Cir. June 13, 2022) (Prost, Mayer, Taranto, JJ.) The Court also reversed the dismissal of a defendant based on personal jurisdiction, finding error in the district court’s refusal to permit jurisdictional discovery before granting a motion to dismiss on that basis.

This case involved two patents directed towards the topical treatment of skin with a composition of adenosine at a certain concentration, held by the University of Massachusetts (UMass). L’Oréal is French-based company (L’Oréal S.A.) and its US-based company (L’Oréal USA) were involved in the suit. L’Oréal S.A. moved to dismiss for lack of personal jurisdiction, and the district court granted the motion without an opportunity for UMass to conduct jurisdictional discovery. After the dismissal, the district court ruled on the construction of a claim limitation and subsequently wielded that construction to invalidate another limitation as indefinite. The district court entered a final judgment of invalidity on this basis. UMass appealed, challenging the claim construction and lack of jurisdictional discovery.

Construction Using “Wherein” Clause

The Federal Circuit explained that there are two steps in reviewing claim construction: determining whether there is a plain meaning of a disputed term and, as necessary, properly construing the term. After determining that there was no plain meaning of the claim term “concentration,” the Court addressed the construction of the phrase “topically applying to the skin a composition comprising a concentration of adenosine.” The Court found that the district court erred in its determination that the “concentration applied to the dermal cells” meant that the concentration must be measured by the concentration directly applied to the dermal cells beneath the skin, rather than the composition applied to the surface of the skin. The Patent Trial & Appeal Board had adopted the same interpretation in an inter partes review, and therefore “concentration applied to the dermal cells” required no further construction.

UMass challenged that the proper construction. The Federal Circuit, citing to support in the specification, stated that the concentration of adenosine found in the composition should be construed as that applied to the epidermis. Viewing the claim as a whole and use of antecedents, the Court explained that “applied” could relate to both direct and indirect application. The Court specifically noted the use of the word “the” in the wherein clause, and found that this read, for antecedent, as the concentration of the composition. In viewing the prosecution history, the Court determined there was no disavowal of indirect application, and the specification and dependent claims supported a read of the term “concentration” to mean the composition applied to the surface of the skin, rather than requiring testing of the concentration to which the dermal cells were actually exposed. The Court also noted that in the prosecution history, UMass [...]

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Lost and “Found”: Fourth Circuit Interpretation of Discovery in Support of Foreign Litigation Opens Circuit Split

by Christopher M. Bruno | Jun 23, 2022 | Patents

The US Court of Appeals for the Fourth Circuit held that a corporation that is not physically present in a district is not “found” in the district for purposes of the federal statute that authorizes courts to order discovery for use in a foreign tribunal. In re Eli Lilly and Co., Case No. 22-1094 (4th Cir. 2022) (Niemeyer, Diaz, JJ.; Floyd, Sr. J.) The Court rejected the approach of the Second Circuit, which previously had held that a district court’s power to order discovery under 28 USC § 1782 was coextensive with the minimum contacts inquiry of specific jurisdiction.

After acquiring a patent portfolio related to the psoriasis drug Taltz, Novartis AG sued Eli Lilly for patent infringement in several European courts. Eli Lilly requested discovery from Novartis in the Eastern District of Virginia under § 1782, which authorizes a district court “of the district in which a person resides or is found” to “order him to give his testimony or statement or to produce a document or other thing for use in a proceeding in a foreign or international tribunal.” Novartis is based in Switzerland and has no offices or employees in the Eastern District of Virginia.

Following a magistrate judge’s grant of Eli Lilly’s ex parte application for a discovery subpoena, the district court vacated that order. The Fourth Circuit affirmed, substantially echoing the district court’s reasoning.

There was no dispute that Novartis did not “reside” in the district; the only issue was whether Novartis could be “found” there. The Fourth Circuit considered the plain meaning of “found,” Supreme Court precedent interpreting similar statutory language, and the legislative history of the statute, and held “that a corporation is found where it is physically present by its officers and agents carrying on the corporation’s business.”

The Fourth Circuit rejected Eli Lilly’s counterargument that the satisfaction of specific jurisdiction requirements was sufficient for a corporation to be “found” in a district, including Eli Lilly’s reliance on the 2019 Second Circuit decision in In re del Valle Ruiz, which held that a corporation was “found” wherever it could be subject to specific jurisdiction. The Fourth Circuit concluded that In re del Valle Ruiz failed to give “found” its plain meaning, incorrectly ignored Supreme Court precedent and did not give appropriate weight to the legislative history of § 1782.

Even if the Fourth Circuit had disagreed with the district court’s interpretation of § 1782, the Court would still have affirmed based on the deferential abuse-of-discretion standard. Because § 1782 permits, but does not require, an order of discovery, the Court found that the district court’s determination that to “request[ ] [ ] a substantial volume of data and materials located abroad [to] be brought into the United States for subsequent use in proceedings abroad, [would be] a nonsensical result” was well reasoned.

With this decision, the Fourth Circuit broke with the Second Circuit and created a circuit split in the interpretation of § 1782.

Ian Howard, a summer associate in the Washington, DC, office, also contributed [...]

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Except Where Futile, Litigant Must Preserve Issue at Jury Instruction Phase to Preserve Claim Construction Dispute

by Joshua Revilla | Jun 2, 2022 | Patents

The US Court of Appeals for the Federal Circuit affirmed the denial of a defendant’s post-judgment motion for a new trial based on a failure to preserve an O2 Micro challenge. The Court also reversed the denial of a prejudgment interest award to the plaintiff. Kaufman v. Microsoft, Case Nos. 21-1634; -1691 (Fed. Cir. May 20, 2022) (Dyk, Reyna, Taranto, JJ.)

Michael Philip Kaufman brought a patent infringement suit against Microsoft asserting his now-expired patent that covered a method for operating a computer to automatically generate an end-user interface that permit users to interact with data in relational databases (which store data in multiple tables that are related to each other in defined ways). Kaufman alleged infringement by Microsoft’s development tools for the .NET framework software platform, specifically Microsoft’s Dynamic Data product that allegedly automatically generated a web application for viewing and editing data. A jury found Microsoft liable for infringement and awarded $7 million in damages. Post-trial, Microsoft moved for judgment as a matter of law and a new trial, arguing that the district court failed to resolve claim construction disputes before trial and that Microsoft was therefore entitled to a new trial under 02 Micro. Kaufman moved for prejudgment interest. Both motions were denied, and both sides appealed.

Microsoft argued that the district court erred by not clarifying the claim term “automatically” and that a new trial was warranted under O2 Micro because the clarification reasonably could have led the jury to a different verdict. The Federal Circuit disagreed, explaining that Microsoft failed to preserve its O2 Micro challenge by not pursuing the matter at the jury instruction phase. The Court reasoned that the parties did not request a construction of “automatically” during the original Markman proceeding, nor did Microsoft propose a definition of “automatically” in its proposed jury instructions defining the term. Further, in its summary judgment briefing, Microsoft only said that there was a “fundamental legal dispute” as to the definition of “automatic.” Microsoft never clearly stated that a construction was needed on the term or offered the district court a formulation of such a claim construction. Microsoft also never defined a proposed construction for the term that would accommodate its action after trial. While the Court allowed that a claim construction issue does not always need to be re-raised in the specific setting of making proposals for, or airing objections to, jury instructions, that exception is limited to situations where the issue was sufficiently raised and settled earlier. The Court explained that application of that principle was settled in O2 Micro, “referring to circumstances in which the claim-construction position of the appellant was ‘made clear to the district court,’ a further objection would have been ‘not only futile but unnecessary,’ and the issue was ‘fully litigated and decided at the Markman stage of the litigation.’”

Turing to Kauffman’s appeal, the Federal Circuit reversed the denial of prejudgment interest. The district court had reasoned that the jury verdict “subsumed interest” and that Microsoft was prejudiced by [...]

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Wild and Untamed Trademarks: Madrid Protocol Grants Right of Priority as of Constructive Use Date

by Katherine Pappas | Apr 28, 2022 | Trademarks

Addressing for the first time the question of enforceability of a priority of right in a trademark granted pursuant to the Madrid Protocol where the registrant’s actual use in commerce began after the allegedly infringing use, the US Court of Appeals for the Ninth Circuit found that the Madrid Protocol grants priority as of the constructive use date, but to prevail on an infringement action based on that superior right of priority, the registrant must still establish the requisite likelihood of confusion under the Lanham Act. Lodestar Anstalt v. Bacardi & Co., Case No. 19-55864 (9th Cir. Apr. 21, 2022) (Baldock, Berzon, Collins, JJ.)

Under the Madrid Protocol, applicants with trademarks in another country may obtain an “extension of protection” (generally equivalent to trademark registration) in the United States without needing to first use the mark in US commerce. Instead, the grant may be based on an applicant’s declaration of bona fide intent to use its mark in the United States.

In 2000 and 2001, Lichtenstein-based company Lodestar developed a brand of Irish whiskey called “The Wild Geese,” which was marketed in the US as “The Wild Geese Soldiers & Heroes.” Around 2008 and 2009, Lodestar developed the idea for the “Untamed” word marks, and in 2009 the US Patent & Trademark Office (PTO) accepted for filing two applications on behalf of Lodestar seeking extension of protection under the Madrid Protocol for the internationally registered “Untamed” word marks. The PTO published the marks for opposition, then granted the extensions of protection in 2011. In 2013, Lodestar developed a rum under The Wild Geese Soldiers and Heroes brand that used the Untamed word mark on the label. The rum was shown at the April 2013 Rum Renaissance Trade Show in Florida, where consumers sampled the rum. The rum was also featured in print advertisements associated with the trade show. But by June 2013, Lodestar had “decided to park the USA rum project as [it was] getting better returns in other markets.”

In 2012, Bacardi began developing the ad campaign “Bacardi Untameable.” Before launching the campaign, Bacardi ran a trademark clearance search that turned up Lodestar’s “Untamed” trademarks. From 2013 to 2017, Bacardi ran its “Bacardi Untameable” campaign. In response, Lodestar began promoting a then-nonexistent product “Untamed Revolutionary Rum” in an effort “to complement the Wild Geese Rum and also to combat Bacardi’s attempts to take over our Untamed mark.” In January 2015, the first Untamed Revolutionary Rum was sold to US retailers. In August 2016, Lodestar sued Bacardi for trademark infringement, arguing injury based on reverse confusion, as well as associated claims for unfair competition. The district court granted summary judgment in favor of Bacardi. Lodestar appealed.

The Ninth Circuit found that the district court erred on the threshold question of whether Lodestar’s Revolutionary Rum should be considered in the analysis of likelihood of confusion. The district court had found that the relevant products were those existing prior to launch of Bacardi’s campaign (excluding the later-created Revolutionary Rum). The Court found [...]

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