US patent law is probably one of the most lenient in the world: it provides for no exclusion in principle and requires solely that an invention must be, as a first condition, useful (within the meaning of 35 USC 101) before it is examined from the viewpoint of “conventional” patentability criteria such as novelty and inventive step.
In the medical or biotechnologies field, the Americans have long played a pioneering role. Were they not the first to recognise the patentability of living things (Diamond v. Chakrabarty, 1980) or transgenic animals (Oncomouse, US patent granted in 1988)?
The situation has always been different in Europe. From the outset, the European Patent Convention ruled out, in particular the patentability of therapeutic treatment, and surgical and diagnostic methods applied to the human or animal body1, These exclusions, together with the means for bypassing them, have been well understood for decades by patent applicants seeking to protect such inventions and patents have therefore been obtained – albeit at times with different scopes, on both sides of the Atlantic.
This situation appeared to be a given until the US courts decided to toughen their stance on the application of the usefulness criterion, invoking (although this was not new) the laws of nature, natural phenomena or natural products.
It started with the Mayo v. Prometheus decision handed down by the Supreme Court on 20 March 2012 in the field of diagnostic methods. In this case, it was considered that a method for optimising the treatment of a patient suffering from an immune deficiency condition, a method that consisted of several steps, constituted no more than observation of the “laws of nature” combined with routine steps and that, for this reason, the method in question was not patentable under 35 USC 101.
This method consisted of determining the levels of a compound in a patient after administering the drug to determine whether the dosage should be increased or decreased on subsequent administration. In effect, the determination revealed the level of degradation of the drug in the body, i.e. a “natural phenomenon” and integrating this natural phenomenon in a diagnostic procedure, itself consisting of conventional technical steps, was not sufficient to satisfy the usefulness criterion.
Drawing on this decision, the Supreme Court then demanded that the Federal Circuit reconsider the Myriad case. In August 2012, the three Federal Circuit judges confirmed the decision they had taken a year earlier, i.e. that isolated DNA is patentable (within the scope of 35 USC 101), on the grounds that these molecules are not found as such in nature, that they are the result of human intervention and have a specific identity and chemical structure.
However, on 13 June 2013, the Supreme Court unanimously reached the exactly opposite conclusion and decided that sequences of isolated nucleic acids are the products of nature and are hence not patentable.
On the same day, the US Patent and Trademark Office (USPTO) issued a Memorandum to the Patent Examining Corps, instructing them to reject any product claim concerning a sequence of natural nucleic acids or a fragment thereof, whether isolated or not, for lack of usefulness under 35 USC 101.
The patentability of methods that implement nucleic acids is not clear, any more than those of proteins, antibodies and their use, etc. Furthermore, this Memorandum announces that after in-depth analysis of the Supreme Court’s decision, more detailed directives will be issued!
At this point, it is evident that application of the usefulness criterion with respect to the laws of nature, natural phenomena or natural products may well be extended to other types of inventions and technical fields… But to what extent?
A preliminary response was given on 4 March 2014, when the USPTO issued a further Memorandum (Guidance Memorandum) to the Patent Examining Corps, with immediate effect.
This Guidance clearly states that it applies to all types of inventions (machine, composition, manufacture or process) concerning or consisting of a law of nature, a natural phenomenon and/or a natural product. It proposes a method for determining whether such inventions are “significantly different” from what exists in nature, a mandatory criterion for considering them as eligible, i.e. as potentially patentable inventions and hence eligible for substantive examination according to the “conventional” patentability criteria, notably novelty and inventive step.
It is important to note that with this new Guidance, the USPTO wished to go well beyond the issue of the patentability of nucleic acids and apply these new eligibility criteria across very large number of technical fields.
This Guidance stipulates, in effect, that the definition of a “natural product” is (but not limited to): any chemical entity derived from a natural source such as an antibiotic, an oil, a fat, a petroleum by-product, a toxin, a resin, etc.; any food product such as a fruit, a seed, a plant; metals and metal compounds present in nature; minerals; natural materials such as sand and soil; nucleic acids; organisms such as bacteria, plants, multicellular animals; proteins and peptides; and any other substance found in or derived from nature.
The procedure set forth in this Guidance, intended to allow US patent examiners to determine whether the invention concerned is “significantly different” (or not) from a law of nature, a natural phenomenon or a natural product, relies on examiners using a battery of factors that are supposed to assist them in their work.
These factors are divided into two categories: factors that weigh toward eligibility (six in all, from a) to f)) and factors that weigh against eligibility (also six, from g) to l)). These factors are of course not definitive, and the creativity of inventors and examiners will no doubt lead, over time, to a lengthening of these respective lists.
So, what are these factors?
Factors ” toward eligibility” include, for instance, factor a) specifying that the product claim does indeed concern a product not present in nature or markedly different, in its structure, from natural products, and factor d) specifying that the claim recites elements/steps that go further than describing the fact or natural product used or applied by means of general instructions.
Factors “against eligibility” include, for instance, factor g) specifying that the product covered by the claim is not markedly different, in its structure, from natural products, and factor j) specifying that the claim recites elements/steps that are commonly accepted, purely conventional or routinely taken in the field under consideration.
Hence, the US examiner, when dealing with an invention that implements a law of nature (e.g. a property of a specific bacterium) or involving the use of a natural product (e.g. salt) will have to seek, in the (initial) twelve factors proposed in the Guidance, those that apply to the claims concerned, toward eligibility and/or against eligibility.
The examiner shall then sum them up and provide a synthesis, particularly concerning the description of the invention, reach the decision on either the eligibility or non-eligibility.
To put it more simply, the US examiner will produce an adapted version of the comparison between the “plus” column and the “minus” column to decide on follow-up action relative to the substantive examination for patentability of the invention concerned.
While the principle of not granting patents for inventions based on the laws of nature, natural phenomena or natural products,- which are by definition universal and therefore the property of all is commendable, we can nonetheless see that the noose is tightening around the scope of inventions in the United States.
Indeed, in order to significantly distinguish from a law of nature, a natural phenomenon or a natural product, claims must include characteristics proving human intervention and, what’s more, in an original way. The task will be to convince the US examiner that the invention goes beyond what happens or is found in nature, that it adds (at least) one essential and original feature or that it involves an unprecedented application. What is disclosed in the description is therefore crucial for defending the invention.
While the approach is not new, it nevertheless adds a new dimension, and although this Guidance is neither legally binding nor “Supreme” case law in the USA, a common-law country, it is highly likely that exchanges with US examiners will become more difficult.
In effect, the procedure proposed in the Guidance (whose relative importance has not been defined for several factors) raises the spectre of complex and potentially numerous exchanges before any substantive examination of the invention.
In a few months, we will be able to analyse the initial consequences of these new practices. One of those, in all probability, will be to note a growing discrepancy between the protection obtained for a given invention on either side of the Atlantic. Who could have anticipated such a development just a few years ago?
P.S: This situation may well not be definitive, the USPTO having (already) decided to prepare a revised version of the March 2014Guidance. Does this mean that the USPTO has realised that it had gone a little too far with these new measures or that certain lobbies have been particularly active?
Whatever the case may be, this new version may be published within a few weeks… presenting the prospect of yet another abrupt change in the field of patentable – or non-patentable inventions in the United States.
