Are microorganisms patentable? YES! err… NO!…umm MAYBE! (part 1)

There are three main points to think about when it comes to the patentability of microorganisms – industrial application; sufficiency of disclosure; and patent eligible subject matter. I will look at patent eligible subject matter in a later article.

Industrial application

Industrial application is fairly straightforward – your microorganism must have some commercial use that is described in the patent specification. You can’t just dig up a new strain of yeast and patent it simply because it is new. If, however, you show that the new strain of yeast has a particular phenotype, for example is maybe resistant to silver (like Candida argentea – my claim to fame that I discovered in a disused copper mine in Wales and then characterised) and perhaps could be used in bioremediation, then you have a commercial application for the new yeast so the industrial application criteria is met. Generally speaking, “industrial application”, provided that you can demonstrate a use for your microorganism, is not considered difficult to satisfy as a test.

Sufficiency

Sufficiency is a bit more difficult, and how that is addressed depends on whether your microbe is “natural” or “engineered”. This article will focus on naturally occurring microbes, and also strains that have been derived by random mutagenesis or directed evolution – i.e. all strains that have some useful phenotype, but the origin of the useful phenotype is unknown. A later article will look at protecting engineered strains.

We all probably know that for an invention to be granted a patent, it has to be new (novel) and inventive (non-obvious) - the clue is in the word “invention”. But a technology also has to be sufficiently disclosed. This is part of the “bargain” that the patent system was founded on – a patentee gets a monopoly period in which to use their invention in return for disclosing that invention to the public in sufficient detail so as to allow other people to use it and develop it further.

Going back to the C. argentea example – if we find out that the yeast is resistant to silver, but we don’t know why – how do we describe the strain in a patent application, in words, so as to enable someone else to work the invention? We can’t. We could sequence the genome and include that in the patent application, but we can’t (currently) recreate strains simply from the genomic sequence. This is also true for strains that have been generated through random mutagenesis or directed evolution, and where it is not known which genes/mutations are responsible for the desirable phenotype.

So, for naturally occurring strains and engineered strains where the mutations accounting for the desirable phenotype are unknown – the only way to describe the strain in enough detail to satisfy the sufficiency criteria is to deposit them at an national depository that is recognised by the Budapest Treaty.   

This treaty sets out the international recognition of deposited microorganisms for the purposes of patent protection – i.e. you only need to deposit your strain at one depository and that should satisfy the disclosure requirements of patents in most countries. It is VERY important to note that the deposit must have been received and accepted by the depository BEFORE you file your patent application (and if you are filing a priority-serving application the deposit must be made before the priority date).

Your patent application would need to refer to the depository institution and the accession number, amongst other information. If the information isn’t correct, the sufficiency requirement may not be met and your whole patent application can fall.

If and when your patent is granted, it is very likely that the claims (the bit that sets out what the invention actually protects) will have to refer to the particular strain, and will refer to the accession number.

Where you have established a use for the microorganism, and have provided data to support that use (e.g. demonstrating that it is resistant to silver, and therefore useful in bioremediation), provided the data is sound, the patent should be considered sufficient.

So it seems to be fairly straightforward – deposit your strain and include the correct info in your patent application and you can tick sufficiency off of your list.

Scope of protection

The bad news - the scope of protection afford by a patent that references a particular deposit could be narrow. 

The patent claims set out what your patent covers. If a third party does something that falls within your claim scope, it is an infringement. A narrow patent claim therefore generally means that it could be possible for a third party to work around your patent and do things that you would rather they didn’t, but you would not be able to stop them (i.e. you want your patent claims to be as broad as possible which is why we as patent attorneys fight hard against the patent examiners to preserve claims which are as broad as is reasonable).

I am not aware that this has been tested yet (at least in the UK courts) but on a literal interpretation of a claim that for example reads:

“A Candida argentea cell as deposited with NCYC under the accession number NCYC 3784"

this claim likely only protects the exact strain, as retrieved from the depository. So, if a third party obtained the strain and made some additional mutations or overexpressed a protein, that could, on a literal interpretation, put it outside the scope of the claim and so use of that mutated strain would not be an infringement. 

On the other hand, when assessing infringement, some countries (including the UK), take account of the doctrine of “equivalents”. In the case of the UK it is possible that the courts would look at whether mutations (for example) in a mutated version of the deposited strain, are “immaterial” in their effect on the inventive concept of the claimed strain i.e. taking into account the purported use of the strain in the patent specification (e.g. bioremediation), do the mutations have any material effect? If the mutations are found by the courts to make no difference to the inventive concept of the deposited strain, then the mutated strain could be found to infringe as an equivalent.

 It is important to note that if the same mutated strain, as well as being resistant to silver, was also resistant to cadmium, and it could be used in bioremediation to take up both silver and cadmium – that could possibly still be an infringement of the claim above, provided that the variation was “immaterial”, although the additional properties may suggest that the variation is, in fact, material.

Finally, it is worth keeping in mind that patentability and freedom to operate are different concepts - the silver and cadmium resistant strain itself could be patentable, even if it infringe the earlier patent, because that variation in its use might be an “inventive” one. 

 That is all to say that although it can be straightforward to deposit a specific strain, and in some instances such as for natural microbes it is the only way to satisfy the patentability requirements, it could potentially lead to a narrow patent.

A narrow patent may however, provide a company the exact protection needed – if e.g. a health benefit is to be tested, clinical trials are conducted with multiple microbial species. The time invested in isolating and subsequently testing such species is significant and it may well be that a narrow patent provides the competitive advantage and “head-start” over competitors who would need to work around the patent protection.

Patent vs Trade Secret?

Depending on what you are doing with your strain, it can sometimes make more sense to keep the strain as a trade secret rather than try and seek patent protection and needing to deposit the strain. 

This is something you need to think about early on in the inventive process – build this into your IP strategy and discuss with your patent attorney team. It is important to understand that in any event, prior to the filing of a patent application, the details of your invention must be kept confidential, otherwise you may find your patent application is not novel or inventive over the information (or invention) which was disclosed to the public before the application date.

A trade secret has to be kept “secret” and practical steps must be taken to preserve the secrecy of this information, over and above that which is used for confidential information. Therefore if your business model involves putting the microbe out into the public domain (either dead or alive) – for example as part of a skin-care product which could be reverse engineered to identify that strain, the strain would no longer be secret, and therefore would not be protected. In these cases looking for protection via a trade secret is not appropriate, and a patent should be utilised instead. 

Similarly, academic research tends to be published at some point – there is no point trying to keep a strain (or indeed any other information) as a trade secret if it will shortly be published in detail in an academic journal.

If on the other hand your microbe is used in the production of a protein (for example) and it is only the resulting protein that is made publicly available, it may be appropriate to consider trade secret protection rather than patent protection. This also comes with caveats – depending on what the product is used for, for example if it is a therapeutic, obtaining regulatory approval may require providing information about the specific strain you are using – again in some cases this can be kept confidential, but if there is a chance that details of your strain may need to be made public, seeking patent protection can be the best option.

Another important thing to note here – under the Budapest Treaty, access to the deposited strain is restricted - but different countries have different rules and there is no guarantee that a strain you deposit at a national depository will not end up in the hands of your competitor without your knowledge.

A key distinction between trade secrets and patents is that trade secrets do not give you the right to stop someone else from independently coming up with the idea of using the same strain, whereas a patent does give you that right.

Broad claims to microorganisms

The way to get a broader patent scope to protect your microorganism, that can in some instances cross strain, species and genus, is to identify what it is about the strain that is responsible for the desirable phenotype, and protect that – which will be the subject of the next article!