AIPPI Congress Report 5: Pharma Day I - Sufficiently plausible

The AmeriKat waiting for a promise to be fulfilled,
ponders whether, perhaps, the promise
was, in fact, always implausible

The quality of seeming reasonable or probable.  It is clear that is the definition of "plausibility", but it is less clear what it means in patent practice.  What does this threshold really mean?  Where is the line drawn?  What are the policy reasons behind it? The first Pharma Day session at AIPPI Sydney had the ever topical issue of what does plausibility mean at its heart.  Warwick Rothnie reports:

"Jurgen Meier (moderator) outlined the theme of the session as looking at increasing questions from European Patent Office examiners beyond the traditional requirements of novelty and inventive step: whether an application for a life science patent is plausible or credible. Although not expressly mentioned in the EPC, the objection derives from the requirements of clarity, support and technical effect. 

Dominic Adair explained that “plausibility” is directed at preventing speculative claiming and so deprive others of freedom to operate. He argued that there could be situations where so-called armchair inventions should be permitted. Unlike mechanical patents, little in pharma is self-evident, especially second medical uses.

Dominic Adair then noted that the English courts required more than just demonstration that the claim was not inherently implausible, but must be assessed as a matter of substance. Nonetheless, the requirement of plausibility is still a “very low” threshold and different to the requirement of “fair expectation of success” in the inventive step inquiry - citing Actavis v Lilly[2015]. 

Questions which remain outstanding are the extent to which the plausibility threshold varies according to the technical field. Also, how is plausibility assessed in a field of fast moving technology, particularly when the assessment is being made in a revocation proceeding many years after filing. Another question is how will the courts decide cases where the molecular mechanism claimed is plausible at the priority date, but subsequently shown to be wrong, even though the claim still works (for reasons unknown). 

Charles Boulakia explained that similar unanswered questions arose also in Canada. Canadian courts had recently admitted that they were confused about how the sufficiency requirement in s 27(3) worked with the utility requirement in s 2. The Canadian Supreme Court had ruled that the questions are:

1. what is the invention?

1. How does it work?

1. Having only the specification can a person skilled in the art successfully produce the invention using only the instructions contained in the patent?

Thus, if a person can make a “prophetic example” work following the instructions in the patent, that should be sufficient. If a minor research project is required, however, the claim will be insufficient. A recent example related to patents for skidoos where the invention turned on how the position of the rider was changed. Implementation of the invention, however, required more detailed instructions than given in the specification. Accordingly, the patent was invalid. Charles Boulakia then emphasised that, for the prophetic example to support validity, the prophetic example must nonetheless actually work. 

In Canada, it is not sufficient to include some examples that can be extrapolated to the claimed general principle. To claim the general principle, there must be examples plus an explicit statement outlining the reasoning which led to the claimed principle. Canadian courts will almost always refuse to take into account data obtained after filing the application. 

Canadian law has, however, abandoned the requirement that the claims satisfied the “promise of the patent”.[1] Intentional misleading could well still be a basis for invalidation. 

Judge Xia Luo, from the Supreme Court in China, explained the position in China (which Jurgen Meier explained her Honour had a large role in deciding). In the Warner-Lambert case the Supreme Court was prepared to admit experimental data after the filing date, but only if certain conditions were met. One important limitation is that data supporting a technical effect not disclosed in the original application is not admissible. Generally, experimental data which was not available to the person skilled in the art at the priority date would not be admissible as it was unfair: the patentee was not making a sufficient disclosure in exchange for the monopoly grant. 

Chinese courts will first consider whether the technical solution claimed in the patent is reproducible by following the instructions in the patent. For a novel compound, the patent must disclose and verify at least one use or application of the compound. 

Michele Wales congratulated AIPPI on adopting the gene patenting resolution yesterday. Ms Wales explained that the US was fully aware that its position was inconsistent with TRIPS, but the patentable subject matter tests in Alice, Myriad etc. were proving to be an effective tool for invalidating patents. Ms Wales considered that some 47% of biotech patents may be invalid. 

In the USA, prophetic examples are allowable, but must be written in the right (present) tense and confirmatory, post-published data is admissible. 

In Amgen v Sarnofi/Regeneron Fed Cir 2017–1480 (Oct 5 2017), Amgen (Repatha) and Sanofi (Praluent) had competing claims to antibodies binding to PCSK9 to lower high LDL levels. 

Amgen’s discovery of the commercial embodiment came after the patent, but there was extensive disclosure of the class in the specification. The Federal Circuit ruled that Sanofi should have been permitted to rely on its evidence about its experiments after the priority date showing the particular difficulty in identifying its own particular antibody. This evidence could be used in support of both its defence to infringement and that there had been insufficient disclosure in the patent to support the claimed monopoly. Accordingly, the Federal Circuit remitted the matter to the District Court for reconsideration.

Ms Wales noted that, following this decision, it will probably be easy for an infringer to create a story supporting the difficulty of developing its invention which could be used to invalidate the competing (Amgen’s) patent. 

The US courts have also eliminated the “antigen exception” for claiming the antigen. Now, it will be necessary to disclose the specific structure of the antibody in the specification as with other “small molecule” claims. This will have great commercial impact with licensees now likely to be re-assessing whether they need a licence at all as many thousands of patents had been based on the “antigen excretion” and were not written to satisfy this “small molecule” requirement. This will have serious ramifications for many Universities and other small and medium enterprises which often rely on licensing their inventions out for development and commercial exploitation."

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1. Contrast the situation in Australia under the Ronneby Road case (appeal pending.)