How to take advantage of both EPO prosecution and German enforcement

Europe is one of the most important markets for the life sciences and pharma industry and Germany is one of its key jurisdictions. As in the rest of Europe, the legal landscape in Germany in patent matters is highly complex, due to different degrees of harmonisation between European countries and a wide range of different options to protect intellectual property on a national and European level.

Until recently, two options were available for obtaining patent protection in Germany: the national route through the German Patent and Trademark Office (GPTO) (in accordance with Germany’s national laws) and the European route through the European Patent Office (following the European Patent Convention). Filing a patent application with the European Patent Office (EPO) meant to file and prosecute a single patent application, which after grant could be validated in any of the member states of the European Patent Convention (EPC), including Germany.

Since 1 June 2023, as a third option, applicants can file a patent application with the EPO; however, after grant, applicants can request the grant of a unitary patent, which, at the moment, provides unitary protection in 17 states, based on a single patent right, including Germany, without needing validation in each member state separately. Similarly, with the creation of the Unified Patent Court (UPC), right holders can enforce unitary patents in a single action in all 17 states that are party to the Agreement on a Unified Patent Court (UPCA), including Germany.

Accordingly, there are now essentially three routes to patent protection in Germany:

• filing a national German patent application (or a national phase from an international patent application);
• filing a European patent application with the EPO and validating in Germany; or
• filing a European patent application with the EPO and requesting a unitary patent after grant.

The majority of patents in the life sciences and pharma sector are filed with the EPO and not the GPTO; therefore, we focus this article on the life sciences practice at the EPO.

As in other parts of the world, patenting life science inventions in Germany can be a tricky business as some biological subject matter is excluded from patent protection and careful patent drafting is required to obtain allowable claims. Furthermore, it is crucial to consider how much and what data should be included in a life sciences patent application, as this may determine the ultimate fate of the application, more so than in other technical areas.

The human body and its elements

The EPO does not grant patents for processes for cloning human beings and modifying the genetic identity of the germ line of human beings. The EPO also does not allow patenting uses of human embryos for industrial or commercial purposes. However, this does not affect inventions for therapeutic or diagnostic purposes, which are applied to the human embryo and are useful to it. The mere discovery of a human gene is also not a patentable invention. However, if the gene is isolated from the human body or otherwise produced by means of a technical process, it may be patentable, especially if such a gene has industrial application and this application is demonstrated and described in the patent.

In the EPO, patent claims involving human embryonic stem cells are generally patentable as long as the claimed subject matter does not necessarily involve the destruction of human embryos. In particular, patent claims on this matter are usually allowable if the patent application has a filing date on or after 5 June 2003 and its technical teaching can be put into practice using human embryonic stem cells derived from parthenogenetically activated human oocytes. Culture media, supports and apparatuses ‘suitable for’ use with human embryonic cells, or even ‘specifically designed’ for this purpose, may also be patentable, since their production normally does not require the use of human embryos as base material. Foetal and post-natal human cells are also, in principle, not excluded from patentability.

Antibodies

Antibody technology is a rapidly developing field in the context of biotechnological and pharmaceutical research. Considering the extensive, time-consuming and expensive research in this field, ensuring appropriate patent protection for inventions based on antibodies is very important. Therefore, a large body of case law has formed concerning the patentability of antibody claims. In the EPO, composition of matter claims directed to antibodies can be defined by the antibody structure, by nucleic acid sequences encoding the antibody, by reference to the target antigen or the epitope that they bind to, by the production process, or by reference to their functional and structural features.

If an antibody is defined by primary sequence information, examiners typically require that the claim recites all complementarity-determining region sequences. If broad functionality is used in the claim, which in the EPO is still possible in certain instances, it has to be carefully assessed whether the application provides an enabling disclosure across the whole scope of the claim and whether the functional definition allows the skilled person to clearly determine the limits of the claim. In particular, the patent application must enable the person skilled in the art to produce further antibodies having the claimed functional property without undue burden. The claim should therefore normally include the relevant characteristics of the method used to determine and define the functional property.

Recently, the EPO has made clear that, in claims directed to antibodies defined by their ability to compete with a reference antibody that is disclosed for the first time in the application, this ability will not normally be considered sufficient to identify antibodies in the state of the art. In these cases, a complete search cannot be carried out and the applicant will be invited to provide more details with respect to the subject matter to be searched.

Furthermore, in all cases relating to antibodies defined by their target antigen, epitope and further functional features, in the absence of any indication to the contrary, a prior-art antibody binding the same target antigen is considered to have the claimed functional properties, thereby leading to an objection of lack of novelty with respect to the claimed antibodies.

Plants and animals

Patenting of plants or animals that have been modified by genetic engineering or other technical processes is generally possible. The fruits of plants and subsequent generations of animals can also be covered by patent protection. However, processes for modifying the genetic identity of animals, which are likely to cause these animals suffering without any substantial medical benefit to humans or the animal, as well as animals resulting from such processes, are not patentable. For example, a claim directed to a pharmaceutical preparation, which involves a certain amount of animal suffering and does not have different mechanisms of action or targets different pathways from other widely available compounds of the prior art may be considered not patentable, since there may be plenty of alternative medicaments on the market that achieve the same or a comparable therapeutic effect without involving the same amount of animal suffering. Plant and animal varieties are not patentable; neither are essentially biological processes for the production of plants and animals. Likewise, plants and animals that are obtained exclusively by means of an essentially biological process are also excluded from patentability, on the national level as well as in the EPO.

Medical use claims

In Germany and the EPO, methods of treatment of the human or animal body are not patentable. However, claims directed to a substance or composition for use in the treatment of a subject are amenable to patent protection. These claims provide purpose-limited product protection for any therapeutic application (first medical use) or for a specific medical use (second or further medical use). For example, an acceptable claim could be directed to compound X for use in the treatment of a disease, providing purpose-limited product protection for compound X, limited to its use in the treatment of the recited disease. The treatment of more than one disease can be covered by a single claim, provided that the treatment of those diseases forms a single general inventive concept. As long as the prior art does not teach the use of compound X for treating the recited disease or diseases, the claim would be novel, even if compound X itself is known in the art. This principle applies only to substances and compositions and cannot be extended to other products, such as a device for an intended medical use (eg, pacemaker or implantable chemical sensor for use in . . .). Recently, the Boards of Appeal of the EPO held that the question of whether a material or an object is a ‘substance or composition’ should be decided, in the first place, on the basis of the claimed material or object as such. No additional restrictions relating to its mode of action are derivable from the EPC.

Plausibility and post-published data

A hotly debated topic over the past few years in Germany, and in particular at the EPO, has been the ‘plausibility’ requirement or test, which often comes up in life sciences cases. While there is no express regulation in the law that requires plausibility for the grant of a European or German patent in particular, the Boards of Appeal of the EPO have held that a relevant technical effect of the claimed invention (eg, a treatment of a particular disease) must have been credible to the skilled person at the time of filing of the application based on the disclosure of the application as filed.

In principle, experimental data are not always required for there to be a plausible teaching of a technical effect. However, in most cases, at least some relevant experimental data (eg, relevant in vitro data) will be necessary in the patent application. It may still be possible to file supplementary experimental data to support the presence of a technical effect after the filing date of the patent application, for example, for convincing the EPO that the claimed invention involves an inventive step. This possibility can be of critical importance in the life science sector, where patent applications are often filed before clinical trials start. Under which circumstances post-published data may be taken into account by the EPO for support of an inventive step has been the subject of decision G 2/21 of the Enlarged Board of Appeal of the EPO in 2023. The Board held that the applicant or proprietor may rely upon a technical effect for inventive step if the skilled person, having common general knowledge in mind, and based on the application as originally filed, would derive this effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention. However, the debate regarding post-published data remains open. Indeed, on 17 January 2024, the appellant/opponent in the appeal proceedings that led to decision G 2/21 filed a petition for review against this decision. The outcome of this petition may push for a further clarification in the use of post-published data to support inventive step.

Enforcement

Germany has been a preferred venue for right holders to enforce their patents for quite some time. In addition to the very experienced judges, the structure of German proceedings and the available remedies provide an ideal set-up to enforce patents both extensively and quickly. Right holders can, for example, seek injunctive relief, recall and destruction of infringing products and accounting and damages and claim cost reimbursement to a certain degree. German law still provides for an ‘automatic injunction’. If the court establishes that there is infringement, it is common for injunctive relief to be granted. Although the disproportionality defence established by the German courts has since been codified in law, it still remains rather the exception than the rule. However, it can become relevant in particular with respect to pharmaceutical patents when considering third parties’ interests (eg, patients who need to be treated, etc).

Germany has a bifurcated patent litigation system. Matters of infringement and matters of validity are dealt with by different courts in separate proceedings (post-grant oppositions are handled by the EPO or GPTO). Typically, the infringement courts of first instance issue a decision within 12 to 15 months and are rather reluctant to stay the proceedings in light of a separate invalidity action before the German Patent Court. Furthermore, provisional measures, such as preliminary injunctions, are possible too. On the other hand, the proceedings before the German Patent Court tend to take much longer. In connection with the automatic injunction, this can result in the injunction gap (ie, the period between the first instance infringement decision, which can be enforced against a security deposit and the decision by the German Patent Court on the validity of the enforced patent). Depending on which side you are, this can be a great advantage.

A notable topic when dealing with pharmaceutical patents is the enforcement of second medical use claims. German law provides for protection against illegitimate use of second medical use inventions by third parties. The requirements for showing infringement of second medical use claims used to be stricter in the past. German courts generally required that the patent owner showed that the product was manufactured and ‘purposefully arranged’ for the claimed use. With the Pemetrexed decision (Case No. X ZR 29/15), the Federal Supreme Court increased the level of protection for the owners of second medical use patents.

Now, second medical use claims are construed as purpose-limited product claims. This claim type provides for protection against any offering or distribution of the product for the patent protected purpose (ie, the medical use). The actual use of the product for the specific (second medical) use is no longer required to find infringement.

The Court of Appeals Dusseldorf, applying this new case law, developed this further in its decisions on Oestrogenblocker (Case No. I-2 W 6/17) and Fulvestrant (Case No. I-2 U 27/18). Accordingly, a second medical use claim can be infringed if: (i) the product in question is suitable for the claimed use; or (ii) the infringer makes use of circumstances, which lead – in a similar way to the purposeful arrangement – to the claimed use of the product. The latter is the case if the product is not only used accordingly in individual cases and the infringer knows about this or should know about this.

Since 1 June 2023, the UPC has also been an option for right holders to enforce patent rights. Its decisions will cover all the contracting member states, including, in particular, Germany. Four Local Divisions (LDs) of the UPC have been established in Germany. They are staffed with experienced German litigation judges. This makes Germany a very good option as a venue for right holders litigating patents before the UPC. The remedies available before the UPC are almost identical to what German patent courts offer. The UPC can grant provisional and protective measures and injunctions as well. Looking at the first decisions to date (all of which were issued in preliminary proceedings), a trend might be that the German LDs stick to German practice. Automatic injunctions are possible – even without a prior oral hearing (eg, LD Dusseldorf, UPC_CFI_177/2023). At the same time, one can hardly deduce implications for proceedings on the merits from this – in preliminary injunction proceedings it is usually a matter of whether injunctive relief is granted, rather than to what extent. With the first decisions on the merits still pending, it remains to be seen how the UPC will handle proportionality considerations. This applies particularly considering that a uniform supranational case law will have to be established. German case law will likely have a certain impact on that, given that, until April 2024, about 75 per cent of the pending infringement actions have been filed before the German LDs. At some point in time, the UPC Court of Appeals will provide guidance. The first landmark decisions can be expected fairly soon and may well be rendered in the life science sector – well-known companies such as Amgen, Abbott and Sanofi are already involved in infringement proceedings. Overall, life science companies seem to be welcoming the UPC with the sector accounting for approximately 30–40 per cent of the pending infringement cases.

From the current status, one can take that Germany remains a favourable venue, in particular considering biotech and pharmaceutical patents – be it the German national courts or the UPC’s LDs.

Supplementary protection certificates

In Germany, supplementary protection certificates (SPCs) are available for effectively extending the patent term of pharmaceutical patents. The legal basis for German SPCs is Regulation (EC) No. 469/2009, which has direct effect in all member states of the European Union. Obtaining an SPC requires a granted European patent and a market authorisation. The maximum term of the SPC is five years. Even though the SPC is based on a granted European patent, as of now, and for the near future, the request for grant of a SPC has to be filed on the national level with the GPTO. However, based on recently published draft legislation, the EU may establish a centralised SPC filing and examination procedure and a unitary SPC at some point in the future.

Summary and outlook

With the UPC just getting underway and further IP legislation on the horizon, the IP landscape in Germany is currently undergoing fundamental changes. Given the peculiarities of protecting and enforcing life sciences inventions in Europe, particularly in Germany, high-quality IP management is decisive for commercial success. This is all the more the case as in the life sciences, different from other technical fields, individual products are often only covered by a small number of patent rights.