Here, it must be remembered that the ‘novelty’ criterion for patentability does not mean “is it new?” in terms of “did it previously exist?”; it means “has it previously been made available to the public?” Hence newly-discovered bacteria and genetically-modified bacteria are both potentially patentable.
As mentioned above, in patent terms, ‘novel’ means not previously ‘made available to the public’. So, the first person to find and isolate a new bacterium from a soil sample, for example, might have made a novel (and potentially patentable) invention.
If the bacterium is claimed in the patent application in an ‘isolated’ form, that form will be novel over the previously-known mixture of that bacterium with numerous other micro-organisms in the soil. If the bacterium is shown to have some practical use and is sufficiently different from other bacteria which have previously been known for that use, then the use and inventive step hurdles may be overcome.
In order to satisfy the enablement requirement, the patent application must contain sufficient information on how to put the invention into practice.
If the new micro-organism is derived from a known one (for example, a plant gene has been inserted into a known E. coli bacterium), then a method of making the new micro-organism can probably adequately be described − in words − in the patent application.
An example of a claim to such a bacterium is the following:
If the micro-organism is not previously known (for example, a newly-identified bacterium or fungus), then it will not be possible to describe how to make such a micro-organism in words in the patent application.
In such cases, a sample of the micro-organism may need to be deposited under the ‘Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure’ with an International Depository Authority (IDA). Under this Treaty, if a sample of the microorganism is deposited with one IDA, the enablement requirement is deemed to be satisfied in all of the (approximately 80) countries that have signed the Treaty. The Treaty’s rules allow access to the deposit by third parties under defined conditions.
Using this or similar procedures, samples of new bacteria, phages, viruses, cell lines, fungi and seeds can be deposited in order to satisfy the enablement requirement.
The same issues apply to human cells. For example, the first person to isolate and purify a particularly advantageous human cell line may be entitled to a patent on that cell line. Following the discovery of stem cells, numerous patent applications have been filed to such cells. In particular, numerous patent applications have been filed towards induced pluripotent stem (iPS) cell lines and methods of inducing iPS cells to form specific cell types.
