USPTO Invalidates Pharmacyclics Patent Challenged by BeiGene in BRUKINSA Dispute
In a significant development in the ongoing intellectual property battle between two major players in the oncology therapeutics market, BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global biotechnology company specializing in cancer treatments, announced that the United States Patent and Trademark Office (USPTO) has issued a Final Written Decision invalidating all challenged claims of Pharmacyclics LLC’s U.S. Patent No. 11,672,803. The ruling marks a critical win for BeiGene in its defense of BRUKINSA® (zanubrutinib), its flagship Bruton’s tyrosine kinase (BTK) inhibitor.
The USPTO’s ruling follows a post-grant review (PGR) proceeding initiated by BeiGene in response to a patent infringement lawsuit filed by Pharmacyclics. The legal battle centers around the ‘803 patent, which Pharmacyclics alleged was infringed by BRUKINSA. In its petition filed on November 1, 2023, BeiGene argued that the claims in the ‘803 patent were overly broad, lacking in novelty, and did not meet the necessary standards of patentability under U.S. law.
After reviewing the petition, the USPTO agreed to institute the PGR proceeding on May 1, 2024, allowing a full assessment of the patent’s validity. Now, one year later, the USPTO has sided with BeiGene, issuing a final decision that all the challenged claims are invalid. While Pharmacyclics retains the right to appeal the decision, the ruling substantially weakens its position and may influence the outcome of related litigation.
Background of the Dispute
Pharmacyclics, a subsidiary of AbbVie Inc., is known for its development of ibrutinib, a pioneering BTK inhibitor marketed under the brand name IMBRUVICA®. BTK inhibitors have become a cornerstone of targeted therapy for B-cell malignancies such as chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), and Waldenström’s macroglobulinemia (WM). BRUKINSA, BeiGene’s competing BTK inhibitor, has steadily gained global market traction and regulatory approvals since its initial launch.
The patent dispute arose when Pharmacyclics filed a lawsuit alleging that BRUKINSA infringed upon its intellectual property, specifically the ‘803 patent, which covers certain formulations and methods of treating cancer using BTK inhibitors. BeiGene responded by filing a PGR—a mechanism created under the America Invents Act (AIA) that allows third parties to challenge the validity of a newly issued patent within nine months of its grant.
Implications of the USPTO Ruling
The USPTO’s decision to invalidate all challenged claims in the ‘803 patent is a major legal and strategic win for BeiGene. In its final ruling, the Patent Trial and Appeal Board (PTAB) agreed with BeiGene’s arguments that the patent claims were either anticipated by prior art or rendered obvious, failing to meet the standards for patent protection.
“We are pleased that the USPTO invalidated all challenged claims of the ‘803 patent,” said Chan Lee, General Counsel of BeiGene. “Today’s decision reinforces our belief that Pharmacyclics’ patent is overly broad and invalid. BeiGene is confident in the strength of our intellectual property supporting BRUKINSA, a clearly differentiated and independently developed medicine.”
Lee emphasized that BRUKINSA is the product of years of internal research and development and has demonstrated clear clinical advantages over existing therapies in key studies. The drug has received regulatory approvals in more than 70 countries and regions for treating multiple B-cell malignancies, including CLL, MCL, WM, and marginal zone lymphoma (MZL).
“With a robust body of clinical evidence and global regulatory endorsements, BRUKINSA continues to set a new standard of care for patients worldwide,” Lee added.
What’s Next for Pharmacyclics?
Although Pharmacyclics may appeal the USPTO’s decision to the U.S. Court of Appeals for the Federal Circuit, the outcome of the PGR proceeding significantly undermines the enforceability of the ‘803 patent. An appeal would likely extend the litigation timeline and add further legal costs, but the chances of reversing a PTAB decision are statistically low, with the Federal Circuit historically affirming a majority of the Board’s rulings.
In the meantime, the invalidation of the patent may have ripple effects on related litigation strategies and licensing negotiations. If upheld, the USPTO decision could also affect Pharmacyclics’ ability to assert similar claims against other BTK inhibitors or pharmaceutical companies operating in the same therapeutic space.
Market Context and Industry Impact
The ruling comes at a pivotal moment in the oncology pharmaceutical landscape. With the global BTK inhibitor market projected to reach $15 billion by the end of the decade, competition among drugmakers is intensifying. BRUKINSA has emerged as a credible rival to IMBRUVICA, particularly in regions such as the U.S., China, and Europe, where payers and healthcare providers are increasingly focused on both clinical efficacy and cost-effectiveness.
Head-to-head clinical trials have shown BRUKINSA to have favorable safety and efficacy profiles compared to ibrutinib. For instance, in the ALPINE trial, BRUKINSA demonstrated superior progression-free survival and lower rates of cardiovascular side effects—key factors that have contributed to its growing adoption.
The legal outcome also highlights the role of post-grant review as a potent tool for challenging questionable patents in the life sciences sector. PGR proceedings are particularly impactful because they allow for a broad range of challenges, including on grounds of prior art, obviousness, and written description. In this case, BeiGene successfully leveraged the process to dismantle an obstacle to its market expansion.
BeiGene’s Strategic Position
Founded in 2010 and headquartered in Cambridge, Massachusetts and Beijing, China, BeiGene has evolved into a major player in the global oncology market. The company is currently in the process of rebranding itself as BeOne Medicines Ltd., signaling its broader ambitions beyond BTK inhibitors. In addition to BRUKINSA, BeiGene’s pipeline includes multiple immuno-oncology agents and small molecule therapies targeting hematologic malignancies and solid tumors.
The victory in the PGR proceeding strengthens BeiGene’s intellectual property position at a time when competition and scrutiny in the oncology sector are mounting. With regulatory approvals continuing to expand and additional clinical data forthcoming, BRUKINSA is poised to further solidify its market position in the BTK inhibitor category.
The USPTO’s invalidation of Pharmacyclics’ ‘803 patent represents a decisive win for BeiGene in its ongoing efforts to defend BRUKINSA against intellectual property challenges. While Pharmacyclics may still pursue an appeal, the current ruling not only weakens its legal footing but also removes a potential barrier to BRUKINSA’s continued commercial momentum.
As pharmaceutical companies compete for market share in the high-stakes world of oncology innovation, this case underscores the importance of rigorous patent examination, evidence-based litigation strategies, and the strategic use of administrative review mechanisms like PGR. For BeiGene, the decision reinforces its confidence in BRUKINSA as a globally differentiated therapy supported by a robust and defensible intellectual property portfolio.
About BeiGene
BeiGene, which plans to change its name to BeOne Medicines Ltd., is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents.
