The Interplay: Key Decisions at the Intersection of Antitrust and Life Sciences - September 2024
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Pharma Companies File Amici Supporting Teva on Orange Book Defense. On August 13 Sanofi and AstraZeneca each filed amicus briefs asking the Federal Circuit to overturn a ruling by a New Jersey federal court finding that Teva improperly listed certain patents regarding its ProAir inhaler in the Orange Book with the alleged intent of delaying FDA approval of competing generic asthma inhalers. We previously discussed the district court’s ruling here. Both briefs criticize a 2020 First Circuit decision regarding Sanofi's Lantus SoloStar insulin injector pen patent. In re Lantus Direct Purchaser Antitrust Litigation, 950 F.3d 1 (1st Cir. 2020). The First Circuit determined there that the patent was ineligible for Orange Book listing because it failed explicitly to claim the drug's active ingredient. Both Teva and Sanofi urge the Federal Circuit to adopt an alternative interpretation of the relevant law. Sanofi and AstraZeneca both argue that the district court erred in applying patent law, but only Sanofi explicitly supports reversal. Sanofi argues for a broad interpretation of “claims the drug” under 21 U.S.C. § 355(b)(1)(A)(viii) of the Food. Drug, and Cosmetic Act that would require listing of patents that “read on” any part of the FDA-approved drug product, including device components of combination products. It contends this best aligns with the listing statute’s text and purpose. Sanofi argues that the First Circuit’s and district court’s reading of the listing statute to mean that only patents claiming the active ingredient in a drug could be listed in the Orange Book is erroneous. Sanofi also described the district court’s reasoning as evidencing “undue hostility” toward patent listings, which it argues is inconsistent with the “balance Congress struck” through the Hatch-Waxman Act. AstraZeneca similarly argues that the district court has narrowed the meaning of “claims” in conflict with its ordinary patent law meaning of “reads on.” As we previously reported here, earlier this year, the Federal Trade Commission also filed an amicus brief in this case supporting plaintiff Amneal and asking that the Court uphold the First Circuit and district court’s reading of the statute. The case is Teva Branded Pharmaceutical Products R&D Inc. v. Amneal Pharmaceuticals of New York LLC, case number 24-1936, in the U.S. Court of Appeals for the Federal Circuit.
FTC Backs FDA Draft Guidance On Biosimilars. On August 20 the Federal Trade Commission (FTC) submitted a nine-page comment to the FDA supporting the agency’s draft guidance regarding considerations in demonstrating interchangeability with a reference product (Draft Guidance). The Draft Guidance presents a shift in FDA policy on designations of biosimilar interchangeability. Once the FDA designates a biosimilar product as “interchangeable,” pharmacists can substitute that product for a biologic without prescriber intervention under state law. Under the Draft Guidance, a biosimilar applicant need no longer submit clinical switching studies—where patients are treated with an alternating regimen of the reference product and the biosimilar, with outcomes compared against patients who did not receive alternating treatment—to support interchangeability. Under the Draft Guidance, the applicant may submit instead “an assessment of why the comparative analytical and clinical data provided in the application or supplement supports a showing that the switching standard… has been met.” The FTC stated that “[i]f implemented, this Draft Guidance would likely have a positive impact on the number of biosimilars designated as interchangeable and the uptake of biosimilar products in general by reducing barriers to entry and increasing competition in biologic marketplaces.” The FTC also pointed to its own efforts to curb biosimilar disparagement, i.e. assertions that biosimilars act differently than their bioequivalent counterparts that the agency fears chills biosimilar uptake, and the Commission’s Interim Staff Report on Pharmacy Benefit Managers as complementary efforts to raise biosimilar availability to “fully realiz[e] the goals of the [Biologics Price Competition and Innovation Act]” and thereby increase competition. The FTC also argued that the clinical switching requirement creates confusion among prescribers and patients regarding the distinction between biosimilars and interchangeable biosimilars.
Par Pharma Escapes Price-Fixing Claims After It Filed for Chapter 11 Bankruptcy. A Connecticut federal court dismissed Par Pharma from two price-fixing lawsuits following the company’s Chapter 11 reorganization. The plaintiffs, attorneys general from nearly all U.S. states and territories, did not respond to a show cause order requesting arguments for keeping Par Pharma in the litigation. Par Pharma notified the court on July 8 that its Chapter 11 plan, which went into effect in late April, discharged preexisting debts and enjoined parties from continuing actions against the company. Par Pharma and its parent company, Endo International PLC, filed for bankruptcy protection in August 2022. Endo, facing roughly $8 billion in debt, had a challenging bankruptcy process, initially proposing a plan that was opposed by the U.S. Department of Justice and other entities. After mediation, a new plan was confirmed in March, cutting $5 billion of debt and resolving DOJ claims with $465 million in payments over 10 years. The plan converted secured debt into 95% equity in a new entity, Endo Inc. The cases are Connecticut et al. v. Aurobindo Pharma USA Inc. et al., 3:16-cv-02056, and Connecticut et al. v. Teva Pharmaceuticals USA Inc., 3:19-cv-00710.
State Attorneys General Request That “Larger” Generic Price-Fixing Case Proceed First Due to Its Impact. A Connecticut federal district granted a group of state attorneys generals’ request that a Connecticut federal court prioritize the case against Teva Pharmaceuticals USA Inc. over a similar case against Heritage Pharmaceuticals Inc. Both cases allege a price-fixing scheme involving multiple generic drugmakers. The states argued that the Teva case, with its broader scope and more numerous allegations, should proceed first because its outcome would significantly impact settlement talks with other pharmaceutical companies. The Teva case was previously selected as the bellwether case in a multidistrict litigation but was removed after a deferred prosecution agreement with the Justice Division. In response to the state attorneys general request, the drugmakers argued that the smaller Heritage case should go first due to its manageability and potential to provide similar guidance. The court agreed with the state attorneys general that it was more appropriate for the Teva case to proceed to trial first due to its the broader scope. Both sides have agreed on a timeline for discovery and summary judgment motions, with the first case expected to reach summary judgment briefings by October 2026 and the second by June 2028. The case is Connecticut et al. v. Aurobindo Pharma USA, Inc. et al., 3:16-cv-02056.
Authors
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Mark A. Ford
Partner
Vice Chair, Regulatory and Government Affairs – Boston Office
[email protected] +1 617 526 6423+1 617 526 6423
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Omar A. Khan
Partner
Co-Chair, Trade Secret Practice
[email protected] +1 212 937 7252+1 212 937 7252
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