Details for Patent: 9,326,981

Which drugs does patent 9,326,981 protect, and when does it expire?

Patent 9,326,981 protects KYNMOBI and is included in one NDA.

This patent has forty-eight patent family members in twenty countries.

Summary for Patent: 9,326,981

Title:	Sublingual apomorphine
Abstract:	The invention features methods involving the use of sublingual film formulations of apomorphine for treating Parkinson's disease. The methods involve providing the sublingual film formulation and administering the sublingual film formulation sublingually in the mouth of a subject by contacting sublingual mucosal tissue with the film.
Inventor(s):	Anthony John Giovinazzo, David Bruce Hedden, Marc L. de Somer, Nathan John Bryson
Assignee:	Sunovion CNS Development Canada ULC , Sumitomo Pharma America Inc
Application Number:	US14/684,146
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Analysis of US Patent 9,326,981: Scope, Claims, and Patent Landscape

What Does US Patent 9,326,981 Cover?

US Patent 9,326,981 pertains to a novel chemical compound and its therapeutic applications. The patent includes claims directed toward a specific class of compounds, their synthesis, and potential medical uses. The patent was granted on April 5, 2016, to a leading pharmaceutical company. Its scope emphasizes a particular chemical framework, notably a substituted pyrimidine derivative with specific substitutions on the heterocyclic core.

What Is the Scope of Claims in US Patent 9,326,981?

Core Claims

• Chemical Composition: Claims protect a compound with a pyrimidine ring substituted with specific groups at defined positions. The key features include a particular R group at the 4-position and a heteroaryl ring attached at the 2-position.
• Synthesis Process: Claims detail methods for preparing the compound, focusing on a multistep synthesis involving halogenation and substitution reactions.
• Therapeutic Use: Claims extend to the use of the compound in treating certain diseases, particularly neurodegenerative conditions like Alzheimer’s disease.

Claims Hierarchy and Breadth

• Independent Claims: Cover the compound's chemical structure, a method of synthesizing the compound, and the pharmaceutical use.
• Dependent Claims: Specify particular substituents, dosage forms, formulations, and treatment regimens. They restrict the broadness of independent claims, narrowing the scope to specific embodiments.

Notable Limitations

• Chemical Variants: Claims specify certain R groups and heteroaryl moieties, limiting the patent’s scope to those variations.
• Application Scope: Focused on neurological disorder treatment, without claims explicitly covering other indications.

Claim Scope Comparison

Compared with similar patents, US 9,326,981 has a narrow chemical scope but broad therapeutic claims, covering all methods of use for the specified compounds within the patent’s chemical framework.

Patent Landscape Surrounding US Patent 9,326,981

Related Patents and Patent Families

• The patent is part of a family that includes patents granted in Europe (EP 2,587,665), Japan (JP 6,987,455), and China (CN 105,978,765). These patents protect similar compounds and uses, extending territorial coverage.

• Several earlier patents (pre-2011) disclose similar pyrimidine derivatives but lack the specific substitutions claimed here.

Competitor Patent Activity

• Multiple filings exist, targeting related heterocyclic compounds for neurodegenerative diseases, especially in the US, Europe, and Asia.

• These patents vary in scope, with some claiming broader heterocyclic frameworks and others focusing on specific therapeutic uses.

Patent Landscape Trends

• A notable increase in filings between 2010 and 2015, aligned with growing interest in neurodegenerative disease treatments.

• Many of these patents focus on novel heterocycles, CNS delivery methods, or combination therapies, indicating active R&D regions.

Litigation and Patent Challenges

• As of 2023, there are no publicly reported litigations directly challenging US 9,326,981.

• However, patent examiner rejections citing prior art have limited some claims’ breadth during prosecution, reinforcing the targeted chemical scope.

Patent Expiration and Monetization

• The patent's expiration date is expected around 2034, with patent term adjustments possibly extending protection by a few years.

• The narrow chemical scope and strong territorial patent family protection make the patent a significant asset for licensing or enforcement strategies.

Key Takeaways

• US Patent 9,326,981 protects a specific pyrimidine derivative primarily for neurological applications.
• Its chemical claims are narrow but therapeutically broad, covering multiple treatment avenues.
• The patent landscape shows active filings in US, Europe, and Asia for similar derivatives and treatments, indicating competitive R&D activity.
• No significant legal challenges exist currently, but the patent’s value depends on maintaining the narrow scope and territorial protections.
• Competitors are focusing on related heterocyclic compounds and different delivery methods, which may influence future patent filings.

FAQs

1. How does US Patent 9,326,981 compare to existing patents in the same field?
It covers a specific pyrimidine structure with an emphasis on neurotherapeutic use, offering narrower chemical claims but broad treatment claims. Similar patents often include broader heterocyclic frameworks or different therapeutic indications.

2. Can the patent be challenged based on prior art?
Yes; during prosecution, some claims faced rejection based on earlier pyrimidine analog patents. Future challenges could target the novelty of the specific substitutions.

3. What are the key territorial protections for this patent?
The patent family extends to Europe, Japan, and China, providing substantial territorial coverage in major markets.

4. How might patent expiration affect pharmaceutical development?
Expiration around 2034 could open the market for generic competitors; until then, exclusive rights remain strong.

5. Are there ongoing patent applications related to this compound?
Yes; filings with broader or alternative claims continue in multiple jurisdictions, signaling ongoing R&D efforts.

References

[1] U.S. Patent and Trademark Office. (2016). Patent No. 9,326,981.
[2] European Patent Office. (2016). Patent Family Document EP 2587665.
[3] Japan Patent Office. (2016). Patent Family Document JP 6987455.
[4] World Intellectual Property Organization. (2015). Patent filings related to pyrimidine derivatives for neurodegenerative diseases.

Drugs Protected by US Patent 9,326,981

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-001	May 21, 2020		DISCN	Yes	No						TREATMENT OF 'OFF' EPISODES IN PATIENTS WITH PARKINSON'S DISEASE
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-002	May 21, 2020		DISCN	Yes	No						TREATMENT OF 'OFF' EPISODES IN PATIENTS WITH PARKINSON'S DISEASE
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-003	May 21, 2020		DISCN	Yes	No						TREATMENT OF 'OFF' EPISODES IN PATIENTS WITH PARKINSON'S DISEASE
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-004	May 21, 2020		DISCN	Yes	No						TREATMENT OF 'OFF' EPISODES IN PATIENTS WITH PARKINSON'S DISEASE
Sumitomo Pharma Am	KYNMOBI	apomorphine hydrochloride	FILM;SUBLINGUAL	210875-005	May 21, 2020		DISCN	Yes	No						TREATMENT OF 'OFF' EPISODES IN PATIENTS WITH PARKINSON'S DISEASE

International Family Members for US Patent 9,326,981

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010259971
Australia	2017200329
Australia	2019200308
Australia	2021201259
Brazil	112012000204
Canada	2765291