In the summer of 1975, at a Medical Research Council (MRC) meeting, a presentation was given by scientists César Milstein and Georges Köhler.1 The topic: monoclonal antibodies. The presentation was attended by Tony Vickers, a member of the MRC, who asked the scientists for copies of an abstract that was soon to be published in Nature. It would reveal Milstein and Köhler’s research into monoclonal antibodies, and a technique for producing them. Acknowledging the importance of this technology, Vickers enquired of the National Research Development Corporation (NRDC), which owned the rights to MRC inventions, what they were doing to patent it. However, in the several months it took for the NRDC to follow up Vickers’ queries, and before a patent application was filed, the Nature article was published.
The consequence of all of this? The opportunity to file for a valid patent on those early Milstein & Köhler research findings was lost. This case highlights the tension that can be felt between the desire to publish and the need to patent, especially in commercially savvy environments such as medical technology and pharmaceuticals.
In this article, we discuss the legal rationale behind why publishing early can hinder future patenting opportunities, and result in loss of any associated commercial and developmental benefits. In part 2 of this article, we also provide practical tips for avoiding this situation.
First, it is important to consider why the publication in Nature was a problem for patenting the Milstein & Köhler work. If the inventors or owners of the technique for producing monoclonal antibodies wanted to patent it, why shouldn’t they?
The reason stems from one of the basic requirements for obtaining a patent in any territory in the world: that the invention being disclosed in the patent is “novel”. The idea being that a patent should only be granted to a truly new invention, such as a new method or product, or a new use of a known product. In most major territories of the world, this novelty requirement is “absolute”, i.e. the invention must be in fact be “new” to the entire world – not just to the territory of the patent application. Therefore, the disclosure in Nature of monoclonal antibodies and the technique used to produce them meant that this subject-matter, when written up in any future patent application, would no longer be new to the world.
Not only can an earlier disclosure result in a patent lacking “novelty”, but it can also have consequences for achieving the second basic requirement of a patent: that the subject-matter being claimed “involves an inventive step”. An earlier disclosure, even when not identical, can result in a later-filed patent application being considered obvious in light of the earlier disclosure, and therefore lacking a real technical contribution to the art (“inventive step”).
A public disclosure
In the case of Milstein and Köhler, the Nature article was clearly a public disclosure, in that the subject-matter was made available in an international scientific journal for anyone to see. Only public disclosures count against a later-filed patent; a secret disclosure would not. For example, telling a sponsor of your research under the terms of a ‘secrecy’ or ‘confidentiality’ agreement is unlikely to be counted as a public disclosure.
But sometimes it is not so clear whether there has been a public disclosure that may damage the chance of a valid patent. Such ‘disclosures’ are not limited to written articles in journals or similar printed publications. Disclosures can be in any form that is ‘made available to the public’, i.e. that the public can get hold of, whether they know of its existence or not. A disclosure may therefore be in the form of, for example: a document, a poster, or made in a website or social media post. Or it may not be written at all, but oral, for example: a formal presentation at a conference or to a third party company or research organisation, or an informal discussion at the pub or on the train! A disclosure may alternatively be graphical (pictures, photos) or a physical, i.e. a three-dimensional article embodying the invention, such as a machine or apparatus. An example of where a physical disclosure became a problem for obtaining a patent was when a prototype traffic signal (the invention) was tested out on a public road.2
Patent requirements around the world
Subject to limited and complex exceptions, the filing date of the patent application usually sets the date before which any public disclosure would invalidate the patent. This suggests that, once a patent application is filed, it is ok to publish the subject-matter contained in it. But that may only be the case if that is the final (or “complete”) patent application.
The reason for this is that it is possible, up to 12 months from filing the first patent application on an invention, to file further patent applications that add developments to the original idea, which naturally occur during a research programme. These further applications can claim the filing date of any of the earlier ones. However, the additions are only entitled to the date on which they were first included. Therefore, it is also important not to publish anything that has been or may be included in the final application before that 12-month anniversary. Otherwise, such publication of the earlier research would invalidate a patent on the additions, at least on the basis of obviousness. In fact, it is best to defer publication of the work until after publication of the patent application, to minimise the chance that even later opportunities to protect follow-on aspects of the R&D will be lost. Patent applications usually publish about 18 months after the first filing date, until when they are kept ‘secret’ by the patent office.
What does all this mean in practice?
- Try to defer publication of the work until after publication of any patent application relating to it or at least until after the final patent application has been filed, i.e. for at least 12-18 months from filing the first patent application.
- Before you disclose it or submit it for publication, run your proposed publication past any sponsor, employer or other person in or connected with your organisation, who may have an interest in the work and should consider any commercial (including patent) implications of publication.
- Ensure that any disclosure of the invention to someone not part of your work or organisation prior to patent filing is done under a non-disclosure or confidentiality (‘secrecy’) agreement.
- Where possible, seek advice from a Patent Attorney before disclosing anything if you are, or may consider, patenting the same or similar subject-matter – or if your employer/sponsor or organisation might be considering patenting.
- Panic! If you have recently disclosed your work or if someone else has disclosed your invention (e.g. when you have reason to think they knew you told them in confidence), there are mechanisms available which may still allow you to file a valid patent application. However, these are limited and should not be relied upon.
In part two, we shall provide practical tips, including wording to use or avoid, which will help to reduce the risk that a public disclosure will impede your chance to be granted valid patents on your work. These suggestions will also help you to gain permission to publish (which is not only of benefit to science as a whole but also for personal career advancement), particularly if your organisation has any pre-publication checking procedures aimed at avoiding risk to the commercial aspects of your work.