Can a patent be invalidated when the inventors later publicly doubt operability and the reliability of reported results?

Question

In a concrete example, the patent application describes a particular method and, as part of the enabling disclosure, reports certain detector readings as confirmation of the expected outcome i.e. confirmation that the method works.

However, one year later, the inventors publish a journal paper in which they summarize this work for a scientific audience. Here, the inventors describe the results as ambiguous and uncertain. They describe the same data referenced in the patent disclosure as indistinguishable from noise and call into question whether the expected outcome actually occurred or not. The inventors say they are not sure what was going on - the effect could have been there, or not. In any case, they have no confidence to argue either way based on the instrumentation used at the time.

So, at this point, nobody actually knows whether the invention works or not as described in the patent application (and the experiment is too elaborate that anyone would try or has since tried again without confidence that it does work). Again: maybe the effect does occur based on the proposed setup, if only a better detector were used - but there is just no way of telling based on the public information to date.

I would think this questions the requirement of enablement "without undue experimentation."

Does such a patent have a chance of surviving or can it be easily litigated? Would it survive if it could later be shown that the effect was in fact present even if it was drowned out by noise at the time and in the described embodiment? If the latter were the case, then the patent author would have made "the right guess" at the time I suppose.

Answer 1

1. If the application is still pending, you may even attempt filing third-party submission (if still possible), and state that the publication is relevant to 101/utility. However, it sounds like this period has passed. Following on from Maca's comments about duty of good faith, it may be considered a responsibility of the applicants to bring the publication to the notice of the Office if it does bring a material question to the operability/utility of the method. Otherwise, there may be an inequitable conduct (unenforceability) argument you could bring in litigation.

2. There may be a reasonable chance of invalidating broad "outcome" claims over 112(a)/enablement, 112(a)/written description, and/or 112(b)/indefiniteness -- or at least obtaining a narrow claim construction (such that you could easily design around).

   It sounds like the inventors don't exactly understand the mechanism by which the outcome is produced, but that it just "magically" does. This on its own does not negate patentability, as long as the method to produce the desired outcome is described and the outcome actually does follow, satisfying 112(a)/enablement and 112(a)/written description.

   a. However, if the inventors are claiming a broad range of methods to produce the outcome without fully understanding why the outcome is produced, this is unlikely to comply with 112(a)/enablement and 112(a)/written description, as they have likely not enabled a PHOSITA to produce the outcome via all possible methods (just the one method they disclosed), nor have they shown possession of all the possible methods at the time of disclosure.

   b. Additionally, if the inventors are claiming all possible methods to produce the outcome, but even they do not understand the mechanism of outcome-production, it is unlikely that a PHOSITA would know which methods they are and aren't claiming -- therefore, invalid under 112(b)/indefiniteness.

   c. Finally, if the claims are not invalidated, you could likely get a narrow claim construction covering only the specific method they described to produce the outcome. Given that they do not understand the mechanism to produce the outcome, it is likely that their method will have extraneous steps. Therefore, if the claims were narrowed in this way, you could likely avoid infringement by merely following the same method they described without an extraneous step, but at least avoid infringement by another method.

Answer 2

It depends. If they are claiming (in the claims) the results or something related to the results, then maybe.

If however they are claiming for example the method and it's described in a way that someone can reproduce it, then probably not. It doesn't matter if the results of that method are bogus if someone skilled in the art could still perform the method. If the result is bogus, then the patent doesn't protect anythig useful, so the patent isn't worth anything anyways though.

Which is why patent law kinda leaves that part open, an invention doesn't really have to be useful in the common meaning of that word, not the patent law meaning (how would the patent office determine that anyways), determining that is the job of the market - either the invention is used - or it isn't.

Answer 3

You haven't said what is actually claimed. But that's what matters. I have assumed that the claims relate to the particular method that you note is described.

Enablement requires that the reader can put the claimed invention into practice. In the case you describe, you have implied that the reader could perform the steps of the method. It is therefore enabled.

Enablement does not look at whether the claimed invention achieves the aims set out in the description. Or to put it another way, whether the method achieves the stated effects is not relevant for enablement.

A more relevant requirement is utility.

Utility requires that the invention has some use. It doesn't have to be particularly good, but it can't be completely useless. In the case you describe, it seems the method might well work. This is enough for the USPTO, who will not question a statement of utility that is prima facie credible. Subsequently, if a patent is litigated, it will be for the court to decide (based on the evidence submitted by each side). There is no way to know how this will go, but in general if there is a credible case for utility, this will often be enough, even if it cannot be proved to work.

I have assumed the description (and the data interpretation) was made in good faith, and then the inventors subsequently had a realisation. Intentional misinterpretation or misleading disclosure in bad faith would likely be a breach of the various duties owed to the USPTO, and would result in invalidity (even if the invention itself worked fine).

Therefore, to your specific questions:

Does such a patent have a chance of surviving or can it be easily litigated?

Yes, there's a reasonable chance of validity. The data being misread at the time is not necessarily fatal, since that's only one way of proving utility, and is not at all required.

Would it survive if it could later be shown that the effect was in fact present even if it was drowned out by noise at the time and in the described embodiment?

This would be helpful, because then the claimed invention can be shown to have utility.