In the UK, following the case of Biogen v Medeva in 1996, the law regarding sufficiency is further entwined with clarity, resulting in two types of insufficiency. The first 'classical' type of sufficiency relates to the skilled person being able to reproduce the invention, given the teaching of the application as a whole and the skilled person's common general knowledge. This corresponds most closely with Article 83 EPC. The second type of sufficiency, which is known from the case as Biogen sufficiency, relates to the skilled person being able to reproduce the invention over the whole scope of the claim. Biogen sufficiency is really then about support in the description, which in UK case law relates closely to whether a priority claim is valid. In the disputed patent in the Biogen case, which related to a DNA sequence for causing a cell to make antigens of the hepatitis B virus, the scope of the claim covered the invention as applied to prokaryotic and eukaryotic cells. The priority application, however, only disclosed the invention as applied to bacterial (i.e. prokaryotic) cells. The House of Lords, following Lord Hoffmann's opinion, found that this resulted in the application not being entitled to priority. As a result, the patent was found to be obvious over an intervening disclosure.
It should now be reasonably clear that Biogen sufficiency does not translate well to opposition proceedings at the EPO, because it is tied up with other issues such as clarity and priority. If arguments of the type raised in Biogen v Medeva were raised during opposition, a counter argument would be that these relate to clarity rather than sufficiency and should therefore be dismissed. This did not, however, stop the opposition division in the case of proceedings relating to EP1767375 from raising Biogen sufficiency as a ground for revoking the patent.
At the conclusion of the opposition in July 2012, the opposition division's sole ground for revocation was sufficiency, as summarised by the following paragraph in the grounds for the decision:
The patent proprietor appealed against the decision, arguing that it was not clear what the OD meant by 'Biogen sufficiency' (although their representative, being a UK based patent attorney, would obviously know what it meant under English law). More importantly though, they argued that the objection was without foundation on the facts of the case. Although claim 1 was broader than the specific description, the skilled person would, the proprietor argued, easily be able to realise the invention using the specification and common general knowledge.
As the Board of Appeal put it, the OD had distinguished between 'classical insufficiency' and 'Biogen sufficiency'. They had found the invention to be disclosed sufficiently clearly and completely for the skilled person to carry it out, thereby fulfilling the classical sufficiency requirement under Article 83. What they had considered the invention to lack though was sufficiency in the sense that the skilled person would not be able to carry out the invention over the whole scope of the claim, since the patent did not disclose other ways of carrying out the invention than those defined in the dependent claims. The Board considered, however, that Biogen sufficiency, as defined by the UK House of Lords, related to Article 84 EPC and not to Article 83, given that the underlying purpose was the requirement for support by the description to ensure that the patent monopoly was justified by the actual technical contribution to the art. The Board was not convinced that the OD had justified the use of Biogen sufficiency in relation to Article 83, and concluded that they had not shown that the patent failed to comply with Article 100(b). Since there were other issues that were left open, including novelty and inventive step, the Board remitted the case to the OD to take a look at these.
What made the OD in this case pull Biogen sufficiency out of the hat to justify revoking a European patent is a mystery to me. Even if it was relevant to the case, using a principle of a national court in proceedings at the EPO is to say the least a bit unconventional. It also looks as if the OD did not even understand what the principle was about. As well as establishing that Biogen sufficiency is not something that should be used in EPO oppositions, the case demonstrates that sufficiency arguments at the EPO, whether raised by the opponent or the opposition division, should be a bit more substantive than simply arguing that the skilled person would not be able to do the invention in another undefined way. Such arguments should rightly be dismissed as being invalid grounds of opposition.
The least to be said here is that the OD did not abide by the Guidelines. Some Boards have even considered this as a substantial procedural violation, e.g. T 129/14.
ReplyDeleteWhen looking at Part 3 of the general remarks in the Guidelines, it is clearly stated that the application of the Guidelines to individual European patent applications or patents is the responsibility of the examining staff and they may depart from these instructions “in exceptional cases”.
Furthermore, in the next paragraph it is clearly stated that the Guidelines do not constitute legal provisions. What matters is primarily the EPC, its Implementing Regulations, the Protocol on the Interpretation of Article 69, the Protocol on Centralisation, the Protocol on Recognition, the Protocol on Privileges and Immunities and the Rules relating to Fees, and secondly to the interpretation put upon the EPC by the Boards of Appeal and the Enlarged Board of Appeal. National case law is not mentioned whatsoever.
I fail to see that in how far the case at stake was exceptional and that case law of national jurisdictions should at all be taken into account.
It is quite easy to make a distinction between Art 83 and art 84. An objection under Art 83 cannot be overcome without infringing Art 123(2), whereas an objection under Art 84 can be overcome. If the applicant/proprietor claims more than what he has disclosed, an objection under Art 83 can apply. He should never obtain more than his contribution to the art, cf. G 1/03. If he limits himself to what has been disclosed there is support under Art 84. The applicant should thus limit his claims to the actual disclosure, and then the objection under Art 83 becomes moot.
The problem here seems to lie at another level. The claim as such is broad, and the applicant only gave one example on how to carry it out. This regularly poses problem to examining and opposition divisions. May be a bit more training in the matter could be useful, but training time goes off from production time, so it is better to leave it at least for the higher management of EPO, starting with VP1.
In order to be on the safe side, the OD considered that the subject-matter of claims 3-5 should be incorporated into claim 1. That is what the OD understood under Biogen insufficiency.
As in opposition, it is not possible to speak about missing essential features, which is a typical Art 84 objection, the only way to deal with it is by invoking Art 83.
The decision of the OD is contradicting itself as it says first that the invention is sufficiently disclosed, see page 8 under classical insufficiency for embarking on Biogen insufficiency on page 9, where it is made clear that claims 3-5 should come into claim 1. That the proprietor did not want to limit himself is understandable and legitimate. For the opponent, he can have a clear interest for a limitation as it could mean going around the patent.
It is simply to be hoped that the OD will abide by the decision of the Board and not reopen the discussion on Art 83. It is enough to confuse the issues of Art 83 and 84 once.
Being (un)kind, one could say that the OD sitting in The Hague, wanted to show that it also knows national case law, and is as clever as the Munich colleagues. To which avail, will indeed remain a mystery.
Thank you for your comments. The point about the difference between A83 and A84 in particular is a good one.
DeleteThe thing that I take away from the decision of the OD is how much raising Biogen insufficiency seemed to throw the patentee. On the face of it, it is an attractive statement in the abstract, to those unfamiliar with Biogen and its decendents: a claim is invalid if it covers embodiments not contemplated by the description.
ReplyDeleteBut that is not Biogen (in)sufficiency at all. Biogen insufficiency only comes into play with the particular kind of product by process claim in the Biogen patent, which don't really exist any more following Kirin Amgen.
Lord Hoffman clarified all of this in Lundbeck v Generics at 27:
"In an ordinary product claim, the product is the invention. It is sufficiently enabled if the specification and common general knowledge enables the skilled person to make it. One method is enough."
and at 30:
"Section 60(1) [primary infringement] of the Act makes it clear that a claim may be either to a product or a process. In the case of a product claim, performing the invention for the purposes of section 72(1)(c) [revocation for lack of sufficiency] means making or otherwise obtaining the product. In the case of a process claim, it means working the process. A product claim is therefore sufficiently enabled if the specification discloses how to make it. There is nothing to say that it must disclose more than one way."
The best guidance for product claims is in Kirin Amgen at 113, concerning the meaning of principle of general application:
"...the notion of a "principle of general application" applies to any element of the claim, however humble, which is stated in general terms. A reference to a requirement of "connecting means" is enabled if the invention can reasonably be expected to work with any means of connection. The patentee does not have to have experimented with all of them."