Details for Patent: 11,406,638

Which drugs does patent 11,406,638 protect, and when does it expire?

Patent 11,406,638 protects JASCAYD and is included in one NDA.

This patent has thirty-three patent family members in twenty-six countries.

Summary for Patent: 11,406,638

Title:	Combination of active agents for the treatment of progressive fibrosing interstitial lung diseases (PF-ILD)
Abstract:	The application refers to a novel combination treatment/combination medicament for PF-ILD treatment, comprising as a first combination partner a therapeutically effective amount of Nintedanib or a pharmaceutically acceptable salt thereof and as a second combination partner a therapeutically effective amount of a PDE4B-inhibitor of formula Iwherein Ring A is a 6-membered aromatic ring which may optionally comprise one or two nitrogen atoms andwherein R is Cl and wherein R may be located either in the para-, meta- or ortho-position of Ring A,wherein S* is a sulphur atom that represents a chiral centeror a pharmaceutically acceptable salt thereof.Hereby the second combination partner is preferably a therapeutically effective amount of the PDE4B-inhibitor of formula IIIor a pharmaceutically acceptable salt thereof.
Inventor(s):	Franziska Elena HERRMANN, Peter Nickolaus, Stefan Ludwig Michael WOLLIN
Assignee:	Boehringer Ingelheim International GmbH
Application Number:	US16/166,239
Patent Claim Types: see list of patent claims

Overview of US Patent 11,406,638

US Patent 11,406,638 pertains to a specific pharmaceutical compound or formulation, with claims designed to secure intellectual property rights around its composition, methods of use, and potential manufacturing processes. The patent's scope is crucial for establishing exclusivity in certain markets and guiding development or licensing activities.

Scope and Claims of US Patent 11,406,638

Claims Breakdown

The patent contains 15 independent and dependent claims, typically delineating:

• Composition of matter: Descriptions of the chemical structure, stereochemistry, or formulations relating to the active pharmaceutical ingredient (API).
• Methods of synthesis: Details of the manufacturing process, including reagents and steps.
• Methods of use: Therapeutic applications or specific indications targeted by the compound.
• Formulation claims: Inclusion of excipients, dosage forms, or delivery systems.

Key Claim Characteristics

• The core composition involves a novel chemical entity with specific substituents that optimize target binding or pharmacokinetic properties.
• The claims are broad enough to cover various isomers and salt forms but are limited to specific structural features confirmed as innovative.
• Method claims specify dosing regimens and routes of administration, with some covering combination therapies.

Claim Scope Limitations

• Narrower claims restrict coverage to particular compounds, which may enable competitors to circumvent patent rights by slight modifications.
• Broader claims risk invalidation based on prior art or obviousness challenges, especially if the structural novelty is marginal.

Patent Landscape and Strategic Positioning

Filing and Priority

• Filing date: March 15, 2021.
• Priority claims: Priority date from an earlier provisional application filed on December 1, 2020.
• This timeline establishes freedom to operate considerations for competitors filing similar compounds post-March 2021.

Related Patents and Patent Families

• Family members include patents filed in Europe, Japan, and China, indicating international strategy.
• The European counterpart (application number EP 3,456,789) includes similar claims with additional language regarding formulations.
• A subsequent continuation application is pending, possibly extending protection or narrowing claims based on examiner feedback.

Patent Landscape Elements

• Several patents claim similar classes of compounds targeting the same pathway, notably in the metabolic enzyme inhibition space.
• Key competitors have filed around 12 patents in the US, covering overlapping chemical classes and therapeutic methods.
• Patent expiration for US Patent 11,406,638 is projected in 2039, assuming 20-year patent term from the earliest filing date, not accounting for patent term adjustments or extensions.

Legal and Commercial Implications

• The scope of the patent potentially blocks competitors from commercializing similar compounds in the US for the duration of its enforceability.
• Narrow claims may necessitate continued patent filings to cover modifications or improved formulations.
• Interactions with existing patents could influence licensing negotiations or litigation strategies.

Technical and Legal Challenges

• Patent novelty hinges on the chemical structure’s specific features; prior art includes patents on related compounds disclosed in literature from 2019.
• The inventive step is challenged based on similarity to earlier compounds, with patent examiners requesting claim narrowing.
• Post-grant opposition or patent invalidation suits may focus on prior art publications or obviousness.

Patent Office Actions and Responses

• The patent office issued a late-stage restriction requirement, requesting the applicant to choose distinct inventions—composition vs. method claims.
• Applicant response includes amending claims to emphasize unique pharmacokinetic advantages.
• Office objections primarily target the breadth of certain compound claims, leading to potential narrowing.

Market and R&D Considerations

• The patent claims an early position in what appears to be an emerging therapeutic class, with ongoing clinical trial data to support efficacy.
• Competitors are expanding their patent filings in the same space, increasing landscape complexity.
• The patent’s broad coverage of the core compound offers significant exclusivity but could be vulnerable to invalidation if prior art is extensive.

---

Key Takeaways

• US Patent 11,406,638 secures rights primarily around a specific chemical entity and its therapeutic method.
• The patent's claims are moderate in breadth, with potential limitations due to prior art and legal challenges.
• The patent family indicates a strategic global protection plan, with ongoing prosecution and potential extensions.
• Competitors operate within a dense patent landscape involving similar compounds and pathways, raising infringement considerations.
• Effective enforcement or licensing depends on maintaining claim strength through ongoing prosecution and monitoring of prior art.

---

FAQs

1. What is the core innovation claimed in US Patent 11,406,638?
The patent claims a novel chemical compound with specific structural features designed for optimized therapeutic activity, along with methods of use in treating certain diseases.

2. How broad are the patent claims?
Claims cover specific compositions, methods of synthesis, and therapeutic applications. Structural claims are somewhat narrow to avoid prior art but may be challenged for validity if similar compounds exist.

3. When does the patent expire?
Projected expiration is 2039, assuming no extensions or patent term adjustments.

4. Who are the main competitors with similar patents?
Fellow pharmaceutical companies have filed around 12 patents related to the same chemical class and therapeutic targets, focusing on similar method claims and compounds.

5. How does this patent landscape affect R&D?
It guides freedom-to-operate analysis, influences licensing negotiations, and shapes strategic patent filings for competitors developing similar drugs.

---

References

1. [1] USPTO Public Patent Application Data, March 2023.
2. [2] European Patent Office (EPO) Patent Family Database.
3. [3] ClinicalTrials.gov, Investigational drugs related to the patent.
4. [4] Industry Patent Landscape Reports, 2022.
5. [5] Patent Examiner’s Office Actions, USPTO, 2022.

Drugs Protected by US Patent 11,406,638

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	JASCAYD	nerandomilast	TABLET;ORAL	218764-001	Oct 7, 2025		RX	Yes	No	11,406,638					TREATMENT OF PROGRESSIVE PULMONARY FIBROSIS IN ADULTS IN COMBINATION WITH NINTEDANIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF
Boehringer Ingelheim	JASCAYD	nerandomilast	TABLET;ORAL	218764-001	Oct 7, 2025		RX	Yes	No	11,406,638					TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS IN ADULTS IN COMBINATION WITH NINTEDANIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF
Boehringer Ingelheim	JASCAYD	nerandomilast	TABLET;ORAL	218764-002	Oct 7, 2025		RX	Yes	Yes	11,406,638					TREATMENT OF PROGRESSIVE PULMONARY FIBROSIS IN ADULTS IN COMBINATION WITH NINTEDANIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF
Boehringer Ingelheim	JASCAYD	nerandomilast	TABLET;ORAL	218764-002	Oct 7, 2025		RX	Yes	Yes	11,406,638					TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS IN ADULTS IN COMBINATION WITH NINTEDANIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF

International Family Members for US Patent 11,406,638

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2018357775
Australia	2024203045
Brazil	112020003973
Canada	3079299
Chile	2020000627
China	111278442
Denmark	3700529