Domestic original pharmaceutical companies have rarely sued European and American generic pharmaceutical companies.
On March 8th, BeiGene filed a patent infringement lawsuit against Sanders, MSN Pharmaceuticals, Inc., and MSN Laboratories Private Ltd. (collectively referred to as "MSN") in the United States.
Previously, Sanders and MSN submitted a Brief New Drug Application (ANDA) notice to the US Food and Drug Administration (FDA) in order to obtain approval for the sale of a generic drug of Zebutinib, challenging individual Zebutinib patents to be invalid, unenforceable, or non infringing, and sent a notice to BeiGene. In the notice, neither Sanders nor MSN challenged the substance patent of Zebutinib, which remains unchanged and protects Zebutinib from generic drug competition until its expiration in 2034.
The patent infringement lawsuit filed by BeiGene against the aforementioned two companies is precisely because of this matter. Baekje Shenzhou believes that Sanders and MSN's submission of ANDA infringes on Zebutinib's patent and will seek a permanent injunction to prevent Sanders and MSN from commercializing Zebutinib's generic drug before the patent expires.
Application to Market (ANDA) lawsuits for generic drugs are common in the US pharmaceutical industry, and BeiGene is expected to receive notifications from other generic drug companies and file more ANDA lawsuits in the future.
But the special feature of the case of BeiGene is that the roles of both parties in patent litigation have changed.
In the past, many foreign original pharmaceutical companies filed patent lawsuits against domestic generic drug companies. For example, in 2019, AstraZeneca filed patent lawsuits against Jiangsu Oselcon's approved Sagagliptin tablets and Huabang Pharmaceutical's long-awaited Anatrazole tablets, respectively. In 2022, Roche Pharmaceutical filed patent lawsuits against Shiyao Group's approved Mabalozavir tablet generic drug. The case of BeiGene is a patent lawsuit filed by a domestic original pharmaceutical company against a foreign generic pharmaceutical company.
Zebutinib is the core product of BeiGene. In 2023, Zebutinib's sales reached 1.3 billion US dollars, a year-on-year increase of 138.7%, becoming the first domestically produced "billion dollar molecule". It is not difficult to understand why BeiGene is trying its best to delay the launch of its generic drug despite litigation.
It is common practice to obstruct competitors in the pharmaceutical industry through patent litigation, and Zebutinib is currently facing patent litigation from foreign investment.
Since the listing of Zebtinib, its biggest competitor Ibrutinib's market share has begun to shrink. Ibrutinib, which is responsible for Abervi and Johnson&Johnson, has seen a decrease of 15.53% and 13.39% in the US and non US markets, respectively. Zebtinib's global sales have increased by 159.03% year-on-year.
And in 2023, the National Comprehensive Cancer Network (NCCN) Guidelines for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) in the United States updated version V1, elevating Zebutinib to the highest level of recommendation for first-line CLL without del (17p)/TP53 mutations, while Ibrutinib metastasizes to "other recommendations.".
Seeing Ibrutinib's market share gradually shrink, Abervi had to take action. On June 16, 2023, Baekje announced that it had received an appeal from Aberdeen, who accused Zebtinib of infringing on a patent of Ibrutinib. However, Aberdeen's patent had just been granted on June 13, 2023. Undoubtedly, Aberdeen's move is to compete with BeiGene for the market.