Obtaining Patents With Fictitious Data – More Than Just Plausible

In the United States, it is possible to obtain a patent using fictitious data as the basis for the patent claims.

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

By allowing prophetic examples, applicants are able to support 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 support patent claims because they do more harm than good to innovation. If the prophetic examples prove to be unfounded they can still be used for obvious purposes against a later inventor who created a working prototype or used working examples. Once a patent is granted, it has a presumption of validity and the prophetic examples it contains are presumed to be activated, which can act as a deterrent to those seeking to innovate in this space. There is also the danger that fictitious data will not be recognized as such, which has turned out to be the case most often with scientists referring to prophetic examples as if they were the results of experimental data. real. This is especially troubling if the prophetic examples are in fact wrong, but remain unchecked with the status of scientific fact.

Commentator Janet Freilich suggest that it is better to view these fictitious data as hypothetical examples rather than prophetic examples, as this more clearly shows that these are verifiable predictions which may or may not be true. Freilich further suggests that inventors could be given a grace period to provide working examples to support their hypothetical examples.

Although the use of fictitious data is not actively considered in other jurisdictions, there are parallels with the requirement in UK and EU case law that an enabling disclosure must at least be plausible, as is considered in the following cases, which will have an influence in New Zealand under the Patent 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. not supported by experimental work) meet the sufficiency requirements of the Patent Act. The Court of Appeal concluded that when considering the sufficiency of a patent, a claim that the invention would work within the full scope of the claim must 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 all cases. However, if it was not possible to make such a prediction, or if the prediction turned out to be wrong and the invention did not work with virtually all products or methods 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 specification claims that a technical effect is plausible. If a problem has in fact not been solved, then a patent should not have been granted in connection with it, because plausible but false 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 was not made plausible by the specification.

In Actavis Group PTC EHF v Eli Lilly and Co [2015] EWHC 3294 a UK judge ruled that the plausibility test for sufficiency is easier to meet than the obviousness test. The judge noted that the test of fair expectation of success for obviousness is not met by being obvious to try. If the obvious were met by the latter, there would not be enough incentives for research and development, as many approaches may be obvious to try without any real idea of ​​their effectiveness. In contrast, plausibility is satisfied by credible disclosure, which is akin to the obvious test to try and easier to meet than the fair expectation test. The purpose of the plausibility test is to exclude speculative patents based on a mere assertion where there is no real reason to assume that the assertion is true. The EPC does not require that claims be supported by data or experimental evidence. Provided they are plausible, claims not supported by such material can be sustained without the need for a fair expectation of success.

In Bristol-Myers Squibb Holdings Ireland v Actavis Group PTC T 488-16 a The EPO boards of appeal have stressed 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 may be used as additional evidence to corroborate a technical effect which has been found to be at least plausible at the time of filing. deposit date. Although the application as filed refers to tests which could be used to determine the degree of activity of the many compounds initially claimed, no experimental results were provided for any compound in any test. Likewise, no activity threshold was indicated. The application as filed also did not show that a person skilled in the art possessed common general knowledge which, even in the absence of data, made it plausible that the compounds of the invention, in particular dasatinib, could have activity. The EPO’s BoA rejected Bristol Myers Squibb’s attempt to infer such knowledge from structurally different compounds due to the lack of any correlation between structural characteristics and function. The EPO BoA noted that the invention is based on a technical effect which is neither obvious nor predictable or based on a conclusive theoretical concept. In such circumstances, at least some technical evidence is needed to show that a technical issue has been resolved. In particular, it has not been considered acceptable to develop a generic formula covering millions of compounds, to vaguely indicate activity, and to leave it to the imagination of the informed reader or to future investigation to establish which compounds exhibit l activity in an appropriate manner to achieve the desired effect.

In the decision of the Australian Patent Office Evolva SA [2017] APO 57 the Hearing Officer endorsed the use of UK and EU case law to assess sufficiency, and in particular the notion of plausibility, for claims subject to Raising the Bar legislation. Summarizing the principles underlying UK and EU affairs, the Hearing Officer found that:

  • the plausibility test is met by a low threshold designed to prohibit speculative claims rather than a threshold that gives a reasonable expectation of success.
  • the scope of the monopoly, as defined in the claims, must correspond to the technical contribution that the patent owner has made to Art. If the statements made in the specification are not plausible, it cannot reasonably be said that the patentee made a contribution to s.

The Hearing Officer also confirmed the UK’s authority for a two-step sufficiency test, stating that:

  • an invention that is plausible can always fail in sufficiency if the specification essentially sets out a research program and there is an excessive load of experimentation required to put it into practice.

In Warner Lambert Company LLC v Generics (UK) Ltd [2018] UKSC 56 the Supreme Court has confirmed that sufficiency of disclosure requires that the specification 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 counterpart contribution to the art must be something more than mere speculation, it the patent owner is responsible for establishing it. . However, plausibility does not require definitive evidence, which would only be available after clinical trials have been completed and which could support a patent application as post-published evidence, but nonetheless a reasonable basis for making the claim must be present in the application on its filing date.

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