Genetic testing or DNA testing is becoming ever more important – for predicting or diagnosing diseases, for preparing patient-specific solutions as part of personalized medicine, or for genealogy purposes.
At the same time, legal issues around genetic testing have stirred up a lot of controversy. One issue lying at the very core of the discussion deals with whether and to what extent genetic tests can be protected by patents.
The German Federal Court of Justice (BGH) issued an important decision on the issue: In Rezeptortyrosinkinase II (ref. X ZR 124/15), the court had to decide whether a patent covering a particular genetic test method would also cover the data created with it.
So, does it?
The plaintiff, a diagnostic laboratory, held a patent covering a genetic test method for detecting a particular nucleic acid molecule, which could serve as a leukemia marker.
The defendant, a Munich-based medical testing lab, offered tests based on this method to patients in Germany. Since the test method was patent-protected in Germany, the defendant would ship the blood samples from Germany to the Czech Republic to carry out the actual testing. Only the test results were then mailed back to Germany.
The plaintiff argued that the test results were a “derivative product” of the protected test method, and that importing the results into Germany would constitute a patent infringement under article 9 of the German Patent Act.
The plaintiff also expressly invoked a judicial precedent: In a previous case (MPEG-2 video signal encoding, judgement of 21/08/2012, ref. X ZR 33/10), the Federal Court of Justice had already held that non-physical objects, particularly a sequence of data resulting from a patented method, could enjoy protection as a “derivative product” under the German Patent Act.
The Ruling (summary for non-lawyers)
The Federal Court of Justice dismissed plaintiff’s suit and arguments. The court ruled that the test results were not a derivative product of the protected test method and did not enjoy extended patent protection under article 9 of the German Patent Act: According to the court, genetic test results constitute “a biochemical finding with certain implications, but not products defendable by a patent”. The results could therefore be imported into Germany without infringing the patent.
The Ruling (details for patent nerds)
The court’s ruling is noteworthy for a number of reasons:
First, the court provides some much-needed guidance on the extent of “derivative production protection” under German patent law.
Contrasting its earlier MPEG-2 decision, the court differentiated cases in which data or information can be a “derivative product” from cases where it can't. In the MPEG-2 decision, the encoded video was, in a sense, “packaged” in the MPEG video codec: the codec served as a wrapper for the video data and therefore, according to the court, constituted an “object”. The video data itself, however, were not patent-protected, given that the video would always require the MPEG codec to be decoded and played.
In contrast, the insight that a certain genome sequence is present in a blood sample (and the derived insight that a patient is at an increased risk for a disease) is not “packaged” within the discovery process: anyone can directly understand and process this information without needing to rely on the patented process that led to this insight. The decisive, legal qualifier for derivate product protection is, therefore, not the quality of the data itself, but the way it is expressed, stored, or encoded.
Second, the court clarified once more that data or information by itself cannot be legally regarded as an “object” – only perpetuation on a data carrier (paper, hard or flash drives) creates the object. Therefore, in the case at hand, the entire chain of events as decried by the plaintiff happened “outside the realm of patent law”.
Implications (for everyone)
The decision has one far-reaching implication: Is patent protection for a genetic test at all recommendable?
Patent applications are generally published 18 months after the date of application. If the patent relates to the detection of certain gene sequences, it is usually easy for competitors to copy and carry out the test in a patent-free country following publication.
Based on the German Federal Court's decision, genetic testing innovators should indeed think twice – should considerable time and money be sunk into a toothless patent? Although there is still room to assert patent infringement in Germany in certain scenarios, depending on the individual circumstances, it may be preferable to keep the test method confidential and rely on confidentiality and secrecy measures rather than have the patent circumvented by competitors.