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Allergan, Inc. v. Orifarm A/S, Preliminary Relief Judge District Court of The Hague, the Netherlands, 15 September 2017, Case number ECLI:NL:RBDHA:2017:10574

Allergan is the holder of the European patent EP 1 658 858 B2 entitled “Use of botulinum toxin for the treatment of recalcitrant voiding dysfunction”. The patent was filed on 15 July 1998 relying on the priority date of 15 July 1997. The patent with Swiss type claims is amongst others in force in the Netherlands and protects Allergan’s Botox product for an injection fluid which is used for the indication urinary incontinence.

On 18 November 2015 Orifarm wrote to inform Allergan that it was planning to import original Allergan Botox products from Poland and other countries into the Netherlands. After obtaining a market authorization Orifarm started distributing the Allergan Botox products from Poland to the Netherlands in April 2016.

Allergan filed summary proceedings in June 2017 arguing that Orifarm infringes the Dutch part of EP 1 68 858 B2 and claiming a preliminary injunction. Allergan, relying on the Specific Mechanism which is included in chapter 2 of annex IV to the Accession Treaty of Czech Republic, Estonia, Cyprus, Hungary, Latvia, Lithuania, Malta, Poland, Slovenia and Slovakia, argued that Orifarm cannot rely on patent exhaustion.

The Specific Mechanism reads:
“With regard to Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia and Slovakia, the holder, or his beneficiary, of a patent or supplementary protection certificate for a pharmaceutical product filed in a Member State at a time when such protection could not be obtained in one of the abovementioned new Member States for that product, may rely on the rights granted by that patent or supplementary protection certificate in order to prevent the import and marketing of that product in the Member State or States where the product in question enjoys patent protection or supplementary protection certificate protection, even if the product was put on the market in that new Member State for the first time by him or with his consent.”

The specific mechanism is intended to compensate for the fact that patent protection for pharmaceutical products was not up to EU standard in the new member states (other than Malta and Cyprus) prior to accession.

According to the PI Judge it was not in dispute between the parties that EP 1 658 858 B2 was valid and that the Botox products imported by Orifarm from Poland into the Netherlands would infringe. It was also not in dispute that the products were originally brought on the Polish market with Allergan’s consent. The point in dispute was whether or not the Specific Mechanism applies and therefore whether or not Orifarm could rely on exhaustion of patent rights.

In this regard the question was whether on the key date determined in the Specific Mechanism patent protection could be obtained in Poland for second medical use claims. To answer this question the PI Judge takes the application date of EP 1 658 858 B2 as the relevant date. The burden of proof lies on claimant Allergan.

The Polish Act on Industrial Property of 30 June 2000, which came into force on 22 August 2001 explicitly allowed the patentability of second medical use inventions. This was not yet the case for the Polish Act on Inventive Activity which was in force since 1993. According to the PI Judge Polish law before the key date was therefore not clear with regard to the question whether or not patent protection for second medical use indications could be obtained.
Allergan had mentioned during the hearing that it was not familiar with Polish patent literature from before the key date which positively confirmed that patent protection could not be obtained for second medical use patents under the Polish Act on Inventive Activity.

Allergan did rely on three decisions of the Polish patent agency which were handed down in 1997 and 1998 in which patent protection for second medical use claims was denied. All three decisions were however overturned on appeal shortly after the key date by the appeal committee which amongst others found that a modern interpretation of Polish law may allow the grant of a second medical use patents.

The PI Judge dismisses Allergan’s argument that the Specific Mechanism is already applicable in cases where it is not certain whether or not patent protection can be obtained. In this regard the PI Judge refers to the Merck/Sigma decision of the ECJ (C-539/13) from which it follows that the Specific Mechanism should be interpreted narrowly as it is an exception to the EU free market principle. The PI Judge further points to the Pfizer/Orifarm case C-681/16 in which the ECJ has not yet given a preliminary ruling but which may be of interest for the case at hand.

In the end the PI Judge concludes that in its preliminary assessment Allergan has insufficiently proven that patent protection could not be obtained for second medical indications before the key date and dismisses Allergan’s injunction claim.

The decision is in line with an earlier decision of the Landgericht Dusseldorf of 7 March 2017 between Allergan and Orifarm GmbH.

A copy of the judgment (in Dutch) can be read here.

Headnote: Mattie de Koning, Simmons&Simmons LLP