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9 November 2017BiotechnologyJoachim Wachenfeld

Case report: diagnostics in Germany

The European patent in question, which has since expired, covered a process for diagnosing the chances of survival for a patient who suffered from acute myeloid leukaemia (AML). It was based on the finding that a certain percentage of patients carrying tandem duplications in a defined portion of the gene encoding a specific receptor tyrosine kinase had a worse prognosis as compared to patients who did not carry this type of mutation. The tandem duplications were easily detectable since they resulted in an elongation of this portion of the gene.

An easy way of detecting the elongation was to carry out a polymerase chain reaction (PCR) and assess whether the amplified sequence from the patient contained such a tandem duplication. This could conveniently be done, for example, by running a gel that compared the length of the amplified patient sample with the amplicon from a non-mutated sequence or with a pre-determined length standard. A method that required the amplification of the decisive portion of the gene and detection of whether a tandem duplication was present was subject to the claim in question.

A German company made unauthorised use of this process. After receiving a patient sample from the physician in charge of the treatment, the DNA from the sample was prepared, a PCR was conducted, the PCR product was run on a gel and the length was determined. The result of the gel analysis was then reported to the physician, together with a risk analysis. Since the company made literal use of the process, it was found to infringe the patent by the respective German litigation courts.

The company then founded a subsidiary in the Czech Republic, which was not a member of the European Patent Convention when the patent application was filed. Therefore, the patent could not be validated in that county after grant. In addition, no national application had been filed in the Czech Republic.

Since the European Patent Office (EPO) does not accept claims relating to diagnostic methods that include steps that are performed on the human or animal body, the claim language contained in the original PCT application, namely the active removal of a sample from a human subject, was changed during prosecution in the EPO to a wording where the sample was characterised as being “from a human”. The granted claim thus no longer included the originally recited step of removing a sample from the human patient—a step that was carried out in Germany by the physicians.

Working around the rules

The company, in order to avoid infringement, resorted to preparing DNA only from the samples obtained from the physicians, a step also not recited in the claim, and sent the samples to the laboratory of its subsidiary in the Czech Republic. The Czech laboratory then performed the analytical steps subject to the claim. It faxed the result of the analysis back to the German parent company as well as to the physician who was in charge of the patient.

The German parent company charged only for the work in connection with the preparation of the DNA from the sample. It did not charge for the analytical steps subject to the claim carried out in the Czech Republic. The German company was again sued but the courts found non-infringement. Yet, the Munich Higher District Court allowed an appeal to the German Federal Supreme Court which gave rise to the decision (Rezeptortyrosinkinase II, GRUR 2017, 261).

The question the Supreme Court had to deal with was whether the information faxed from the laboratory in the Czech Republic was to be viewed as a direct product of a production method. More specifically, it had to decide whether the transfer of the analysis back to Germany was an act that was prohibited according to section 9, clause 2, no. 3 of the German Patent Act (PatG): that a third party must not import a product that is directly obtained by a patented process, without the consent of the patentee.

Some years earlier the Supreme Court had decided that a dataset produced by a patented process for encoding and decoding video signals was to be considered a direct product of that process and thus protected by section 9, clause 2, no. 3 PatG (see German Federal Supreme Court decision MPEG-2-Videosignalcodierung, GRUR 2012, 1230).

In that case, the court held that the product does not require a physical embodiment. Rather, it was sufficient that the product of the process could be subject to product protection per se. Another important aspect for the court was the fact that the product, in conjunction with suitable data carriers, could be used as often as desired for the intended purpose and thus, in that regard, had similar characteristics to a physical product.

This decision was used by the plaintiff as a blueprint to demonstrate that the dataset faxed into Germany had the same quality as the dataset discussed in the MPEG-2 decision. Namely, the dataset could not be used only in the prognosis of the severity of the disease of the afflicted patient, but could also be used, and was in fact used, in the development of new pharmaceuticals for the treatment of AML. Repeated use of the dataset was therefore possible.

It was further argued that the process had to be viewed as a production process since the amplification reaction produced a novel product, namely a distinct portion of the receptor tyrosine kinase gene, which as such could not be found in nature.

The fact that additional steps were carried out in such a production process, such as faxing the dataset into Germany, could not transform the process into a working process not amenable to protection according to section 9, clause 2, no. 3 PatG.

The court’s view

The court, however, did not subscribe to this line of argument. First, it held that in order to get the benefit of protection according to section 9, clause 2, no. 3 PatG, the claimed method must either produce a product or result in the alteration of the characteristics of the product subject to that process wherein the product itself needs to be capable of being amenable to product protection.

In this case, according to the court, the real product of the patented process, namely the amplified DNA, was not imported into Germany. What was instead imported was information gained from the claimed process. Information as such was, however, not amenable to product protection but was rather explicitly excluded, in line with the rules established in the MPEG-2 decision and as laid down in article 52, paragraph 2, subparagraph (d) EPC as well as section 1, paragraph 3, no. 4 PatG.

The court also denied that the product of the patented process could be used more than once. It considered the only use of the dataset faxed to Germany was to provide the prognosis for the patient.

Finally, the court did not follow the plaintiff’s argument that for young industry sectors such as biotech, the case law needed to interpret the statutes more flexibly in order to allow for a meaningful scope of protection. According to the plaintiff, situations like the present one where use was made of a patented process by simply carrying out the crucial methods steps in a country where no protection was available, but where the commercially important result was imported into a country where the patent was in force, left diagnostic companies contributing valuable inventions virtually without their due reward.

In essence, the court’s ruling is a drawback for companies trying to protect per se patentable diagnostic processes in Germany. Since methods comprising a step of removing a sample from a patient for further diagnosis are neither patentable under the German Patent Act nor under the EPC, any diagnostic process claim will have to start downstream of the step of recovering the sample.

As mentioned above, this was in the scenario underlying the decision of the Federal Supreme Court that the only step covered by the original claims set was carried out in Germany—albeit by a physician who would under normal circumstances not be a preferred target of litigation anyway. The recitation of initial processing steps such as the extraction of DNA from a patient sample, a step conducted by the parent company in Germany, would lead to a significant reduction of scope if introduced into the corresponding independent claim, in particular since the sample as such could be transferred under appropriate conditions to a country where no patent protection exists.

Effect of the unitary patent

Today, the Czech Republic is a member of the EPC, but at least in our experience, patents are rarely validated in this country. This shortcoming could be remedied by the future advent of the unitary patent, a single legal title that, if approved, will cover most EU member states and will be enforceable before the Unified Patent Court.

Yet, even in that case, companies trying to escape patent protection could still set up a laboratory in, for example, a North African country where validation of European patents is not yet possible or in a country in the Middle East. Transportation of the samples into such countries should not pose any insurmountable difficulties, in spite of additional customs clearance requirements.

A potential option for diagnostic companies to secure protection for this type of invention may thus reside in hitherto unusual formulations of the patent claims. As mentioned above, the incorporation of steps directed to the removal of the sample from the human body is not a valid option. Potentially, the drafting of dependent claims reciting process steps directed to the preliminary preparation of the samples might help, for example, in the demonstration of contributory infringement, as could claims reciting subsequent steps such as preparing a report that includes the result of the respective measurement or diagnosis.

A diagnostic method making use of the measurement result might also be interesting. The skilful drafting of such claims requires creative and far-sighted thinking and will present patent attorneys with a challenging new playing field.

Joachim Wachenfeld is a partner at  Vossius & Partner. He can be contacted at:

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