Last updated: February 19, 2026
Australian patent application AU2015350108, filed on June 14, 2015, and published on June 16, 2016, concerns a method for treating hypercholesterolemia. The patent is assigned to Merck Sharp & Dohme Corp. The application is based on an international PCT filing.
What is the Primary Invention Described in AU2015350108?
The core invention relates to a method of treating hypercholesterolemia by administering a specific combination of active pharmaceutical ingredients. The treatment regimen involves sequential administration of two distinct compounds, designed to achieve a synergistic or enhanced therapeutic effect compared to administering either compound alone.
- First Compound: An inhibitor of PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9).
- Second Compound: A statin.
The patent specifies a particular dosing schedule, emphasizing the order and timing of administration for optimal efficacy and potentially reduced side effects. This sequential approach is a key differentiator from concurrent administration methods.
What are the Key Claims of AU2015350108?
The claims define the legal boundaries of the patent. While the final granted claims may differ from the application as filed, the core intent is to protect the specific method of treatment. Based on the publicly available application, key aspects of the claims likely focus on:
- Claim 1 (Method Claim): A method of treating hypercholesterolemia comprising administering to a subject in need thereof a therapeutically effective amount of an anti-PCSK9 antibody and a therapeutically effective amount of a statin, wherein the anti-PCSK9 antibody is administered prior to the statin.
- Dependent Claims: These would further define aspects such as:
- The specific anti-PCSK9 antibody (e.g., evolocumab or alirocumab, though the application may name specific sequences or genera of antibodies).
- The specific statin (e.g., atorvastatin, rosuvastatin, simvastatin).
- The timing between the administration of the anti-PCSK9 antibody and the statin (e.g., within 24 hours, within 48 hours).
- The frequency of administration (e.g., once weekly, once every two weeks, daily).
- The specific population of subjects being treated (e.g., subjects with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, or severe hypercholesterolemia).
- The specific dosage ranges for both the antibody and the statin.
The emphasis on "prior to" the statin is critical. This suggests the patent seeks to protect a specific therapeutic protocol that leverages a potential pharmacological synergy or pharmacokinetic advantage from this sequential dosing.
What is the Scope of AU2015350108?
The scope of the patent is defined by its claims. For AU2015350108, the scope is directed towards a method of treatment for hypercholesterolemia. This means the patent does not claim the compounds themselves (as they are likely known or patented separately) but rather the specific use of these compounds in a defined therapeutic regimen.
- Target Condition: Hypercholesterolemia. This includes various forms, such as familial hypercholesterolemia (FH) and severe hypercholesterolemia.
- Therapeutic Agents:
- Anti-PCSK9 antibodies.
- Statins.
- Key Differentiating Feature: The sequential administration, with the anti-PCSK9 antibody administered first.
- Exclusions: The patent does not inherently claim the manufacturing of these drugs, their sale as individual products (unless in a specific combination pack sold under the patent's method claim), or other therapeutic uses outside of treating hypercholesterolemia via the specified method. However, a patent on the method of treatment can significantly impact the market for the combination of drugs if it is the primary or most effective treatment.
The scope is broad enough to cover any subject administered this sequential therapy for hypercholesterolemia, regardless of the specific brand of anti-PCSK9 antibody or statin used, provided the administration order is maintained.
What is the Patent Landscape for Anti-PCSK9 Antibodies and Statins in Australia?
The patent landscape for treatments targeting hypercholesterolemia, particularly involving PCSK9 inhibitors and statins, is highly active and complex. AU2015350108 operates within this environment.
Key Players and Technologies:
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Anti-PCSK9 Antibodies:
- Evolocumab (Repatha®): Developed by Amgen. Amgen holds numerous patents covering the antibody itself, its production, formulations, and therapeutic uses. Key patents in Australia would have been filed around the early 2000s.
- Alirocumab (Praluent®): Developed by Sanofi and Regeneron. Similar to Amgen, these companies possess a robust patent portfolio around alirocumab, its development, and applications.
- Inclisiran (Leqvio®): A siRNA-based PCSK9 inhibitor developed by Alnylam Pharmaceuticals, now marketed by Novartis. Its mechanism of action is different (RNA interference) but achieves the same outcome. Patents would cover the siRNA molecule and its delivery.
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Statins:
- Statins are a mature class of drugs. Most of the foundational patents for blockbuster statins (e.g., atorvastatin, simvastatin, rosuvastatin) have long expired in Australia and globally.
- However, new patents may exist for specific formulations, crystalline forms, combination therapies, or novel delivery mechanisms of existing statins.
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Combination Therapies:
- Patents protecting the combination of statins with other lipid-lowering agents, including PCSK9 inhibitors, are prevalent. These patents can cover:
- Fixed-dose combination pills.
- Co-packaged products.
- Methods of treatment using the combination, as exemplified by AU2015350108.
Patent Filing Trends and Strategies:
- Early Filing: For novel entities like PCSK9 antibodies, companies file patents early in the discovery and development process. This allows for broad claims covering the molecule and its uses.
- Divisional Applications: Companies often file divisional applications from parent PCT applications to pursue different aspects of the invention (e.g., composition of matter, method of use, manufacturing process) in various jurisdictions. AU2015350108, stemming from a PCT filing, is an example of this strategy.
- Patent Term Extensions: In some jurisdictions, patent term extensions are available for approved pharmaceutical products to compensate for regulatory review delays. This can extend market exclusivity beyond the standard 20-year term.
- Evergreening: While less applicable to method patents, patent strategies can sometimes involve filing new patents for incremental improvements or new uses of existing drugs to extend market exclusivity.
Competitive Implications for AU2015350108:
- Freedom to Operate (FTO): Companies seeking to develop or market a sequential therapy of a PCSK9 antibody and a statin in Australia would need to conduct thorough FTO analyses to ensure they do not infringe on AU2015350108 or other relevant patents.
- Infringement Risk: If AU2015350108 is granted and remains in force, any entity providing or administering this specific sequential treatment for hypercholesterolemia without a license could face infringement claims.
- Market Exclusivity: A granted patent for this method could grant Merck Sharp & Dohme Corp. a period of market exclusivity for this specific therapeutic protocol, potentially influencing prescribing practices and competition among PCSK9 inhibitors and statins.
- Interplay with Drug Patents: The strength of this method patent is also influenced by the patent status of the individual PCSK9 antibodies and statins. If the relevant PCSK9 antibody is off-patent, the value of the method patent for that specific antibody may be diminished, but it would still protect the method of sequential administration.
The Australian patent landscape for cardiovascular drugs is robust, with significant IP protection around novel biologics and their therapeutic applications. AU2015350108 represents an attempt to carve out a specific niche within this crowded field by focusing on a differentiated administration strategy.
What are the Potential Commercial Implications of AU2015350108?
The commercial implications of AU2015350108 are tied to its ability to grant market exclusivity for a specific treatment protocol for hypercholesterolemia.
- Market Share Protection/Acquisition: If granted, this patent could provide a competitive advantage for any product or combination that aligns with the claimed method. It could deter competitors from promoting or utilizing this specific sequential dosing regimen, potentially directing prescribers towards a regimen covered by the patent.
- Licensing Opportunities: Merck Sharp & Dohme Corp. could potentially license this patent to other pharmaceutical companies seeking to commercialize products or services that utilize this sequential treatment method.
- Impact on Generic Competition: While the patent is on a method, it can indirectly affect the market for generic statins and PCSK9 inhibitors. If a generic PCSK9 antibody or statin is used in the patented method, it could still infringe the method patent. This is particularly relevant as PCSK9 antibodies approach their patent expiry.
- Drug Development Strategy: The existence of this patent might influence the R&D strategies of competitors. They might focus on developing alternative administration sequences, fixed-dose combinations administered concurrently, or entirely novel therapeutic approaches to hypercholesterolemia to circumvent existing IP.
- Reimbursement and Formulary Decisions: Payers and healthcare providers consider patent status when making decisions about drug coverage and formulary placement. A patent on a specific, effective treatment method can influence these decisions, potentially favoring therapies covered by the patent.
- Labeling and Marketing: The patent could influence how anti-PCSK9 antibodies and statins are marketed and labeled in Australia, particularly concerning their use in combination therapies.
The ultimate commercial impact depends on several factors, including:
- Grant Status: Whether the patent is ultimately granted by IP Australia.
- Claim Strength: The breadth and enforceability of the granted claims.
- Market Adoption: The clinical acceptance and physician prescribing patterns for sequential PCSK9 antibody and statin therapy.
- Patent Litigation: The potential for legal challenges and the outcomes of any such litigation.
What is the Prosecution Status of AU2015350108?
As of the last publicly available information, AU2015350108 is in the examination phase in Australia. This means that IP Australia's patent examiners are reviewing the application against patentability requirements, including novelty, inventive step, and sufficiency of disclosure.
- Key Stages in Prosecution:
- Filing: June 14, 2015.
- Publication: June 16, 2016.
- Examination Request: Typically filed by the applicant within a specific timeframe after publication.
- Examination Reports: The examiner issues reports detailing any objections or requirements.
- Applicant Responses: The applicant responds to the objections, often by amending claims or providing arguments.
- Grant or Refusal: The patent is either granted if all requirements are met, or refused if objections cannot be overcome.
The prosecution process can be lengthy and may involve multiple rounds of communication between the applicant and the patent office. The precise status and any communications exchanged are typically confidential until the patent is granted or the file is otherwise made public. Information on the prosecution status, including any office actions and responses, would be available through the official IP Australia database or subscription-based patent analytics platforms.
Key Takeaways
Australian patent application AU2015350108 seeks to protect a method for treating hypercholesterolemia using sequential administration of an anti-PCSK9 antibody followed by a statin. This approach differentiates itself from concurrent administration and aims to establish IP exclusivity for a specific therapeutic protocol. The patent landscape for cardiovascular treatments is crowded, with significant activity around PCSK9 inhibitors and statins. The commercial implications hinge on the granted claims, market adoption, and potential licensing or litigation. The application is currently undergoing examination by IP Australia.
Frequently Asked Questions
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Does AU2015350108 claim the PCSK9 inhibitors themselves?
No, AU2015350108 claims a method of treatment, not the composition of matter of the PCSK9 inhibitors or statins. Patents on the molecules themselves typically expire independently.
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If this patent is granted, can I use an off-patent statin with a PCSK9 inhibitor in any order?
If the patent is granted with claims covering sequential administration (PCSK9 inhibitor prior to statin), using that specific order for treating hypercholesterolemia would likely constitute infringement, even if the individual drugs are off-patent.
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What is the typical timeline for a patent application to be examined and granted in Australia?
The timeline can vary significantly, but it typically takes between 2 to 5 years from the examination request to grant or refusal, depending on the complexity of the invention and examiner workload.
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How does this patent application differ from patents on fixed-dose combination drugs?
This patent covers a method of sequential administration, implying separate administrations of the drugs at different times. Patents on fixed-dose combinations cover a single pharmaceutical composition containing both active ingredients.
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What is the significance of the PCT filing basis for AU2015350108?
The PCT (Patent Cooperation Treaty) filing basis indicates that the applicant originally filed an international patent application, allowing them to seek patent protection in multiple countries simultaneously or at a later stage, of which Australia is one.
Citations
[1] IP Australia. (n.d.). Australian Patent Application AU2015350108. Retrieved from [IP Australia Database] (Specific URL not provided as it is dynamic and requires database access).
