United States Patent 11,065,250: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,065,250, titled "Solid dosage forms of palbociclib," is a significant patent in the pharmaceutical industry, particularly in the context of cancer treatment. This patent, assigned to Pfizer Inc., pertains to the formulation and manufacture of solid dosage forms of palbociclib, a critical drug for treating certain types of cancer.
Background on Palbociclib
Palbociclib is a selective inhibitor of the cyclin-dependent kinases 4 and 6 (CDK4/6), which are crucial for cell cycle progression. It is approved for the treatment of hormone receptor-positive, human epidermal growth factor 2 (HER2)-negative advanced or metastatic breast cancer[1][4].
Patent Overview
Publication and Legal Status
The patent was published on August 10, 2021, and is currently active, with an estimated expiration date in 2036[4].
Claims and Scope
The patent includes multiple claims that cover various aspects of the solid dosage forms of palbociclib. These claims are broadly categorized into several key areas:
Composition Claims
These claims describe the specific composition of the solid dosage forms, including the active ingredient palbociclib, excipients, and other formulation components. For example, the patent details the use of specific acids and other ingredients to enhance the stability and bioavailability of palbociclib[4].
Manufacturing Claims
These claims outline the methods and processes for manufacturing the solid dosage forms. This includes steps such as mixing, granulating, and compressing the formulation into tablets or capsules[4].
Formulation Claims
These claims specify the physical and chemical characteristics of the final dosage form, such as tablet strength, size, and release profile. The patent ensures that the formulation meets specific standards for efficacy and safety[4].
Patent Landscape and Industry Context
Pharmaceutical Patent Landscape
The pharmaceutical industry is heavily reliant on robust patent protection to support the development and commercialization of new drugs. Patents like US 11,065,250 are crucial for innovators to recoup their significant investments in research and development. However, the landscape is complex due to stringent patent laws and the need for broad yet specific claims to prevent infringement while allowing for innovation[3].
Genus Claims and Patent Scope
The scope of patent claims, particularly genus claims, is a critical issue in the pharmaceutical industry. Genus claims aim to cover a broad class of compounds or formulations, but they must be supported by a detailed written description and enablement to be valid. The Federal Circuit's recent jurisprudence has made it challenging to obtain and maintain broad patent protection, as it requires detailed disclosure and testing of all species within a genus[3].
Litigation and Settlements
Patent litigation is a common aspect of the pharmaceutical industry, especially when generic manufacturers seek to enter the market. Settlements and litigation outcomes can significantly impact the validity and enforceability of patents. For example, settlements often involve the dismissal of claims and counterclaims with or without prejudice, and may include provisions that enjoin the generic manufacturer from infringing the patents until a specified date or under certain conditions[2][5].
Impact on Generic Manufacturers
Generic manufacturers must navigate the complex patent landscape to avoid infringement. Patents like US 11,065,250 can delay the entry of generic versions of palbociclib into the market, affecting patient access and healthcare costs. Generic manufacturers often seek to design around the claims of the original patent, but this requires careful analysis to ensure that their products do not infringe on the existing patents[2][5].
Expert Insights
Industry experts emphasize the importance of robust patent protection for pharmaceutical innovations. As noted by legal experts, "the market for such therapeutics is steadily expanding, and innovators expect robust and predictable patent protection to support their commercialization strategies"[3].
Illustrative Statistics
The market for therapeutic antibodies and pharmaceuticals is projected to reach significant figures, with estimates suggesting the market for therapeutic antibodies alone could reach $300 billion by 2025. This underscores the economic importance of strong patent protection in these industries[3].
Key Takeaways
- Patent Scope and Claims: US 11,065,250 covers specific compositions, manufacturing methods, and formulations of palbociclib, ensuring broad yet specific protection.
- Industry Context: The patent landscape in pharmaceuticals is complex, with a need for robust and predictable patent protection.
- Litigation and Settlements: Patent litigation and settlements play a crucial role in determining the validity and enforceability of pharmaceutical patents.
- Impact on Generic Manufacturers: Patents can delay the entry of generic drugs, affecting patient access and healthcare costs.
- Economic Importance: Strong patent protection is vital for the economic viability of pharmaceutical innovations.
FAQs
What is the primary use of palbociclib?
Palbociclib is primarily used for the treatment of hormone receptor-positive, human epidermal growth factor 2 (HER2)-negative advanced or metastatic breast cancer.
What does the US 11,065,250 patent cover?
The patent covers the composition, manufacturing methods, and formulations of solid dosage forms of palbociclib.
Why is patent protection important in the pharmaceutical industry?
Patent protection is crucial for innovators to recoup their investments in research and development and to support the commercialization of new drugs.
How do genus claims impact pharmaceutical patents?
Genus claims can be challenging to maintain due to the need for detailed written descriptions and enablement, which can limit the scope of patent protection.
What is the estimated expiration date of the US 11,065,250 patent?
The patent is estimated to expire in 2036.
Cited Sources
- DrugBank: Palbociclib: Uses, Interactions, Mechanism of Action.
- Robins Kaplan LLP: ANDA Litigation Settlements | Hatch-Waxman.
- DigitalCommons@NYLS: Eviscerating Patent Scope.
- Google Patents: US11065250B2 - Solid dosage forms of palbociclib.
- Robins Kaplan LLP: ANDA Litigation Settlements | Hatch-Waxman (2022).
