Obtaining Patents with Fictional Data - More Than Just Plausible

In the USA it is possible to obtain a patent using fictional data as the basis for the patent’s claims.

The USPTO allows this provided the experimental data is expressed in the present or future tense, such data is known as prophetic examples or paper examples. In contrast, experimental data from actual experiments are expressed in the past tense and are known as working examples. Patents can be granted where only prophetic examples are used, although there can also be a mixture of prophetic and working examples.

By allowing for prophetic examples applicants are able to provide support for broad claims without having to undertake costly and time-consuming experiments. A valid patent can be obtained through the use of prophetic examples, although it can be invalidated if the predictions later prove to be incorrect.

However, several commentators argue that prophetic examples should not be allowed to provide support for patent claims as they do more harm than good for innovation. If the prophetic examples are shown to be unsound they can still be used for obviousness purposes against a subsequent inventor who has created a functioning prototype or used working examples. Once a patent is granted it has a presumption of validity and prophetic examples within it are presumed to be enabled, which can have a chilling effect on others seeking to innovate in that space. There is also the danger that the fictional data is not recognised as such, which has been shown to be the case with scientists more often than not referring to prophetic examples as if it was actual experimental data results. This is particularly troubling if the prophetic examples are actually wrong, yet remain unchecked with the status of scientific facts.

One commentator, Janet Freilich, suggests that it is better to think of such fictional data as hypothetical examples rather than as prophetic examples as that more clearly shows that they are testable predictions that may or may not be true. Freilich further suggests that inventors could be given a grace period in which to provide working examples to back-up their hypothetical examples.

While the use of fictional data is not actively catered for in other jurisdictions, there are some parallels with the requirement under UK and European jurisprudence that an enabling disclosure has to at least be plausible as considered in the following cases, which will be influential in New Zealand under the Patents Act 2013.

In Regeneron Pharmaceuticals Inc v Genentech Inc [2013] EWCA 93 the UK Court of Appeal clarified when patent claims containing predictions (i.e. unsupported by experimental work) satisfy the sufficiency requirements of the Patents Act. The Court of Appeal found that when considering the sufficiency of a patent an assertion that the invention would work across the scope of the claim had to be plausible or credible. If it was possible to make such a prediction, then it could not be said that the claim was insufficient simply because the patentee had not demonstrated that the invention worked in every case. However, if it was not possible to make such a prediction, or if it was shown that the prediction was wrong, and the invention did not work with substantially all the products or methods falling within the scope of the claim, then the scope of the monopoly would exceed the technical contribution made by the patentee to the art and the claim would be insufficient.

In Generics [UK] Limited v Yeda Research & Development Co Ltd [2013] EWCA 925 the UK Court of Appeal held that post-priority evidence can be used to demonstrate lack of invention by contradicting assertions in the specification to the effect that a technical effect is plausible. If a problem has not in fact been solved, then a patent should not have been granted in relation thereto, since plausible but untrue predictions do not constitute a contribution worthy of patent protection. The Court of Appeal also confirmed that post-dated evidence cannot be used to establish a technical effect that has not been made plausible by the specification.

In Actavis Group PTC EHF v Eli Lilly and Co [2015] EWHC 3294 a UK Judge held that the test for plausibility in regards to sufficiency is easier to satisfy than the test for obviousness. The Judge noted that the fair expectation of success criterion for obviousness is not satisfied by being obvious to try. Were obviousness to be satisfied by the latter there would be insufficient incentive for research and development, since many approaches may be obvious to try without any real idea of whether they will work. By contrast, plausibility is satisfied by a disclosure that is credible, which is akin to the obvious to try test and easier to satisfy than the fair expectation of success criterion. The purpose of the plausibility criterion is to exclude speculative patents based on mere assertion where there is no real reason to suppose that the assertion is true. The EPC does not require claims to be supported by data or experimental proof. Provided they are plausible, claims unsupported by such material can stand without needing to have a fair expectation of success.

In Bristol-Myers Squibb Holdings Ireland v Actavis Group PTC T 488-16 an EPO Boards of Appeal (BoA) emphasised the importance of demonstrating the plausibility of the proposed inventive subject matter at the filing date. According to established case law the plausibility of the technical effect cannot be established by evidence filed after the filing date, although such evidence can be used as supplementary evidence to corroborate a technical effect that was deemed to at least be plausible at the filing date. Although the application as filed generically referred to assays that could be employed in ascertaining the degree of activity of the numerous compounds initially claimed, no experimental results were provided for any compound in any assay. Nor had any threshold level for activity been given. The application as filed also did not show that the skilled person was in the possession of common general knowledge which, even in the absence of data, made it plausible that the compounds of the invention, in particular dasatinib, could be expected to show the claimed activity. The EPO BoA rejected Bristol Myers Squibb’s attempt to infer such knowledge from structurally different compounds due to the absence of any correlation between structural features and function. The EPO BoA noted that the invention relies on a technical effect which is neither self-evident nor predictable or based on a conclusive theoretical concept. In such circumstances at least some technical evidence is required to show that a technical problem has been solved. In particular, it was not considered acceptable to draw up a generic formula covering millions of compounds, vaguely indicate an activity and leave it to the imagination of the skilled reader or to future investigations to establish which compounds exhibit the activity in a way that is suitable to achieve the desired effect.

In Australian Patent Office decision Evolva SA [2017] APO 57 the Hearings Officer approved the use of UK and European jurisprudence in assessing sufficiency, and in particular the notion of plausibility, for applications subject to the “Raising the Bar” legislation. In summarising the principles behind the UK and European cases on point the Hearings Officer found that:

• the plausibility criterion is satisfied by a low threshold designed to prohibit speculative claiming rather than one that gives a reasonable expectation of success.
• the scope of the monopoly, as defined in the claims, must correspond to the technical contribution the patentee has made to the art. If the assertions made in the specification are not plausible then it cannot be reasonably said that the patentee has made a contribution to the art.

The Hearings Officer also affirmed UK authority for a two-stage test for sufficiency, stating that:

• an invention that is plausible may still fail on sufficiency if the specification essentially sets out a research programme and there is an undue burden of experimentation required to put it into practice.

In Warner Lambert Company LLC v Generics (UK) Ltd [2018] UKSC 56 the Supreme Court confirmed that sufficiency of disclosure requires that the specification should at least make the claimed subject matter plausible. Such a requirement is considered crucial in the case of second medical use patents, since the active ingredient is already known so the quid pro quo contribution to the art needs to be something more than mere speculation, with the onus being on the patentee to establish it. However, plausibility does not require definitive evidence, which would only be available after clinical trials were done and which can further support a patent application as post-published evidence, but nonetheless some reasonable basis for making the claim needs to be present in the application on its filing date.

Author: Quinn Miller

//piperpat.com/news/article/obtaining-patents-with-fictional-data-more-than-just-plausible