United States Patent 8,404,276: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 8,404,276 is associated with the drug Inbrija, a formulation of levodopa for the treatment of Parkinson's disease. This patent is part of a broader landscape of intellectual property protections surrounding Inbrija. Here, we will delve into the scope, claims, and the overall patent landscape of this specific patent.
Patent Overview
Patent Title and Number
The patent in question is titled "Capsules containing high doses of levodopa for pulmonary use" and bears the number US 8,404,276.
Issuance and Expiration
This patent was issued on April 2, 2013, and is set to expire on November 20, 2023, unless extended or challenged[5].
Scope of the Patent
Technology and Innovation
The patent covers the formulation and delivery method of high doses of levodopa via pulmonary administration. This is a significant innovation in the treatment of Parkinson's disease, as it provides an alternative to traditional oral administration, which can have variable absorption rates and side effects[4].
Claims
The patent includes several claims that define the scope of the invention. These claims typically cover:
- The composition of the capsules containing high doses of levodopa.
- The method of preparing these capsules.
- The pulmonary delivery system for administering the levodopa.
- Specific dosages and formulations that are optimized for pulmonary use[5].
Mechanism of Action
Levodopa and Parkinson's Disease
Levodopa is a precursor to dopamine, and its administration helps to increase dopamine levels in the brain, which is crucial for managing Parkinson's disease symptoms. The pulmonary delivery method ensures rapid absorption and onset of action, which can be particularly beneficial for patients experiencing "off" episodes[1][4].
Patent Landscape
Related Patents
The patent 8,404,276 is part of a series of patents related to Inbrija, including US 9,393,210, US 8,685,442, and US 8,545,878, all of which cover various aspects of the drug's formulation and delivery. These patents collectively protect the intellectual property surrounding Inbrija until their respective expiration dates, with some extending until November 2032[5].
Litigation and Challenges
The patents associated with Inbrija, including US 8,404,276, have been subject to various legal proceedings and challenges. For instance, there have been inter partes reviews (IPRs) and other patent litigations aimed at challenging the validity of these patents. These challenges can potentially impact the patent's validity and the timing of generic drug entry into the market[5].
Exclusivities and Generic Launch
In addition to patent protections, Inbrija has been granted certain exclusivities by the FDA, which further delay the launch of generic or bioequivalent versions of the drug. These exclusivities are crucial in maintaining the market exclusivity of Inbrija beyond the patent expiration dates[5].
Impact on the Pharmaceutical Industry
Innovation and Competition
Patents like US 8,404,276 play a significant role in encouraging innovation within the pharmaceutical industry. By protecting the intellectual property of novel formulations and delivery methods, these patents incentivize companies to invest in research and development. However, they also create barriers to entry for generic competitors, which can impact the availability and affordability of treatments[3].
Regulatory Environment
The regulatory environment, including the issuance and enforcement of patents, is critical for pharmaceutical companies. The validity and scope of patents like US 8,404,276 are closely monitored by regulatory bodies and can be subject to challenges and reviews, which can affect the patent's lifespan and the company's market position[2].
Key Takeaways
- Patent Scope: The patent covers the formulation and pulmonary delivery of high doses of levodopa.
- Claims: Specific claims include the composition, preparation, and delivery method of the levodopa capsules.
- Expiration: The patent is set to expire on November 20, 2023.
- Related Patents: Part of a series of patents protecting Inbrija, with some expiring as late as November 2032.
- Litigation: Subject to various legal challenges and IPRs.
- Exclusivities: FDA-granted exclusivities further delay generic launch.
FAQs
What is the primary innovation covered by US Patent 8,404,276?
The primary innovation is the formulation and pulmonary delivery method of high doses of levodopa for treating Parkinson's disease.
When is the patent set to expire?
The patent is set to expire on November 20, 2023.
Are there other patents related to Inbrija?
Yes, there are several other patents related to Inbrija, including US 9,393,210, US 8,685,442, and US 8,545,878.
What are the implications of FDA exclusivities on generic drug launch?
FDA exclusivities delay the launch of generic or bioequivalent versions of Inbrija, even after the patent expiration dates.
How do patent challenges affect the pharmaceutical industry?
Patent challenges can impact the validity and lifespan of patents, affecting the market exclusivity and investment in research and development by pharmaceutical companies.
What is the significance of pulmonary delivery of levodopa?
Pulmonary delivery ensures rapid absorption and onset of action, which is beneficial for managing Parkinson's disease symptoms, especially during "off" episodes.
