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The scope and infringement of patents claiming strains of bacteria

Summary

This article examines how patents protecting specific bacterial strains work and what they actually protect. Courts around the world have shown that patents covering specific bacterial deposits usually protect more than just exact copies of the original bacteria. The strength of these patents depends heavily on how well the bacteria are described and characterized in the patent documents.

Background

Increasing numbers of patents claiming specific deposited strains of bacteria are being filed and granted, yet significant uncertainty remains regarding the exact scope of such patent claims. Live bacteria represent extremely complex products with regulatory and competitive considerations that differ substantially from other therapeutics.

Objective

This review examines the scope and potential infringement of patent claims limited to deposited bacterial strains by analyzing court decisions across multiple jurisdictions and discussing factors that determine commercial value of such patents.

Results

Case law analysis reveals that claims limited to specific deposited strains are likely to have useful scope in practice and be infringed by competitor products, despite potentially narrow literal interpretation. Patents with detailed strain characterization including sequence information, fermentation characteristics, and functional attributes are significantly stronger in enforcement.

Conclusion

While claims limited to deposited bacterial strains could theoretically be extremely narrow, courts in practice recognize infringement by related strains sharing key characteristics. Patent value is enhanced by comprehensive characterization details and depends heavily on regulatory and competitive context.
  • Published in:Access Microbiology,
  • Study Type:Review,
  • Source: PMID: 36133178, DOI: 10.1099/acmi.0.000449
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