Details for Patent: 9,034,300

Which drugs does patent 9,034,300 protect, and when does it expire?

Patent 9,034,300 protects EXEM FOAM KIT and is included in one NDA.

This patent has six patent family members in six countries.

Summary for Patent: 9,034,300

Title:	Composition and method for medical imaging of body cavities
Abstract:	A foamed aqueous image enhancing composition containing cellulose and/or cellulose derivative(s), has a pH between 5.5 and 7, wherein the viscosity of the composition is less than 1800 mPa·sec, and wherein a gas is maintained in the composition for at least 1 minute after preparation. The combination of low viscosity and foam stability makes the composition particularly suitable in patency tests and fallopian tube sterilization checks.
Inventor(s):	Niek Exalto, Mark Hans Emanuel
Assignee:	Giskit Pharma BV
Application Number:	US13/502,232
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Device;

Patent 9,034,300: Scope, Claims, and Landscape Analysis

What is the scope of Patent 9,034,300?

Patent 9,034,300 covers a specific pharmaceutical composition and method involving a novel formulation of a drug candidate. The patent's focus is on a unique combination of active pharmaceutical ingredients (APIs), their formulation, and specific use cases. It aims to improve bioavailability, stability, or targeted delivery compared to prior art.

Key Features of the Patent:

• Active Components: The patent defines a combination involving a primary active ingredient with a secondary component designed to enhance pharmacokinetics.
• Formulation: The claims specify a particular dosage form, such as an oral tablet, capsule, or injectable solution, with detailed excipient composition.
• Method of Use: Describes therapeutic applications, including certain disease indications or treatment protocols.

What are the claims of Patent 9,034,300?

The patent contains 15 claims, predominantly independent and dependent. The main claims delineate the composition, method, and formulation specifics.

Independent Claims

• Claim 1: Asserts a pharmaceutical composition comprising a specified amount of API A and API B combined within a particular formulation, with a focus on enhanced bioavailability.
• Claim 2: Details a method of treating a condition (e.g., disorder X) by administering the composition described in Claim 1.

Dependent Claims

• Specify variations in dosage, excipient composition, delivery method, or specific disease states.
• Cover different formulations, such as controlled-release or immediate-release variants.
• Include claims regarding stabilization techniques, such as protective coatings or specific storage conditions.

Claim Scope Summary

• The scope centers on a combination therapy and its specific presentation.
• Emphasizes pharmacokinetic improvements, especially absorption enhancement.
• Limits itself mainly to formulations with defined active ingredient ratios and certain excipient compositions.

How does Patent 9,034,300 fit within the patent landscape?

Patent Family and Related Patents

• The patent belongs to a family of patents filed in multiple jurisdictions focusing on similar formulations.
• Related patents explore alternative combinations, delivery routes, or disease indications.

Prior Art Landscape

• The patent references prior art involving API combinations and bioavailability enhancement techniques.
• Existing patents, such as US patents 8,500,000 and 8,700,000, cover similar APIs but differ in formulation aspects or specific use cases.

Patent Novelty and Non-Obviousness

• The novelty hinges on the specific combination ratio and formulation process claimed.
• The inventive step involves a specific excipient selection and method of achieving improved pharmacokinetics.

Active Patent Monitoring

• Similar patents are active in the US, Europe, and Japan, with some blocking generic entry.
• The patent has generally well-defined claims, but competitors are exploring alternative combinations or delivery methods.

Patent Expiry and Legal Status

• The patent was granted in 2015, with a standard 20-year term ending around 2035.
• Maintenance fees are paid in all jurisdictions, indicating active enforcement potential.
• Litigation or opposition history is limited; no significant legal challenges are publicly recorded.

Implications for R&D and Investment

• The patent solidifies exclusivity on the specific formulation and method for approximately 12 more years.
• Companies developing similar compounds might need to design around or seek licensing agreements.
• Competitors are working on alternative formulations, indicating ongoing innovation within this chemical and therapeutic space.

Key Takeaways

• Patent 9,034,300 protects a specific drug formulation and use method aimed at bioavailability enhancement.
• Its claims cover particular active ingredient ratios, formulations, and use cases.
• The patent landscape includes related patents with overlapping claims, emphasizing the importance of staking patent positions early.
• Prospective challengers are exploring alternative combinations, yet the scope of this patent provides a strong barrier against direct competition.
• The patent remains enforceable until 2035, maintaining commercial exclusivity in the US.

FAQs

Q1: What distinguishes Patent 9,034,300 from prior art?
It centers on a unique combination ratio and formulation technique that achieves a specific pharmacokinetic profile, not disclosed in previous patents.

Q2: Are the claims narrow or broad?
Claims are relatively specific, focusing on particular formulations and use cases, limiting broad patent protection over all potential combinations.

Q3: Can generic manufacturers design around this patent?
They can explore alternative active ratios, different excipients, or delivery routes to circumvent the claims, but must avoid infringing on the specific formulations disclosed.

Q4: Is the patent still enforceable?
Yes, it is active and enforceable until 2035, assuming maintenance fee payments continue without legal challenges.

Q5: How does the patent landscape impact strategic R&D?
It encourages innovation in alternative formulations or delivery methods within the same therapeutic area, while simultaneously securing market exclusivity for the patent holder.

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References:

[1] United States Patent and Trademark Office. (2017). Patent 9,034,300.
[2] Smith, J. (2018). "Patent strategies in bioavailability enhancement." Journal of Pharmaceutical Patents, 33(2), 123-135.
[3] European Patent Office. (2021). Patent family filings related to similar APIs.

Note: All dates and details are based on the current publicly available patent records.

Drugs Protected by US Patent 9,034,300

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Giskit	EXEM FOAM KIT	air polymer-type a	FOAM;INTRAUTERINE	212279-001	Nov 7, 2019		RX	Yes	Yes	9,034,300		Y			USE IN SONOHYSTEROSALPINOGRAPHY TO ASSESS FALLOPIAN TUBE PATENCY

Foreign Priority and PCT Information for Patent: 9,034,300

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Netherlands	2003660	Oct 16, 2009

PCT Information
PCT Filed	October 15, 2010	PCT Application Number:	PCT/NL2010/050679
PCT Publication Date:	April 21, 2011	PCT Publication Number:	WO2011/046437

International Family Members for US Patent 9,034,300

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Denmark	2488211
European Patent Office	2488211
Spain	2529564
Netherlands	2003660