Did I really need to say that?

From time to time we all say things that, on reflection, might have been better left unsaid. In most cases the repercussions are trivial, but sometimes something said earlier can have a profound effect later on. Our message may have been understood, in which case we would have been better off keeping our lips sealed. Otherwise, we have been misunderstood. We have not said what we meant to say and we have not given enough thought to our words and their potential implications.

In a research context, what we are concerned about here are those sorts of statements that foreshadow a particular outcome or application of observed results that perhaps cannot be inferred from the results as they stand. Often these statements are, at best, highly speculative or at worst, not within the realms of possibility in the natural world! We are talking about those statements that you tend to see at the end of an ‘Abstract’. For example, ‘This work suggests that …’, or at the end of an ‘Introduction’, ‘In this study we sought to show that … ‘, or in a ‘Discussion’ when it says, ‘A cure for cancer is an entirely credible prospect of my work.’

We say these things to identify real world relevance, economic or social impact in the underlining work. It is not surprising therefore that more often than not it is these statements that a patent examiner—or litigant—will more immediately seize on as an opportunity to prevent one from monopolising that economic impact with a patent. This is especially where no reasonable interpolation can be made from the underlining work.

So why is it that these sorts of statements provide opportunity for a patent to be rejected? It is because you cannot obtain a patent if your invention is obvious over what was known before you filed your patent, including what you said or published before you filed your patent. Even if you can obtain a patent in these circumstances, it can later be revoked by a court in litigation.

Obviousness is a particularly difficult ground to have to fight a patent examiner on because the relevant test—whether a skilled worker in view of the particular statement would as a matter of course have been directly led to the invention in the patent—is often poorly understood or otherwise incorrectly applied. The issue is to be considered in the light of what was generally well-known and understood by the skilled worker before the priority date.

Experience shows that in many cases, the patent examiner does not have enough time to properly brief himself on the knowledge as it was generally understood before the patent was filed. Sometimes this knowledge existed many years before he is called to examine the patent and has, since its existence, evolved into something quite different.

In these circumstances, it is perhaps not surprising that an examiner will consider the relevance of a particular document by reviewing those parts of it in which they would expect to find a statement (such as those above) and then interpret that statement as defining knowledge as it was generally understood and accepted before the patent was filed. Given time constraints, once these statements have been identified, there may be resistance to investigate the issue further. This is often the case and an examiner will routinely cite a document on the basis of speculative statements contained in it.

It is then for the patent owner to persuade the examiner otherwise. This can involve many hours of legal argument and expert testimony. Eventually the examiner may be persuaded to withdraw but often not until many dollars have been spent. On some occasions, especially in jurisdictions such as Europe, the patent is found invalid. Other times the scope of the monopoly in the patent may have to be severely pruned. This is to render the patent subject to design around or otherwise its commercially ineffective.

Case study: Peptide-based vaccine development

This issue should be of considerable concern to those working in immunology, given the long development times to a patentable product. For example, let’s say that a peptide-based vaccine has been invented that provides both prophylactic and therapeutic protection against a particular disease. The peptide is part of a larger protein that is expressed on the surface of a strain of bacteria.

To arrive at a peptide based vaccine, a number of key stages need to be achieved. For example:

• Stage one: Identification of the bacterial cause of the disease
• Stage two: Isolation of the pathological strain of bacteria
• Stage three: Characterisation of the bacteria including all or part of its proteome, and
• Stage four: Determination of a suitable epitope of a bacterial protein for use as a vaccine.

In this hypothetical example, it is likely that a patent for a vaccine would only be granted with the results from stage four at hand which show that a protective or therapeutic immune response is generated when a human is immunised with the peptide. However, in a development process that might take three to six years leading to the vaccine, it is entirely appropriate that the authors of the work will want to publish results of experiments of stages one to three. The concern is the temptation to add a speculative statement that a protein or part of a protein expressed in the surface of the bacteria may act as a suitable vaccine for the disease at these times.

Indeed the practice of disclosing the next step in the development of an invention before a patent has been filed is so widespread that an experienced patent examiner will routinely search on disclosure made by the inventor on a patent application. Note that in our digital age we need to be concerned with electronic journal publications but also any other type of media including websites.

Question the potential impacts of releasing information

In conclusion, the primary message is not that you should never identify commercial application of research if a patent has not been filed. Ultimately a decision is for the author of the research to make within the operation of research and intellectual property policies of the relevant institution. Rather, what is proposed here is that we must first consider the potential impact of releasing information to the outside world before that information is released. Within this proposal the following questions are relevant:

• Do I really need to say this now?
• Am I aware of what I might wish to do later (that is, file a patent, license know how) so that if I say this now I understand future implications?
• Do the words that I propose convey the message I intend?
• Is it possible that those words could be misunderstood by another to convey something else?

Remember, no matter how speculative, tentative or exploratory a statement may appears to you, a patent examiner, or an adversarial third party, may take an entirely different view many years in the future.

You understand what I mean don’t you?

This article was written by Tom Gumley, Partner and Adam Denley, Patent Scientist, Melbourne.

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