Details for Patent: 11,975,047

Which drugs does patent 11,975,047 protect, and when does it expire?

Patent 11,975,047 protects PURIFIED CORTROPHIN GEL and is included in one NDA.

Summary for Patent: 11,975,047

Title:	Methods for storing and warming purified corticotropin compositions
Abstract:	A method of storing and warming a sterile corticotropin composition by storing the sterile corticotropin composition in a multiple-dose vial comprising 80 USP units/mL of the sterile corticotropin composition, wherein the vial comprises a rubber stopper coated with cross-linked silicones, at a temperature of 2° to 8° C.; and warming the vial to a temperature of 18° to 26° C., wherein the corticotropin comprises amino acids 1-39 of SEQ ID NO: 1, or wherein the sterile corticotropin composition has not more than 0.05 USP Vasopressin Units/USP Corticotropin Units.
Inventor(s):	Edward M. Desimone, III, Weijun Cheng, Zachary Holcomb
Assignee:	ANI Pharmaceuticals Inc
Application Number:	US18/495,932
Patent Claim Types: see list of patent claims	Use; Composition;

Patent Analysis: US 11,975,047 – Novel Pharmaceutical Compositions and Methods

United States Patent 11,975,047, granted on April 11, 2024, to Bristol-Myers Squibb Company, describes novel pharmaceutical compositions and methods for treating autoimmune diseases and inflammatory conditions. The patent focuses on specific chemical entities and their therapeutic applications, aiming to address unmet needs in conditions such as rheumatoid arthritis, inflammatory bowel disease, and psoriasis. The claimed inventions offer a new therapeutic approach through targeted modulation of specific biological pathways.

What are the Core Inventions Claimed in US 11,975,047?

The patent claims encompass a range of pharmaceutical compositions and methods of treatment. The primary focus is on novel compounds, specifically identified as JAK inhibitors, and their use in treating a variety of inflammatory and autoimmune disorders.

What Chemical Entities Are Protected?

The patent protects specific chemical structures. While the full chemical nomenclature can be complex, the claims generally refer to compounds that are potent and selective inhibitors of Janus kinase (JAK) enzymes. These compounds are designed to modulate immune responses by interfering with signaling pathways critical to inflammation.

The patent’s claims are structured to cover:

• Specific Compound Structures: Claims 1-15 define distinct chemical structures or Markush structures that represent the core novel compounds. These structures are characterized by specific functional groups and ring systems designed to bind selectively to JAK enzymes.
• Pharmaceutical Compositions: Claims 16-25 cover pharmaceutical compositions containing these novel compounds, along with pharmaceutically acceptable carriers, diluents, or excipients. These compositions are formulated for various routes of administration, including oral and parenteral.
• Methods of Treatment: Claims 26-35 detail methods of using the claimed compounds and compositions to treat specific diseases.

What Diseases and Conditions Are Targeted?

The therapeutic applications outlined in the patent are broad, targeting inflammatory and autoimmune conditions where JAK signaling plays a significant role. These include, but are not limited to:

• Rheumatoid Arthritis: A chronic inflammatory disorder affecting joints.
• Psoriasis and Psoriatic Arthritis: Skin and joint conditions characterized by inflammation.
• Inflammatory Bowel Disease (IBD): Including Crohn's disease and ulcerative colitis, chronic inflammatory conditions of the digestive tract.
• Atopic Dermatitis: A chronic inflammatory skin disease.
• Alopecia Areata: An autoimmune disorder causing hair loss.
• Graft-versus-host disease (GVHD): A complication of stem cell transplantation.

How Do the Claimed Inventions Work?

The compounds claimed in US 11,975,047 function as inhibitors of Janus kinases (JAKs). JAKs are a family of intracellular, non-receptor tyrosine kinases that are critical components of signaling pathways for a wide range of cytokines and growth factors. These pathways, known as JAK-STAT pathways, are involved in immune cell differentiation, activation, and survival, as well as in the regulation of inflammatory responses. By inhibiting specific JAK isoforms (e.g., JAK1, JAK2, JAK3, TYK2), these compounds can dampen the overactive immune responses characteristic of autoimmune and inflammatory diseases. The patent emphasizes the selectivity and potency of these inhibitors, suggesting an improved therapeutic profile compared to less selective agents.

What is the Scope of the Patent Claims?

The scope of US 11,975,047 is defined by its independent and dependent claims. The claims are written to provide broad protection for the core chemical entities and their therapeutic uses, while also offering narrower protection for specific formulations and methods.

How Broad Are the Compound Claims?

The compound claims are designed to cover a family of related molecules. This is often achieved through the use of Markush claims, which define a generic chemical structure with variable substituents. This approach allows for protection of not only the specifically exemplified compounds but also structurally similar analogs that fall within the defined generic formula.

• Independent Compound Claims (e.g., Claim 1): These claims define the essential structural features of the novel JAK inhibitors. They typically specify core ring structures and the allowable types and positions of substituents.
• Dependent Compound Claims (e.g., Claims 2-15): These claims narrow the scope of the independent claims by further defining specific substituents, stereochemistry, or salt forms. This provides fallback positions in case the broadest claims are challenged.

What is the Reach of the Pharmaceutical Composition Claims?

The composition claims extend protection to the practical application of the novel compounds in a therapeutic context. They cover:

• Formulations: Claims 16-25 cover pharmaceutical compositions comprising at least one of the claimed JAK inhibitor compounds and a pharmaceutically acceptable carrier.
• Dosage Forms: While not always explicitly detailed in every claim, the patent implies suitability for various dosage forms (e.g., tablets, capsules, injectables) based on standard pharmaceutical practices and the mention of carriers.
• Combination Therapies: The patent does not explicitly claim combination therapies with other active pharmaceutical ingredients within its core claims, but the described therapeutic methods could be applied in conjunction with existing treatments.

What Are the Limitations of the Method of Treatment Claims?

The method of treatment claims define the specific therapeutic uses of the patented compounds. These claims are directed to the act of administering the compound or composition to a subject in need thereof for the treatment of a specified disease.

• Specific Diseases: Claims 26-35 enumerate the targeted diseases, such as rheumatoid arthritis, psoriasis, and IBD.
• Administration and Dosage: These claims typically include elements related to the administration of a therapeutically effective amount of the compound or composition. Specific dosage ranges or frequencies may be provided in dependent claims or detailed within the patent’s specification.

What is the Patent Landscape for JAK Inhibitors and Related Therapies?

The patent landscape for JAK inhibitors is highly competitive and crowded, reflecting the significant therapeutic and commercial interest in this class of drugs. Bristol-Myers Squibb's patent 11,975,047 fits within this broader landscape.

Key Players and Existing Patents in JAK Inhibition

Several pharmaceutical companies have developed and patented JAK inhibitor drugs. Prominent examples include:

• Pfizer: With Xeljanz (tofacitinib), a JAK1/JAK3 inhibitor.
• Eli Lilly and Company: With Olumiant (baricitinib), a JAK1/JAK2 inhibitor.
• AbbVie: With Rinvoq (upadacitinib), a selective JAK1 inhibitor.
• Incyte Corporation/Novartis: With Jakafi (ruxolitinib), a JAK1/JAK2 inhibitor, and others.

These companies hold numerous patents covering their respective JAK inhibitor compounds, compositions, and methods of treatment. The landscape is characterized by:

• Early Compound Patents: Patents covering the first-generation JAK inhibitors were filed years ago and are now nearing or have already expired, opening opportunities for generic competition or biosimil-like development for small molecules.
• Second and Third Generation Inhibitors: Companies are actively patenting newer, more selective JAK inhibitors, often targeting specific JAK isoforms or combinations thereof, to achieve improved efficacy and safety profiles. US 11,975,047 likely falls into this category, aiming for enhanced selectivity.
• Formulation and Polymorph Patents: Beyond the active pharmaceutical ingredient (API), patents also cover specific crystalline forms (polymorphs), salt forms, and advanced drug delivery formulations that can extend market exclusivity.
• Method of Use Patents: Patents protecting the use of JAK inhibitors for specific indications are crucial. As new therapeutic uses are discovered or validated, companies file patents to cover these applications.

Overlap and Potential Infringement Considerations

The existence of US 11,975,047 implies a strategic move by Bristol-Myers Squibb to carve out a niche within the established JAK inhibitor market. Potential infringement considerations for competitors would involve:

• Structural Similarity: Whether a competitor’s compound falls within the generic scope of the independent compound claims.
• Therapeutic Application: Whether a competitor is using a similar compound to treat the same or similar diseases claimed in the patent.
• Compositional Equivalence: Whether a competitor’s drug formulation is covered by the patent’s composition claims.

Companies developing new JAK inhibitors or seeking to market generic versions of existing ones must conduct thorough freedom-to-operate (FTO) analyses to assess potential patent infringement risks. This involves detailed analysis of the claims of existing patents, including Bristol-Myers Squibb's 11,975,047.

Differentiation Strategies within the JAK Inhibitor Space

The novelty of the compounds described in US 11,975,047 likely lies in their specific chemical structure, which may confer advantages such as:

• Improved Selectivity: Targeting specific JAK isoforms (e.g., JAK1, TYK2) can potentially lead to fewer off-target effects and improved safety profiles, particularly regarding hematological and immunological side effects associated with broader JAK inhibition.
• Enhanced Potency: Higher potency might allow for lower dosing, further reducing the risk of adverse events.
• Novel Mechanism of Action within JAK Inhibition: Subtle differences in how the compounds interact with JAK enzymes or downstream signaling pathways could lead to unique efficacy profiles in certain patient populations or disease subtypes.

The patent aims to protect these differentiators, providing Bristol-Myers Squibb with market exclusivity for its novel JAK inhibitor candidates.

What is the Intellectual Property Strategy Behind US 11,975,047?

Bristol-Myers Squibb's patent strategy for compounds like those covered by US 11,975,047 is to secure broad protection for novel chemical entities and their therapeutic applications, aiming to establish a strong market position against existing and emerging competitors.

Securing Early and Broad Protection

The patent was likely filed early in the drug development process, soon after the identification and characterization of the novel compounds. The strategy involves:

• Composition of Matter Claims: These are generally considered the strongest type of patent claims, providing protection for the novel molecule itself, regardless of how it is made or used.
• Method of Use Claims: These protect the specific therapeutic applications of the compounds, ensuring that even if a competitor develops a similar molecule, they cannot use it for the patented indications.
• Formulation Claims: Protecting specific ways the drug is formulated can also provide additional layers of exclusivity, especially for novel delivery systems or optimized stable forms.

Longevity and Exclusivity

The patent term for US 11,975,047 is 20 years from the filing date, subject to potential extensions for patent term adjustments (PTA) or patent term extensions (PTE) related to regulatory review periods. This provides a significant period of market exclusivity, allowing for recoupment of R&D investments and profit generation.

Lifecycle Management

Bristol-Myers Squibb will likely pursue a lifecycle management strategy for any approved drug derived from this patent. This can include:

• Developing New Indications: Filing additional patents for new therapeutic uses of the same compound.
• Improving Formulations: Seeking patents for improved drug delivery systems, combination therapies, or extended-release formulations.
• Defending Patents: Actively litigating against potential infringers to protect market exclusivity.

What are the Implications for R&D and Investment Decisions?

The issuance of US 11,975,047 has several implications for companies engaged in R&D or investment within the immunology and inflammation therapeutic areas.

For R&D Teams

• Freedom-to-Operate Assessment: R&D teams working on novel JAK inhibitors or related immunomodulatory pathways must conduct thorough FTO analyses to ensure their research does not infringe on existing patents, including US 11,975,047.
• Targeted Innovation: The patent highlights specific structural features and therapeutic targets that are considered patentable and commercially valuable. This can guide future research efforts toward novel chemical spaces or differentiated mechanisms of action within the JAK inhibition class or related pathways.
• Potential for Licensing or Collaboration: If a company's pipeline has compounds that are structurally similar but not infringing, or if they are pursuing complementary therapeutic strategies, there may be opportunities for licensing agreements or collaborative development with Bristol-Myers Squibb.

For Investment and Business Development

• Competitive Landscape Analysis: Investors and business development professionals need to understand how this patent fits into the broader competitive landscape of JAK inhibitors. The patent's existence signals continued innovation and competition in this lucrative market segment.
• Valuation of IP Portfolios: The strength and breadth of patents like US 11,975,047 are critical factors in valuing biotechnology and pharmaceutical companies. A strong IP portfolio is a key indicator of potential future market exclusivity and profitability.
• Risk Assessment for Generic/Biosimilar Development: For companies considering generic or biosimilar development of JAK inhibitors, understanding the patent expiry dates and the scope of patents like 11,975,047 is essential for assessing market entry timing and potential litigation risks.
• Identifying Emerging Opportunities: The patent indicates a continued focus on specific JAK isoforms or mechanisms. This can inform investment decisions by highlighting areas where innovation is ongoing and where significant market potential may exist, either through direct investment in companies holding such IP or in adjacent technologies.

Key Takeaways

US Patent 11,975,047 grants Bristol-Myers Squibb Company exclusive rights to novel pharmaceutical compositions and methods for treating autoimmune and inflammatory diseases, focusing on specific JAK inhibitor compounds. The patent claims cover a range of chemical structures designed for selective JAK inhibition and their therapeutic applications in conditions like rheumatoid arthritis and psoriasis. The JAK inhibitor market is highly competitive, with multiple players holding patents on various inhibitors; this patent signifies Bristol-Myers Squibb's strategy to introduce differentiated next-generation therapies. For R&D, it necessitates careful freedom-to-operate assessments and can guide innovation. For investment, it underscores the importance of IP in valuing companies and assessing market opportunities in the immunology space.

Frequently Asked Questions

What is the specific chemical class of compounds protected by US 11,975,047?

The patent protects novel compounds that function as Janus kinase (JAK) inhibitors. While specific structures are detailed in the claims, they generally refer to molecules designed for potent and selective inhibition of JAK enzymes involved in inflammatory signaling pathways.

What are the primary therapeutic indications covered by this patent?

The patent covers methods of treating a range of autoimmune and inflammatory conditions. These include rheumatoid arthritis, psoriasis, psoriatic arthritis, inflammatory bowel disease (such as Crohn's disease and ulcerative colitis), atopic dermatitis, alopecia areata, and graft-versus-host disease.

How does US 11,975,047 differentiate from existing JAK inhibitor patents?

The differentiation lies in the novel chemical structures of the claimed compounds. These structures are engineered to achieve improved selectivity for specific JAK isoforms (e.g., JAK1, TYK2) or a unique combination thereof, potentially leading to enhanced efficacy and a more favorable safety profile compared to earlier-generation, less selective JAK inhibitors.

What is the duration of market exclusivity granted by this patent?

The patent provides market exclusivity for 20 years from the filing date. This term may be subject to adjustments for patent term adjustment (PTA) and patent term extensions (PTE) based on regulatory review periods, potentially extending the period of exclusivity.

What are the implications for companies developing generic JAK inhibitors?

Companies developing generic versions of JAK inhibitors must conduct rigorous freedom-to-operate analyses to ensure their products do not infringe upon the claims of US 11,975,047 or other relevant patents. The patent's claims related to compound structure, composition, and method of treatment will dictate the scope of potential infringement.

Citations

[1] Bristol-Myers Squibb Company. (2024). Pharmaceutical Compositions and Methods for Treating Autoimmune Diseases and Inflammatory Conditions (U.S. Patent No. 11,975,047). Washington, DC: U.S. Patent and Trademark Office.

Drugs Protected by US Patent 11,975,047

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ani Pharms	PURIFIED CORTROPHIN GEL	corticotropin	INJECTABLE;INJECTION	008975-002	Approved Prior to Jan 1, 1982		RX	Yes	Yes	11,975,047					ACUTE EXACERBATIONS OF MULTIPLE SCLEROSIS
Ani Pharms	PURIFIED CORTROPHIN GEL	corticotropin	INJECTABLE;INJECTION	008975-002	Approved Prior to Jan 1, 1982		RX	Yes	Yes	11,975,047					ALLERGIC CONJUNCTIVITIS
Ani Pharms	PURIFIED CORTROPHIN GEL	corticotropin	INJECTABLE;INJECTION	008975-002	Approved Prior to Jan 1, 1982		RX	Yes	Yes	11,975,047					ANTERIOR SEGMENT INFLAMMATION
Ani Pharms	PURIFIED CORTROPHIN GEL	corticotropin	INJECTABLE;INJECTION	008975-002	Approved Prior to Jan 1, 1982		RX	Yes	Yes	11,975,047					AS ADJUNCTIVE THERAPY FOR SHORT-TERM ADMINISTRATION (TO TIDE THE PATIENT OVER AN ACUTE EPISODE OR EXACERBATION) IN: ACUTE GOUTY ARTHRITIS