“Bristol Myers characterized AstraZeneca’s actions as ‘deliberate, egregious, willful, and in reckless disregard of valid patent claims.’”
Bristol Myers filed a lawsuit Monday claiming AstraZeneca has infringed on a patent related to its Yervoy cancer drug. The pharmaceutical company launched the suit in the United States District Court for the District of Delaware.
Bristol Myers claimed AstraZeneca’s Imjudo cancer treatment infringes on its patent and that AstraZeneca failed to first obtain a license or permission.
The cancer treatment in question is known as cancer immunotherapy, which according to the lawsuit “represents a scientific breakthrough that has revolutionized cancer treatment by manipulating a patient’s immune system to eliminate cancer cells.” Yervoy has been approved by the U.S. Food and Drug Administration (FDA) to treat melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non–small cell lung cancer (NSCLC), malignant pleural mesothelioma, and esophageal cancer, either alone or in combination with the company’s drug, Opdivo.
The Imjudo treatment’s prescription and instructions infringe multiple claims of Bristol Myers’ U.S. Patent No. 9,320,811 and U.S. Patent No. 9,273,135, according to the complaint.
Bristol Myers characterized AstraZeneca’s actions as “deliberate, egregious, willful, and in reckless disregard of valid patent claims.” The company continued, “[the] defendants are exploiting BMS’s inventions and willfully infringing BMS’s intellectual property rights.”
This is the second case Bristol Myers has filed against AstraZeneca accusing the company of infringing on a patent related to cancer treatment. In March 2022, Bristol Myers claimed AstraZeneca’s cancer drug Imfinzi infringed on one of its patents.
Competition and Profit
Bristol Myers claimed that AstraZeneca has been aware of one of its patents since at least December 2021, when the company approached Bristol Myers to license the CTLA-4 patent estate, which the Yervoy patent is a part of.
According to the lawsuit, AstraZeneca has marketed the Imjudo treatment since October 2022, after it won approval to use the drug to treat liver and lung cancer. Imjudo and Bristol Myers’s Yervoy are marketed to treat the same cancers.
While Imjudo is relatively new to the market, Bristol Myers has booked big revenue numbers with Yervoy. According to a company financial report, Bristol Myers raked in over $2 billion in revenue from Yervoy.
Bristol Myers has been aggressive in patent litigation against AstraZeneca in this field recently because they “are direct competitors in the immunotherapy field, and more specifically, in the CTLA-4 antibody field,” according to the lawsuit.
This case builds on the March 2022 lawsuit, as Imjudo is only approved to be used in combination with Imfinzi.
Similar to the most recent lawsuit, Bristol Myers claimed AstraZeneca had previous knowledge of its patents due to disclosures and discussions between the two companies.
Bristol Myers also claimed it has suffered “substantial damages, including lost profits” due to the patent infringement. It is also seeking attorney fees.
In a somewhat similar case in 2017, Merck agreed to pay Bristol Myers $625 million in damages as a result of a patent infringement lawsuit related to cancer drugs. That patent was associated with shutting off a chemical pathway for programmed cell death receptor 1 (PD-1). Merck’s cancer treatment drug also infringed on Opdivo, the same drug mentioned in Bristol Myers’ March 2022 lawsuit against AstraZeneca.
Opdivo has made more money for Bristol Myers in recent years than Yervoy.. According to the company’s financial report, it made $7.5 billion in revenue from Opdivo in 2021. At the time of the 2017 lawsuit, Bristol Myers made just shy of $5 billion in revenue from Opdivo.
There is no publicly available information regarding AstraZeneca’s revenue from Imjudo, however, through the third quarter of 2022, the multinational has pulled in over $2 billion in revenue for Imfinzi, according to the company’s latest financial statements.
While there is no data on Imjudo’s market success, the company did list its FDA approval as a key milestone for the year.
Cancer immunotherapy is a booming market, with an estimated global revenue of USD 104.96 billion in 2021. That is expected to expand at a compound annual growth rate (CAGR) of 7.2% from 2022 to 2030. 1.7 million people in the United States are diagnosed with cancer each year according to the Center for Disease Control and Prevention, and about 600,000 people die each year in the country due to cancer.
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