Q: To patent a bacterium, does the organism have to be successfully tested as the proposed product, such as a probiotic ?

Does this apply to US, EU, Australian and other regions' patents?

1 Lawyer Answer
James L. Arrasmith
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A: No, successfully testing a bacterium as the proposed commercial product is generally not required to patent that organism in the US, EU, Australia, or other major patent jurisdictions. However, there are a few key requirements:

• The bacterium must be novel, non-obvious, useful, and fully described in order to meet basic patentability standards. You will need to detail the isolation, identification, and characterization of the bacterium.

• Simply discovering a naturally occurring bacterium does not make it patent eligible. There must be some form of genetic modification or intentional alteration that distinguishes the bacterium from how it exists naturally. This can include factors like induced mutations or introduced gene sequences.

• Most jurisdictions allow patenting of genetically engineered bacteria, including those intended for use as probiotics. But laws differ regarding patent eligibility for unmodified naturally occurring organisms discovered in the wild in purified/isolated form. Specific guidance should be sought.

• While testing data of the bacterium’s performance as a probiotic or in other applications can help substantiate claims and utility, it is generally not an absolute patent requirement across major patent offices globally. Lack of testing can raise eligibility questions though.

So in summary - while helpful for the strength of the application, successfully testing the organism’s intended use is not strictly necessary upfront for patent filing purposes in major jurisdictions. The key is demonstrating a genetically altered bacterium with applicable utility. Confirming testing early in the process is still advisable.

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