The United Kingdom Patents Court,decision of Justice Arnold in Warner -Lambert Company, LLC v Actavis Group Ptc EHF & Ors [2015] EWHC 72 (Pat) (21 January 2015) (“Warner-Lambert”) has clarified that in order to infringe Swiss-type claims a subjective intention on behalf of the manufacturer is required. It also highlights that better protection for a second medical use invention may be provided in a jurisdiction which allows method of treatment claims.

Swiss-type claims are a special type of claim rendered necessary by exclusions on the patentability of methods of medical treatment. They are generally of the format:

“The use of compound X in the manufacture of a medicament for the treatment of disease Y”

As noted by the Court of Appeal in Pharmaceutical Management Agency Ltd v Commissioner of Patents [2000] 2 NZLR 529 at paragraph [047]:

“The Swiss claim is not a product claim. It is a use claim, but that use is not novel. It is known to use the active compound or composition in the making of a medicament. It is the purpose for which the medicament is made that is novel.”

Swiss-type claims are a common method of protecting second medical uses. In some jurisdictions they are now outdated (such as in Europe following the EPC 2000 and the decision of the Enlarged Board of Appeal in G2/08 of 19 February 2010). In other jurisdictions, such as New Zealand they remain the only method for claiming protection for a second medical use of a pharmaceutical compound. Surprisingly, given the lengths which were gone to achieve protection for this type of claim in a number of jurisdictions, there is very little consideration of what constitutes infringement of such a claim. The decision in Warner-Lambert v Actavis will hopefully provide some guidance.

The claims in question in Warner-Lambert v Actavis were as follows:

“1. Use of [pregabalin] or a pharmaceutically acceptable salt thereof for the preparation of a pharmaceutical composition for treating pain.

3. Use according to Claim 1 wherein the pain is neuropathic pain.”

Pregabalin is known to be useful for a number of purposes including the treatment of pain, epilepsy and general anxiety disorder (GAD). Patent protection for pregabalin itself has expired, but a patent for the second medical use as claimed above remains in force. When Actavis proposed to enter the market with generic pregabalin “skinny-labelled” for epilepsy and GAD in order to avoid infringement. Warner-Lambert sought an interlocutory injunction specifying Actavis take certain actions.

Justice Arnold refused to grant an injunction on the grounds that, on the facts given, there was not a serious question to be tried. Justice Arnold considered that Actavis would not infringe the above claims, even though Actavis knew it was likely that the generic product would be prescribed or provided for the treatment of pain. In doing so Justice Arnold was required to consider what constitutes infringement of a Swiss-type claim.

It was common ground that the word “for” in Swiss-type claims meant “suitable and intended for”. The key questions were whose intention is relevant and what is meant by “intended”.

As to the first question, Justice Arnold was clear, the relevant intention is that of the person who performs the process of manufacture (paragraph 99).

As to the second question, Warner-Lambert submitted that

“it was sufficient for this purpose that Actavis intended to sell pregabalin and knew that pharmacists were likely to dispense it for treating (neuropathic) pain if positive steps were not taken to prevent this.”

Justice Arnold rejected this submission and held at paragraph 111 that:

“the word “for” in Swiss form claims imports a requirement of subjective intention on the part of the manufacturer that the medicament or pharmaceutical composition will be used for treating the specified condition.”

Thus in order to infringe a Swiss-type claim, the process of preparing a medicament or composition must be done with the intention that the pharmaceutical composition will be used for treating the specified condition. It is not sufficient to show knowledge by the manufacturer that the composition is likely to be used for that purpose.

Subjective intention will be hard to establish, but Justice Arnold did not consider it to be insurmountable. Examples he gave including where the indication was listed in the summary of product characteristics or in the patient information leaflet for marketing approval of the generic medicament, or where the generic manufacturer promotes prescribing or dispensing of the drug for the protected purpose in some other way.

Relevance to New Zealand law

We consider the principles applied by Justice Arnold in coming to his decision are equally applicable under New Zealand law. As such the decision in Warner-Lambert v Actavis will be highly persuasive in determining infringement of Swiss-type claims in New Zealand.

Distinction from Method of Treatment claims

The case also highlights the difference in the protection provided by method of treatment claims versus that provided by Swiss-type claims. In Warner-Lambert v Actavis the interlocutory injunction was denied inter alia on the ground that there was not a serious question to be tried.

In contrast in the Australian case Warner-Lambert Company LLC v Apotex Pty Ltd[2014] FCA 241 the Full Federal Court considered the claim:

“A method of treating pain comprising administering a therapeutically effective amount of [pregabalin] to a mammal in need of said treatment.”

In that case the Full Federal Court granted an interlocutory injunctions restraining Apotex from entering into the Australian market. We reported this case here. A notable difference between the two cases is that in Australia infringement by the generic supplier was held to be under section 117 of the Patents Act (AU) 1990. This section states that it is an infringement to supply a product if the supplier has “reason to believe” that the product will be used in an infringing manner.

In Warner-Lambert v Actavis, Warner-Lambert pleaded but did not press a claim infringement of section 60(2) of the Patents Act (UK) through “the supply of essential means”. This provision is of similar effect to section 117 of the Patents Act (AU) 1990. Justice Arnold commented that they were correct not to pursue infringement under section 60(2):

“There can be only be infringement under section 60(2) if there can be infringement by the person supplied or by a user further down the chain of supply (although it is not necessary for there actually to be an infringing act). This is not the case here, since no wholesaler or pharmacist will use [pregabalin] to prepare a pharmaceutical composition.” [paragraph 113]

Thus at least as far as interlocutory proceedings are concerned, it seems clear that a patent having method of treatment claims provides greater protection than a patent solely having Swiss-type claims. It follows that better protection for a second medical use invention is provided in a jurisdiction which allows method of treatment claims such as Australia, than in one which only allows Swiss-type claims such as New Zealand.