05 July 2015

Patenting Swiss-Style, In Australia and the UK

Swiss FlagLast week I wrote about the ways in which medical treatments – including pharmaceutical compounds and therapeutic methods – are protected using a variety of different forms of patent claim.  One of these is the so-called ‘Swiss-style’, ‘Swiss-type’, or simply ‘Swiss’ claim, which takes the form ‘[compound] for use in the manufacture of a medicament for treatment of [new condition].’  I explained that Swiss-type claims are treated as if they cover any and every method of making a medicament of any kind that includes the compound as an active ingredient, and with the intention of it being used to treat the new condition.

By sheer coincidence, on 29 June 2015 Justice Yates, in the Federal Court of Australia, handed down a ruling in Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4) [2015] FCA 634, in which he has a great deal to say about Swiss-type claims.  Furthermore, the previous week the England and Wales Court of Appeal issued a decision in Actavis UK Ltd & Ors v Eli Lilly & Company [2015] EWCA Civ 555, which also involved Swiss-type claims.

It is interesting to compare the two decisions, particularly because, in my view, the UK court managed to completely undermine the European prohibition on patents for methods of medical treatment and must surely, therefore, be wrong!

Judicial Consideration of Swiss-Type Claims in Australia

The Australian case relates to a compound known as aripiprazole, the original version of which is marketed under the name ABILIFY, and which is used to treat schizophrenia.  The relevant patent is no. 2005201772, which is owned by Otsuka. 

This litigation has been ongoing for some time.  I first wrote about it when Otsuka was successful in obtaining a preliminary injunction preventing the introduction of a generic competitor, and then again when Generic Health sought leave to appeal that decision (they were unsuccessful: see Generic Health Pty Ltd v Otsuka Pharmaceutical Co., Ltd [2013] FCAFC 17).

By way of example, claim 1 of the patent takes the following form:

Use of a carbostyril compound of [a given structural formula] ... or a pharmaceutically acceptable salt or solvate thereof, for the production of a medicament, effective in the treatment of disorders of the central nervous system associated with [the] 5HT1A receptor subtype, which disorder:

(i) is selected from cognitive impairment caused by treatment-resistant schizophrenia, cognitive impairment caused by inveterate schizophrenia, or cognitive impairment caused by chronic schizophrenia, and

(ii) fails to [respond] to antipsychotic drugs selected from chlorpromazine, haloperidol, sulpiride, fluphenazine, perphenazine, thioridazine, pimozide, zotepine, risperidone, olanzapine, quetiapine, or amisulpride.

Despite its wordiness, this is plainly a Swiss-type claim, in which the compound is (for present purposes) aripiprazole, and the (allegedly) new use of the compound is the treatment of schizophrenia in certain specified circumstances.

Perhaps surprisingly, although many Australian patents include Swiss-type claims they have received very little consideration from the courts here up until now.  Swiss-type claims scored a passing mention or two in the High Court’s important 2013 decision in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50, which was concerned with the patentability of methods of medical treatment. It seems generally to have been assumed (though never formally decided) that Swiss-type claims are valid in Australia, in part because they have been approved by the Court of Appeal in New Zealand, where methods of medical treatment are (as in Europe) unpatentable: see Pharmaceutical Management Agency Ltd v Commissioner of Patents [1999] NZCA 330.

Justice Yates has therefore given Swiss-type claims fairly comprehensive consideration, including a review of their origins under the European system as a ‘workaround’ to protect second medical uses without claiming prohibited methods of treatment, as well as their subsequent acceptance by the English courts.

Characterisation of Swiss-Type Claims in Australia

The court was required to determine how Swiss-type claims should be characterised under Australian law.  Following his discussion of the background, and the approach in other jurisdictions, Justice Yates concluded (at [120]) that ‘an invention defined by a Swiss type claim is appropriately characterised as method or process’ of manufacturing a medicament, and not as a claim to the product itself.

This came as a relief to me, because had he decided otherwise I would have had to correct what I had written about Swiss-type claims only a couple of days prior to the judgment being delivered!

Are Swiss-Type Claims ‘Legitimate’ in Australia?

While the judgment addresses the proper characterisation of Swiss-type claims, on the assumption that they are a valid form of claiming, it stops short of positively endorsing this style of claim as legitimate in Australia.  Justice Yates noted that (at [114]):

The rationale for Swiss type claims … is not one that applies to Australian patents. The legal position in Australia is different. Methods for treating the human body with pharmaceutical products are patentable …. The particular impediment presented by the [European Patent Convention] in respect of methods for treatment does not exist for the applicant for an Australian patent.

At [116] His Honour further notes that while Generic Health ‘put in issue’ whether Swiss-type claims are ‘a valid form of claiming’, it did not ultimately present substantive arguments on this question, and ‘must be taken as having accepted, for the purposes of its submission, the general proposition that a new therapeutic use for a known medicament can provide the element of novelty required to support an invention claimed in the form of a Swiss type claim.’  He was therefore not required to address ‘the fundamental question raised by the respondent because the respondent has not itself addressed that question.’

I think that we must therefore accept that the validity of the Swiss style of claim has still not been directly addressed by an Australian court, and that everyone continues simply to operate on the assumption that such claims are legitimate, despite being strictly unnecessary in this country.

The UK Case – Supply of Non-Infringing Product for Infringing Use

The UK case relates to a compound known as pemetrexed disodium, which is used as a cancer treatment which Eli Lilly has marketed under the brand name ALIMTA since 2004.  The compound is protected by way of European Patent No. 0432677.  The litigation results from applications by Actavis for declarations of non-infringement of the European patent.  Validity of the patent has not been challenged (although there are procedural reasons why Actavis could not challenge validity in this context, even if it had wanted to do so.)

The key question is therefore whether Actavis would infringe any of the claims of the patent, including the following Swiss-type claim 1:

Use of pemetrexed disodium in the manufacture of a medicament for use in combination therapy for inhibiting tumor growth in mammals wherein said medicament is to be administered in combination with vitamin B12 or a pharmaceutical derivative thereof, said pharmaceutical derivative of vitamin B12 being hydroxocobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-chlorocobalamin perchlorate, azidocobalamin, chlorocobalamin or cobalamin.

Actavis' non-infringement argument is based simply on the fact that the active ingredient in its proposed product is one of: (a) pemetrexed diacid; (b) pemetrexed ditromethamine; or (c) pemetrexed dipotassium.  Thus Activis does not propose to make or market a product containing pemetrexed disodium, as in the Lilly patent claims, and therefore cannot infringe those claims.

However, the Court of Appeal has found that, because the product to be supplied by Actavis is generally to be reconstituted in saline (i.e. sodium chloride solution) for injection by the physician, and is (at that point) effectively a pemetrexed disodium solution, Actavis would be liable as a contributory infringer.

Has the UK Court Made Infringers of Physicians?

The problem I see with the Court of Appeal decision is that if Actavis is liable as a contributory infringer, then the attending physician must be liable as a direct infringer.  Arguably, the infringement would arise from performing the final step in the ‘manufacture’ of pemetrexed disodium, rather than as a result of performing a method of treatment, but surely this is a distinction without a difference?  What, on one view, might be the final step of manufacture is, on an alternative view, the first step in treatment of the patient (i.e. reconstitute the compound in saline for injection).

It is also worth noting a particular difference between Otsuka’s Swiss-type claim in Australia, and Lilly’s Swiss-type claim in Europe.  For whatever reason, Lilly claimed ‘use of pemetrexed disodium’ whereas Otsuka claimed ‘use of a carbostyril compound of [a given structural formula] ... or a pharmaceutically acceptable salt or solvate thereof’.  This raises the question of why, if it is so simple to cover off on all of the viable, and therapeutically irrelevant, variations of the active ingredient, Lilly did not do so.

(And, no, you cannot look to the record of examination of the application, a.k.a. the ‘prosecution history’, to try to find out why, because the impermissibility of this approach under UK law was confirmed by the Court of Appeal.)

Conclusion – Swiss-Type Claims Still a Dubious Fiction?

As I said in my previous post, Swiss-type claims are predicated on the legal fiction that a second (or other subsequent) medical use of a known compound can be protected by way of a patent on any and all methods of making a medicament using the compound, for the purpose of the newly-discovered use.

Of course, we know that in the normal course of events this would not be true.  Absent the legal fiction, a claim directed to making a medicament including a known compound as the active ingredient would need to be supported by a description of some new and non-obvious method of making the medicament.  Furthermore, the scope of such a claim would be restricted to the new method described, and any obvious variations.

We all turn a blind eye, however, and pretend that novelty in the medical use confers novelty on manufacture of the medicament for that use.  Such fictions have their place, but ought to be limited to the specific circumstances in which they achieve some justifiable end.

There is, I think, a hint in Justice Yates’ judgment that the role of the legal fiction of the Swiss-type claim may be questionable in Australia, given that methods of medical treatment are patentable in this country (although, to be fair to all of the patentees who have been granted such claims, there was some uncertainty about this prior to the High Court’s Apotex decision in December 2013).

As for the judgment of the England and Wales Court of Appeal, the idea that a legal fiction of this kind could be extended to encompass direct infringement by medical practitioners is one that I consider highly questionable.  There has been enacted in Europe a deliberate and express policy of avoiding the possibility of patent infringement in the course of performing treatments on the human body, by way of declaring such activities inherently unpatentable.  If the decision of the Court of Appeal stands (I understand there is a possibility of appeal to the Supreme Court), then medical practitioners in the UK are squarely back in the crosshairs of any Swiss-type claim where the final steps in preparing a medication are performed at the patient’s bedside.

Surely that cannot be right?


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