The names of the parties in the case commented upon today first reminded me of the classic movie Kramer vs. Kramer. But you could also think about the Doppelgänger.
See, the case at hand is Novartis v. Novartis or, to be more precise, SAS Novartis Pharma v. Novartis Pharma AG.
The judgment is very short and utterly uninteresting in itself, but as you will see the underlying context is much more noteworthy.
Let’s start with the judgment per se first.
Novartis Pharma AG is the owner of European patent No. EP 1096932 entitled “Combined use of valsartan and calcium channel blockers for therapeutic purposes“.
Novartis Pharma AG is also the owner of French SPC No. 07C0042, which was granted in 2008. This SPC is based on the EP’932 patent and on a European Marketing authorization (MA) and is directed to a medicinal product comprising the two active substances valsartan and amlodipine.
The corresponding commercial drug marketed by the Novartis group is Exforge®.
The EP’932 patent was opposed by 8 different opponents at the EPO. In first instance, the patent was maintained in amended form by the opposition division.
On appeal, after the issuance of the summons to oral proceedings, Novartis Pharma AG withdrew all its requests and disapproved of the text of the patent, which led to the revocation of the patent on October 7, 2015.
On January 29, 2018, another company from the Novartis group, namely SAS Novartis Pharma, filed a complaint with the Paris Tribunal de grande instance (TGI) and requested that the TGI should revoke SPC No. 07C0042, as a consequence of the revocation of the basic patent.
The “defendant” Novartis Pharma AG agreed, and the court thus pronounced the requested revocation of the SPC on April 5, 2018.
Now, in case you are wondering, of course the various Novartis companies have not run amok.
No, this unusual ruling seems to be the result of a very elaborate strategy, which can be (at least partly) comprehended based on publicly available information.
The first thing you need to know is that two divisional applications were filed based on the EP’932 patent.
The first one was deemed to be withdrawn, but the second one led to the grant of another patent, EP 2322174. On the face of it, the EP’174 patent contains claims which are somewhat similar to those of EP’932, and which still cover the combination of valsartan and amlodipine.
The second important thing is that another French SPC application (No. 16C0008) was filed based on the divisional patent EP’174, still for the combination of valsartan and amlodipine, on March 7, 2016 (thus a few months after the grant of EP’174 on September 15, 2015 and after the revocation of the parent EP’932 patent on October 7, 2015).
Based on publicly available information, the second SPC was initially granted in June 2016. But then, three months later, on September 26, 2016, the decision to grant the SPC was withdrawn by the INPI (French patent office). Indeed, the withdrawal or cancellation of any decision issued by the INPI is possible as a matter of principle within a four-month time limit.
Examination of SPC application No. 16C0008 was immediately resumed, and an office action was issued, in which an objection was raised based on the existence of the prior SPC No. 07C0042. As a reminder, article 3(c) of the SPC regulation (aka Regulation (EC) No. 469/2009 of the European Parliamant and of the Council of May 6, 2009) provides that a certificate can only be granted if “the product has not already been the subject of a certificate“.
As a first line of defense, Novartis replied that the revocation of the EP’932 patent also automatically entails the annihilation of the first SPC No. 07C0042, in a retroactive manner. Therefore, they argued, the valsartan + amlodipine product in the second SPC application No. 16C0008 had not already been the subject of a certificate.
But the INPI was not convinced and maintained its objection.
With that in mind, the strange Novartis v. Novartis action suddenly becomes much more understandable.
Novartis’ purpose was to obtain an official ruling from a court of law per which the first SPC was revoked. This strengthened their argument with the INPI. And the strategy was successful, as the objection based on article 3(c) of the SPC regulation was overcome and the second SPC was finally granted (for the second time) in June 2018.
Based on the arguments submitted by Novartis which can be read in the SPC file wrapper, second SPCs replacing the first round of SPCs were also obtained in a similar manner in a number of other European countries.
At this stage, one question remained for me: why did Novartis find it useful to surrender its parent patent and all SPCs obtained based on it, and to start the entire procedure from scratch based on the divisional patent and a second set of SPC applications?
Well, sometimes a blogger has to play detective. Comparing the two different SPC applications, it appears that both are based on the same MA having effect in France, namely European MA No. EU/1/6/371/001-24. But then one difference immediately becomes obvious in the next box of the application form.
In the first SPC application, the first MA obtained in the Community or EEE is indicated as being this same MA No. EU/1/6/371/001-24, dated January 16, 2007. But in the second SPC application, the first MA obtained in the Community or EEE is indicated as being a slightly earlier Swiss MA No. 57771/01-03, dated December 22, 2006. Actually, since the AstraZeneca judgment of the CJEU (C-617/12), we have known that Swiss MAs count as potential first MAs in the Community or EEE, as they are automatically recognized in Liechtenstein.
So the Doppelgänger mystery is solved – I think: the initial SPC application contained a mistake, in that the indication of the first MA obtained in the Community or EEE was not correct. Hence the need to get rid of the first patent and first SPC, in order to obtain a corrected SPC based on the second patent.
I would be curious to know whether Novartis’ clever strategy succeeded in all European countries or whether it failed in some of them.
More generally, I would be curious to know what readers make of all this.
Should the revocation of a first SPC indeed make it possible to request a second SPC as if the first SPC had never been granted?
This does raise policy issues. Imagine that the first SPC had been revoked further to a nullity suit filed by a true third party. Would it be fair to allow the SPC owner to obtain a second SPC essentially identical to the first one, based on a divisional patent?
At any rate, this case will probably be a further incentive to file divisional applications for important inventions which could potentially be protected by an SPC. More than ever, divisional applications appear to be a very powerful (some would say, too powerful) tool in the hands of IP right holders.
CASE REFERENCE: TGI de Paris, 3ème chambre, 1ère section, April 5, 2018, SAS Novartis Pharma v. Novartis Pharma AG, RG No. 18/02118.