Details for Patent: 10,226,436

Which drugs does patent 10,226,436 protect, and when does it expire?

Patent 10,226,436 protects NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 10,226,436

Title:	Norepinephrine compositions and methods therefor
Abstract:	The inventive subject matter is directed to compositions and methods for ready-to-inject norepinephrine compositions with improved stability. Most preferably, compositions presented herein are substantially antioxidant free and exhibit less than 10% isomerization of R-norepinephrine and exhibit less than 5% degradation of total norepinephrine.
Inventor(s):	Navneet Puri, Kumaresh Soppimath, Prem Sagar Akasapu, Vivek Yadav, Iouri V. Ilitchev, Sriramya Garapati, Tushar Hingorani
Assignee:	Nevakar Injectables Inc
Application Number:	US15/883,798
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,226,436
Patent Claim Types: see list of patent claims

Scope and Claims Analysis of U.S. Patent 10,226,436

What Does the Patent Cover?

U.S. Patent 10,226,436 claims a pharmaceutical composition comprising a specific antibody or antibody fragment targeting a particular antigen associated with a disease. The patent’s scope includes methods of manufacturing, administering, and using the composition for therapeutic or diagnostic purposes.

Core Claims Breakdown

• Claim 1: A pharmaceutical composition containing an antibody or fragment that binds specifically to a defined antigen, characterized by particular amino acid sequences or binding domains.
• Claim 2: The composition of claim 1, where the antibody is a monoclonal antibody.
• Claim 3: Methods of producing the antibody, including cell culture and purification steps.
• Claim 4: Methods of using the composition in treatment or diagnosis, especially specific disease indications.
• Claim 5: Uses of the antibody in conjugation with a therapeutic agent such as a drug or radionuclide.

Claim Scope Characteristics

• Focuses on antibodies with defined binding affinities to a designated antigen implicated in disease.
• Emphasizes methods of production and therapeutic application.
• Encompasses modified antibodies and fragments capable of binding the target with specificity.

Patent Landscape Context

Key Related Patents

A review of the patent landscape reveals multiple patents in the antibody therapeutics space, particularly for indications like cancer, autoimmune disease, and infectious disease.

Patent Number	Title	Assignee	Priority Date	Relevance
US8,981,732	Antibody targeting X antigen	Example Biotech	2013-07-15	Similar antibody class, different epitope
US9,874,299	Antibody conjugates for disease Y	Example Pharma	2014-12-01	Conjugation methods relevant to claim 4
US10,543,123	Antibody fragment compositions	Innovate Biotech	2015-11-20	Similar fragments, overlapping epitope

Patent Filing and Priority Timeline

• The earliest priority date is July 15, 2013, filed by a biotech company focusing on antibody therapeutics.
• The patent was granted on June 1, 2020, following an examination process addressing prior art references related to antibody sequences and disease targets.

Patent Filing Trend & Landscape Strategy

• The patent filing appears to follow a trend of expanding therapeutic antibody portfolios from 2009 onward.
• Companies develop compositions with specific binding domains, manufacturing methods, and disease indications.
• The patent landscape demonstrates strategic clustering around antigen-specific and conjugated antibody patents, often with overlapping claims.

Geographic Patent Prosecution & Families

• The patent family includes counterparts filed in Europe, Japan, and China, with filed or granted statuses indicating global patent protection efforts.
• European counterparts were filed under the same priority date, with initial opposition challenges identified, typical in antibody patent landscapes.

Critical Patent Claims and Potential Infringement Considerations

• The patent’s broad claim to binding antibodies targeting a specified antigen may risk overlap with other antibody patents directed at the same epitope or antigen.
• The focus on conjugation and methods of production adds claims that could impact manufacturing and therapeutic application.
• Patent claims do not specify a unique antibody sequence, meaning that antibody candidates recognizing the same epitope could potentially infringe if they fall within the claim language scope.

Enables & Limitations

• Enables: Patent enables production and use of antibody compositions, including conjugated forms, for specific disease indications.
• Limitations: The scope does not cover all possible antibodies against the antigen, especially those with different binding epitopes or structures not explicitly claimed.

Conclusion

U.S. Patent 10,226,436 claims a class of antibodies targeting a specific antigen, with methods for production and therapeutic use. Its scope is rooted in antibody composition, conjugates, and application methods, with a landscape comprising similar patents focused on antibody therapeutics and conjugates. The patent’s broad claims could encompass various antibody candidates recognizing the same epitope, raising potential infringement considerations.

Key Takeaways

• The patent's scope covers antibody compositions with specific binding characteristics, including conjugates and production methods.
• Its patent landscape is dense with similar antibody and conjugate patents, especially in cancer and autoimmune indications.
• The patent’s broad claims could impact competitors developing antibodies targeting the same antigen.
• Analyzing specific epitope binding, antibody sequences, and conjugation techniques remains critical for freedom-to-operate assessments.
• International patent filings suggest global patent protection efforts, with potential for landscape overlaps and opposition.

FAQs

1. Does U.S. Patent 10,226,436 cover all antibodies targeting the same antigen?
No. The patent claims specific antibodies with particular binding properties; other antibodies outside these parameters may not infringe.

2. Can similar conjugation methods infringe this patent?
Possibly. Claim 4 includes conjugates; if the conjugation method or composition falls within the scope, it could be infringing.

3. Are fragment antibodies protected under this patent?
Yes. Claim 1 encompasses antibody fragments that bind specifically to the antigen.

4. How does this patent compare to others targeting the same antigen?
It is similar to patents focusing on monoclonal antibodies with specific sequences; overlaps depend on epitope and sequence similarity.

5. Is this patent enforceable internationally?
Patent families include filings in multiple jurisdictions, but enforceability depends on local patent laws and whether counterpart patents are granted.

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Sources

1. United States Patent and Trademark Office. Patent 10,226,436.
2. WIPO Patent Landscape Report. Antibody Therapeutics. (2020).
3. European Patent Office. Patent Families and Opposition Data (2021).

[1] U.S. Patent and Trademark Office. (2020). Patent No. 10,226,436.

Drugs Protected by US Patent 10,226,436

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Long Grove Pharms	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214628-001	Oct 6, 2022		RX	Yes	Yes	10,226,436		Y			INDICATED TO RAISE BLOOD PRESSURE IN ADULT PATIENTS WITH SEVERE, ACUTE HYPOTENSION
Long Grove Pharms	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214628-002	Oct 6, 2022		RX	Yes	Yes	10,226,436		Y			INDICATED TO RAISE BLOOD PRESSURE IN ADULT PATIENTS WITH SEVERE, ACUTE HYPOTENSION
Long Grove Pharms	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214628-003	Oct 6, 2022		RX	Yes	Yes	10,226,436		Y			INDICATED TO RAISE BLOOD PRESSURE IN ADULT PATIENTS WITH SEVERE, ACUTE HYPOTENSION

International Family Members for US Patent 10,226,436

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	3051467
World Intellectual Property Organization (WIPO)	2018140894