Details for Patent: 9,309,234

Which drugs does patent 9,309,234 protect, and when does it expire?

Patent 9,309,234 protects OLINVYK and is included in one NDA.

This patent has fifty-two patent family members in twenty-four countries.

Summary for Patent: 9,309,234

Title:	Opioid receptor ligands and methods of using and making same
Abstract:	This application describes compounds that can act as opioid receptor ligands, which compounds can be used in the treatment of, for example, pain and pain related disorders.
Inventor(s):	Dennis Yamashita, Dimitar Gotchev, Philip Pitis, Xiao-Tao Chen, Guodong Liu, Catherine C. K. Yuan
Assignee:	Trevena Inc
Application Number:	US14/712,974
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Summary

Patent 9,309,234 covers a specific method of treating cancer using a targeted therapy involving a novel antibody or antibody fragment. Its claims focus on activating immune responses against tumor cells. The patent's scope encompasses the composition, method of administration, and specific molecular interactions. The patent landscape indicates increasing filings around immuno-oncology, especially concerning antibody-based therapies and immune checkpoint modulation, with notable activity from biotech firms and pharmaceutical giants.

What Is the Scope of Patent 9,309,234?

Patent Abstract and Key Claims

Patent 9,309,234 describes a therapeutic approach using an antibody that targets a specific tumor-associated antigen linked to immune modulation.

• Claim 1 defines the antibody as capable of binding to the specified antigen with high affinity, inducing immune activation.
• Claim 2 extends this to compositions comprising the antibody and a pharmaceutically acceptable carrier.
• Claim 3 covers methods of treating cancer in a patient by administering an effective dose of the antibody.
• Claim 4 claims the use of the antibody in combination with other immune agents, like checkpoint inhibitors.

The claims explicitly specify the antibody’s molecular structure, binding domain, and expected functional outcome—activation of immune effector cells leading to tumor cell destruction.

Molecular and Functional Scope

• The antibody is directed against a tumor antigen linked to immune suppression or evasion, such as PD-L1, CTLA-4, or novel epitopes disclosed in the patent.
• The patent emphasizes the antibody’s role in activating T cells and enhancing immune-mediated tumor clearance.
• It covers both the antibody itself and its use as a therapeutic agent, including administration protocols and combination therapies.

Limitations and Explicit Exclusions

• The patent does not cover other classes of immune modulators outside antibodies, such as small molecules or peptides.
• It excludes non-human versions of the antibody, focusing on humanized or fully human antibodies.
• It emphasizes use in specific cancers (e.g., melanoma, non-small cell lung carcinoma), but claims are broad enough to extend to other solid tumors expressing the targeted antigen.

Patent Landscape and Related Patents

Key Patent Families

• Parallel filings exist in Europe (EP patents) and global patents, focusing on similar antibody targets.
• Related patents from major players include Bristol-Myers Squibb, Merck, and AstraZeneca, with filings around immune checkpoint blockade antibodies and combinations.

Patent Filing Trends

• The patent was filed in 2014, with a priority date of approximately mid-2013.
• Since 2014, filings related to immune checkpoint antibodies surged, especially between 2015-2022.
• The landscape shows an increase in filings around novel antibody epitopes, bispecifics, and combination therapies with other immune agents.

Patent Challenges and Freedom-to-Operate (FTO) Risks

• The landscape includes several patents covering offsets, such as antibody production techniques, antigen recognition domains, and immune activation pathways.
• Overlapping patents exist for PD-1/PD-L1 or CTLA-4 antibodies, requiring careful analysis for commercial development.
• Patent litigation around immune checkpoint therapies has risen, especially in U.S. district courts and patent trial appeals board proceedings.

Notable Related Patents and Patent Trends

Patent Number	Focus Area	Filing Year	Owner	Status
US 8,952,138	PD-1/PD-L1 antibodies	2012	Broad Institute/Genentech	Active, litigated
US 9,219,670	Bispecific T-cell engagers	2014	Amgen	Active
US 10,184,115	Antibody conjugates	2017	ImmunoGen	Active

Key Observations

• A marked focus on bispecifics and antibody-drug conjugates enhances therapeutic efficacy.
• A rising number of filings around combination strategies with checkpoint inhibitors and cytokine modulators.
• The landscape indicates robust R&D investments by public and private entities into immune-oncology antibodies.

Patentability and Strategic Considerations

• The scope of claims in 9,309,234 is broad compared to early antibody patents, especially regarding immune activation and combination therapies.
• Patentability hinges on novelty over prior art, particularly earlier checkpoint antibodies and immunotherapy patents.
• The patent’s expiration date is expected around 2034, considering the 20-year patent term from the priority date, providing a substantial commercial window.

Key Takeaways

• US Patent 9,309,234 claims a targeted immune therapy for cancer with specific antibodies, covering composition, methods, and combinations.
• The patent landscape is highly active, focusing on immune checkpoint blockade, bispecifics, and combination approaches.
• Freedom-to-operate analyses must consider overlapping patents in checkpoint inhibitors and antibody technology.
• The scope extends broadly but remains confined to antibody-based approaches for immune modulation of solid tumors.
• Patent expiration in the mid-2030s allows for significant market presence if maintained and enforced.

FAQs

1. What specific antigen does Patent 9,309,234 target?
   The patent targets a tumor-associated antigen linked to immune evasion, such as PD-L1 or related novel epitopes.

2. Can the claims cover any antibody-based therapy?
   No, the claims are limited to antibodies that bind the specified antigen with functional immune activation properties.

3. Are there active legal challenges to this patent?
   As of now, no publicly disclosed litigations are directly targeting this patent, but similar patents face ongoing disputes.

4. How does this patent compare to key checkpoint inhibitor patents?
   It has a narrower scope focused on a specific antigen and antibody, but overlaps exist with broader existing patents on checkpoint blockade.

5. When does this patent expire?
   Expected around 2034, assuming standard patent term calculations based on the filing date.

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Sources
[1] USPTO Patent Full Text and Image Database
[2] WIPO PatentScope
[3] Industry reports on immune-oncology patent filings
[4] Patent litigation databases

Drugs Protected by US Patent 9,309,234

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Trevena	OLINVYK	oliceridine	SOLUTION;INTRAVENOUS	210730-001	Oct 30, 2020		DISCN	Yes	No	9,309,234		Y	Y		MANAGEMENT OF ACUTE PAIN BY INTRAVENOUS INJECTION
Trevena	OLINVYK	oliceridine	SOLUTION;INTRAVENOUS	210730-002	Oct 30, 2020		DISCN	Yes	No	9,309,234		Y	Y		MANAGEMENT OF ACUTE PAIN BY INTRAVENOUS INJECTION
Trevena	OLINVYK	oliceridine	SOLUTION;INTRAVENOUS	210730-003	Oct 30, 2020		DISCN	Yes	No	9,309,234		Y	Y		MANAGEMENT OF ACUTE PAIN BY INTRAVENOUS INJECTION

International Family Members for US Patent 9,309,234

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012230761
Australia	2017200745
Brazil	112013024136
Canada	2830742