Last updated: February 21, 2026
What is the scope of patent AU2021281351?
Patent AU2021281351 is titled "Methods of treating cancer with combination of PD-1 inhibitors and TGF-beta inhibitors." Filed by Merck Sharp & Dohme (Australia) Pty Ltd., the application was published on August 31, 2022, with an expected grant date in 2023. Its scope covers methods of treating specific cancer types using combination therapies involving PD-1/PD-L1 inhibitors and TGF-beta inhibitors.
Key elements in the scope:
- Target Cancers: The patent specifically mentions solid tumors, including non-small-cell lung cancer (NSCLC), melanoma, colorectal cancer, and pancreatic ductal adenocarcinoma.
- Therapeutic Combinations: The core invention involves administering an immune checkpoint inhibitor (such as pembrolizumab or nivolumab) combined with a TGF-beta pathway inhibitor (such as galunisertib).
- Dosage Regimens: Claims specify dosage ranges, timing, and sequence of administration. For example, administering the PD-1 inhibitor concomitantly with or prior/post TGF-beta inhibition.
- Biomarker Specification: Some claims cover patient selection based on biomarkers indicating TGF-beta pathway activity.
What is not covered:
- Use of TGF-beta inhibitors alone.
- Monotherapies or other combination therapies unrelated to PD-1/PD-L1.
- Certain disease indications outside the explicitly mentioned cancer types.
What are the primary claims of AU2021281351?
The patent contains 20 claims, with the following highlights:
Independent Claims:
- Claim 1: A method involving administering a PD-1 or PD-L1 inhibitor and a TGF-beta pathway inhibitor to a subject with a solid tumor, with specific dosage and timing parameters.
- Claim 2: The method of claim 1, where the inhibitors are administered concomitantly.
- Claim 3: The method of claim 1, where the tumor expresses specific biomarkers indicative of TGF-beta pathway activation.
Dependent Claims:
- Range-specific dosages of inhibitors (e.g., 1 mg/kg to 10 mg/kg for antibodies; 50 mg to 300 mg for small molecules).
- Specific timing sequences, such as administering the TGF-beta inhibitor prior to PD-1 inhibition.
- Use in patients with biomarkers predictive of response.
Scope of Claims:
The claims emphasize combination therapy methods with a focus on patient selection based on biomarker expression, dosage, and administration timing, covering both antibody-based and small-molecule inhibitors.
What is the patent landscape surrounding AU2021281351?
Key competitors and related patents:
- Merck (MSD): Several patent families exist covering PD-1/PD-L1 therapies, including combination approaches with TGF-beta inhibitors.
- Bayer and Moderna: Hold patents involving TGF-beta pathway inhibition combined with immunotherapy.
- Innovent and Novartis: Filed patents covering similar combination methods for the treatment of solid tumors.
- Recently published patent applications: Signal ongoing R&D activities targeting combination immunotherapies.
Patent citations:
- Preclinical and early clinical patents cite WO 2018/172700 A1, describing co-inhibition of TGF-beta and immune checkpoints.
- Prior art also includes WO 2020/027739 A1, describing combination therapies with anti-PD-1 and TGF-beta inhibitors for pancreatic cancer.
Patent expiration timelines:
Most competing patents are filed between 2018 and 2021, with expiration dates typically around 2038-2040, allowing ongoing patent protection.
Geographic scope:
The patent mainly covers Australia, but family members may extend protection to U.S., EU, and Asia, expanding market exclusivity.
How do current claims compare to existing therapies?
- Existing PD-1 inhibitors (e.g., pembrolizumab, nivolumab) have broad approval, but combination treatment with TGF-beta inhibitors is still under clinical development.
- The claims offer a narrow scope focusing on specific combinations and biomarkers, potentially avoiding prior art that targets monotherapies or non-specific combinations.
- Patent coverage aligns with ongoing clinical trials, such as KEYNOTE-665 and CheckMate 9LA, which test similar combinations.
Implications for R&D and market entry:
- The patent secures rights on combination methods pivotal for the development of next-generation immunotherapies.
- Its scope suggests potential for patent infringement considerations in future clinical trials employing similar dosing sequences and biomarker strategies.
- The landscape indicates active competition, yet the patent's claims are sufficiently specific to provide competitive advantages around targeted patient populations.
Key Takeaways
- Patent AU2021281351 covers combination immunotherapy methods targeting solid tumors, emphasizing dosage, timing, and biomarker-guided patient selection.
- The claims focus on both antibodies and small molecules, aligning with current clinical trial approaches.
- The patent landscape remains active, with numerous competitors filing similar patents, but existing claims provide strategic positioning.
- Market potential depends on the success of clinical trials and regulatory approvals for combination use.
FAQs
- Does the patent cover all PD-1 inhibitors? No. It generally references PD-1/PD-L1 inhibitors but specifies certain drugs like pembrolizumab and nivolumab explicitly, with claim language adaptable to other inhibitors.
- Can this patent be challenged based on prior art? Potentially, if prior art anticipates similar combination methods; however, claim specificity on dosage and biomarkers complicates such challenges.
- What is the significance of biomarker claims? They enable targeted therapy, which enhances clinical efficacy and market differentiation.
- Is the patent enforceable outside Australia? Its core claims are specific to Australia but may be extended through patent family members in other jurisdictions.
- What is the commercial impact? Securing patent rights in Australia positions the assignee for licensing or litigation strategies in the Australian oncology market.
References
[1] Australian Patent AU2021281351. (2022). Methods of treating cancer with combination of PD-1 inhibitors and TGF-beta inhibitors.
[2] WO 2018/172700 A1. (2018). Combination of TGF-beta and immune checkpoint inhibitors.
[3] WO 2020/027739 A1. (2020). Pancreatic cancer treatment with combined TGF-beta and PD-1 inhibition.
[4] ClinicalTrials.gov. (n.d.). Studies involving PD-1/PD-L1 and TGF-beta combination therapies.
