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, uses of human embryos for industrial or commercial purposes and 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. 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, in the past, human embryonic stem cells were generated by a process that required the destruction of the human embryo and were, therefore, excluded from patent protection. However, after 5 June 2003, the EPO considers that it has generally been possible to prepare human embryonic stem cells derived from parthenogenetically activated oocytes, without the destruction of the human embryo. For any patent application with a filing date on or after 5 June 2003 that does not involve the destruction of the human embryo, the EPO thus provides a workaround.

Antibodies

An ever-increasing number of therapeutically and commercially successful drugs are based on antibodies and other recombinant proteins. Corresponding patents are often heavily litigated and opposed in post-grant proceedings before the EPO. 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 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. In particular, if an antibody is defined by primary sequence information, examiners typically require that the claim recites all CDR sequences. If broad functional language 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.

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, 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. This rather new legislation followed a series of Board of Appeal decisions at the EPO that triggered a wide discussion on the patentability of plants that ultimately led to an amendment of the German Patent Act and, somewhat later, of the Implementing Regulations to the EPC by the Administrative Council.

Medical use claims

In Germany and the EPO, methods of treatment of the human or animal body are excluded from patentability, in contrast to, for example, the United States, where method of treatment claims are patentable. For instance, a claim directed to a method for treating a patient with cancer comprising administering a compound X to the patient would not be patentable in the EPO. However, claims directed to a substance or composition for use in the treatment of a subject is 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). In the above-mentioned example, an acceptable claim could be directed to compound X for use in the treatment of cancer, providing purpose-limited product protection for compound X, limited to its use in the treatment of cancer. As long as the prior art does not teach the use of compound X for treating cancer, the claim would be novel, even if compound X itself is known in the art.

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 numerous times that a relevant technical effect needs to be plausibly demonstrated in the patent application.

The plausibility of a technical effect is often key to demonstrating that the claimed subject matter has an inventive step (eg, for a composition of matter claim) over the prior art or is sufficiently disclosed (eg, for a second medical use claim). In principle, experimental data is not always required for there to be a plausible teaching of a technical effect, such as a therapeutic effect in the case of a second medical use claim. However, in most cases, at least some relevant experimental data (eg, relevant in vitro data) will be necessary in the patent application.

As a result, if the patent application is filed too early, it may not contain enough experimental data to plausibly show that the technical effect is achieved. On the other hand, waiting to file the application increases the risk of having to cope with critical prior art.

If filed too early, it may still be possible to file supplementary experimental data to support the presence of a technical effect, for example, for convincing the EPO that the claimed invention involves an inventive step. Under which circumstances this post-published data may be taken into account by the EPO for support of an inventive step has been the subject of recent decision G 2/21 of the Enlarged Board of Appeal of the EPO. 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. The Board also made comments to the effect that the bar of having post-published data considered in support of sufficiency of disclosure is higher compared to inventive step. This means that, in particular for second medical use claims, applicants should be very careful to include sufficient data in the original application documents.

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 for enforcing patents. 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 a proportionality test has been introduced into the German Patent Act, this will only apply to a limited number of cases and is the exception rather than the norm. Third parties’ interests also have to be considered in this respect, which can, in particular with respect to pharmaceutical patents, become relevant (patients that need to be treated, etc). However, this has already been the case according to German case law. Furthermore, provisional measures, such as preliminary injunctions, are possible too.

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. 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 use is no longer required to find infringement.

The Court of Appeals Dusseldorf, applying this new case law, developed this further in its decisions 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: the product in question is suitable for the claimed use; or 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 of the contracting member states, including, in particular, Germany. Four local divisions 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. Whether there will be automatic injunctions is not yet fully settled. The UPCA suggests certain discretion of the UPC when it comes to injunctive relief. At least the local divisions in the contracting member states that are used to automatic injunctions will likely be more inclined to proceed in a similar fashion as in their national proceedings. Hence, it is likely that the German local divisions of the UPC will grant automatic injunctions. In the end, we will have to see how the UPC’s case law develops over time, in particular considering biotech and pharmaceutical patents.

Supplementary protection certificates

In Germany, supplementary protection certificates (SPC) 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 opening its doors 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, in particular 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.