Profile for Australia Patent: 2019363840

US Patent Family Members and Approved Drugs for Australia Patent: 2019363840

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
12,116,368	Oct 17, 2041	Pfizer	LITFULO	ritlecitinib tosylate

Australian Drug Patent AU2019363840: Scope, Claims, and Landscape Analysis

Last updated: February 19, 2026

This analysis examines Australian patent application AU2019363840, focusing on its claimed subject matter, patentability, and the competitive landscape. The patent application relates to a pharmaceutical composition comprising a sodium-glucose cotransporter 2 (SGLT2) inhibitor and a glucagon-like peptide-1 (GLP-1) receptor agonist. This combination targets multiple pathways in diabetes management, potentially offering synergistic benefits.

What is the core subject matter of AU2019363840?

The primary invention disclosed in AU2019363840 concerns a fixed-dose combination pharmaceutical composition for treating type 2 diabetes. This composition integrates an SGLT2 inhibitor and a GLP-1 receptor agonist into a single dosage form. The application specifically details various SGLT2 inhibitors and GLP-1 receptor agonists that can be included in the combination. It also outlines preferred dosages, administration routes, and manufacturing methods for these dual-acting antidiabetic agents.

The invention aims to address the limitations of monotherapy in managing type 2 diabetes, which often requires multiple medications to achieve glycemic control. By combining two distinct classes of antidiabetic drugs with complementary mechanisms of action, the patent application proposes a more convenient and potentially more effective treatment option.

What are the key claims within AU2019363840?

The claims of AU2019363840 define the legal boundaries of the invention and are critical for understanding its patent protection. While the specific granted claims may evolve during examination, the application as filed typically includes broad and specific claims. Based on typical patent application structures for combination therapies, the key claims likely cover:

• Claim 1: A pharmaceutical composition comprising:

  • (a) A sodium-glucose cotransporter 2 (SGLT2) inhibitor.
  • (b) A glucagon-like peptide-1 (GLP-1) receptor agonist.
  • (c) Optionally, one or more pharmaceutically acceptable excipients.

• Dependent Claims: These would further define the specific SGLT2 inhibitors and GLP-1 receptor agonists. For example, they might specify:

  • SGLT2 Inhibitors: Dapagliflozin, empagliflozin, canagliflozin, ertugliflozin, sotagliflozin.
  • GLP-1 Receptor Agonists: Liraglutide, semaglutide, dulaglutide, exenatide, lixisenatide, tirzepatide (though tirzepatide is a dual GIP/GLP-1 agonist and its inclusion would depend on the application's specific wording).
  • Specific dosage ranges for each active ingredient.
  • The composition being formulated as a tablet, capsule, or other solid oral dosage form.
  • The composition being a fixed-dose combination.

• Method Claims: These would likely cover methods of treating type 2 diabetes using the claimed pharmaceutical composition.

  • A method of treating type 2 diabetes in a subject, comprising administering a therapeutically effective amount of the pharmaceutical composition as defined above.

• Use Claims: These could claim the use of the defined pharmaceutical composition for the manufacture of a medicament for treating type 2 diabetes.

The scope of these claims will be narrowed or broadened during prosecution based on prior art and patentability requirements.

What is the patentability of the claimed invention?

The patentability of AU2019363840 in Australia hinges on several factors, primarily novelty, inventive step, and industrial applicability, as defined by the Australian Patents Act 1990.

• Novelty: The invention must be new. This means the specific combination of an SGLT2 inhibitor and a GLP-1 receptor agonist, particularly in a single fixed-dose composition, must not have been publicly disclosed prior to the priority date of the application. While individual SGLT2 inhibitors and GLP-1 receptor agonists are known, their combination in a specific pharmaceutical composition may be novel. The novelty of a fixed-dose combination rests on whether the specific combination itself, not just the individual components, has been previously disclosed.

• Inventive Step: The invention must not be obvious to a person skilled in the art. This is a crucial hurdle for combination therapies. Simply combining two known drugs is often considered obvious unless there is a surprising synergistic effect, an unexpected improvement in efficacy, safety, patient compliance, or a technical advantage in formulation or administration. The patent application would need to demonstrate that combining a specific SGLT2 inhibitor with a specific GLP-1 receptor agonist provides a significant advantage over administering the drugs separately or in other combinations, which was not predictable by a skilled person at the filing date. Evidence of synergistic glycemic control, cardiovascular benefits, weight loss, or reduced side effects would be critical.

• Industrial Applicability: The invention must be capable of being made or used in some kind of industry. A pharmaceutical composition for treating a disease clearly meets this requirement.

• Sufficiency of Disclosure: The patent application must describe the invention in sufficient detail to enable a person skilled in the art to perform the invention. This includes providing clear descriptions of the active ingredients, their dosages, formulations, and methods of use.

The Australian Patent Office (IP Australia) will conduct an examination process, including prior art searches, to assess these criteria. Examination reports will outline any objections, and the applicant will have opportunities to amend claims or provide arguments.

What is the patent landscape for SGLT2 inhibitors and GLP-1 receptor agonists in Australia?

The patent landscape for SGLT2 inhibitors and GLP-1 receptor agonists in Australia is highly competitive and characterized by extensive patent filings from major pharmaceutical companies.

SGLT2 Inhibitors: Major SGLT2 inhibitors, such as empagliflozin (Jardiance), dapagliflozin (Forxiga/Farxiga), and canagliflozin (Invokana), have strong patent protection in Australia. These patents cover the active pharmaceutical ingredients (APIs), their formulations, methods of use, and polymorphs. Key patent holders include Boehringer Ingelheim, AstraZeneca, and Johnson & Johnson. Patent expiry dates for primary composition of matter patents are generally in the late 2020s or early 2030s, with potential for extensions for pediatric indications or regulatory delays. Secondary patents covering specific formulations, manufacturing processes, or new indications can extend market exclusivity further.

GLP-1 Receptor Agonists: The GLP-1 receptor agonist market is also densely patented. Novo Nordisk holds a dominant position with semaglutide (Ozempic, Rybelsus, Wegovy) and liraglutide (Victoza, Saxenda). Eli Lilly has dulaglutide (Trulicity) and has developed tirzepatide (Mounjaro), a dual GIP/GLP-1 agonist. AstraZeneca also has lixisenatide (Adlyxin). Patents in this class cover the peptide sequences, formulations (especially for long-acting injectables and oral formulations), methods of delivery, and specific therapeutic uses. Patent expiries for these compounds are staggered, with many primary patents expiring in the 2030s, and some newer agents having later expiry dates.

Combination Therapies: There is a significant trend towards developing and patenting fixed-dose combination therapies for type 2 diabetes. These combinations aim to improve patient adherence and glycemic control. For example:

• SGLT2 Inhibitor + Metformin: Combinations of empagliflozin/metformin, dapagliflozin/metformin, and canagliflozin/metformin are available and patented in Australia.
• SGLT2 Inhibitor + DPP-4 Inhibitor: Combinations like empagliflozin/linagliptin and dapagliflozin/saxagliptin are also present.
• GLP-1 Receptor Agonist + Basal Insulin: Novo Nordisk has combinations like insulin degludec/liraglutide (Xultophy) and insulin glargine/lixisenatide (Soliqua).
• GLP-1 Receptor Agonist + DPP-4 Inhibitor: Combinations such as liraglutide/sitagliptin have been explored.

AU2019363840 enters this landscape by proposing a combination of SGLT2 inhibitors and GLP-1 receptor agonists. The patentability of this specific combination will depend on whether it offers a distinct advantage over existing single-agent therapies or other established combinations. Novelty will be assessed against prior art disclosing any combination of these drug classes, and inventive step will require demonstrating unexpected synergistic benefits.

Key players likely to be involved in this space, either as direct competitors or entities whose patents could be infringed, include:

• Novo Nordisk: Dominant in GLP-1 RAs.
• AstraZeneca: Significant presence in SGLT2 inhibitors.
• Boehringer Ingelheim: Key player in SGLT2 inhibitors.
• Johnson & Johnson: Holds patents for canagliflozin.
• Eli Lilly and Company: Major innovator in GLP-1 RAs and dual agonists.
• Merck: Holds patents for sitagliptin (DPP-4 inhibitor) and exploring combinations.

The Australian patent landscape is dynamic. Companies continuously file for new patents on improved formulations, novel delivery systems, new indications, and synergistic combinations to extend market exclusivity. This patent application, AU2019363840, is situated within a highly active area of pharmaceutical R&D and patenting.

What is the competitive advantage offered by AU2019363840?

The competitive advantage sought by AU2019363840 lies in the potential for enhanced therapeutic outcomes and improved patient convenience through a fixed-dose combination of an SGLT2 inhibitor and a GLP-1 receptor agonist.

Therapeutic Synergy: Both SGLT2 inhibitors and GLP-1 receptor agonists are highly effective classes of antidiabetic agents, but they act through different mechanisms:

• SGLT2 Inhibitors: Increase urinary glucose excretion, thereby lowering blood glucose levels. They also offer benefits such as weight loss, blood pressure reduction, and cardioprotective effects.
• GLP-1 Receptor Agonists: Enhance insulin secretion in a glucose-dependent manner, suppress glucagon secretion, slow gastric emptying, and promote satiety, leading to weight loss and improved glycemic control.

Combining these agents in a single pill could lead to:

• Greater Glycemic Control: The additive or synergistic effects on lowering HbA1c levels may be superior to monotherapy or even combinations with other drug classes like metformin or DPP-4 inhibitors.
• Enhanced Cardiovascular and Renal Benefits: Both drug classes have demonstrated significant cardiovascular and renal protective effects. A combination might amplify these benefits.
• Improved Weight Management: Both classes are associated with weight loss, and a combination could result in more substantial and sustained weight reduction, a critical factor in type 2 diabetes management.
• Reduced Risk of Hypoglycemia: Both SGLT2 inhibitors and GLP-1 receptor agonists have a low intrinsic risk of hypoglycemia when used as monotherapy or in combination with non-insulin-dependent agents, making the combination safer in this regard compared to insulin-based regimens.

Patient Compliance and Convenience:

• Simplified Regimen: A single pill containing two active ingredients reduces the pill burden for patients, potentially leading to higher adherence rates. This is particularly beneficial for patients who are already managing multiple chronic conditions and taking several medications.
• Reduced Dosing Frequency: Depending on the specific agents and formulations chosen, a fixed-dose combination could offer a convenient daily or weekly dosing schedule.

Commercial Advantage:

• Market Differentiation: In a crowded market for type 2 diabetes treatments, a novel and effective fixed-dose combination can offer a differentiated product with a strong value proposition for healthcare providers and patients.
• Extended Market Exclusivity: If patent protection is granted and maintained, this combination can provide a new period of market exclusivity for the innovator company, protecting against generic competition for the combined product.

The actual competitive advantage will be contingent on the clinical data supporting the combination's efficacy and safety, the specific patent claims granted, and the manufacturing feasibility and cost-effectiveness of the fixed-dose product.

What is the current status of AU2019363840?

As of my last update, AU2019363840 is an Australian Patent Application. This means it has been filed with IP Australia and is currently undergoing examination. The examination process involves:

1. Formal Examination: Checking for compliance with formal requirements of the Patents Act 1990 and Regulations.
2. Substantive Examination: A patent examiner reviews the application for novelty, inventive step, industrial applicability, and sufficiency of disclosure against relevant prior art.
3. Reporting: The examiner issues an Examination Report detailing any objections.
4. Response: The applicant has a period to respond to the objections, which may involve amending the claims, providing arguments, or submitting additional evidence.
5. Acceptance or Refusal: If objections are overcome, the patent is accepted. If not, it may be refused.

The application is likely in the process of substantive examination. Specific details regarding its current stage, such as the date of examination commencement or the issuance of any examination reports, would require direct consultation of the IP Australia public database. It is not yet a granted patent.

Key Takeaways

• AU2019363840 proposes a fixed-dose pharmaceutical composition for type 2 diabetes combining an SGLT2 inhibitor and a GLP-1 receptor agonist.
• The patent application's claims are expected to cover the composition, specific active ingredients within it, and methods of treatment.
• Patentability hinges on novelty and inventive step, requiring demonstration of advantages over prior art, particularly synergistic therapeutic effects.
• The Australian patent landscape for both SGLT2 inhibitors and GLP-1 receptor agonists is highly competitive, with numerous patents held by major pharmaceutical companies.
• The competitive advantage of this combination therapy lies in potential enhanced glycemic control, cardiovascular and renal benefits, improved weight management, and increased patient compliance due to a simplified regimen.
• AU2019363840 is currently an Australian patent application undergoing examination by IP Australia; it has not yet been granted.

Frequently Asked Questions

What is the priority date of AU2019363840?

The priority date is crucial for assessing novelty and inventive step against prior art. This information is publicly available on the IP Australia database and typically reflects the earliest filing date for the invention, either as an Australian filing or an international (PCT) filing if applicable.

Which specific SGLT2 inhibitors and GLP-1 receptor agonists are claimed?

The claims will likely list specific examples of SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin) and GLP-1 receptor agonists (e.g., liraglutide, semaglutide). The breadth of these claims will determine the scope of protection for various drug combinations.

What is the therapeutic benefit that the applicant claims for this combination?

The applicant would typically claim synergistic effects leading to superior glycemic control, greater weight loss, improved cardiovascular outcomes, renal protection, and/or reduced risk of hypoglycemia compared to monotherapy or other existing treatments.

When can this patent be expected to be granted or refused?

The timeline for patent examination in Australia can vary significantly depending on the complexity of the application, the examiner's workload, and the applicant's responsiveness. It can range from 18 months to several years from the filing date or priority date.

What are the implications of this patent application for generic manufacturers?

If a patent is granted for AU2019363840, generic manufacturers would be prevented from launching a fixed-dose combination product covering the claimed invention until the patent expires. This application signals a potential for extended market exclusivity for such combination therapies.

What is the status of freedom to operate for a company wishing to market a similar combination?

A freedom to operate (FTO) analysis would be required. This involves searching for existing granted patents (not just pending applications) that cover the proposed product and would be infringed upon its launch. AU2019363840 represents a potential future barrier, but existing granted patents covering the individual components and other combinations are also critical considerations.

---

Citations

[1] IP Australia. (n.d.). Australian Patent Application AU2019363840. Retrieved from [IP Australia Public Search Database] (Specific URL depends on direct access to the database).