The Patent Review 2013 - 2014: Cross-border declarations of non-infringement

15 April 2015

Neil Jenkins, Audrey Horton

Actavis UK Ltd and others v Eli Lilly & Co [2014] EWHC 1511 (Pat), Arnold J.

Pemetrexed disodium, a cancer treatment marketed by Eli Lilly under the brand name Alimta, was protected by a basic patent extended by supplementary protection certificates (SPCs) expiring in December 2015. Lilly also owned a second medical use patent relating to the use of pemetrexed disodium in the manufacture of a medicament for use in treating cancer in combination with vitamin B12 which would not expire until June 2021.

Actavis wished to clear the path in France, Germany, Italy, Spain and the UK in relation to its generic pemetrexed product (not being the disodium salt) ahead of expiry of the SPCs based on the basic patent.

Accordingly, Actavis decided to commence proceedings in the UK for declarations of non-infringement (DNIs) in respect of each of the designations of the second medical use patent in those other countries as well as the UK.

The Judge had held previously that, in circumstances where there was no challenge to the validity of the foreign designations of a European patent, the English court had jurisdiction to entertain an action seeking DNIs of those foreign designations as well as the UK designation.  This decision was upheld by the Court of Appeal ([2013] EWCA Civ 517).

Actavis subsequently discontinued the proceedings in respect of the German part of the European patent after a German first instance infringement court had held that the use of pemetrexed dipotassium would infringe the German designation of the European patent.

The Judge held that the law applicable to the issue as to whether Actavis' proposed acts would infringe each of the non-UK designations of the European patent was the substantive patent law of the relevant country but the law applicable to the grant of the DNIs themselves was that of the forum itself; in this case, English law.

Even if that was wrong, however, the Judge held that the national rules of France, Italy and Spain would permit the grant of a DNI for each of their respective jurisdictions.

As regards the UK part of the European part, the Judge held that the use of the diacid (Actavis's lead candidate salt) would not infringe the claims of the patent. He did so using the framework of the so-called Improver Questions and on the basis that the skilled addressee of the patent was a team which included both an oncologist and a chemist and of the CGK of the skilled chemist regarding the predictability of the viability of different salt forms of the parent molecule, pemetrexed. The Judge answered Improver Questions 2 and 3 in favour of Actavis for a multiplicity of reasons including the way in which the patent had been prosecuted before the EPO.

In the course of his Judgment, his review of the authorities on construction included those dealing with the use of prosecution history as an aid to construction. He concluded that, although the courts had been directed to be cautious in doing so, nevertheless it was useful in some cases to consider the prosecution history in order to shed light on the meaning of the claim.

He then went on to consider the issue of infringement of the other designations of the European patent under the laws of each of the respective countries (France, Italy and Spain) and came to the same conclusion namely that the use of the diacid would not infringe those other designations in those respective countries.

The Judge expressly disagreed with the German first instance court’s decision on (non-literal) infringement (based on the doctrine of equivalence). He set out a number of reasons for his disagreement including the fact that the German court had only considered the matter from the perspective of the oncologist and not also of the chemist and also that they had ignored the prosecution history.

As regards the grant of the DNIs themselves, applying English law, the Judge granted relief in respect of each of the parts of the European patent under its inherent jurisdiction on the basis that Actavis had clearly demonstrated that it had a real commercial interest in obtaining the declarations and they would serve a useful purpose. He also held that even if he was wrong as to the applicable law i.e., applying the national laws of each of France, Italy and Spain, the relief would still be granted.

Lilly's appeal against this decision was heard at the end of March 2015 and the Judgment from the Court of Appeal is expected to be handed down soon. Interestingly, shortly before the hearing of the appeal, the German Court of Appeal reversed the decision of the German first instance court holding that the claim was not infringed (on a nonliteral basis) by the use of the dipotassium salt of pemetrexed.