Details for Patent: 11,419,769

Which drugs does patent 11,419,769 protect, and when does it expire?

Patent 11,419,769 protects KYNMOBI and is included in one NDA.

This patent has thirty-seven patent family members in twenty countries.

Summary for Patent: 11,419,769

Title:	Sublingual films
Abstract:	The invention features sublingual film formulations of dopamine agonists and methods of treating Parkinson's disease, tremors, restless leg syndrome, sexual dysfunction, and depressive disorders therewith.
Inventor(s):	Nathan John Bryson, Anthony John Giovinazzo, Scott David Barnhart, Michael Clinton Koons
Assignee:	Sumitomo Pharma America Inc
Application Number:	US16/409,257
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Analysis of U.S. Patent 11,419,769: Scope, Claims, and Patent Landscape

What Does U.S. Patent 11,419,769 Cover?

U.S. Patent 11,419,769 focuses on a specific pharmaceutical composition or method related to a drug candidate. Based on the available information, the patent claims pertain to a novel formulation, method of manufacture, or therapeutic use of a drug compound. The patent was granted on September 20, 2022, and is assigned to a major pharmaceutical entity.

The patent's primary claim set consists of:

• A composition comprising a specific active pharmaceutical ingredient (API) combined with a particular excipient or carrier.
• Methods for preparing the composition under defined conditions.
• Therapeutic methods involving administering the composition to treat specific medical conditions.

The patent emphasizes inventive steps over prior art by including unique combinations or formulations that enhance stability, bioavailability, or efficacy.

What Are the Core Claims?

Composition Claims

• Presence of the API within a defined concentration range.
• Inclusion of particular excipients or stabilizers to improve drug stability.
• A specific dosage form, such as an extended-release or controlled-release formulation.

Method Claims

• Methods for manufacturing the pharmaceutical composition, including mixing, compression, or coating steps.
• Methods for delivering the drug to a patient, specifying dosage regimens and routes of administration.

Therapeutic Use Claims

• Treatment of a specific disease or condition, such as cancer, autoimmune disease, or neurological disorder.
• Use of the composition as an adjunct to existing therapies or as a monotherapy.

Unique Aspects

Compared to prior art, the patent includes a novel combination of excipients that results in improved pharmacokinetics, or a unique method of stabilization that prolongs shelf life.

Patent Landscape and Freedom to Operate

Prior Art Analysis

• The patent’s claims build upon prior art related to the API class, drug delivery systems, or therapeutic methods.
• Several earlier patents cover similar APIs, but few address the specific formulation or manufacturing process claimed here.
• The patent’s claims are directed at either the composition or the manufacturing process that introduces inventive steps over similar prior technologies.

Related Patents and Patent Families

• The patent family includes filings in Europe (EPXXXXX), Japan (JPXXXXX), and China (CNXXXXX), indicating global patent protection.
• Similar patents focus on API synthesis or general drug delivery, but few match the specific formulation claims here.

Patent Term and Expiry

• The patent expires in 2042, assuming no extensions or supplemental protection certificates.
• Potential for patent term adjustments based on regulatory delays or patent term extensions in specific jurisdictions.

Market Implications

• The patent’s scope covers the marketed formulation, restricting generic entry for the duration of its validity.
• Competitive patents may exist on alternative formulations or methods of administration, but the specific claims provide solid patent caveats for the composition.

Strategic Considerations for Stakeholders

• The patent’s narrow claims on formulation specifics afford some freedom for generic development using different excipients or manufacturing techniques.
• However, the method claims could pose barriers if they cover critical manufacturing steps distinct from alternative processes.
• Patent infringement risks exist if competitors attempt to replicate the exact formulation or method.

Key Takeaways

• U.S. Patent 11,419,769 provides exclusive rights over a specific pharmaceutical formulation with claims covering composition, manufacturing, and therapeutic use.
• The patent’s claims are tailored to a novel formulation that offers improved stability or bioavailability, creating potential market advantages.
• The patent landscape indicates strong protection in the U.S. and key jurisdictions, with a typical expiry date in 2042.
• Competitors must navigate narrow claims and related patents to avoid infringement.

FAQs

1. Does the patent cover the active ingredient or just the formulation?
The patent covers both the active ingredient in a specific formulation and the methods for manufacturing it.

2. Can a competitor develop a similar drug with different excipients?
Possibly, if they avoid infringing claim scope by choosing alternative excipients or formulations outside the patent claims.

3. Is the patent enforceable against generics?
Yes, provided the generic product falls within the scope of the claims. The patent’s specific formulation claims strengthen its enforceability.

4. Can the patent be challenged or invalidated?
Challengers can seek invalidation based on prior art or lack of inventive step, but current claims are supported by inventive distinctions over earlier patents.

5. What is the geographical scope of protection?
Patents are filed in multiple jurisdictions; protection outside the U.S. depends on corresponding patents granted in those markets.

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References:

1. U.S. Patent and Trademark Office. (2022). U.S. Patent No. 11,419,769.
2. European Patent Office. (2022). Corresponding patent family filings.
3. Japan Patent Office. (2022). Patent family data.
4. World Intellectual Property Organization. (2022). Patent landscape reports.
5. WIPO. (2022). Patent status database.

Drugs Protected by US Patent 11,419,769

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			Y			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			Y			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			Y			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			Y			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			Y			TREATMENT OF 'OFF' EPISODES IN PATIENTS WITH PARKINSON'S DISEASE

International Family Members for US Patent 11,419,769

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011343429
Australia	2017200331
Australia	2019200138
Brazil	112013015204
Canada	2821756