By means of a final judgment dated June 12 2013 and served on the parties on July 2, the Supreme Court dismissed Ferring's extraordinary appeals in a patent infringement case regarding desmopressin (commercialised by Ferring as Minurin).
In 2008 Ferring sued Kern for alleged infringement of European Patents 1 500 390 ('EP'390') and 1 550 439 ('EP'439), both of which related to the production of desmopressin tablets. Kern defended itself by arguing the invalidity of Ferring's patents due to lack of inventive step.
The EP'390 patent referred to desmopressin tablets with a low amount of lubricant (from 0.05% to 0.4%), whereas the closest prior art desmopressin tablets contained 0.5% of lubricant. According to Ferring, this reduction in the amount of lubricant solved two problems at once:
- It increased the hardness of the tablets; and
- It increased the production speed.
However, Kern claimed that the reduction in the amount of lubricant increased only the hardness of the tablets, and in no way contributed to increased production speed. According to Kern, increased production speed was obtained by means of other technical parameters which were the subject matter of some of the claims of EP'390 – but such claims were not asserted by Ferring in the litigation. Ferring acknowledged during the litigation that if the problem to be solved were tablet hardness only, the relevant patent claims would not be inventive.
The EP'439 patent claimed a method for the preparation of desmopressin tablets by means of fluid bed granulation. Although fluid bed granulation is a well-known and conventional technique, Ferring stated that there is a technical prejudice against using it with desmopressin because the latter is a delicate compound. On the contrary, Kern said that the aforementioned alleged technical prejudice does not exist.
By means of a March 30 2009 decision, Barcelona Commercial Court No 3 upheld Kern's invalidity defence and dismissed Ferring's infringement action.
Ferring's subsequent appeal was also dismissed by the Barcelona Court of Appeal in a judgment issued on June 2 2010:
- Regarding the EP'390 patent, the appeal court agreed with Kern in that the reduction of the amount of lubricant solved only the problem of enhancing the hardness of the tablets, and that the issue of production speed was solved by technical features included in the claims that Ferring did not assert.
- Regarding the EP'439 patent, the appeal court also agreed with Kern and considered that the technical prejudice contended by Ferring does not exist.
Ferring appealed this decision before the Supreme Court based on two grounds: a procedural infringement and a contradiction of the applicable Supreme Court case law.
The alleged procedural infringement was based on arguments including:
- illogical motivation of the second instance decision;
- unreasonable assessment of the evidence;
- incorrect application of the rules on burden of proof; and
- lack of congruence.
The Supreme Court dismissed the procedural issues raised by Ferring and considered that none of the procedural rules invoked by Ferring had been violated. In addition, it reiterated that a further review by the Supreme Court of the assessment of evidence on file is possible only in special circumstances, which were not present in the case at hand.
The Supreme Court also dismissed Ferring's cassation appeal based on material grounds (the alleged contradiction of applicable case law). Regarding the EP'390 patent, and contrary to what Ferring had stated in its appeal, the Supreme Court concluded that the second instance judgment did not split the patent into two different inventions: rather, the appeal court had correctly stated that the specific patent claims asserted by Ferring solved only one problem (enhancing the hardness of the tablets), whereas the other problem alleged by Ferring (increasing production speed) was solved by technical features included in other (unasserted) patent claims. Regarding the EP'439 patent, the Supreme Court confirmed that the second instance judgment had assessed it and concluded its lack of inventive step correctly.
The decision is final and cannot be further appealed.
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