IP UPDATE
Exploring the latest in intellectual property law
IP UPDATE
Exploring the latest in intellectual property law
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No Need To Be Explicit: Implicit Finding of Expectation of Success Is Sufficient

by | Oct 5, 2023 |

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board unpatentability decision, finding that a combination of prior art references only requires an implicit indication of a reasonable expectation of success. Elekta Ltd. v. Zap Surgical Systems, Case No. 21-1985 (Fed. Cir. Sept. 21, 2023) (Reyna, Stoll, Stark JJ.)

Elekta owns a patent directed to a “method and apparatus for treatment by ionizing radiation.” The claimed invention uses a radiation source such as a linear accelerator (linac) mounted on concentric rings to deliver a beam of ionizing radiation to a target area on the patient. Zap challenged the patent as obvious in an inter partes review (IPR) proceeding. In its Final Written Decision, the Board agreed, concluding that a skilled artisan would have been motivated to combine the asserted prior art references. Elekta appealed.

Elekta raised three arguments on appeal:

  1. The Board’s findings on motivation to combine were not supported by substantial evidence.
  2. The Board failed to make any findings (explicit or implicit) on a reasonable expectation of success.
  3. Even if the Board made such findings, they were not supported by substantial evidence.

The Federal Circuit first considered the issue of motivation to combine the prior art references disclosing radiation imagery with references disclosing radiation therapy, noting that the obviousness determination does not always require the prior art to expressly state a motivation for every obviousness combination. Elekta had challenged the asserted combination based on a physical impracticality in combining the art due to the weight of the linac. The Board, however, disagreed largely because of the level of skill in the art in addition to its definition of the relevant field as one that “includes the engineering design of sturdy mechanical apparatuses capable of rotationally manipulating heavy devices.” The Court found that the Board’s finding of motivation to combine was supported by substantial evidence, including the prosecution history, the prior art teaching and the expert testimony of record.

The Federal Circuit next considered Elekta’s argument that the Board erred by failing to articulate findings on reasonable expectation of success. The Court explained that “an obviousness determination requires finding that a person of ordinary skill in the art would have had a reasonable expectation of success,” referring to “the likelihood of success in combining references to meet the limitations of the claimed invention.” The Court concluded, however, that unlike the motivation to combine determination, which must be an explicit analysis under KSR, a finding of reasonable expectation of success may be implicit. The Court acknowledged that this could be seen as being in tension with its review of Board determinations under the Administrative Procedure Act but concluded that “there is no such tension where the Board makes an implicit finding on reasonable expectation of success by considering and addressing other, intertwined arguments, including . . . those [regarding] a motivation to combine.”

Finally, the Federal Circuit addressed Elekta’s argument that, even if the Board made an implicit finding on reasonable expectation of [...]

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Grubhub Relishes Victory Against Trademark Preliminary Injunction

by | Sep 28, 2023 |

Upholding the denial of a preliminary injunction motion in a trademark infringement dispute, the US Court of Appeals for the Seventh Circuit concluded that the district court did not err in finding that the trademark owner failed to show a likelihood of success on its reverse confusion theory. Grubhub Inc. v. Relish Labs LLC, Case No. 22-1950 (7th Cir. Sept. 12, 2023) (Lee, Jackson-Akiwumi, Wood, JJ.)

Relish Labs and the Kroger Company (Home Chef) create and deliver meal kits with pre-portioned ingredients that customers can cook at home. Home Chef began using its “HC Home Mark,” which is protected by five federal trademark registrations, in 2014. Home Chef has spent more than $450 million on advertising and reached $1 billion in annual sales in October 2021.

Grubhub is an online food ordering and delivery service that provides on-demand order management, dispatching and procurement. In June 2021, Grubhub was acquired by Netherlands-based Just Eat Takeaway (JET), an international food delivery company that typically combines its “JET House Mark” with the marks of its local brands.

Before finalizing its acquisition of Grubhub, JET filed an international trademark application for the JET House Mark. However, the US Patent & Trademark Office (PTO) examiner preliminarily rejected the mark, finding it to be “confusingly similar” to the HC Home Mark. JET did not respond and withdrew the application. After acquiring Grubhub, JET adopted the “Grubhub House Logo,” which combined the Grubhub logo with the JET House Mark. Grubhub introduced the new logo in July 2021 and has spent millions of dollars rebranding.

After receiving a cease-and-desist letter from Home Chef, Grubhub sued, seeking a declaratory judgment that its logo did not infringe Home Chef’s marks. Home Chef countered with a motion for preliminary injunction, which was referred to a magistrate judge. The magistrate judge recommended that the court grant Home Chef preliminary injunctive relief, but the district court rejected the recommendation and denied Home Chef’s motion, finding that it had not shown a likelihood of success on the merits. Home Chef appealed.

On appeal, the Seventh Circuit began by addressing which Grubhub mark was at issue: the JET House Mark alone or the Grubhub House Logo (which incorporated the logo portion of the JET House Mark). The Court noted that Grubhub had not used the JET House Mark without the Grubhub brand name in the United States and thus agreed with the district court that the accused mark was the Grubhub House Logo:

Turning next to Home Chef’s reverse confusion theory, the Seventh Circuit addressed the relevant four factors [...]

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Hit Rewind: Analogous Art and Field of Endeavor

by | Sep 21, 2023 |

Addressing the Patent Trial & Appeal Board’s application of the field of endeavor and reasonably pertinent tests for determining analogous art, the US Court of Appeals for the Federal Circuit found that the Board should not have required a petitioner to precisely articulate the relevant field of endeavor for the patent and prior art using the magic words, “field of endeavor.” However, the Court agreed with the Board that the prior art was not reasonably pertinent because it concerned a different problem than the challenge addressed by the patent. Netflix, Inc. v. DivX, LLC, Case No. 22-1138 (Fed. Cir. Sept. 11, 2023) (Stoll, Hughes, and Stark, JJ.)

Netflix filed an inter partes review (IPR) challenging DivX’s patent directed toward a feature called “trick play functionality,” which refers to the ability to fast forward, rewind and skip frames in a multimedia file. The patent’s background explains that the invention generally relates to the “encoding, transmission and decoding of multimedia files.” Notably, the claimed invention implements a multimedia file based on the Audio Video Interleave (AVI) structure with an additional storage structure called an “index chunk.”

In its petition, Netflix asserted that the challenged claims were obvious over two prior art references, Zetts in view of Kaku. Kaku disclosed the use of an AVI file with an index chunk to show image data and/or play sound data in a digital camera. Kaku explained that the invention’s primary object is to reproduce a motion image in a device with minimal memory but clarified that the invention is “applicable to every electronic appliance to reproduce motion images.” Netflix asserted that Zetts disclosed a system for facilitating trick play while Kaku disclosed using an AVI file format with an index chunk to store video/audio data.

In its patent owner response, DivX argued that Kaku was non-analogous art because the challenged patent relates to facilitating trick play in streamed multimedia content, whereas Kaku utilizes M-JPEG files in limited-memory cameras. DivX similarly argued that Kaku was not reasonably pertinent to the problem of “facilitating trick play functionality in streaming services.” Netflix countered that Kaku must be considered for its AVI teachings and/or the “encoding and decoding of multimedia files,” both of which are “applicable to every electronic appliance to reproduce motion images” and render Kaku reasonably pertinent. The Board rejected Netflix’s obviousness argument, holding that it failed to identify the field of endeavor for the DivX patent or Kaku, as well as the problem to be addressed by the DivX patent. Netflix appealed.

The Federal Circuit first considered the Board’s conclusion that Netflix failed to identify an overlapping field of endeavor for Kaku and the DivX patent. The Court explained that the field of endeavor is determined by reference to explanations of the invention’s subject matter in the specification and is not limited to the specific point of novelty or the particular focus within a field. Rather, a field of endeavor may be broadly defined because it relies on the specification’s complete disclosure. Applying this principle, the [...]

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Less Is More: IPR Claim Amendments May Not Enlarge Claim Scope

by | Sep 14, 2023 |

The US Court of Appeals for the Federal Circuit affirmed a decision from the Patent Trial & Appeal Board denying a motion to amend claims during an inter partes review (IPR) proceeding, explaining that a claim amendment is improper if a proposed claim is broader in any respect relative to the original claims, even if it is overall narrower. Sisvel International S.A. v. Sierra Wireless, Inc., et al., Case Nos. 22-1387; -1492 (Fed. Cir. Sept. 1, 2023) (Prost, Reyna, Stark, JJ.)

Sisvel owns two patents directed to methods and apparatuses that rely on the exchange of frequency information in connection with cell reselection between a mobile station (or user cell phone) and a central mobile switching center. Sierra Wireless filed petitions for IPR alleging that claims of Sisvel’s patents were unpatentable as anticipated and/or obvious in view of certain prior art. During the IPR proceeding, the Board determined that the claim term “connection rejection message” should be given its plain and ordinary meaning of “a message that rejects a connection.”

The Board also denied Sisvel’s motion to amend the claims of one of the patents, finding that the amendments would have impermissibly enlarged the claim scope. the Board focused on a limitation relating to “setting a value,” comparing the original claims’ requirement with that of the proposed substitute claims. The original claims required that the value be set “based at least in part on information in at least one frequency parameter” of the connection rejection message while the substitute claims recited that the value may be set merely by “using the frequency parameter” contained within the connection rejection message. The Boeasoneasoned that in the proposed substitute claim, the value that is set need not be based on information in the connection rejection message, and thus the claim was broader in this respect than the original claims. After denying the motion to amend, the Board concluded that the original claims were unpatentable. Sisvel appealed.

Sisvel challenged the Board’s construction of “connection rejection message,” arguing that the term should be limited to a message from the specific cellular networks disclosed in the specification. The Federal Circuit rejected Sisvel’s argument, finding that the intrinsic evidence provided no persuasive basis to limit the claims to any particular cellular network disclosure. Having agreed with the Board’s construction, the Court affirmed the unpatentability determination.

Sisvel also challenged the Board’s refusal to permit Sisvel to amend the claims. Sisvel argued that the Board had incorrectly found that the proposed substitute claims were broader than the original claims because when all the limitations were considered as a whole, the scope of the substitute claims was narrower than the original claims.

Citing 35 U.S.C. § 316(d)(3), the Federal Circuit noted that when a patent owner seeks to amend its claims during an IPR, the amended claims “may not enlarge the scope of the claims of the patent.” The Court explained that removal of a claim requirement can broaden the resulting amended claim and concluded that such was the case [...]

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Sins of the Fathers? Grandparent IPR Factors into Current Institution Decision

by | Sep 7, 2023 | ,

US Patent & Trademark Office (PTO) Director Kathi Vidal vacated and remanded a Patent Trial & Appeal Board decision denying institution of an inter partes review (IPR) because the Board improperly applied the precedential Advanced Bionics framework in rendering its decision. Keysight Tech., Inc. v. Centripetal Networks, Inc., IPR2022-01421 (PTAB Decision Review Aug. 24, 2023) (Vidal, Dir.)

Keysight Tech. petitioned for an IPR proceeding against a patent owned by Centripetal Networks, challenging the validity of all claims. After the Board denied institution, Director Vidal issued a sua sponte director review decision, vacating and remanding the Board’s decision.

The Centripetal patent is the great-grandchild of, and shares the same disclosure as, an earlier Centripetal patent that was subject to an IPR proceeding during the pendency of the presently challenged patent. The Final Written Decision (FWD) in the earlier IPR found all claims of the patent unpatentable. The patent owner included that FWD in an Information Disclosure Statement (IDS) submitted during the prosecution of the presently challenged patent, and the examiner initialed it as having been considered.

In its decision denying institution, the Board cited the guidance of Advanced Bionics, which articulates a framework that requires that the Board determine the following:

  • Whether the same or substantially the same prior art or arguments made in the petition were previously presented to the PTO during prosecution of the challenged patent
  • Whether the PTO erred in a manner material to the patentability of the challenged claims when it allowed the claims of the patent.

If both factors are met in the affirmative, the Board should not exercise its discretion to deny institution.

Here, the Board found that the first factor of the Advanced Bionics framework was met because the petitioner’s arguments in its petition were the same or substantially the same as those in the FWD in the IPR of the grandparent patent. However, the Board found that the second part of the framework was not satisfied and therefore denied institution.

Although Director Vidal agreed with the Board’s findings under the first factor, she vacated the Board’s findings pursuant to the second factor after determining that this factor was also met. Director Vidal found that the PTO erred in a manner material to the patentability of the challenged claims for the following reasons:

  • The challenged patent and the grandparent were directed to the same subject matter.
  • The prior art references submitted to the PTO during the prosecution of the challenged patent were the same as those asserted in earlier IPR and were considered by the examiner through the patent owner’s IDS.
  • In the grandparent IPR, the Board held all of the claims of the patent unpatentable due to these same prior art references.
  • The examiner’s statement of reasons for allowing the challenged patent was that the claims were directed to limitations that appeared in both the currently challenged claims and the claims found unpatentable in the grandparent patent.

As the director noted, the overlap between the claim limitations in the [...]

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Nothing Lost in Translation: Book’s Spanish Version Isn’t Different Creative Work

by | Aug 31, 2023 |

In a precedential opinion, the Trademark Trial & Appeal Board of the US Patent & Trademark Office upheld an examiner’s refusal to register a trademark on the ground that the proposed mark was the title of a single creative work and therefore did not function as a trademark. In re Douglas Wood, Serial No. 88388841 (TTAB, Aug. 15, 2023) (Adlin, Larkin, English, ATJs).

Douglas Wood sought to register the standard-character mark CHURCH BOY TO MILLIONAIRE for goods ultimately identified as “Books in the field of faith-based coaching, personal development, motivational and inspirational topics; books in the nature of memoirs; books about personal development; printed matter in the field of personal development, namely, books, booklets, curricula, newsletters, magazines, printed periodicals.” Since the title of a single book cannot be registered as a trademark, in support of the application Wood stated that the proposed mark was used on two separate books, an English-language book titled Church Boy to Millionaire and a Spanish-language book titled De Chico de Iglesia a Millonario. According to Wood, he published two books of different titles that had been marketed under the same mark as evidenced by use on his website.

The examining attorney refused registration, finding that the mark was the title of a single creative work and thus did not function as a trademark. Wood appealed.

The Board determined that Church Boy to Millionaire was the title of a single work, and that the book’s Spanish translation did not qualify as a separate work that might create a “series” entitled to trademark protection. The Board explained that “[t]he title of a single creative work, such as a book, is not considered to be a trademark, and is therefore unregistrable.” The Board further differentiated trademarks from copyrights, explaining that “[u]nlike a copyright that has a limited term, a trademark can endure for as long as the trademark is used. Therefore, once copyright protection ends, and the work falls in the public domain, others must have the right to call the work by its name.”

Wood argued that Church Boy to Millionaire and its Spanish translation, De Chico de Iglesia a Millonario, were different works since the choice of the translator had a large impact on the version created. The Board explained that the issue was whether the content “has change[d] significantly” in translation. The Board acknowledged that translators can employ their unique skills and cultural understandings to produce different content for a book in another language. However, the examining attorney showed that Wood did not provide any evidence that the Spanish version had content that significantly differed from the English version. On the contrary, the evidence of use contradicted Wood’s position that the Spanish translation featured different content because his website’s links directed customers to “get the book today” and “get the book in Spanish,” which effectively confirmed [...]

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Don’t Be So Stern: Copying Carries Significant Weight in Assessing Objective Evidence

by | Aug 31, 2023 |

The US Court of Appeals for the Federal Circuit vacated and remanded a Patent Trial & Appeal Board decision invalidating a patent, finding that the Board erred in assessing nexus and weight to be accorded to objective evidence of nonobviousness. Volvo Penta of the Americas, LLC v. Brunswick Corp., Case No. 22-1765 (Fed. Cir. Aug. 24, 2023) (Moore, Lourie, Cunningham, JJ.)

Volvo Penta owns a patent directed to a tractor-type stern drive for a boat. A stern drive is a type of engine that is mounted in the hull of a boat and connected to a drive unit mounted outside of the hull, typically on the stern. In the industry, this arrangement is often referred to as an inboard/outboard drive. In 2015, Volvo Penta launched its commercial embodiment of the patent called the Forward Drive and was popular particularly for wake surfing and other water sports. The Forward Drive included forward-facing propellers that increased the distance between the propeller and swimmers or surfers compared to prior pulling-type stern drive boats.

In August 2020, Brunswick launched its own drive, the Bravo Four S, which embodies Volvo Penta’s patent. On that same day, Brunswick filed a petition for inter partes review asserting that the challenged claims were anticipated or obvious based on several references, two of which were Kiekhaefer and Brandt. In response, Volvo Penta argued that a person of ordinary skill in the art would not have been motivated to combine Kiekhaefer and Brandt with a reasonable expectation of success and that the objective indicia of nonobviousness overcame any prima facie case of obviousness. In support, Volvo Penta offered evidence of copying, industry praise, commercial success, skepticism, failure of others and long-felt but unsolved need. Volvo Penta also argued that it was entitled to a presumption of nexus between the objective indicia and the claimed invention, and, even if there was no presumption, there was still nexus.

The Board found that Kiekhaefer did not anticipate the challenged claims, but it would have been obvious to redesign the stern drive of Brandt in light of Kiekhaefer’s outboard motor to arrive at the challenged claims. After finding a motivation to combine (and prima facie obviousness), the Board turned to Volvo Penta’s objective evidence of nonobviousness. The Board first determined that Volvo Penta was not entitled to a presumption of nexus because, even though the Forward Drive and Bravo Four S indisputably embody the challenged claims, Volvo Penta did not make sufficient arguments on coextensiveness. The Board also found that regardless of the presumption, Volvo Penta did not otherwise show nexus because it failed to identify the “unique characteristics” or “merits” of the claimed invention.

Despite finding no nexus, the Board still analyzed the objective evidence and concluded that Volvo Penta’s objective evidence weighed somewhat in favor of nonobviousness but that Brunswick’s strong evidence of obviousness outweighed the objective evidence. The Board therefore concluded that the challenged claims were unpatentable. Volvo Penta appealed.

Volvo Penta raised three primary arguments on appeal:

  1. The Board’s [...]

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No Two Ways About It: No Disparagement ≠ Teaching Away, Free Samples ≠ Commercial Success

by | Aug 31, 2023 |

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board invalidating two patents: one as anticipated because disclosure of a genus anticipated the claimed species, and the other as obvious because the prior art did not disparage the claimed invention and therefore was not a “teaching away.” The Court also found that free samples cannot be used to show commercial success. Incept LLC v. Palette Life Sciences, Inc., Case Nos. 21-2063; -2065 (Fed. Cir. Aug. 16, 2023) (Schall, Taranto, JJ.) (Newman, J., concurring in part, dissenting in part).

Incept owns two patents related to improved methods for treating cancer, particularly prostate cancer, using radiation. The patents describe methods of introducing a filler between a radiation-targeted tissue and other tissue to increase the distance between the two and thereby decrease the amount of radiation received by the non-targeted tissue. Palette filed inter partes review petitions against each patent, asserting that the claims of one patent were anticipated and the claims of the other were obvious. Both theories of invalidity relied on the same prior art reference, Wallace. The Board instituted review and ultimately found both patents unpatentable. Incept appealed.

As to the patent that the Board found anticipated, Incept argued that the Board erred legally by “picking and choosing” from the teachings of Wallace to piece together elements. Incept argued that Wallace teaches a genus of millions to billions of possible compositions while its patent claims a species. Thus, according to Incept, the genus had to be defined well enough that a person of ordinary skill could have envisioned each member of the genus.

The Federal Circuit found no legal error in the Board’s anticipation analysis. The Court rejected Incept’s assertion that its patent claimed a species, finding that the patent described a method to inject a composition that had the same general properties as the composition described in Wallace. The Court also found that the Board’s conclusion that Wallace taught biodegradable compositions (where Wallace stated that “a portion of the polymer may be biodegradable”) was supported by substantial evidence and noted that it was not the Court’s duty to reweigh factual determinations.

As to the Board’s obviousness finding of the other patent, Incept alleged that the Board improperly reiterated its anticipation analysis, disregarded statements in Wallace that teach away, did not separately analyze the dependent claims and disregarded evidence of commercial success. The Court was unpersuaded by any of these arguments.

First, the Federal Circuit noted that since the anticipation analysis had no error, it was not improper for the Board to rely upon that analysis for its obviousness determination. The Court noted that the Board relied on the teachings of another piece of prior art concerning the challenged patent’s displacement limitation. The Court also dismissed Incept’s allegation that the motivation to combine analysis was conclusory.

The Federal Circuit rejected Incept’s assertion that Wallace taught away from biodegradable compositions, noting that Wallace provided a preference for an alternative but did not criticize, discredit or [...]

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Disgorgement of Profits Appropriate Remedy for Breach of Contract, Trademark Infringement

by | Aug 24, 2023 |

In a trademark infringement and breach of contract case involving real estate companies with a shared name, the US Court of Appeals for the Fourth Circuit affirmed summary judgment in favor of the trademark owner, including almost $43 million in profit disgorgement. Dewberry Engineers v. Dewberry Group, Case Nos. 22-1622; -1845 (4th Cir. Aug. 9, 2023) (Gregory, Thacker, JJ.) (Quattlebaum, J., dissenting).

Dewberry Engineers and Dewberry Group (formerly Dewberry Capital) operate in the same states, and both provide commercial real estate services. Dewberry Engineers started in the mid-1950s as a civil engineering and surveying firm in northern Virginia. Over time, its business expanded to include real estate development services such as architecture and site development. Dewberry Group similarly provides real estate development services through its affiliates, including the Dewberry Hotel in Charleston, South Carolina.

In 2006, Dewberry Group sent Dewberry Engineers a cease-and-desist letter, asserting that Dewberry Group had “senior common law rights” to use “Dewberry” in real estate. In response, Dewberry Engineers sued Dewberry Group for infringing its federally registered DEWBERRY trademark. That litigation ended in 2007 when the parties entered a confidential settlement agreement (CSA). Among other things, the CSA stated that Dewberry Group:

  • Would not challenge Dewberry Engineers’ trademark registrations
  • Could use its “Dewberry Capital” name except in enumerated geographical areas where it instead must use “DCC”
  • Would use no logo other than its “column” logo.

In 2017, Dewberry Group rebranded and attempted to register DEWBERRY GROUP and other marks, which the US Patent & Trademark Office (PTO) repeatedly rejected.

In 2020, Dewberry Engineers filed suit claiming breach of contract and trademark infringement under the Lanham Act and Virginia common law. The district court granted summary judgment to Dewberry Engineers on the contract claim, finding that Dewberry Group had violated the unambiguous CSA by changing its logo, among other offenses. The district court also granted summary judgment to Dewberry Engineers on its trademark infringement claim, finding that Dewberry Engineers’ mark was not only valid, it was incontestable since it had been in continuous use for more than five years. The district court also found that the likelihood-of-confusion factors favored infringement. The district court entered a permanent injunction against Dewberry Group’s use of “Dewberry” and granted Dewberry Engineers its attorneys’ fees and profit disgorgement. Because the court believed the tax information Dewberry Group provided did not show the true “economic reality” of the close relationship between Dewberry Group and its affiliates, the disgorgement calculation also included some of Dewberry Group’s affiliated companies’ profits. Dewberry Group appealed, challenging the summary judgment grant, the permanent injunction and the monetary awards.

The Fourth Circuit began by noting that there was “uncontroverted evidence” that Dewberry Group used the DEWBERRY trademark, used a logo other than its column logo and failed to use “DCC” in restricted areas, all in breach of the undisputedly valid CSA. The Court therefore affirmed the district court’s finding that Dewberry Group breached the CSA.

The Fourth Circuit next addressed the trademark infringement claim. The Court rejected [...]

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Tune to the Right Channel: Disclosure Lacking Fraud Information Isn’t an FCA Qui Tam Bar

by | Aug 17, 2023 |

The US Court of Appeals for the Ninth Circuit reversed a district court’s decision to dismiss a qui tam action brought under the False Claims Act (FCA) after analyzing the public disclosure bar channels. The case required the Ninth Circuit to examine Congress’s 2010 amendments to the FCA public disclosure bar to determine whether the claims were substantially the same as information publicly disclosed in any one of three enumerated channels. Silbersher v. Valeant Pharm. Int’l, Inc., No. 20-16176 (9th Cir. Aug. 3, 2023) (Schroeder, Sanchez, Antoon, JJ.)

The FCA imposes civil liability on anyone who knowingly presents a fraudulent claim for payment to the federal government. The FCA includes a qui tam provision that allows private citizens (or “relators”) to bring fraud claims on behalf of the government. In 2010, Congress’s public disclosure bar precluded qui tam actions if substantially the same allegations or transactions were publicly disclosed in one of three channels:

  1. In a federal criminal, civil or administrative hearing in which the government or its agent is a party
  2. In a congressional, Government Accountability Office (GAO) or other Federal Report hearing, audit or investigation
  3. From the news media, unless the action is brought by the Attorney General or the person bringing the action is an original source of the information.

Valeant owns the “Otterbeck patents” for its drug Apriso’s delayed-release formula. Valeant initiated an infringement action against Lupin, a generic drug manufacturer that attested in an abbreviated new drug application (ANDA) that the Otterbeck patents were invalid because of prior art that described a similar delayed-release formula. Thereafter, Valeant extended its monopoly by applying for and being granted a new patent that claimed a recent discovery that Apriso was effective when taken without food. GeneriCo then challenged the new patent in an inter partes review (IPR) proceeding, arguing that it was obvious that Apriso would be effective without food. GeneriCo presented two medical studies as support. The Patent Trial & Appeal Board agreed and invalidated the claims in the new patent.

Zachary Silbersher, GeneriCo’s IPR lawyer and a relator in another FCA suit in the same court, discovered that Valeant failed to disclose certain information to the US Patent &Trademark Office (PTO) during the IPR proceeding. Specifically, he discovered that three years before applying for the new patent, Valeant applied for another patent where it claimed it made an unexpected finding that taking Apriso’s active ingredient with food made the drug more effective. This claim was the opposite of the claim made in the new application that had been invalidated in the IPR proceeding.

Silbersher brought an FCA case seeking damages from Valeant, alleging that Valeant fraudulently obtained the Otterbeck and new patent to prolong its monopoly and charge an artificially high price for Apriso. The district court dismissed Silbersher’s qui tam action as precluded by the public disclosure bar because the IPR qualified as an “other Federal hearing” under channel two of the bar, as described above. Silbersher appealed.

The Ninth Circuit analyzed whether [...]

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