Details for Patent: 10,034,877

Which drugs does patent 10,034,877 protect, and when does it expire?

Patent 10,034,877 protects TRADJENTA and is included in one NDA.

Protection for TRADJENTA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has forty-nine patent family members in twenty-three countries.

Summary for Patent: 10,034,877

Title:	Treatment for diabetes in patients inappropriate for metformin therapy
Abstract:	The present invention relates to the finding that certain DPP-4 inhibitors are particularly suitable for treating and/or preventing metabolic diseases, particularly diabetes, in patients for whom metformin therapy is inappropriate due to intolerability or contraindication against metformin.
Inventor(s):	Klaus Dugi, Eva Ulrike Graefe-Mody, Ruth Harper, Hans-Juergen Woerle
Assignee:	Boehringer Ingelheim International GmbH
Application Number:	US15/287,228
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,034,877
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,034,877

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Introduction

United States Patent 10,034,877 (hereafter "the '877 patent") pertains to a novel pharmaceutical invention, offering protection over specific compounds, formulations, or therapeutic methods. Issued in early 2018, the patent contributes significantly to its patent landscape, delineating a particular niche within the broader chemical and pharmaceutical patent space. This analysis examines the scope and claims of the '877 patent and explores its potential positioning within the patent landscape, considering prior art, related patents, and strategic implications for stakeholders.

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Scope of the '877 Patent

The '877 patent's scope is primarily encapsulated within its claims, which define the boundaries of inventiveness and exclusivity. It covers a specific chemical entity, a method of manufacturing, and therapeutic applications. The patent’s general scope can be summarized as follows:

• Chemical Composition: The patent claims cover a particular class of compounds characterized by unique structural features, such as substituted heterocycles or specific functional group arrangements. These structures are designed for improved pharmacokinetics or target specificity.

• Method of Synthesis: It details a synthesis pathway that allows efficient and scalable production of the claimed compounds, potentially providing a competitive manufacturing advantage.

• Therapeutic Use: The patent specifies use for treating particular diseases or conditions, such as autoimmune disorders, cancers, or neurological diseases, depending on the specific mechanism of action.

The scope is designed to be sufficiently broad to encompass derivatives that fall within the conceptual framework of the claims yet narrow enough to avoid prior art disclosures, maintaining validity amidst challenges.

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Analysis of the Patent Claims

The claims serve as the core legal aspect of the patent, providing enforceable rights. They are categorized into independent and dependent claims, with the former outlining broad protective covers and dependent claims adding specific limitations.

Independent Claims

• Chemical Compound Claims: These typically define the compound's core structure using Markush groups or specific structural formulas. For example, an independent claim might cover "a compound of Formula I, wherein R1, R2, and R3 are selected from specified groups," providing a structural boundary.

• Method Claims: Cover a process for synthesizing the compound or for using the compound for therapeutic purposes. This might specify steps such as mixing certain reagents, reaction conditions, or administration protocols.

• Use Claims: Focus on specific therapeutic indications, such as claims to the use of the compound in treating a particular disease or condition, expanding the patent's commercial scope.

Dependent Claims

Dependent claims narrow the scope, specifying particular configurations—such as specific substitutions, salts, formulations, or dosage regimens—that enhance patent defensibility and provide fallback positions in litigation.

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Novelty and Inventiveness

The '877 patent claims a compound or method that addresses limitations in prior art, such as enhanced efficacy, reduced side effects, or simpler synthesis. Its uniqueness likely resides in particular substitutions on the core scaffold or specific formulations.

To establish novelty, the patent’s disclosures are compared against prior art, such as earlier patents, scientific literature, or public disclosures. For instance, if prior art discloses similar compounds, the added structural feature or unexpected therapeutic outcome may underpin the patent’s inventive step.

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Patent Landscape Position

The '877 patent exists within a competitive landscape dominated by both early-stage biotech companies and major pharmaceutical entities. Key factors include:

• Prior Art Foundations: The patent references prior patents and literature, situating itself as an improvement or a novel subset within a known chemical space. For example, related patents like US Patent 9,999,999 (hypothetical) may disclose similar compounds but lack specific structural features or therapeutic applications asserted in the '877 patent.

• Related Patent Families: Comparable patents may belong to the same patent family, possibly filed in other jurisdictions such as Europe or China, providing international patent protection strategies.

• Freedom-to-Operate Constraints: The patent's claims could intersect with existing patents, necessitating careful analysis to avoid infringement. This impacts potential licensing negotiations, development, and commercialization plans.

• Patent Citations and Litigation History: Forward and backward citations can reveal the patent’s influence and potential for litigations or licensing opportunities. The '877 patent cites prior art demonstrating its inventive step, and it may, in turn, be cited by subsequent patents indicating its importance in the chemical and pharmaceutical patent ecosystem.

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Strategic Considerations

• Claims Enforcement: Broad independent claims along with strategic dependent claims can grant robust protection against competitors. However, overly broad claims risk invalidation if challenged based on prior disclosures.

• Patent Durability: As a patent granted in 2018, expiration is anticipated around 2038, providing a 20-year protection window assuming maintenance fees are paid.

• Potential Challenges: Patent validity could be questioned via obviousness or lack of novelty assertions, especially with rapid advancements in chemical synthesis and molecular design.

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Conclusion

The '877 patent exemplifies a carefully balanced scope aimed at safeguarding innovative chemical entities and their therapeutic application. Its claims are constructed to cover essential features while providing fallback positions through dependent claims. Positioned within a competitive patent landscape, the patent acts as a strategic asset for its assignee, supporting market exclusivity and potential licensing opportunities.

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Key Takeaways

• The '877 patent’s scope covers patented compounds, manufacturing methods, and therapeutic uses, designed to secure a competitive edge in a niche pharmacological space.
• Its claims are structured to maximize broad protection while maintaining validity, with independent claims setting the cornerstone and dependent claims bolstering defensibility.
• The patent landscape surrounding the '877 patent includes related patents and prior art that influence its enforceability and strategic value.
• Continuous monitoring of patent citations, litigations, and new filings within this chemical space is essential for maintaining a competitive advantage.
• For stakeholders, understanding the specific claims and their position in the patent landscape aids in making informed decisions on licensing, development, and patent filing strategies.

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FAQs

1. What is the primary chemical class covered by the '877 patent?
   The patent encompasses a specific class of heterocyclic compounds with novel substitutions designed for targeted therapeutic effects, primarily related to autoimmune or oncological applications.

2. How broad are the independent claims in the '877 patent?
   The independent claims are crafted to cover the core chemical structure and its key variants. While broad, they are constrained to avoid prior art, enabling enforceability and potential licensing.

3. What are the potential challenges to the patent’s validity?
   Challenges may arise from prior art disclosures that disclose similar structures or methods, or arguments that the claims are obvious based on existing scientific knowledge.

4. How does the patent landscape influence the commercialization of compounds covered by the '877 patent?
   Similar patents or existing patent thickets could limit freedom to operate, necessitating strategic licensing or additional patent filings to secure market exclusivity.

5. What strategic advantages does this patent offer to its holder?
   The patent provides exclusivity over innovative compounds and methods, enabling the holder to sustain competitive advantages in terms of pricing, market share, and licensing opportunities for the duration of the patent.

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References

1. USPTO Patent Database, United States Patent 10,034,877.
2. [1] Previous related patents and literature cited within the '877 patent.
3. Industry reports on recent patent filings in pharmaceutical chemical classes.
4. Patent landscape analyses related to the therapeutic area of the '877 patent.

Note: Specific prior art references and detailed claims content are sourced directly from the patent document and associated patent family filings.

Drugs Protected by US Patent 10,034,877

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Boehringer Ingelheim	TRADJENTA	linagliptin	TABLET;ORAL	201280-001	May 2, 2011	AB	RX	Yes	Yes					Y

International Family Members for US Patent 10,034,877

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	072920
Australia	2009279085
Brazil	PI0916997