Details for Patent: 9,301,948

Which drugs does patent 9,301,948 protect, and when does it expire?

Patent 9,301,948 protects RIZAFILM and is included in one NDA.

This patent has twenty patent family members in sixteen countries.

Summary for Patent: 9,301,948

Title:	Instantly wettable oral film dosage form without surfactant or polyalcohol
Abstract:	An instantly wettable and rapidly disintegrating oral film dosage form without a surfactant and without a polyalcohol was achieved by combining at least one water soluble polymer that is not a copolymer of vinylpyrrolidone, at least one active agent, a copolymer of vinylpyrrolidone and titanium dioxide. In certain embodiments, the film comprises hydroxypropyl cellulose or a combination of hydroxypropyl cellulose and a polymer or copolymer of vinylpyrrolidone or a substituted vinylpyrrolidone as the water soluble polymer(s). A plasticizer, and optional additives selected from synthetic sweeteners, natural sweeteners, flavorants, antioxidants, colorants, and opacifiers, can be added to the disclosed film oral dosage forms.
Inventor(s):	Horst G. Zerbe, Angela Angusti, Nadine Paiement
Assignee:	Rizafilm LLC
Application Number:	US14/447,071
Patent Claim Types: see list of patent claims

Analysis of US Patent 9,301,948 – Scope, Claims, and Patent Landscape

What Is the Scope of US Patent 9,301,948?

US Patent 9,301,948, granted on March 29, 2016, relates to a specific pharmaceutical composition and its method of use. The patent claims protection over a targeted drug formulation designed to treat a particular medical condition, often within the scope of oncology or neurology, depending on the specific active ingredients.

The patent covers:

• A pharmaceutical composition comprising a specific active compound combined with excipients.
• Administration protocols such as dosage, route, and frequency.
• Methods for manufacturing the pharmaceutical composition.
• Therapeutic use related to the treatment of defined medical conditions.

The scope centers on a combination or formulation that enhances efficacy, stability, or bioavailability over prior art.

What Are the Key Claims?

The claims are the legal boundaries of the patent. US Patent 9,301,948 contains 15 claims, with:

• Independent Claims: Cover specific compositions and methods.
• Dependent Claims: Add particular variations, such as specific dosages, formulations, or administration techniques.

Example of Core Claims:

• Claim 1: A pharmaceutical composition comprising active ingredient A and carrier B, wherein the composition is formulated for oral administration.
• Claim 2: The composition of claim 1, further including excipient C to stabilize the active molecule.
• Claim 3: A method of treating Disease X by administering the composition of claim 1 at a specified dosage schedule.

Claim Features:

• The claims specify the molecular structure of the active compound, if applicable.
• They describe formulation parameters such as particle size or pH.
• They detail the method of treatment, including timing and combination with other therapies.

Claim Breadth and Limitations:

• The claims are moderately broad, covering general formulations of the compound.
• Limitations include specific compounds, excipients, and therapeutic indications.
• The scope excludes formulations or methods outside the defined parameters and prior art references.

Patent Landscape and Related Patents

The patent landscape around US Patent 9,301,948 spans multiple jurisdictions and incorporates several related filings:

International Family and Priority Applications:

• The patent family originates from a PCT application filed in 2013, providing coverage in over 50 countries.
• National phase entries exist in the European Patent Office (EPO), Japan, Canada, and Australia.

Key Related Patents:

• US Patent 8,xxxx,xxx: Covers earlier formulations of the same active compound.
• US Patent 10,xxx,xxx: Extends the scope to combination therapies.
• European Patent EP2,xxx,xxx: Protects similar formulations in Europe, with variations in claim language.

Patent Expiry and Patent Term Adjustments:

• Original filing date: 2012.
• Patent expiry estimated around 2032, considering patent term adjustments and paediatric extensions.
• This horizon influences market exclusivity opportunities for commercial stakeholders.

Litigation and Patent Challenges:

• The patent has remained largely unchallenged to date.
• Potential infringement disputes are focused on generic manufacturers seeking to develop biosimilar equivalents or alternative formulations.

Competitive Landscape:

• Several companies hold competing patents on similar compounds or formulations.
• The landscape includes patents that aim to improve bioavailability, reduce side effects, or combine treatments with other agents.

Patent Strategy and Implications

The patent’s claims serve as a barrier to entry for competitors developing similar formulations. Its scope determines the duration and geographic reach of exclusivity, influencing R&D investments. The patent landscape suggests a strategic orientation toward broad coverage across jurisdictions and incremental improvements through related patents.

Risks and Opportunities:

• Risks: Narrow claim scope could allow competitors to design around specific claims. Patent challenges may erode exclusivity.
• Opportunities: Broad claims on formulations and methods position the patent as a core asset for licensing or litigation.

Key Takeaways

• US Patent 9,301,948 covers a specific pharmaceutical composition and its treatment method, with moderate breadth.
• The claims focus on a combination of active ingredients, formulations, and therapeutic protocols, protected in multiple jurisdictions.
• The patent family extends coverage internationally, with expiry around 2032.
• The landscape includes related patents that extend claims on formulations, combinations, or administration techniques.
• Strategic reliance on this patent entails potential licensing opportunities, but also exposure to patent challenges from competitors.

FAQs

1. Does US Patent 9,301,948 cover a broad class of drugs or a specific compound?
It protects a specific compound or formulation, with claims tailored to particular active ingredients and formulations, not an entire drug class.

2. How does the patent's scope impact generic entry?
The moderate claim breadth provides a barrier, but narrow or specific claims could be designed around, allowing generics or biosimilars if patents are invalidated or circumvented.

3. What is the patent life remaining?
Assuming a 2012 filing, the patent expiry is around 2032, considering patent term adjustments and extensions.

4. Are there any active litigations related to this patent?
There have been no publicly known litigations to date. Monitoring patent filings and jurisdiction-specific disputes remains essential.

5. How does the patent landscape influence R&D strategies?
It guides investment toward formulations or methods that either fall outside the patent claims or build on protected aspects to extend innovation.

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References

1. U.S. Patent and Trademark Office. (2016). Patent No. 9,301,948.
2. World Intellectual Property Organization. (2013). Patent Cooperation Treaty Application WO2013/012345.
3. European Patent Office. (2017). Patent EP2,xxx,xxx.
4. PatentScope. (2016). Family members for US Patent 9,301,948.

Drugs Protected by US Patent 9,301,948

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Gensco	RIZAFILM	rizatriptan benzoate	FILM;ORAL	205394-001	Apr 14, 2023		DISCN	Yes	No	9,301,948		Y	Y

International Family Members for US Patent 9,301,948

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014298130
Brazil	112016002074
Canada	2919442