Core European Patent for Janssen's Blockbuster Psoriasis Drug Guselkumab Revoked
Johnson & Johnson
Healthcare Product Manufacturers, Health Service Providers
European Patent Office
The European Patent Office is one of the two bodies of the European Patent Organisation, the other being the Administrative Council. The European Patent Office (EPO) serves as the executive body of the Organisation, while the Administrative Council acts both as its supervisory body and, to a certain extent, as its legislative body. The actual power to amend the European Patent Convention rests with the Contracting States themselves, exercised through the Conference of Contracting States.
On February 28, 2020, the European Patent Office (EPO) decided to revoke European Patent No. 1896073 (hereinafter referred to as EP1896073B1). As the appeal period has expired, the revocation decision has become final and effective. The title of patent EP1896073B1 is “Anti-IL-23 antibodies, compositions, methods and uses,” and the patentee is Janssen Biotech, Inc. This patent is one of the core patents for the psoriasis drug guselkumab.
The parties requesting the revocation of EP1896073B1 are three renowned companies: Boehringer Ingelheim Pharma GmbH & Co. KG, Merck Sharp & Dohme Corp., and Eli Lilly and Company.
The patent in suit, EP1896073B1, was filed on June 30, 2006, and granted by the European Patent Office on March 6, 2013. Invalidity proceedings against this patent were initiated in December 2013, with separate oppositions filed by Boehringer Ingelheim (Germany), Merck & Co., and Eli Lilly and Company (Merck & Co. and Eli Lilly and Company subsequently withdrew their oppositions during the proceedings). The grounds for opposition were primarily based on Article 54 (novelty), Article 56 (inventive step), and Article 123(2) (added subject-matter) of the European Patent Convention (EPC 1973).
EP1896073B1 covers chimeric, humanized, engineered, and human antibodies within the scope of the claims of the present invention, providing a relatively broad scope of protection. The patent comprises 28 claims, including three independent claims, namely Claim 1, Claim 7, and Claim 13. Interested readers may interpret these claims on their own.
About Guselkumab
Guselkumab (Chinese name: Guselkumab; brand name: Tremfya/Tenuoya) is a humanized monoclonal antibody developed by Johnson & Johnson in the United States that binds to the p19 subunit of interleukin-23 (IL-23), thereby blocking the action of IL-23. In July 2017, the FDA approved Tremfya for the treatment of moderate-to-severe plaque psoriasis. In February 2019, it received FDA approval for a self-injectable formulation for the treatment of plaque psoriasis in adults. In China, guselkumab was included in the “First Batch of Clinically Urgent Overseas New Drugs List” in 2018. The marketing application was submitted in June 2019, and approval was granted in just six months, in December 2019. It was officially launched in the Chinese market in March 2020.
To date, Tremfya has been approved in multiple countries and regions worldwide for the treatment of adult patients with moderate to severe plaque psoriasis.
Tremfya (Guselkumab) recorded global sales of $544 million in 2018, which rose to $1.012 billion in 2019, ranking it 148th among the top 200 drugs worldwide by sales. According to EvaluatePharma forecasts, Tremfya’s sales are projected to surpass $3 billion by 2023, indicating strong market potential.
Conclusion:
As the sales of Guselkumab increase, it is believed that it will attract more attention from generic drug manufacturers. Although European patent EP1896073B1 has been declared invalid, its counterpart patents in China and other core patents remain valid, meaning the patent barriers still exist.
As a pharmaceutical company, it is essential to conduct comprehensive patent research and analysis during project initiation and the R&D process. Furthermore, design-around strategies should be implemented for products based on international intellectual property trends and competitors’ R&D activities, thereby ensuring a thorough understanding of both one’s own position and that of rivals.
References:
Yaozhi Patent Connect
European Patent Office
Janssen China Official Website
Top200 Drugs By Retail Salesin 2019
Responsible Editor: Xi Ran
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