A step too far
The recent decision in Teva UK Limited & another v AstraZeneca AB  EWHC 2873 (Pat) has taken the ‘inventive step’ test in patent applications to another level and has begun to cause concern that threshold for gaining patent protection has been raised significantly.
The criteria which must be satisfied in order to apply for a patent in England and Wales is set out in section 1 of the Patents Act 1977 which states:
- “A patent may be granted only for an invention in respect of which the following conditions are satisfied, that is to say —
- (a) the invention is new;
- (b) it involves an inventive step;
- (c) it is capable of industrial application.”
The section goes on to set out a number of exceptions which are not capable of being protected by patent.
Each of these requirements has been the subject of much discussion and developing case law has assisted practitioners in understanding how the courts will apply each of these tests.
The “inventive step” case law
The ‘inventive step’ test is also known as the ‘obviousness’ test, the authority for which was previously the case of Pozzoli SPA v BDMO SA  EWCA Civ 588. Prior to Pozzoli the Windsurfing test had been used by the Courts for over 20 years. In Pozzoli the Court restated the Windsurfing principles that the starting point was to identify (i) the person skilled in the relevant ‘art’ and (ii) the ‘common general knowledge’ of that person.
Taking it back to basics, if the concept upon which the patent is based is within the ‘common general knowledge’ of an individual skilled in the same area (or art) to which the patent application applies then the patent applied for cannot involve an inventive step (or be ‘new’ for that matter) as it is already known about.
The Teva decision
The Courts have previously avoided expanding the ‘common general knowledge’ of the skilled person to prevent the test becoming to restrictive. The decision in Teva UK has however made the “obviousness” test more restrictive by widening the definition of ‘common general knowledge’. Mr Justice Sales, sitting in the Patents Court, stated that the previous guidance from the Courts on ‘common general knowledge’ needed “to be adapted and kept appropriately up to date for the procedures for dissemination of scientific knowledge in the age of the internet and digital databases of journal articles”.
His view is that the ‘common general knowledge’ of the skilled person would include academic articles which “would not have been likely to have been read by the notional skilled person in the ordinary course of keeping himself up to date” but “would have been quickly identified by any person conducting a literature search and review into [the state of the art]”.
The case itself concerned a patent application for a combination of drugs for treating asthma following an asthma attack. The combination was commonly used for habitual preventative treatment of asthma but not for relief following an attack. It was accepted that standard reference texts, guidelines and leading journal articles would fall within the definition of ‘common general knowledge’. Mr Justice Sales widened this to include “primary articles” and “secondary articles”. He described “primary articles” as “sufficiently prominent in the main academic journals in the field as to constitute part of the relevant common general knowledge”.
Whilst “secondary articles” comprised a range of journal articles: “which were not in leading journals in the field of respiratory medicine, and would not have been likely to have been read by the notional skilled person in the ordinary course of keeping himself up to date. On the other hand, these materials would have been quickly identified by any person conducting a literature search and review into the use of formoterol and ICS in relation to the treatment of asthma.”
As a result the ‘common general knowledge’ now includes articles which the skilled person may come across when researching a specific issue. Mr Justice Sales further elaborated on the point:
“The authorities indicate that common general knowledge includes not just information directly in the mind of the notional skilled person, but such information as he would be able to locate by reference to well-known textbooks. This guidance needs to be adapted and kept appropriately up to date for the procedures for dissemination of scientific knowledge in the age of the internet and digital databases of journal articles. Searches of such databases are part and parcel of the routine sharing of information in the scientific community and are an ordinary research technique. In my view, if there is a sufficient basis (as here) in the background common general knowledge relating to a particular issue to make it obvious to the unimaginative and uninventive skilled person that there is likely to be -- not merely a speculative possibility that there may be -- relevant published material bearing directly on that issue which would be identified by such a search, the relevant common general knowledge will include material that would readily be identified by such a search.”
This test therefore ascribes to the skilled person adept, competent and thorough research skills. The decision is sure to cause concern for those intending to apply for patent protection as the ‘inventive step’ and indeed the ‘new’ hurdles are now much higher than they were previously. We will have to wait and see whether Mr Justice Sales test is applied or varied by future cases.