MOPPing up selection patents: are you Reddy ...?

This Kat has always felt in his heart of hearts that selection patents were something of a kindly-intended exception to the rule that validity required an invention to require an inventive step. For this reason he has been taking an interest in the thoughts of Julie Carlisle (European Patent Attorney and Chartered Patent Attorney, Mewburn Ellis LLP) -- who has been taking a close look at how the obviousness of selection inventions is to be determined in the United Kingdom.  She writes:

"As reported on the IPKat here the UK Manual of Patent Practice (MOPP) was revised in October 2010. One of its revisions was the introduction of new guidelines for assessing the obviousness of 'selection inventions', in light of the Court of Appeal decision in Dr Reddy.

The new criteria applied by the UK Intellectual Property Office for an inventive selection can be found in paragraph 3.89 of the MOPP (emphasis added):

In order for there to be a technical contribution, and thus for the selection to be inventive, the following criteria derived from relevant statements in the EPO Board of Appeal decision in T 939/92 AGREVO/Triazoles 6 OJEPO 309 should be satisfied: 

(i) the selection must not be arbitrary but must be justified by a hitherto unknown technical effect; 

(ii) a technical effect which justifies the selection of the claimed group must be one which can be fairly assumed to be produced by substantially all the selected members; 

(iii) this technical effect can only be taken into account if it can be accepted as having been demonstrated in the specification as filed.

It seems to me that, while criteria (i) and (ii) can be derived from T939/92 (see points 2.5.3, 2.5.4 and 2.6 of the Reasons), and were expressly recited/approved in Dr Reddy (see paragraph 99, for example), criteria (iii) cannot be found anywhere in either of these cases.

The effect of criteria (iii) is quite serious - it means (and this has been confirmed to me by a UK examiner) that UKIPO policy is that post-filing data cannot be used to support inventive step. It will be ignored, even if it clearly shows that the claimed compounds have massively improved biological properties compared to the prior art.

So the fairly common scenario in the pharmaceutical field, wherein an original broad claim is narrowed down to focus on the eventual lead compound(s), will very often result in a refusal for lack of inventive step, unless the data that has made that/those compound(s) special and desirable was already available on filing and included in the application as filed. The timescale of R&D in the pharma field means that this data will very often NOT have been available at patent filing, so this approach is potentially concerning.

It is also almost exactly the opposite of the EPO approach, which the Court of Appeal said we should now be following.

In T939/92, explicit reference was made to the fact that the patentee could have filed further evidence (i.e. post-filing) such as experimental tests to prove that the technical effect asserted was possessed by the selected compounds (in that case they did actually not do so, hence no inventive step could be acknowledged). This is consistent with the current EPO approach to routinely allowing post-filing data showing a technical effect, in support of support inventive step:

EPO Guidelines for Examination
Chapter C-VI
5.3.5 Evidence
Under certain circumstances, however, later filed examples or new effects, even if not allowed into the application, may nevertheless be taken into account by the examiner as evidence in support of the patentability of the claimed invention. For instance, an additional example may be accepted as evidence that the invention can be readily applied, on the basis of the information given in the originally filed application, over the whole field claimed (see III, 6.3). Similarly a new effect (e.g. the one mentioned in VI, 5.3.4) may be considered as evidence in support of inventive step, provided that this new effect is implied by or at least related to an effect disclosed in the originally filed application.

In Dr Reddy as well, note the last sentence of paragraph 114, where the Court mentioned and appeared to approve the notion that evidence not present in the application itself can be used to support the presence of a new technical effect, as at the EPO:

"...at least in some cases, the Board appears to allow further evidence to support the validity; accordingly, although not referred to in the Patent, it may be appropriate to add that this conclusion is supported by the research reported in Chakrabarti 1980."

The UKIPO's justification for criteria (iii) apparently comes from older case law - especially that recited in paragraph 3.91 of the MOPP:

3.91 The “hitherto unknown technical effect” (i.e. advantage gained or disadvantage avoided) relied upon to justify a selection invention, and evidence to support that technical effect, should be clearly disclosed in the specification at the time of filing if it would not otherwise be apparent to a person skilled in the art. Otherwise it will not be possible to see that the technical effect has indeed been demonstrated. In Glaxo Group Ltd’s Patent [2004] RPC 43 (see also 3.30 and 3.31.1), the Patents Court held that unexpected bonus effects not described in the specification could not form the basis of a valid claim to a selection invention. If there is no statement of advantage, or indeed no evidence to support that statement, in the specification at the time of filing it may not normally be added later (see 76.14), since, as stated by Jacob J. in Richardson-Vicks Inc.s’ Patent [1995] RPC 568 at 581, in the context of synergy, demonstration of the advantage “by experiments conducted after the date of the patent cannot help show obviousness or non-obviousness … and it would be quite wrong for later-acquired knowledge to be used to justify the amended claim.”

BUT neither of these cases are actually concerned with selection inventions. ALSO both of these cases pre-date Dr Reddy, which did not cite either of these cases.

The Court of Appeal's decision in the Dr Reddy case should now be the definitive word on what the criteria for selection inventions are in the UK, and it does not place any limitation on the nature of the technical effect, or on when it has to be proven.

The question of whether a selected group of compounds has a special technical property is surely a question of fact - either the compounds have (e.g.) an improved activity compared to the wider group of prior art compounds from which they are notionally selected, or they don't. Whether it is expressly proven in the application as filed should not matter.

Provided there is basis in the application for claiming the 'selected' class (i.e. basis for narrowing to the compounds which have the advantageous property, if necessary) it should be possible to claim these disclosed compounds since, fairly clearly, they represent a contribution to the art...

So I have come to the conclusion that criteria (iii) as set out by the UKIPO must, simply put, be wrong".

Julie wonders if any of the readers of this weblog has any further thoughts on this. She would also be personally very interested in hearing from anyone who has successfully navigated the new guidelines, and who has had a chemical selection patent granted at the UKIPO.

Selection patents: a personal overview here