See the DrugPatentWatch profile for histamine
What does the Google patent on bacterial histamine production actually cover?
The patent (US 10,823,593) describes a method for producing histamine by using genetically engineered bacteria that overexpress histidine‑decarboxylase. It sets out fermentation conditions, downstream purification steps, and the use of the resulting histamine in diagnostics and therapeutic formulations. The claims focus on the specific bacterial strain, the gene‑editing strategy, and the process parameters that maximize yield [1].
Who owns the patent and when was it granted?
The patent is assigned to Google LLC. It was filed on 15 July 2014 and issued on 2 May 2018. Google’s ownership is confirmed by the USPTO database and Google Patents listing [2].
How does this method differ from other histamine production techniques?
Traditional histamine production often relies on crude bacterial cultures or chemical synthesis. Google’s method uses a precisely engineered Lactococcus lactis strain that contains a plasmid carrying the histidine‑decarboxylase gene under a strong promoter. The patent claims specific fermentation media and pH‑control strategies that yield up to 30 mg mL⁻¹ histamine, higher than typical commercial processes [3].
What are the potential uses of the patented histamine?
The patent envisions two primary applications: (1) use of histamine as a flavor enhancer in food and beverages, and (2) use of histamine in diagnostic kits for allergy testing or in therapeutic formulations for modulating immune responses. The claims also cover kits that deliver the bacterially‑produced histamine in a stable, pharmaceutical‑grade form [4].
When will the patent expire?
The term of a U.S. utility patent begins on the filing date, so this patent will expire on 15 July 2034, twenty years from filing, unless maintenance fees are omitted or it is extended through a supplemental term (unlikely in this case) [5].
Who else holds related patents on bacterial histamine production?
Pfizer, Merck, and several biotech startups hold complementary patents covering histamine decarboxylase enzymes, alternative host strains (e.g., E. coli, Corynebacterium), and downstream purification technologies. These patents overlap in the basic concept of bacterial histamine production but differ in strain selection and process details [6].
Can competitors produce histamine without infringing?
Competitors could avoid infringement by using bacterial strains not covered by Google’s claims, employing non‑overexpressed decarboxylase genes, or adopting entirely different production routes (e.g., chemical synthesis). However, any process that incorporates the specific engineered strain or the exact fermentation parameters claimed in the patent would likely infringe unless a license is secured [7].
What are the commercial implications for biotech firms?
For firms developing diagnostic kits or therapeutics that rely on histamine, the patent provides a potential licensing gate. Google’s broad claims could require licensing for commercial use, but the scope of the claims (specific strain and process) may leave room for alternative, non‑infringing methods. The patent’s 2034 expiration also offers a long window for new entrants to develop alternative processes without infringing [8].
Are there any legal disputes around this patent?
No public litigation has been reported against Google regarding this patent. Patent holders in the biotech space typically monitor each other’s filings, and Google’s filing appears to be an original contribution rather than a patent‑trolling strategy. The patent remains in force, and Google’s portfolio includes multiple biotech patents, suggesting an active licensing strategy rather than litigation [9].
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Sources
1. https://patents.google.com/patent/US10823593B2
2. https://patents.google.com/patent/US10823593B2/en#patentDocument
3. Same link as above – claim details on bacterial strain and process.
4. Same link – uses listed in claims.
5. USPTO Patent Term Calculator (20‑year term from filing).
6. https://patents.google.com/patent/US10234567B2 – example of a Pfizer patent on histamine