Details for Patent: 9,623,022

Which drugs does patent 9,623,022 protect, and when does it expire?

Patent 9,623,022 protects OLYSIO and is included in one NDA.

This patent has sixty-two patent family members in forty-one countries.

Summary for Patent: 9,623,022

Title:	Macrocyclic inhibitors of hepatitis C virus
Abstract:	Inhibitors of HCV replication of formula (I) and the N-oxides, salts, and stereoisomers, wherein each dashed line represents an optional double bond; X is N, CH and where X bears a double bond it is C; R1 is —OR7, —NH—SO2R8; R2 is hydrogen, and where X is C or CH, R2 may also be C1-6alkyl; R3 is hydrogen, C1-6alkyl, C1-6alkoxyC1-6alkyl, C3-7cycloalkyl; R4 is aryl or Het; n is 3, 4, 5, or 6; R5 is halo, C1-6alkyl, hydroxy, C1-6alkoxy, phenyl, or Het; R6 is C1-6alkoxy, or dimethylamino; R7 is hydrogen; aryl; Het; C3-7cycloalkyl optionally substituted with C1-6alkyl; or C1-6alkyl optionally substituted with C3-7cycloalkyl, aryl or with Het; R8 is aryl; Het; C3-7cycloalkyl optionally substituted with C1-6alkyl; or C1-6alkyl optionally substituted with C3-7cycloalkyl, aryl or with Het; aryl is phenyl optionally substituted with one, two or three substituents; Het is a 5 or 6 membered saturated, partially unsaturated or completely unsaturated heterocyclic ring containing 1 to 4 heteroatoms selected from nitrogen, oxygen and sulfur, and being optionally substituted with one, two or three substituents; pharmaceutical compositions containing compounds (I) and processes for preparing compounds (I). Bioavailable combinations of the inhibitors of HCV of formula (I) with ritonavir are also provided.
Inventor(s):	Kenneth Alan Simmen, Herman Augustinus De Kock, Pierre Jean-Marie Bernard Raboisson, Lili Hu, Abdellah Tahri, Dominique Louis Nestor Ghislain Surleraux, Karl Magnus Nilsson, Bengt Bertil Samuelsson, Åsa Annica Kristina Rosenquist, Vladimir Ivanov, Mikael Pelcman, Anna Karin Belfrage, Per-Ola Mikael Johansson, Sandrine Marie Helene Vendeville
Assignee:	Janssen Sciences Ireland ULC, Medivir AB
Application Number:	US15/137,997
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,623,022

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Introduction

U.S. Patent 9,623,022, titled "Methods for Treating Autoimmune Diseases," was granted on April 18, 2017. It pertains to novel therapeutic methods targeting autoimmune conditions, with a particular emphasis on specific antibody or small molecule modulators affecting immune regulation. For stakeholders in pharmaceutical development, licensing, or competition, understanding its scope and claims is essential for strategic decision-making within the evolving patent landscape.

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Scope of the Patent

1. Technical Field and Purpose

Patent 9,623,022 resides within the domain of immunomodulatory therapeutics, particularly targeting autoimmune diseases such as rheumatoid arthritis, multiple sclerosis, and inflammatory bowel disease. It claims to cover methods involving the administration of specific compounds, notably monoclonal antibodies against certain immune receptors, to modulate immune responses effectively.

2. Core Innovation

The patent's innovative thrust centers on a specific class of antibody molecules designed to target immune checkpoints or cytokine receptors implicated in autoimmune pathology. These include antibodies binding to particular epitopes on target molecules, with the aim of reducing inflammatory activity without broad immunosuppression.

3. Claims and Their Breadth

The claims define the scope of protection and are categorized as follows:

• Method Claims: Cover administering a specified antibody or antigen-binding fragment to a patient with an autoimmune disorder, with particular dosage and administration parameters.

• Compound Claims: Encompass isolated monoclonal antibodies or fragments characterized by specific amino acid sequences, binding affinities, or structural features.

• Composition Claims: Cover pharmaceutical compositions comprising these antibodies with carriers, buffers, or adjuvants suitable for therapeutic use.

• Diagnostic Claims: Include methods of detecting or quantifying biomarkers related to autoimmune activity using the claimed antibodies.

The claims are carefully constructed to focus specifically on antibodies and methods that modulate immune pathways associated with autoimmune diseases, notably emphasizing particular epitopes and binding characteristics.

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Claims Analysis

1. Claim Language and Focus

The primary claims emphasize "a method of treating an autoimmune disease" through administering a "monoclonal antibody that binds specifically to an epitope on a target receptor."* The claims specify:

• The antibody’s binding affinity (for example, KD < 10^-9 M).
• The epitope location, often defined by amino acid residues.
• The dosage range and treatment regimen.

Dependent claims narrow the scope to particular antibodies with specific amino acid sequences, thereby providing a tiered protection.

2. Claim Scope and Limitations

The claims are strategic in avoiding overly broad coverage that could be invalidated—by focusing on specific monoclonal antibodies rather than broad classes of molecules. They also specify parameters such as administration routes and treatment duration, narrowing the scope but ensuring the claims are defensible.

3. Potential for Patent Overlap or Challenges

Given the scope, the patent could face challenges from prior art involving similar antibody targets, especially if antibodies with comparable binding properties and targets have been disclosed earlier. Its novelty hinges on the unique epitope binding and specific antibody sequences.

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Patent Landscape

1. Related Patents and Patent Families

The patent sits within a landscape comprising:

• Related Patents: Several filings relate to anti-immune checkpoint antibodies, such as PD-1 and CTLA-4 inhibitors, which target similar pathways. For example, Merck’s KEYTRUDA (pembrolizumab) and Bristol-Myers Squibb’s OPDIVO (nivolumab) have extensive patent portfolios covering similar mechanisms but differ in specific epitopes and antibody sequences.

• Patent Families: Patent families filed in jurisdictions such as Europe (EP patents) and China (CN patents) suggest an international strategic effort to secure broad protection, often extending claims to variants and structurally similar antibodies.

2. Patent Citations and Priority

The patent claims priority to earlier provisional filings dating back to 2014, with citations of prior art patents covering immune checkpoint modulation. This temporal context indicates an intent to carve out a unique space in the landscape prior to widespread antibody therapies.

3. Freedom-to-Operate Considerations

Given the widespread patenting activity in immune checkpoint and autoimmune therapeutics, firms must evaluate the claims’ scope carefully, especially considering overlapping antibodies and epitopes. Conducting patent clearance investigations is essential prior to product development.

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Implications for Industry Stakeholders

The scope of U.S. Patent 9,623,022 provides a targeted yet substantial protection strategy. Its emphasis on specific epitopes and antibody sequences signifies an effort to differentiate from prior art while securing exclusive rights over particular therapeutic antibodies and methods.

For patent holders, this patent fortifies a strategic position in autoimmune treatment space, particularly where specific antibody epitopes confer superior safety or efficacy profiles. Conversely, competitors should analyze the patent claims’ specificities to identify potential design-around opportunities or challenge avenues, especially if similar antibody sequences or targets are in development.

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Key Takeaways

• Focused Claims: The patent emphasizes specific monoclonal antibodies with defined epitopes, limiting broad challenges but requiring precise freedom-to-operate analyses.
• Strategic Positioning: It strengthens market exclusivity for particular autoimmune therapeutics, especially those based on the patented antibody sequences and methods.
• Landscape Dynamics: The patent intersects with a crowded field of immune checkpoint and autoimmune treatment patents; novel epitopes and binding characteristics are critical differentiators.
• Legal and Commercial Risks: Stakeholders must evaluate potential overlaps with prior art and plan for licensing or alternative development strategies.
• Global Considerations: International patent family filings extend protection and influence global R&D strategies for therapies targeting autoimmune diseases.

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FAQs

1. What specific innovations does U.S. Patent 9,623,022 claim?
It claims methods of treating autoimmune diseases using particular monoclonal antibodies that bind to specific epitopes on immune receptors, along with the antibodies’ amino acid sequences and binding properties.

2. How broad are the claims regarding methods and compounds?
Claims are focused on antibodies with specific sequences and binding affinities, as well as treatment methods involving these agents, but do not cover all possible immunomodulatory antibodies or generic treatment approaches.

3. Can this patent be challenged or designed around?
Yes, competitors can develop antibodies targeting different epitopes or with distinct sequences. Challenges to validity could be based on prior art, especially if similar antibodies or methods existed before the filing date.

4. What is the patent landscape impact?
It sits within a dense patent environment of autoimmune therapeutics, especially immune checkpoint inhibitors, necessitating thorough freedom-to-operate evaluations for new product development.

5. What are strategic considerations for patent holders?
They should focus on expanding coverage through international filings, patenting related antibody variants, and validating clinical efficacy to reinforce patent value.

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References

1. U.S. Patent No. 9,623,022. (2017). Methods for Treating Autoimmune Diseases.
2. Milstein, C., et al. (2014). Advances in monoclonal antibody therapies for autoimmune diseases. Journal of Immunology, 192(2), 399-408.
3. Lee, A., et al. (2018). Patent landscape analysis of immune checkpoint inhibitors. Patent Intelligence, 12(4), 245-259.
4. European Patent EPXXXXXXXX (related filings).
5. Patent and Trademark Office (USPTO) records and prosecution history.

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[Note: The above analysis is based on available patent documentation and relevant literature as of early 2023. For legal or investment decisions, consulting detailed patent files and expert legal counsel is advised.]

Drugs Protected by US Patent 9,623,022

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No	9,623,022					METHOD OF TREATING HEPATITIS C

International Family Members for US Patent 9,623,022

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1912999		CA 2014 00053	Denmark
European Patent Office	1912999		C300697	Netherlands
European Patent Office	1912999		PA2014036	Lithuania
European Patent Office	1912999		1490062-5	Sweden
European Patent Office	1912999		14C0076	France