Posted: July 12th, 2016
Novartis AG v. Alvogen IPCO S.a.r.l and Focus Farma, District Court The Hague, the Netherlands, 6 July 2016, Case no. ECLI:NL:RBDHA:2016:7502
On 6 July 2016 the The Hague District Court rejected Novartis’ claim against Alvogen and Focus Farma based on infringement of its patent for patches containing rivastigmine, as it held the patent to be invalid.
Novartis AG is co-owner of EP 2 292 219 B1 (EP 219), granted on 12 June 2013. EP 219 relates to a “Transdermal therapeutic system for the administration of rivastigmine”. When the patent was granted, Alvogen IPCO S.a.r.l and Focus Farma B.V. were already on the market with the Permente patch, a generic version of the rivastigmine patch that Novartis markets under the trade mark “Exelon”.
In the previous PI decision of 18 November 2014, the Court of Appeal of The Hague had held that EP 219 was likely to be revoked or invalidated in opposition or final relief proceedings. Novartis’ position that EP 219 does not just protect a rivastigmine-patch with improved adhesive properties, but every transdermal patch containing rivastigmine that has the same starting dose as Novartis’ Exelon patch, would essentially come down to the patent protecting a dosage regime.
Like the Provisions Judge in first instance, the Court of Appeal did not follow Novartis in its broad interpretation and held that the patent was likely to be revoked or invalidated for reasons of added matter. The Opposition Division of EPO in its decision of 15 December 2015 had also revoked EP 219 for containing added matter.
Albeit on different grounds, also the District Court of The Hague considers EP 219 invalid and therefore it rejects the claims of Novartis. The District Court holds that EP 219 lacks inventive step. According to the Court, the skilled person, starting from US 2001/0048938 as the closest prior art, would find the starting dose as claimed in EP 219, a TTS of 5 cm2 with a loaded dose of 9 mg rivastigmine, by performing routine tests on the basis of ‘trial and error’. The solution to the objective technical problem, namely how a patient may quickly be adjusted to a tolerable and safe dosage of rivastigmine, is, according to the Court, obvious in light of the closest prior art.
The decision of the District Court is in line with the decision of the UK High Court of Justice (Arnold J) of 27 April 2015 ( EWHC 1068 (Pat)) that held EP 219 invalid on the basis of added matter and lack of inventive step. The Court does not address the other arguments that Alvogen and Focus Farma brought to substantiate its invalidity defence, being added matter, lack of novelty and insufficient disclosure, nor did it address the arguments that the Permente patches do not fall within the scope of protection of claim 1.
You can find a copy of the judgment here.
Head note: Jaap Bremer, BarentsKrans