IP UPDATE
Exploring the Latest in Intellectual Property Law
IP UPDATE
Exploring the Latest in Intellectual Property Law
Results for "Patent application"
Subscribe to Results for "Patent application"'s Posts

Stay in the Know: Informational Message Is Not a Source Identifier

by | Feb 1, 2024 |

Addressing whether the mark EVERYBODY VS. RACISM was registrable, the US Court of Appeals for the Federal Circuit affirmed the Trademark Trial & Appeal Board’s final refusal to register the mark because it failed to function as a source identifier. In re: GO & Assoc., LLC, Case No. 22-1961 (Fed. Cir. Nov. 13, 2023) (nonprecedential) (Fed. Cir. Jan. 22, 2024) (precedential) (Lourie, Reyna, Hughes, JJ.)

On June 2, 2020, GO & Associates filed a trademark application seeking registration on the principal register of EVERYBODY VS. RACISM, identifying the goods and services as various apparel “promoting public interest and awareness of the need for racial reconciliation and encouraging people to know their neighbor and then affect change in their own sphere of influence.”

In a non-final office action, the examining attorney refused to register the mark, asserting that it “failed to function as a source identifier for GO’s goods and services.” The examiner noted that the mark “merely convey[ed] support of, admiration for, or affiliation with the ideals conveyed by the message.” The examiner presented examples of the mark being used in informational settings, such as by referees in the National Basketball Association; in YouTube videos; on clothing; and in titles of rap songs, podcasts and church sermons. Although GO presented evidence that the mark had hardly been used or searched prior to its use in May 2020, the examining attorney continued to reject the application. The examiner found that “the ornamental uses of the mark only reinforced the fact that consumers would likely view the mark as a sentiment rather than a source.” The examiner also noted that the applicant’s first use of the mark coincided with the “general timeline of the heated anti-racism protests throughout the nation in the wake of the George Floyd killing.”

GO appealed to the Board. The Board found “that the record as a whole show[ed] wide use of the proposed mark in a non-trademark manner to consistently convey an informational, anti-racist message to the public, as opposed to a source identifier of GO’s goods and services,” and affirmed the examiner’s refusal to register the mark. GO appealed to the Federal Circuit.

Affirming the Board’s decision, the Federal Circuit emphasized that the threshold requirement for the issuance of a mark is whether it is source identifying: “what makes a trademark a trademark under the Lanham Act is its source-identifying function.” The mark must identify the source for the public and distinguish that source from others.

The Federal Circuit noted that whether a mark is source identifying depends on “how the mark is used in the marketplace and how consumers perceive it.” In particular, the US Patent & Trademark Office prohibits registering marks that it calls “informational matter” (i.e., “slogans, terms, and phrases used by the public to convey familiar sentiments, because consumers are unlikely to perceive the matter as a trademark or service mark for any goods and services”). Reviewing the Board’s findings for substantial evidence, the Court found that the Board properly weighed the [...]

Continue Reading



read more

Resorting to Extrinsic Evidence Is Necessary When Intrinsic Evidence Is Muddied

by | Nov 16, 2023 |

The US Court of Appeals for the Federal Circuit determined that the limitation “a pH of 13 or higher” could not be construed using the asserted patents’ intrinsic evidence and therefore remanded to the district court with instructions to consider the extrinsic evidence and its impact on claim construction. Actelion Pharms. Ltd v. Mylan Pharms. Inc., Case No. 22-1889 (Fed. Cir. Nov. 6, 2023) (Reyna, Stoll, Stark, JJ.)

Mylan Pharmaceuticals sought market entry for its generic epoprostenol—a small molecule hypertension drug—via an abbreviated new drug application (ANDA). Mylan certified under Paragraph IV with respect to two Orange Book-listed patents that Actelion Pharmaceuticals owned. Actelion timely asserted both patents and achieved a favorable claim construction for the term “a pH of 13 or higher.” This limitation is central to the pharmaceutical breakthrough that the asserted patents disclose, which is stably solubilizing the otherwise unstable epoprostenol. The asserted patents teach that epoprostenol bulk solutions’ pH should preferably be adjusted to about 12.5 to 13.5. Mylan contended that this language meant the claim should not encompass anything below pH 13 (i.e., leaving only a fraction of the disclosure’s preferred range within the scope of the issued claims). The district court disagreed, adopting Actelion’s position that the limitation encompassed values that “rounded” to pH 13 (i.e., pH 12.5 and above). This prompted a stipulated infringement judgment. Mylan appealed.

The Federal Circuit reviewed the district court’s construction de novo, explaining that the district court’s construction was a ruling as a matter of law because no extrinsic evidence was considered. The Court then examined the claim language, specifications and prosecution histories in turn.

Regarding the claim language, the Federal Circuit rejected the parties’ invitations to acknowledge certain prior decisions as articulating bright-line rules. Instead, the Court appeared to endorse analyzing the intrinsic evidence on a case-by-case basis when construing similar range limitations. For example, the Court explained that “there is no blanket rule that ranges, or specifically open-ended ranges, must foreclose rounding.” The Court also rejected the following rules concerning range precision:

  • Avoiding rounding requires terms of precision, such as “precisely” or “exactly.”
  • The absence of approximation language dictates a precise value.

In contrast, the Federal Circuit signaled that district courts should properly account for a range’s technical implications (or at least ranges concerning the pH scale) even if that means looking to extrinsic evidence.

Regarding the specifications and prosecution histories, the Federal Circuit disagreed with the district court’s finding that both were inconsistent with Mylan’s position that the disputed limitation reflected a higher degree of precision. The Court concluded that there was little to glean from either, finding that the specifications were as clear as “muddied water” and the prosecution histories provided no insight into the relevant pH range—between pH 12 and pH 13.

The Federal Circuit ultimately concluded that this was an instance in which properly construing a claim limitation required the aid of extrinsic evidence, invoking the Supreme Court of the United States’ guidance from Teva v. Sandoz that extrinsic evidence [...]

Continue Reading



read more

Still Exceptional: Fee-Shift Appropriate in View of Noninfringement Stipulation

by | Nov 16, 2023 |

In a split decision, the US Court of Appeals for the Federal Circuit affirmed a district court’s award of more than $5 million in attorneys’ fees, finding that the district court did not abuse its discretion in finding the underlying case “exceptional” under 35 U.S.C. § 285 or in calculating the total fees awarded. In re PersonalWeb Tech., Case No. 21-1858 (Fed. Cir. Nov. 3, 2023) (Reyna, Lourie, JJ.) (Dyk, J., dissenting).

Under 35 U.S.C. § 285, a “court in exceptional cases may award reasonable attorney fees to the prevailing party.” In Octane Fitness (2014), the Supreme Court of the United States held that an exceptional case is “simply one that stands out from others with respect to the substantive strength of a party’s litigating position (considering both the governing law and the facts of the case) or the unreasonable manner in which the case was litigated,” and the court considers the totality of the circumstances in making this determination.

PersonalWeb’s litigation positions at issue date back to 2011, when PersonalWeb first asserted five patents against an e-commerce company. After an unfavorable claim construction ruling, PersonalWeb stipulated to dismiss the action, and the district court entered the dismissal with prejudice.

In 2018, PersonalWeb asserted the patents against customers of the e-commerce company. The e-commerce company intervened and filed a new action against PersonalWeb seeking a declaratory judgment to bar the infringement actions against the customers based on the 2011 dismissal. Some of the cases proceeded while others were stayed. The district court granted summary judgment against PersonalWeb on claims directed to two allegedly infringing products for two separate reasons: because of the Kessler doctrine and claim preclusion, and because PersonalWeb conceded that it could not prevail after an unfavorable claim construction order.

The district court also entered an award of attorneys’ fees and costs against PersonalWeb, finding the case to be “exceptional” for the following reasons:

  • The infringement claims were “objectively baseless and not reasonable when brought because they were barred due to a final judgment in the [2011 action].”
  • PersonalWeb frequently changed its infringement positions to overcome the hurdle of the day.
  • PersonalWeb unnecessarily prolonged this litigation after claim construction foreclosed its infringement theories.
  • PersonalWeb’s conduct and positions regarding the customer cases were unreasonable.
  • PersonalWeb submitted declarations that it should have known were inaccurate.

The district court calculated the attorneys’ fees to be more than $5 million and costs to be more than $200,000. PersonalWeb appealed.

PersonalWeb argued that the district court erred in awarding fees and, even if fees were warranted, the court erred in assessing almost $2 million of the $5 million award. The Federal Circuit found that the district court did not abuse its discretion in any of its findings related to the fee grant, agreeing with the district court’s application of the Kessler doctrine. In Kessler, the Supreme Court ruled that after a final judgment of noninfringement, follow-up suits by the same patentee over the same non-infringing product against customers of the party [...]

Continue Reading



read more

See Here: No Standing Based on Vague Future Plans or Adverse Priority Findings

by | Nov 16, 2023 |

The US Court of Appeals for the Federal Circuit dismissed an appeal from a final written decision in an inter partes review (IPR) proceeding, finding that the petitioner lacked standing because it suffered no injury in fact. Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLC, Case No. 22-1706 (Fed. Cir. Nov. 7, 2023) (Moore, Stoll, Cunningham, JJ.)

Allgenesis Biotherapeutics filed an IPR petition challenging a patent owned by Cloudbreak Therapeutics. The challenged patent discloses compositions and methods for treating the eye condition pterygium. During the IPR proceeding, Cloudbreak disclaimed all but two of the claims. The Patent Trial & Appeal Board issued a final written decision finding that Allgenesis failed to show that the remaining two claims were unpatentable. As part of its decision, the Board made a priority decision that a Patent Cooperation Treaty (PCT) application belonging to Allgenesis was not prior art to Cloudbreak’s patent. Allgenesis appealed.

Article III of the US Constitution limits the Federal Circuit’s jurisdiction to adjudication of “cases” or “controversies,” which means the appellant must have (1) suffered an injury in fact (2) that is fairly traceable to the challenged conduct of the defendant and (3) likely to be redressed by a favorable judicial decision.

Allgenesis attempted to establish Article III standing based on two separate arguments. First, Allgenesis argued that it had standing based on potential infringement liability. To support that argument, Allgenesis offered a declaration by its vice president of finance that included information about a Phase II trial completed three years prior and a related 2020 publication. That declaration, however, did not identify any specific plan to conduct a Phase III trial or to seek US Food and Drug Administration (FDA) approval, and instead only contained generic statements that the project was not abandoned. While Allgenesis’s briefing and oral argument included statements that it planned to engage in a Phase III trial, the Federal Circuit determined that there was no record support for this claim. The Court found that the evidence before it did not constitute the necessary concrete plans to convey standing to appeal the final written decision. Allgenesis also attempted to rely on its own failed attempts at seeking a settlement from Cloudbreak, but the Court concluded that this was insufficient to show a substantial risk of infringement.

Allgenesis’s second argument was that the Board’s priority decision created an injury in fact. Allgenesis argued that the Board’s determination about the priority date of Cloudbreak’s patent affected Allgenesis’s patent rights because it would have a preclusive effect on Allgenesis’s pending applications. The Federal Circuit was unpersuaded and explained that collateral estoppel does not attach to a non-appeal priority decision from an IPR decision. To the extent that an examiner did reach the same conclusion as the Board, Allgenesis would be free to appeal that decision.

Practice Note: For Board petitioners seeking to establish standing to appeal unfavorable final written decisions, it is necessary to develop sufficient support to show standing in fact. For life sciences companies working in drug development, declarations [...]

Continue Reading



read more

Downloaded: No Relief From Stipulated Claim Construction

by | Oct 26, 2023 |

The US Court of Appeals for the Federal Circuit ruled that a claim interpretation that flows naturally from the parties’ stipulated claim construction is binding on the parties even if the interpretation reads preferred embodiments out of the claims. Finjan LLC v. SonicWall, Inc., Case No. 22-1048 (Fed. Cir. Oct. 13, 2023) (Reyna, Cunningham, JJ.) (Bryson, J., dissenting).

In 2017, Finjan sued SonicWall for infringing several of Finjan’s patents related to cybersecurity technology systems that identify malicious material in downloadable content and programming code. The asserted patents included claims directed to ways to protect network-connectable devices from undesirable downloadable operations. During claim construction, the parties stipulated that a “downloadable” should be construed as “an executable application program, which is downloaded from a source computer and run on the destination computer.”

SonicWall moved for summary judgment, arguing that it did not infringe the patents because the accused devices received and inspected supposed “downloadables” as unextracted packets, which do not constitute executable files under the stipulated claim construction. The district court granted partial summary judgment in favor of SonicWall, finding that Finjan failed to offer evidence that “the accused […] products ‘ever possess a reassembled file or executable application.’” Finjan appealed.

Finjan argued that the district court’s ruling was incorrect because it impermissibly grafted additional requirements onto the stipulated claim construction, and that the district court’s interpretation was inconsistent with claim language found in other parts of the asserted patents. The Federal Circuit rejected these arguments, noting that the district court’s infringement ruling followed directly from the parties’ stipulated definition of the term “downloadables.” Under the stipulated claim construction and in accordance with Finjan’s own expert’s interpretation of the meaning of “executable,” a device “that merely receives and forwards packets without reassembling their contents does not receive a downloadable . . . because that device does not receive an executable application program.” The Court emphasized that Finjan could not challenge its earlier claim construction stipulation. Further, the Court noted that the stipulated definition of “downloadables” was derived verbatim from the specifications of two of the asserted patents.

Judge Bryson dissented for two reasons. First, he noted that the district court’s interpretation of the claims would read preferred embodiments out of the patent and effectively eviscerate from the patent’s scope any device that screens content from the internet. Second, Judge Bryson found that elsewhere in the asserted patents’ specifications it was clear that the meaning of “downloadables” used by the district court was incorrect. Contrary to the majority, Judge Bryson did not find the stipulated claim construction dispositive because Finjan merely challenged the meaning of the word “executable” within the stipulated claim construction, rather than the contents of the stipulation itself.

Practice Note: This decision offers a few helpful lessons for practitioners. First, it is important to write claims in language that is both expansive enough to encompass all intended embodiments but precise enough to survive invalidity challenges. By carefully selecting specific but broad language, and writing claims more accurately, patentees may avoid semantic noninfringement arguments. [...]

Continue Reading



read more

A Matter of Style: No Need to Select “Primary” Reference in Obviousness Challenge

by | Oct 19, 2023 |

The US Court of Appeals for the Federal Circuit affirmed an obviousness decision by the Patent Trial & Appeal Board, explaining that nothing requires a petitioner to identify a prior art reference as a “primary reference” in an obviousness challenge. Schwendimann v. Neenah, Inc., Case Nos. 22-1333; -1334; -1427; -1432 (Fed. Cir. Oct. 6, 2023) (Prost, Clevenger, Cunningham, JJ.)

Jodi Schwendimann filed lawsuits accusing Neenah of infringing several patents related to transfer sheets and methods for transferring images onto dark fabrics. Neenah filed several petitions for inter partes review (IPR) challenging various claims based on obviousness. The Board instituted the IPR challenges.

Schwendimann’s patents addressed a method for ensuring that dark images could be seen when transferred onto dark fabrics. Multilayer image transfer sheets were known in the prior art, teaching a two-step process to first apply a light background onto dark fabric and then apply the dark image on top. Schwendimann’s claims described a single-step solution, incorporating a white background, possibly of titanium dioxide, into the image transfer sheet so that a white background and dark image could be applied simultaneously onto a dark fabric.

All of the IPR petitions cited Kronzer as a prior art reference. Kronzer described multilayered image transfer sheets with varying configurations, although it lacked white pigment in a layer to transfer an image onto dark fabric. Another prior art reference, Oez, taught the use of a white pigment, such as titanium dioxide, in multilayered image transfer sheets. Schwendimann did not dispute that Kronzer and Oez taught or suggested all limitations recited in the challenged claims. Instead, she argued that there was no motivation for a skilled artisan to combine the references or to expect that such combination would yield a reasonable expectation of success. The Board considered and addressed each argument, relying on Neenah and Schwendimann’s experts’ testimony and the complementary and compatible nature of the references. The Board found the challenged claims obvious over Kronzer in view of Oez. Schwendimann appealed.

Schwendimann argued that substantial evidence did not support the Board’s findings that a skilled artisan would have been motivated to combine Kronzer and Oez and would have had a reasonable expectation of success in making the proposed combination. The Federal Circuit explained that substantial evidence means “such relevant evidence as a reasonable mind might accept as adequate to support a conclusion” and considered these two arguments together.

The Federal Circuit found that Schwendimann failed to show that the Board’s findings were not supported by “substantial evidence.” Like the Board, the Federal Circuit used both expert witnesses’ testimonies to explain that the references shared a common goal of improving image transfer characteristics. The Court found that Schwendimann’s arguments that Oez taught away from the proposed combination failed because Oez’s disclosure did not discourage a skilled artisan from using white pigment identified in the challenged patents or lead the skilled artisan in a direction divergent from the path taken in the challenged patents. Her argument that adding titanium dioxide into Kronzer’s transfer sheets could [...]

Continue Reading



read more

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 from its [...]

Continue Reading



read more

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 [...]

Continue Reading



read more

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 that [...]

Continue Reading



read more

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 [...]

Continue Reading



read more

BLOG EDITORS

Paul Devinsky

Amol Parikh

STAY CONNECTED

Subscribe

TOPICS

ARCHIVES