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Pay for Delay Is Sometimes Okay

by | May 23, 2024 | ,

The US Court of Appeals for the Second Circuit affirmed the dismissal of a lawsuit against pharmaceutical companies accused of violating antitrust laws by using reverse payments to delay entry of a generic version of a patented drug. CVS Pharmacy, Inc. v. Forest Labs. Inc., Case Nos. 23-410; -418; -420; -423 (2d Cir. May 13, 2024) (Jacobs, Sack, Nardini, JJ.)

This case involves a drug called Bystolic, which is a beta blocker designed to treat high blood pressure. Numerous purchasers of Bystolic and its generic versions brought state and federal antitrust claims against Forest Labs. and the generic manufacturers. The purchasers alleged that Forest Labs. unlawfully paid off the generic manufacturers to delay the market entry of their products and prolong Forest Labs.’ ability to reap monopoly profits. The purchasers claim that Forest Labs. covered up these payments by pretextually compensating the generics for goods and services that Forest Labs. did not truly need. The purchasers claim that without such “side deals,” generic versions of Bystolic would have entered the market earlier – whether by the generic manufacturers prevailing in the infringement litigation, entering at risk (i.e., with litigation ongoing) or agreeing to a settlement allowing for earlier market entry.

The payments made by Forest Labs. are known as “reverse payments” because, unlike a typical settlement payment, the patent holder pays the alleged patent infringer even though they have no claim for damages. In 2013, the Supreme Court explained in FTC v. Actavis that such payments should be evaluated pursuant to antitrust law’s rule of reason, under which courts balance anticompetitive effects against procompetitive benefits. The Supreme Court explained that while reverse payments may look dubious, they are not automatically unlawful. Instead, these payments may “sometimes” violate the antitrust laws, but only if they are both “large” and “unjustified.” According to the Supreme Court, whether a reverse payment passes antitrust muster “depends upon its size, its scale in relation to the payor’s anticipated future litigation costs, its independence from other services for which it might represent payment, and the lack of any other convincing justification,” including fair value for goods and services exchanged as part of a bona fide commercial relationship.

Forest Labs. and the generic manufacturers moved to dismiss the purchasers’ claims for failure to state a claim. The district court granted the motion, concluding that the purchasers’ allegations did not plausibly show an antitrust violation under Actavis. The purchasers’ appealed.

The Second Circuit affirmed the dismissal. Analyzing Actavis, the Court explained that reverse payments are subject to the rule-of-reason analysis and the relevant inquiry involves determining why the payment was made. The Court noted that the payments must be analyzed against a backdrop of the strong public policy favoring settlement of disputes, meaning that the payments violate antitrust law only if they are both large and unjustified or unexplainable. In turn, whether a reverse payment is “unjustified” depends on whether it “reflects traditional settlement considerations,” including “fair value” for products or services provided by the generic manufacturer pursuant [...]

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Same Product in Different Packaging May Constitute Separate Market for Antitrust Purposes

by | Mar 28, 2024 | ,

Addressing an issue of first impression, the US Court of Appeals for the Second Circuit concluded that two medications that contain the same ingredients but are packaged in different forms constitute separate markets for purposes of assessing antitrust violations. Regeneron Pharm., Inc. v. Novartis Pharma AG, Case No. 22-0427 (2d Cir. Mar. 18, 2024) (Parker, Lee, Merriam, JJ.)

Regeneron sued Novartis in the US District Court for the Southern District of New York alleging antitrust violations under the Sherman Act and New York state law claims. The specific products at issue were prescription medications used to treat the overproduction of vascular endothelial growth factor (VEGF). VEGF is a naturally occurring protein but, if overproduced, can lead to eye disorders, including permanent blindness. Both Regeneron and Novartis produce medication to combat overproduction of VEGF. The first form of anti-VEGF medications developed was packaged into vials and administered in a two-step process where a physician draws the product into a syringe then injects the product into the patient’s eye. However, a newer version of anti-VEGF drugs come in a prefilled syringe (PFS) designed to be administered in one step. The PFS packaging carries a significantly lower risk of complications and infections. PFSs have become the “preferred way [to] administer [] anti-VEGF medications.” Novartis moved to dismiss the complaint under Fed. R. Civ. P. 12(b)(6). After the district court granted the motion, Regeneron appealed.

The district court reasoned that original and newer products competed in the same market because they were the exact same medication, just sold in different forms. The Second Circuit disagreed. PFSs reduce the likelihood of complications and have become the preferred form of administration for treatment of VEGF overproduction over vials. The Second Circuit concluded that the district court improperly focused its analysis on whether the two products were “functional substitutes” and not on whether they were “economic substitutes.” The Second Circuit concluded that the district court had applied the improper standard for the relevant market and should instead consider whether the two drugs are economic substitutes. That is to say, the district court should look to whether the different packaging for the VEGF treatments are reasonably interchangeable by consumers. Regeneron alleged they are not due to PFSs’ preferred status among physicians (although PFSs are more costly than vials).

As to the state law claims, the district court dismissed Regeneron’s tortious interference claims as untimely. On appeal, Regeneron argued that Novartis should be equitably estopped from invoking the statute of limitation because the defendants “took steps to prevent Regeneron from learning of Novartis’s tortious interference until after the statute of limitation period had expired.” The Second Circuit found that Novartis concealed a co-inventor’s role in the procurement of a patent, which Regeneron only found out about during subsequent patent litigation, and that such concealment was in violation of a contract. Thus, the Court “conclude[d] that [Regeneron’s] allegations were sufficient to permit Regeneron to invoke equitable estoppel.” Additionally, the complaint “plausibly alleged a claim for tortious interference with contract.”



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Noncompulsory Counterclaims Don’t Confer Appellate Jurisdiction

by | Aug 17, 2023 | , ,

The US Court of Appeals for the Federal Circuit determined that it does not have appellate jurisdiction to review noncompulsory patent counterclaims in a case otherwise unrelated to the originally asserted patents. Teradata Corp. v. SAP SE, Case No. 22-1286 (Fed. Cir. Aug. 1, 2023) (nonprecedential) (Lourie, Taranto, Hughes, JJ.)

Teradata makes and sells data warehouse systems and services. SAP develops and sells software. The two companies began collaborating while SAP was simultaneously developing its own database (HANA) and component software. SAP eventually informed Teradata that it would stop selling certain Teradata products. Teradata sued SAP, alleging misappropriation of trade secrets on the theory that SAP used Teradata’s proprietary information to create HANA. Teradata also alleged various antitrust violations, arguing that SAP “illegally tied” HANA and HANA’s supporting software. In response, SAP filed counterclaims against Teradata for allegedly infringing SAP patents related to database organization and optimization. On Teradata’s motion, the district court agreed to sever one of the four patent infringement claims but allowed the others to proceed. The district court reasoned that Teradata’s claims and SAP’s counterclaims all arose from “the same transaction or occurrence,” namely SAP’s development of HANA.

The district court granted summary judgment to SAP on Teradata’s antitrust and technical trade secret claims and stayed proceedings on Teradata’s business trade secret claim and to Teradata on SAP’s patent counterclaims. Teradata appealed to the Federal Circuit.

SAP moved to transfer the appeal to the Ninth Circuit. The Federal Circuit denied the motion but instructed the parties to address the jurisdictional issue in the merits brief. 28 U.S.C. § 1295(a)(1) grants the Federal Circuit exclusive appellate jurisdiction over final decisions in which a party claims or asserts a compulsory counterclaim related to patents. As it relates to this case, the issue was whether SAP’s patent infringement counterclaims were “compulsory,” meaning SAP would be unable to later sue on these patent infringement allegations “if it did not press them in this action.”

The Federal Circuit began by looking at Federal Rules of Civil Procedure 13(a), which states that a counterclaim is “compulsory” if it arises from the same transaction or occurrence as a plaintiff’s claim. The Court explained that it uses three tests to determine whether the transaction or occurrence is sufficiently related between the claim and counterclaim:

  1. Whether the legal and factual issues are substantially the same
  2. Whether the evidence will be substantially the same
  3. Whether there is “a logical relationship between the claim and the counterclaim.”

Taken together, these tests essentially ask if there is substantial overlap between what the plaintiff and the defendant must establish to succeed on the claim and counterclaim, respectively.

The Federal Circuit found that the first two tests clearly weighed against SAP’s counterclaim being compulsory. While an understanding of the accused products and alleged trade secrets would be necessary for both the claim and the counterclaim, “same-field overlap” is not enough to make the issues or necessary evidence “substantially the same.”

As to the third test, the Federal Circuit found [...]

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Fifth Circuit Affirms Dismissal of Walker Process Claim, Disagrees with Federal Circuit Transfer of Action

by | Aug 25, 2022 | ,

The US Court of Appeals for the Fifth Circuit affirmed a summary judgment order dismissing a Walker Process monopolization action brought by Ronald Chandler and his oilfield service company Chandler Manufacturing (collectively, Chandler). The Fifth Circuit affirmed the lower court’s tossing of the action, holding that the alleged claims lacked a nexus to antitrust injury and were time barred under the four-year statute of limitations. Ronald Chandler et al. v. Phoenix Services, LLC, Case No. 21-10626 (5th Cir. Aug. 15, 2022) (Wiener, Graves, Duncan, JJ.)

A Walker Process monopolization action involves antitrust claims regarding fraudulently obtained patents. Chandler alleged that even though Phoenix Services’ patent for fracking technology was declared unenforceable in separate federal litigation in 2018, Phoenix Services continued to enforce the patent to exclude competitors from the market (for example, by sending cease-and-desist letters to Chandler’s clients that attempted to utilize the technology). A Walker Process claim requires a showing of the following:

  • The defendant obtained its patent by “knowing and willful fraud on the patent office and maintained and enforced the patent with knowledge of the fraudulent procurement.”
  • The plaintiff can satisfy all other elements of a Sherman Act monopolization claim.

In the district court, a Texas federal judge granted summary judgment to Phoenix Services, finding that Chandler filed the lawsuit too late and that the defendants involved ultimately could not be held liable. Chandler appealed.

The Fifth Circuit first addressed its appellate jurisdiction. The Court made it clear that it did not agree with the Federal Circuit’s transfer of this Walker Process case (on the basis that it did “not present a substantial issue of patent law” since the underlying patent had already been declared unenforceable in earlier litigation), but that under the Supreme Court’s 1988 decision in Christianson v. Colt Indus. Operating Corp. it did not find the transfer “implausible.” It therefore accepted jurisdiction but noted that its acceptance did not mean that it found the Federal Circuit’s decision correct.

The Fifth Circuit acknowledged that unlike the situation in Xitronix v. KLA-Tencor, where it and the Federal Circuit debated the appellate jurisdiction issue of Walker Process claims, the patent involved here had already been declared unenforceable. However, the Fifth Circuit pointedly noted its position that Walker Process claims should fall under the appellate purview of the Federal Circuit.

On the merits, the Fifth Circuit agreed with the Texas district court that Chandler did not sufficiently demonstrate that its alleged lost profits were caused by Phoenix Services’ alleged antitrust behavior. The Court found that Chandler failed to present substantial evidence that the cease-and-desist letters materially harmed Chandler’s business.

Antitrust plaintiffs must show the following:

  • Injury-in-fact, e., an injury to the plaintiff proximately caused by the defendants’ conduct
  • Antitrust injury
  • Proper plaintiff status, which ensures that other parties are not better situated to bring suit.

Only injury-in-fact was analyzed in the appeal. Chandler argued that the cease-and-desist letter sent to its clients eventually drove the client out of business. However, the Fifth Circuit [...]

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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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Fifth Circuit Takes U-Turn, But Still Concludes Automotive Supplier Can’t Force SEP Holder to Issue License

by | Jun 30, 2022 | ,

In response to a petition for panel rehearing, the US Court of Appeals for the Fifth Circuit withdrew its prior decision finding that an automotive parts supplier did not have constitutional standing to pursue an antitrust lawsuit against owners of standard essential patents (SEPs). The Court issued a new opinion summarily affirming the district court’s original decision finding constitutional standing but dismissed the case based on lack of antitrust standing. Continental Automotive Systems, Inc. v. Avanci, LLC et al., Case No. 20-11032 (5th Cir. June 21, 2022) (Stewart, Ho, Engelhardt, JJ.) (per curiam).

Continental sued several SEP holders and their licensing agent, Avanci, for violation of Sections 1 and 2 of the Sherman Antitrust Act based on Avanci’s refusal to license the SEPs on fair, reasonable and nondiscriminatory (FRAND) terms. Avanci moved to dismiss, arguing that Continental lacked both constitutional standing and antitrust standing. The district court found that Continental had constitutional standing because its lack of success obtaining licenses on FRAND terms was an injury. However, the district court found that Continental lacked antitrust standing and therefore dismissed the lawsuit. Continental appealed.

The Fifth Circuit issued its original opinion in March 2022, finding that Continental’s theory of injury was insufficient to confer constitutional standing. The Court explained that Avanci’s refusal to sell licenses did not result in a cognizable injury to Continental, and that Continental had no rights to enforce FRAND contracts between the individual patent holders and the standard setting organization (SSO) since Continental was not part of the SSO to which the SEP holders belonged. The Court also found that even if Continental was contractually entitled to a license on FRAND terms, the SSO contract had not been breached because the individual patent holders fulfilled their obligations to the SSO by actively licensing Continental’s customer, which meant that the SEP licenses were (derivatively) available to Continental on FRAND terms. Finding that Continental lacked constitutional standing, the Court did not reach the issue of whether Continental lacked antitrust standing.

Continental filed a petition for panel rehearing and rehearing en banc. Numerous third parties, including legal and economic scholars, industry associations and tech companies, also filed amici briefs supporting Continental, arguing that the Fifth Circuit wrongly found that Continental was not an intended beneficiary of the FRAND obligations that the SEP owners made to the relevant SSO.

On June 14, 2022, the Fifth Circuit issued an order withdrawing its March 2022 opinion. A week later, the Court issued a new opinion summarily stating that “[h]aving reviewed the district court’s detailed order, and considered the oral arguments and briefs filed by the parties and amicus curiae, we AFFIRM the judgment of the district court that Continental failed to state claims under Sections 1 and 2 of the Sherman Act.”

Practice Note: Although the ultimate outcome did not change, the Fifth Circuit withdrew its previous finding that third-party beneficiaries to SSOs did not have constitutional standing to file a lawsuit.



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European Commission Seeks Comments on Revised Horizontal Guidelines Draft

by and | Apr 7, 2022 | ,

On 1 March 2022, the European Commission launched a public consultation inviting stakeholders to comment on a revised Horizontal Block Exemption Regulations on Research & Development and Specialisation (HBERs) draft, as well as on a revised draft of the guidelines on the applicability of Article 101 of the Treaty on the Functioning of the European Union (TFEU) to horizontal co-operation agreements (Horizontal Guidelines). Comments are due no later than 26 April 2022.

This more general antitrust public consultation aims at drafting revised versions of existing normative texts and should not be confused with the European Commission’s more targeted “Call for Evidence” regarding a new framework for standard-essential patents (SEPs). Comments in response to the Call for Evidence must be submitted by 9 May 2022, and the new framework “may combine legislative and non-legislative action.” (For more information on the European Commission’s Call for Evidence, click here.) While these two EU public consultations are separate, they and their corresponding EU policies overlap on the question of SEPs.

Chapter 7 of the revised Horizontal Guidelines draft concerns SEP antitrust issues, such as the question of standardisation agreements and their compliance with EU antitrust law. The public consultation provides stakeholders in the SEP licensing and standardisation fields an opportunity to ensure that their interests will be considered during the drafting process of the revised Horizontal Guidelines.

The overall objective of the Horizontal Guidelines is to provide guidance on the European Commission’s application of the general norms prohibiting anticompetitive market behaviour set out in Art. 101 (1) and 101 (3) of the TFEU. The Horizontal Guidelines are de facto binding as EU courts and businesses use them to comply with Art. 101 (1) and (3) of the TFEU and to anticipate the European Commission’s enforcement of these norms.

The revised draft of the Horizontal Guidelines takes into consideration the evaluation process following a public consultation in 2019 that gave stakeholders the opportunity to review the 2011 version of the Horizontal Guidelines, which is currently in force. In the revised draft, Chapter 7 focuses on standardisation agreements as follows:

 

  • The new draft proposes to introduce more flexibility in the effects analysis by allowing (under specific circumstances) more limited participation in the development of a standard.
    • A standardisation agreement should not be considered to lead to
      restrictive effects on competition under Article 101 (1) of the TFEU if
      the restriction on the participants is limited in time       with a view
      to progressing quickly and if, at major milestones, all competitors have an
      opportunity to be involved in terms of continuing the development of the
      standard (marginal no. 496).
    • A standardisation agreement should be considered as removing potential
      negative effects resulting from limited participation stakeholders as long as
      stakeholders are kept informed and consulted on the work in progress. The
      objective is to promote procedures that recognize the collective representation
      [...]

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Second Circuit Rejects FTC Challenge of 1-800 Contacts, Highlighting Procompetitive Trademark Policy

by and | Jun 24, 2021 | ,

The US Court of Appeals for the Second Circuit vacated a final order of the Federal Trade Commission (FTC), which had found that agreements to refrain from bidding on keyword search terms for internet advertisements violated Section 5 of the FTC Act. The Court made clear that although trademark agreements are not necessarily immune from antitrust scrutiny, they are entitled to significant deference. 1-800 Contacts, Inc. v. Federal Trade Commission, Case No. 18-3848 (2d Cir. June 11, 2021) (Per Curium). The Second Circuit held that the FTC applied an incorrect analytical framework and incorrectly concluded that the agreements were an unfair method of competition under the FTC Act.

1-800 Contacts and its competitors advertise online through search advertising. They bid on search engine keywords, which help display their websites in response to consumer searches. They also bid on negative keywords, which prevent their ads from being displayed when consumers search for specified terms.

Between 2004 and 2013, 1-800 Contacts entered into a series of settlement agreements to resolve trademark disputes with competitors, as well as one commercial agreement with a competitor, all of which included terms prohibiting the parties from using each other’s trademarks, URLs and similar terms as search advertising keywords. The agreements also required the parties to use negative keywords so that a search including one party’s trademarks would not trigger a display of the other party’s ads. 1-800 Contacts enforced these agreements when it believed them to be breached.

The FTC challenged the agreements, alleging that they “unreasonably restrain truthful, non-misleading advertising as well as price competition in search advertising auctions,” violating Section 5 of the FTC Act, 15 U.S.C. § 45. An administrative law judge (ALJ) subsequently found the agreements to violate Section 5. 1-800 Contacts appealed to the full Commission, which affirmed the ALJ’s decision. 1-800 Contacts appealed.

The Second Circuit vacated the FTC’s decision but noted that the FTC was correct to reject 1-800 Contacts’ argument that trademark settlement agreements are necessarily immune from antitrust scrutiny. Citing the Supreme Court decision in Actavis, the Second Circuit held, “the mere fact that an agreement implicates intellectual property rights does not immunize an agreement from antitrust attack.”

The Second Circuit disagreed with the FTC’s specific antitrust analysis, however. The Court held that the FTC erred by applying an “inherently suspect” analysis—also known as a “quick-look” analysis—rather than the rule of reason. The Court focused on the fact that “the restraints at issue here could plausibly be thought to have a net procompetitive effect because they are derived from trademark settlement agreements,” and the fact that the FTC acknowledged as much by finding that the company’s justifications were “cognizable and, at least, facially plausible.” The Second Circuit also noted that courts have limited experience with these types of agreements. The Court concluded that “[w]hen, as here, not only are there cognizable procompetitive justifications but also the type of restraint has not been widely condemned in our judicial experience . . . . [w]e are bound . . [...]

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Federal Circuit Lacks Appellate Jurisdiction over Standalone Walker Process Claims

by and | Jun 24, 2021 | ,

The US Court of Appeals for the Federal Circuit ordered the transfer of a case asserting standalone Walker Process antitrust claims involving an unenforceable patent to the regional circuit, in this case the US Court of Appeals for the Fifth Circuit. Chandler v. Phoenix Services LLC, Case No. 20-1848 (Fed Cir. June 10, 2021) (Hughes, J.) The case originated in the US District Court for the Northern District of Texas, over which the Fifth Circuit has appellate jurisdiction. The decision to transfer was based on a subject matter jurisdiction analysis for Walker Process claims. The Federal Circuit reiterated that its precedent does not mandate exclusive Federal Circuit jurisdiction over all Walker Process cases.

In 2006, Phoenix Services and Mark Fisher (collectively, Phoenix) acquired a company called Heat On-The-Fly and its patent to protect a purported proprietary fracking process. Heat-On-The-Fly, and later Phoenix, sought to enforce the patent against numerous parties. During the patent application process, however, Heat On-The-Fly had failed to disclose numerous public uses of the fracking process prior to the application filing. In 2018, in an unrelated case, Energy Heating, LLC v. Heat On-The-Fly, the Federal Circuit, held that “failure to disclose prior uses of the fracking process rendered the . . . patent unenforceable due to inequitable conduct.” The plaintiffs in the case at hand, Ronald Chandler, Chandler MFG., Newco Enterprises and Supertherm Heating Services (collectively, Chandler), alleged that Phoenix’s continued enforcement of the patent violated Walker Process pursuant to § 2 of the Sherman Act.

Walker Process monopolization claims originate from a 1965 Supreme Court decision that recognized an antitrust cause of action under the Sherman and Clayton Acts when a party fraudulently obtains a patent for the purpose of attempted monopolization. Walker Process Equipment, Inc. v. Food Machinery & Chemical Corp. To succeed on a Walker Process claim, a plaintiff must satisfy two elements:

  • The plaintiff must show that the defendant obtained the patent through knowing and willful fraud on the US Patent & Trademark Office and enforced that patent with knowledge of its fraudulent procurement.
  • The plaintiff must be able to satisfy all other elements for a Sherman Act monopolization claim.

Pursuant to 28 U.S.C. § 1295(a)(1), the Federal Circuit retains jurisdiction over any civil case arising under any act of Congress relating to patents. In this instance, the Federal Circuit stated that Walker Process antitrust claims may relate to patents “in the colloquial use of the term,” but under 1988 Supreme Court precedent, Christianson v. Colt Indus., the Federal Circuit’s jurisdiction only extends to cases where the cause of action is created under federal patent law, or where the plaintiff’s right to relief “necessarily depends on resolution of a substantial question of federal patent law.”

Here, the Federal Circuit relied on its own 2018 precedent where it analyzed subject matter jurisdiction for Walker Process claims. Xitronix Corp v. KLA-Tencor Corp. (Xitronix I). Xitronix I involved alleged fraud by the defendants to obtain a patent. The Court acknowledged [...]

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Fourth Circuit Breathes New Life into Monopolization Suit

by and | Apr 22, 2021 | ,

The US Court of Appeals for the Fourth Circuit revived an antitrust suit alleging that a pharmaceutical manufacturer illegally maintained its monopoly for its innovator drug by precluding competition beyond the expiration date of the patent covering the drug. The Court found that the case was filed within the statute of limitations because the antitrust claims did not accrue until the consumers were injured by paying supracompetitive prices for the drug after the patent expired. Baltimore v. Actelion Pharm., Ltd., Case No. 19-2233 (4th Cir. Apr. 13, 2021) (Niemeyer, J.)

Actelion received an exclusive license under a patent issued in 1994 for Tracleer, the “only oral treatment for pulmonary arterial hypertension.” Although Actelion’s patent for Tracleer expired in November 2015, no competitor brought a generic version of Tracleer to market. The mayor of Baltimore and Baltimore’s Government Employees Health Association (collectively, Baltimore) alleged that Actelion intended to “preclud[e] competition from generic drug manufacturers” by orchestrating a “multi-year scheme” to prevent multiple manufacturers from attempting to bring a generic version of the drug to market. According to the complaint, from 2009 to 2012, four generic drug manufacturers repeatedly requested samples of Tracleer from Actelion to develop generic versions of the drug. Potential entrants must obtain samples of a branded drug to demonstrate that a generic drug is bioequivalent to the branded drug—in this case, Tracleer. Baltimore alleged that Actelion refused consistently, stating it had the right to elect with whom it did business. Actelion also allegedly prevented distributors from selling Tracleer samples to generic drug manufacturers.

Baltimore alleged that by precluding generic competitors from the market, Actelion was able to maintain an illegal monopoly over Tracleer for three years after its patent expired and charge inflated prices for the drug in violation of § 2 of the Sherman Act and various state antitrust and consumer protection laws. Baltimore alleged that but for Actelion’s conduct, consumers would have purchased less expensive generic alternatives instead of branded Tracleer. Baltimore filed suit on November 19, 2018. The district court dismissed Baltimore’s complaint, finding that the majority of the claims were barred by the four-year statute of limitations. The district court found that the last overt anticompetitive act occurred in February 2014, when Actelion executed settlement agreements with several generic manufacturers. The district court rejected Baltimore’s argument that the claims accrued on the date of patent expiration (November 2015) or, in the alternative, from each sale of Tracleer at supracompetitive prices. Baltimore appealed.

The Fourth Circuit determined that the November 2018 suit was not time-barred by the statute of limitations. The Court found that although Actelion’s last overt anticompetitive act took place in 2014, the alleged harm to the plaintiffs did not begin until November 2015 when the patent expired. Section 4 of the Clayton Act provides a private right of action for violations of federal antitrust laws and states that any such action is “barred unless commented within four years after the cause of action accrued.” The Court further noted that the Supreme Court [...]

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