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
PREMIUM
James L. Arrasmith pro label Lawyers, want to be a Justia Connect Pro too? Learn more ›
Answered

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.

Justia Ask a Lawyer is a forum for consumers to get answers to basic legal questions. Any information sent through Justia Ask a Lawyer is not secure and is done so on a non-confidential basis only.

The use of this website to ask questions or receive answers does not create an attorney–client relationship between you and Justia, or between you and any attorney who receives your information or responds to your questions, nor is it intended to create such a relationship. Additionally, no responses on this forum constitute legal advice, which must be tailored to the specific circumstances of each case. You should not act upon information provided in Justia Ask a Lawyer without seeking professional counsel from an attorney admitted or authorized to practice in your jurisdiction. Justia assumes no responsibility to any person who relies on information contained on or received through this site and disclaims all liability in respect to such information.

Justia cannot guarantee that the information on this website (including any legal information provided by an attorney through this service) is accurate, complete, or up-to-date. While we intend to make every attempt to keep the information on this site current, the owners of and contributors to this site make no claims, promises or guarantees about the accuracy, completeness or adequacy of the information contained in or linked to from this site.