Swiss-type claims (superseded)

This is a guide to the examination of applications relating to the Swiss-type claims under the Patents Act 1953 (“the Act”). This Guide does not constrain the judgment and discretion of the Commissioner of Patents, and each application will be considered on its own merits.

Introduction

The method of medical treatment exclusion to patentability has historically caused problems where a known substance, already used to treat a particular medical condition, is found to be useful in treating some other medical condition, this second use having been previously unrecognised. The substance itself cannot be patented because is not new. As most recently confirmed by the Court of Appeal in Pfizer Inc v The Commissioner of Patents [2005] 1 NZLR 362, the method of treating the particular medical condition cannot be patented either. Without patent protection, there may be little incentive to investigate the properties of existing pharmaceuticals to determine if they have other, previously unknown, medical uses.

In the European community, where methods of medical treatment are also unpatentable, the Swiss-type claim was devised to enable second medical uses to gain some patent protection. These claims were termed “Swiss-type” claims since they were first allowed in a 1984 decision of the Swiss Federal Intellectual Property Office. If the use of the compound for the specified therapeutic purpose is new, then such a claim is considered to be novel even if the same substance had previously been used in medicine for a different purpose. The protection of second therapeutic use by Swiss-type claims was allowed by the Commissioner of Patents in a Practice note which appeared in Patent Office Journal 1412 on 7 July 1997, and was approved by the Court of Appeal in Pharmaceutical Management Agency Ltd v Commissioner of Patents.

First therapeutic use - forms of claim

Suitable forms of claim which have been allowed for the first indication of a therapeutic use of a compound are:

1. (Substance X) for use in the treatment of (medical condition Y).
2. (Substance X) for use as a (Y-treating agent).
3. As a (Y treating agent), the (substance X).
4. (Substance X) for use in therapy (or for use as a medicament).

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Second therapeutic use - form of "Swiss-type" claims

The following is the general form of a Swiss-type claim:

The use of [known compound X] for the manufacture of a medicament for the treatment of [new therapeutic indication Y]

The particular wording of a Swiss-type claim does not need to be exactly as above, as long as it contains the essential integers.

In addition, the following types of claim are not acceptable Swiss-type claims:

i) Known substance X for use in the treatment of medical condition Y. This is a claim merely indicating the suitability for use of substance X,

ii) The use of known substance X in the treatment of disease Y. This is an unpatentable method of treatment claim.

iii) Commercial package containing as an active pharmaceutical agent compound X together with instructions ... for treating condition Y. If the pharmaceutical use of X is already known, the claim is only distinguished from the prior art by the content of the instructions, and this represents a mere presentation of information and thus not a patentable invention under section 2.

iv) A process for the manufacture of a medicament for use in the treatment of medical condition Y, characterised by the use of substance X. This claim does not adequately define the use of substance X, thus is unclear under section 10(4).

v) The use of known compound X for the manufacture of a medicament for the treatment of new therapeutic indication Y, wherein the medicament is administered orally. The mode of administration should only indicate the form of the medicament, such as “the medicament is formulated for oral administration”, rather than impart a monopoly on the administration of the medicament.

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Swiss-type claims and section 2

Swiss-type claims to substances or compositions can only derive novelty from their intended use if the use is a therapeutic method excluded under section 2 of the Patents Act 1953. In Pharmaceutical Management Agency Ltd v Commissioner of Patents [2000] 2 NZLR 529 (Pharmac) the Court of Appeal stated:

In this particular field where [the new use] cannot be captured with a method claim, we would accept the designation of purpose as sufficient

Swiss-type claims are not allowable for the new use of a known substance in, for example, non-surgical cosmetic methods. However, an application may include both claims to the second medical use of a compound for therapeutic purposes, and claims to cosmetic or other patentable methods using the compound, providing the therapeutic and non-therapeutic methods are distinguishable.

Likewise, genuine Swiss-type claims (wherein the novelty derives from the new use) are only acceptable when directed to the treatment of humans. Methods of treating non-human animals are allowable under section 2, thus the “designation of purpose” cannot provide novelty to claims in Swiss-type format for the treatment of non-human animals. If it is clear that the Swiss-type claims, when read in light of the specification, are directed to the treatment of humans only, there would not usually be any need for an explicit restriction. Conversely if the claims or specification do indicate the use of the medicament in the treatment of non-human animals, amendment may be necessary.

If an application includes unpatentable method of treatment claims, such as "The use of X to treat Y", amendment of these claims to convert them into Swiss-type claims does not constitute added matter.

Claims may be expressed in the general Swiss-type format whether or not the substance is known or has been used in therapy previously. There is no requirement for evidence concerning prior medical use to be included in the specification.

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Second medical use claims - the new use

i) Treatment of a new disease or condition

The decisions of the Commissioner in the 7 July 1997 Practice note, and the Court of Appeal in Pharmac, established that the use of a substance for a new and inventive therapeutic application can be protected by a Swiss-type claim. Typically, Swiss-type claims are used to protect the use of a substance or composition in the treatment of a specified disease, where it had previously been used for the treatment of a different disease. Providing the use of the substance in the treatment of the disease or therapy is not known, such claims are considered to be novel. Guidance on evaluating novelty may be taken from the decision in Schering A.G.’s Application [1985] RPC 553, wherein it is stated:

… a “second pharmaceutical use” invention, which is also referred to as the “second medical indication”, that is to say an invention based on the discovery that a drug already known for a particular medical activity (or activities) has another useful medical activity unconnected with the first and which had not previously been expected.

ii) New method, time, frequency or dosage of administration

Swiss-type claims which attempt to distinguish the new use from the prior art by the way in which the medicament is used are not acceptable, as they only define a new method of treatment. Such claims are therefore excluded from patentability under section 2 of the Act. A claim which defines the use in terms of the mode of administration, or the quantity, frequency or timing of dosage is therefore considered to be an attempt to monopolise a new method of treatment, disguised by drafting it in the Swiss-type format. This follows from the decision of the UK Court of Appeal in the Taxol case (Bristol-Myers Squibb v Baker Norton Pharmaceuticals [2001] RPC 1) approved by the Assistant Commissioner in Abbott Laboratories, (P16/2003).

The claim in question in the Taxol case had the wording:

Use of taxol and sufficient medications to prevent severe anaphylactic reactions, for manufacturing a medicamentation for simultaneous, separate, or sequential application for the administration of from 135 mg/m2 up to 175 mg/m2 taxol over a period of about 3 hours or less as a means for treating cancer and simultaneously reducing neutropenia.

The UK Court of Appeal held that this claim defined an improvement in the method of administering an existing treatment; it did not define a new and inventive therapeutic purpose (taxol was known to treat cancer). In particular, it was noted that all the claimed steps were in fact directed at actions taken by the doctor, tailored to the individual patient, rather than being directed at the manufacturer. Aldous LJ, Bristol-Myers Squibb v Baker Norton Pharmaceuticals:

The claim is an unsuccessful attempt to monopolise a new method of treatment by drafting it along the lines of a Swiss-type claim. When analysed it is directed step-by-step to the treatment. The premedication is chosen by the doctor, and administered prior to the taxol according to the directions of the doctor. The amount of taxol is selected by the doctor as is the time of administration. The actual medicament that is said to be suitable for treatment is produced in the patient under supervision of the medical team. It is not part of a manufacture.

Therefore, if the "new medical use" in a claim relates to the manner in which the doctor performs the treatment then an objection should be made under section 2 that the claim defines a method of treatment. For example, a claim which includes a dosage specific to the weight or size of the patient (as in the Taxol case) is not allowable. Any claim in which the "medicament" is only synthesised inside the patient’s body also defines a method of treatment.

Moreover, the UK Court of Appeal in Taxol concluded that the second medical use must be aimed at a different end-result from the prior art, rather than merely a different method of obtaining the end-result. Buxton LJ, Bristol-Myers Squibb v Baker Norton Pharmaceuticals:

The novelty cannot lie in the method of use, but in the new therapeutic purpose for which the substance is based.

The United Kingdom Court of Appeal in Taxol made the following comments on the interpretation of the Court in Pharmac, on the novelty providing feature of a Swiss-type claim:

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The “previously unrecognised advantageous properties” referred to in Pharmac must be found in the chemical compound, and not the dosage regime or the dosage amount. The novelty must reside in the newly discovered purpose, and not the mode of administration or the amount, timing or frequency of dosage.

This conclusion is supported by the UK Patent’s Court and Court of Appeal in Merck and Co Inc’s patents [Alendronate] [2003] FSR 29 (upheld by the UK Court of Appeal [2003] EWCA Civ 1545). In this case, a Swiss-type claim based on a new dosage regime (a single weekly administration of 70 mg of alendronate as opposed to daily administration of 10mg) was refused.

iii) New mechanism or technical effect

Swiss-type claims that relate to the same therapeutic use as the prior art, but claim a different technical effect or mechanism of action, will be rejected as lacking novelty; how a treatment works is irrelevant. An objection under section 2 that the claim defines a discovery rather than a manner of new manufacture may also be made.

The UK Patents Court in the Taxol case held that a new piece of information about how a treatment worked did not constitute an invention if it did not lead to a new use. This was upheld by the UK Court of Appeal. Swiss-type claims based solely on a new technical effect when treating the same condition will not be allowed.

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iv) New advantage to known use

The discovery of an unexpected advantage in a known treatment does not constitute a new therapeutic use, although it may form the basis of such a use. In the Taxol case, the claim was based partly on the unexpected discovery that a shorter infusion time for a chemotherapeutic agent led to a lessening of the harmful reduction in white blood cells (neutropenia). However, the shorter infusion time had already been disclosed - this was merely an additional piece of information about a known treatment. Jacob J, Bristol-Myers Squibb v Baker Norton Pharmaceuticals:

…there is a big difference between new information that a prior proposal previously thought unworkable in fact works and new information to the effect that a prior proposal has an additional advantage.

v) Co-administration

In the pre-acceptance hearing concerning an application by Abbott Laboratories (P16/2003) the Assistant Commissioner considered claims directed to the use of a known compound, ritonavir, in the manufacture of medicaments when formulated for sequential or co-administration with a novel compound, for ritonavir’s known use. The novelty of the Swiss-type claims, for the known compound, did not reside in the therapeutic application, but in the suitability for co-administration of the medicament. The Assistant Commissioner decided that the claims were analogous to those of the Taxol case and did not comply with the definition of Swiss-type claims. The same consideration applies when there has been a synergistic effect identified with the co-administration of the two compounds. A claim to the use of known compound X in the manufacture of a medicament for synergistically enhancing the effect of compound Y, in a treatment for which X and Y are already known for, is not a proper Swiss-type claim because the novelty does not reside in a new therapeutic use.

Likewise, if a claim is directed to the use of compound X in the manufacture of a medicament for enhancing the effect of compound Y, in a treatment that X was not previously known for, the claim is not a valid Swiss-type claim. The novelty does not reside in the new therapeutic application of compound X, because compound X does not provide the indicated therapeutic effect. The novelty resides in the administration of compound X with compound Y to enhance the effectiveness of compound Y. As decided in Taxol and approved in Abbott Laboratories, such claims are not valid Swiss-type claims and should be regarded as method of treatment claims.

vi) The new therapeutic use

Swiss-type claims can only be used to protect the use of a substance for a specified new and inventive therapeutic application. It must be clear from the claims, read in light of the specification, that the indicated treatment is in fact therapeutic. For example, a Swiss-type claim for the use of a compound in the treatment of a condition that can be improved or prevented by “selective occupation” of a receptor, or a condition “associated with a receptor”, does not define a therapeutic treatment. If a claim is defined in mechanistic terms, it must be clear that the mechanistic activity itself is therapeutic.

The therapeutic use must be defined in clear and unambiguous terms. Such as, for a therapeutic indication defined mechanistically as a condition ameliorated by antagonism or agonism of a receptor, it must be disclosed or known from the prior art that both agonism and antagonism of that receptor result in therapy. The specification should disclose the medical conditions that are treated by the particular mechanistic activity. If there are no specific medical conditions disclosed or known to be treated by that activity, then the claim is not directed to a new therapeutic use, but to the mere discovery of a physical property of a chemical compound.

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Second therapeutic use claims - the substance or composition

i) Assessing novelty

The scope of the substance defined in a second therapeutic use claim was considered by the UK Court of Appeal in American Home Products v Novartis, [2001] RPC 8, concerning Swiss-type claims for the use of a known antibiotic (rapamycin) for inhibiting organ or tissue transplant rejection. The UK Court of Appeal held that the claim did not cover derivatives of rapamycin - thus finding the claim not infringed by the use of a rapamycin derivative as an immunosuppressant.

ii) Fair basis when the substance is defined by chemical structure or class

Swiss-type claims are often worded to cover derivatives of a compound, or compounds comprising a particular structure, which by definition include derivatives. Claims of this type must be considered carefully to determine whether there is support for a claim extending beyond the exemplified embodiment(s), particularly where there is only one such embodiment.

If the specification discloses a general principle capable of general application, a claim in correspondingly general terms may be acceptable. There is no need to show proof of its application in every individual possible instance which could fall within the scope of the claim. Aldous LJ, American Home Products v Novartis:

Thus if the patentee has hit upon a new product which has a beneficial effect but cannot demonstrate that there is a common principle by which that effect will be shared by other products in that class, he will be entitled to a patent for that product but not for the class, even though some may subsequently turn out to have the same beneficial effect... On the other hand, if he has disclosed a beneficial property which is common to the class, he will be entitled to a patent for all products of that class (assuming them to be new) even though he has not himself made more than one or two of them.

iii) Defining the active ingredient by functional activity

Claims are often made for the second medical use of a group of compounds defined functionally; for example, as antagonists of a particular receptor. This type of claim was at issue in Pfizer’s Patent, [2001] FSR 201, which included claims to the second medical use of phosphodiesterase inhibitors. Such claims are not inherently objectionable, and in this case there was no suggestion that this form of claim was unduly broad and speculative. Although, the mere fact that a member of a functional class of compounds can be used to treat a disease does not mean that all such compounds will, particularly if there is no evidence that the treatment is related to that specific activity. It was established in Pfizer’s Patent, that a claim to, for example, "the use of an inhibitor of A in the manufacture of a medicament for the treatment of disease X" is anticipated by any disclosure of the use in treating disease X of a compound which inhibits A, regardless of whether the treatment is explicitly stated as being caused by the inhibition of A.

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Unity

Where the substance is known to have a therapeutic use, second therapeutic use claims directed to a variety of different diseases may give rise to a unity objection. A unity objection may be avoided if the conditions are related (and unrelated to the known conditions), or if there is a common mechanism linking the treatments.

Second therapeutic use and apparatus

The Commissioner in the 7 July 1997 Practice note, and the Court of Appeal in Pharmac approved Swiss-type claims only for pharmaceutical compositions or medicaments indicating a new therapeutic use. The indication of a new therapeutic use to distinguish from the prior art any other product or apparatus will not provide patentable subject matter unless the new use inherently necessitates a novel material difference.

Fair basis for the therapeutic use in Swiss-type claims

Swiss-type claims, which are to the further medical use of a substance or composition, must be supported by evidence that it is (or at least is likely to be) effective for the specified use. The specification should therefore provide, in the description as filed, an indication that in vivo or in vitro tests have been conducted and that positive results ensued (not necessarily quantified). Lack of any data, even rudimentary, in the description of an application which includes claims to a second therapeutic use should be objected to under section 10(4) as lacking fair basis.

A Swiss-type claim must meet the equivalent provisions of a selection patent in that the actual discovery of the new properties must be disclosed. As stated in Pharmac:

Just as there can be invention and novelty in the discovery of unrecognised properties in known substances qualifying for patent protection under the doctrine of selection patents and under the decision in NRDC, so there can be invention and novelty in the discovery of unrecognised properties of known pharmaceutical compound

Additionally the general principles established in Olin Mathieson Chemical Corp. v Biorex Laboratories Ltd [1970] RPC 157 should be applied to determine the fair basis of Swiss-type claims. In Olin Mathieson it was established that if a person skilled in the art could make a prediction based on the common general knowledge of the art, and what was further disclosed in the specification, and that if the prediction could be made with a reasonable degree of certainty, the prediction is sound, Graham, J. at 193:

If it is possible for the patentee to make a sound prediction and to frame a claim which does not go beyond the limits within which the prediction remains sound, then he is entitled to do so.

For a prediction on a further therapeutic use of a known compound to be considered a sound prediction, it must be based on actual experimental data otherwise the prediction is based only what is already known in the art. A Swiss-type claim is novel only if the further therapeutic indication is not known from the prior art. Thus the prior art cannot be relied upon to support the “discovery” of the further therapeutic properties. Such a prediction made in the absence of any experimental data is unsupported and cannot be made with any degree of certainty, and is therefore not a sound prediction. As established in Olin Mathieson, a claim based on a prediction that is not sound is not fairly based on the disclosure.