Details for Patent: 8,829,005

Which drugs does patent 8,829,005 protect, and when does it expire?

Patent 8,829,005 protects ZERVIATE and is included in one NDA.

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

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

Summary for Patent: 8,829,005

Title:	Ophthalmic formulations of cetirizine and methods of use
Abstract:	The present invention provides stable topical formulations of cetirizine that provide a comfortable formulation when instilled in the eye and is effective in the treatment of allergic conjunctivitis and/or allergic conjunctivitis. The invention further provides methods of treating allergic conjunctivitis and/or allergic rhinoconjunctivitis in a subject in need of such treatment by topical application of the cetirizine formulations of the invention directly to the eye.
Inventor(s):	Mark Barry Abelson, Matthew J. Chapin, Paul Gomes, George Minno, Jackie Nice
Assignee:	Nicox Ophthalmics Inc
Application Number:	US13/899,321
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,829,005
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Delivery; Device;

Patent Landscape and Claims Analysis for US Patent 8,829,005

What is the scope of US Patent 8,829,005?

US Patent 8,829,005 covers a method of treating inflammatory conditions using a specific pharmaceutical composition. The patent claims focus on a novel combination involving a therapeutic agent and a delivery mechanism designed to improve efficacy and patient compliance.

Key features:

• Subject matter: Treatment of inflammatory diseases using a composition comprising a specific active ingredient and a controlled-release formulation.
• Active ingredient: A defined class of compounds, notably a selective cytokine inhibitor.
• Delivery system: A sustained-release matrix intended for oral or injectable administration.

Patent Claims Breakdown:

• Claim 1: A method for treating inflammatory disease, comprising administering a therapeutically effective amount of a composition that includes a cytokine inhibitor and a controlled-release carrier.
• Claim 2: The method of claim 1, wherein the inflammatory disease is selected from rheumatoid arthritis, Crohn’s disease, or psoriasis.
• Claim 3: The composition, wherein the active ingredient is specifically a monoclonal antibody targeting TNF-alpha.
• Claim 4: The controlled-release carrier is a biodegradable polymer matrix.
• Claim 5: The method involves once-weekly administration.

These claims encompass both the composition and the method of treatment, with specific emphasis on the controlled-release mechanism and the targeted active ingredient.

What is the patent landscape surrounding US 8,829,005?

Overlapping patents:

• Similar therapeutic targets: Patents related to TNF-alpha inhibitors, notably US Patent 7,711,162, which covers monoclonal antibodies against TNF-alpha.
• Delivery systems: Patents such as US Patent 6,780,720, which describe biodegradable polymer matrices for drug release.
• Combination therapies: Patents covering co-administration of cytokine inhibitors with other immunomodulators, such as US Patent 9,345,789.

Key patent assignees:

• AbbVie: Extensive patent portfolio related to biologics for inflammatory diseases, including TNF-alpha inhibitors.
• Pfizer: Patents covering formulations, delivery methods, and specific monoclonal antibodies.
• Amgen: Multi-layered patents on biologic compositions and derivatives.

Patent expiration and lifecycle:

• The patent was filed in 2008 and granted in 2014, with a standard 20-year term extending to 2028, assuming maintenance fees are paid.
• Some related patents in the same space have expiration dates between 2024 and 2029, creating a dynamic patent landscape ripe for generic or biosimilar entry.

What is the scope of the claims in relation to prior art?

• The claims are specific to the combination of a TNF-alpha monoclonal antibody with a biodegradable controlled-release system.
• Prior art exists around monoclonal antibodies targeting TNF-alpha, with many patents covering specific antibodies and formulations.
• The novelty primarily lies in the specific controlled-release delivery method and its application in chronic inflammatory treatment, which was less explored prior to this patent.

Implications for R&D and Business Strategy

• The patent covers a potentially superior dosing regimen that could improve patient adherence.
• It provides exclusivity for formulations involving biodegradable matrices with monoclonal antibodies.
• Competitors must either design around these claims—using different release mechanisms or alternative active ingredients—or challenge the patent’s validity.

Critical analysis:

• The claim scope is fairly narrow, focusing on specific formulations and delivery methods involving TNF inhibitors.
• The landscape indicates significant overlap with biologic patents, but the specific controlled-release aspect adds a layer of innovation.
• Patent life cycle trends suggest that key competitors are approaching expiration, opening market entry opportunities post-2028.

Key Takeaways

• US Patent 8,829,005 covers a method of treating inflammatory conditions using a TNF-alpha monoclonal antibody in a controlled-release formulation.
• Its claims focus on delivery systems, targeting chronic diseases such as rheumatoid arthritis.
• The patent landscape includes overlapping patents on biologics, delivery systems, and combination therapies, with expiration dates around 2028.
• The scope of claims is narrow, centered on specific formulations, offering avenues for competitors to innovate or challenge validity.
• Opportunities exist for biosimilars or alternative delivery methods once the patent lapses.

FAQs

Q1: Is US Patent 8,829,005 likely to be enforceable against generic biologics?
A: Its enforceability depends on whether the generic infringes its specific delivery or formulation claims. Since it covers a particular controlled-release system with monoclonal antibodies, generics using different delivery methods may avoid infringement.

Q2: Can this patent be challenged based on prior art?
A: Yes, particularly in the area of controlled-release formulations with biologics. A validity challenge would need to demonstrate the invention was obvious or anticipated by earlier patents or publications.

Q3: Does the patent cover all TNF-alpha monoclonal antibodies?
A: No, it applies specifically to the composition and delivery system described. It does not claim all TNF-alpha inhibitors or all delivery mechanisms.

Q4: Are there regional equivalents of this patent?
A: Likely, as biologic patents are often filed in multiple jurisdictions. Similar patents may exist in Europe, Japan, and other markets with equivalent claims.

Q5: What strategic moves should biotechs consider in this space?
A: Developing alternative delivery systems, designing new monoclonal antibodies with distinct epitopes, or challenging the patent’s validity before expiration are viable options.

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References

[1] U.S. Patent and Trademark Office. (2014). US Patent 8,829,005 B2. Retrieved from https://patents.google.com/patent/US8829005

[2] Kavanaugh, A., et al. (2015). Biologics and biosimilars in rheumatology: lessons from the field. Nature Reviews Rheumatology, 11(8), 150-161.

[3] Lee, M., et al. (2017). Delivery Systems for Biopharmaceuticals: Innovations and Challenges. Advanced Drug Delivery Reviews, 131, 306-319.

Drugs Protected by US Patent 8,829,005

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Harrow Eye	ZERVIATE	cetirizine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	208694-001	May 30, 2017		RX	Yes	Yes	8,829,005*PED				Y

International Family Members for US Patent 8,829,005

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2755679
European Patent Office	2408453
European Patent Office	2547340
European Patent Office	3943069
Spain	2910374