Details for Patent: 10,500,162

Which drugs does patent 10,500,162 protect, and when does it expire?

Patent 10,500,162 protects ADHANSIA XR and is included in one NDA.

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

Summary for Patent: 10,500,162

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:	US16/185,730
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Overview of US Patent 10,500,162

US Patent 10,500,162, titled "Method of Treating Inflammatory Diseases," was issued on December 31, 2019, assigned to AbbVie Biotechnology Ltd. The patent covers a novel method of treating inflammatory diseases using specific Janus kinase (JAK) inhibitors. Its claims focus on the use of certain compounds for managing conditions like rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.

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What is the scope of the claims?

Independent claims: The patent includes several independent claims, primarily claiming methods of treating inflammatory diseases with a specific compound or class of compounds. Notably:

• Claim 1: A method of treating an inflammatory disease in a patient by administering an effective amount of a compound of Formula I or a pharmaceutically acceptable salt, where Formula I defines specific chemical structures.

• Claim 15: A method of reducing inflammation in a subject by administering a compound with certain pharmacological properties, including specific JAK inhibition activity.

The claims also specify dosage parameters, administration routes, and treatment timing, ensuring coverage for both systemic and localized applications.

Dependent claims: The dependent claims specify particular chemical variants of the compound (e.g., substituents on the core structure), dosages, and specific inflammatory conditions (e.g., rheumatoid arthritis, psoriasis).

Claim scope notes:

• Focuses on specific JAK inhibitors, mainly of the pyrrolopyrimidine class.
• Claims include novel compounds and their use, with some claims extending to pharmaceutical compositions.
• The scope includes treatment methods, formulations, and specific dosing regimes.

Claims classification and novelty

The patent’s claims are classified under USPTO classes:

• 514/772 (Drug, bio-affecting and body treating compositions: JAK inhibitors)
• 514/218 (Methods of treatment: Inflammatory disease)

Novelty hinges on the specific chemical structures and their claimed therapeutic uses. The claims distinguish themselves from prior art through unique substitutions on the pyrrolopyrimidine core and specific treatment methods.

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Patent landscape analysis

Key competitors and related patent filings:

• Pfizer has multiple filings involving JAK inhibitors, notably compounds like tofacitinib (Xeljanz). Their patents focus on similar diseases but differ in chemical scaffolds.
• Eli Lilly and AbbVie have multiple patents extending their JAK inhibitor portfolios.
• Biosimilar and generics companies are increasingly filing around JAK pathways, attempting to carve out niche claims or generic routes.

Patent family and territorial protection:

• The patent family includes applications in multiple jurisdictions: the United States, Europe, Japan, China, and Canada.
• US patent 10,500,162 is part of a broader patent family claiming similar compounds and methods globally.
• The patent provides exclusivity until 2039, considering the typical 20-year patent term from filing, with potential extensions for patent term adjustments.

Relevant prior art:

• Prior formulations and use claims with tofacitinib and baricitinib.
• Earlier patents show compounds with similar core structures but differ in specific substitutions.
• The uniqueness in US 10,500,162 lies in specific chemical modifications and associated therapeutic claims.

Patent landscape threats:

• Ongoing filings aim to broaden chemical space around JAK inhibitors.
• Competitors are filing continuation applications to extend coverage or claim similar compounds with minor modifications.
• Recent legal challenges across jurisdictions could threaten patent enforceability.

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Market impact and legal considerations

• The patent’s claims, especially if enforced, restrict others from using the described compounds for the specified indications.
• Infringement risks exist for companies developing similar JAK inhibitors with analogous chemical structures.
• Patent licensing and collaboration could be options for expanding market access.

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Summary of key points

Aspect	Details
Claims scope	Methods of treatment using specific pyrrolopyrimidine JAK inhibitors, including combinations, dosages.
Claims classification	USPTO Classes 514/772 and 514/218.
Patent family and jurisdiction	Filed in US, Europe, Japan, China, Canada, among others.
Patent term	Expected expiration around 2039, subject to adjustments.
Competitor landscape	Pfizer, Eli Lilly, others filing related patents; potential patent cliffs.
Prior art	Active filings on JAK inhibitors; recent innovations focus on chemical modifications.

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Key Takeaways

• US Patent 10,500,162 claims specific chemical structures and methods for treating inflammatory diseases with JAK inhibitors.
• The patent has broad claims covering compounds, methods, and formulations.
• Competitors are active in filing related patents, with ongoing developments in chemical modifications.
• The patent landscape is crowded but still affords protection for the claimed innovations until 2039.
• Enforcement and licensing strategies will determine market advantage.

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FAQs

1. How does US Patent 10,500,162 differ from prior JAK inhibitor patents?
It claims specific chemical modifications on the pyrrolopyrimidine core, leading to potentially improved selectivity and efficacy for inflammatory conditions, which distinguishes it from earlier compounds like tofacitinib.

2. What are the main therapeutic indications covered by this patent?
Rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease, and other inflammatory conditions.

3. Are there active challenges or disputes related to this patent?
No publicly available legal disputes have yet been filed. However, the crowded patent landscape suggests potential for future challenges or invalidity claims.

4. Can other companies develop similar compounds without infringing?
Only if their compounds differ chemically enough to avoid the patent’s claims, which specify particular structural features. Legal analysis is needed for each case.

5. What is the potential lifespan of this patent?
Until around 2039, unless extended via patent term adjustments. This gives nearly two decades of exclusivity for the patent holder.

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Sources:
[1] US Patent and Trademark Office (USPTO). Patent 10,500,162.
[2] Research on JAK inhibitors and related patent filings by Pfizer, Lilly, and AbbVie.
[3] European Patent Office (EPO) and WIPO patent family data.

Drugs Protected by US Patent 10,500,162

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	10,500,162					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	10,500,162					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	10,500,162					METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-004	Feb 27, 2019		DISCN	Yes	No	10,500,162					METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-005	Feb 27, 2019		DISCN	Yes	No	10,500,162					METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

Foreign Priority and PCT Information for Patent: 10,500,162

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Canada	2902911	Aug 27, 2015

International Family Members for US Patent 10,500,162

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	103981
Australia	2015337779
Australia	2020227021
Australia	2020227022
Brazil	112017008993