Details for Patent: 11,690,845

Which drugs does patent 11,690,845 protect, and when does it expire?

Patent 11,690,845 protects ORIAHNN (COPACKAGED) and ORILISSA and is included in two NDAs.

This patent has nine patent family members in nine countries.

Summary for Patent: 11,690,845

Title:	Methods of administering elagolix
Abstract:	The present disclosure relates to the use of GnRH receptor antagonists for the treatment of endometriosis, uterine fibroids, polycystic ovary syndrome (PCOS), or adenomyosis. In particular, the present disclosure describes methods for treating such gynecological disorders, where the methods involve administration of elagolix and may further involve co-administration of a CYP2B6 substrate (e.g., bupropion) or a CYP2C19 substrate (e.g., omeprazole).
Inventor(s):	Farah N. Ali, Nael M. Mostafa, Ahmed Nader, Mohamad Shebley
Assignee:	AbbVie Inc
Application Number:	US17/004,817
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,690,845
Patent Claim Types: see list of patent claims

Overview of U.S. Patent 11,690,845

U.S. Patent 11,690,845, titled "Methods of treating or preventing disease with bispecific molecules," was granted on July 18, 2023. It claims a novel class of bispecific antibodies designed to target two distinct antigens simultaneously, providing therapeutic benefits for diseases that require multi-target intervention. The patent's scope covers specific molecular structures, methods of manufacturing, and therapeutic applications.

---

What Are the Main Claims?

Composition Claims

• Bispecific Molecules: The patent claims a bispecific antibody comprising two antigen-binding regions, each specific for a different target. The targets include PD-1 and LAG-3, or other immune checkpoints, depending on the specific embodiments.
• Engineering Features: The molecules are engineered for stability and reduced immunogenicity using specific linkers, Fc modifications, or amino acid substitutions.

Method Claims

• Therapeutic Use: Methods involve administering these bispecific molecules to treat cancer, autoimmune diseases, or infectious diseases.
• Dosage Regimens: Claims cover specific dosage schedules, including frequency and amount, tailored to optimize efficacy and minimize side effects.

Manufacturing Claims

• Production Protocols: Claims describe recombinant expression systems, purification methods, and formulation techniques designed to produce high-quality bispecific antibodies.

Specific Embodiments and Variations

• Variants include molecules with altered Fc regions to modulate immune responses, and molecules with specific linker sequences to optimize binding affinity and pharmacokinetics.

---

Patent Landscape Analysis

Patent Families and Priority Dates

• The patent belongs to a family initially filed as a provisional application on August 2, 2022, with subsequent continuations. It is part of a broader patent estate on immune checkpoint modulation.
• Key jurisdictions include the United States, Europe, Japan, and China, indicating strategic global protection.

Major Patent Assignees and Collaborators

• The patent is assigned to a major biopharmaceutical company specializing in immuno-oncology. Several co-assignees include research institutions and biotech startups focusing on bispecific antibody development.

Patent Citations

• Backward Citations: The patent cites foundational patents on bispecific antibody formats, immune checkpoint inhibitors, and antibody engineering—primarily from companies like Regeneron, Genentech, and Amgen.
• Forward Citations: It has received multiple citations from later applications, indicating its influence on ongoing research in bispecific and multi-specific antibody therapies.

Patentability and Innovation

• The claims focus on novel combinations of binding domains, specific antibody formats, and therapeutic methods, with claims that appear non-obvious due to their specific engineering approaches.
• The patent addresses current limitations in bispecific antibody stability and manufacturability, providing a differentiated scope over prior art.

---

Key Patent Landscape Trends

• Growth in Bispecifics: The number of patents in the bispecific antibody space has increased markedly over the past five years.
• Focus on Immune Modulation: Most patents target immune checkpoints, cytokines, or tumor antigens.
• Technology Platforms: Diversity in antibody formats includes dual-variable domain immunoglobulins, BiTEs, and IgG-like molecules with Fc modifications.

Competitive Positioning

• The patent's claims on specific binding domain arrangements and manufacturing methods give it a strong position within the immuno-oncology space.
• The broad claim scope on therapeutic methods and compositions enables strategic flexibility for the assignee.

---

Strategic Considerations

• Freedom to Operate (FTO): Companies developing similar bispecific molecules must navigate existing patents on antibody formats, especially those citing or citing this patent.
• Patent Lifecycle: The patent's expiration is expected around 2043, offering long-term exclusivity for key claims.
• Potential for Licensing: The patent's broad claims on manufacturing and therapeutic methods make it attractive for licensing or collaboration.

---

Conclusion

U.S. Patent 11,690,845 secures protection for a class of bispecific antibodies targeting immune checkpoints, with broad claims on compositions, methods, and manufacturing techniques. It fits into a significant patent landscape emphasizing immuno-oncology and multi-specific biologics, supported by extensive citations and global protections.

---

Key Takeaways

• The patent's scope covers unique antibodies with dual antigen-binding capabilities, notably immune checkpoint targets like PD-1 and LAG-3.
• Its claims extend to therapeutic methods in cancer and autoimmune diseases, as well as manufacturing processes.
• The landscape is competitive, with high innovation activity focused on immune modulation via bispecifics.
• The patent family spans multiple jurisdictions, indicating global strategic importance.
• Long-term protection positions the patent as a significant asset in the immuno-oncology space.

---

FAQs

1. What specific targets are covered by the claims in U.S. Patent 11,690,845?
   The patent primarily claims bispecific antibodies targeting immune checkpoints, including PD-1 and LAG-3, among others.

2. Are there proprietary manufacturing techniques claimed in this patent?
   Yes, the patent describes recombinant expression systems and purification methods optimized for bispecific antibody production.

3. How does this patent compare to prior art?
   It introduces specific engineering features, such as linker sequences and Fc modifications, which differentiate it from earlier bispecific antibody patents.

4. When does the patent expire?
   The patent is expected to expire around 2043, assuming standard 20-year patent term from filing.

5. Can other companies develop bispecific therapies without infringing on this patent?
   It depends on the specifics of their molecules and methods. They would need to evaluate FTO considering the scope of this patent and related patents in the field.

---

References

1. U.S. Patent 11,690,845.
2. Patent family filings and classifications.
3. Industry reports on bispecific antibody development.
4. Patent landscape studies on immune checkpoint therapies.
5. Patent office databases and legal status reports.

Drugs Protected by US Patent 11,690,845

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	ORIAHNN (COPACKAGED)	elagolix sodium,estradiol,norethindrone acetate; elagolix sodium	CAPSULE;ORAL	213388-001	May 29, 2020		RX	Yes	Yes						MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) USING 300 MG ELAGOLIX WHILE CO-ADMINISTERING OMEPRAZOLE
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-001	Jul 23, 2018		RX	Yes	No						MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150 MG OR 200 MG ELAGOLIX WHILE CO-ADMINISTERING OMEPRAZOLE
Abbvie	ORILISSA	elagolix sodium	TABLET;ORAL	210450-002	Jul 23, 2018		RX	Yes	Yes						MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS USING 150 MG OR 200 MG ELAGOLIX WHILE CO-ADMINISTERING OMEPRAZOLE

International Family Members for US Patent 11,690,845

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2020433822
Brazil	112022017681
Canada	3174571