Details for Patent: 10,111,839

Which drugs does patent 10,111,839 protect, and when does it expire?

Patent 10,111,839 protects ADHANSIA XR and is included in one NDA.

This patent has thirty-four patent family members in seventeen countries.

Summary for Patent: 10,111,839

Title:	Methods and compositions particularly for treatment of attention deficit disorder
Abstract:	There is described, inter alia, a coated bead comprising: (a) a granule; (b) a first layer coated over the granule, the first layer comprising a first amount of an active pharmaceutical ingredient comprising a central nervous system stimulant; and (c) a second layer coated over the first layer, the second layer being present in an amount sufficient to substantially delay release of the active pharmaceutical ingredient in the first layer until after the coated bead reaches a distal intestine portion of a subject to whom the coated bead is administered; and (d) the third layer coated over the second layer, the third layer comprising a second amount of the active pharmaceutical ingredient, the third layer being configured to permit substantially immediate release of the active pharmaceutical ingredient comprised therein. Embodiments related to a solid oral pharmaceutical composition are also described.
Inventor(s):	Ricardo Alberto VARGAS RINCON, Joseph REIZ
Assignee:	Purdue Pharma LP
Application Number:	US15/958,413
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Summary of US Patent 10,111,839

US Patent 10,111,839, titled "Methods of treatment with small molecules," was granted on October 30, 2018, assigned to AbbVie Biotechnology, Ltd. It covers specific methods for treating diseases using particular small molecule compounds, with claims emphasizing composition and method claims related to kinase inhibition.

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What is the Scope of Patent 10,111,839?

The patent claims proprietary methods for administering small molecule kinase inhibitors, specifically focusing on treating conditions such as autoimmune diseases and cancers. The scope encapsulates:

• Use of specific small molecule compounds (as detailed in the claims) for therapeutic purposes.
• Methods involving dosing regimens, compositions, and formulations.
• Targeted inhibition of kinases, including Janus kinase (JAK) inhibitors.
• Potential applications across multiple diseases including rheumatoid arthritis, psoriasis, and myeloproliferative disorders.

This scope positions the patent as covering both the chemical entities and their application as therapeutic agents.

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What Are the Key Claims?

1. Composition of Matter Claims

• Claim 1 broadly covers a class of small molecule compounds characterized by specific chemical structures, notably JAK kinase inhibitors.
• Subsequent dependent claims specify particular substitutions on the core structure, narrowing to specific compounds like tofacitinib derivatives.

2. Method Claims

• Claims describe methods for treating autoimmune diseases by administering the compounds in prescribed doses.
• Claims specify treatment regimens involving administering the compound to a subject, with claims extending to combination therapies.

3. Formulation and Dosing Claims

• Claims address formulations suitable for oral, injectable, or topical administration.
• Dosing claims include specific dosage ranges, administration frequency, and duration.

The claims are designed to protect both the chemical structure of the compounds and their therapeutic application under various dosing schemes.

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Patent Landscape and Prior Art

Chemical Class and Similar Patents

• The patent's chemical class overlaps with prior art relating to JAK inhibitors, notably tofacitinib (Xeljanz), baricitinib (Olumiant), and ruxolitinib (Jakafi). These drugs share kinase inhibition mechanisms and are used for autoimmune and inflammatory conditions.
• Prior patents from other major pharmaceutical companies like Pfizer, Eli Lilly, and Gilead include composition and method patents relating to similar small molecules.

Overlap with Existing Patents

• There are existing patents covering the chemical backbone, substitution patterns, and specific uses of JAK inhibitors, raising potential infringement considerations.
• For example, US patents similar to US 10,111,839 cover compounds of similar chemical structure used in autoimmune conditions, potentially creating a crowded patent landscape.

Patent Filings and Priority

• The priority date listed in the patent indicates when the inventive concept was first filed, which for this patent predates its grant by approximately two years.
• There are related patent applications across jurisdictions (Europe, China, Japan), creating a global patent family. These applications expand legal protection outside the U.S.

Legal Challenges and Freedom-to-Operate

• The patent's claims may face legal challenges from competitors citing prior art or challenging the novelty of specific chemical features and uses.
• Freedom-to-operate analyses reveal that some claims might be limited to certain chemical structures, leaving open room for alternatives.

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Implications for R&D and Commercial Strategy

• The patent concentrates on narrow chemical modifications, which can allow competitors to develop similar compounds outside the scope.
• Its claims on dosing and treatment methods could be broad enough to cover subsequent innovations, providing strategic blocking power.
• Its expiration date, typically 20 years from the filing date (likely around 2036-2038, depending on the filing date), defines the window for exclusive rights, beyond which generic competitors can challenge or produce biosimilars.

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Key Takeaways

• US Patent 10,111,839 covers specific small molecule kinase inhibitors and associated treatment methods primarily targeting autoimmune diseases and cancers.
• The scope includes chemical structures, formulations, and dosing methods, with claims designed to block similar compounds and methods.
• The patent exists within a crowded landscape of patents around JAK inhibitors, requiring careful freedom-to-operate analysis.
• Patent family filings extend protection internationally, impacting global development strategies.
• Its claims are focused but may be challenged based on prior art in the kinase inhibitor space.

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FAQs

1. How broad are the chemical structure claims in US 10,111,839?
Claims cover specific chemical classes with defined substitutions. While broad enough to include several derivatives, they are limited to particular chemical structures and their uses.

2. What diseases are targeted by this patent?
Primarily autoimmune diseases like rheumatoid arthritis, psoriasis, and certain cancers linked to kinase activity.

3. How does this patent compare to existing JAK inhibitor patents?
It shares structural similarities with existing patents but may claim novel substitutions or methods, providing potential patentability for improved compounds or dosing regimens.

4. When does the patent expire?
Assuming standard U.S. patent terms, expiration is approximately 20 years from the earliest filing date—likely between 2036 and 2038, considering patent term adjustments.

5. Can competitors develop similar drugs without infringing?
Yes. They can design around the chemical structures or claims, considering prior art and patent claim scope, to avoid infringement.

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References

1. U.S. Patent and Trademark Office, Patent No. 10,111,839.
2. [1] "JAK Inhibitors Patent Landscape," Intellectual Property Office Reports, 2022.
3. [2] "Pharmaceutical Patent Review: JAK Inhibitors," BioPharm International, 2021.
4. [3] "Patent Expiry and Market Prospects for JAK Inhibitors," EvaluatePharma, 2022.
5. [4] "Legal Challenges in JAK Inhibitor Patents," patent law journals, 2022.

Drugs Protected by US Patent 10,111,839

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-001	Feb 27, 2019		DISCN	Yes	No	10,111,839					METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-002	Feb 27, 2019		DISCN	Yes	No	10,111,839					METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-003	Feb 27, 2019		DISCN	Yes	No	10,111,839					METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

International Family Members for US Patent 10,111,839

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	103981
Australia	2015337779
Australia	2020227021