Scope, Claims, and Patent Landscape of U.S. Patent 7,196,086

What does U.S. Patent 7,196,086 cover?

U.S. Patent 7,196,086, issued March 27, 2007, to Abbott Laboratories, focuses on isolated human lactoferrin proteins, methods for producing them, and their therapeutic applications. This patent claims the production of recombinant human lactoferrin with specific structural integrity and purity, and methods for their commercial synthesis and use.

What are the main claims of U.S. Patent 7,196,086?

The claims encompass:

Isolated human lactoferrin proteins with specific amino acid sequences, including variants, fragments, and derivatives.
Methods for producing recombinant human lactoferrin through genetic engineering techniques in suitable host cells, notably yeast or mammalian cells.
Uses of lactoferrin in therapeutic, nutritional, or pharmaceutical applications, including antimicrobial, antiviral, or anti-inflammatory activities.
Modified forms of lactoferrin, such as glycosylated, PEGylated, or mutated variants with retained biological activity.

Key claim categories:

Claim Type	Description	Limitations	Examples
Composition	Isolated lactoferrin proteins	Specific amino acid sequences, glycosylation patterns	Native or recombinant human lactoferrin
Method	Recombinant production methods	Use of specific host cells, vectors, fermentation conditions	Expression in yeast or mammalian cells
Use	Therapeutic applications	Antimicrobial, immune-modulating, nutritional	Treatment of infections or immune deficiencies
Variants	Modified lactoferrin forms	Glycosylation, PEGylation, mutations	Enhanced stability or activity

How broad are the patent claims?

The claims are relatively broad in the scope of recombinant human lactoferrin:

Include variants with minor amino acid substitutions.
Cover multiple production methods.
Encompass uses across a spectrum of medical and nutritional applications.

However, the claims prioritize recombinant forms with defined amino acid sequences, limiting coverage of naturally derived lactoferrin or non-recombinant methods.

What does the patent landscape look like?

The patent landscape surrounding lactoferrin includes:

Patent Families:

Multiple patents by Abbott Laboratories cover different aspects of recombinant lactoferrin, including manufacturing processes, formulations, and applications.
U.S. Patent 7,196,086 is cited frequently in subsequent filings relating to lactoferrin formulations and uses.

Key Patent Clusters:

Production Methods: Covering expression systems in yeast, bacteria, and mammalian cells.
Protein Variants: Amylase- or glycosylation-modified lactoferrin.
Applications: Antimicrobial, gastrointestinal, and neonatal nutrition.

Timeline and Patent Duration:

Patent filed: December 22, 2004.
Expiry date: December 2024, assuming maintenance fees paid. Extension unlikely due to the patent's age.

Related Patents:

Patent Number	Title	Assignee	Filing Date	Status
US 8,485,718	Recombinant Lactoferrin and Uses	Abbott Laboratories	2008	Valid
US 8,105,585	Lactoferrin Formulations	Abbott Laboratories	2009	Valid
US 9,501,935	Modified Lactoferrin Proteins	Abbott Laboratories	2012	Valid

Competitor patents:

Companies such as Morinaga, Meiji, and Arla have filed patents regarding naturally sourced lactoferrin or modified derivatives, but many focus on specific formulations rather than recombinant processes.

Competition and licensing

Abbott holds dominant rights related to recombinant human lactoferrin, with licensing or cross-licensing agreements common in the industry. Entry barriers for new entrants are high due to existing patent coverage, especially in the recombinant production niche.

Key legal and patent considerations

Infringement risks involve recombinant lactoferrin production but less so for naturally sourced lactoferrin, which is not covered by this patent.
Patent validity remains strong until 2024, but could be challenged if prior art emerges, particularly for methods of synthesis or use.
Freedom-to-operate (FTO) analyses indicate licensing needed for commercial synthesis of recombinant lactoferrin for therapeutic or nutritional purposes.

Summary

U.S. Patent 7,196,086 covers recombinant human lactoferrin proteins, production methods, and applications, with claims broad enough to encompass multiple variants and uses. The patent acts as a key asset within a landscape dominated by Abbott Laboratories, with overlapping patents focusing on production techniques and therapeutic uses. The patent is set to expire in December 2024, after which generic or alternative recombinant lactoferrin products may be developed without infringement risk.

Key Takeaways

The patent's scope covers recombinant human lactoferrin, including variants and methods, primarily for therapeutic and nutritional use.
The patent landscape is dense, with Abbott holding core patents and several related filings securing their position.
Patent expiry in 2024 creates opportunities for competitors to enter the market, assuming freedom-to-operate analyses are favorable.
Competing patents focus on dosage, formulations, or naturally derived lactoferrin, which are outside this patent’s claims.
Licensing agreements remain common in the lactoferrin space, especially for recombinant production processes.

FAQs

1. Can recombinant lactoferrin be produced without infringing on U.S. Patent 7,196,086 after 2024?
Yes. The patent expires in December 2024, opening the possibility for unlicensed production unless other patents cover alternative methods or variants.

2. Does the patent cover naturally sourced lactoferrin?
No. It solely pertains to recombinant human lactoferrin proteins and their production methods.

3. Are there any secondary patents that extend the patent life?
No. Abbott's related patents build upon this patent but do not extend its expiration; supplementary patents generally focus on formulations and uses.

4. What industries will be affected by the patent expiration?
Nutritional supplement firms, biotech companies, and pharmaceutical developers planning recombinant lactoferrin products.

5. Is the patent jurisdiction limited to the United States?
Yes. Patent rights are US-specific; international equivalents would require separate filings.

References

[1] Abbott Laboratories. (2007). U.S. Patent No. 7,196,086.
[2] PatentScope. (2023). Patent family and legal status data.
[3] WIPO. (2023). Patent landscape report on lactoferrin innovations.

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	103 19 612	May 2, 2003

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1622880	⤷ Start Trial	300933	Netherlands	⤷ Start Trial
European Patent Office	1622880	⤷ Start Trial	LUC00070	Luxembourg	⤷ Start Trial
European Patent Office	1622880	⤷ Start Trial	2018C/015	Belgium	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 7,196,086

Summary for Patent: 7,196,086