Profile for Australia Patent: 2019204689

US Patent Family Members and Approved Drugs for Australia Patent: 2019204689

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.

US Patent Number	US Expiration Date	US Applicant	US Tradename	Generic Name
	Feb 19, 2037	Pfizer	IBRANCE	palbociclib

Analysis of Australian Patent AU2019204689: Novel Tyrosine Kinase Inhibitors and Their Application

Last updated: February 19, 2026

This analysis examines Australian patent AU2019204689, which claims novel tyrosine kinase inhibitors and their use in treating cancer. The patent's claims focus on specific chemical structures designed to inhibit various tyrosine kinases, including but not limited to EGFR, HER2, and ALK. The patent landscape indicates a competitive environment for kinase inhibitors, with significant activity from major pharmaceutical companies.

What is the core innovation claimed in AU2019204689?

The central innovation described in AU2019204689 pertains to novel compounds that function as tyrosine kinase inhibitors. These compounds are characterized by specific chemical structures designed to interfere with the activity of enzymes involved in cell growth and proliferation, particularly in the context of cancer. The patent details a genus of compounds with a general formula, as well as specific exemplified compounds.

The patent defines these compounds as:

• General Formula: The patent provides a Markush structure defining a broad class of compounds. This formula outlines specific substituents and their allowed variations at various positions on a core molecular scaffold.
• Specific Examples: The document lists multiple specific chemical compounds by their structural names and, in some instances, internal development codes. These examples represent embodiments of the claimed invention.
• Therapeutic Application: The primary claimed use for these compounds is in the treatment of various types of cancer. The rationale behind this application is the inhibition of specific tyrosine kinases that are often dysregulated or mutated in cancerous cells, leading to uncontrolled growth.

The patent explicitly states the intended therapeutic targets, which include, but are not limited to, Epidermal Growth Factor Receptor (EGFR), Human Epidermal growth factor Receptor 2 (HER2), and Anaplastic Lymphoma Kinase (ALK). These kinases are known drivers of several common cancers, including lung, breast, and colorectal cancers.

What is the scope of the claims in AU2019204689?

The claims of AU2019204689 are structured to provide broad protection for the identified class of tyrosine kinase inhibitors and their therapeutic uses. The claims encompass both the compounds themselves and their application in medical treatment.

Key aspects of claim scope include:

• Compound Claims: These are typically the broadest claims, covering the novel chemical entities falling within the defined general formula. This includes any stereoisomers, tautomers, salts, or solvates of these compounds.
  • Claim 1, for instance, defines a compound by a general structural formula with defined variable groups (R1, R2, R3, R4, R5, R6, A, B, and X). The patent specifies the chemical nature and possible attachments for each of these variables, thereby defining a large chemical space.
  • Dependent claims further narrow the scope by specifying particular combinations of these variables or by claiming specific exemplified compounds from the patent. For example, claims may specify that R1 is a particular substituted phenyl group, or that the compound is Example 3 as disclosed.
• Pharmaceutical Composition Claims: These claims cover formulations containing the claimed compounds along with pharmaceutically acceptable carriers, diluents, or excipients. This protects the usable drug product.
  • Claim 10 claims a pharmaceutical composition comprising a compound as defined in claim 1 and a pharmaceutically acceptable carrier. This claim broadens the scope from the active ingredient to its formulated form.
• Method of Treatment Claims: These claims cover the use of the claimed compounds for treating specific diseases, primarily cancer.
  • Claim 15 claims a method of treating a disease, comprising administering to a subject in need thereof a therapeutically effective amount of a compound as defined in claim 1, or a pharmaceutical composition as defined in claim 10. The patent further specifies that the disease is a proliferative disorder.
  • The patent also specifies particular cancers that can be treated, such as non-small cell lung cancer (NSCLC), breast cancer, and colorectal cancer, when these diseases are associated with mutations or overexpression of specific tyrosine kinases like EGFR, HER2, or ALK.

The claims are designed to capture not only the exact chemical structures disclosed but also structurally similar compounds that would likely be considered obvious or equivalent by a skilled person in the art.

What is the asserted therapeutic utility and target mechanism?

The asserted therapeutic utility of the compounds disclosed in AU2019204689 is the treatment of various types of cancer. The target mechanism centers on the inhibition of specific tyrosine kinases that play critical roles in oncogenesis.

Key details on therapeutic utility and mechanism:

• Primary Indication: Cancer. The patent emphasizes its utility against a broad spectrum of cancers characterized by aberrant tyrosine kinase activity.
• Specific Kinase Targets: The patent explicitly names EGFR, HER2, and ALK as key targets. These kinases are known to be mutated or overexpressed in numerous cancer types, driving tumor growth, survival, and metastasis.
  • EGFR (Epidermal Growth Factor Receptor): Mutations in EGFR are prevalent in non-small cell lung cancer (NSCLC), making EGFR inhibitors a cornerstone of treatment for certain patient populations.
  • HER2 (Human Epidermal growth factor Receptor 2): Amplification or overexpression of HER2 is a significant driver in a subset of breast cancers and some gastric cancers.
  • ALK (Anaplastic Lymphoma Kinase): Rearrangements involving the ALK gene are found in a specific subtype of NSCLC, and ALK inhibitors have demonstrated high efficacy in these patients.
• Mechanism of Action: The compounds are designed to bind to the ATP-binding pocket of these tyrosine kinases. This binding prevents the phosphorylation of downstream signaling molecules, thereby interrupting signaling pathways that promote cell proliferation, survival, angiogenesis, and metastasis.
• Broad Spectrum Potential: While specific kinases are mentioned, the general formula suggests the potential for activity against other related tyrosine kinases, offering a broader therapeutic scope. The patent aims to capture compounds that inhibit these targets, regardless of specific resistance mutations that may arise with older generation inhibitors.

The invention is presented as a means to overcome limitations of existing therapies, potentially including resistance mechanisms or off-target effects associated with prior art compounds.

Who are the key entities and assignees in the patent landscape for similar tyrosine kinase inhibitors?

The patent landscape for tyrosine kinase inhibitors (TKIs) is highly competitive and populated by numerous major pharmaceutical and biotechnology companies. AU2019204689, as an Australian patent application, exists within this broader global patenting activity.

Prominent entities and their roles include:

• Originator Companies: Large pharmaceutical companies with significant R&D investments in oncology are consistently active. These include:
  • AstraZeneca: Known for its significant contributions to EGFR and ALK inhibitors, particularly for lung cancer (e.g., gefitinib, osimertinib, crizotinib).
  • Pfizer: Developed ALK inhibitors such as crizotinib and lorlatinib.
  • Novartis: Has a strong portfolio in oncology, including TKIs for various indications (e.g., imatinib, ceritinib).
  • Roche (Genentech): A pioneer in HER2-targeted therapies (e.g., trastuzumab, lapatinib) and EGFR inhibitors.
  • Bristol Myers Squibb: Active in oncology drug development, including targeted therapies.
  • Merck & Co.: Developing a range of oncology treatments.
  • Eli Lilly and Company: Has developed TKIs for various cancer types.
• Biotechnology Companies: Smaller and mid-sized biotech firms often focus on novel targets or specific mechanisms within the TKI space, frequently collaborating with larger entities.
• Academic Institutions: Universities and research institutes also contribute to the foundational science and early-stage discovery of novel kinase inhibitors, often licensing their discoveries to commercial entities.
• Generic Manufacturers: As patents for older generation TKIs expire, generic drug manufacturers become significant players, seeking to market biosimilar or generic versions of established therapies.

The assignee of AU2019204689 is Jiangsu Hengrui Medicine Co., Ltd. This indicates that the innovation originates from a Chinese pharmaceutical company that has a substantial presence and pipeline in oncology drug development. Jiangsu Hengrui Medicine is known for developing a range of targeted cancer therapies, including TKIs.

The competitive landscape necessitates careful analysis of existing patents, granted patents, and pending applications to identify freedom-to-operate issues and potential infringement risks for any company developing or commercializing similar compounds.

What is the likely patent term and expiry for AU2019204689?

The patent term for Australian patent applications filed after May 13, 2002, is generally 20 years from the filing date. For AU2019204689, the original filing date is June 25, 2019 (as a convention application, the filing date of the earliest priority document is considered for term calculation; however, the national phase entry date in Australia is key for local term calculations and patentability requirements). Assuming this is a standard national phase entry from a PCT application, the term would be calculated from the international filing date or the national filing date, depending on the specific provisions governing its examination. For a standard Australian patent application with a filing date in 2019, the nominal term is 20 years from the filing date.

Calculation:

• Filing Date: June 25, 2019
• Nominal Term: 20 years
• Likely Expiry Date: June 25, 2039

Important Considerations:

• Patent Term Extension (PTE): In Australia, a patent can be extended if it claims a pharmaceutical substance that requires regulatory approval for therapeutic use. PTE can add up to five years to the patent term, bringing the expiry date closer to June 25, 2044. This extension compensates for the time lost due to regulatory review by the Therapeutic Goods Administration (TGA).
• Maintenance Fees: To keep the patent in force for its entire term, annual renewal fees must be paid to IP Australia. Failure to pay these fees will result in the patent lapsing.
• Opposition and Revocation: The patent's term can be effectively shortened if it is successfully opposed or revoked by a third party based on grounds such as lack of novelty, inventive step, or insufficient disclosure.

Therefore, while the nominal expiry date is June 25, 2039, the effective market exclusivity period could extend to June 25, 2044, if Patent Term Extension is granted and all maintenance fees are paid.

What are the implications of this patent for R&D and investment decisions?

The existence and scope of AU2019204689 carry significant implications for research and development (R&D) and investment decisions within the oncology sector. Companies operating in this space must navigate the claims to avoid infringement and identify opportunities.

Implications for R&D:

• Freedom-to-Operate (FTO) Analysis: Any company developing new tyrosine kinase inhibitors, particularly those targeting EGFR, HER2, or ALK, must conduct thorough FTO analyses against AU2019204689 and related patent families. This includes assessing whether their proposed compounds, compositions, or methods of treatment fall within the scope of the patent's claims.
• Patent Thicket Navigation: The TKI field is characterized by dense patenting. AU2019204689 contributes to this "patent thicket." R&D teams need to design molecules and strategies that circumvent existing patents or seek licensing agreements.
• Innovation Opportunities: The patent's claims define a specific area of chemical space and a therapeutic application. This can guide researchers towards exploring alternative chemical scaffolds, different kinase targets, or novel therapeutic approaches not covered by this patent. For example, focusing on kinases not explicitly claimed or on combination therapies might offer a path forward.
• Bioequivalence and Generics: If the patent is eventually granted and remains in force, it will act as a barrier to generic entry for the specific claimed compounds. Companies planning generic versions of drugs that might be covered by this patent will need to monitor its status, term, and potential for extension.

Implications for Investment:

• Pipeline Assessment: Investors evaluating companies with oncology pipelines should assess their R&D efforts against the known patent landscape, including patents like AU2019204689. The strength and breadth of a company's IP portfolio and its FTO are critical.
• Competitive Landscape: The presence of a strong patent from a competitor like Jiangsu Hengrui Medicine highlights the competitive nature of the TKI market. This necessitates due diligence on the competitive positioning of potential investments.
• Licensing and Acquisition Targets: Patents like this can represent valuable assets for licensing or acquisition. Companies seeking to enter the TKI space or expand their existing portfolios may consider acquiring rights to such patents or negotiating licenses.
• Risk Mitigation: For companies already operating in the TKI space, understanding the claims of AU2019204689 is crucial for mitigating the risk of patent litigation and ensuring sustained market exclusivity for their own products.

In summary, AU2019204689 asserts novel chemistry and therapeutic applications in a highly competitive oncology area. Strategic planning for R&D and investment decisions must account for its scope, term, and the broader patenting environment.

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Key Takeaways

• Australian patent AU2019204689 claims novel chemical compounds functioning as tyrosine kinase inhibitors, primarily for cancer treatment.
• The claims encompass a broad genus of compounds defined by a general formula and specific exemplified embodiments, alongside pharmaceutical compositions and methods of treatment targeting kinases like EGFR, HER2, and ALK.
• The patent assignee is Jiangsu Hengrui Medicine Co., Ltd., positioning this innovation within their oncology R&D efforts.
• The nominal patent term is 20 years from the filing date (June 25, 2019), potentially extending to 2044 with Patent Term Extension.
• This patent necessitates rigorous freedom-to-operate analysis for R&D activities and informs investment decisions by highlighting competitive IP and market exclusivity.

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Frequently Asked Questions

1. What specific cancers are primarily targeted by the compounds claimed in AU2019204689? The patent indicates utility in treating various cancers, with specific mentions including non-small cell lung cancer (NSCLC), breast cancer, and colorectal cancer. The underlying rationale is the inhibition of kinases frequently dysregulated in these malignancies.

2. Does AU2019204689 cover combination therapies? While the primary claims focus on individual compounds and pharmaceutical compositions containing them, the method of treatment claims could potentially be interpreted to include combination therapies if administered in conjunction with other agents. However, the claims are not explicitly directed to novel combination therapies as a distinct inventive concept.

3. Are there any known resistance mechanisms that these compounds are designed to overcome? The patent asserts novel compounds, implying an aim to address limitations of existing therapies. While specific resistance mechanisms are not detailed in the abstract or summary of the claims provided here, novel kinase inhibitors are frequently developed to overcome acquired resistance to first- or second-generation inhibitors.

4. What is the status of AU2019204689 (e.g., pending application, granted patent)? The provided information refers to AU2019204689 as an Australian patent. A thorough search of IP Australia's databases would be required to confirm its current status (e.g., application pending examination, granted, lapsed). The analysis assumes it is a granted patent or a pending application with substantial claims.

5. How does this patent affect the development of generic versions of existing tyrosine kinase inhibitors? If AU2019204689 claims newly discovered compounds, it would prevent generic versions of those specific novel compounds from being marketed until its expiry. It does not directly impact the generic availability of older, off-patent TKIs, but its broad scope could encompass novel polymorphs or formulations of existing drugs if they fall within the claimed chemical structures.

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Citations

[1] IP Australia. (n.d.). Australian Patent Application AU2019204689. Retrieved from [IP Australia Public Search portal or relevant patent database] (Actual retrieval URL would depend on access method).