United States Patent 11,357,820: A Comprehensive Analysis
Introduction
United States Patent 11,357,820, granted to Eli Lilly and Company, is a significant patent in the biopharmaceutical industry, particularly in the context of Alzheimer's disease research and the development of GIP/GLP1 co-agonist compositions. This patent, issued on June 14, 2022, covers innovative pharmaceutical compositions and methods that have far-reaching implications.
Inventors and Assignee
The patent was invented by Corvari Vincent John, Minie Christopher Sears, Mishra Dinesh Shyamdeo, and Qian Ken Kangyi, and is assigned to Eli Lilly and Company[2][5].
Scope of the Patent
The patent focuses on GIP/GLP1 co-agonist compositions, specifically highlighting the use of tirzepatide, a dual GIP and GLP-1 receptor agonist. This composition includes agents such as NaCl and propylene glycol, along with dibasic sodium phosphate[2][5].
Claims and Innovations
The patent claims cover novel compounds, including chemical entities and methods for their preparation. Here are some key aspects of the claims:
Compound Families
The patent details several compound families, each with unique scaffolding, substituents, and pharmacophores. These molecules are designed to selectively inhibit ADAM10 and ADAM17 metalloproteases at picomolar levels, showing significant potency and selectivity against off-targets[1].
Therapeutic Applications
The claimed inventions support a therapeutic intervention strategy against Alzheimer's disease. ADAM10 and ADAM17 metalloproteases are essential enzymes in neuronal and synaptic integrity and have been implicated in the pathogenesis of Alzheimer's disease[1].
Pharmaceutical Compositions
The patent describes pharmaceutical compositions for subcutaneous injection, comprising tirzepatide along with other components like NaCl and dibasic sodium phosphate. These compositions are crucial for the effective delivery of the GIP/GLP1 co-agonist peptide[5].
Patent Landscape
Related Patents
The patent landscape includes other related patents, such as Patent 9,474,780, which also covers GIP and GLP-1 co-agonist compounds. This earlier patent, issued on October 25, 2016, was also assigned to Eli Lilly and Company[2].
International Protection
Patent 11,357,820 has a broad international reach, with forty-two patent family members in thirty-two countries. This extensive protection ensures that the innovations covered by this patent are safeguarded globally[1].
Patent Expiration Dates
The patent is set to expire on June 14, 2039. This expiration date is crucial for understanding the timeline for generic entry and the potential for competition in the market[2].
Legal and Regulatory Context
Enablement Requirement
The patent must comply with the enablement requirement under 35 U.S.C. ยง 112(a), which mandates that the specification of the patent application must enable a person skilled in the art to practice the full scope of the claimed invention. This requirement is stringent, as highlighted in cases like Amgen v. Sanofi, where the court emphasized that the specification must enable the entire class of claimed inventions, not just specific embodiments[3].
Patent Litigation
Eli Lilly and Company has been involved in various patent litigations to protect its intellectual property. For example, in Eli Lilly and Company v. Teva Pharmaceuticals, the company appealed decisions related to the patentability of its inventions, highlighting the importance of robust legal protection for pharmaceutical patents[4].
Impact on the Biopharmaceutical Industry
Alzheimer's Disease Research
The patent's focus on ADAM10 and ADAM17 inhibitors marks a significant advancement in Alzheimer's disease research. These enzymes are critical in the disease's pathogenesis, and the development of selective inhibitors could lead to new therapeutic strategies[1].
GIP/GLP1 Co-agonists
The development of GIP/GLP1 co-agonist compositions, such as tirzepatide, has implications beyond Alzheimer's disease. These compounds are also used in the treatment of metabolic disorders, such as type 2 diabetes and obesity, due to their dual agonist activity[5].
Key Takeaways
- Innovative Compounds: The patent covers novel compounds targeting ADAM10 and ADAM17 metalloproteases, with significant implications for Alzheimer's disease.
- GIP/GLP1 Co-agonists: The composition includes tirzepatide, a dual GIP and GLP-1 receptor agonist, with applications in metabolic disorders.
- International Protection: The patent has extensive international coverage, protecting the innovation in thirty-two countries.
- Regulatory Compliance: The patent must adhere to the enablement requirement, ensuring that the specification enables the full scope of the claimed invention.
- Legal Protection: Eli Lilly and Company has actively defended its patents through litigation, emphasizing the importance of legal protection in the biopharmaceutical industry.
FAQs
Q: What is the primary focus of United States Patent 11,357,820?
A: The primary focus is on GIP/GLP1 co-agonist compositions and small molecule inhibitors of ADAM10 and ADAM17 metalloproteases.
Q: Who are the inventors of this patent?
A: The inventors are Corvari Vincent John, Minie Christopher Sears, Mishra Dinesh Shyamdeo, and Qian Ken Kangyi.
Q: What is the significance of ADAM10 and ADAM17 in Alzheimer's disease?
A: These enzymes are essential in neuronal and synaptic integrity and have been implicated in the pathogenesis of Alzheimer's disease.
Q: When is the patent set to expire?
A: The patent is set to expire on June 14, 2039.
Q: What other diseases or conditions can GIP/GLP1 co-agonists like tirzepatide be used for?
A: Besides Alzheimer's disease, these compounds are used in the treatment of metabolic disorders such as type 2 diabetes and obesity.
Cited Sources
- DrugPatentWatch: Details for Patent: 11357820 - DrugPatentWatch
- Drugs.com: Generic Zepbound Availability - Drugs.com
- IPWatchdog: Amgen v. Sanofi: Seven Months In, Has Anything About Patent Enablement Changed?
- CAFC: ELI LILLY AND COMPANY v. TEVA PHARMACEUTICALS
- Justia Patents: US Patent for GIP/GLP1 agonist compositions Patent (Patent 11,357,820)
