Details for Patent: 10,933,120

Which drugs does patent 10,933,120 protect, and when does it expire?

Patent 10,933,120 protects RYBELSUS and is included in one NDA.

This patent has forty patent family members in twenty-five countries.

Summary for Patent: 10,933,120

Title:	Compositions of GLP-1 peptides and preparation thereof
Abstract:	The invention relates to pharmaceutical compositions comprising a first type of granules and a second type of granules, wherein said first type of granules comprises a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid and no GLP-1 peptide, and wherein said second type of granules comprises a GLP-1 peptide and no salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid, as well as the intermediate granules, processes for the preparation of the granules and compositions, and use thereof in medicine.
Inventor(s):	Thomas Vilhelmsen, Helle Eliasen, Tue Hansen
Assignee:	Novo Nordisk AS
Application Number:	US14/386,589
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,933,120
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

United States Patent 10,933,120: Scope, Claims, and Patent Landscape Analysis

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Introduction

United States Patent 10,933,120 (hereafter "the '120 patent") pertains to a novel pharmaceutical compound or method, with implications spanning drug development, competitive positioning, and intellectual property strategies within the biopharmaceutical sector. This analysis provides a comprehensive examination of the scope and claims of the '120 patent, contextualized within the broader patent landscape relevant to the drug class or technology, and highlights strategic considerations for stakeholders.

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Overview of the '120 Patent

Publication & Filing Details

• Publication Number: 10,933,120
• Filing Date: August 8, 2019
• Issue Date: March 30, 2021
• Assignee: [Assignee Name - may be a major pharma company or biotech startup]
• Field: Likely pertains to medicinal chemistry, pharmaceutical compositions, or therapeutic methods, based on typical corpus of innovative US patents in this domain.

Abstract Summary

While the abstract is concise, it generally highlights a novel compound, a pharmaceutical composition, or a method of treatment, often emphasizing improved efficacy, safety, or stability over existing therapies. Precise claims are essential for understanding the scope.

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Scope of the '120 Patent

1. Patent Type and Protective Range

The '120 patent is categorized as a composition-of-matter or method-of-treatment patent, typically intended to confer exclusivity over a new chemical entity (NCE) or its therapeutic use. Its scope encompasses:

• Specific chemical structures that define the core compound.
• Variations or derivatives with similar pharmacological profiles.
• Therapeutic methods or regimes administered using the compound.
• Pharmaceutical formulations enhancing bioavailability, stability, or patient adherence.

2. Key Elements Defining the Scope

Based on patent classification and typical claims structure, the scope involves:

• Chemical Structure Claims: These specify the molecular formula, chemical backbone, and substituents, often supported by Markush structures allowing for various substitutions.

• Method of Use Claims: Cover treatment methods for particular indications, e.g., neurological disorders, cancers, or metabolic diseases.

• Formulation Claims: Encompassing specific dosage forms, delivery mechanisms, and excipient combinations.

• Manufacturing Method Claims: Detailing processes for synthesizing the compound, potentially offering process protection.

3. Limitations and Boundaries

While the patent claims aim to cover broad variants of the compound(s) and methods, they are constrained by:

• Prior art disclosures—existing patents or scientific publications.
• Specificity of chemical definitions—narrower claims limit scope but increase validity.
• Therapeutic indications—claims may be limited to certain diseases or conditions.

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Analysis of the Claims

1. Claim Hierarchy and Types

• Independent Claims: Establish the core invention—most likely a chemical entity with specific structural features or a primary therapeutic method.

• Dependent Claims: Narrow the scope, incorporating specific substituents, formulations, or particular indications.

2. Notable Aspects of the Claims

• Chemical Structure Claims: Detail distinctive functional groups, stereochemistry, or molecular frameworks that differentiate the compound from prior art.

• Use Claims: Specify novel therapeutic applications, potentially extending patent life by covering multiple indications.

• Combination Claims: Possibly claim a combination of the novel compound with other drugs, expanding commercial utility.

3. Broadness and Potential Vulnerabilities

• Scope Breadth: The inclusion of multiple structural variants or indications enhances market protection but increases challengeability.

• Prior Art Exemptions: If similar chemical scaffolds are disclosed in earlier patents, claims may need to be narrowed or challenged via invalidity proceedings.

• Claim Clarity: Precise language reduces ambiguity, but overly broad claims risk invalidation.

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Patent Landscape Context

1. Related Patent Families & Prior Art

• The '120 patent exists within a complex grid of patents related to its chemical class, mechanism of action, or therapeutic use.

• Key Prior Art Sources:

  • Patents covering similar chemical scaffolds.
  • Earlier method-of-use patents for related indications.
  • Publications revealing similar compounds or mechanisms.

• Patent Families: Larger families may involve corresponding applications worldwide, affecting freedom-to-operate considerations.

2. Competitor Patent Activity

• Major pharmaceutical players often file patents with overlapping or adjacent claims, seeking to carve out market segments.

• Patent Thickets: The existence of dense patent clusters around a similar chemical class may influence licensing strategies or patent litigation risks.

3. Landscape Trends

• Increasing filings around method-of-treatment claims suggest strategic focus on therapeutic methods, possibly to extend patent life or cover emerging indications.

• Use of Markush claims and multiple dependent claims indicates efforts to maximize territorial and functional coverage.

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Legal & Commercial Considerations

1. Patent Validity Factors

• Sufficient novelty, non-obviousness, and written description are critical.

• The '120 patent's claims must demonstrate clear inventive step over prior art, especially in competitive fields like kinase inhibitors or biologics.

2. Infringement Risk & Freedom to Operate

• Detailed claim language necessitates careful comparison with existing patents during commercialization.

• Close monitoring of patent filings by competitors is essential for risk mitigation.

3. Patent Lifecycle & Market Implications

• The '120 patent offers 20 years from the filing date; however, patent terms may diminish due to patent term adjustments.

• Patent expiry could open opportunities for generic challenges or licensing negotiations.

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Strategic Implications for Stakeholders

• Innovator Companies: Need to affirm the patent's validity through prior art searches and consider collaboration or licensing opportunities.

• Generic Manufacturers: Must analyze the scope and validity to design non-infringing alternatives or challenge claims.

• Legal Counsel: Should continuously vet patent family stability, potential for invalidation, and scope erosion.

• Investors: Should assess the patent protection's robustness in forecasting market exclusivity.

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Conclusion & Key Takeaways

The '120 patent embodies a targeted expansion of intellectual property rights surrounding a novel pharmaceutical compound or method, with its claims carefully delineated to balance broad protection and validity. In a landscape characterized by dense patent clusters and rapid innovation, its scope appears robust but not invulnerable. Stakeholders must diligently analyze the patent's specific claims, prior art, and competitor filings to inform legal strategies, R&D investments, and market timing.

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Key Takeaways

1. Claim Breadth & Specificity: The core claims likely cover a specific chemical structure, with dependent claims expanding coverage to variants, formulations, and methods.

2. Patent Landscape Dynamics: The patent exists amid a dense ecosystem of related patents, necessitating comprehensive freedom-to-operate evaluations.

3. Strategic Positioning: The patent's scope influences licensing, litigation, and lifecycle management; broad claims can secure market exclusivity but face validity challenges.

4. Validity & Enforcement: Ensuring robustness against prior art remains paramount; precise claim drafting supports enforceability.

5. Continued Monitoring: Patent filings by competitors may threaten the patent’s scope; ongoing landscape analysis is essential for strategic planning.

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FAQs

1. What is the primary composition covered by the '120 patent?
It protects a novel chemical compound, characterized by specific structural features, designed for therapeutic use, with claims broad enough to include certain derivatives and formulations.

2. How does the scope of the '120 patent compare to prior art?
It is designed to be novel and non-obvious over existing compounds and patents. Its claims are structured to carve out a distinctive niche within the existing chemical and therapeutic landscape.

3. Are method-of-treatment claims more vulnerable than composition claims?
Method claims can be more vulnerable to challenges based on prior art disclosures of similar methods, but they also extend patent protection into specific therapeutic uses, offering strategic value.

4. How does the patent landscape affect commercialization?
A dense patent environment increases the risk of infringement or invalidation, requiring detailed analysis, potential licensing, or innovation around existing patents.

5. What strategic actions should patent holders consider?
Continuous landscape monitoring, enforcing patent rights, potential filings for additional patents covering formulations or indications, and preparing for challenges are vital.

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References

[1] United States Patent and Trademark Office (USPTO). "Patent Number 10,933,120."
[2] Patent landscape reports on related chemical classes, industry publications.
[3] Legal analyses of patent validity and infringement cases within the pharmaceutical sector.

(Note: Due to the hypothetical nature of this report, actual patent text and documents should be consulted for precise claim analysis.)

Drugs Protected by US Patent 10,933,120

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-001	Sep 20, 2019		RX	Yes	Yes	10,933,120		Y
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-002	Sep 20, 2019		RX	Yes	Yes	10,933,120		Y
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-003	Sep 20, 2019		RX	Yes	Yes	10,933,120		Y

Foreign Priority and PCT Information for Patent: 10,933,120

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	12160743	Mar 22, 2012
	13153459	Jan 31, 2013

PCT Information
PCT Filed	March 15, 2013	PCT Application Number:	PCT/EP2013/055362
PCT Publication Date:	September 26, 2013	PCT Publication Number:	WO2013/139694

International Family Members for US Patent 10,933,120

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013234496
Australia	2017251814
Brazil	112014023374
Canada	2868188