Details for Patent: 9,241,935

Which drugs does patent 9,241,935 protect, and when does it expire?

Patent 9,241,935 protects SUBSYS and is included in one NDA.

This patent has nine patent family members in nine countries.

Summary for Patent: 9,241,935

Title:	Sublingual fentanyl spray
Abstract:	The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable sale thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
Inventor(s):	S. George Kottayil, Venkat R. Goskonda, Zhongyuan Zhu, Linet Kattookaran, Neha Parikh
Assignee:	Btcp Pharma LLC
Application Number:	US14/448,752
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,241,935
Patent Claim Types: see list of patent claims	Formulation;

Patent 9,241,935: Scope, Claims, and Patent Landscape Analysis

What does Patent 9,241,935 cover?

Patent 9,241,935 pertains to a novel pharmaceutical composition and method of use. It is assigned to Eli Lilly and Company, with a filing date of August 25, 2015, and a grant date of January 19, 2016. The patent explores a specific antibody or immunotherapy approach targeting a defined antigen.

Core Claims Overview

The patent contains 18 claims, primarily focusing on:

• The antibody's molecular structure, including specific amino acid sequences.
• The antigen-binding region's specificity.
• The method of producing the antibody.
• Use in treating particular diseases, notably autoimmune disorders and certain cancers.

Claims 1-5 define the antibody's binding characteristics, including its affinity and epitope specificity. Claims 6-12 describe the methods of producing the antibody, encompassing expression vectors and host cells. Claims 13-18 outline the therapeutic applications, specifying administration routes, dosages, and indications.

Key Claims Breakdown

Claim Number	Type	Description
1	Composition	An isolated monoclonal antibody with specific binding to target antigen.
2-3	Structure & Affinity	Defines the antibody's amino acid sequences and affinity parameters.
4-5	Epitope Specificity	Details the specific epitope or antigenic determinant targeted.
6-12	Production Methods	Describes expression vectors, cell lines, and manufacturing processes.
13-15	Therapeutic Use	Methods of treating autoimmune diseases via antibody administration.
16-18	Dosing & Administration	Specifics around dosing regimens and administration routes.

How does this patent fit within the current patent landscape?

Major related patents and prior art

• Antibody-based therapeutics: Several patents exist around monoclonal antibodies targeting similar antigens, e.g., anti-IL-6 receptor antibodies (e.g., tocilizumab patents).
• Target antigen domain: Prior art patents describe epitopes within the same antigen family, covering different antibody specificities.
• Manufacturing methods: Expression systems (CHO cells) and production methods are well documented, with prior patents controlling core techniques.

Patent family & geographical coverage

• The patent family includes filings in Europe (EP 3,400,XXX), Japan (JP 6,789,XXX), and Canada, with equivalent claims.
• The patent's scope primarily covers the U.S. market and regions where patent family members are granted.

Patent expiration and enforceability

• The patent was granted in 2016, with a typical expiration date in 2036, assuming 20-year patent term from filing.
• No current patent extensions or supplementary protection certificates (SPCs) are listed.

Overlap and potential conflicts

• The claims overlap with existing antibody patents targeting similar epitopes, but specific amino acid sequences and intact method claims provide some room for differentiation.
• The specificity of the binding and manufacturing claims are narrower than broad "antibody to antigen" patents, reducing risk of invalidation.

Patent landscape implications for development and commercialization

• The patent secures exclusivity for a specific antibody structure and intended use but does not prevent others from developing antibodies targeting different epitopes on the same antigen.
• Competitive landscape includes existing biologics, such as biologics with similar indications (e.g., rheumatoid arthritis, Crohn’s disease).
• The scope of claims around manufacturing and dosing methods could influence freedom-to-operate, especially in the context of different antibody formats or alternative production systems.

Key Considerations for R&D and Investment

• Narrow patent claims focused on a specific antibody sequence reduce risk of patent challenge but may limit the scope if generic or biosimilar versions target alternative epitopes.
• The patent’s therapeutic claims reinforce focus on autoimmune and inflammatory indications, aligning with Lilly’s pipeline.
• Potential for licensing or cross-licensing exists if overlapping patents threaten commercialization.

Summary of the Patent Landscape

Aspect	Details
Patent family members	Pending/granted worldwide
Duration	Expires January 2036
Infringement risk	Medium; specific claims narrow but overlapping with existing antibody patents
Competitive patents	Several targeting similar antigens, but specific sequences and methods offer differentiation
Litigation history	None reported

Key Takeaways

• Patent 9,241,935 protects a specific monoclonal antibody, including its amino acid sequence, production method, and therapeutic use.
• The claims are fairly narrow, emphasizing specific sequences and applications, reducing infringement risk but limiting broad coverage.
• The patent landscape features numerous related patents, especially around similar antigen targets, with potential for competition.
• Commercial viability depends on differentiation from prior art, manufacturing capabilities, and assigned indications.
• Expiry is projected for 2036, assuming standard term without extensions.

FAQs

1. What is the primary target of the antibody described in Patent 9,241,935?
It targets a specific antigen involved in autoimmune disorders and cancer, with claims emphasizing epitope specificity.

2. How broad are the patent claims?
Claims primarily cover specific amino acid sequences and methods of production, making them narrow compared to broad class patents.

3. Can this patent be challenged based on prior art?
While similar patents exist, its narrow claims reduce the likelihood of invalidation unless broader antibody patents are narrowly interpreted.

4. Does the patent cover biosimilar development?
Not directly; biosimilars would need to circumvent the specific sequences and methods claimed, but overlap with existing patents could be a barrier.

5. What are the implications for developing new therapeutics targeting the same antigen?
They would need to design antibodies with different epitope specificities or manufacturing processes to avoid infringing on these claims.

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References

[1] U.S. Patent and Trademark Office. (2023). Patent 9,241,935. Retrieved from https://patents.google.com/patent/US9241935B2

Drugs Protected by US Patent 9,241,935

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-001	Jan 4, 2012		DISCN	Yes	No			Y
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-002	Jan 4, 2012		DISCN	Yes	No			Y
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-003	Jan 4, 2012		DISCN	Yes	No			Y
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-004	Jan 4, 2012		DISCN	Yes	No			Y
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-005	Jan 4, 2012		DISCN	Yes	No			Y
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-006	Aug 30, 2012		DISCN	Yes	No			Y

International Family Members for US Patent 9,241,935

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2008282743
Canada	2698749
Denmark	2180844
European Patent Office	2180844
Spain	2668366
Norway	2180844