In an important judgment, the Court of Appeal has considered the interpretation of "Swiss form" second medical use claims i.e. claims directed to the use of a chemical compound for the preparation of a pharmaceutical composition "for" the treatment of a particular disease.
Floyd LJ, giving the judgment of the Court, concluded that a manufacturer who knows (including having constructive knowledge), or can reasonably foresee, the ultimate intentional use of the composition for the patented indication will infringe such a claim. This differed from the decision at first instance, where Arnold J held that a specific subjective intention or desire on the part of the manufacturer that the composition be used for the patented indication was required.
The Court of Appeal has also opened up the possibility that indirect infringement under s60(2) Patents Act 1977 might occur not only where the invention is put into effect by one person alone, but also where the actions of more than one person, when taken together, put the invention into effect.
Warner-Lambert Company, LLC v Actavis Group PTC EHF and others  EWCA Civ 556 click here
Warner-Lambert markets pregabalin (under the brand name Lyrica) for three different indications – neuropathic pain, generalised anxiety disorder and epilepsy. Patent protection for the drug itself expired in 2013 but Warner-Lambert owns a patent (EP (UK) No. 0 934 061) directed to the use of pregabalin for the preparation of a pharmaceutical composition for treating pain, in particular neuropathic pain (a "Swiss form" claim).
Actavis sought to sell generic pregabalin in the UK with a "skinny label" i.e. the marketing approval sought by Actavis was only for the non-patented indications (generalised anxiety disorder and epilepsy).
The procedural history
Warner-Lambert commenced patent infringement proceedings in the UK against Actavis, and applied for an interim injunction (pending trial) requiring Actavis to take a number of steps to prevent their generic product from being dispensed for the treatment of pain.
On 21 January 2015, the High Court refused to grant an interim injunction against Actavis on the basis that (i) there was no serious issue to be tried on infringement (direct or indirect) and (ii) the interim relief requested was not justified on the balance of the risk of injustice.
Following a subsequent application made by Actavis the High Court struck out Warner-Lambert's claim for indirect patent infringement on 6 February 2015.
Warner-Lambert appealed both decisions to the Court of Appeal.
The main infringement proceedings are due to come to trial (along with revocation proceedings brought by Actavis and Mylan in relation to the same patent) at the end of June 2015.
No serious issue to be tried – direct infringement
At the heart of the appeal was the question of how Swiss form claims should be construed. Floyd LJ, delivering the judgment of the Court of Appeal, noted that this is a "very difficult question".
The court focussed on the meaning of the word "for" in Swiss form claims – what does it mean to claim the use of a compound X for the preparation of a pharmaceutical composition for treating disease Y?
At first instance, it was common ground that the word "for" in that context would be understood to mean "suitable and intended for" and the High Court proceeded on that basis. There was no dispute that pregabalin was suitable for treating neuropathic pain as referred to in the claims. The Court of Appeal characterised the ensuing argument as being focussed on (i) whose intention was relevant, and (ii) what is comprised in the requirement for intention.
The High Court concluded at first instance that subjective intention on the part of the manufacturer was required.
On appeal, both sides accepted that a Swiss form claim must include "some kind of mental element" and thus "for" could not simply be construed as meaning "suitable for". The Court of Appeal agreed, observing that the latter construction would give the claim a scope that is far broader than the patentee's contribution to the art, and would not distinguish it over known uses of the known drug.
Both parties made submissions on what "suitable and intended for" might mean, but ultimately the Court of Appeal held that focussing in detail on the meaning of the word "intention" (which does not appear in the claim) would not be the correct approach. Instead, Floyd LJ proceeded to analyse the claim, noting first the distinction between the technical subject matter of the claim on one hand, and the rights which the patent gives rise to under national law of infringement on the other.
The Court of Appeal held that Swiss form claims are process claims, and identified the subject matter of the claim in this case as "making pregabalin for patients to whom it will be intentionally administered for treating pain". The intention for which the compound is administered is what is at the heart of the invention.
Against that background, the skilled person would understand that the word “for” in the claim was a link between the act of manufacture using pregabalin and the ultimate intentional use of the drug by the end user to treat pain. The next question was: what is sufficient to constitute that link?
Floyd LJ said it was too extreme to suggest that, where a drug is in fact used for a patented indication, it would be considered to have been made "for" that indication. Instead, he considered whether subjective intention was required on the part of the manufacturer that the drug will be used for the patented indication, or if foreseeability that the drug would be intentionally used in that way was enough.
The Court of Appeal held that the skilled person would understand the purpose of a Swiss form claim to be that of avoiding the twin perils of lack of novelty and lack of patentable subject matter. The Court rejected arguments from Actavis that (i) a subjective mental element on the part of the manufacturer would be necessary to provide a Swiss form claim with novelty and (ii) a fundamental principle of English patent law (that no-one should be prevented from doing by the grant of a patent what they did, or could have done, before) required a subjective mental element.
Ultimately the Court of Appeal held that the skilled person would understand that the manufacturer who knows (including having constructive knowledge) or could reasonably foresee that some of its drug will intentionally be used for the treatment of pain is making use of the patentee’s inventive contribution in the same way as a manufacturer who actively desires that result. The use of the word “for” in the claim was a requirement that the manufacturer knows or can reasonably foresee the ultimate intentional use for pain, not that he/she had that specific intention or desire him/herself.
Floyd LJ then considered direct infringement of the claim as he had construed it. He noted that there is no mental requirement in the infringement test under s 60(1)(b) Patents Act 1977 regarding the use of a patented process. He went on to hold that a manufacturer would be found to be using the claimed process, and therefore infringing the patent, if he/she manufactures pregabalin when he/she knows or foresees that users (i.e. pharmacists) will intentionally administer it for pain. The Court of Appeal noted, however, that even if infringement was made out at trial, it did not follow that unqualified relief (i.e. a final injunction to stop marketing of pregabalin by Actavis) would be available to Warner-Lambert as of right.
No serious issue to be tried – indirect infringement
Under s60(2) Patents Act 1977, indirect infringement arises where a person supplies or offers to supply in the United Kingdom the means, relating to an essential element of the invention, for putting the invention into effect when that person knows, or it is obvious to a reasonable person in the circumstances, that those means are suitable for putting, and are intended to put, the invention into effect in the United Kingdom.
The reference to "putting the invention into effect" implies that at the end of the chain of events started by the supply of the "means relating to an essential element of the invention" there is an act which would constitute direct infringement of the patent in question.
Floyd LJ agreed with the High Court's finding at first instance that there are difficulties with Warner-Lambert's indirect infringement claim because the pharmacists were not "preparing a pharmaceutical composition" as required by the claims.
However, the Court of Appeal nonetheless decided to reverse the first instance decision to strike out Warner-Lambert's claim for indirect infringement, allowing it to go to trial. They did so for three separate reasons (each of which was held to be sufficient in its own right):
- courts in two EPC member states (German and the Netherlands) considering the same question had previously held that indirect infringement can arise in this situation and had granted provisional relief;
- if there is infringement of the process claim under s60(1)(b) then dealings downstream in the direct product of the process would also be infringements under s60(1)(c);
- "putting the invention into effect" in s60(2) might be concerned not just with the situation where a single person carries out the invention such that that person would be liable for infringement, but also the situation where one person manufactures pregabalin and supplies it to another who intentionally uses it for the treatment of pain. If the person supplying pregabalin has the requisite knowledge (i.e. in the sense required in s60(2)) then they do provide means suitable and intended to put the invention into effect, albeit by the combination of manufacturer and user, rather than by any one person alone.
Balance of justice regarding the injunction
The Court of Appeal reviewed the High Court's decision to refuse Warner-Lambert's request for a preliminary injunction on the basis of the balance of justice. Floyd LJ said that the first instance judge had properly evaluated the factual material before him and came to a conclusion with which the Court of Appeal could not interfere.
The High Court's decision to refuse the preliminary injunction was upheld (on the grounds of the balance of justice) but Floyd LJ disagreed with the approach taken to the construction of Swiss form claims at first instance. Consequently the decision at first instance to strike out Warner-Lambert's indirect infringement claim was reversed. The Court of Appeal has provided helpful, and detailed, guidance on issues of construction and infringement affecting Swiss form claims. It remains to be seen whether Actavis will be found to infringe when the matter goes to trial at the end of June and, if they do, what remedy the court will award to Warner-Lambert.
- It will no longer be possible for a generic pharmaceutical manufacturer to argue that because they themselves have no specific intention that their generic product will be used for a patented indication, they do not fall within a Swiss form claim.
- There is, therefore, more scope than there was after the High Court decision in this case for originators to take action where it is foreseeable that some of the generic medicine may be used for a patented indication regardless of the generic manufacturer's intention.
- Merely providing a generic medicine with a "skinny" label which does not mention indications covered by a Swiss form claim is unlikely to be enough to avoid a patent infringement claim in this situation.
- Arguably, even encouraging against prescription of the generic product for the patented indication will not be enough if it is still foreseeable that patients will end up using the generic for the patented indication.
- However, any application for an injunction by a patentee in this situation will still have to be justified on the balance of justice which will depend on all the facts.
- This case only dealt with Swiss form claims, and in fact Arnold J made clear at first instance that it should not be assumed that anything he said about such claims necessarily applied to EPC 2000 second medical use claims. It therefore remains to be seen how the English courts will deal with the question of intention in relation to EPC 2000 claims.