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In September 2016, the German Federal Supreme Court decided a patent case that could have a major impact on companies working in the diagnostics field. Joachim Wachenfeld of Vossius & Partner reports.
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.
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Joachim Wachenfeld, Vossius & Partner, patent, EPC, German Federal Supreme Court, patent, diagnostics, , Germany, unitary patent