Patents & Trademarks
The low-down on the situation regarding patents & trademarks in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for USD 99.
1. What are the basic requirements to obtain patent and trademark protection?
The general principals of patents and trademarks are regulated in the Federal Act on the Protection of Trade Marks and Indications of Source (TmPA) as well as in the Federal Act on Patents for Inventions (PatA) and the corresponding regulations.
Patents may be obtained on the basis of a national or European application or via the designation of Switzerland (directly or through the European application) pursuant to the Patent Cooperation Treaty (PCT).
Patent law protects inventions. A patent grants the owner the right to prohibit all others from commercially using the protected invention. Patents for technical inventions are granted only for new inventions which are susceptible of industrial application and which do not result in an obvious way from the state of the art (an inventive step is required) and which are sufficiently disclosed.
The invention as such merely gives rise to expectancy, the so-called “right to the grant of a patent”. Although this includes the legitimation to file a patent application and the right to be named as the inventor, it does not grant any claims to protection under patent law. Exclusivity claims in particular can only be enforced on the basis of the granted patent. In order to obtain patent protection, a patent needs to be registered with the Swiss Federal Institute of Intellectual Property (IPI). The patent is granted by registration in the patent register. Until then, there is no exclusive right and the inventor is not entitled to bring any action against any infringing party.
Upon filing a patent application, the IPI will first conduct a formal examination and then proceed to the validation of the technical elements of the invention upon receipt of the examination fee. Unlike the European Patent Office, the IPI does not examine whether the invention is new or whether it results in an obvious way from the state of the art. However, it is examined whether an invention within the meaning of the Patent Act exists at all, whether it is legally disclosed and whether the structure of the technical documents meets the legal requirements. The IPI therefore recommends carrying out a patent search. Consequently, the applicant is under no obligation to disclose prior art. The publication is published at the latest 18 months following the application or the earlier designated priority date. The patents are granted on the basis of mere examination of formal aspects (see below) and the term of protection is 20 years from the filing date.
Supplementary Protection Certificates (SPC) can be obtained for medicinal products and plant protection products. The IPI grants a SPC upon request if, at the time of the application a product (active substance or combination of active substances), a process for its manufacture or a possible use is protected by a patent and insofar as a marketing authorization under pharmaceutical law exists in Switzerland. The certificate protects all uses of a product as a medicinal product or plant protection product that were granted before the patent expired and are protected by the patent. It grants the same rights as the patent and is also subject to the same restrictions. The application for a certificate must be submitted to the IPI within six months of the first authorization to place the product on the Swiss market as a medicinal product, or six months after the grant of the patent if it was granted later than the authorization under pharmaceutical law. As part of the revision of the Therapeutic Products Act (TPA) the legislator created the possibility of a six months SPC extension for pediatric pharmaceuticals. The pediatric extension is either possible by extending an already granted SPC, or through a new pediatric SPC.
A trade mark is a protected sign that distinguishes the goods or services of one company from those of other companies. That distinguishing function is intended to individualize the goods and services designated so that consumers can distinguish a product once valued from the quantity of goods and services offered by other company.
Trademark law is based on the so-called registration principle, according to which the trademark is not created until it is entered in the trademark register. Meaning that trademark protection can be obtained through national registration or designation of Switzerland via the Madrid System (see further question 5). The minimum requirements for a trademark, in order to be registered are:
- The sign does not infringe on other’s rights (e.g. older trademarks);
- the sign needs to be distinctive;
- the sign must not be descriptive;
- the sign does not go against public order or public morality.
A trademark right belongs to the person or company who first files the trademark. A trademark is valid for 10 years from the date of filing the application and may be renewed indefinitely for subsequent periods of 10 years each (if an application for renewal is submitted and the fees are paid).
2. What agencies or bodies regulate patents and trademarks?
As mentioned under question 1, the IPI (https://www.ige.ch/en.html) is the first point of contact for its customers concerning industrial IP rights, meaning trademarks, patents and designs in Switzerland.
The IPI is also the designated office for dealing with international patent applications claiming patent protection in Switzerland pursuant to the PCT. Applicants domiciled in Switzerland may also file European patent applications with the IPI, with the exception of divisional applications. Further the IPI is the designated office for international trademark applications under the Madrid Agreement (and Protocol) on the basis of a Swiss trade-mark, as mentioned in question 5.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
As mentioned under question 1, for an invention to be patentable, it must be of a technical character and entail a physical interaction with the environment. Furthermore, the invention must be executable and reproducible in industrial application.
The PatA excludes certain inventions from patentability, partly for moral and ethical reasons, partly because they are not to be monopolized by a patent. The following are excluded from patenting:
- methods for diagnostic, therapeutic or surgical procedures practiced on the human or animal body. Though substances and compositions solely intend-ed for medical use or for use in the manufacture of means to a medical end (a “Swiss-type claim”, also available for second and further medical indications) are patentable even if the underlying substances and composition form part of the prior art;
- the human body as such, at all stages of its formation and development, including the embryo (an element of the human body is, however, patentable if it is produced by means of a technical process and a beneficial technical effect is indicated);
- naturally occurring gene sequences or partial sequences (however, technically produced derivatives of gene sequences may be patented if their function is specifically indicated);
- 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, such as the process for cloning human beings, processes for modifying the germ line genetic identity of human beings or the creation of other organisms by using human genetic material as well as the use of human embryos for non-medical purposes;
- essentially biological processes for the production if animal breeds and plant varieties as well as certain biotechnological inventions, however, in the event that biological material is directly obtained by a patent manufacturing pro-cess, the effects of the patent also extend to the propagated material and products in which the biological material in incorporated.
As already mentioned, a trademark is a sign that distinguishes the goods or services of one company from those of other companies. Trademark protection is available not only for words and devices but also for sounds, holograms and three-dimensional objects, as well as combinations of such elements with each other or with colors.
The absolute grounds for exclusion are that certain signs may not be protected as trademarks (avoidance of false monopolization). Excluded from trade mark protection are:
- signs that belong to the public domain, except where they have become established as a trade mark through use for the goods or services for which they are being claimed.
- signs contrary to public policy, morality or applicable law;
- shapes that constitute the essence of the claimed goods and shapes of the claimed goods or their packaging that are technically necessary;
- signs that are misleading.
Whether a sign satisfies the condition of one of those absolute grounds for exclusion must, in principle, be decided on the basis of the overall impression. The IPI, following the case law of the Federal Supreme Court, tends to be strict with signs lacking distinctiveness or showing deceptive contents or misleading indications of origin.
In Switzerland there is no protection of signs not registered as trademarks. An exception is made for any use relevant under the Federal Act against Unfair Competition (UCA) or if a sign is considered a “notorious trademark”, because the mark is known to the Swiss public for any reasons whatsoever, for example, intensive promotion or celebrity association.
4. How can patents and trademarks be revoked?
Once granted, the patent may be opposed by third parties within a time limit of nine months of the publication of the entry in the Patent Register. The notice of opposition must be filed in a written reasoned statement. Opposition may only be filed on the grounds of non-patentability essentially for reasons of public policy or morality (i.e. the human body, a naturally occurring sequence or partial sequence of a gene, or inventions that are contrary to the public policy or morality, see question 3.).
Hence, the requirements of novelty or non-obviousness can only be scrutinized by the Federal Patent Court in nullity or infringement proceedings by virtue of a counterclaim or objection. If the IPI finds in favor of the opposition in its entirety or in part, it may revoke the patent or maintain it as amended. The decision regarding an opposition is subject to appeal to the Federal Administrative Court.
The proprietor of an earlier trademark may file an opposition to a registration on the basis of relative grounds for refusal, such as the similarity to an earlier trademark. The opposition must be submitted in writing to the IPI with a statement of reasons within three months of publication of the registration. The opposition fee must also be paid within this time limit. If the opposition is justified, the registration shall be revoked in whole or in part; if this is not the case, the opposition shall be rejected.
Furthermore, a trademark is protected if it is used in relation to the goods or services for which it is claimed. Where the holder has not used the trademark in relation to the goods or services for which it is claimed for an uninterrupted period of five years following the expiry of the opposition period with no opposition having been filed or upon conclusion of opposition proceedings, he may no longer assert his right to the trademark, unless there are proper reasons for non-use. If use of the trademark is commenced or resumed after more than five years, the right to the trademark is restored with effect from the original priority date, unless non-use of the trademark has been invoked prior to its commencement or resumption of use. Any person who invokes non-use of a trademark is required to substantiate his claim; evidence of use is required to be provided by the proprietor of the trademark. Since January 2017, it is possible to file a request for the cancellation of a trademark in case of non-use with the IPI and not only by means of civil action.
5. Are foreign patents and trademarks recognized and under what circumstances?
The patent gives its owner the right to prohibit others from commercially using the invention. The scope of protection of the Swiss part of a European patent or a Swiss patent is limited to the territory of Switzerland and Liechtenstein in accordance with the principle of territoriality (according to a special treaty, the protection of patents granted for Switzerland also extends to the Principality of Liechtenstein). Therefore, only the act of use carried out in Switzerland is illegal. However, it is not necessary for the infringer to be active in Switzerland himself. It is sufficient if his activities have an economic effect in the territory of Switzerland.
The trademark right gives the proprietor the exclusive right to use and dispose of the trademark to identify the goods or services for which it is claimed. This right is limited to the territory in which the trademark is registered, meaning that a trademark needs to be registered in Switzerland in order to obtain such exclusivity in Switzerland.
The international registration of trademarks is regulated by the Madrid Agreement Concerning the International Registration of Marks (MMA) as well as the Madrid Protocol (MMP), these treaties are administered by the International Bureau of the World Intellectual Property Organization (WIPO) in Geneva. The MMA enables a trademark owner who has registered a trademark in his home country (national basic registration) to apply for an international registration at WIPO. In this case, the trademark will be registered for all the contracting states designated by the applicant unless these states expressly refuse within 12 months. Switzerland is a member of these treaties.
6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?
The Federal Act on Medicinal Products and Medical Devices (TPA) applies to the handling of therapeutic products (medicinal products and medical devices), particularly in their manufacture and placing on the market; narcotics, in so far as they are used as therapeutic products as well as therapeutic treatments, such as gene therapy, in so far as they directly relate to therapeutic products. Swissmedic (Swiss Agency for Therapeutic Products) is the Swiss authority responsible for the authorization and supervision of such therapeutic and medicinal products.
The UCA is aimed at all participants in the competition. The aim is to express the equivalence of the interests of business, consumers and the general public. In principle, a cumulative applicability of the Act in relation to intellectual property rights is to be assumed. Meaning that if a patent or trademark registration is waived, the protection of secrets under unfair competition law shall remain. The Act regulates general unfair practice; there are no special barriers to competition related to medicines or devices.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
Generally, there are no additional or specific restrictions in the context of medicines or devices, other than the above-mentioned restrictions related to patent or trademark law (see question 3). However, the TPA protects human and animal health by guaranteeing that only high quality, safe and effective therapeutic products are placed on the market. The TPA further regulates the principles for placing products on the market and the authorization procedure (as mentioned above in question 6).
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
Generally, there are no formalities required for a patent or trademark license, neither for a Swiss licensor, nor for a foreign licensor. However, as with any legal transaction, written form is recommended, especially for evidence reasons and in order to avoid possible interpretation disputes. Further the registration in the patent or trademark registered brings some advantages.
According to the PatA license agreements of third parties not recorded in the patent register are invalid against persons who have acquired in good faith the rights to the patent. This means that the registration of the license agreement in the patent register is not a constitutive requirement for the establishment of the license. In the internal relationship between licensor and licensee, the entry in the register therefore only has declaratory effect. In external relations, the entry in the register strengthens the legal position of the licensee vis-à-vis an acquirer of rights to the patent who must allow the licensee to use the patent in accordance with the license agreement.
According to the TmPA a license agreement can be entered in the trademark register at the request of one of the parties. It then becomes binding on any rights to the trademark subsequently acquired. The entry in the register has no direct effect between the parties. A license agreement is valid even if the license is not registered in the trademark register.