Question:  What do the following products have in common – an oligonucleotide with identical nucleotide sequence to part of the human genome, gunpowder and a novel mixture of several naturally-occurring bacterial strains?

Answer:  They are all ‘not markedly different from what exists in nature’ according to the USPTO’s Guidance notice of 04 March 2014 – and are thus not ‘patent eligible’ subject matter.

This conundrum illustrates the serious challenges that applicants now face in persuading the USPTO that inventions based on natural products or ‘laws of nature’ are eligible for patent protection.  Applicants will need to persuade the USPTO that claims to such inventions are ‘patent eligible’ separately from the more-familiar analysis of novelty and inventive step.

According to the USPTO’s Guidance notice, when a naturally-occurring product has been isolated for the first time, claims that attempt to protect it in its broadest sense will not be allowed, even if the product was unknown before its isolation.  Applicants may have to rely on process or method claims to protect the isolation process instead of using broad product claims.

Similarly, when a new process or method relates to a newly-found natural correlation, a claim that broadly defines an application of the natural correlation is likely to be rejected.

The Guidance will be used by USPTO patent examiners to apply an interpretation of US patent law (specifically, 35 U.S.C. section 101) following the widely-reported US Supreme Court decisions from Mayo v Prometheus (2012) and A.M.P. v Myriad Genetics (2013).

Novelty Is Not Enough

A claimed invention might be not be patent eligible despite being novel.  For example, an oligonucleotide with a nucleotide sequence that’s identical to a known part of the human genome is novel if the oligonucleotide has been made as a ‘stand-alone molecule’ for the first time, e.g. by excising it from the genome. 

However, the Guidance states that such oligonucleotides are not markedly different from the naturally-occurring genomic sequence because the genetic sequence has not been altered.  Hence, according to the Guidance, such oligonucleotides are not patent eligible because the structural changes inherent to a ‘stand-alone’ nucleic acid are not significant enough to confer eligibility.

Similarly, a novel mixture of naturally-occurring bacteria that fix nitrogen in the roots of a particular plant is not considered to be a patent eligible product.  According to the Guidance, the mixture is not significantly different to what exists in nature because, individually, the bacteria are structurally and functionally unchanged – even though the mixture is new.

Other examples are given in which isolated or purified naturally-occurring compounds are regarded as ‘not markedly different’ from what is found in nature, and are thus not regarded as patent eligible.

Explosive Logic – What Constitutes a Significant or Marked Difference?

Surprisingly, gunpowder is exemplified as a class of products that isn’t necessarily patent eligible because simple gunpowder mixtures contain only saltpetre, sulphur and charcoal, which are all naturally-occurring. 

Despite severe criticism of this example, the USPTO maintains that simple gunpowder mixtures are not markedly different from what is found in nature because they can be separated, using vibration, into their component parts.  Clearly, this logic focusses only on a lack of structural change at a molecular level: the gunpowder’s explosive properties – which are absent from its unmixed constituents – are ignored.

Overall, the Guidance emphasises the importance of structural differences between a claimed product and any corresponding naturally-occurring products.  While functional differences should help to demonstrate a ‘marked difference’, it appears that showing a structural difference from natural products will be the key to persuading the USPTO that a product claim is patent eligible.

Process and Method Claims – Where is Your Point of Novelty?

The Guidance also contains examples of process and method claims that apply ‘natural principles’, which are essentially natural correlations.  In summary, if the novel part of the process lies in the application of a newly-found correlation, e.g. between a marker and a disease, the USPTO will object to claims that attempt to protect the application of this correlation in its broadest sense.

In other words, claims that broadly define detection of a marker for diagnosing a particular disease – or interaction with a marker to treat a disease – are likely to be subject to an objection under section 101.  The use of broadly-defined conventional techniques to apply a newly-found natural correlation, are unlikely to be enough to bring the claim within the realms of patent eligibility.

Instead, the Guidance indicates that highly-specific techniques for applying a newly-found natural correlation will have to be recited in the claim.

In one example, a method for diagnosing a human disease is claimed, where a misfolded protein is detected by using very particular methods, set out in the claim.  This claim is considered eligible because it is restricted to one particular method (specifically, binding the misfolded protein with an antibody, which is then detected using flow cytometry).  Of course, limiting a claim to a very particular method of applying the newly-found correlation severely limits the claim’s value.

When drafting new applications relating to such natural correlations, it will be important to include successive claims, with increasingly specific methods of applying the correlation.  Hopefully, a balance can be reached that affords reasonable protection while satisfying this new practice at the USPTO.

Patent practice in Europe is not affected by these guidelines, which apply only to the USPTO. European patent law explicitly exclude from patentability the human body, at various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene.  However, an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. Similarly, the European Patent Office does not regard discoveries or scientific theories as being inventions but an invention involving the practical application of a discovery or theory to provide a beneficial outcome has always been, and remains, patentable in Europe and is often claimable in its broadest sense.