United States Patent 10,098,845: A Detailed Analysis of Scope, Claims, and Patent Landscape
Overview of the Patent
United States Patent 10,098,845, titled "Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof," is a significant patent in the field of pharmaceuticals, particularly for the treatment of Parkinson's disease. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Purpose
The patent focuses on the development of muco-adhesive, controlled release formulations of levodopa and its esters. Levodopa is a crucial medication for treating Parkinson's disease, and these formulations aim to improve the drug's delivery and efficacy.
Scope of the Patent
Indications and Uses
The patent covers formulations designed for the treatment of Parkinson's disease, a neurodegenerative disorder characterized by motor symptoms such as tremors, stiffness, and bradykinesia. The muco-adhesive and controlled release aspects are intended to enhance the bioavailability and stability of levodopa, providing a more consistent therapeutic effect[4].
Formulation Details
The patent describes various formulations, including oral solid dosage forms such as beads, tablets, and capsules. These formulations incorporate polymers, salts, and other excipients to achieve controlled release and muco-adhesive properties. The use of polymers like methacrylic acid copolymer and alginic acid is highlighted, along with the incorporation of ingredients like polyvinylpyrrolidone and fumaric acid[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover the composition of the formulations, the methods of preparation, and the specific uses of the formulations. For example, Claim 1 might describe a muco-adhesive, controlled release formulation comprising levodopa or its esters, along with specific polymers and excipients[4].
Dependent Claims
Dependent claims further specify the details of the independent claims, such as the types of polymers used, the ratio of active ingredients to excipients, and the methods of manufacturing the formulations. These claims help to narrow down the scope and ensure that the patent covers specific and novel aspects of the invention[4].
Mechanism of Action
Aromatic-L-amino-acid Decarboxylase Inhibition
The formulations described in the patent work by inhibiting the enzyme aromatic-L-amino-acid decarboxylase, which is responsible for the premature conversion of levodopa to dopamine outside the brain. This inhibition, often achieved through the use of decarboxylase inhibitors like carbidopa, ensures that more levodopa reaches the brain, where it is needed to alleviate Parkinson's symptoms[1][4].
Patent Landscape
Patent Scope Metrics
The scope of a patent can be measured using metrics such as independent claim length and independent claim count. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process. The examination process tends to narrow the scope of patent claims, ensuring clarity and specificity[3].
Patent Quality and Innovation
The patent landscape for pharmaceuticals, particularly for Parkinson's disease treatments, is complex. There is ongoing debate about patent quality, with concerns over overly broad claims and decreased clarity. However, patents like US 10,098,845 contribute to innovation by providing clear and specific claims that protect novel formulations while encouraging further research and development[3].
Exclusivity and Patent Life
The patent life for US 10,098,845 is estimated to be 20 years from the date of filing, although this can be variable due to factors such as patent infringement litigation and the development of new formulations. Additionally, the FDA may grant exclusivity periods that run simultaneously with the patent, providing the manufacturer with sole marketing rights for a specified period[5].
Litigation and Claim Construction
Claim Construction Principles
In patent litigation, the construction of claims is crucial. The court's determination of claim meaning involves a two-step process: first, determining the meaning of disputed claim terms, and then comparing the accused device to the claims as construed. The focus is on the claim language itself, and the ordinary and customary meaning of claim terms as understood by a person of ordinary skill in the art[2].
Patent Infringement
Patent infringement suits, such as those involving pharmaceutical patents, often hinge on the construction of claims. The history of the patent's prosecution, including any amendments or disclaimers made during the process, is critical in determining the scope of the claims and whether infringement has occurred[2].
Key Takeaways
- Muco-adhesive and Controlled Release Formulations: The patent covers innovative formulations designed to improve the delivery and efficacy of levodopa for Parkinson's disease treatment.
- Specific Claims and Formulations: The patent includes detailed claims on the composition, preparation, and use of these formulations, ensuring clarity and specificity.
- Patent Scope and Quality: The patent adheres to metrics of patent scope, contributing to innovation and clarity in the pharmaceutical field.
- Exclusivity and Patent Life: The patent's life and any FDA-granted exclusivity periods are crucial for the manufacturer's market position.
- Litigation and Claim Construction: The patent's claims are subject to strict construction principles in litigation, ensuring that the scope of the invention is clearly defined.
FAQs
What is the primary purpose of the muco-adhesive, controlled release formulations described in US 10,098,845?
The primary purpose is to improve the delivery and efficacy of levodopa for the treatment of Parkinson's disease by ensuring a more consistent therapeutic effect.
How do the formulations described in the patent inhibit the premature conversion of levodopa?
The formulations inhibit the enzyme aromatic-L-amino-acid decarboxylase, often through the use of decarboxylase inhibitors like carbidopa.
What metrics are used to measure the scope of a patent like US 10,098,845?
Metrics such as independent claim length and independent claim count are used to measure the scope of a patent.
How does the patent landscape impact innovation in pharmaceuticals?
The patent landscape, by providing clear and specific claims, encourages innovation and further research while protecting novel formulations.
What is the significance of claim construction in patent litigation?
Claim construction is crucial in determining the meaning of disputed claim terms and comparing the accused device to the claims as construed, which is essential for resolving patent infringement suits.
Sources
- DrugBank Online: Carbidopa: Uses, Interactions, Mechanism of Action.
- GovInfo: United States District Court - Patent Infringement Suit.
- Hoover Institution: Patent Claims and Patent Scope.
- Google Patents: Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof.
- Drugs.com: Generic Crexont Availability - Drug Patents and Exclusivity.
