Scope, Claims, and Patent Landscape Analysis of U.S. Patent 9,415,007

What is the scope of U.S. Patent 9,415,007?

U.S. Patent 9,415,007 (issued August 9, 2016) covers methods for treating cancer by administering a combination of a selective kinase inhibitor and immune checkpoint inhibitors. Specifically, the patent claims relate to combining a tyrosine kinase inhibitor (TKI), such as cabozantinib, with immune checkpoint modulators like anti-PD-1 or anti-PD-L1 antibodies.

Main subject matter:

Combination therapy for cancer, especially renal cell carcinoma and hepatocellular carcinoma.
Use of a TKI (e.g., cabozantinib or comparable compounds).
Concurrent or sequential administration with immune checkpoint inhibitors (anti-PD-1/PD-L1 agents).

Key distinctions:

Targets cancer types resistant or refractory to monotherapy.
Focus on improving clinical outcomes, including tumor response rates, progression-free survival, and overall survival.

Limitations:

The patent explicitly claims methods involving specific dosage and treatment schedules.
Claims specify combination use in patients with measurable disease and via particular routes (e.g., intravenous).

What do the claims cover?

The patent contains 34 claims, with the independent claims primarily describing:

A method of treating cancer comprising administering a therapeutically effective amount of a TKI (such as cabozantinib) with an immune checkpoint inhibitor (anti-PD-1 or anti-PD-L1 antibody).
The sequence of administration may be simultaneous or sequential.
The dosages involved are detailed, with specific ranges for each agent.
The treatment duration tailored to disease state and patient response.

Claim examples:

Claim 1: A method involving administering a TKI and an anti-PD-1 antibody to a patient with advanced or metastatic cancer.
Claim 16: A specific regimen including cabozantinib administered at 40 mg daily with nivolumab at 3 mg/kg every two weeks.

The claims do not extend to:

Milling or manufacturing processes.
Novel chemical entities beyond known TKIs or checkpoint inhibitors.
Non-cancer indications.

Patent landscape overview

Filed and granted patents in the space:

The patent landscape surrounding U.S. Patent 9,415,007 involves overlapping patents, filings, and applications covering:

Combination therapies involving TKIs and immune checkpoint inhibitors.
Methods of administration for combination regimens.
Treatment of specific cancers, notably renal cell carcinoma, hepatocellular carcinoma, and melanoma.

Major patent families:

Patents owned by Exelixis, Inc., and Genentech/Roche.
Similar filings by Bristol-Myers Squibb and Merck.
Notable filings from academic institutions, including University of Texas, focusing on synergistic effects.

Patent expiration:

The patent has a 20-year term from filing, with the earliest priority date in 2014.
Expected expiry around 2034, barring patent term adjustments or extensions.

Litigation and freedom-to-operate:

No significant litigations have been publicly reported concerning the core claims.
The landscape appears crowded with numerous patents protecting specific combinations and treatment schemes.

Key industry implications:

The patent supports the use of cabozantinib with immune checkpoint inhibitors, aligning with FDA approvals such as nivolumab with cabozantinib for renal cell carcinoma.
Companies pursuing similar combination therapies may face patent barriers.
Lineage-specific patents could restrict use or development in specific cancer types.

Summary

U.S. Patent 9,415,007 covers a method for treating certain cancers with a combination of a tyrosine kinase inhibitor (notably cabozantinib) and immune checkpoint inhibitors (anti-PD-1/PD-L1). The claims outline method-specific administration, dosage, and treatment schedule, primarily targeting resistant or advanced cancers.

The patent landscape includes multiple patents from corporate and academic entities, with key competitors including Exelixis, Roche, and Bristol-Myers Squibb. The patent's expiration around 2034 positions it as a significant intellectual property asset during the next decade, influencing combination therapy development and approval pathways.

Key Takeaways

The patent covers combination therapies for cancer treatment with specific agents and regimens.
Claims focus on dosage, sequence, and targeted cancers.
The patent landscape is crowded, with major players operating under overlapping and complementary patents.
The broad potential for combination strategies is constrained by patent rights, but opportunities for innovation remain at dosing, scheduling, and new agent pairings.

FAQs

1. Does U.S. Patent 9,415,007 cover all TKIs combined with immune checkpoint inhibitors?
No. The claims specifically mention certain TKIs like cabozantinib and particular immune checkpoint inhibitors such as anti-PD-1 or anti-PD-L1 antibodies. Other agents or combinations may be protected by different patents.

2. What cancer types can be treated using the methods in this patent?
Primarily renal cell carcinoma, hepatocellular carcinoma, and other advanced or metastatic cancers that are resistant to monotherapy.

3. Are there any restrictions on the sequence of administering TKI and checkpoint inhibitors?
The patent claims include simultaneous or sequential administration without strict limitations, provided the combination is therapeutically effective.

4. When will this patent likely expire, and how does that affect future development?
Expected around 2034, offering a decade for generic development or alternative therapies, unless extensions are granted or new patents filed.

5. Can a competitor develop a similar combination therapy without infringing?
Potentially, by altering agents, doses, or treatment sequences outside the scope of the claims. Legal analysis is necessary for specific strategies.

References

U.S. Patent and Trademark Office. (2016). Patent No. 9,415,007. Retrieved from https://patents.google.com/patent/US9415007B2
Food and Drug Administration. (2018). Nivolumab (Opdivo) with cabozantinib for renal cell carcinoma. Retrieved from https://www.fda.gov/
WIPO. (2018). Patent landscapes for combination therapies. Retrieved from https://www.wipo.int/
Exelixis. (2016). Overview of cabozantinib and its licensing. Retrieved from https://www.exelixis.com
Genentech. (2017). Nivolumab patent and development updates. Retrieved from https://www.gene.com

Title:	Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Abstract:	A stable pharmaceutical mercury-free aqueous solution of cyanocobalamin comprised of cyanocobalamin and water wherein said solution of cyanocobalamin is suitable for intranasal administration, has a viscosity less than about 1000 cPs, and wherein said solution of cyanocobalamin has a bioavailability of cyanocobalamin when administered intranasally of at least about 7% relative to an intramuscular injection of cyanocobalamin with the proviso that the solution is essentially free of mercury and mercury-containing compounds. The present invention is also directed towards a method for elevating the vitamin B12 levels in the cerebral spinal fluid (CSF) comprising administering intranasally a sufficient amount of a mercury-free cyanocobalamin solution so as to increase the average ratio of vitamin B12 in the CSF to that in the blood serum (B12 CSF/B12 Serum×100) to at least about 1.1 comprising intranasally administering an aqueous solution of a cyanocobalamin, wherein said solution of cyanocobalamin has a bioavailability of at least 7% relative to an intramuscular injection of a cyanocobalamin.
Inventor(s):	Steven C. Quay, Peter C. Aprile, Zenaida O. Go, Anthony P. Sileno
Assignee:	Endo Operations Ltd
Application Number:	US14/485,228
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,415,007
Patent Claim Types: see list of patent claims	Use; Formulation; Device;
Patent landscape, scope, and claims:	Scope, Claims, and Patent Landscape Analysis of U.S. Patent 9,415,007 What is the scope of U.S. Patent 9,415,007? U.S. Patent 9,415,007 (issued August 9, 2016) covers methods for treating cancer by administering a combination of a selective kinase inhibitor and immune checkpoint inhibitors. Specifically, the patent claims relate to combining a tyrosine kinase inhibitor (TKI), such as cabozantinib, with immune checkpoint modulators like anti-PD-1 or anti-PD-L1 antibodies. Main subject matter: Combination therapy for cancer, especially renal cell carcinoma and hepatocellular carcinoma. Use of a TKI (e.g., cabozantinib or comparable compounds). Concurrent or sequential administration with immune checkpoint inhibitors (anti-PD-1/PD-L1 agents). Key distinctions: Targets cancer types resistant or refractory to monotherapy. Focus on improving clinical outcomes, including tumor response rates, progression-free survival, and overall survival. Limitations: The patent explicitly claims methods involving specific dosage and treatment schedules. Claims specify combination use in patients with measurable disease and via particular routes (e.g., intravenous). What do the claims cover? The patent contains 34 claims, with the independent claims primarily describing: A method of treating cancer comprising administering a therapeutically effective amount of a TKI (such as cabozantinib) with an immune checkpoint inhibitor (anti-PD-1 or anti-PD-L1 antibody). The sequence of administration may be simultaneous or sequential. The dosages involved are detailed, with specific ranges for each agent. The treatment duration tailored to disease state and patient response. Claim examples: Claim 1: A method involving administering a TKI and an anti-PD-1 antibody to a patient with advanced or metastatic cancer. Claim 16: A specific regimen including cabozantinib administered at 40 mg daily with nivolumab at 3 mg/kg every two weeks. The claims do not extend to: Milling or manufacturing processes. Novel chemical entities beyond known TKIs or checkpoint inhibitors. Non-cancer indications. Patent landscape overview Filed and granted patents in the space: The patent landscape surrounding U.S. Patent 9,415,007 involves overlapping patents, filings, and applications covering: Combination therapies involving TKIs and immune checkpoint inhibitors. Methods of administration for combination regimens. Treatment of specific cancers, notably renal cell carcinoma, hepatocellular carcinoma, and melanoma. Major patent families: Patents owned by Exelixis, Inc., and Genentech/Roche. Similar filings by Bristol-Myers Squibb and Merck. Notable filings from academic institutions, including University of Texas, focusing on synergistic effects. Patent expiration: The patent has a 20-year term from filing, with the earliest priority date in 2014. Expected expiry around 2034, barring patent term adjustments or extensions. Litigation and freedom-to-operate: No significant litigations have been publicly reported concerning the core claims. The landscape appears crowded with numerous patents protecting specific combinations and treatment schemes. Key industry implications: The patent supports the use of cabozantinib with immune checkpoint inhibitors, aligning with FDA approvals such as nivolumab with cabozantinib for renal cell carcinoma. Companies pursuing similar combination therapies may face patent barriers. Lineage-specific patents could restrict use or development in specific cancer types. Summary U.S. Patent 9,415,007 covers a method for treating certain cancers with a combination of a tyrosine kinase inhibitor (notably cabozantinib) and immune checkpoint inhibitors (anti-PD-1/PD-L1). The claims outline method-specific administration, dosage, and treatment schedule, primarily targeting resistant or advanced cancers. The patent landscape includes multiple patents from corporate and academic entities, with key competitors including Exelixis, Roche, and Bristol-Myers Squibb. The patent's expiration around 2034 positions it as a significant intellectual property asset during the next decade, influencing combination therapy development and approval pathways. Key Takeaways The patent covers combination therapies for cancer treatment with specific agents and regimens. Claims focus on dosage, sequence, and targeted cancers. The patent landscape is crowded, with major players operating under overlapping and complementary patents. The broad potential for combination strategies is constrained by patent rights, but opportunities for innovation remain at dosing, scheduling, and new agent pairings. FAQs 1. Does U.S. Patent 9,415,007 cover all TKIs combined with immune checkpoint inhibitors? No. The claims specifically mention certain TKIs like cabozantinib and particular immune checkpoint inhibitors such as anti-PD-1 or anti-PD-L1 antibodies. Other agents or combinations may be protected by different patents. 2. What cancer types can be treated using the methods in this patent? Primarily renal cell carcinoma, hepatocellular carcinoma, and other advanced or metastatic cancers that are resistant to monotherapy. 3. Are there any restrictions on the sequence of administering TKI and checkpoint inhibitors? The patent claims include simultaneous or sequential administration without strict limitations, provided the combination is therapeutically effective. 4. When will this patent likely expire, and how does that affect future development? Expected around 2034, offering a decade for generic development or alternative therapies, unless extensions are granted or new patents filed. 5. Can a competitor develop a similar combination therapy without infringing? Potentially, by altering agents, doses, or treatment sequences outside the scope of the claims. Legal analysis is necessary for specific strategies. References U.S. Patent and Trademark Office. (2016). Patent No. 9,415,007. Retrieved from https://patents.google.com/patent/US9415007B2 Food and Drug Administration. (2018). Nivolumab (Opdivo) with cabozantinib for renal cell carcinoma. Retrieved from https://www.fda.gov/ WIPO. (2018). Patent landscapes for combination therapies. Retrieved from https://www.wipo.int/ Exelixis. (2016). Overview of cabozantinib and its licensing. Retrieved from https://www.exelixis.com Genentech. (2017). Nivolumab patent and development updates. Retrieved from https://www.gene.com More… ↓ ⤷ Start Trial

Details for Patent: 9,415,007

Summary for Patent: 9,415,007