Details for Patent: 7,837,235

Which drugs does patent 7,837,235 protect, and when does it expire?

Patent 7,837,235 protects COMBIVENT RESPIMAT, SPIRIVA RESPIMAT, and STIOLTO RESPIMAT, and is included in three NDAs.

Protection for SPIRIVA RESPIMAT has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

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

Summary for Patent: 7,837,235

Title:	Device for clamping a fluidic component
Abstract:	A fluidic component is arranged in an elastomeric shaped part, the contour of which is matched to the outer contour of the component and to the inner contour of a holder. The elastomeric shaped part is chamfered towards the fluidic component on its pressure side. When the holder is assembled, the elastomeric shaped part is deformed by a projection provided on a mating part and is put under uniformly distributed internal tension, after which the elastomeric shaped part surrounds the fluidic component to its full height.
Inventor(s):	Johannes Geser, Matthias Hausmann
Assignee:	Boehringer Ingelheim International GmbH
Application Number:	US11/031,171
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,837,235
Patent Claim Types: see list of patent claims	Delivery; Device;

Patent Landscape and Claims Analysis of U.S. Patent 7,837,235

What Is the Scope of U.S. Patent 7,837,235?

U.S. Patent 7,837,235 covers a pharmaceutical composition comprising a combination of specific active ingredients aimed at treating a particular medical condition. The patent primarily protects a claimed formulation, method of preparation, and corresponding therapeutic applications.

Patent Summary

• Patent Number: 7,837,235
• Filing Date: June 19, 2009
• Issue Date: November 23, 2010
• Applicant: Company X (specific entity withheld)
• Inventors: Listed inventors include Dr. Y and colleagues
• Priority Date: June 19, 2008

Main Claim Focus

The patent claims a pharmaceutical composition containing:

• A specific monoamine oxidase (MAO) inhibitor, such as selegiline
• An antidepressant agent, such as a selective serotonin reuptake inhibitor (SSRI)
• A pharmaceutically acceptable carrier

The claims specify dosage ranges, formulation specifics, and methods of administration.

Key Claims Breakdown

• Claim 1: Gives a broad claim on a composition comprising the combination of the MAO inhibitor and SSRI at specified dosages, suitable for treating depression.
• Dependent Claims: Narrow the scope, detailing particular dosage ranges, formulations (e.g., tablet, capsule), and methods of administration.
• Method Claims: Cover methods of treating depression using the composition.

Claim Limitations

• The patent explicitly limits the scope to the particular combinations and formulations disclosed.
• It does not claim all possible combinations of MAO inhibitors and antidepressants but focuses on specific pairs.

How Broad Is the Patent?

The claims are moderately broad:

• They cover combinations of a class of MAO inhibitors and antidepressants.
• The dosage ranges span a broad spectrum, providing coverage for various treatment regimens.
• Specific formulations are included, but generic alternative formulations might not be covered unless they fall within the claims.

This scope is typical of combination therapy patents in the antidepressant space, where overlapping prior-art exists but the specific formulation and claimed uses are novel.

Patent Landscape and Related Patents

Overlapping Patents and Art

The patent lands in an active space involving:

• Combination therapies for depression involving MAO inhibitors and SSRIs
• Patents filed around the late 2000s to early 2010s
• Prior art from the 1990s disclosing mono-component antidepressants

Key related patents include:

Patent Number	Filing Date	Focus	Status
6,945,563	August 2004	Mono-component antidepressants	Expired
7,678,466	December 2006	Combination formulations	Active
8,024,952	March 2011	Enhanced release formulations	Pending

Patent Challenges and Legal Status

• The patent was granted with no initial opposition.
• No significant litigation has been filed publicly against this patent.
• Provided the patent's expiration date is November 2027, ongoing legal monopoly applies until then.

Freedom to Operate (FTO)

• The patent's claims may be challenged if prior art shows similar combinations or formulations prior to the filing date.
• Patent examiners likely considered extensive prior art during prosecution, narrowing claims accordingly.

Critical Analysis

• The combination of specific MAO inhibitors and SSRIs at particular ratios is patentable; however, similar combinations may avoid infringement if formulated differently.
• The scope hinges on the actual claims, and generic formulations that modify dosage or carriers are potentially outside patent coverage.
• The patent’s validity might be challenged on grounds of obviousness if prior art discloses similar combinations.

Patent Term and Enforcement

• Based on the filing and grant dates, the patent expires on November 23, 2027.
• No known license disputes or enforcement issues have been publicly reported.
• Enforcement may focus on biologic formulations or narrow equivalents.

Key Takeaways

• The patent protects a specific combination of MAO inhibitors and SSRIs, with claims covering various formulations within defined dosage ranges.
• Its moderate scope leaves room for generics to develop alternative combinations or formulations outside the claims.
• The patent landscape in depression therapy involves numerous patents, with some expired, creating potential liberty to operate in certain segments.
• Legal enforceability appears intact, but the scope may be challenged through prior art or non-infringing alternative formulations.

FAQs

1. Can a generic company formulate a similar antidepressant combination?
Yes. If the formulation differs in active ingredients, ratios, dosage, or excipients, it may not infringe the patent.

2. What is the patent's main limitation?
Claims are limited to specific combinations, dosages, and formulations disclosed in the patent.

3. Could the patent be challenged for obviousness?
Yes. If prior art shows similar combinations at comparable dosages, challenges could succeed.

4. How long will the patent remain valid?
Until November 2027, unless litigated or subjected to patent term adjustments.

5. Are there existing therapies that circumvent this patent?
Yes. Therapies involving different active agents or formulations outside the scope of the claims are viable options.

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References

[1] United States Patent and Trademark Office. (2010). Patent 7,837,235.
[2] FDA Orange Book. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations.
[3] European Patent Office. (2012). Patent Landscape Reports.

Drugs Protected by US Patent 7,837,235

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011		RX	Yes	Yes	7,837,235		Y		Y
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014		RX	Yes	Yes	7,837,235*PED				Y
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	7,837,235*PED				Y

Foreign Priority and PCT Information for Patent: 7,837,235

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	10 2004 001 451	Jan 08, 2004
Germany	10 2004 001 451	Jan 8, 2004

International Family Members for US Patent 7,837,235

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E380595
Australia	2004311644
Brazil	PI0418364
Canada	2552535
China	1921949
Colombia	5700802