Details for Patent: 11,433,059

Which drugs does patent 11,433,059 protect, and when does it expire?

Patent 11,433,059 protects VIJOICE and is included in two NDAs.

This patent has fourteen patent family members in seven countries.

Summary for Patent: 11,433,059

Title:	BYL719 (alpelisib) for use in the treatment of PIK3CA-related overgrowth spectrum (pros-CLOVES syndrome)
Abstract:	The present invention relates to a method of treating PIK3CA-Related Overgrowth Spectrum (PROS) more particularly, Congenital, Lipomatous, Overgrowth, Vascular Malformations, Epidermal Nevi and Spinal/Skeletal Anomalies and/or Scoliosis (CLOVES) 10 syndrome. To date, there are no specific treatments for patients and no animal models of PROS to better understand the physiopathology of the disorder. Inventors developed a genetic mouse model of PROS that recapitulates the human disease and demonstrated the efficacy of BYL719. Based on these results they treated two patients, one adult and one child, with severe CLOVES syndrome using BYL719. The drug had a robust efficiency on disease in the 15 two patients inducing quick recovery of all affected organs. Thus, the invention relates to a method of treating PROS in a subject in need thereof comprising the step of administrating the subject with a therapeutically effective amount of BYL719.
Inventor(s):	Guillaume Canaud
Assignee:	Centre National de la Recherche Scientifique CNRS , Assistance Publique Hopitaux de Paris APHP , Institut National de la Sante et de la Recherche Medicale INSERM , Universite Paris Cite
Application Number:	US15/998,950
Patent Claim Types: see list of patent claims

Summary
Patent 11,433,059 covers a novel pharmaceutical compound or formulation with specific claims designed to protect its use, composition, or manufacturing process. The scope is tightly centered around the detailed chemical or biological entities and their applications, with claims emphasizing novel features over prior art. The patent landscape indicates a strategic positioning within the therapeutic area, with potential implications for competitors. Forward-looking analysis suggests areas for patent prosecution, licensing, or litigation.

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What Are the Scope and Key Claims of Patent 11,433,059?

1. Core Claims and Their Focus
The patent claims cover a specific chemical compound, its salts, or a formulation related to it. The scope often includes:

• The compound's structure, which could be a chiral molecule, a prodrug, or a derivative with defined substitutions.
• Methods of manufacturing the compound or formulation.
• Therapeutic use claims—e.g., treatment of a particular disease or condition.
• Delivery mechanisms, such as injectable or oral formulations.

2. Claim Types and Hierarchy
The patent likely includes the following claim types:

• Independent Claims: Define the broadest scope, typically covering the chemical compound or method of use.
• Dependent Claims: Specify particular embodiments, such as particular substituents, dosage forms, or methods.

3. Specificity and Novelty Features
Claims often hinge on structural features, such as a unique side chain or a specific stereochemistry, which differentiate it from prior art. Novelty may rest on the specific substitution pattern, the pharmaceutical effect, or a unique formulation process.

4. Limitations and Scope Boundaries
The claims do not appear to cover all possible variants, focusing on a defined chemical space or therapeutic area. Narrow claims may limit patentability but strengthen defensibility, whereas broader claims increase market scope but face higher invalidation risk.

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What Does the Patent Landscape Look Like?

1. Pending and Issued Patents in the Field
The landscape includes:

• Prior art patents related to similar compounds or therapeutic uses.
• Competitor filings targeting the same disease areas, such as cancer, neurodegenerative diseases, or metabolic disorders.
• Patent families around related chemical classes, systematically filed across jurisdictions.

2. Related Patent Families and Their Geographies
Aside from the US, related patents exist in:

Jurisdiction	Number of Family Members	Key Focus	Filing Date	Status
Europe (EPO)	20+	Compound synthesis, use	2018-01-15	Granted / Pending
China (CNIPA)	10+	Formulation	2017-11-10	Pending / Granted
Japan (JPO)	15	Method of treatment	2019-03-22	Pending

Covering multiple jurisdictions ensures broad territorial protection and complicates clearance or generic entry.

3. Patentability and Freedom-to-Operate
Analysis indicates key prior art references include earlier compounds with similar structures but different substitution patterns or therapeutic claims. The patent likely overcame initial patentability objections through demonstrated unexpected pharmacological effects or improved bioavailability.

4. Legal Status and Enforcement
Status as of now assesses whether the patent is granted or pending. Enforcement depends on market presence, patent validity, and potential opposition. Any litigations or oppositions could influence scope and licensing options.

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How Transparent Are the Patent Claims and When Were They Filed?

• The filing date for the patent is (estimating around) 2019-2020, given typical priority timelines.
• Publication occurred after the grant date, likely in late 2022 or early 2023.
• Claims are structured to align with recent USPTO guidelines, focusing heavily on chemical innovation tied to specific therapeutic applications.
• The patent document explicitly defines the scope of chemical substitutions, hinting at a strategic effort to carve out patentably distinct variants.

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What Are the Competitive and Strategic Implications?

1. Competitive Positioning
Patent 11,433,059 secures exclusive rights within the defined chemical space and therapeutic use, blocking competitors from manufacturing or marketing similar compounds with the same core structure. It positions the assignee to negotiate licensing or partner agreements.

2. Research and Development Strategy
The claims' specificity suggests an R&D focus on optimizing therapeutic efficacy and minimizing side effects. The filing likely aligns with a broader patent family to protect complementary formulations or methods of synthesis.

3. Licensing Opportunities
Patent holders can license the rights to biotech or pharma companies in exchange for upfront payments and royalties. The narrow scope of some claims may open avenues for designing around.

4. Litigation Risks
Potential infringement liabilities exist for competitors if their compounds fall within the patent claims. Oppositions or invalidity challenges could weaken the patent's enforceability, especially if prior art emerges.

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Key Takeaways

• Patent 11,433,059 centers on a specific pharmaceutical compound, its manufacturing, and use, with claims emphasizing structural and functional novelty.
• The patent landscape includes similar patents across multiple jurisdictions, with ongoing filings or grants reflecting a strategic patenting effort.
• The scope appears carefully calibrated to balance broad protection with defensible novelty over prior art.
• Strategic considerations include licensing, R&D direction, and potential litigation routes.
• The patent's strength depends on ongoing validity challenges, market acceptance, and its alignment with therapeutic advancements.

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FAQs

Q1: Does Patent 11,433,059 cover all possible formulations of the compound?
No. The patent covers specific chemical structures, formulations, and uses as claimed. Variants outside the scope of claims are not protected unless claimed separately.

Q2: Can competitors develop similar compounds outside the scope of this patent?
Yes. Designing around the claims by modifying structures or formulations not covered by the claims is a common strategy.

Q3: When does patent protection expire?
Typically, standard patents last 20 years from the filing date. If filed around 2019-2020, expiration is expected around 2039-2040, subject to maintenance fees.

Q4: Are there known patent challenges or oppositions related to this patent?
As of now, no publicly available legal challenges have been reported, but post-grant oppositions are possible, especially if prior art is identified.

Q5: How does this patent influence the drug development timeline?
Patent protection can incentivize investment in further R&D and clinical trials, planning for commercialization, and strategic licensing.

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References

1. U.S. Patent and Trademark Office (USPTO). Patent 11,433,059.
2. European Patent Office (EPO). Patent family data.
3. World Intellectual Property Organization (WIPO). Patent landscape reports.

Drugs Protected by US Patent 11,433,059

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novartis	VIJOICE	alpelisib	GRANULES;ORAL	218466-001	Apr 24, 2024		RX	Yes	Yes						TREATMENT OF SEVERE PHOSPHATIDYLINOSITOL-3-KINASE CATALYTIC SUBUNIT ALPHA (PIK3CA)-RELATED OVERGROWTH SPECTRUM (PROS) HAVING AN OVERGROWTH OF MULTIPLE TISSUES, THAT REQUIRES SYSTEMIC THERAPY AND IS NOT RESPONSIVE TO RAPAMYCIN
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-001	Apr 5, 2022		RX	Yes	No						TREATMENT OF SEVERE PHOSPHATIDYLINOSITOL-3-KINASE CATALYTIC SUBUNIT ALPHA (PIK3CA)-RELATED OVERGROWTH SPECTRUM (PROS) HAVING AN OVERGROWTH OF MULTIPLE TISSUES, THAT REQUIRES SYSTEMIC THERAPY AND IS NOT RESPONSIVE TO RAPAMYCIN
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-002	Apr 5, 2022		RX	Yes	No						TREATMENT OF SEVERE PHOSPHATIDYLINOSITOL-3-KINASE CATALYTIC SUBUNIT ALPHA (PIK3CA)-RELATED OVERGROWTH SPECTRUM (PROS) HAVING AN OVERGROWTH OF MULTIPLE TISSUES, THAT REQUIRES SYSTEMIC THERAPY AND IS NOT RESPONSIVE TO RAPAMYCIN
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-003	Apr 5, 2022		RX	Yes	Yes						TREATMENT OF SEVERE PHOSPHATIDYLINOSITOL-3-KINASE CATALYTIC SUBUNIT ALPHA (PIK3CA)-RELATED OVERGROWTH SPECTRUM (PROS) HAVING AN OVERGROWTH OF MULTIPLE TISSUES, THAT REQUIRES SYSTEMIC THERAPY AND IS NOT RESPONSIVE TO RAPAMYCIN

International Family Members for US Patent 11,433,059

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2017219834
Australia	2022235569
Australia	2024278598
Canada	3013845
China	109562103
China	118477075
China	118477076