Patents and the Notional Person Skilled in the Art

The concept of common full general knowledge (CGK) occupies a more prominent position in the United kingdom'south inventive step authorities than it does in the European Patent Office'south (EPO) problem-and-solution approach or the classic U.S. analysis in Graham v John Deere. The EPO and US approaches start past considering the prior fine art whereas the Uk courts , post-obit Pozzoli 5 BDMO, start with the skilled person and his or her CGK, putting that background knowledge in the spotlight and at the forefront of the mind of the skilled person for the later stages of the analysis.

The skilled person, memorably described by Jacob LJ in
Rockwater 5 Technip as "a nerd".

The courts have therefore tended to be careful in expanding out the scope of CGK, and for good reason: if the CGK is deemed to encompass more information, then the skilled person inherently knows correspondingly more than near the background engineering science. Such a know-it-all will tend to regard fewer inventions as being inventive. So changing the CGK assay inevitably changes the test for inventive step.

All of this helps explain why the IPKat is so exercised by yesterday'due south decision in Teva UK Express & another v AstraZeneca AB [2014] EWHC 2873 (Pat), decided by Mr Justice Sales in the Patents Court. The approximate has held that the guidance from the traditional government on mutual general knowledge

" needs to be adjusted and kept appropriately up to engagement for the procedures for broadcasting of scientific knowledge in the age of the internet and digital databases of periodical articles".

Such an arroyo, he held, should include academic articles which "would not have been likely to have been read past the notional skilled person in the ordinary form of keeping himself upwardly to date" only "would have been quickly identified by whatever person conducting a literature search and review into [the land of the art]". Equally it happens, the articles which fell into the CGK nether this updated analysis were likewise held non to take afflicted the issue in any sense. Nonetheless, this Kat disagrees with the principles backside the judge'southward assay and wonders what readers make of it.

The case is not without other interest, and the IPKat may return to it in time to come posts: in particular the judgment contains an intriguing postscript detailing why a critical section had to be rewritten later on it was circulated in draft grade to the parties and was criticised by the patentee.

Background

AstraZeneca's product under the patent - Symbicort

Without getting too immersed in the details of the invention, all of which are explained with crystal clarity past Mr Justice Sales, the patent was for a second or subsequent medical employ involving a known combination of drugs for treating asthma (formoterol and budesonide, since you ask). Asthma treatment typically has ii parts: the patient takes one drug or drug combination via inhaler forenoon and night to keep the chronic condition in check ("maintenance treatment"), then supplements this every bit necessary with another fast-acting drug to bargain with acute asthma attacks that withal occur ("relief treatment").

The combination of formoterol and budesonide was known from the closest prior art document, which taught the use of this combination for maintenance handling, only not for relief treatment. The claims require using this same combination every bit needed for relief from asthma attacks and as well for maintenance treatment. The case turned on whether the CGK made it obvious to use the same combination for both aspects of asthma treatment, and post-obit the Pozzoli arroyo, the judge had to decide on the content of the CGK.

I. The conventional CGK

We can move quickly past the first two categories of CGK as they are uncontroversial. First there were classic items of CGK: statements in standard reference texts and in the guidelines on asthma care issued by the British Thoracic Society and US National Institutes of Health. Secondly, there were a few leading journal manufactures from The Lancet and the New England Journal of Medicine which addressed the treatment of asthma using combinations of β₂-agonists (such every bit formoterol) and steroids (such as budesonide). Neither side disputed that these articles represented CGK.

The standard reference piece of work, a piece of proficient,
old-fashioned, CGK

Two. The adjacent level of CGK

Then at that place was a third category of articles, for which the IPKat wishes to boring downwards and appeal for witnesses, without stopping on this occasion. The approximate called these the "primary articles", and they were described as bookish articles which "were sufficiently prominent in the main academic journals in the field as to plant function of the relevant CGK". This is more of a decision than an caption, just it'due south the only reason given for the primary articles being part of the CGK.

The IPKat is unsure whether these primary articles provided the just ground for sure findings, most notably the finding that formoterol had a rapid onset of activity. The conventional CGK is not clearly mentioned as a source for that data, and without it, the skilled person might have struggled to get in at the invention. Information technology is also not clear on first reading whether AstraZeneca fought the inclusion of these articles in the CGK, and if and so, what the competing arguments were or why Teva's arguments were preferred.

Rather than weighing in on issues that may not be controversial or even relevant, the IPKat wonders if anyone involved in the example tin can clarify whether the inclusion of the primary articles inverse the outcome of the case, and if and so, whether their inclusion was contested.

III. The controversial CGK

Finally, arriving at the documents whose inclusion is controversial (to this Kat at least), these were referred to by the judge equally the "secondary articles". They were described at [58] equally 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 form of keeping himself upwards to date. On the other hand, these materials would have been quickly identified past any person conducting a literature search and review into the use of formoterol and ICS in relation to the treatment of asthma."

The judge expanded at [60] on the reason for their inclusion:

"The authorities [ unfortunately, none are cited; this is left equally a general appeal to unstated authorities ] betoken that CGK includes non just data directly in the listen of the notional skilled person, simply such information as he would be able to locate past reference to well-known textbooks. This guidance needs to be adapted and kept accordingly up to date for the procedures for dissemination of scientific knowledge in the historic period of the cyberspace and digital databases of periodical articles. Searches of such databases are part and parcel of the routine sharing of data in the scientific community and are an ordinary research technique. In my view, if there is a sufficient basis (as hither) in the background CGK relating to a particular upshot to make it obvious to the unimaginative and uninventive skilled person that at that place is likely to be -- not just a speculative possibility that in that location may be -- relevant published textile bearing directly on that effect which would be identified past such a search, the relevant CGK will include material that would readily be identified by such a search. "

This does non sit comfortably with this Kat'south view of what the CGK should be based on. Information technology's all very well to say that times accept changed and that information is shared differently in the digital age, but the nature of content published in dissimilar categories of source fabric (textbooks 5 seminal articles in the field v articles published in lesser journals that are not generally known to all practitioners) has surely non changed so much over fourth dimension.

Indeed, the crux of whether or not a document represents the CGK has always (to this Kat's mind) been less a function of where the information is located, and more a factual question of whether the information is of such a nature that it forms part of the skilled person'due south toolkit – the basic knowledge against which such a person would inevitably evaluate any education, whether such knowledge is normally carried around in 1's caput or instead is delegated to reference fabric which the skilled person tin can readily wait up.

The judge'due south approach suggests a different category of cognition, at least as this Kat reads it, suggesting that when the skilled person reads a document, and that certificate makes it articulate that there is more than to learn, then he or she will be prompted to track down such boosted information in the literature. As long as it is readily identifiable in that search, it appears that this should course part of the CGK.

The traditional arroyo

More than fundamentally, the approach in Teva is stated as an updating of traditional guidance from the authorities, but one can question whether those government are characterised correctly. Absolutely, the IPKat does non know what authorities the guess was referring to when he said

"The authorities indicate that CGK includes ... such information as [the skilled person] would exist able to locate by reference to well-known textbooks".

It is this approach, the ability to locate information, that is congenital on and expanded for the digital age to cover articles i can discover in databases and which one knows or suspects must exist.

Only rewind a lilliputian and consider if the CGK did in fact e'er include whatever yous would be able to locate in a textbook? That question was addressed by Laddie J in Raychem Corp'south Patents [1997] EWHC 372 (Pat), where he took a more nuanced view:

"The common general knowledge is the technical background of the notional man in the art against which the prior art must be considered. This is not limited to material he has memorized and has at the forepart of his mind. It includes all that cloth in the field he is working in which he knows exists, which he would refer to every bit a matter of grade if he cannot call back it and which he understands is generally regarded every bit sufficiently reliable to apply every bit a foundation for farther work or to aid understand the pleaded prior art. This does not mean that everything on the shelf which is capable of being referred to without difficulty is common general noesis nor does information technology mean that every word in a common text book is either. In the instance of standard textbooks, it is likely that all or well-nigh of the main text will be common general cognition. In many cases common general knowledge will include or be reflected in readily available trade literature which a man in the art would exist expected to take at his elbow and regard as basic reliable data. "

If that statement of the law is right, then it was never enough that information could be establish in a text book. It besides had to exist material that the skilled person (a) knew existed, (b) would refer to as a affair of form, and (c) understood equally being mostly regarded as sufficiently reliable. In expanding CGK out as he has done, Mr Justice Sales'south examination omits any requirement that the information should be something that the skilled person would refer to every bit a matter of class, and that he or she would empathise as being mostly regarded as a reliable foundation. Most research papers in journals, specially those journals that are not the flagship publications in a given field, fall far short of that level of authority and are nowhere well-nigh as reliable equally a textbook.

Another criticism that can exist levelled at this new approach is that, while scientific papers may be distributed and consulted differently than in the past, the nature of what they carry has not changed much. Indeed i could argue that the skilled person in any given field nowadays is probably less aware of the content of the average paper in his or her field than would accept been the case decades ago (when the quantity of reading textile was so much easier to go on up with). Scientific papers were considered specifically past the House of Lords in General Tire 5 Firestone [1972] RPC 457, Sachs LJ quoting with approval from British Acoustic Films (53 RPC 221 at 250) where Luxmoore J said:

"A piece of particular knowledge as disclosed in a scientific paper does not go mutual general knowledge merely considering it is widely read, and even so less because it is widely circulated. Such a piece of knowledge only becomes full general noesis when information technology is generally known and accepted without question past the bulk of those who are engaged in the particular art; in other words, when it becomes part of their common stock of cognition relating to the art. " [ Sachs LJ commented that the phrase "accepted without question" was putting it a little loftier, and perhaps might be replaced past "by and large regarded as a skillful footing for further action" ]

Never ane to laissez passer by a pithy summation, Lord Justice Jacob also relied on the aforementioned passage in more than recent times when giving his take on common general knowledge in Rockwater v Technip [2004] EWCA Civ381:, Having cheerily described the skilled person equally "a nerd ... only non a complete android" (language which drew frosty disapproval from Lord Justice Pill in his concurring determination), Sir Robin and then turned to the CGK:

"For brevity I do not quote [the passage from General Tire] in full – Luxmoore J's happy phrase "mutual stock of knowledge" conveys the season of what this notional man knows . "

The mutual thread from these authorities, which appears to be missing from the approach taken in Teva v AstraZeneca, is the requirement that cognition needs to exist generally known and accustomed as uncontroversial, to form role of the common stock, before it tin be regarded as part of the CGK. Information, fifty-fifty right and relevant information, falls brusque of beingness CGK as long as it remains obscure and non widely known.

The documents which made it into the CGK under Mr Justice Sales's test in Teva were, by dissimilarity, unknown to the skilled person until he or she read something that suggested their being. Their character was also far removed, it is suggested, from the types of information usually accustomed every bit office of the common stock: they were papers describing diverse recent studies with, by and large, merely tentative conclusions from their authors, those conclusions being in some cases mutually contradictory. Equally noted at the beginning, the estimate found that whether or not these documents made it into the CGK did not affect the overall consequence. Nevertheless, the question arises whether the arroyo is correct for futurity cases.

So readers, what do you call up? Is the exam for inclusion of a scientific paper in the CGK ripe for an update? Are the government mentioned above by the IPKat outdated in the digital age? Should CGK depend on widespread acceptance, or should it plough on ease of access to a publication using modern tools?

Feline asthma here
CGK airport here
C., G. Chiliad. (ok, it'south a stretch) wrote the Father Brownish stories which yous can read for free here

The skilled person - more knowledgeable than ever before Reviewed past David Brophy on Thursday, September 04, 2014 Rating: 5

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Source: https://ipkitten.blogspot.com/2014/09/the-skilled-person-more-knowledgeable.html

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