Last updated: February 19, 2026
This analysis details Chilean patent application CL2018002515, filed on September 11, 2018, by ASTRAZENECA AB. The patent claims a novel pharmaceutical composition comprising a specific combination of compounds, their methods of use, and related diagnostic methods. The claimed invention addresses the treatment of various cancers, particularly those driven by genetic mutations.
What Does CL2018002515 Claim?
The patent application CL2018002515 primarily claims a pharmaceutical composition and its therapeutic applications. The core of the invention lies in the combination of a programmed death-ligand 1 (PD-L1) inhibitor and a poly (ADP-ribose) polymerase (PARP) inhibitor.
What is the Pharmaceutical Composition?
The claimed pharmaceutical composition comprises:
- A compound that inhibits PD-L1. This includes but is not limited to durvalumab, an antibody that binds to PD-L1.
- A compound that inhibits PARP. This includes but is not limited to olaparib, an orally active PARP inhibitor.
- Optionally, a pharmaceutically acceptable carrier.
The composition can be formulated for co-administration or sequential administration of the PD-L1 inhibitor and the PARP inhibitor.
What are the Claimed Methods of Treatment?
The patent application asserts methods of treating various types of cancer. These cancers are characterized by specific genetic alterations, including:
- Tumors with homologous recombination deficiency (HRD).
- Tumors with a mutation in a BRCA1 or BRCA2 gene.
- Tumors with microsatellite instability (MSI) status.
- Tumors with specific PD-L1 expression levels.
The claimed methods involve administering the combination of a PD-L1 inhibitor and a PARP inhibitor to a subject in need thereof. The patent also covers diagnostic methods to identify patients likely to benefit from this combination therapy. This includes identifying tumors with HRD, BRCA mutations, or specific MSI status.
What is the Patent Landscape for This Invention?
The patent landscape for combination therapies involving PD-L1 inhibitors and PARP inhibitors is dynamic and highly competitive. Several pharmaceutical companies hold patents on individual components and their combinations for various indications.
Key Competitors and Their Patents
Major players in oncology drug development are actively patenting similar therapeutic strategies. This includes companies developing PD-1/PD-L1 checkpoint inhibitors and PARP inhibitors.
- AstraZeneca AB: As the applicant for CL2018002515, AstraZeneca is a key entity. Their portfolio includes durvalumab (Imfinzi) as a PD-L1 inhibitor and olaparib (Lynparza) as a PARP inhibitor. They hold numerous patents covering these drugs individually and in combination for various cancer types. For instance, patent WO2016135279A1 also describes combinations of PD-L1 inhibitors and PARP inhibitors for treating cancers.
- Merck & Co., Inc.: Known for its PD-1 inhibitor pembrolizumab (Keytruda), Merck has also explored combinations with other agents. Their patent filings often cover broad classes of compounds and their use in various cancer settings. Patent US9968769B2 describes combinations of immune checkpoint inhibitors with other agents for cancer treatment.
- Pfizer Inc.: Pfizer has developed PARP inhibitors and has been active in patenting combination therapies. Their research also extends to other immunotherapy targets. Patent WO2017095778A1 covers combinations for treating specific cancer types.
- Clovis Oncology, Inc.: A significant player in PARP inhibitor development with its drug rucaparib, Clovis Oncology has also filed patents on combination therapies. Patent WO2018012008A1 relates to combinations including PARP inhibitors.
- Tesaro, Inc. (acquired by GlaxoSmithKline): Tesaro developed niraparib, another PARP inhibitor, and has patents covering its use in combination with other therapies.
The landscape is characterized by a high volume of patent filings, often focusing on specific cancer types, patient populations defined by biomarkers, and distinct dosing regimens.
Relevant Patent Families and Geographic Coverage
Patent families related to durvalumab and olaparib combinations are extensive. These applications are filed in major pharmaceutical markets including the United States, Europe, Japan, and other key territories. The Chilean application CL2018002515 is part of a broader strategy to secure intellectual property rights globally.
Analyzing patent families requires examining PCT applications and their national phase entries. For instance, PCT application WO2017058055A1 by AstraZeneca describes similar combination therapies, which may be linked to the Chilean filing.
Trends in Combination Therapy Patents
Current trends in patenting combination therapies for cancer include:
- Biomarker-Driven Therapies: Patents increasingly specify patient selection criteria based on genetic mutations (e.g., HRD, BRCA status, MSI-high) or protein expression levels (e.g., PD-L1 expression). This is directly reflected in CL2018002515.
- Specific Cancer Indications: Claims are often tailored to specific cancer types (e.g., ovarian, breast, lung, prostate) or stages of disease.
- Dosing and Administration Regimens: Novel dosing schedules, routes of administration, and treatment sequences are being patented to differentiate from existing therapies and enhance efficacy or reduce toxicity.
- Second-Generation Inhibitors: Patents are emerging for next-generation PD-1/PD-L1 inhibitors and PARP inhibitors, as well as combinations with other novel agents.
What are the Implications of This Patent?
The patent CL2018002515, if granted and maintained, provides AstraZeneca with exclusive rights to market and sell the claimed combination therapy in Chile. This has significant implications for the pharmaceutical market, competition, and patient access.
Market Exclusivity and Competition
Upon grant, this patent will grant AstraZeneca a monopoly over the claimed composition and method of use in Chile for the patent's term, typically 20 years from the filing date. This exclusivity prevents competitors from launching generic or biosimilar versions of the combination therapy during this period.
The competitive landscape for cancer therapies is intense. The presence of this patent could deter other companies from developing and marketing similar combination treatments in Chile or require them to seek licensing agreements.
R&D and Investment Decisions
For R&D departments and investors, this patent indicates a defined innovation and a protected market segment.
- For AstraZeneca: It secures their investment in developing durvalumab and olaparib in combination for specific cancer indications. It provides a basis for market penetration and revenue generation.
- For Competitors: It necessitates careful assessment of patent scope and potential freedom-to-operate issues before investing in similar research or commercialization strategies in Chile. This may lead to focusing on different patient populations, alternative drug combinations, or exploring markets with expired patents.
- For Investors: Understanding the patent portfolio surrounding these drugs is critical for evaluating market potential, risk, and the competitive positioning of companies involved in oncology. The strength and breadth of the patent claims, as well as potential challenges to their validity, are key considerations.
Patent Validity and Enforcement
The strength of CL2018002515 will depend on its examination by the Chilean National Institute of Industrial Property (INAPI) and its ability to withstand potential post-grant challenges. Key factors for patentability include novelty, inventive step (non-obviousness), and industrial applicability.
If challenged, the patent's validity could be scrutinized based on prior art, including scientific literature and earlier patents. Enforcement by AstraZeneca would involve monitoring the market for infringing products and potentially pursuing legal action to prevent unauthorized use of the patented technology.
Key Takeaways
Chilean patent application CL2018002515 by AstraZeneca AB protects a pharmaceutical composition comprising a PD-L1 inhibitor and a PARP inhibitor for treating specific types of cancer. The claims extend to methods of use in patients with homologous recombination deficiency, BRCA mutations, or specific MSI and PD-L1 expression profiles, and include associated diagnostic methods. The patent landscape for such combination therapies is robust, with multiple pharmaceutical companies actively patenting similar strategies. This patent, if granted, would provide AstraZeneca with market exclusivity in Chile, influencing R&D and investment decisions by both AstraZeneca and its competitors.
Frequently Asked Questions
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What is the specific mechanism by which the combination of PD-L1 inhibitors and PARP inhibitors is claimed to be effective in treating cancer?
The patent claims the synergistic effect of inhibiting PD-L1 to enhance anti-tumor immune responses and inhibiting PARP to exploit DNA repair deficiencies in cancer cells, particularly those with homologous recombination deficiency (HRD). This dual approach aims to overcome tumor resistance and improve therapeutic outcomes.
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Are there any specific examples of PD-L1 inhibitors and PARP inhibitors mentioned in the patent application?
While the patent claims broadly cover compounds that inhibit PD-L1 and PARP, it explicitly mentions durvalumab as an example of a PD-L1 inhibitor and olaparib as an example of a PARP inhibitor within its disclosure.
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What does "homologous recombination deficiency" (HRD) mean in the context of cancer treatment?
HRD refers to a state where a cancer cell's ability to repair damaged DNA through homologous recombination is impaired. This often results from mutations in genes like BRCA1 or BRCA2. Tumors with HRD are considered more sensitive to DNA-damaging agents like PARP inhibitors.
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What is the significance of "microsatellite instability" (MSI) status in relation to this patent?
Microsatellite instability (MSI) is a condition in cancer cells characterized by a high mutation rate due to defects in DNA mismatch repair. Tumors with MSI-high status are often more responsive to immunotherapy, and the patent may be claiming combinations that enhance efficacy in this patient subgroup.
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Does this patent application restrict the use of durvalumab or olaparib individually in Chile?
This patent application specifically claims a combination therapy. It does not inherently restrict the use of durvalumab or olaparib as monotherapies, provided those individual uses are covered by separate patents or are otherwise permissible. However, any new combination therapy involving these agents would need to consider the scope of this patent.
Citations
[1] AstraZeneca AB. (2018). Pharmaceutical compositions comprising a PD-L1 inhibitor and a PARP inhibitor and uses thereof (Chilean Patent Application No. CL2018002515). National Institute of Industrial Property (INAPI).
[2] AstraZeneca AB. (2016). Combination of PD-L1 inhibitor and PARP inhibitor (PCT International Application No. WO2017058055A1). World Intellectual Property Organization.
[3] Merck & Co., Inc. (2018). Combination therapies for treating cancer (U.S. Patent No. US9968769B2). United States Patent and Trademark Office.
[4] Pfizer Inc. (2017). Combinations for treating cancer (PCT International Application No. WO2017095778A1). World Intellectual Property Organization.
[5] Clovis Oncology, Inc. (2018). Combinations for treating cancer (PCT International Application No. WO2018012008A1). World Intellectual Property Organization.
