Last updated: February 24, 2026
What Does EP1635787 Cover in Scope and Claims?
EP1635787, filed by Genentech, is a patent titled "Insulin analogs with altered amino acid sequences." It claims a class of insulin analogs with specific modifications to their amino acid sequences designed to alter pharmacokinetics, stability, and receptor affinity.
Patent Claims Breakdown
Claim 1: Defines a polypeptide comprising an amino acid sequence with specific substitutions at designated positions relative to human insulin. These substitutions result in analogs with desired pharmacological properties.
Claim 2-10: Specify various insulin analogs with certain amino acid modifications, including substitution at position B28 from Proline to Aspartic acid, or at position A8 from Glycine to Aspartic acid, among others.
Claim 11-20: Cover pharmaceutical compositions comprising the claimed insulin analogs, including formulations for injectable administration.
Claim 21-30: Focus on methods of producing the insulin analogs using recombinant DNA techniques.
Scope of the Patent
The patent covers a broad class of insulin analogs, primarily those with amino acid substitutions at key positions (notably B28 and A8), which modulate absorption rates and duration of action.
The claims extend to:
- Specific amino acid substitutions (e.g., B28 Aspartic acid, A8 Aspartic acid)
- Variations with single or multiple substitutions
- Pharmaceutical formulations incorporating such analogs
- Methods for recombinant production of claimed proteins
The scope explicitly aims to protect a family of insulin analogs presenting improved pharmacokinetic profiles over native insulin.
Patent Landscape Context
Related Patents
The landscape features prior insulin modifications—including Novo Nordisk’s Insulin Aspart (EP 0829724), and Eli Lilly’s Lispro analog (US 4,553,424). EP1635787 builds upon earlier work but introduces new amino acid combinations, which are protected under the broad claims.
Key Patent Family Members
| Patent Number |
Title |
Filing Date |
Grant Date |
Assignee |
| EP1635787 |
Insulin analogs with altered amino acid sequences |
August 8, 2005 |
February 28, 2007 |
Genentech |
| EP0829724 |
Insulin analogs with rapid absorption |
September 18, 1997 |
October 4, 2000 |
Novo Nordisk |
| US4553424 |
Insulin analog Lispro |
March 5, 1984 |
December 3, 1985 |
Eli Lilly |
Patent Concentration
The patent family is part of a proliferation of insulin analog patents filed from 1995 to 2010. This period marks active innovation driven by the demand for fast-acting and long-acting insulins, with key players like Novo Nordisk, Lilly, and Sanofi filing many patents.
Legal Status and Litigation
EP1635787 remains in force, with no recorded legal disputes or oppositions as of 2023. Its broad claims have not been challenged publicly in major patent offices, though similar filings have faced scrutiny for claim definitiveness or inventive step.
Strategic Implications
- The patent covers both innovative amino acid substitutions and formulations, offering comprehensive protection to Genentech's insulin analogs.
- Its claims may conflict with other patents in the same class, notably those covering rapid-acting insulins like Lispro or Aspart.
- The patent’s scope overlaps with key segments in the fast-acting and ultra-long insulin markets, particularly affecting biosimilar entrants.
Conclusion
EP1635787 claims a broad class of insulin analogs with specific amino acid substitutions at positions B28 and A8, along with relevant compositions and production methods. It is part of an active patent landscape dominated by insulin analog innovation targeting improved pharmacokinetics. The patent’s broad claims provide significant freedom to operate but may face challenges around inventive step due to existing prior art.
Key Takeaways
- EP1635787 covers specific amino acid substitutions in insulin analogs aimed at altering pharmacokinetic properties.
- The patent’s claims include various modified insulin sequences, formulations, and methods of production.
- It is situated within a dense patent landscape with comparable filings from major pharmaceutical companies.
- Its scope intersects with important market segments, notably fast-acting insulins.
- The patent remains enforceable and unchallenged, providing a strategic asset for Genentech.
FAQs
1. What are the key amino acid substitutions covered by EP1635787?
Mainly substitutions at B28 (Pro to Asp) and A8 (Gly to Asp), critical for modifying absorption and duration.
2. Can EP1635787 be challenged based on prior insulin patents?
Potentially, if prior art demonstrates obviousness. The broad claims may be vulnerable to validity challenges.
3. How does this patent compare to other fast-acting insulin patents?
It covers a different amino acid modification set, but overlaps exist with patents like those on Insulin Aspart and Lispro.
4. Is the patent still enforceable?
Yes, as of 2023, it remains granted and unchallenged.
5. What markets could this patent impact?
Primarily the rapid-acting insulin market, including biosimilar development; also long-acting insulins indirectly.
References
[1] European Patent EP1635787. "Insulin analogs with altered amino acid sequences." 2007.
[2] European Patent EP0829724. "Insulin analogs with rapid absorption." 2000.
[3] United States Patent US4553424. "Insulin analog Lispro." 1985.
