In its decision in Rezeptortyrosinkinase II (ref: X ZR 124/15), published on 18 January 2017, the German Federal Court of Justice provided important guidance on patent protection for data generated with patented test methods. This issue had come before German courts in several cases where laboratories performed in vitro tests for the diagnosis of German patients outside Germany, because the applied test was protected by a German method patent. In Rezeptortyrosinkinase II, blood samples were shipped from Germany to the Czech Republic for testing and the results subsequently mailed back to Germany for use in patient diagnosis. Since the test was covered by a German method patent, the patentee sued for patent infringement in Munich. It was argued by the patentee that the test results are products directly obtained by the patented method and consequently mailing the test results to Germany amounted to patent infringing import under section 9 of the German Patent Act.

In a previous case regarding a similar test, the Higher Regional Court of Düsseldorf in Blut/Gehirnschranke (ref: 2 U 40/10) had dismissed the Claimant’s argument, holding that test results are information, which cannot be protected by a patent. In the present case, the Regional Court of Munich (ref: 7 O 13161/14) came to the same result, but with a different reasoning. It was held by the Court that test results are excluded from patent protection because they are simple, in that they can be communicated verbally and memorised without the use of data carriers. Moreover, since the information was useful only in the diagnosis of one particular patient, it could not be put to repeated use like a physical product. This reasoning created legal uncertainty for cases where data resulting from a test is more complex and cannot be memorised.

On appeal, the Higher Regional Court of Munich also dismissed the claim, but did not follow the reasoning of the first instance. Instead, it considered that test results constitute information and not products, and therefore were generally excluded from patent protection under Art. 52 (2)(d) of the EPC. However, the Court regarded the matter as not yet finally resolved, and granted leave for further appeal to the Federal Court of Justice.

The Federal Court of Justice confirmed the view of the Higher Regional Court of Munich, that test results are information and therefore the scope of a patent covering the test method cannot be extended to the test results. This case is fundamentally different to the Federal Court of Justice's earlier decision in MPEG-2-Videosignalcodierung (ref: X ZR 33/10), where it held that encoded video data can be protected as products obtained by a patented encoding method, as the form of protection was based on the technical features of the data resulting from the patented encoding process. As a result, patent protection was directed at the technical format of the encoded data and not at the content. In the present case, the patented method only generates information, not a specific technical format in which this information is presented, and consequently protection for the test method does not extend to the test results.

Even though it is now clear that test results generated in other countries can freely be communicated to Germany without infringing German method patents, performing tests for German patients in a foreign country is still not entirely immune from German patent infringement actions. The Rezeptortyrosinkinase II case was special because all steps of the patented method where performed outside Germany. In cases where patented test methods are partly performed in Germany and partially in other countries, direct infringement of the method patent is still possible under the rules established in cases such as Prepaid-Telefonkarte (ref: 2 U 51/08), a decision of the Düsseldorf Higher Regional Court. This applies especially in cases where the entire testing is controlled by a defendant acting inside Germany and the test results are ultimately used in Germany, because in such cases all method steps can be attributed to the defendant in Germany. This was not the case in Rezeptortyrosinkinase II, because none of the patented method steps were performed in Germany.

Overall, while Rezeptortyrosinkinase II provides additional legal security for in vitro testing for German patients performed outside Germany, there is still room to assert patent infringement in Germany in these scenarios. Whether a German method patent is actually infringed by tests performed outside Germany depends on the way in which the method claims are drafted and how the cooperation between German and foreign partners active in the testing services is actually organised.