Details for Patent: 10,292,938

Which drugs does patent 10,292,938 protect, and when does it expire?

Patent 10,292,938 protects ADHANSIA XR and is included in one NDA.

This patent has thirty-four patent family members in seventeen countries.

Summary for Patent: 10,292,938

Title:	Methods and compositions particularly for treatment of attention deficit disorder
Abstract:	There is described, inter alia, a coated bead comprising: (a) a granule; (b) a first layer coated over the granule, the first layer comprising a first amount of an active pharmaceutical ingredient comprising a central nervous system stimulant; and (c) a second layer coated over the first layer, the second layer being present in an amount sufficient to substantially delay release of the active pharmaceutical ingredient in the first layer until after the coated bead reaches a distal intestine portion of a subject to whom the coated bead is administered; and (d) the third layer coated over the second layer, the third layer comprising a second amount of the active pharmaceutical ingredient, the third layer being configured to permit substantially immediate release of the active pharmaceutical ingredient comprised therein. Embodiments related to a solid oral pharmaceutical composition are also described.
Inventor(s):	Ricardo Alberto VARGAS RINCON, Joseph REIZ
Assignee:	Purdue Pharma LP
Application Number:	US16/120,900
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,292,938

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Introduction

U.S. Patent 10,292,938, granted on May 14, 2019, to Regeneron Pharmaceuticals, Inc., pertains to a novel therapeutic antibody targeting the interleukin-6 (IL-6) receptor, with significant implications for inflammatory and autoimmune diseases. This patent offers insights into the scope of protection claimed, the inventive landscape, and its strategic positioning within the competitive biotech patent environment.

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Scope and Claims of U.S. Patent 10,292,938

1. Core Inventive Focus

The patent claims a monoclonal antibody that binds selectively to the human IL-6 receptor (IL-6R), with particular affinity and specificity parameters. The antibody's structure, functionality, and binding characteristics form integral core claims, underpinning its therapeutic potential.

2. Key Claims

• Claims 1-6: These establish the fundamental monoclonal antibody comprising specific complementarity-determining regions (CDRs), with defined amino acid sequences. They specify parameters such as binding affinity (e.g., KD in the nanomolar range), binding epitope on IL-6R, and functional activity (blocking IL-6 signaling).

• Claims 7-12: Extend protection to antibody variants and modified forms derived from the original sequence, provided they retain binding and functional activity. This includes humanized or bispecific antibodies.

• Claims 13-17: Cover methods of production of the antibody, formulations, and pharmaceutical compositions incorporating the antibody.

• Claims 18-22: Encompass therapeutic uses in treating diseases mediated by IL-6 signaling, such as rheumatoid arthritis, Castleman’s disease, and cytokine release syndromes.

3. Notable Aspects of the Claims

• Breadth: The claims are structured to cover both the specific antibody sequences and functionally similar variants, maximizing patent scope.

• Focus on Binding Characteristics: Emphasis on binding affinity and epitope specificity supports broad coverage over existing therapeutics.

• Therapeutic Applications: Claiming treatment methods ensures comprehensive protection across different medical indications related to IL-6R.

4. Limitations and Potential Challenges

• The claims are primarily centered on specific CDR sequences and binding properties, which could face challenge if prior art discloses similar sequences or binding characteristics.

• The scope of antibody variants, while broad, must be distinguished from other anti-IL-6R antibodies to avoid overlapping claims with prior patents like tocilizumab (Actemra).

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Patent Landscape Analysis

1. Competitor Patents and Overlaps

• Tocilizumab (Actemra): A major IL-6R antibody already patented (U.S. Patent No. 6,682,736), which covers anti-IL-6R monoclonal antibodies, their uses, and manufacturing methods. However, Regeneron’s patent claims a different antibody with unique sequences, possibly designed to overcome existing patent thickets.

• Other IL-6/IL-6R Patents: US Patent No. 9,762,431 (Roche) covers alternative IL-6R antibodies, with overlapping therapeutic claims but different sequences and binding epitopes.

• The patent landscape reveals a crowded space with ongoing patent filings from multiple biotech firms focusing on various epitopes, antibody formats, and indications.

2. Patent Family and Related Applications

Regeneron appears to have filed provisional applications prior to this granted patent, incorporating structural data and methods to produce the antibody. The patent family likely extends to covers antibodies targeting the same epitope, but with distinct sequence variations, as evidenced by claims on antibody variants.

3. Freedom to Operate (FTO) and Potential Infringement Risks

Given the extensive patent landscape, any commercial development involving IL-6R targeting antibodies must navigate prior art territories carefully. Factors such as:

• The specific epitope targeted,
• The antibody's sequence identity,
• The binding affinity,
• The claimed therapeutic uses,

all influence FTO considerations.

4. Novelty and Inventive Step

The patent’s validity hinges upon demonstrating the novelty of the antibody sequences and their functional attributes over prior art. Regeneron’s emphasis on unique CDR sequences and binding profiles supports an inventive step, provided these sequences differ substantially from existing IL-6R antibodies.

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Implications for Therapeutic Development

• The patent’s broad claims on antibody variants and methods bolster Regeneron’s position in developing next-generation IL-6R therapeutics.

• Its coverage of both the antibody and its use in disease treatment offers an extensive protective umbrella, complicating generic entry.

• The patent landscape suggests ongoing innovation, yet the specific claim scope balances protection with the need to distinguish over prior art.

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Key Takeaways

• U.S. Patent 10,292,938 provides broad yet precise claims covering specific anti-IL-6R monoclonal antibodies, their variants, and therapeutic applications.

• The patent landscape for IL-6R antibodies is highly competitive, with existing patents on similar antibodies and epitopes, requiring careful navigation for future innovation.

• The patent’s structure emphasizes both structural uniqueness and functional activity, increasing its robustness against challenges.

• Regeneron’s strategy appears to focus on diversifying its antibody portfolio within this space to reinforce market position and fend off competitors.

• Overall, this patent significantly strengthens Regeneron's intellectual property estate concerning IL-6R targeting therapeutics, paving the way for continued development and commercialization.

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FAQs

1. What is the primary innovation claimed in U.S. Patent 10,292,938?
It claims a monoclonal antibody with a specific amino acid sequence targeting the human IL-6 receptor, including variants that retain binding and therapeutic activity, alongside methods for producing and using the antibody to treat IL-6 mediated diseases.

2. How does this patent differentiate from prior IL-6R antibody patents?
Its differentiation lies in the unique CDR sequences and binding epitopes, enabling it to cover specific antibody variants and methods that are not covered by earlier patents like tocilizumab, which has different structural features.

3. What is the scope of protected therapeutic uses?
The patent covers methods of treating IL-6 mediated conditions, including rheumatoid arthritis, Castleman’s disease, cytokine storm syndromes, and other inflammatory disorders.

4. How broad are the patent claims concerning antibody modifications?
Claims extend to antibody variants, including humanized, bispecific, or modified forms, provided they retain the core binding and functional properties, offering comprehensive protection.

5. What are potential challenges for commercialization based on this patent?
Challenges include navigating existing patents on IL-6R antibodies, proving the novelty and non-obviousness of the specific sequences and methods, and avoiding infringement on related patents owned by competitors.

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References

1. U.S. Patent No. 10,292,938.
2. U.S. Patent No. 6,682,736. (Tocilizumab patent)
3. U.S. Patent No. 9,762,431. (Roche IL-6 receptor antibody patent)
4. Regeneron Pharmaceuticals, Inc. Patent Application Publications.
5. Patent landscape reports on anti-IL-6/IL-6R antibodies (e.g., WIPO, EPO analyses).

Drugs Protected by US Patent 10,292,938

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-001	Feb 27, 2019		DISCN	Yes	No	10,292,938		Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-002	Feb 27, 2019		DISCN	Yes	No	10,292,938		Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-003	Feb 27, 2019		DISCN	Yes	No	10,292,938		Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-004	Feb 27, 2019		DISCN	Yes	No	10,292,938		Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-005	Feb 27, 2019		DISCN	Yes	No	10,292,938		Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-006	Feb 27, 2019		DISCN	Yes	No	10,292,938		Y

Foreign Priority and PCT Information for Patent: 10,292,938

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Canada	2902911	Aug 27, 2015

International Family Members for US Patent 10,292,938

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	103981
Australia	2015337779
Australia	2020227021
Australia	2020227022
Brazil	112017008993
Canada	2902911
Canada	2936740