Two companies in the field of hematological oncology, AbbVie and BeiGene, have once again taken legal action. Industry media Fierce Biotech recently reported that AbbVie has filed a lawsuit against BeiGene, accusing the latter of stealing AbbVie's trade secrets during the development of BTK degradation agents. A spokesperson for BeiGene denied these allegations and stated that AbbVie's action was "to prevent the development of BGB-16673", and the company will "conduct a firm defense".
Since Ibrutinib and Zebrutinib, AbbVie and BeiGene have been "pinching" in the field of hematological oncology.
AbbVie claims former employee switched jobs and 'took away' trade secrets
In the latest lawsuit filed, AbbVie's lawyer stated that BeiGene "lured and encouraged" the defendant in the case, former AbbVie scientist Liu Huaqing, to switch jobs and share patent information about AbbVie's BTK degradation agent development project for hematological tumors that he had come into contact with during his time at AbbVie.
The lawsuit mainly revolves around AbbVie's research on the BTK degradation agent candidate drug ABBV-101, which is currently in the first phase of clinical trials for B-cell malignancies. In terms of BeiGene, the variety number is BGB-16673, which is used for the third line treatment of adult patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. It recently obtained the fast track qualification from the US Food and Drug Administration (FDA). Compared with traditional BTK inhibitors (including Ibrutinib developed jointly by AbbVie and Johnson&Johnson, and Zebutinib from BeiGene), this new investigational drug blocks some of the protein's functions and can completely degrade related proteins.
According to the lawsuit, Liu Huaqing worked at Abbott Laboratories, the predecessor of AbbVie, from 1997 to 2013, and continued to work at AbbVie after its spin off from Abbott Laboratories until his retirement in 2019. Lawyer AbbVie added that Liu Huaqing served as a senior research expert for AbbVie's BTK degradation agent project from September 2018 to December 2019. According to his LinkedIn page, Liu Huaqing immediately jumped to BeiGene as an executive director.
AbbVie stated in the lawsuit that while Liu Huaqing was still working at AbbVie, BeiGene "discovered, targeted, and recruited him to leave AbbVie and join BeiGene's competing BTK degradation agent project." The lawsuit also claimed that BeiGene's interest in Liu Huaqing "exceeded his ability as a scientist. The legal team of AbbVie subsequently stated that the company's competitors in the cancer field lured and encouraged Liu Huaqing to violate confidentiality agreements, "steal AbbVie BTK degradation agent trade secrets and confidential information, provide it to BeiGene, and ultimately apply relevant information in BeiGene
AbbVie believes that within six months of Liu Huaqing's joining, BeiGene submitted a series of patent applications for the first time, which used and disclosed the trade secrets of AbbVie's BTK degradation agent. AbbVie also claimed that the BTK downgrade agent disclosed by BeiGene in its patent application "used trade secrets and key design elements developed by Liu Huaqing before his resignation, which are similar in many aspects".
BeiGene denies allegations: launches firm defense
BeiGene, on the other hand, has a different view. In an interview with the New Beijing News, BeiGene denied AbbVie's allegations and stated that it will launch a resolute defense to defend its intellectual property rights.
We believe that the lawsuit intends to impede the development process of BGB-16673, which is currently the fastest progressing BTK degradation agent in clinical development. BeiGene had already applied for a patent for BGB-16673 several years before AbbVie first applied for a BTK degradation agent patent According to data shared by BeiGene, as of now, more than 300 patients from 15 countries and regions have received treatment in the BGB-16673 global clinical development project, which was launched several years earlier than the AbbVie project.
BeiGene stated that the company's focus on advancing the BGB-16673 development project will not be interrupted by this lawsuit. The drug has the potential to become an important treatment option for patients with disease progression and limited choices after using BTK inhibitors.
Lawsuits related to blood tumor drugs are not new for AbbVie and BeiGene. In the summer of 2023, AbbVie claimed in a lawsuit that BeiGene's Zebutinib infringed on one of its Ibrutinib patents.
A securities filing submitted by BeiGene last year showed that in October of that year, the court overseeing the case decided to shelve the infringement lawsuit against BeiGene and wait for the results of the patent examination by the United States Patent and Trademark Office (USPTO). In May of this year, the US Patent and Trademark Office approved BeiGene's appeal and is expected to make a final decision on patent validity within a year.
The 'enemy' of BTK inhibitors
The competition between AbbVie and BeiGene in the field of BTK inhibitors has a long history.
As an important therapeutic drug for treating diseases such as B-cell lymphoma, inflammation, and autoimmune disorders, there are currently five BTK inhibitors approved worldwide, namely Ibrutinib (Johnson&Johnson/AbbVie), Akatinib (AstraZeneca), Terarutinib (Ono Pharmaceuticals), Zebutinib (BeiGene), and Obutinib (Norinco). Hematology oncology is a concentrated area for various products.
Among them, Ibrutinib is the world's first BTK inhibitor, approved for market in 2013, leading to a revolutionary breakthrough in the field of hematological cancer treatment, and its sales scale has also skyrocketed. Currently, it has brought billions of dollars in revenue to AbbVie, and its market share was once absolutely leading. In 2021, Ibrutinib's market share reached 87%.
Zebutenib is a BTK inhibitor independently developed by Baekje China, which was first approved by the US FDA for listing in November 2019, becoming the first indigenous innovative drug in China to go to sea, and was approved for listing in China in June 2020. With the expansion of indications, Zebutinib is gradually opening up the market and also seizing the market share of Ibrutinib. In 2020, Zebutinib, which had been on the market for two years, brought in $41.7 million in revenue for BeiGene. At the same time, Ibrutinib's global sales reached $9.442 billion. However, by 2023, Zebutinib's sales not only approached $1.2 billion, but also became China's first "blockbuster" drug to enter the "billion dollar molecule" club. It should be noted that in the field of biopharmaceuticals, drugs with annual revenues exceeding $1 billion are often referred to as "blockbuster" drugs. The birth of a "heavyweight bomb" drug not only signifies a milestone commercial achievement for the company, but also proves that the drug has the ability to revolutionize treatment. Zebutinib became a "blockbuster" drug four years after its approval, and data shows that other "blockbuster" drugs take an average of about 10 years. In the first half of this year, the global sales of Zebutinib were 1.126 billion US dollars, while Ibrutinib was 3.225 billion US dollars, and the gap between the two is getting smaller and smaller.
The 'head to head' test is a direct confrontation between the two sides. In December 2022, during the annual meeting of the American Society of Hematology (ASH), BeiGene announced the final analysis results of progression free survival (PFS) for Zebutinib and Ibrutinib in the global Phase 3 head to head ALPINE trial. Data shows that in addition to superior efficacy, Zebutinib also exhibits higher safety and tolerability. The so-called head to head research refers to conducting clinical trials with previously used therapeutic drugs or methods as controls, with the aim of conducting more detailed studies and comparisons of drug efficacy or safety. In head to head research, it is divided into efficacy studies and equivalent/non inferiority studies. Efficacy studies are conducted to directly verify whether one drug is superior to another, with stronger efficacy and safety.
The Frost&Sullivan report shows that the global BTK inhibitor market size will reach 13.2 billion US dollars by 2026, and the Chinese BTK inhibitor market size will reach 6.4 billion yuan by 2026. The BTK degradation agent under development has attracted much attention due to its ability to solve the problem of resistance to BTK inhibitors. During the research and development stage, the two already fiercely competitive rivals have "pinched" each other.
New Beijing News reporter Zhang Xiulan