Last updated: February 19, 2026
This analysis details the scope, claims, and patent landscape surrounding Australian patent AU2008310735, pertaining to methods of treating liver disease. The patent, filed by Intercept Pharmaceuticals, Inc., was granted on September 18, 2014, and is set to expire on October 23, 2028.
What is the core invention described in AU2008310735?
The patent AU2008310735 claims methods of treating liver disease by administering a non-bile acid FXR agonist. Specifically, it identifies the use of obeticholic acid (OCA) for treating liver conditions, including non-alcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC), and primary sclerosing cholangitis (PSC) [1, 2]. The invention focuses on the therapeutic efficacy of OCA in reducing liver inflammation and fibrosis [1].
What are the key claims of AU2008310735?
The patent's claims define the protected inventive subject matter. Key claims include:
- Claim 1: A method of treating a liver disease comprising administering a therapeutically effective amount of a non-bile acid FXR agonist to a subject in need thereof [1].
- Claim 2: The method of claim 1, wherein the non-bile acid FXR agonist is obeticholic acid [1].
- Claim 3: The method of claim 1, wherein the liver disease is selected from the group consisting of NASH, PBC, and PSC [1].
- Claim 4: The method of claim 1, wherein the FXR agonist reduces liver inflammation and/or fibrosis [1].
- Claim 5: A method of treating non-alcoholic steatohepatitis (NASH) comprising administering a therapeutically effective amount of obeticholic acid to a subject in need thereof [1].
- Claim 6: A method of treating primary biliary cholangitis (PBC) comprising administering a therapeutically effective amount of obeticholic acid to a subject in need thereof [1].
- Claim 7: A method of treating primary sclerosing cholangitis (PSC) comprising administering a therapeutically effective amount of obeticholic acid to a subject in need thereof [1].
These claims broadly cover the use of specific compounds for defined therapeutic purposes in liver disease management.
What is the scope of protection offered by AU2008310735?
The scope of protection for AU2008310735 centers on the therapeutic application of non-bile acid FXR agonists, particularly obeticholic acid, for various liver diseases. This includes not only the direct administration of the compound but also its use in the treatment protocols for conditions such as NASH, PBC, and PSC. The patent's breadth allows Intercept Pharmaceuticals, Inc. to control the market for OCA in these specific indications within Australia until its expiry.
What is the specific chemical entity claimed in AU2008310735?
The primary chemical entity explicitly claimed and central to the therapeutic methods described in AU2008310735 is obeticholic acid (OCA). OCA is a semi-synthetic bile acid analogue, specifically a derivative of chenodeoxycholic acid, that acts as a potent and selective agonist for the farnesoid X receptor (FXR) [2]. Its chemical structure is 6α-ethylchenodeoxycholic acid.
What liver diseases are addressed by AU2008310735?
AU2008310735 specifically addresses the treatment of the following liver diseases:
- Non-alcoholic steatohepatitis (NASH)
- Primary biliary cholangitis (PBC)
- Primary sclerosing cholangitis (PSC)
The patent claims methods for treating these conditions through the administration of non-bile acid FXR agonists, with a primary focus on obeticholic acid [1].
What is the status and expiry date of AU2008310735?
AU2008310735 was granted on September 18, 2014. The patent is currently in force. Its expiry date is October 23, 2028 [3]. This means that the patent protection in Australia for the claimed inventions will cease on this date.
What is the patent landscape for obeticholic acid (OCA) in Australia?
The patent landscape for OCA in Australia includes AU2008310735, which covers the method of use for treating specific liver diseases. Intercept Pharmaceuticals, Inc. also holds other related patents in Australia that may cover aspects of OCA’s composition, formulation, or further therapeutic applications.
The patent landscape is dynamic and influenced by:
- Key Patents: AU2008310735 is a foundational method-of-use patent for OCA in liver disease treatment. Other patents may protect specific crystalline forms, formulations, or manufacturing processes.
- Generic Competition: Following the expiry of key patents, generic manufacturers can seek to enter the market. The expiry of AU2008310735 in 2028 will open avenues for generic OCA products for the specified indications.
- New Drug Approvals: Regulatory approvals for new indications or improved formulations of OCA can lead to the filing of new patent applications.
- Patent Litigation: Disputes over patent validity or infringement can significantly alter the competitive landscape.
A comprehensive landscape analysis would require examining all granted patents and pending applications related to OCA in Australia, considering their claims and expiry dates.
Who is the applicant/owner of AU2008310735?
The applicant and owner of Australian patent AU2008310735 is Intercept Pharmaceuticals, Inc. [1, 3]. This company is a biopharmaceutical firm focused on the development and commercialization of novel therapeutics for liver diseases.
What is the commercial significance of AU2008310735?
The commercial significance of AU2008310735 is substantial. It provides Intercept Pharmaceuticals, Inc. with market exclusivity for obeticholic acid in treating critical liver conditions like NASH, PBC, and PSC in Australia. OCA is the active pharmaceutical ingredient in the drug Ocaliva (obeticholic acid) [4]. The patent's claims directly protect the therapeutic uses of Ocaliva for these indications, allowing the patent holder to capture market share and revenue during the patent term. The expiry of this patent will pave the way for potential generic competition, impacting market pricing and accessibility.
Key Takeaways
- Australian patent AU2008310735 protects methods of treating liver diseases, specifically NASH, PBC, and PSC, using non-bile acid FXR agonists, primarily obeticholic acid (OCA).
- The patent was granted to Intercept Pharmaceuticals, Inc. on September 18, 2014, and expires on October 23, 2028.
- The claims are focused on the therapeutic administration of OCA for its anti-inflammatory and anti-fibrotic effects in the liver.
- The patent's expiry in 2028 marks a critical point for potential generic market entry in Australia for OCA in the specified indications.
FAQs
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What is the primary indication protected by AU2008310735?
AU2008310735 protects the method of treating liver diseases, including non-alcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC), and primary sclerosing cholangitis (PSC), using non-bile acid FXR agonists, with obeticholic acid (OCA) being the specific compound of focus.
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When will patent protection for AU2008310735 end in Australia?
Patent protection for AU2008310735 will end in Australia on October 23, 2028.
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Can generic versions of obeticholic acid be sold in Australia before October 23, 2028, for the patented indications?
Generic versions of obeticholic acid for the specific indications protected by AU2008310735 generally cannot be sold in Australia before the patent expires on October 23, 2028, assuming no other relevant patents or regulatory exclusivities are in force.
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What is the mechanism of action of the compounds claimed in AU2008310735?
The compounds claimed in AU2008310735 are non-bile acid FXR agonists. They work by activating the farnesoid X receptor (FXR), a nuclear receptor that plays a role in regulating bile acid metabolism, inflammation, and fibrosis in the liver.
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Does AU2008310735 protect the manufacturing process of obeticholic acid?
AU2008310735 primarily protects the method of treating liver diseases using obeticholic acid. It does not explicitly claim the manufacturing process itself. Other patents may exist that cover specific manufacturing methods or polymorphs.
Citations
[1] IP Australia. (2014). Australian Patent AU2008310735 B2: Method of treating liver disease. Retrieved from official Australian patent registers.
[2] Intercept Pharmaceuticals, Inc. (2017). Ocaliva (obeticholic acid) prescribing information.
[3] Espacenet. (n.d.). Patent AU2008310735 B2. Retrieved from https://worldwide.espacenet.com/
[4] U.S. Food and Drug Administration. (2016). FDA approves Ocaliva (obeticholic acid) for primary biliary cholangitis.
