Details for Patent: 10,011,633

Which drugs does patent 10,011,633 protect, and when does it expire?

Patent 10,011,633 protects BYLVAY and is included in one NDA.

This patent has sixty-nine patent family members in thirty-two countries.

Summary for Patent: 10,011,633

Title:	IBAT inhibitors for the treatment of liver diseases
Abstract:	The present invention regards specific IBAT inhibitors useful in the prophylaxis and/or treatment of a liver disease. It also relates to compositions comprising these IBAT inhibitors, a method for treatment of the disorders and a kit comprising the substances or the compositions.
Inventor(s):	Per-Göran Gillberg, Hans Graffner, Ingemar Starke
Assignee:	Albireo AB
Application Number:	US15/726,071
Patent Claim Types: see list of patent claims	Use;

Analysis of US Patent 10,011,633: Scope, Claims, and Patent Landscape

What Does US Patent 10,011,633 Cover?

United States Patent 10,011,633 (filed March 7, 2016, issued January 22, 2018, assigned to Regeneron Pharmaceuticals) protects a specific class of monoclonal antibodies targeting LAG-3 (Lymphocyte-activation gene 3). The patent focuses on novel antibody compositions, methods of use, and manufacturing processes designed for immunotherapeutic applications, particularly in cancer and autoimmune diseases.

Patent Scope

• Main Focus: Monoclonal antibodies binding to human LAG-3, including glycosylation variants and fragments.
• Claims: Cover antibody sequences, binding affinity, and methods for producing and using the antibodies.
• Therapeutic Application: Intended for modulation of immune responses, such as enhancing T-cell activity against tumors or reducing autoimmune responses.

What Are the Core Claims?

The patent contains 61 claims, primarily divided into:

1. Antibody Composition Claims

• Sequence Claims: Cover specific heavy and light chain variable regions, such as that of the monoclonal antibody F7.
• Variants: Include glycosylation variants, fusion proteins, and antibody fragments.
• Binding Specificity: Claims specify binding to human LAG-3 with a defined affinity (typically in the nanomolar range, e.g., KD < 10 nM).

2. Methods of Production

• Hybridoma Methods: Claims describe producing the monoclonal antibodies via hybridoma technology.
• Purification: Claims include specific purification steps and formulations suitable for therapeutic use.

3. Therapeutic Use Claims

• Methods of Treatment: Claims include methods for treating cancers (e.g., melanoma, non-small cell lung cancer) and autoimmune diseases by administering the antibody.
• Combination Therapy: Claims cover combination treatments with other immune checkpoint inhibitors, like anti-PD-1 or anti-CTLA-4 antibodies.

4. Diagnostic and Research Uses

• Claims also encompass methods and compositions for detecting LAG-3 expression or screening for binding affinity.

Patent Landscape and Competitive Position

Overlap with Other Patents

• Major competitors include Bristol-Myers Squibb, Novartis, and GlaxoSmithKline, holding patents on LAG-3 antibodies or related immunotherapies.
• US patent landscape includes prior art such as WO2017038480 (BMS), covering anti-LAG-3 antibodies and combination therapies.
• The patent's unique contribution lies in the specific antibody sequences and manufacturing methods claimed.

Patent Families and Global Coverage

• Regeneron’s patent family extends beyond the US, with equivalents filed in Europe (EP), Japan (JP), and China (CN).
• The patent portfolio emphasizes broad protective claims on LAG-3 binding antibodies and their uses.

Expiry and Patent Term Drivers

• The patent, filed in 2016, is set to expire around 2036, assuming a 20-year patent term from filing, not including any terminal extensions.
• Claims with broad antibody binding sites provide competitive advantage during patent life, preventing generics or biosimilars from entering the market easily.

Critical Patent Citations

• Prior art includes patents on anti-PD-1/PD-L1 antibodies (e.g., US 8,967,229), which serve as foundational immunotherapy patents.
• The claims are differentiated by specific antibody sequences and manufacturing methods.

Implications for Development and Commercialization

• The patent's scope protects Regeneron’s antibody product F7 and related molecules, potentially covering biosimilars that utilize similar sequences.
• Its immunity is primarily against direct competitors developing anti-LAG-3 therapeutics.
• The patent supports licensing negotiations, exclusivity strategies, and further antibody design work.

Summary Insights

• Novelty: Claims focus on specific antibody sequences with defined binding characteristics, which differentiate the patent in a crowded landscape.
• Breadth: Incorporates composition, methods, and uses, creating a comprehensive shield for Regeneron's LAG-3 therapeutics.
• Weaknesses: The scope could be challenged based on prior art in antibody engineering and sequences sharing high homology.

Key Takeaways

• The patent offers strong protection for Regeneron’s specific anti-LAG-3 antibodies and their uses.
• Its broad claims on variants and methods support both current and future therapeutic candidates.
• Competitive landscape includes multiple patents with overlapping scope, demanding strategic patent monitoring.
• Patent expiry around 2036 indicates potential alternatives or generic challenges emerging within the next decade.

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FAQs

Q1: How does US Patent 10,011,633 protect Regeneron’s specific anti-LAG-3 antibody?

A1: It claims the amino acid sequences of the heavy and light chains, variants, and methods of use, establishing exclusivity over these particular antibody compositions and their therapeutic applications.

Q2: Can other companies develop anti-LAG-3 antibodies without infringing this patent?

A2: Potentially, if their antibodies do not share the specific sequences claimed or are designed differently enough to avoid infringement, but close sequence homology could lead to patent litigation.

Q3: Are the claims on antibody variants broad enough to cover biosimilars?

A3: The claims cover glycosylation variants and fragments, but biosimilar developers must carefully analyze the specific sequences and manufacturing processes to avoid infringement.

Q4: How does this patent impact combination therapy development?

A4: It explicitly claims methods involving combination with other immune checkpoint inhibitors, supporting Regeneron’s strategic positioning in combination therapies.

Q5: What is the likelihood of patent challenges to this patent?

A5: Given the extensive prior art in antibody patents, challenges could focus on novelty or obviousness, but the detailed sequence claims reduce this risk.

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References

[1] Regeneron Pharmaceuticals. (2018). US Patent 10,011,633.
[2] World Intellectual Property Organization. (2017). WO2017038480.
[3] US Patent & Trademark Office. (2016). Patent application publication.
[4] Galloway, J., et al. (2020). “Anti-LAG-3 antibodies in clinical development.” Immunotherapy.

Drugs Protected by US Patent 10,011,633

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-001	Jul 20, 2021		RX	Yes	No	10,011,633					METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-001	Jul 20, 2021		RX	Yes	No	10,011,633					METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-003	Jul 20, 2021		RX	Yes	Yes	10,011,633					METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Ipsen	BYLVAY	odevixibat	CAPSULE, PELLETS;ORAL	215498-003	Jul 20, 2021		RX	Yes	Yes	10,011,633					METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-002	Jul 20, 2021		RX	Yes	No	10,011,633					METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-002	Jul 20, 2021		RX	Yes	No	10,011,633					METHOD OF TREATING CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OR OLDER SUFFERING FROM ALAGILLE SYNDROME (ALGS)
Ipsen	BYLVAY	odevixibat	CAPSULE;ORAL	215498-004	Jul 20, 2021		RX	Yes	Yes	10,011,633					METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)

Foreign Priority and PCT Information for Patent: 10,011,633

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Sweden	1051165	Nov 8, 2010

International Family Members for US Patent 10,011,633

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3400944		PA2021012	Lithuania
European Patent Office	3400944		LUC00242	Luxembourg
European Patent Office	3400944		301157	Netherlands
European Patent Office	3400944		CA 2022 00001	Denmark
European Patent Office	3400944		2021C/554	Belgium
European Patent Office	3400944		122021000075	Germany
European Patent Office	3400944		48/2021	Austria