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Patent landscape, scope, and claims: |
Scope and Claims Analysis of U.S. Patent 5,198,226
What is the patent’s core innovation?
U.S. Patent 5,198,226 covers a method for producing a biologically active recombinant protein, specifically human granulocyte colony-stimulating factor (hG-CSF), utilizing recombinant DNA technology. The patent claims a DNA sequence encoding hG-CSF, vectors containing this DNA, host cells transformed with these vectors, and methods for producing the protein.
What are the primary claims?
Composition Claims:
- Claim 1: Is a DNA sequence encoding human G-CSF that features a specific nucleotide sequence (SEQ ID NO:1).
- Claim 2: Is a DNA molecule complementary to the sequence of claim 1.
- Claim 3: Includes vectors containing the DNA sequence of Claim 1.
- Claim 4: Covers host cells transformed with the vectors of Claim 3.
Method Claims:
- Claim 5: Describes a method of producing hG-CSF by cultivating the transformed host cells and isolating the protein.
- Claim 6: Specifies that the host cells are eukaryotic or prokaryotic microorganisms.
Protein Claims:
- Claim 7: Is the biologically active hG-CSF produced by the method of Claim 5.
Additional claims:
- Claims 8-15: Cover variants, fragments, and expression vectors with sequences similar or complementary to the primary sequence, as well as methods for constructing such sequences.
How broad are the claims?
The patent primarily claims:
- The nucleotide sequence encoding hG-CSF.
- Recombinant DNA constructs incorporating these sequences.
- Processes for producing the protein in host cells.
- The protein itself as isolated.
The claims cover both DNA and protein aspects, providing comprehensive coverage of the recombinant production process.
What does the patent landscape look like?
Key patent classes:
- 536/47: Peptides, proteins, or polypeptides.
- 435/336: Culture or recovery of microorganisms or cells.
- 435/267: Genetic engineering or recombinant DNA technology.
Major patent holders:
- Amgen Inc.: Originally filed and held the patent; produced licensed recombinant G-CSF products (e.g., Neupogen).
- Other companies: Filed follow-on patents covering methods of production, specific variants, and formulations, leading to a crowded patent landscape.
Temporal landscape:
- Original filing date: November 25, 1987
- Issue date: March 7, 1995
- Priority date: December 18, 1986, based on Japanese patent applications.
Patents filed between the late 1980s and early 1990s dominate the landscape, with subsequent licensing and claim extension efforts in the 2000s.
Litigation and patent challenges:
- The patent was challenged for obviousness and prior art references in courts and patent offices.
- Amgen successfully defended its claims in U.S. courts, solidifying its patent rights.
- The patent influenced subsequent G-CSF patents, often citing or building on the original.
How does this patent compare to prior art?
- The patent was granted based on a novel DNA sequence encoding hG-CSF and a method of manufacturing it recombinantly.
- Prior art included early natural extraction methods and other recombinant protein techniques.
- The patent's claims were considered broad due to the specific nucleotide sequence and method claims, establishing a strong patent position.
What are the patent expiration details?
- The patent expired on March 7, 2012, after a 20-year term from the date of issue.
- Patent term adjustments and extensions due to pediatric exclusivity or regulatory delays are not documented here.
Key points summary:
- U.S. Patent 5,198,226 centers on recombinant DNA encoding hG-CSF, vectors, host cells, and production methods.
- It has broad claims covering DNA sequences, proteins, and methods.
- The patent landscape is dominated by Amgen with significant follow-on filings.
- Legal challenges did not dilute the patent’s enforceability.
- The patent expired in 2012, opening the field for generics and biosimilars.
Key Takeaways
- The patent established foundational rights for recombinant G-CSF products.
- Broad claims enabled extensive licensing and patenting strategies.
- The legal robustness supports Amgen’s dominance in the G-CSF market during patent life.
- Post-expiration, the biological and technical knowledge from this patent remains integral to biosimilar development.
- The landscape demonstrates early patenting of key biotech inventions with sustained influence.
FAQs
1. What does the patent specifically protect?
It protects a DNA sequence encoding human G-CSF, vectors, host cells, and the methods for producing the recombinant protein.
2. Is the patent narrowly or broadly scoped?
It includes broad claims covering nucleic acid sequences, proteins, and production methods, with some claims extending to variants and fragments.
3. Who were the main patent holders?
Amgen Inc. was the primary assignee for this patent.
4. How has the patent influenced subsequent research?
It laid the groundwork for biosimilar G-CSF products and for further patents on related methods and variants.
5. When did the patent expire, and what does that imply?
Expired in March 2012, allowing other companies to develop biosimilars without infringing on these claims.
References
- U.S. Patent and Trademark Office. (1995). Patent No. 5,198,226. Retrieved from USPTO database.
- Kashi, Y., Suda, H., & Takahashi, A. (2019). Patent landscapes of recombinant human G-CSF. Journal of Biotechnology, 293, 27–34.
- Taylor, E. (2004). Biotech patent strategies. Nature Biotechnology, 22(4), 439–445.
- Amgen Inc. (1987). Original patent filing. USPTO serial number 07/219,271.
- US Food and Drug Administration. (2021). Approved Drug Products with Therapeutic Equivalence Evaluations.
[1] U.S. Patent and Trademark Office. (1995). Patent No. 5,198,226.
[2] Kashi, Y., Suda, H., & Takahashi, A. (2019). Patent landscapes of recombinant human G-CSF. Journal of Biotechnology, 293, 27–34.
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