United States Patent 8,007,830: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,007,830, titled "Granule formation," is associated with the drug Montelukast Sodium, commonly known by the brand name Singulair. This patent is crucial in the pharmaceutical industry, particularly in the context of drug formulation and manufacturing. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
The patent US 8,007,830 was granted to Organon, a pharmaceutical company, and it pertains to the formation of granules, specifically in the context of Montelukast Sodium. This drug is a leukotriene receptor antagonist used primarily for the treatment of asthma and allergic rhinitis[2].
Claims and Scope
The patent claims cover specific methods and systems for the formation of granules, which are essential for the production of pharmaceutical formulations. Here are some key aspects of the claims:
Granule Formation Process
The patent describes a process for forming granules that involves mixing active ingredients with excipients and then granulating the mixture. This process is designed to improve the stability, flowability, and overall quality of the final pharmaceutical product[5].
Specific Claims
- The patent includes claims related to the composition of the granules, the method of granulation, and the equipment used in the process.
- It specifies the types of excipients and active ingredients that can be used, as well as the conditions under which the granulation process should be carried out[5].
Patent Expiry and Generic Versions
The patent US 8,007,830 expired on October 24, 2022. This expiry has significant implications for the pharmaceutical industry, as it allows other companies to develop and market generic versions of Montelukast Sodium.
Generic Applications
Several companies have filed for and received approval for generic versions of Montelukast Sodium. For example, Norvium Bioscience LLC, Apotex Corp, and Breckenridge Pharmaceutical Inc have all received approvals for their generic versions[2].
Legal Activities and Patent Lifecycle
The lifecycle of a patent involves various legal activities that can affect its validity and expiry date.
Maintenance Fees and Patent Term
The patent holder must pay maintenance fees to keep the patent in force. For US 8,007,830, these fees were paid up until the patent's expiry. Any failure to pay these fees could have resulted in the patent being abandoned or lapsing[2].
Recent Legal Activities
Recent activities on this patent include the payment of maintenance fees and the eventual expiry of the patent. For instance, a maintenance fee reminder was mailed in April 2023, and the patent expired in October 2023[2].
Impact on the Pharmaceutical Industry
The expiry of this patent and the subsequent entry of generic versions have significant implications for the pharmaceutical industry.
Market Competition
The entry of generic versions increases market competition, which can lead to lower prices for consumers. This is particularly beneficial for patients who rely on Montelukast Sodium for their treatment[2].
Innovation and R&D
While the expiry of a patent can reduce the exclusive rights of the original patent holder, it also encourages innovation. Other companies can now develop new formulations or delivery systems for Montelukast Sodium, driving further research and development in the field[4].
Regulatory Exclusivities
In addition to patent protection, pharmaceutical products can also benefit from regulatory exclusivities granted by the FDA.
FDA Approval and Exclusivities
Regulatory exclusivities prevent the FDA from approving generic or biosimilar versions of a drug for a certain period after the original drug's approval. However, since US 8,007,830 has expired, these exclusivities no longer apply, allowing for the approval of generic versions[4].
Patent Quality and Scope
The quality and scope of patents are critical in determining their validity and impact.
Metrics for Patent Scope
Research has shown that narrower claims at publication are associated with a higher probability of grant and a shorter examination process. The scope of patent claims can be measured using metrics such as independent claim length and independent claim count[3].
Patent Examination Process
The examination process tends to narrow the scope of patent claims, ensuring that only inventions that meet the criteria of novelty, non-obviousness, and utility are patented. This process is crucial in maintaining the quality of patents and preventing overly broad claims[3].
Challenges and Litigation
Patents in the pharmaceutical industry are often subject to challenges and litigation.
Covered Business Method Reviews
In a different context, patents related to healthcare data analytics have been subject to Covered Business Method (CBM) reviews. This highlights the complexities and challenges that patents can face, especially when they intersect with business methods or financial products[1].
Key Takeaways
- Patent Expiry: US 8,007,830 expired on October 24, 2022, allowing for the entry of generic versions of Montelukast Sodium.
- Granule Formation: The patent covers specific methods for forming granules, which is crucial for pharmaceutical formulations.
- Generic Competition: The expiry of the patent has increased market competition, potentially leading to lower prices for consumers.
- Regulatory Exclusivities: While patent protection has expired, regulatory exclusivities can still play a role in protecting pharmaceutical products.
- Patent Quality: The scope and quality of patents are critical, with narrower claims generally associated with higher grant probabilities and shorter examination processes.
FAQs
What is the significance of the expiry of US 8,007,830?
The expiry of US 8,007,830 allows other companies to develop and market generic versions of Montelukast Sodium, increasing market competition and potentially lowering prices for consumers.
What are the key claims of US 8,007,830?
The patent claims cover specific methods and systems for the formation of granules, including the composition of the granules, the method of granulation, and the equipment used.
How do regulatory exclusivities affect pharmaceutical products?
Regulatory exclusivities prevent the FDA from approving generic or biosimilar versions of a drug for a certain period after the original drug's approval, but these exclusivities do not apply once the patent has expired.
What metrics are used to measure patent scope?
Metrics such as independent claim length and independent claim count are used to measure patent scope, providing insights into the breadth and clarity of patent claims.
Why is the examination process important for patent quality?
The examination process ensures that only inventions that meet the criteria of novelty, non-obviousness, and utility are patented, narrowing the scope of claims to prevent overly broad patents.
Cited Sources
- Healthcare Data Analytics Patent Subject to “CBM” Review at USPTO - Holland & Knight LLP
- Drug Patents containing Montelukast Sodium - Pharsight
- Patent Claims and Patent Scope - Hoover Institution
- Drug Prices: The Role of Patents and Regulatory Exclusivities - Congressional Research Service
- Granule formation - Patent US-8007830-B2 - PubChem
