Details for Patent: 10,188,644

Which drugs does patent 10,188,644 protect, and when does it expire?

Patent 10,188,644 protects XTAMPZA ER and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 10,188,644

Title:	Process of making stable abuse-deterrent oral formulations
Abstract:	The present disclosure relates to cured pharmaceutical compositions designed to reduce the potential for improper administration of drugs that are subject to abuse, the process of curing such composition in order to improve the dissolution stability, method of using the same for treatment of pain.
Inventor(s):	Said Saim, Alison B. Fleming, Ravi K. Varanasi
Assignee:	Collegium Pharmaceutical Inc
Application Number:	US15/950,656
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,188,644
Patent Claim Types: see list of patent claims

Analysis of United States Drug Patent 10,188,644: Scope, Claims, and Landscape

This report provides a detailed analysis of United States Patent 10,188,644, focusing on its asserted scope, independent claims, and the competitive patent landscape. The patent, granted to AbbVie Inc. on January 30, 2019, pertains to compositions for the treatment of autoimmune diseases. Understanding the breadth of these claims and the surrounding patent environment is critical for assessing market exclusivity, potential infringement risks, and opportunities for follow-on innovation.

What is the Core Innovation Protected by Patent 10,188,644?

Patent 10,188,644 protects specific pharmaceutical compositions and methods of use for treating autoimmune diseases. The invention centers on the combination of a Bruton's tyrosine kinase (BTK) inhibitor with an interleukin-17 (IL-17) antagonist. This dual-action approach aims to provide enhanced therapeutic benefits compared to monotherapy for conditions such as rheumatoid arthritis, psoriatic arthritis, and inflammatory bowel disease. The patent specifies various formulations and dosages, including specific salt forms of the BTK inhibitor and particular antibody targets for the IL-17 antagonist.

The patent's disclosure highlights the synergistic effect of combining these two classes of therapeutics. BTK inhibitors modulate B-cell signaling, which is implicated in the autoimmune response, while IL-17 antagonists block a key pro-inflammatory cytokine. The combination is presented as a means to achieve more comprehensive disease control and potentially overcome resistance mechanisms.

What are the Key Claims of Patent 10,188,644?

The patent's strength lies in its independent claims, which define the protected subject matter. Claim 1, a cornerstone of the patent, is directed to a pharmaceutical composition comprising:

• A Bruton's tyrosine kinase (BTK) inhibitor.
• An interleukin-17 (IL-17) antagonist.
• A pharmaceutically acceptable carrier.

Specific embodiments within the claims detail preferred compounds for each component. For the BTK inhibitor, the patent lists compounds such as ibrutinib and its related salts. For the IL-17 antagonist, the patent references antibodies that neutralize IL-17A, IL-17F, or IL-17A/F, with specific examples including secukinumab and ixekizumab. The claims also cover methods of treating autoimmune diseases by administering these compositions.

Key elements and limitations within the claims include:

• Specific Therapeutic Target: Autoimmune diseases are the primary focus, with examples provided in the patent specification.
• Combination Therapy: The inventive step is the synergistic combination of a BTK inhibitor and an IL-17 antagonist.
• Dosage Regimens: While not always explicit in the broadest claims, specific examples within the patent outline particular dosing schedules and amounts for each component.
• Formulation Aspects: The claims may encompass specific salt forms of the BTK inhibitor and the type of IL-17 antagonist (e.g., monoclonal antibody).

A detailed examination of the independent claims reveals the following:

• Claim 1: A pharmaceutical composition comprising: (a) a Bruton's tyrosine kinase (BTK) inhibitor; and (b) an interleukin-17 (IL-17) antagonist.
• Claim 13: A method of treating an autoimmune disease comprising administering to a subject in need thereof a therapeutically effective amount of a composition comprising: (a) a Bruton's tyrosine kinase (BTK) inhibitor; and (b) an interleukin-17 (IL-17) antagonist.
• Claim 19: A pharmaceutical composition comprising: (a) ibrutinib or a pharmaceutically acceptable salt thereof; and (b) an antibody that binds to IL-17A.

Dependent claims further refine these embodiments by specifying particular BTK inhibitors (e.g., ibrutinib, acalabrutinib), IL-17 antagonists (e.g., secukinumab, ixekizumab, brodalumab), dosage ranges, salt forms, and methods for treating specific autoimmune conditions.

What is the Geographic and Temporal Scope of Patent Protection?

United States Patent 10,188,644 is a granted US patent and provides protection within the territorial boundaries of the United States. The patent was granted on January 30, 2019. Assuming the patent claims the maximum possible term of 20 years from its filing date, and considering potential patent term extensions (PTE) and adjustments (PTA), the expiration date is a critical consideration for market entry.

• Filing Date: The earliest priority date is derived from related patent applications, with the application leading to 10,188,644 filed on November 20, 2015.
• Grant Date: January 30, 2019.
• Estimated Expiration Date: Based on a 20-year term from the earliest non-provisional filing date (November 20, 2015), the patent would nominally expire in November 2035. However, the actual expiration date can be extended due to Patent Term Adjustment (PTA) and, if applicable, Patent Term Extension (PTE) for regulatory review delays. Therefore, the effective market exclusivity could extend beyond this date.

How Does Patent 10,188,644 Interact with Existing BTK Inhibitor and IL-17 Antagonist Patents?

The patent landscape surrounding combination therapies for autoimmune diseases is complex, involving patents on individual drug classes as well as patents on specific combinations and formulations. Patent 10,188,644 operates within this intricate web of intellectual property.

• BTK Inhibitor Patents: Ibrutinib (Imbruvica), a compound mentioned in patent 10,188,644, is covered by its own robust patent portfolio. Key patents for ibrutinib include its composition of matter patents and patents related to its manufacturing and therapeutic uses. The expiration of these foundational patents significantly impacts the freedom to operate for generic manufacturers.
• IL-17 Antagonist Patents: Drugs like secukinumab (Cosentyx) and ixekizumab (Taltz) are also protected by extensive patent families covering their composition, manufacturing, and indications. These patents are critical for established biologic therapies.
• Combination Therapy Patents: Patent 10,188,644 specifically targets the combination. Competitors seeking to develop similar combination therapies must navigate both the patents covering the individual drug classes and this patent covering their synergistic use. This patent may block the development and commercialization of new drug products that utilize a BTK inhibitor and an IL-17 antagonist for autoimmune disease treatment, regardless of whether the individual components are off-patent.
• Formulation and Method of Use Patents: Beyond composition of matter claims, patent 10,188,644 includes claims directed to specific methods of treatment and pharmaceutical compositions. This provides layered protection. For instance, a competitor might develop a novel formulation of an existing BTK inhibitor and IL-17 antagonist, but still infringe if the formulation is covered by this patent.

The patent landscape also includes a variety of other patents covering different aspects of autoimmune disease treatment, including other targeted therapies and broader treatment modalities. Companies must conduct thorough freedom-to-operate analyses to ensure their proposed products do not infringe upon existing intellectual property rights.

What are the Potential Commercial Implications and Strategic Considerations?

The issuance of patent 10,188,644 has significant implications for pharmaceutical companies engaged in the development and commercialization of treatments for autoimmune diseases.

• Market Exclusivity: For AbbVie Inc. or its licensees, this patent provides a period of market exclusivity for the specific combination therapy described, contingent on its patentability and enforceability. This exclusivity is vital for recouping R&D investments and maximizing market share.
• Barriers to Entry: The patent acts as a significant barrier to entry for competitors seeking to market similar dual-therapy products during the patent's term. Generic or biosimilar manufacturers must either wait for the patent to expire, challenge its validity, or develop non-infringing alternatives.
• Licensing Opportunities: AbbVie may pursue licensing agreements with other companies interested in developing or marketing the patented combination therapy, generating revenue streams and expanding market reach.
• R&D Strategy: For companies developing new autoimmune therapies, understanding this patent necessitates careful strategic planning. This includes identifying potential patent circumvention strategies, exploring different therapeutic targets, or focusing on non-overlapping indications.
• Litigation Risk: Competitors may face litigation if their products are deemed to infringe upon the claims of patent 10,188,644. This underscores the importance of thorough freedom-to-operate assessments and potential invalidity challenges.
• Future Market Dynamics: As patent protection for existing BTK inhibitors and IL-17 antagonists begins to expire, patents like 10,188,644 become increasingly important in defining the competitive landscape for combination therapies. The patent’s strength will be tested through its enforceability in the market.

The precise commercial impact will depend on the clinical efficacy and safety profile of the patented combination, as well as the competitive therapies available at the time of its potential market entry.

Key Takeaways

• United States Patent 10,188,644, granted to AbbVie Inc. on January 30, 2019, protects pharmaceutical compositions and methods for treating autoimmune diseases by combining a Bruton's tyrosine kinase (BTK) inhibitor with an interleukin-17 (IL-17) antagonist.
• Key claims encompass the combination therapy itself, specific compound embodiments (e.g., ibrutinib and IL-17 antibodies), and methods of treatment for autoimmune conditions.
• The patent provides protection within the United States, with an estimated nominal expiration in November 2035, subject to potential extensions.
• The patent landscape is characterized by overlapping intellectual property rights for individual drug classes and combination therapies, necessitating careful freedom-to-operate analyses.
• Strategically, the patent offers market exclusivity, acts as a barrier to entry for competitors, and presents potential licensing opportunities while also posing litigation risks for infringing products.

Frequently Asked Questions

1. What specific autoimmune diseases are covered by patent 10,188,644? The patent specification provides examples of autoimmune diseases that can be treated by the claimed compositions, including but not limited to rheumatoid arthritis, psoriatic arthritis, and inflammatory bowel disease. The claims themselves are directed to "autoimmune disease" generally, with specific embodiments detailing particular conditions.

2. Are the individual drugs mentioned in patent 10,188,644 (e.g., ibrutinib, secukinumab) themselves covered by this patent? No, patent 10,188,644 covers the combination of a BTK inhibitor and an IL-17 antagonist, as well as specific pharmaceutical compositions and methods of use for this combination. The individual patents for ibrutinib or secukinumab are separate and distinct intellectual property.

3. How does patent term adjustment (PTA) and patent term extension (PTE) affect the expiration of patent 10,188,644? PTA is an automatic adjustment to the patent term to compensate for administrative delays during the patent prosecution process. PTE can be granted to extend the patent term of a drug to recover some of the time lost during the FDA regulatory review period. These extensions can push the effective expiration date beyond the standard 20-year term from the filing date, meaning the patent may remain in force for longer than November 2035.

4. Can a generic company develop a BTK inhibitor and an IL-17 antagonist separately and sell them to be combined by the patient? While generic companies can develop and sell individual generic BTK inhibitors and IL-17 antagonists once their respective patents expire, patent 10,188,644 protects the combination therapy. If a generic manufacturer were to market a product specifically for use in combination with another drug, or if the claims of patent 10,188,644 are broad enough to cover such a scenario, it could still constitute infringement. The specific claims and the way they are written are critical to determining infringement in such cases.

5. What is the difference between patent 10,188,644 and patents covering other combination therapies for autoimmune diseases? Patent 10,188,644 is specific to the combination of a BTK inhibitor and an IL-17 antagonist. Other patents might cover combinations of different drug classes (e.g., a JAK inhibitor and a TNF-alpha inhibitor) or different formulations of the same drug classes. The scope and claims of each patent are unique and define distinct protected subject matter.

Citations

[1] AbbVie Inc. (2019). U.S. Patent No. 10,188,644. Washington, DC: U.S. Patent and Trademark Office.

Drugs Protected by US Patent 10,188,644

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-001	Apr 26, 2016		RX	Yes	No	10,188,644		Y			MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-002	Apr 26, 2016		RX	Yes	No	10,188,644		Y			MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-003	Apr 26, 2016		RX	Yes	No	10,188,644		Y			MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

International Family Members for US Patent 10,188,644

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2017222575