For Swiss national patents:

• – Before 1 July 2008: Case law of the Swiss patent office which introduced protection for second medical uses by means of what became known as the Swiss-type claim format.
• – As of 1 July 2008: Article 7d Patent Act which codified the earlier practice.

For European patents:

• – Before 13 December 2007: Case law of the Enlarged Board of Appeal (G 5|83) which confirmed patentability of second medical uses in the form of the Swiss-type claim format.
• – As of 13 December 2007: Article 54(5) EPC which permits protection by means of purpose limited product claims. European patents have the same effects in Switzerland as a Swiss national patent.

According to case law of the Swiss Federal Supreme Court (BGE 137 III 170) and of the Enlarged Board of Appeal (G 2|08):

• – a new therapeutic application (in general);
• – treatment of a new indication;
• – a new therapeutic application based on the group of subjects to be treated;
• – a new therapeutic application based on a different mode of administration;
• – a new therapeutic application based on a dosage regimen;
• – a new therapeutic application based on a different technical effect.

To the knowledge of the Swiss group there is no case law denying patentability of specific second medical uses.

For the sake of completeness it should be reminded that the general exclusions from patentability (in particular of inventions whose exploitation is contrary to human dignity or that disregard the integrity of living organisms or that are in any other way contrary to public policy or morality) also apply to second medical use inventions.

For Swiss national patents: The Swiss patent act prescribes the Swiss-type claim format.

For European patents: The EPC allows for the purpose limited product claim format; in G 2|08, the Enlarged Board of Appeal held that the Swisstype claim format is no longer available.

See above answers ad d) e contrario: For Swiss national patents, all claim formats other than the Swiss-type claim format are not permissible, while for European patents all claim formats other than the purpose limited product claim format are not permissible.

In particular, method of treatment claims are not available both for Swiss national patents and for European patents. Article 53(c) EPC states: “European patents shall not be granted in respect of methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body”. The respective provision in the Swiss patent act (Article 2(2)(a)) is practically identical.

No.

• i) For example: the party marketing the drug with label instructions which describe the patented use;
• ii) the physician prescribing the drug for such use;
• iii) the pharmacist dispensing a drug for such purpose;
• iv) the patient using the drug for such purpose?

cf. table 1

Table 1

The Swiss patent act provides for the following privileges that may be relevant in the context of the infringement of second medical use claims:

• – Article 9(1)(a) provides for a private use exemption. A patient taking a non-patented substance for a patented second medical use is exempt from infringement under this provision.
• – Article 9(1)(b) states a research and experimental use exemption. Accordingly, whoever uses a non-patented substance in the research related to a patented second medical use is exempt from infringement.
• – Article 9(1)(c) contains a Bolartype exemption. Whoever makes use of a second medical use claim in the context of obtaining the marketing authorization for a non-patented substance for a patented second medical use is exempt from infringement.

One chamber of Swiss parliament accepted proposed additional Articles 9(1)(g) and 9(1)(h) which would exempt from infringement (i) any act involving a medicament performed in the context of medical practice and (ii) the preparation of drugs in pharmacies on the basis of a medical prescription. These provisions are intended to ensure that physicians and pharmacists do not become liable for infringement of a second medical use claim in the purpose limited product claim format by prescribing, dispensing and preparing a medicament. If these exemptions are enacted, the second, third and last lines in table 2 change above.

Although the Swiss group had filed a third party observation suggesting introducing these additional privileges not in the form of exemptions from infringement but as defenses against enforcement, this suggestion had not been taken into account. The Swiss group’s suggestion aims at preventing the privileges from also benefitting manufacturers and suppliers of skinny labeled generics.

Table 2

See above tables.

Yes.

Yes.

It is required that the party knows, should know or promotes an infringing use.

See 5.c.

There is no pertinent Swiss case law. Generally, Swiss law provides for the following preliminary relief: preliminary injunction and preliminary taking of evidence.

There is no pertinent Swiss case law. Generally, Swiss law provides for the following final relief: permanent injunction and monetary relief (damages, reasonable royalty or account of profits).

The Swiss patent office did not give policy reasons when it admitted the Swisstype claim format for the protection of second medical use inventions in 1984. The Enlarged Board of Appeal held the following when it adopted that claim format in G 5|83:

“No intention to exclude second (and further) medical indications generally from patent protection can be deduced from the terms of the European Patent Convention; nor can it be deduced from the legislative history of the articles in question.”

It is the understanding of the Swiss group that the policy reasons for permitting protection of second medical use inventions are that such inventions may provide benefits that are as important and desirable as any other inventions in the field of health care. The industry should be incentivized to allocate research funds also to the improvement of existing drugs, e.g. by reducing side effects or enhancing patient compliance, and to the search for further applications of existing drugs.

There is no broad consensus on this in Switzerland. On the one hand, the Federal Supreme Court and representatives of the Swiss patent office are concerned that the purpose limited product claim format envisaged by the EPC will restrict the freedom of medical practitioners to prescribe or administer generics. The above-mentioned proposal for the adoption of additional exemptions from infringement (proposed Articles 9[1] [g] and 9[1][h]) is the Swiss government’s response to this concern.

The pharmaceutical industry, on the other hand, takes a different view. The claim format is only one element that determines the scope of protection actually conferred by a patent. Further elements that need to be taken into account are statutory exemptions, the statutory requirements for liability as contributory infringer, and, above all, the regulatory framework. As shown in the above tables, the adoption of the additional exemptions proposed by the Swiss government would have the effect that a second medical use claim – regardless of whether such claim is in the Swiss-type claim or in the purpose limited product claim format – may not be enforced against a generic company providing a skinny labeled generic that is then used cross-label for the patented second medical use. This is considered problematic in particular because the regulatory framework in Switzerland encourages patent-infringing cross-label use in such circumstances: doctors do not need to indicate the use on the prescription; pharmacists are encouraged to dispense generics rather than branded drugs; because the prescription does not indicate the intended use, the pharmacist is not in a position to verify compliance of the intended use with the label of the dispensed generic; health insurance companies reimburse cross-label use of a generic. So while the regulatory framework encourages patent infringing uses, it is feared that patent law alone will not provide the adequate means to effectively counter such infringing uses.

See answer to b).

The Swiss group sees no reasons for limiting the types of second medical uses that may be permissible subject matter. Rather, the limits should be drawn by the standard requirements for patentability, in particular the requirements of novelty and inventive step.

See answer to a).

It is the view of the Swiss group that the claim format is less important than the actual scope of protection conferred by a second medical use claim. Nevertheless, the Swiss group favors the purpose limited product claim formats.

As long as one of the formats named under c) is permissible, the Swiss group sees no reasons for not allowing also other formats.

It is the view of the Swiss group that anybody should be liable who (i) prepares or supplies a drug with instructions referring to the patented second medical use or (ii) prepares or supplies a drug with instructions that do not refer to the patented second medical use but otherwise promotes such use or at least knows or, in light of the circumstances, should know of such use but does not take adequate measures to prevent such use.

It is the view of the Swiss group that it is not necessary to exempt certain parties or institutions from liability. It would suffice to provide that second medical use claims may not be enforced against certain parties or institutions, e.g. against patients, doctors and pharmacists.

• – Preparing or supplying a drug with instructions referring to the patented second medical use.
• – Promoting for a patented second medical use a drug with instructions that do not refer to the patented second medical use.
• – Preparing or supplying a drug with instructions that do not refer to the patented second medical use if the respective person knows or should know in light of the circumstances that the drug is in fact used for the patented second medical use but does not take adequate measures to prevent such use.