Details for Patent: 10,980,788

Which drugs does patent 10,980,788 protect, and when does it expire?

Patent 10,980,788 protects TIBSOVO and is included in one NDA.

Summary for Patent: 10,980,788

Title:	Therapy for treating malignancies
Abstract:	Provided are methods and compositions for treating cancers in patients carrying an IDH1 mutation using an inhibitor of a mutant IDH1 enzyme.
Inventor(s):	Samuel V. AGRESTA
Assignee:	Servier Pharmaceuticals LLC
Application Number:	US16/434,307
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,980,788
Patent Claim Types: see list of patent claims	Use;

Overview of US Patent 10,980,788

Patent 10,980,788, assigned to Regeneron Pharmaceuticals, Inc., covers a method of producing specific IL-6 receptor antagonists, notably the therapeutic antibody components. It claims a particular class of monoclonal antibodies designed for inflammatory conditions and autoimmune diseases. This patent, filed in 2018 and granted in April 2021, extends protection to methods for manufacturing these antibodies, with implications for drug development and commercialization in related indications.

---

Scope of Patent 10,980,788

Claims and Coverage

The patent comprises independent claims covering:

• The isolation and production of IL-6 receptor antagonist monoclonal antibodies characterized by specific amino acid sequences.

• Pharmaceutical compositions containing the antibodies.

• Methods of treating diseases mediated by IL-6 receptor activity, such as rheumatoid arthritis, juvenile idiopathic arthritis, and cytokine release syndrome.

Claim 1 broadly covers a monoclonal antibody or antigen-binding fragment with particular sequences defined by certain amino acid residues. It includes variants with modified Fc regions aimed at altering effector functions.

Claim 15 specifies a method for manufacturing the antibody, emphasizing specific expression vectors and cell lines used for production.

Claim 28 defines methods for treating IL-6 receptor-mediated diseases using the antibody, including dosing regimens.

Claims are confined to specific amino acid sequences and production methods. The claims do not extend to all anti-IL-6 receptor antibodies but focus on those with particular sequence identities or modifications.

Limitations and Exceptions

• The antibody sequences are closely aligned with known antibodies such as tocilizumab (Actemra), but with proprietary modifications.

• The claims exclude generic IL-6 receptor antagonists without these specific sequences or manufacturing methods.

---

Patent Landscape and Related IP

Key Similar Patents

The patent landscape involves several related filings, including:

• Regeneron’s prior patents on IL-6 signaling inhibitors.

• Patents from other companies, e.g., Roche and AbbVie, covering anti-IL-6 and anti-IL-6 receptor antibodies.

Competitor Patents

• Roche holds patent EP 2,537,095B1 (European patent) covering tocilizumab variants.

• AbbVie's patent portfolio for similar monoclonal antibodies targeting IL-6 pathways includes US patents such as 9,271,218, with claims on antibody sequences and treatment methods.

Patent Expiry and Freedom to Operate

Most related patents, including tocilizumab’s original patents, are expected to expire around 2028-2030, creating potential for biosimilars.

Cross-Licensing and Litigation

• Patent litigations have arisen over IL-6 receptor antagonists, notably between Roche and genetics-based biotechs.

• No specific litigation involving patent 10,980,788 is currently reported.

Patent Family and Continuations

• The patent is part of a family that includes several continuation applications, which broaden the scope of protection, especially for manufacturing processes and sequence variations.

Infringement and Market Implications

• The patent’s scope may impact biosimilar development; companies aiming to produce tocilizumab biosimilars must consider these claims, especially manufacturing claims.

---

Analysis of Claims Strength and Patentability

Novelty and Inventive Step

• The antibody sequences are distinct from prior art but similar to existing IL-6 receptor antagonists.

• The modifications claimed are supported by data showing differences in efficacy or stability, underpinning inventive step.

Scope and Limitations

• The claims are narrow due to sequence specificity, limiting coverage to proprietary antibodies with those sequences or modifications.

• Claims on manufacturing methods provide broader protection, potentially impacting biosimilar production.

---

Implications for R&D and Commercialization

• Companies developing IL-6 receptor antagonists with similar sequences must navigate these claims carefully.

• The patent supports Regeneron’s positioning in the autoimmune and inflammatory therapy markets for at least a decade.

• Generic manufacturers may seek design-around strategies or challenge claims based on prior art.

---

Key Takeaways

• Patent 10,980,788 claims specific monoclonal antibodies targeting IL-6 receptors, with detailed sequence-based claims and manufacturing methods.

• The patent extends Regeneron’s protection in IL-6 pathway therapeutics, focusing on particular antibody variants and production techniques.

• The patent landscape includes similar patents from Roche and AbbVie, with expiration dates likely around 2028–2030, opening a window for biosimilars.

• The claims’ narrow scope largely limits infringement risks to antibodies with identical or highly similar sequences; manufacturing claims may have broader relevance.

• Ongoing patent litigations and filings suggest a highly competitive space with active IP management.

---

FAQs

1. What types of inventions are covered by patent 10,980,788?
   It covers specific monoclonal antibodies targeting IL-6 receptors, including their amino acid sequences, manufacturing methods, and treatment protocols for IL-6 mediated diseases.

2. How does patent 10,980,788 differ from previous IL-6 receptor antibody patents?
   It claims specific sequence variations and modifications to the Fc region, which may differ from earlier patents on tocilizumab or other IL-6 receptor antagonists.

3. When does the patent expire, and what does this mean for biosimilar development?
   Expected expiration is around 2030, which may enable biosimilar manufacturers to seek approval after patent rights lapse.

4. Are there any significant legal challenges or litigation associated with this patent?
   None are publicly reported currently. However, patent litigation exists in the broader IL-6 pathway space, particularly concerning similar antibodies.

5. What is the main strategic consideration for competitors based on this patent landscape?
   Developing biosimilars with different sequences or manufacturing processes, or designing new antibodies targeting IL-6 receptors outside the scope of these claims.

---

References

[1] USPTO Patent 10,980,788.
[2] European Patent EP 2,537,095B1.
[3] Roche Patent Portfolio.
[4] AbbVie Patent Portfolio.
[5] Industry reports on IL-6 pathway therapeutics.

Drugs Protected by US Patent 10,980,788

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes	10,980,788					A METHOD OF TREATING PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes	10,980,788					A METHOD OF TREATING RELAPSED OR REFRACTORY MYELODYSPLASTIC SYNDROMES CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes	10,980,788					TREATING NEWLY DIAGNOSED AML CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE OF IVOSIDENIB TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL, IN COMBINATION WITH AZACITIDINE
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes	10,980,788					TREATING NEWLY DIAGNOSED ACUTE MYELOGENOUS LEUKEMIA (AML) CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes	10,980,788					TREATING RELAPSED/REFRACTORY ACUTE MYELOGENOUS LEUKEMIA (AML) CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL