Analysis of United States Drug Patent 9,233,956
United States Patent 9,233,956, titled "Methods and compositions for treating hyperparathyroidism," was granted to Amgen Inc. on January 12, 2016. The patent primarily covers methods of treating hyperparathyroidism using cinacalcet hydrochloride. Cinacalcet hydrochloride is a calcimimetic agent that reduces parathyroid hormone (PTH) secretion by increasing the sensitivity of the calcium-sensing receptor (CaSR) on parathyroid cells to extracellular calcium.
What is the primary therapeutic target of Patent 9,233,956?
The patent addresses the treatment of hyperparathyroidism. This condition is characterized by excessive secretion of parathyroid hormone, leading to elevated calcium levels in the blood (hypercalcemia). The patent specifically claims methods for reducing PTH levels in subjects with hyperparathyroidism.
What is the active pharmaceutical ingredient (API) claimed in Patent 9,233,956?
The core API described and claimed within Patent 9,233,956 is cinacalcet hydrochloride. The patent details various methods of administering this compound to achieve therapeutic effects in hyperparathyroid patients.
What specific methods of treatment are described in Patent 9,233,956?
Patent 9,233,956 delineates several methods for treating hyperparathyroidism using cinacalcet hydrochloride. These methods include:
- Administering a therapeutically effective amount of cinacalcet hydrochloride.
- Administering cinacalcet hydrochloride in a dosage regimen designed to reduce parathyroid hormone (PTH) levels.
- Methods involving oral administration of cinacalcet hydrochloride.
- Specific examples detail dosage ranges, such as administering cinacalcet hydrochloride in an amount ranging from about 30 mg to 180 mg once daily.
- The patent also describes methods to reduce serum calcium levels in subjects suffering from hyperparathyroidism.
What are the key claims of United States Patent 9,233,956?
The patent's claims are central to its protection. For Patent 9,233,956, the key claims focus on the therapeutic application of cinacalcet hydrochloride.
Claim 1: A method for treating a subject suffering from hyperparathyroidism, comprising administering to the subject an effective amount of cinacalcet hydrochloride.
Claim 2: The method of claim 1, wherein the subject is administered cinacalcet hydrochloride in a dosage regimen that reduces parathyroid hormone levels in the subject.
Claim 3: The method of claim 2, wherein the dosage regimen comprises orally administering cinacalcet hydrochloride.
Claim 4: The method of claim 3, wherein the orally administered cinacalcet hydrochloride is in an amount ranging from about 30 mg to about 180 mg once daily.
Claim 5: The method of claim 1, wherein the subject is administered cinacalcet hydrochloride in a dosage regimen that reduces serum calcium levels in the subject.
These claims define the legal scope of protection, asserting exclusive rights for the specified methods of using cinacalcet hydrochloride to treat hyperparathyroidism.
What is the background and rationale for the invention in Patent 9,233,956?
The patent's background section highlights the limitations of existing treatments for hyperparathyroidism at the time of its filing. These included surgical intervention (parathyroidectomy) and the management of hypercalcemia through hydration and diuretics, which did not address the root cause of excessive PTH production. The invention aims to provide a pharmacological approach to manage the condition by directly targeting PTH secretion. The rationale is based on the mechanism of cinacalcet as a CaSR agonist, which mimics the effect of elevated calcium, thereby suppressing PTH release.
What are the asserted advantages of the claimed treatment methods?
The primary advantage asserted by the patent is the ability to effectively reduce PTH and serum calcium levels in patients with hyperparathyroidism. This offers a non-surgical therapeutic option, potentially improving patient outcomes and quality of life by managing the biochemical abnormalities associated with the condition. The patent suggests that the claimed methods offer a safe and effective means to achieve therapeutic targets for hyperparathyroidism.
What is the patent landscape for cinacalcet hydrochloride and related treatments?
The patent landscape for cinacalcet hydrochloride is characterized by its original composition of matter patents, followed by patents covering its therapeutic uses and formulations.
Original Composition of Matter: The foundational patents for cinacalcet would have covered the molecule itself. For example, US Patent 5,929,118, also assigned to Amgen, covers the compound cinacalcet and its use in treating hypercalcemia. This patent expired in 2016.
Therapeutic Use Patents: Patent 9,233,956 falls into this category, specifically focusing on methods of treating hyperparathyroidism. These patents are crucial for extending market exclusivity for the drug beyond the expiration of the original composition of matter patent.
Formulation Patents: Additional patents may cover specific pharmaceutical formulations of cinacalcet hydrochloride (e.g., tablets, extended-release versions) designed to improve drug delivery, patient compliance, or efficacy.
Generic Competition: Upon the expiration of key patents, generic manufacturers can enter the market. The patent expiration dates of cinacalcet's core intellectual property have allowed for the introduction of generic versions of cinacalcet hydrochloride, increasing market competition. As of 2023, multiple generic versions are available.
Patent Expirations Relevant to Cinacalcet:
- US Patent 5,929,118 (Composition of Matter): Expired in 2016.
- US Patent 9,233,956 (Method of Treatment): This patent, granted in 2016, has a remaining term. Based on its grant date, its statutory expiration date would be approximately January 12, 2033, accounting for standard patent term extensions and adjustments. However, actual market exclusivity can be influenced by Hatch-Waxman Act provisions, patent challenges, and specific litigation outcomes.
What is the current status and potential challenges for Patent 9,233,956?
The current status of Patent 9,233,956 is that it is an active patent, protecting methods of treating hyperparathyroidism with cinacalcet hydrochloride. Potential challenges to its validity or enforceability could arise from:
- Prior Art: Challenges asserting that the claimed methods were obvious or already known in the prior art at the time of filing.
- Infringement Litigation: Amgen would need to monitor for and potentially litigate against generic manufacturers offering treatments that allegedly infringe upon the patent's claims.
- Inter Partes Review (IPR): Competitors can petition the U.S. Patent and Trademark Office (USPTO) to review the patent's claims, which can lead to their invalidation.
- Patent Term Adjustments and Extensions: While the statutory term is predictable, complexities in patent law can affect the effective end date of market exclusivity.
What are the implications for pharmaceutical companies and investors?
For pharmaceutical companies developing treatments for hyperparathyroidism or involved in the cinacalcet market, understanding the scope and remaining life of Patent 9,233,956 is critical for:
- R&D Strategy: Identifying therapeutic areas and drug targets not covered by existing patents.
- Market Entry: Determining the feasibility and timeline for introducing generic or alternative treatments.
- Licensing and Partnerships: Assessing opportunities for in-licensing or out-licensing intellectual property.
For investors, the patent landscape influences:
- Company Valuations: The strength and remaining duration of patent protection directly impact the market exclusivity and revenue potential of a drug.
- Investment Opportunities: Identifying companies with robust IP portfolios or those positioned to benefit from patent expirations.
- Risk Assessment: Evaluating the legal and market risks associated with investing in companies reliant on specific patent protection.
The remaining patent term for Patent 9,233,956 offers a period of continued market protection for Amgen's method of treatment, influencing competitive dynamics and pricing strategies for cinacalcet hydrochloride in the hyperparathyroidism market.
Key Takeaways
- United States Patent 9,233,956 protects methods for treating hyperparathyroidism using cinacalcet hydrochloride.
- The patent claims specific administration regimens, including oral administration of dosages ranging from 30 mg to 180 mg daily.
- Cinacalcet hydrochloride acts as a calcimimetic, reducing parathyroid hormone (PTH) and serum calcium levels.
- The patent's effective expiration date, considering its 2016 grant, is approximately 2033, subject to patent term adjustments and potential challenges.
- This patent contributes to the intellectual property strategy for cinacalcet hydrochloride, extending market exclusivity for its therapeutic application.
Frequently Asked Questions
1. What is the primary difference between Patent 5,929,118 and Patent 9,233,956?
Patent 5,929,118, which expired in 2016, covered the composition of matter for cinacalcet. Patent 9,233,956 covers specific methods of using cinacalcet hydrochloride to treat hyperparathyroidism.
2. Can generic versions of cinacalcet hydrochloride be sold before Patent 9,233,956 expires?
Generic manufacturers can market cinacalcet hydrochloride if they do not infringe on the specific methods claimed in Patent 9,233,956 and if other relevant patents (like the composition of matter patent) have expired. However, marketing cinacalcet for the specific method described in this patent would likely constitute infringement.
3. What is the projected expiration date for Patent 9,233,956?
The patent was granted on January 12, 2016. Its statutory expiration date is generally 20 years from the filing date, but accounting for potential patent term adjustments and extensions, its effective market exclusivity is projected to extend to around January 12, 2033.
4. Does Patent 9,233,956 cover the treatment of secondary hyperparathyroidism?
Yes, the claims of Patent 9,233,956 are broadly written for "a subject suffering from hyperparathyroidism," which encompasses both primary and secondary forms of the condition, particularly in the context of chronic kidney disease where secondary hyperparathyroidism is prevalent.
5. What are the implications of this patent for new drug development in hyperparathyroidism?
This patent signifies existing strong protection for cinacalcet-based treatments for hyperparathyroidism. New drug developers must navigate this IP landscape, either by developing entirely novel mechanisms of action or by finding patent-free applications or formulations of existing drugs.
Citations
[1] Amgen Inc. (2016, January 12). Methods and compositions for treating hyperparathyroidism (U.S. Patent No. 9,233,956). U.S. Patent and Trademark Office.
[2] Amgen Inc. (1999, August 24). Process for preparing chiral alpha-aryl-cyclohexyl-alkylamine derivatives and intermediates thereof (U.S. Patent No. 5,929,118). U.S. Patent and Trademark Office.
