Novartis v. Actavis, Valsartan, District Court Oslo, Norway, 10 February 2011, Case No. 10-062600TVI-OTIR/04
On 10th of February 2011 the Oslo District Court rendered its decision in a case between Novartis AG/Novartis Norge AS (hereafter Novartis) and Actavis Group PTC hf/Actavis Norway AS (hereafter Actavis) regarding Novartis’ patent NO 304023. Novartis had initiated the proceedings, requiring preliminary measures to stop Actavis’ infringement of patent NO 304 023 by producing and selling products containing the pharmaceutical ingredient valsartan.
The patent in question is a process patent and the question before the court was whether the process used by Actavis to fabricate valsartan – QSSA Route C – constituted an infringement of patent NO 304 023.The District Court assessed the question using the doctrine of equivalence.
There are three criteria in the doctrine of equivalence according to Norwegian patent law:
1) The infringing object (here: The alternative method to prepare valsartan) should solve the same problem as the patented invention,
2) the modifications made should have been obvious to the skilled person, and
3) the infringing object must not be part of the free technique (known and freely available technical knowledge).
The parties agreed that the dispute concerned the second criterion only. The District Court reviewed this question based on what was known about the process at the time of the alleged infringement. An alternative solution would have been to base the review on the knowledge on the day of the patent application. The District Court’s evaluation implies that the patentee benefits from the technical development from the day the patent was granted and to the day of the infringement.
When reviewing whether Actavis’ procedure, QSSA Route C, infringed the patent, the District Court first had to establish whether it was a modification of the solution offered by the patent-in-suit. The court concluded that QSSA Route C was a modification based on the description of the patent.
Next, the District Court had to evaluate whether the modified process was obvious to a person skilled in the art. The court formulated this as a question of whether a person skilled in the art would be able to attempt the process described in the patent with the modification made and have a reasonable expectation to succeed. The District Court concluded that this was the case – the modifications that were made were not sufficiently different – and thus constituted an infringement of the registered patent. On this point one of the expert judges dissented – in his opinion the QSSA Route C represented an essentially different process.
The wording of the District Court’s rendering of the obviousness test may suggest that the court has misinterpreted the criterion since it did not say that it was a question of whether the skilled person would have attempted the process in dispute with a reasonable expectation of success.
Another question reviewed in the case was whether the SPC/NO 1998 024, covering the distribution of valsartan in generic mono products, also covers valsartan in so-called combination products. The court concluded that the term “product” in the Norwegian Patents Act 1967 section 3 also includes combination products. Thus, the SPC/NO 1998 024 prohibits the marketing and sale of combination products containing valsartan produced in a way which infringes the registered patent by others than Novartis.
The District Court’s judgment was that Actavis was forbidden to market and sell any products containing valsartan produced by using the process QSSA Route C until 13 May 2011. Actavis were also ordered to withdraw all products containing the infringing object from the Norwegian marked.
Novartis was admitted a compensation of NOK 7,000,000 for lost selling volume caused by Actavis’ infringement. The judgment has recently been appealed to the Borgarting Court of Appeal.
The original version of the judgment can be found (in Norwegian) on the Norwegian Medicines Agency’s website, here.
Head note and summary: Thomas Hagen