A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Monday 6 October 2014

Pradaxa in Portugal: IP court trumps Patent Office refusal

A note on Boehringer Ingelheim Pharma GmbH & Co. KG v Instituto Nacional da Propriedade Industrial (Case File No. 300/13.0HYLSB) appears in the most recent BMA Newsflash from the Lisbon, Portugal firm of Baptista, Monteverde & Asociados.  It reads like this:
A decision of the Intellectual Property Court (IP Court) granting a Supplementary Protection Certificate (SPC) on a second medical use, despite the existence of a previous SPC for the same product and the same basic patent, contradicting the practice of the Portuguese Patent Office (PTO), was published in the IP Bulletin.

Boehringer applied for the SPC No. 511 referring to the medicine Pradaxa (dabigatran etexilate in the form of a mesylate) and respecting the basic patent EP1485094, to protect the medical use of dabigatran etexilate for the prevention of cerebrovascular accident (CVA) and systemic embolism in adult patients with non-valvular atrial fibrillation.

The PTO refused SPC 511 by sustaining that it does not comply with the requirements of Article 3(d) of Regulation 469/2009 (SPC Regulation), alleging that this SPC is not associated with the first marketing authorization (MA) for the same product, since a SPC based on the same patent and on the same active ingredient had already been applied for (SPC 490).

Boehringer filed a judicial appeal against the decision of refusal of the PTO claiming that SPC 490 was applied for the use of the active ingredient dabigatran etexilate (as mesylate) for primary prevention of venous thromboembolic events in adults who have undergone an operation to replace the hip or knee, while SPC 511 is intended to protect the use of the same active ingredient for the prevention of cerebrovascular accident (CVA) and systemic embolism in adult patients with non-valvular atrial fibrillation. Consequently, Boehringer concluded that since the therapeutic use is different, it cannot be said that there is more than one SPC for the same basic patent.

The IP Court allowed Boehringer’s appeal and revoked the decision of refusal of the PTO.

In the aforementioned decision, the IP Court quoted the jurisprudence of CJEU, namely Case 130/2011 Neurim [on which see earlier SPC Blog posts here]), according to which "like a patent protecting a ‘product’ or a patent protecting a process by which a ‘product’ is obtained, a patent protecting a new application of a new or known product, such as that at issue in the main proceedings, may, in accordance with Article 2 of the SPC Regulation, enable an SPC to be granted and, in that case, in accordance with Article 5 of the regulation, the SPC confers the same rights as conferred by the basic patent as regards the new use of that product".

Considering the teachings of the CJEU, the IP Court held that since the new therapeutic use of the drug Pradaxa -- prevention of cerebrovascular accident (CVA) and systemic embolism in adult patients with non-valvular atrial fibrillation -- comprises the active ingredient protected by the basic patent of the SPC 511, it should be understood that this therapeutic use is not covered by any previous MA and therefore SPC 511 must be granted.

This decision shows the harmonization of Portuguese jurisprudence with the jurisprudence of the CJEU regarding SPC and shall serve as an important precedent for the PTO to change its practice relating to SPC on second medical uses".


Anonymous said...

Does this answer the question of how Article 3(c) will be handled under Neurim? There is no mention in the report of how Article 3(c) was dealt with, but presumably the IP Court considered the issue of whether the patentee had already been granted a certificate for the same "product" (bearing in mind that Yissum tells us that the definition of the product does not incorporate the newly-authorised use).

It will also be very interesting to see how the issue of double protection for the new indication (prevention of CVA and systemic embolism in adult patients with NVAF) will be handled by the courts, as it is clear that SPC no. 490 also protects that indication (as, under Article 4, that SPC will cover "any use
of the product as a medicinal product that has been authorised
before the expiry of the certificate").

Anonymous said...

Is there not a bigger problem in that SPC 511 also protects the indication that was initially protected by SPC 490? If so, after SPC 490 has expired, will SPC 511 be held unenforceable in respect of the indication relating to prevention of VTEs?

Ulrike said...

I believe the biggest problem here is that the patent doesn't even claim the uses! It's a patent on a formulation.
I read Neurim to say that you could get a SPC for a product on a patented use. But only if the scope of the second patent/SPC is not comprising the first use. f the first SPC was for the patent on a formulation (as in this case)it covered any use thereof. There is no room for a second SPC.
Just my humble opinion.