Who needs the UPC anyway?
1 August 2014
Judgment was handed down on 15 May 2014 in the long running patent dispute between Actavis and Eli Lilly (Lilly) with respect to Lilly’s patent relating to the use of the anti-cancer drug pemetrexed disodium (Alimta®). Claim 1 defines a use of the drug with vitamin B12.
In the first case of its kind, Actavis sought declarations of non-infringement at the UK High Court in relation to the UK, French, Italian and Spanish designations of Lilly’s European patent. Lilly counterclaimed for threatened infringement of the UK designation of the patent.
The case has many interesting aspects but the key substantive issue was whether or not the words “pemetrexed disodium” used in the claims of the patent cover any forms of pemetrexed which are pharmaceutically acceptable and sufficiently soluble, (in particular pemetrexed diacid, potassium or ditromethamine which Actavis were hoping to market), or whether they only cover the specific chemical compound pemetrexed disodium.
During prosecution of the patent, Lilly narrowed the claim to “pemetrexed disodium” in response to objections relating to lack of clarity and lack of sufficient disclosure. Whilst the UK courts have traditionally been reluctant to use the prosecution history as an aid to claim construction, in this case it was considered to assist in ensuring that the patentee did not accept narrow claims during prosecution and then subsequently argue for a broad construction of those claims for the purpose of infringement.
Accordingly, it was held that the claim integer “pemetrexed disodium” could not be construed under either a literal or non-literal interpretation to extend to other salts. It follows that dealings in pemetrexed diacid, dipotassium and ditromethamine by Actavis would not constitute direct or indirect infringement of the UK, French, Italian or Spanish designations of the Patent.
Interestingly in Germany the opposite conclusion was reached. Arnold J addressed the discrepancy by noting that the German court did not give enough weight to the fact that amendments had been made during prosecution.
As such, Actavis were entitled to the declarations of non-infringement sought in respect of each of the UK, French, Italian and Spanish designations of the patent. Initially, Lilly had challenged the UK court’s jurisdiction to rule on the foreign designations of the patent. This challenge was rejected by both Arnold J in the High Court and by the Court of Appeal. Arnold J held that under English law, Actavis were entitled to the declarations of non-infringement, since they are a matter of procedure, but that in any event it would have been so entitled even if the issue had been one that should be decided under the laws of each of the foreign jurisdictions.
This is the first time that the High Court has exercised jurisdiction over foreign designations of a European patent. This may be the first step for parties to bring proceedings in relation to multiple designations of European patents in a single court, provided that validity is not in question.
Kirsty Simpson
Life Sciences & Chemistry
If you require further information on anything covered in this briefing, please contact Kirsty Simpson (ksimpson@withersrogers.com; +44 207 940 3600) or your usual contact at the firm.
This publication is a general summary of the law. It should not replace legal advice tailored to your specific circumstances.
© Withers & Rogers LLP, August 2014
