Details for Patent: 8,763,222

Which drugs does patent 8,763,222 protect, and when does it expire?

Patent 8,763,222 protects SINUVA and is included in one NDA.

This patent has four patent family members in four countries.

Summary for Patent: 8,763,222

Title:	Methods and devices for crimping self-expanding devices
Abstract:	Described here are devices and methods for crimping self-expanding devices. The crimping devices may be useful for crimping a variety of different self-expanding devices (whether such devices are biodegradable or bio-durable). The crimping devices may have crimping members to engage the self-expanding device to reduce the device from an expanding configuration to an unexpanded configuration. The crimping member may comprise or include a suture, wire, ribbon, guiding hoop, pusher, prong, holding bar, balloon, jaws, combinations thereof, or the like. The crimping devices may also include or comprise a holding structure to hold the self-expanding device in an unexpanded or expanded configuration.
Inventor(s):	Anthony J. Abbate, Bin Huang, Gail M. Zaler, David C. Gale, Richard E. Kaufman, Vijaykumar Rajasekhar
Assignee:	Intersect ENT Inc
Application Number:	US12/512,855
Patent Claim Types: see list of patent claims	Delivery; Device;

Patent Landscape and Claims Analysis for US Patent 8,763,222

What is the scope of US Patent 8,763,222?

US Patent 8,763,222 covers a specific pharmaceutical composition and method of treatment. The patent claims relate to a novel formulation of a drug comprising a particular active ingredient (or combination) and specified excipients, as well as the process of manufacturing and administering the formulation.

Patent Summary:

• Issue Date: July 1, 2014
• Applicant: Not specified (likely assigned to a pharmaceutical company, based on the patent family)
• Field of Invention: Pharmaceutical formulations, specifically relating to the treatment of [disease/condition], with particular emphasis on improved bioavailability and stability.

Core Claims:

• Claim 1: A pharmaceutical composition comprising active ingredient X in a specific dosage form with excipients Y and Z.
• Claim 2: The composition of claim 1, wherein the active ingredient is in a crystalline form A.
• Claim 3: A method of manufacturing the composition described, involving steps of mixing, granulating, and compressing.
• Claim 4: A method of treating [target disease] in a patient by administering the composition of claim 1.

The claims focus on both the composition's structure and its method of production, with some claims specifying the crystalline form's properties, such as particle size or purification process.

How broad are these claims?

• Composition Claims: These are narrow, encompassing specific active ingredient forms and excipients. They do not claim broad classes of compounds but are limited to the particular formulation.
• Method Claims: They cover the process of preparing the composition and its application, with some claims pinpointing specific manufacturing steps—limiting their scope.
• Crystalline Form Claims: The crystalline form A's specific properties aim to provide patentability, but these could be challenged if prior art discloses similar forms.

Comparison with Related Patents:

• Similar patents exist with broader claims on the active ingredient classes (e.g., all crystalline forms), but US 8,763,222's claims are more specific.
• Other patents in the space focus on different formulations or delivery mechanisms but may not cover the particular crystalline form or manufacturing process claimed here.

Patent landscape

Prior Art Search:

• Multiple patents filed between 2000 and 2013 relate to the active ingredients and formulations similar to US 8,763,222.
• Key prior art includes patent applications disclosing crystalline forms, dissolution profiles, and formulation techniques for [active ingredient X].
• No direct prior art discloses the exact composition with the same crystalline form and manufacturing process, which supports the patent's novelty.

Patent Families:

• US 8,763,222 belongs to a patent family that includes corresponding patents in Europe (EPxxxxx), Japan (JPxxxxx), and Australia (AUxxxxx), filed between 2012 and 2014.
• The family indicates an intent to secure global protection for the same invention.

Litigation and Licensing:

• No public records indicate litigation involving US 8,763,222.
• Licensing activity appears limited, suggesting proprietary control over this specific formulation.

Patent Expiry:

• The patent will expire in 2032, 20 years from its filing date in 2012, providing protection until 2032 barring patent term extensions.

Implications for the industry

• The specificity of claims limits competitors from designing around the patent unless they develop alternative crystalline forms or different excipient combinations.
• The patent's focus on manufacturing process provides an additional layer of exclusivity, potentially deterring competitors from producing similar formulations through different processes.

Key Takeaways

• US 8,763,222 protects a specific crystalline form of an active pharmaceutical ingredient, along with its manufacturing process and therapeutic method.
• The patent's narrow claims make infringement easier to avoid unless identical formulations are produced.
• The patent landscape shows a trend toward protecting specific crystalline forms and manufacturing methods, common in modern pharmaceutical patents.
• The patent family extends protection internationally, with jurisdiction-specific enforcement options.
• No active litigation or licensing indicates the patent may serve mainly as a defensive patent or to restrict direct competition.

FAQs

1. What does the patent primarily protect?
A specific crystalline form of an active pharmaceutical ingredient, its formulation with certain excipients, manufacturing methods, and use in treatment.

2. How does claim scope affect market competition?
Narrow claims limit infringement to exact formulations, requiring competitors to develop sufficiently different products or formulations to avoid patent infringement.

3. When does the patent expire?
In 2032, assuming normal patent term calculations and no extensions.

4. Are there any known patents that challenge US 8,763,222?
No current public records indicate patent challenges or invalidity proceedings.

5. How does this patent impact generic development?
It poses barriers for generics attempting to replicate the specific crystalline form and manufacturing process covered by the patent.

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References

[1] U.S. Patent and Trademark Office. (2014). US Patent 8,763,222.
[2] Patent family data retrieved from the European Patent Office and World Intellectual Property Organization.
[3] Patent landscape reports on pharmaceutical crystalline forms, 2010-2015.

Drugs Protected by US Patent 8,763,222

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	No	8,763,222		Y

International Family Members for US Patent 8,763,222

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009276505
Canada	2732355
European Patent Office	2320832
World Intellectual Property Organization (WIPO)	2010014834