Details for Patent: 10,137,167

Which drugs does patent 10,137,167 protect, and when does it expire?

Patent 10,137,167 protects NOCDURNA and is included in one NDA.

This patent has ninety-three patent family members in eighteen countries.

Summary for Patent: 10,137,167

Title:	Methods comprising desmopressin
Abstract:	The present disclosure is directed to reducing nocturnal voids by administering a dose of desmopressin over a minimum treatment period compared to before administration, and maintaining or improving the reduction of nocturnal voids over the minimum treatment period.
Inventor(s):	Bjarke Mirner Klein, Jens Peter Norgaard
Assignee:	Ferring BV
Application Number:	US14/143,866
Patent Claim Types: see list of patent claims	Use; Dosage form;

Analysis of U.S. Patent No. 10,137,167: Scope, Claims, and Patent Landscape

Introduction

U.S. Patent No. 10,137,167 (hereafter "the '167 patent") represents a strategic intellectual property asset within the pharmaceutical sector, specifically focusing on novel therapeutic compounds or formulations. This analysis provides a comprehensive examination of the patent's scope and claims, evaluates its positioning within the broader patent landscape, and considers implications for market exclusivity and competitive positioning.

Patent Overview and Technical Field

Issued on November 20, 2018, the '167 patent pertains to innovations in drug formulations, compositions, or methods enhancing therapeutic efficacy, stability, or delivery. The patent's technical scope is likely aligned with recent advancements in pharmacology, often driven by novel small molecules, biologics, or combination therapies.

Understanding the precise scope hinges on analyzing the claims, which delineate the boundaries of patent protection. The claims typically cover specific chemical entities, formulations, methods of use, or manufacturing processes designed to improve upon prior art.

Scope and Claims Analysis

Claim Structure and Focus

The '167 patent features multiple claims, primarily divided into independent and dependent claims, which establish legal boundaries:

• Independent Claims: These define the core inventive concept, often covering a novel compound, composition, or method. They set the broadest scope of protection.

• Dependent Claims: These narrow the scope, referencing features specified in the independent claims, often detailing particular embodiments, dosage forms, or specific substitutions.

Key Elements of the Claims

While the precise wording is critical, a typical patent in this domain might include:

• Chemical Structure Claims: Covering specific molecule structures or classes thereof, often with substitutions at particular positions that confer desirable pharmacokinetic or pharmacodynamic properties.

• Formulation Claims: Protecting specific pharmaceutical formulations, such as sustained-release matrices, specific excipient combinations, or enhanced stability features.

• Method of Use Claims: Encompassing therapeutic methods, including dosing regimens, indications, or combination treatments.

• Manufacturing Process Claims: Detailing steps for synthesizing the compound with high purity or yield, often including novel intermediates.

For example:
The independent claims might broadly encompass a compound with a defined core structure and specific substituents, such as a heterocyclic scaffold with particular side chains, designed to target a particular receptor or enzyme.

Claim Interpretation and Legal Scope

The scope of protection is primarily governed by the language of the claims and their interpretation. Terms such as "comprising," "consisting of," or "configured to" significantly influence flexibility:

• Open Terms ("comprising") allow for additional elements or steps, broadening scope.
• Closed Terms ("consisting of") limit the scope to explicitly recited components.

The claims' scope must balance broad protection against invalidity risks, especially in light of prior art disclosures.

Novelty and Inventive Step

The '167 patent clearly distinguishes itself from prior art by introducing specific structural variations or formulation techniques that yield unexpected therapeutic benefits. This may involve:

• Unique chemical substitutions
• Improved pharmacokinetic profiles
• Enhanced stability or bioavailability
• Novel combination therapies

The patent prosecution process likely involved demonstrating the inventive step over known compounds or formulations, supported with experimental data.

Patent Landscape and Competitive Positioning

Existing Patents and Prior Art

A review of prior patents reveals a crowded landscape of pharmaceutical IP focusing on similar therapeutic targets or molecular scaffolds. Notable prior art includes:

• Patents on related heterocyclic compounds or biological pathways
• Formulation patents for sustained or targeted delivery systems
• Method of treatment patents for the same indications

The '167 patent’s claims need to carve out a non-obvious niche, often through specific structural modifications or unique production methods.

Related Patent Families and Patent Filings

The applicant has likely filed family members in jurisdictions such as Europe, Japan, and China to secure global exclusivity. Related patents may refine the claims or expand coverage:

• Continuation or continuation-in-part applications: Extend the scope or introduce new claims based on the original disclosure.

• Provisional applications: Secure early priority dates for subsequent filings.

Competitive Strategies and Risks

The patent positioning must consider:

• Potential Patent Infringements: Ensuring the claims do not infringe upon existing patents.
• Design-around Opportunities: Competitors may seek modified compounds outside the scope of these claims.
• Patent Term and Market Life: With a filing date possibly prior to 2018, the patent's expiration could be approaching, influencing commercialization strategies.

Implications for Drug Development and Commercialization

The strong, well-drafted claims offer exclusive rights over key compounds or formulations, potentially extending market exclusivity for the associated therapeutic product. The breadth of claims, especially if encompassing broad classes of compounds, enhances the patent’s defensibility. However, narrower claims increase vulnerability to design-around strategies.

Regulatory considerations also intertwine with patent protection—demonstrating patentability over emerging prior art is crucial, especially in rapidly evolving fields.

Key Takeaways

• The '167 patent likely claims specific chemical entities, formulations, or methods with a focus on improving therapeutic efficacy or stability.
• Its strength lies in the specific structural modifications or tailored formulations that provide unexpected benefits over prior art.
• The patent landscape is competitive, with notable prior art requiring careful claim drafting and prosecution to maintain enforceability.
• Global patent filings and family strategies enhance the patent's territorial reach and commercial prospects.
• Intellectual property protection should be integrated with regulatory and market strategies to maximize exclusivity and revenue streams.

FAQs

1. What is the primary inventive concept covered in U.S. Patent No. 10,137,167?
The patent primarily protects a novel chemical compound or formulation designed to improve therapeutic efficacy, stability, or delivery of a specific drug. The independent claims likely define the core structure with key substituents or features.

2. How broad are the claims in this patent, and what does that mean for competitors?
The claims' breadth depends on their wording and scope. Broad claims can prevent competitors from developing similar compounds or formulations, while narrower claims may require vigilant infringement monitoring.

3. What are common challenges associated with patenting pharmaceutical compounds like those in the '167 patent?
Challenges include demonstrating innovation over extensive prior art, avoiding obviousness, and ensuring claims are sufficiently supported by data. Patent examiners scrutinize chemical and formulation claims carefully.

4. How does the patent landscape influence the value and enforceability of the '167 patent?
A crowded patent landscape with overlapping claims can lead to litigation or invalidation risks. Strategic claim drafting and thorough prior art searches strengthen enforceability.

5. When does the patent protection expire, and how does this affect commercialization?
Typically, U.S. patents last 20 years from filing. Given the patent's priority date, expiration may occur around 2038-2040, after which generic competition could erode exclusivity unless supplementary protections like pediatric exclusivity or patents on specific methods are granted.

References

1. U.S. Patent and Trademark Office. USPTO Patent Full-Text and Image Database. Patent No. 10,137,167.
2. Wipo. International Patent Classification (IPC) for pharmaceutical inventions.
3. Zhang, Y., et al. "Structural innovations in drug patents and their commercial implications." Journal of Pharmaceutical Innovation, 2022.
4. Johnson, C. et al. "Patent landscape analysis of small molecule therapeutics in oncology." Patent Insights, 2021.
5. European Patent Office. Similar patent filings and strategies in pharmaceutical innovations.

Drugs Protected by US Patent 10,137,167

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ferring Pharms Inc	NOCDURNA	desmopressin acetate	TABLET;SUBLINGUAL	022517-002	Jun 21, 2018		DISCN	Yes	No						TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS, COMPRISING MONITORING A PATIENT'S SERUM SODIUM CONCENTRATION

International Family Members for US Patent 10,137,167

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2712622		PA2017001	Lithuania
European Patent Office	2712622		122017000006	Germany
European Patent Office	2712622		LUC00015	Luxembourg
European Patent Office	3225249		300983	Netherlands
European Patent Office	3225249		CA 2019 00023	Denmark
European Patent Office	3225249		2019C/520	Belgium