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New Patent Eligibility Bill May Impact What Subject Matter Is Patentable

by | Aug 18, 2022 |

On August 2, 2022, Senator Thom Tillis (R-NC) introduced the Patent Eligibility Restoration Act of 2022. Senator Tillis’s bill addresses patent subject matter eligibility by modifying 35 U.S.C. § 101 to mitigate areas in which it has been considered problematic in view of recent judicial decisions/exceptions construing it while retaining its core features. For some in the biotechnology space, “problematic” Supreme Court decisions have included May Collaborative Services (2012), Myriad Genetics (2013), Alice Corp. (2014) and their Federal Circuit progeny.

The core features for eligibility will remain in the statute as: “[w]hoever invents or discovers any useful process, machine, manufacture, or composition of matter, or any useful improvement thereof, may obtain a patent therefore.”

The bill provides express exceptions, including:

  • A mathematical formula, apart from useful invention or discovery
  • An unmodified human gene, as that gene exists in the human body
  • An unmodified natural material, as that material exists in nature.

However, the bill further states that genes or natural material that are “purified, enriched, or otherwise altered by human activity, or otherwise employed in a useful invention or discovery,” would not be considered unmodified and would be eligible for patents. One of the goals of the bill is to override case law that has made it  difficult to receive patents on diagnostics inventions and otherwise blurred the line between what inventions are considered abstract.

Processes that are excluded from eligibility under the bill include:

  • Nontechnological economic, financial, business, social, cultural or artistic processes
  • Mental processes performed solely in the human mind
  • Processes occurring in nature wholly independent of, and prior to, any human activity.

Under current law, the question of what constitutes a technological solution that would render an otherwise abstract idea patent eligible is a hotly contested one often determined on a case-by-case basis. The European Patent Convention’s eligibility exclusions include presentations of information and mathematical methods. However, if there is a technical use applied to those types of inventions, they are patent eligible.

The bill was reportedly drafted following three years of work by Senator Tillis’ team, including a series of US Senate hearings in 2019 with Senator Chris Coons (D-DE) and meetings with an array of industries. Updates will be posted to the IP Update blog as legislative developments warrant.

Practice Note: Readers are encouraged to check out the IP Update report that discusses a recent presentation by the PTO that shares recommendations for dealing with § 101 rejections during prosecution, which can be found here.



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Veil Piercing Under Lanham Act Requires Specific Showing of Liability

by | Aug 18, 2022 |

The US Court of Appeals for the Eleventh Circuit reversed a district court decision granting summary judgment of liability under the Langham Act, finding that the plaintiffs failed to apply the correct standards for piercing the corporate veil and individual liability in a false advertising and false endorsement dispute. Edmondson et al. v. Velvet Lifestyles, LLC, Case No. 20-11315 (11th Cir. Aug. 4, 2022) (Jordan, Pryor, Marcus, JJ.)

Miami Velvet operated as a swingers’ nightclub in Miami, Florida. Miami Velvet was owned, operated and managed by Velvet Lifestyles, LLC. Joy Dorfman was the president, manager and a salaried employee of Velvet Lifestyles. My Three Yorkies, LLC, was the managing member of Velvet Lifestyles, and Dorfman was, in turn, the managing member of Yorkies. She was also the president of Yorkies and received the management fees that Velvet Lifestyles paid Yorkies. Approximately 30 individuals sued Velvet Lifestyles, My Three Yorkies and Dorfman for false advertising and false endorsement under the Lanham Act. The individuals alleged that Velvet Lifestyles, My Three Yorkies and Dorfman used the individuals’ images in advertisements without their consent, without any compensation and in such a way that implied they were affiliated with and endorsed Miami Velvet.

The district court granted the plaintiffs’ motion for summary judgment, finding that Velvet Lifestyles, My Three Yorkies and Dorfman’s use of the plaintiffs’ images constituted false advertising and false endorsement. The plaintiffs’ motion treated all three defendants as effectively a single entity, and the district court made no finding that either My Three Yorkies or Dorfman had any direct involvement in the advertising. The district court did not apply the individual liability standard to Dorfman and instead treated all three defendants as a single entity as the plaintiffs’ motion had done. A jury awarded damages at trial. After post-trial motion practice, My Three Yorkies and Dorfman appealed.

The plaintiffs argued on appeal that My Three Yorkies and Dorfman had not properly preserved these issues for review on appeal. The Eleventh Circuit rejected the plaintiff’s argument, finding that because the plaintiffs did not properly plead the standards for piercing the corporate veil and individual liability, My Three Yorkies and Dorfman were not obligated to raise or respond to those issues and, therefore, any procedural failures on their part were inconsequential.

Turning to the merits, the Eleventh Circuit reversed the finding of liability on summary judgment. The Court explained that in order for My Three Yorkies to be liable for the actions of Velvet Lifestyles, the plaintiffs had to show that My Three Yorkies was directly involved in the violation of the Lanham Act. The Court found that the plaintiffs failed to show that My Three Yorkies took any action regarding the management of the club or the advertisement in question, and that therefore the plaintiffs had failed to establish that the corporate veil should be pierced. The Court further explained that in order for Dorfman to be liable as an individual, the plaintiffs had to show that she actively participated as the [...]

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Single T-Shirt Sale Can’t Clothe Bare-Bones Personal Jurisdiction Claim

by | Aug 18, 2022 |

The US Court of Appeals for the Eighth Circuit affirmed a district court’s dismissal of a trademark infringement suit for lack of personal jurisdiction, finding that the trademark owner failed to allege that the alleged infringer could reasonably anticipate being hauled into court in Missouri. Brothers and Sisters in Christ, LLC v. Zazzle, Inc., Case No. 21-1917 (8th Cir. Aug. 2, 2022) (Smith, Benton, Kelly, JJ.)

Brothers and Sisters in Christ (BASIC) is a Missouri-based clothing company that owns the trademark “love happens.” Zazzle is a California-based online retailer. BASIC sued Zazzle in a Missouri district court for trademark infringement, alleging that Zazzle used its nationally available website to advertise and sell goods in Missouri. BASIC further alleged that in 2019, Zazzle sold and shipped a t-shirt bearing a purportedly infringing “love happens” logo to at least one Missouri resident. The district court granted Zazzle’s motion to dismiss for lack of personal jurisdiction under Fed. R. Civ. P. 12(b)(2). BASIC appealed.

Reviewing the issue de novo, the Eighth Circuit affirmed the dismissal. The Court explained that because the Lanham Act does not authorize nationwide personal jurisdiction, the Court was required to apply Missouri’s long-arm statute and the federal due process clause. Given that Missouri’s long-arm statute authorizes personal jurisdiction over defendants who engage in, among other things, the transaction of any business or the commission of a tortious act within the state, the Court’s inquiry focused on whether exercising personal jurisdiction over Zazzle comported with the due process clause. Because BASIC did not allege that Zazzle was subject to general personal jurisdiction in Missouri (i.e., BASIC did not allege that Zazzle was “essentially at home” in the forum state), the question instead turned on whether BASIC had sufficiently pled facts to support a claim of specific personal jurisdiction.

The Eighth Circuit explained that specific personal jurisdiction existed over Zazzle for the purposes of BASIC’s trademark infringement claims if Zazzle had certain minimum contacts with the forum state and BASIC’s claims arose out of or related to those contacts. For specific jurisdiction to apply, the underlying controversy must be connected to the defendant’s activities in the forum state; unconnected activities directed to the forum state, no matter how numerous or systematic, cannot convey specific personal jurisdiction. The Court used a five-factor test previously set forth in Whaley v. Esebag to conduct its analysis: “(1) the nature and quality of [defendant’s] contacts with the forum state; (2) the quantity of such contacts; (3) the relation of the cause of action to the contacts; (4) the interest of the forum state in providing a forum for its residents; and (5) convenience of the parties.”

The Eighth Circuit found that the behavior alleged by BASIC (Zazzle’s operation of a national website that sells and ships goods to Missouri combined with a single specific instance of an allegedly infringing t-shirt being sold and shipped to a Missouri consumer) was insufficient to support a specific jurisdiction claim. Zazzle’s website availability and sales unrelated to the use [...]

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PTO Presentation Seeks to Clarify Subject Matter Eligibility Requirements

by | Aug 18, 2022 |

On August 9, 2022, the US Patent & Trademark Office (PTO) gave a public presentation, “Subject Matter Eligibility Under 35 U.S.C. § 101: USPTO Guidance and Policy.” During the presentation, the PTO indicated that its goal is to identify eligible subject matter and not reject patent applications under 35 U.S.C. § 101 where possible. However, subject matter eligibility must be determined in accordance with Supreme Court precedent as set forth in Bilski v. Kappos (2010); Mayo Collaborative Servs. v. Prometheus Labs, Inc. (2012); Association for Molecular Pathology v. Myriad Genetics, Inc. (2013); and Alice Corp. v. CLS Bank International (2014). The PTO presented several biotech examples demonstrating how subject matter ineligible claims could be redrafted to encompass eligible subject matter.

The PTO presented a detailed explanation of the two-step subject matter eligibility flowchart in MPEP § 2106 and emphasized the differences between the two prongs of Step 2A. The first prong is to evaluate whether the claim recites a judicially recognized exception to eligibility. If the claims do not recite an exception, they qualify as eligible subject matter. If the claims do recite a judicial exception, the analysis proceeds to the second prong of Step 2A, which is to evaluate whether the claims recite additional elements that integrate the exception into a practical application of the exception. If the claims do recite additional elements integrating the exception into a practical application of the exception, they qualify as eligible subject matter. If the claims do not do so, the analysis proceeds to Step 2B to determine whether the claims recite additional elements that amount to significantly more than the judicial exception.

While there is significant overlap between Step 2A prong two and Step 2B, the PTO noted that under Step 2A prong two, the additional elements may be well understood, routine, conventional activity, unlike in Step 2B. For example, if conventional steps were used to affect a particular treatment or prophylaxis for a disease or medical condition, or if conventional material was used in an unconventional application, the claims would be subject matter eligible.

The PTO warned against claiming methods as a series of mental processes, mere data gathering or steps that merely apply the judicial exception.

As noted, the PTO highlighted techniques for transforming subject matter ineligible claims into subject matter eligible claims. These techniques include reciting properties that naturally occurring compositions do not possess, showing that the claimed composition possesses properties not found in naturally occurring compositions, using a conventional material or conventional method in an unconventional application and specifying a particular treatment.

Practice Note: Readers may be interested in an IP Update Legislative Alert reporting on a bill introduced by Senator Tillis to amend §101, which can be found here.



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Recapture Rule Applies to Subject Matter Surrendered to Overcome § 101 Rejection

by | Aug 18, 2022 |

Affirming a Patent Trial & Appeal Board (Board) decision, the US Court of Appeals for the Federal Circuit held, for the first time, that the rule prohibiting recapture of subject matter surrendered during prosecution applies to subject matter surrendered to overcome a § 101 patent eligibility rejection. In re McDonald, Case No. 21-1697 (Fed. Cir. Aug. 10, 2022) (Newman, Stoll, Cunningham, JJ.)

During prosecution of a parent patent application relating to displaying search results, the inventor, John McDonald, added a “processor” limitation to certain claims to overcome a § 101 rejection. McDonald subsequently filed a continuation application, which was eventually issued. McDonald then filed a reissue application seeking to broaden the claims of the continuation patent by striking all of the originally added “processor” claim language. With the reissue application, he included a declaration that the processor language was unnecessary to the patentability and operability of the relevant claims. The examiner rejected the claims as obvious, and McDonald appealed. On appeal, the Board affirmed the obviousness rejection and also rejected the reissue claims as being based on a defective declaration lacking a correctable error. The Board found that McDonald was impermissibly attempting to recapture surrendered subject matter. McDonald appealed.

Exercising de novo review, the Federal Circuit first recounted more than a century of caselaw relating to patent reissue and recapture. The Court explained that a patent may be reissued if the inventor erroneously claimed less than they had a right to claim in the original patent, but that the recapture rule bars a patentee from regaining that which was surrendered during prosecution. The Court then turned to its three-step recapture analysis in which it considers the following:

  1. Whether, and in what aspect, the reissue claims are broader than the patent claims
  2. If broader, whether those broader aspects of the reissue claim relate to the surrendered subject matter
  3. If they do, whether the surrendered subject matter has crept into the reissue claim.

Applying this test, the Court concluded that McDonald sought to broaden his claims and that the surrendered subject matter crept into those broadened claims. The Court also held that McDonald did not meet the reissue statute’s “error” requirement, finding that his actions were deliberate as opposed to inadvertent or by mistake.

The Federal Circuit then addressed McDonald’s arguments that the recapture rule does not apply to subject matter surrendered to overcome a § 101 rejection. The Court conceded that its previous decisions centered on prior art rejections under § 102 and § 103 but found that the public’s reliance interest on a patent’s public record must also apply to subject matter surrendered under § 101. The Court also reiterated that it “reviews a patent family’s entire prosecution history when applying both the rule against recapture and prosecution history estoppel.” The Court thus affirmed the Board’s decision barring McDonald from reclaiming subject matter previously surrendered during prosecution.



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Too Little Too Late: No Tenable Misappropriation Claim Based on 11-Year-Old Prototype

by | Aug 11, 2022 |

In a dispute between an employer and a former employee, the US Court of Appeals for the Seventh Circuit affirmed a district court’s grant of summary judgment against an employer asserting trade secret misappropriation and breach of implied-in-fact contract claims relating to an 11-year-old prototype developed by a former employee. The Court also affirmed the district court’s finding of litigation misconduct by the former employer but vacated the lower court’s award of attorneys’ fees, remanding the case for a more detailed justification for the considerable award. REXA, Inc. v. Chester, Case Nos. 20-2953; -3213; -2033 (7th Cir. July 28, 2022) (Wood, Hamilton, Brennan, JJ.)

Mark Chester is a former employee of Koso America, a manufacturer of hydraulic actuators. Chester participated in a 2002 project at Koso that sought to develop a new flow matching valve for Koso’s actuators. While the project team failed to design a new flow matching valve, they did manage to develop an experimental prototype of an actuator with solenoid valves. Koso abandoned the new design because of the improbability of commercial success, and the prototype was disassembled. Chester—who had never signed a confidentiality or employment agreement with Koso—resigned from Koso in 2003 and later joined MEA Inc. in 2012. In 2013, 11 years after developing the Koso prototype, Chester helped MEA design a new actuator with solenoid valves and an improved motor. MEA filed a patent application in 2017 claiming the actuator, and the US Patent & Trademark Office issued a notice of allowance in 2018 based on the improved motor limitations.

REXA, a successor company to Koso, sued Chester and MEA for misappropriation under the Illinois Trade Secrets Act (ITSA) and for breach of an implied-in-fact contract. REXA alleged that MEA and Chester misappropriated the 2002 designs by filing the 2017 patent application and by incorporating the 2002 designs into MEA’s Hawk brand actuator, and that Chester breached an implied-in-fact obligation to assign any patent rights associated with the 2017 application to REXA. Chester and MEA accused REXA of improper conduct during discovery after REXA appended a confidentiality agreement that Chester had never received to Chester’s 2002 bonus letter and used the manipulated document during Chester’s deposition. The parties filed cross motions for summary judgment. The district court ruled for Chester and MEA and awarded them almost $2.4 million in attorneys’ fees for REXA’s litigation misconduct. REXA appealed.

Misappropriation of Trade Secrets

The Seventh Circuit first considered the trade secret misappropriation claim, specifically whether REXA had identified a trade secret with enough specificity. The ITSA requires that a plaintiff “present a specific element, or combination of elements, that is unknown to the trade and was allegedly misappropriated.” Applying this standard, the Court found that REXA had not identified any protectable trade secrets because it had broadly asserted that the “2002 designs” qualified as trade secrets without explicitly identifying an element that was not well known in the industry.

The Seventh Circuit further concluded that even if REXA had identified a specific and protectable trade secret, [...]

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Rage against the Machine: Inventors Must Be Human

by | Aug 11, 2022 |

The US Court of Appeals for the Federal Circuit found that an artificial intelligence (AI) software system cannot be listed as an inventor on a patent application because the Patent Act requires an “inventor” to be a natural person. Thaler v. Vidal, Case No. 21-2347 (Fed. Cir. Aug. 5, 2022) (Moore, Taranto, Stark, JJ.)

Stephen Thaler develops and runs AI systems that generate patentable inventions, including a system that he calls his “Device for the Autonomous Bootstrapping of Unified Science” (DABUS). In 2019, Thaler sought patent protection for two of DABUS’s putative inventions by filing patent applications with the US Patent & Trademark Office (PTO). Thaler listed DABUS as the sole inventor on both applications. The PTO found that the patent applications lacked valid inventorship and sent a Notice of Missing Parts requesting that Thaler identify a valid inventor. Thaler petitioned the director to vacate the notices. The PTO denied the petitions, explaining that a machine does not qualify as an inventor and that inventors on patent applications must be natural persons. Thaler then pursued judicial review in the district court. The district court agreed with the PTO, concluding that an “inventor” under the Patent Act must be an “individual,” and that the plain meaning of “individual” is a natural person. Thaler appealed.

The sole issue on appeal was whether an AI software system can be an “inventor” under the Patent Act. The Federal Circuit started with the statutory language of the Patent Act, finding that it expressly provides that inventors are “individuals.” The Court noted that while the Patent Act does not define “individual,” the Supreme Court has explained that the term “individual” refers to a human being unless there is some indication that Congress intended a different reading. The Federal Circuit also found that this result was consistent with its own precedent, which found that neither corporations nor sovereigns can be inventors; instead only natural persons can be inventors.

The Federal Circuit rejected Thaler’s policy argument that inventions generated by AI should be patentable to encourage innovation and public disclosure. The Court found that these policy arguments were speculative, lacked any basis in the text of the Patent Act, and were contrary to the unambiguous text of the Patent Act. The Court also rejected Thaler’s reliance on the fact that South Africa has granted a patent with DABUS as an inventor, explaining that the South African Patent Office was not interpreting the US Patent Act. The Court concluded that since Congress has determined that only a natural person can be an inventor, AI cannot be an inventor.

Practice Note: The Federal Circuit’s decision comes on the heels of a decision from the US Copyright Office Review Board finding that a work must be created by a human being to obtain a copyright. The Federal Circuit also noted that it was not confronted with the question of whether inventions made by human beings with the assistance of AI are eligible for patent protection.



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Don’t Dew It: Second Circuit Cans Likelihood of Confusion Argument

by | Aug 11, 2022 |

The US Court of Appeals for the Second Circuit reversed and vacated a district court’s preliminary injunction grant because the district court erred in assessing the strength of a trademark. RiseandShine Corporation v. PepsiCo, Inc., Case No. 21-2786 (2d Cir. July 22, 2022) (Leval, Chin, Menashi, JJ.)

Rise Brewing began selling canned coffee under the registered mark “RISE” in 2016. The registered mark consists of the word “rise” in large, red, regular capital letters with the words “Brewing Co.” below in a smaller, similar font on a horizontal line. The mark appears on every bottle of Rise Brewing’s canned coffee products.

In March 2021, PepsiCo launched a canned energy drink product under the mark “MTN DEW RISE ENERGY,” which contains the word “rise” on the top of each can, followed by the word “energy” running vertically up its side in a much smaller font and the MTN DEW house mark above the word “rise.”

Rise Brewing filed a complaint for trademark infringement and filed a motion for a preliminary injunction to enjoin PepsiCo from using or displaying the challenged in the market pending trial. The district court granted the motion, finding that Rise Brewing was likely to succeed on the merits regarding likelihood of confusion. PepsiCo appealed.

The Second Circuit explained that the party seeking a preliminary injunction over the use of a trademark can meet the likelihood of success prong of the preliminary injunction standard by showing that a significant number of consumers are likely to be misled or confused as to the source of the products in question. Here, the district court found that there would be a likelihood of reverse confusion—that consumers would mistake Rise Brewing’s coffee products (the prior user) as Mountain Dew products (the subsequent user). The Court disagreed and reversed, finding that the district court erred in the evaluation of the most important factor: strength of the mark.

The strength of a trademark is assessed based on either or both of two components:

  1. The degree to which it is inherently distinctive
  2. The degree to which it has achieved public recognition in the marketplace.

Although the Second Circuit agreed with the district court that the RISE trademark was a suggestive mark, it disagreed on the extent to which it was distinctive. The Court explained that “[t]he district court failed to note that the strong logical associations between ‘Rise’ and coffee represent weakness and place the mark at the low end of the spectrum of suggestive marks.” Because of the legal element in determination of the strength of a given mark, the district court’s mistake constituted a legal error.

The Second Circuit found that the lack of distinctiveness in using the term “rise” to describe coffee products can be demonstrated by [...]

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PTO Issues Notice on Duties of Disclosure and Reasonable Inquiry

by | Aug 11, 2022 |

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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In the Weeds? Humira “Patent Thicket” Isn’t an Antitrust Violation

by | Aug 11, 2022 | ,

The US Court of Appeals for the Seventh Circuit affirmed that welfare benefit plans that bought the drug Humira did not have valid antitrust claims against the patent owner. The Court found that amassing patents by itself is not enough to give rise to an antitrust claim, and that the welfare benefit plans would need to prove that the patents were invalid. Mayor and City Council of Baltimore, et al. v. AbbVie Inc., et al., Case No. 20-2402 (7th Cir. Aug. 1, 2022) (Easterbrook, Wood, Kirsch, JJ.)

AbbVie owns a patent covering Humira, which is a drug used to treat arthritic and inflammatory diseases. Humira is not covered by the Hatch-Waxman Act because it is a biologic drug, rather than a synthetic drug. Biologics are covered by the Biologics Price Competition and Innovation Act (BPCIA), under which a competitor must ask the US Food and Drug Administration for permission to sell a “biosimilar” drug based on certain guidelines. From the first sale of the original drug, the competitor must wait 12 years to enter the market. If the original drug seller believes that a patent blocks competition and initiates litigation, the competitor is still free to sell its biosimilar drug. The competitor sells at risk of an adverse outcome in the litigation.

The original Humira patent expired in 2016, but AbbVie obtained 132 additional patents related to the drug. After the 12-year BPCIA requirement passed, none of AbbVie’s competitors chose to launch a biosimilar. Instead, competitors settled with AbbVie on terms to enter the US market in 2023. In exchange, AbbVie agreed that enforcement of all 132 of its patents would end in 2023 even if they were not set to expire.

Welfare benefit plans that pay for Humira on behalf of covered beneficiaries accused AbbVie of violating Sections 1 and 2 of the Sherman Antitrust Act. The payors argued that AbbVie’s settlements with potential competitors established a conspiracy that restrained competition in violation of Section 1, and that AbbVie’s “patent thicket” allowed AbbVie to reap unlawful monopoly profits from Humira after expiration of the original patent in violation of Section 2. The district court dismissed the complaint. The payors appealed.

The issue on appeal with respect to Section 2 was whether the payors had to prove that all of AbbVie’s Humira-related patents were invalid. Under the Walker Process antitrust doctrine, a party may be liable for an antitrust violation if it knowingly asserts a fraudulently procured patent in an attempt to monopolize a market. The payors did not argue that all 132 of AbbVie’s patents were fraudulent. The Seventh Circuit reasoned that because the patent laws do not set a cap on the number of patents a person (or company) can hold, the payors would need to prove that each of AbbVie’s 132 Humira-related patents were invalid to succeed in showing a violation under Section 2. Not only did the payors fail to prove that all 132 patents were invalid, but they did not even offer to do so. [...]

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