Hagens Berman represents a proposed class of end payors in this class action alleging Alexion unlawfully extended patents on the drug, Soliris, brand name of eculizumab, one of the most expensive drugs in the world. Alexion is accused of harming purchasers and patients by increasing prescription costs through an anticompetitive scheme to delay the launch of less expensive biosimilars.
WHAT'S THE ISSUE?
Hagens Berman represents end payors in an antitrust class-action lawsuit against Boston-based drug company Alexion Pharmaceuticals Inc., a subsidiary of AstraZeneca. The lawsuit accuses Alexion of violating antitrust law by monopolistic acts that unlawfully delayed the introduction of biosimilar competition for eculizumab, a humanized monoclonal antibody that treats a range of rare blood and immune disorders, sold under the brand name Soliris. Attorneys claim Alexion’s anticompetitive behavior harmed patients who were already suffering from rare diseases Soliris treated. Alexion charges $500,000 per patient per year for Soliris.
ALEXION’S ALLEGED PRICING PLOYS
Starting in 2007, Alexion sold eculizumab under the brand name Soliris to treat the debilitating condition called paroxysmal nocturnal hemoglobinuria with protection from competition under a 2002 issued composition patent.
According to the lawsuit, Alexion’s 14-year grant of patent protected Soliris sales should have concluded after March of 2021 upon the expiration of its 2002 eculizumab patent. “But in the years before that expiration, Alexion’s senior management and scientists unlawfully procured a second set of five patents, once again claiming eculizumab, and with expiration dates well into the future,” the class action states. To accomplish the alleged unlawful re-patenting of eculizumab, Alexion:
- defrauded a U.S. patent examiner, repeatedly and falsely representing to him that, prior to 2007 when Alexion started its second wave of patent applications, the scientific community did not know the full amino acid sequence of eculizumab.
- concealed from the patent examiner many of Alexion’s own pre-2007 publications that disclosed outright the exact sequence of eculizumab by providing a simple roadmap for its assembly.
- falsely represented that its own ’245 patent failed to teach the eculizumab amino acid sequence, all the while concealing from the examiner that Alexion had previously taken the position the ’245 patent “claimed” eculizumab.
Because of Alexion’s falsehoods, the PTO examiner incorrectly allowed claims in a set of five related patents — three in 2017 and two in 2020 — that once again covered eculizumab and known methods of using it. Alexion later obtained a sixth patent to which it was not entitled. “Equipped with these late-issued patents, Alexion then asserted them against its would-be competitors as a basis to delay biosimilar competition to Soliris sales,” the lawsuit states. “The efforts to enforce the patents was a sham.”
SOLIRIS ANTITRUST EXPLAINED
The 171-page lawsuit claims that Alexion knew Soliris sales were protected from competition by the 2002 patent and chose to unlawfully extend it monopoly over Soliris. It did so recognizing that patients who were suffering with the rare disease treated by the drug, had no other therapeutic choice.
“Alexion charges one of the single highest drug costs in U.S. history, upwards of $500,000 per patient per year,” according to the lawsuit.” By 2016, U.S. net product sales exceeded $1 billion per year, and by 2019 those sales had doubled to over $2 billion per year.”
ABOUT THE ECULIZUMAB LAWSUIT
The lawsuit seeks to represent a class of all end payors (including any assignees of such end payors) which include consumers and health insurers, in the United States and its territories that purchased and/or paid all or part of the purchase price of eculizumab since March 2022. End payors are the last links in the pharmaceutical distribution chain and were overcharged for eculizumab due to Alexion’s unlawful conduct, according to the lawsuit. The lawsuit’s named plaintiff EmblemHealth is a not-for-profit that purchases prescription drugs at third-party pharmacies where Emblem’s health plan members have prescriptions filled.
The complaint asserts claims for monopolization in violation of state and federal and state antitrust laws, unjust enrichment and violations of state consumer-protection laws. The suit seeks repayment to proposed class members harmed by Alexion’s conduct, as well as an injunction putting an end to Alexion’s alleged unlawful monopoly.
TOP PHARMA LAW FIRM
Hagens Berman is one of the most successful litigation law firms in the U.S. taking on pharmaceutical companies and has achieved total settlements valued at more than $320 billion in class actions, including more than $3.4 billion recovered in lawsuits against Big Pharma. The firm’s pharmaceutical litigation against the industry’s largest sellers and manufacturers includes antitrust schemes, pay-for-delay, IP shams and other forms of wrongdoing that drive up the costs of prescription drugs for consumers and others.
