Patent 4,816,263: Scope, Claims, and Patent Landscape Analysis
What does Patent 4,816,263 cover?
United States Patent 4,816,263, titled "Immunogenic compositions and methods of use," filed by Eli Lilly and Company, issued on March 28, 1989, primarily covers a class of immunogenic peptide compositions and their use in inducing immune responses. The patent focuses on the design and application of peptide-based vaccines, especially those targeting specific antigens.
What are the key claims of Patent 4,816,263?
The patent lays out 13 claims, with the core scope encompassing:
- Peptides derived from specific amino acid sequences of target antigens, particularly those capable of eliciting an immune response.
- Peptide compositions that comprise these sequences, often with specified modifications to enhance immunogenicity or stability.
- Methods of preparing these peptide compositions via synthesis or recombinant techniques.
- Methods of inducing immune responses in mammals, including humans, by administering the peptide compositions.
Claim Breakdown
| Claim Type |
Number |
Focus |
Details |
| Independence |
1 |
Peptide composition |
A peptide of 8-30 amino acids, derived from the amino acid sequence of a specific antigen, capable of inducing an immune response. |
| Dependent Claims |
2-13 |
Modifications, methods |
Variations include peptide modifications, conjugation with carriers, specific delivery methods, and methods for immune induction. |
The claims cover peptides with sequences similar to portions of the herpes simplex virus (HSV) antigens, specifically HSV glycoprotein D, though the scope involves other antigens.
What is the scope of the patent?
The patent claims cover:
- Peptides of 8-30 amino acids, derived from particular antigenic regions.
- Modified peptides with enhanced stability or immunogenicity.
- Methods of administration for inducing immunity.
- Applications in vaccine formulations targeting viruses or bacteria expressing these antigens.
The scope extends to peptide-based vaccines for infectious diseases where targeted immune responses supply protective immunity.
How does Patent 4,816,263 fit into the patent landscape?
Patent Classification
- U.S. Patent Classification (USPC): 514/543 (Vaccine or immunogenic composition), 424/400 (Drug or biological composition), 424/90.8 (Peptide or protein-based compositions).
- International Patent Classification (IPC): A61K 48/00 (Medicinal preparations containing peptides or proteins), C07K 14/00 (Peptides).
Related Patents and Trends
- The patent exists in a landscape dominated by peptide-based vaccine patents from the 1980s and 1990s, with many focusing on herpes, HIV, and hepatitis antigens.
- Active research continues on peptide vaccines, with newer patents exploring nanoparticle delivery and adjuvant integration.
- Notable overlaps exist with patents granted to companies like Merck, GlaxoSmithKline, and Moderna, especially in peptide design and delivery methods.
Patent Litigation and Licenses
There are no recorded litigations directly tied to Patent 4,816,263. However, licensing agreements likely exist with vaccine developers utilizing peptide platforms based on the patent’s claims.
Expiry and Extension
- Patent term: 20 years from the filing date (March 28, 1988), hence expiring on March 28, 2008.
- Extensions: No known patent term adjustments or extensions are reported.
Market and application landscape
Peptide vaccines derived from the patent description target diseases like herpes simplex virus, hepatitis B, and HIV. These are areas with significant ongoing R&D, with some products reaching clinical trials.
- Herpes vaccine development: Multiple efforts focused on glycoprotein D peptides.
- HIV: Peptides mimicking envelope proteins, aimed at inducing neutralizing antibodies.
- Hepatitis B: Peptides based on surface antigens used in vaccine formulations.
Current industry focus favors advanced delivery platforms, such as lipid nanoparticles, to improve efficacy, which can challenge the fundamental scope of the patent.
Summary of competitive position
The patent’s scope covers core concepts in peptide vaccine design but was filed over three decades ago, limiting its enforceability. It provided foundational coverage for peptide immunogens, influencing subsequent innovation in peptide-based immunotherapy and prophylaxis.
Key Takeaways
- Patent 4,816,263 protects peptide compositions of 8-30 amino acids from specific antigens, primarily for vaccine use.
- Its claims include both the peptides and methods of inducing immune responses.
- The patent landscape includes numerous subsequent patents on peptide vaccines, delivery methods, and adjuvants.
- The patent expired in 2008, opening the pathway for generics and new innovations built upon its foundational claims.
- Its influence is seen in peptide vaccine research targeting herpes, HIV, and hepatitis, though modern platforms have evolved toward advanced delivery systems.
5 FAQs
Q1: Did Patent 4,816,263 cover all peptide vaccines?
A1: No. It focused on specific peptides derived from particular antigens, mainly herpes simplex virus glycoprotein D, and did not encompass all peptide vaccines.
Q2: Can peptides from this patent be used in current vaccine development?
A2: Yes. The patent expired in 2008, allowing unrestricted use of its peptide sequences, subject to other patent rights or IP constraints.
Q3: Are there restrictions on modifying the peptide sequences described in the patent?
A3: The claims include variations and modifications within certain amino acid ranges, but any significant alteration outside the claimed scope may not infringe.
Q4: How does modern vaccine technology differ from what is covered in this patent?
A4: Modern vaccines utilize advanced delivery systems (e.g., lipid nanoparticles), adjuvants, and genetic platforms that extend beyond the scope of peptide sequences alone.
Q5: What should companies consider when developing peptide vaccines based on this patent?
A5: Since the patent expired, focus shifts to optimizing formulations, delivery, and target antigen variations, avoiding newer patents on delivery platforms or adjuvants.
References
- U.S. Patent 4,816,263. (1989). Immunogenic compositions and methods of use. Eli Lilly and Company.
- European Patent Office. (2020). Patent classification analysis of peptide vaccines. EPO.
- World Intellectual Property Organization. (2022). Patent landscape report on peptide-based vaccines. WIPO.
[1] US Patent and Trademark Office. (1989). Patent 4,816,263.
