5.5 Patent infringement
5.5.1 Claim construction
According to Section 14 of the Patent Act and Article 69 of the EPC, the scope of protection of a patent is determined by the patent claims, whereby the description of the patent and (if available) the drawings are considered for the interpretation of the claims. Different from other jurisdictions, it is not admissible to use the files of a grant procedure as interpretation material. Conversely, prior art mentioned in the description of the patent can be used for interpretation purposes as well as opposition or nullity decisions.57
Patents are construed from the perspective of the so-called average person skilled in the art on the filing date or priority date of the patent. The person skilled in the art is defined as an imaginary person with professional training or qualifications (e.g., a skilled worker, master or engineer) and practical experience of the kind usually gained by those who have worked in the operational or industrial practice of relevant companies in the field to which the teaching of the patent belongs.
Patent protection cannot be derived from the patent description or the drawings alone: a technical teaching that is exclusively described there (both in terms of an extension or a limitation of the claim) but that is not reflected in the patent claims is not covered by the patent.58 Conversely, the claim must always be interpreted, not only if the wording of the claim is unclear, to determine the technical meaning associated with the wording of the claim.59 This is mandatory for the simple reason that the patent specification is its own dictionary for the terms used in it, and, therefore, only by referring to the description can information be gained about what the claim means and intends to protect with a certain wording.
In principle, the claim, description and drawings form a coherent unit and must be interpreted in a way such that contradictions do not arise unless contradictions are irreconcilable, in which case the patent claim prevails over the description or the drawings. Embodiments mentioned in the description must therefore give reason to ask whether it is possible to interpret the features of the main claim such that all variants described as being in accordance with the invention are also covered by the wording of the claim. Only if such an interpretation is precluded by the specific wording of the claim is there room for an interpretation that an embodiment disclosed in the description is not covered by the claim. However, such cases are rare exceptions.60
Furthermore, the technical meaning or function of the individual feature and the extent to which it contributes to the invention laid down in the patent claim (a so-called functional interpretation) should always be considered.61 However, in the case of spatially, physically or substance-defined features, this should not be reduced to the mere function of the feature. Rather, the feature should be interpreted in a sense that is consistent with the spatially, physically or substance-defined nature of the feature.62 The function-oriented interpretation may exceptionally give rise to a situation wherein the meanings of terms used in different contexts in the patent claim do not necessarily mean the same thing but are instead defined according to the technical functions given by each individual context.63 This may also result in a feature having different content than the corresponding feature in another publication in the state of the art.64
In addition, it must also be ensured that the wording of the claim is fully understood and that the necessary infringement argument is therefore also made with regard to those implicit features that follow only indirectly from the other features of the claim. The following aspects also need to be taken into account when interpreting the features of the claim:
- References in the claim do not limit the protection to an exemplary embodiment.
- It cannot be concluded from the absence of a feature in a drawing (that it is part of the technical teaching) that the feature in question is not present.
- A claim feature may merely express a technical matter of course for the skilled person in the art.
- Features in a patent claim that do not leave any gaps to be filled on the basis of the self-evident knowledge of the average person skilled in the art are to be interpreted in such a way that, from the entirety of the claim features, a suitable subject matter for the purposes of the invention results.
- Most often, the term “in particular” introduces an optional feature. However, this might not be the case when the text following the phrase contains an exemplary concretization of a more general feature that has been mentioned in advance.
- The terms “contains” and “comprises” allow additional components besides those explicitly mentioned in the claim; the terms “consists of” and “is composed of” are to be understood as an exhaustive list such that no additional components are allowed.
- The designation of a component in the plural may suggest the possibility of the use of a generic designation; however, this only applies if there are positive indications in the description that an object with the component as singularly designated is also intended to be in accordance with the invention.
- An obviously false designation (falsa demonstratio) in the claim may be corrected based on the description and the drawings.
- Patents need to be interpreted by considering the description and the drawings. It should not influence the interpretation of the patent claim whether this results in an inadmissible extension patent beyond the content of the application. Patent interpretation and added matter are two different issues that should not be mingled.65 The same is true with regard to patentability: a patent should not be interpreted narrowly just because that would allow its delineation from prior art.
5.5.2 Infringement analysis
184.108.40.206 Direct patent infringement
The patent owner generally has an exclusive right to use the invention. Which specific acts are prohibited to third parties depends on whether a product or a method is protected. The different acts that constitute a direct patent infringement are set out in Section 9.
In terms of product claims, third parties are not entitled to manufacture, offer, put on the market or use a product that is the subject matter of the patent. Moreover, they are not entitled to import or possess such a product for the aforementioned purposes (Section 9 no. 1). “Manufacture” covers the entire creation process of the product, not only the final step.66 The manufacturer of individual parts could also be considered the manufacturer of the overall product if the manufacturer supplies the individual parts to a third party that assembles them into the protected overall product.67 An offer is any act by which the product is made available to third parties. It does not need to be an offer for a contract but could also be a mere (internet) advertisement.68 The offered product does not need to be manufactured or brought within the territory of Germany. However, the mere transit of infringing products does not constitute an act of infringement in Germany.
In terms of process claims, a third party is not entitled to use, or offer for use, a process that is the subject matter of the patent if the third party knows or if it is obvious from the circumstances that use of the process is prohibited in the absence of the consent of the proprietor of the patent (Section 9 no. 2). A use of a process requires, in principle, that all the steps of the method are carried out within Germany. However, if the method is carried out partly within Germany and partly abroad, the method claim could nevertheless be infringed. This would require that the method steps carried out abroad can be attributed to the person who carried out the method steps within Germany.69
Furthermore, a third party is not entitled to offer, place on the market or use a product that is produced directly by a process that is the subject matter of the patent, or to either import or possess such a product for the aforementioned purposes (Section 9 no. 3). This refers to a product obtained directly by the process, which is at least the case when the process is not followed by any further processing or treatment operations. According to case law, however, the process does not need to be the last step in any case, but the decisive fact is whether the further-treated product obtained by the patented process maintains its characteristics.70
220.127.116.11 Indirect patent infringement
According to the concept of indirect infringement, any party is prohibited, in the absence of the consent of the proprietor of the patent, from supplying or offering to supply, within Germany, persons other than those entitled to exploit the patented invention with means relating to an essential element of the invention for use within Germany if the third party knows or if it is obvious from the circumstances that those means are suitable and intended for using that invention (Section 10(1)). Typical cases of indirect patent infringement are, for example:
- the offer and supply of a device with which a patented method can be carried out;71
- the offer and supply of a component of a device that can be combined with other components to form the complete patented combination; and
- the offer and supply of a machine with which a patented device can be manufactured.
The offered or supplied means must relate to an essential element of the patented invention. According to the case law of the FCJ, such a means relates to an element of the invention if it is capable of interacting with the element of the invention realizing the invention.72 If the means are mentioned in the patent claim, they are generally considered to relate to an essential element of the invention.
The means must be objectively suitable for a direct patent infringement. Thus, if the means are used together with other means or for use of a method, a direct patent infringement must be possible.73 However, an indirect infringement does not require a direct infringement by the offered or supplied person.
Furthermore, the means must be offered or supplied within Germany,74 for use in Germany75 and must be delivered to a person who is not entitled to exploit the invention. Thus, an export of the means would, in principle, not constitute an indirect infringement. However, according to case law, the supply of parts to a person abroad could constitute an indirect infringement if the products containing those parts are reimported to Germany.
The offered or supplied person must intend to use the means in an infringing way, and the person offering or supplying the means must know that the means are suitable and intended for exploiting the invention, or it must be at least obvious to them. If the means could also be used in a noninfringing way, the injunction could be limited to an infringing use, for instance, by way of a specific warning notice.76 The means must not be generally available commercial products, such as nails or screws, except where the supplier induces the supplied person to use the products in an infringing way (Section 10(3)).
18.104.22.168 Infringement by equivalent means
The scope of protection is not limited to literal patent infringement. When an element specified in the patent claim is replaced by a variant, a patent infringement by equivalent means could be considered. According to the case law of the FCJ, three requirements must then be fulfilled:77
- 1. The variant must solve the problem according to the patent with means having essentially the same effect as the element specified in the patent claim.
- 2. The skilled person must be able, due to their expert skill, to find the variant as having essentially the same effect as the element in the patent claim.
- 3. The skilled person must be able to find the variant as having the same effect by considerations oriented to the technical teaching protected by the patent claim.
In terms of the first requirement, it is decisive that the overall effects according to the patent – specifically those advantages of the element specified in the claim – are essentially achieved.78 This requirement is not met if the variant achieves the effects of the element specified in the patent claim only in part. It is also not met if the variant has disadvantageous properties that the embodiment, as specified in the patent claim, does not have or that are to be avoided according to the teaching of the patent claim.
The third requirement is not met if the variant is a technical means that the patent seeks to avoid or a means that the patent-in-suit intends for the same technical effect only in a different context. Furthermore, an infringement is usually excluded if it is clear from the overall context of the patent claim that it is limited to a specific solution. Furthermore, the third requirement is not met if the variant is a means that the patent specification refers to as an alternative to the claimed solution79 or if the patent specification discloses several possibilities as to how a given technical effect of the invention can be achieved but where only one of these possibilities has been specified in the claim.80 However, an infringement by equivalent means cannot be denied only because the embodiment claimed by the patent would have been understood by the person skilled in the art as a special application of a more general solution principle with regard to the description or for other reasons even if, on the basis of this knowledge, the person skilled in the art would have been able to find further embodiments corresponding to this solution principle.81
Even if the court finds the three requirements to be met, the so-called Formstein defense82 can be raised. Under this defense, it could be objected that the embodiment making use of the patent by equivalent means is not patentable because it lacks novelty or does not involve an inventive step and that the patent cannot be extended to a nonpatentable subject matter.
According to a core principle of German procedural law, any allegation made by the plaintiff that is not expressly denied by the defendant is taken as granted. Thereby, both parties need to comply with the procedural obligation for a truthful presentation of facts pursuant to Section 138(1) of the Code of Civil Procedure.83 The level of substantiation expected from the defendant’s explanations depends on the level of substantiation of the plaintiff’s allegation. The defendant’s burden of proof is higher when the facts concerned are those that only they – but not the plaintiff – have knowledge of. The FCJ has held that the defendant must disclose information on which the plaintiff bears the burden of proof in cases where the relevant information is not accessible to the plaintiff but can easily and reasonably be provided by the defendant.84 Similarly, on facts that do not concern the defendant’s own actions or perceptions, the defendant may contest by “declaring their lack of knowledge” pursuant to Section 138(4) of the Code of Civil Procedure.
Defendants can dispute the description of the attacked embodiment and – if the latter is described correctly – the infringement allegation itself by demonstrating that the attacked embodiment is, in fact, not covered by the scope of protection of the patent. In this case, noninfringement is to be demonstrated on the basis of the relevant limitations.
If the subject matter of the patent is a process for manufacturing a new product, it is deemed that the same product produced by someone else is produced using the patented process until there is proof to the contrary pursuant to Section 139(3). In their noninfringement argumentation, the defendant can demonstrate that the attacked embodiment does not contain elements of the “new product.” They can also demonstrate that their product is manufactured according to a process that differs from the patented process.
22.214.171.124 Right of prior use
Public prior use can be used as novelty-destroying prior art or to demonstrate obviousness in proceedings on the validity of a patent. Private prior use pursuant to Section 12 constitutes a defense in infringement proceedings: “the patent shall have no effect in respect of a person who, at the time the application was filed, had already begun to use the invention in Germany or had made the necessary arrangements for doing so.” Legally, it is a vindicatory defense that resolves the infringement’s unlawfulness. It gives the prior user the right to use the invention “for the needs of [their] own business.”
Section 12 has two main requirements: (i) possession of the invention and (ii) use of the invention. Both requirements need to have been fulfilled on the day the application was filed (Section 12(1)) or – if priority is effectively claimed – on the priority date (Section 12(2)). The defendant is said to have “possession” of the invention when they knew what to do in order to carry out the invention completely. The defendant must either have used the invention by, for example, producing, offering or marketing the product or, at least, have made necessary arrangements for so doing. In the latter case, the defendant must additionally show their intention to use the invention.
The scope of the right to private prior use is limited. Territorially, it is limited to the use of the invention in Germany. Personally, the right is limited to the specific company that had possession of the invention and can only be transferred together with that company: it cannot be licensed or sold independently. Further, it is limited to the product used by the defendant on the priority date and does not comprise any products developed from that unless the product used by the defendant before the priority date and the variation used by the defendant after the priority date are mentioned in the patent claim as two equal alternatives of an element, or the variation was self-evident for the person skilled in the art at the priority date.85
126.96.36.199 Exhaustion, license and compulsory license
The exhaustion defense requires that the patent proprietor or a third party acting with its consent deliberately placed the patented product or the direct product of a patented method on the market in Germany or any state of the European Economic Area.86 It is sufficient that the product was placed on the market with the explicit or implied consent of the patent proprietor, not necessarily by the patent proprietor themselves.87 The person acquiring such a product is then free to use it without infringing the patent.
The exhaustion defense relates strictly to the specific product placed on the market with the patent proprietor’s consent. This means that the entirety of the patented product needs to have been placed on the market. Exceptions discussed in the literature relate to whether a patent can already be exhausted when the crucial part of the device (e.g., a chip as the crucial part of a phone) is placed on the market, because marketing the part implicitly allows the use in and for the whole device.88
For process patents, the patent is not exhausted by, for example, placing on the market a machine that is suitable for the patented process if the machine itself is not protected by the patent.89
Section 15(2) stipulates exclusive and nonexclusive licenses. If the alleged infringer demonstrates that the use of the patent is covered by a license, this license constitutes consent regarding the use of the patent, thereby excluding infringement. Section 15(3) protects the rights conferred to the licensee if the patent is transferred to a third party or if a further license is granted.
A license between the patent owner and the alleged infringer’s manufacturers or suppliers also covers their direct or indirect customers. In the likely case that the defendant is not aware of the details of a (confidential) license agreement between their manufacturer or supplier and the (former) patent owner, the defendant may request that the court order the plaintiff to provide the license agreement pursuant to Section 142 of the Code of Civil Procedure. Upon request, the court may take measures necessary to safeguard the legitimate confidentiality interests of the plaintiff.
Section 24 of the Patent Act regulates compulsory licenses. While such licenses had little practical relevance in the past, they have become more important, especially in pharmaceutical patent cases. In 2017, the first compulsory license was successfully confirmed by the FCJ for the AIDS medicament Isentress.90 Compulsory licenses can be requested in separate proceedings before the FPC. On the basis of these proceedings, a stay might be requested in patent infringement proceedings pursuant to Section 148(1) of the Code of Civil Procedure, similar to a nullity action against the patent.
188.8.131.52 Experimental and other privileges
The Patent Act knows both a research (or experimental use) exemption, which applies to all fields of technology, as well as a “Bolar” exemption, limited to pharmaceutical inventions and products. Both are provided for in Section 11, which determines to which acts the effect of the patent shall not extend.
The research exemption, regulated in Section 11(2), determines that the effect of the patent shall not extend to acts “done for experimental purposes relating to the subject matter of the patented invention.” The provision’s aim is to guarantee the freedom of research and teaching as laid down in Article 5(3) of the German Constitution.
An “experiment,” according to this provision, is a “planned action to acquire knowledge.” The purpose of the experiment must be to acquire knowledge about the invention. While the knowledge must be of scientific interest, this term is interpreted broadly. The scientific interest must be prevailing; however, it is not harmful if there are additional commercial interests. For example, a purely scientific interest is given if clinical trials are conducted to find out whether an active ingredient covered by the subject matter of the patent can be used in treating other diseases. A mixed scientific and commercial interest is given if these scientific insights can and are intended to be used in a later market authorization procedure. Conversely, purely commercial interests – which are not covered by the exemption – are given when the only purpose is to gain commercial insights about the market structure or to calculate the price of a product.
The Bolar exemption, also referred to as the “Roche–Bolar rule,” regulated in Section 11(2b), was introduced in 2005, implementing EU Directives 2001/8291 and 2001/83.92 The aim of this exemption is to privilege generic and biosimilar manufacturers in preparing their market authorization. However, in contrast to the EU directives and other EU member states’ provisions, its wording is broader and not limited to generic manufacturers (it also applies to researching pharmaceutical companies) or in terms of territorial scope. It goes further than the research exemption, as it is not limited to trials related to the patented invention itself. The scope of “necessary” studies, trials and resulting practical requirements is defined by the national rules of the state in which the market authorization is applied for.