United States Patent 9,820,938: A Detailed Analysis of Scope and Claims
Overview of the Patent
The United States Patent 9,820,938, titled "Stable liquid formulation of AMG 416 (etelcalcetide)," was issued on November 21, 2017. This patent pertains to a liquid formulation of etelcalcetide, a peptide agonist of the calcium-sensing receptor, and methods for its preparation and use.
Background of Etelcalcetide
Etelcalcetide is a medication used to treat secondary hyperparathyroidism in patients with chronic kidney disease. It works by activating the calcium-sensing receptor, which helps to regulate calcium levels in the blood[4].
Scope of the Patent
Formulation Stability
The patent focuses on the development of a stable liquid formulation of etelcalcetide. This formulation is designed to minimize degradation of the peptide, ensuring its efficacy over an extended period. The patent specifies that the formulation has less than 10% degradation when stored at 2-8°C for up to 2, 3, or 4 years. In some embodiments, the degradation is even lower, at less than 8% over the same storage conditions[1].
Composition
The formulation includes etelcalcetide as the active ingredient, along with various excipients and stabilizers. The specific composition is tailored to maintain the stability and bioactivity of the peptide. The patent details the concentration of etelcalcetide and the types of excipients used, such as succinate, which play a crucial role in maintaining the stability of the formulation[1].
Claims of the Patent
Method of Preparation
The patent includes claims related to the method of preparing the stable liquid formulation. This involves specific steps and conditions to ensure the formulation remains stable and effective. The method includes the selection of appropriate excipients, the concentration of etelcalcetide, and the storage conditions to prevent degradation[1].
Use of the Formulation
The patent also claims the use of the stable liquid formulation for treating secondary hyperparathyroidism in patients with chronic kidney disease. This includes the administration route, dosage, and any specific instructions for use to ensure the formulation's efficacy and safety[1].
Patent Landscape and Implications
Pharmaceutical and Biotechnology Industry
The patent landscape in the pharmaceutical and biotechnology industries is complex, with significant emphasis on patent protection to support commercialization strategies. The scope and claims of patents like US 9,820,938 are critical in defining the intellectual property rights of the inventor. However, recent jurisprudence, particularly from the Federal Circuit, has made it challenging to obtain and maintain broad patent protection for drugs and biologics due to stringent requirements under Section 112(a) of the U.S. patent laws[3].
Genus Claims and Enablement
The Federal Circuit's rigid stance on genus claims has impacted the pharmaceutical industry significantly. Genus claims, which aim to capture a class of items rather than specific embodiments, are often invalidated if they do not meet the written description and enablement requirements. This makes it difficult for innovators to claim the full scope of their invention without risking invalidation, while narrow claims can be easily designed around by competitors[3].
Market and Commercial Impact
The market for therapeutic peptides and biologics, such as etelcalcetide, is substantial and growing. The stability and efficacy of formulations like the one described in US 9,820,938 are crucial for maintaining market share and ensuring patient safety. The patent's claims and scope provide a competitive edge by protecting the formulation's unique characteristics and methods of preparation[3].
Legal and Regulatory Considerations
Patent Litigation and Settlements
Patent litigation and settlements in the pharmaceutical industry often involve complex negotiations and agreements. For example, settlements in ANDA (Abbreviated New Drug Application) litigation can involve the dismissal of claims and the termination of 30-month stays, allowing generic manufacturers to move forward with their applications while respecting the original patent holder's rights[2].
Patent Expiration and Extensions
The patent for etelcalcetide, including US 9,820,938, has various expiration dates depending on the specific claims and extensions. For instance, some patents related to etelcalcetide are estimated to expire in 2030 or 2034, with pediatric extensions potentially extending the exclusivity period[4][5].
Key Takeaways
- Stability and Efficacy: The patent ensures the stability and efficacy of etelcalcetide formulations, crucial for treating secondary hyperparathyroidism.
- Patent Scope and Claims: The patent's scope and claims are carefully defined to protect the unique formulation and method of preparation.
- Industry Impact: The patent landscape in pharmaceuticals and biotechnology is complex, with stringent requirements affecting the scope of patent claims.
- Market Significance: The market for therapeutic peptides and biologics is significant, and patent protection is vital for maintaining competitive advantage.
- Legal Considerations: Patent litigation and settlements, as well as patent expiration dates, are critical factors in the pharmaceutical industry.
FAQs
What is etelcalcetide used for?
Etelcalcetide is used to treat secondary hyperparathyroidism in patients with chronic kidney disease. It works by activating the calcium-sensing receptor to regulate calcium levels in the blood[4].
What is the significance of the stable liquid formulation in US 9,820,938?
The stable liquid formulation ensures that etelcalcetide remains effective over an extended period, with less than 10% degradation when stored at 2-8°C for up to several years[1].
How does the Federal Circuit's stance on genus claims affect pharmaceutical patents?
The Federal Circuit's rigid stance on genus claims makes it challenging for innovators to obtain broad patent protection, as claims must meet stringent written description and enablement requirements to avoid invalidation[3].
What are the implications of patent litigation and settlements in the pharmaceutical industry?
Patent litigation and settlements can involve complex agreements, including the dismissal of claims and the termination of 30-month stays, allowing generic manufacturers to proceed while respecting original patent holders' rights[2].
When do the patents related to etelcalcetide expire?
The patents related to etelcalcetide have various expiration dates, with some estimated to expire in 2030 or 2034, depending on the specific claims and extensions[4][5].
Sources
- US9820938B2 - Stable liquid formulation of AMG 416 (etelcalcetide)
- ANDA Litigation Settlements | Hatch-Waxman - Robins Kaplan LLP
- Eviscerating Patent Scope - DigitalCommons@NYLS
- Etelcalcetide: Uses, Interactions, Mechanism of Action - DrugBank
- Untitled - Patents Gazette
