Warner-Lambert v Actavis; the Court of Appeal has its say on second medical use claims in the UK
The IPKat is delighted to receive from a Katfriend this brief summary of an important decision handed down this morning. More detailed consideration may follow in due course.
IPKat readers who have followed this saga will know that earlier this year Mr Justice Arnold gave the first detailed consideration of what a Swiss-form claim means, see blog post here and here. Today the Court of Appeal handed down its decision in the latest of this ongoing litigation involving Warner-Lambert's blockbuster Lyrica product.
As a brief refresher, in Warner-Lambert Company, LLC v Actavis Group Ptc EHF & Others [2015] EWHC 72 (Pat) Arnold J construed the Swiss form claim as requiring the infringer (for example a generic producer) to “subjectively intend” the medicine to be used for the patented indication. Under this test the patentee would not be able to succeed on infringement unless it could show that the generic company had aimed at or targeted the patented use in some way. In his subsequent judgment dated 6 February 2015, Arnold J ordered that Warner-Lambert’s claim for indirect infringement under section 60(2) of the Patents Act be struck out.
In a judgment handed down today Warner-Lambert Company, LLC v Actavis Group Ptc EHF & Others [2015] EWCA Civ 556 the Court of Appeal (led by Lord Justice Floyd) has put forward a wider test for the infringement of second medical use patents. On direct infringement under section 60(1)(c) of the Patents Act, Lord Justice Floyd departed from Arnold J’s subjective intent test which amounted in effect to requiring that the patentee prove that it is the generic’s “wish or desire” to sell some medicine for the patented indication. Floyd LJ concluded that it was sufficient for infringement that the producer knows (including constructive knowledge) or can reasonably foresee that the medicine would ultimately be intentionally used for pain. Floyd LJ commented that on his construction of the claim “it is plain that Warner-Lambert have an arguable case of infringement”. Infringement will now be considered at the trial at the end of June. On indirect infringement under section 60(2) of the Patents Act, the Court also allowed Warner-Lambert’s appeal against the striking out of that claim.
The Court of Appeal did however decline Warner-Lambert’s proposed interim relief. Warner-Lambert had sought (1) that a contractual condition be included in any agreement entered into by Actavis with any pharmacy or with any intermediary for the supply to a pharmacy of its generic pregabalin product that the pharmacy use reasonable endeavours to ensure generic pregabalin would not be supplied or dispensed to patients who have been prescribed pregabalin for pain; (2) that Actavis inform Warner-Lambert’s solicitors of the name of any intermediary they intended to supply their product to; and (3) that Actavis’ generic pregabalin product be supplied in bulk packaging bearing a notice stating legibly 'This product should not be dispensed for pain.' The Court of Appeal commented that, even if infringement is found at trial, “it does not follow that unqualified relief will follow as of right”. This case has already seen the grant of a novel order addressed to NHS England requiring it to give central guidance to prescribers and dispensers. No doubt other developments will follow.
IPKat readers who have followed this saga will know that earlier this year Mr Justice Arnold gave the first detailed consideration of what a Swiss-form claim means, see blog post here and here. Today the Court of Appeal handed down its decision in the latest of this ongoing litigation involving Warner-Lambert's blockbuster Lyrica product.
As a brief refresher, in Warner-Lambert Company, LLC v Actavis Group Ptc EHF & Others [2015] EWHC 72 (Pat) Arnold J construed the Swiss form claim as requiring the infringer (for example a generic producer) to “subjectively intend” the medicine to be used for the patented indication. Under this test the patentee would not be able to succeed on infringement unless it could show that the generic company had aimed at or targeted the patented use in some way. In his subsequent judgment dated 6 February 2015, Arnold J ordered that Warner-Lambert’s claim for indirect infringement under section 60(2) of the Patents Act be struck out.
In a judgment handed down today Warner-Lambert Company, LLC v Actavis Group Ptc EHF & Others [2015] EWCA Civ 556 the Court of Appeal (led by Lord Justice Floyd) has put forward a wider test for the infringement of second medical use patents. On direct infringement under section 60(1)(c) of the Patents Act, Lord Justice Floyd departed from Arnold J’s subjective intent test which amounted in effect to requiring that the patentee prove that it is the generic’s “wish or desire” to sell some medicine for the patented indication. Floyd LJ concluded that it was sufficient for infringement that the producer knows (including constructive knowledge) or can reasonably foresee that the medicine would ultimately be intentionally used for pain. Floyd LJ commented that on his construction of the claim “it is plain that Warner-Lambert have an arguable case of infringement”. Infringement will now be considered at the trial at the end of June. On indirect infringement under section 60(2) of the Patents Act, the Court also allowed Warner-Lambert’s appeal against the striking out of that claim.
The Court of Appeal did however decline Warner-Lambert’s proposed interim relief. Warner-Lambert had sought (1) that a contractual condition be included in any agreement entered into by Actavis with any pharmacy or with any intermediary for the supply to a pharmacy of its generic pregabalin product that the pharmacy use reasonable endeavours to ensure generic pregabalin would not be supplied or dispensed to patients who have been prescribed pregabalin for pain; (2) that Actavis inform Warner-Lambert’s solicitors of the name of any intermediary they intended to supply their product to; and (3) that Actavis’ generic pregabalin product be supplied in bulk packaging bearing a notice stating legibly 'This product should not be dispensed for pain.' The Court of Appeal commented that, even if infringement is found at trial, “it does not follow that unqualified relief will follow as of right”. This case has already seen the grant of a novel order addressed to NHS England requiring it to give central guidance to prescribers and dispensers. No doubt other developments will follow.