Follow-up on priority and on SPCs

Dear readers, this is just a brief follow-up post on two topics previously addressed on this blog: partial priority at the EPO and vaccine SPCs.

First, partial priority at the EPO. This was already addressed in the past here and especially there, where I talked about the decision of the Enlarged Board of Appeal G 1/15.

Since then, another decision T 282/12 has been issued and has swiftly been presented on all good blogs (here, here and there).

In this decision, it was ruled that the priority of a claim was partially invalid because the alleged priority document was partially not the first application for the invention at stake.

As I have previously observed, although G 1/15 was almost unanimously welcome by the patent profession as a cure to the toxic divisional plague, the relatively flexible and generous approach of partial priority adopted in this ruling can also turn against patent proprietors when they file successive similar applications.

In this respect, T 282/12 is not really groundbreaking. The same already happened in T 1222/11, the decision which was the first one to theorize the “generous approach” later endorsed by G 1/15. In this earlier decision, the refusal of the patent application at stake was confirmed by the Board due to the invalidity of a priority claim in view of an earlier application (by the same applicant) which contained the same examples as the alleged priority document. I always thought that it was somewhat paradoxical that this decision considered as life-saving by many in fact killed the patent application at stake.

There is one remaining issue which may give rise to additional discussions, though.

T 282/12 states that the priority is only partially, and not fully, invalid if part of the claimed subject-matter was disclosed by the same applicant in an earlier application than the priority document. T 1222/11 was in my opinion not so clear in this respect. However, is it really certain that this is consistent with the Paris convention and the EPC? After all, these treaties do not expressly contain the notion of a “partial first application“.

So, it remains to be seen whether future decisions will be fully in line with this aspect of T 282/12 or not. It also remains to be seen what national courts will make of all this, as they are not bound by the Enlarged Board’s findings – least of all French courts if I may say so.

In the meantime, extreme caution should be exerted when filing successive applications on similar subject-matter, especially when the supporting examples are the same. 

Second topic, totally unrelated to the first one: vaccine SPCs.

Almost two years ago, Lionel Vial reported on this blog on the refusal of an SPC application filed by GlaxoSmithKline Biologicals (GSK) for the Cervarix vaccine by the INPI, and on the confirmation of this refusal by the Paris Cour d’appel.

Interestingly, another French SPC application was filed by a different applicant, namely the Loyola University of Chicago, still for the Cervarix vaccine, and based on the same marketing authorization as the GSK application.

The same causes often produce the same effects. Thus, this second SPC application was also refused by the INPI, and the appeal filed by Loyola was dismissed by the Paris Cour d’appel.

As explained by Lionel in the earlier post, the Cour d’appel considered that the active substance in the Cervarix vaccine was in fact the same product as the active substance in the earlier Gardasil vaccine, for which an SPC had already been granted to GSK.

The Cour d’appel did not change its mind in the Loyola case and reminded that only one SPC can be granted per product. The fact that the patent mentioned in the SPC application as well as the applicant were different did not change anything.

To Loyola’s credit, whether both active substances are actually the same is not straightforward here. This is because one critical protein in the Cervarix vaccine is obtained differently (via insect cells rather than yeast cells), and is truncated, relative to the same protein in the Gardasil vaccine. Therefore, it was probably worth giving it another try despite the previous negative decision.

An interesting variation of the insect pictured in the earlier Cervarix post.

Loyola made ample reference to its own patent and to a later scientific publication as evidence that the difference in protein structure had an impact on biological properties.

But the court said:

[…] The INPI rightly states that this change is minor […]. Even though the appellant claims a different structure and different properties, they do not show that these modifications are anything but minor, as the active substance remains the same and the preventive purpose remains the same. The INPI rightly states that an increase in the capacity to form VLPs, a higher yield, a higher purity level, a more regular shape, a reduction in the risk of cellular DNA encapsidation or even a better stability, are changes which do not alter the nature of the active substance or its preventive purpose; they do not make it possible to conclude that the products are different. 

So, once again, insects and yeast – same difference.

CASE REFERENCE: T 282/12, (Coated tablets / JOHNSON & JOHNSON), Board of Appeal 3.3.07, November 9, 2017, Pfizer Inc. v. Johnson & Johnson Consumer Inc.

CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 1, December 19, 2017, Loyola University of Chicago v. Directeur Général de l’INPI, RG No. 2016/17848.

One thought on “Follow-up on priority and on SPCs”

  1. T 282/12 is a logical consequence of G 1/15.
    What applies one way, should also apply the other way.
    I would say you cannot have the cake and eat it.

    It is certainly good for applicants to be aware of the problem. But here it was a typical problem due to US continuations and continuations in part which was at the basis of the priority problem. So I am not so sure that outside this circle of applicants the problem will really exist.

    It is worth noticing that in order to consider the priority valid, and hence disregarding the earlier filing, the opposition division erred when it found that when applying Art 123(2) it concluded that the priority based on the continuation in part was valid. It simply compared apples with pears. This is a comment often found in examiner’s report of the EQE.

    But without this mistake of the opposition division we would not have such an interesting decision.

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