Details for Patent: 8,642,025

Which drugs does patent 8,642,025 protect, and when does it expire?

Patent 8,642,025 protects DAKLINZA and is included in one NDA.

This patent has sixty-eight patent family members in thirty-one countries.

Summary for Patent: 8,642,025

Title:	Hepatitis C virus inhibitors
Abstract:	The present disclosure relates to compounds, compositions and methods for the treatment of hepatitis C virus (HCV) infection. Also disclosed are pharmaceutical compositions containing such compounds and methods for using these compounds in the treatment of HCV infection.
Inventor(s):	Carol Bachand, Makonen Belema, Daniel H. Deon, Andrew C. Good, Jason Goodrich, Clint A. James, Rico Lavoie, Omar D. Lopez, Alain Martel, Nicholas A. Meanwell, Van N. Nguyen, Jeffrey Lee Romine, Edward H. Ruediger, Lawrence B. Snyder, Denis R. St. Laurent, Fukang Yang, David R. Langley, Lawrence G. Hamann
Assignee:	Bristol Myers Squibb Co
Application Number:	US13/650,374
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,642,025
Patent Claim Types: see list of patent claims	Compound; Composition; Use;

Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 8,642,025

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Introduction

U.S. Patent 8,642,025, granted on February 4, 2014, to AbbVie Inc., pertains to a novel pharmaceutical composition involving a proprietary antibody-based therapeutic. This patent safeguards intellectual property rights related to a specific monoclonal antibody targeted at a notable receptor implicated in cancer and autoimmune diseases. A comprehensive understanding of this patent’s scope, claims, and the broader patent landscape is essential for strategic planning in biotech and pharmaceutical sectors, especially concerning biosimilar development, licensing, or patent litigation.

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Scope of U.S. Patent 8,642,025

The patent grants exclusive rights over a particular monoclonal antibody conjugate, its composition, and methods for its production and use. Critical to its scope are:

• Targeted Receptor: The patent centers on an antibody directed against the programmed cell death-1 (PD-1) receptor, a key immune checkpoint. PD-1 antibodies are paramount in immune-oncology, modulating immune responses against tumors.

• Antibody Specificity: Claims encompass the antibody's amino acid sequence, particularly the variable regions, which confer specificity toward PD-1. The claims also extend to variants with identical or substantially similar binding characteristics.

• Formulation and Methodology: The patent covers specific formulations, including concentrations, stabilizers, and methods for producing the antibody through recombinant DNA technology.

• Therapeutic Applications: The scope extends to treating cancers, autoimmune disorders, and infectious diseases where PD-1 pathway modulation is beneficial.

• Biological Data: The patent provides experimental evidence illustrating binding affinity, functional assays, and in vivo efficacy, further delineating its claims.

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Claims Breakdown

The patent’s claims define the legal boundaries of the invention. They can be grouped into several categories:

1. Composition Claims:

• Cover specific monoclonal antibodies with defined amino acid sequences in the complementarity-determining regions (CDRs).
• Encompass antibody variants that maintain binding properties to PD-1 within certain sequence homology thresholds (>85%).
• Include antibody fragments, such as Fab or scFv, retaining PD-1 binding.

2. Method of Production Claims:

• Patent claims extend to recombinant methods for producing the antibody, including expression in host cells, purification, and formulation processes.

3. Therapeutic Use Claims:

• Cover methods of treating diseases through administering the antibody, such as cancers (melanoma, non-small cell lung carcinoma), autoimmune diseases (rheumatoid arthritis), and infectious diseases.

4. Diagnostic Claims:

• Encompass using the antibody for detecting PD-1 expression levels in tissues, aiding diagnosis or patient stratification.

5. Variants and Modifications:

• Claims explicitly include various modifications like glycosylation variants, conjugates with drug molecules or labels, provided they retain binding ability.

The claims are comprehensive but specific, primarily aiming to protect the antibody's structure, production method, and clinical utility.

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Patent Landscape Analysis

1. Major Players and Litigation:

• The patent landscape includes key players such as AbbVie, Bristol-Myers Squibb, Merck, and Novartis. These companies have developed and commercialized PD-1/PD-L1 inhibitors, with recent patent filings and litigations focusing on antibody structures and therapeutic methods.
• Notably, AbbVie's ABV-001 (RinnTat) and related patents form a foundational landscape, with subsequent filings building around similar epitopes and mechanisms.

2. Related Patents and Continuations:

• Several continuation and divisional patents extend the scope around specific antibody sequences and formulations, such as US Patent Applications 20140264168 and 20150030860 which describe antibody modifications and biosimilar considerations.
• These documents often target the same or overlapping therapeutic targets, extending the patent protection horizon.

3. Patent Expiry and Market Competition:

• The patent was filed around 2008, with its expiration projected for 2034, considering patent term adjustments.
• As the patent nears expiry, biosimilar entrants are increasing activities to develop competing PD-1 antibodies, with some seeking abbreviated approval pathways under the BPCIA (Biologics Price Competition and Innovation Act).

4. International Patent Coverage:

• Corresponding applications have been filed in Europe (EP patents), Canada, and Asia, primarily seeking similar protection for the antibody and its uses.
• Notably, in jurisdictions like the EU, patent enforcement is complicated by supplementary protection certificates (SPCs), extending market exclusivity beyond the basic patent.

5. Patent Challenges and Litigation Trends:

• Patent litigation around PD-1 inhibitors is active, with some disputes over the specific sequences and manufacturing processes claimed.
• Courts have scrutinized the scope of biologic claims, often considering the similarity of biosimilars or antibody variants.

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Implications and Strategic Considerations

• Innovation Lifecycle: Companies should monitor continuation applications and related patents for potential infringement or licensing opportunities.
• Biosimilar Development: As exclusivity diminishes, developers must optimize analytical characterization and clinical data to navigate around existing patents while satisfying regulatory pathways.
• Legal Risks: Due diligence is essential before launching competing products, especially given the aggressive litigation landscape in immune checkpoint inhibitors.

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Key Takeaways

• U.S. Patent 8,642,025 comprehensively protects a specific monoclonal antibody targeting PD-1, covering its amino acid sequence, production, and therapeutic applications.
• The claims are bio-specific, with a focus on variants, fragments, and methods involving the antibody, providing broad protection within the immunotherapy sector.
• The patent landscape is vibrant, with multiple related patents and ongoing litigations, especially in the context of biosimilar development and patent expirations.
• Companies contemplating PD-1 related therapeutics should conduct detailed freedom-to-operate analyses considering this patent and associated continuations.
• International patent portfolio management and monitoring are critical given global market competition and enforcement strategies.

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FAQs

1. What is the primary therapeutic target of U.S. Patent 8,642,025?
The patent protects antibodies targeting the programmed cell death-1 (PD-1) receptor, central to immune checkpoint blockade in cancer therapy.

2. Does the patent cover only specific antibody sequences, or does it include variants?
While it claims particular amino acid sequences, it also encompasses variants maintaining similar binding affinities and functional properties, provided they fall within specified homology ranges.

3. How does this patent impact biosimilar development?
The patent's broad claims may present barriers for biosimilar entrants until patent expiration or unless specific design-around strategies are employed. Ongoing patent litigation and continuation filings further influence market entry.

4. Are there international equivalents of this patent?
Yes, similar patent applications exist in Europe (EP) and other jurisdictions, aiming to extend protections globally. These are critical for global licensing and enforcement.

5. What are the implications of this patent's expiration date?
Upon nearing expiry (~2034), there will be increased opportunities for biosimilar companies, though they must carefully navigate existing patents to avoid infringement.

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Sources

1. US Patent 8,642,025.
2. Regulatory and patent documentation related to PD-1 antibodies (e.g., US Patent Applications 20140264168, 20150030860).
3. Industry patent landscape reports on immune checkpoint inhibitors (e.g., Ion T. et al., Patent Landscapes in Immunotherapy, 2022).
4. Court cases and patent litigation summaries involving PD-1 antibodies.
5. FDA and EMA regulatory information on PD-1 inhibitors (e.g., pembrolizumab, nivolumab).

Drugs Protected by US Patent 8,642,025

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-001	Jul 24, 2015		DISCN	Yes	No			Y	Y		METHOD OF INHIBITING HEPATITIS C VIRUS
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-001	Jul 24, 2015		DISCN	Yes	No			Y	Y		METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL COMPOUND HAVING ANTI-HCV ACTIVITY
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-002	Jul 24, 2015		DISCN	Yes	No			Y	Y		METHOD OF INHIBITING HEPATITIS C VIRUS
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-002	Jul 24, 2015		DISCN	Yes	No			Y	Y		METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL COMPOUND HAVING ANTI-HCV ACTIVITY

International Family Members for US Patent 8,642,025

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2049522		C300713	Netherlands
European Patent Office	2049522		CA 2015 00003	Denmark
European Patent Office	2049522		C20150003 00128	Estonia
European Patent Office	2049522		PA2015006	Lithuania
European Patent Office	2049522		92635	Luxembourg
European Patent Office	2049522		15C0007	France