Short Summary
GXD-Bio Corporation, the registered owner of European Patent EP 3 346 403 concerning a method for quantifying gene expression in FFPE breast cancer tissue samples using OAZ1 as an endogenous reference gene, sued multiple Myriad entities and Eurobio Scientific for patent infringement relating to the EndoPredict test. The defendants filed a counterclaim for revocation, and GXD-Bio sought to amend the patent via three auxiliary claim requests. The Local Division Munich revoked the patent, dismissed the amendment application, and dismissed the infringement action, finding that the EndoPredict test did not infringe because it uses three reference genes (CALM2, OAZ1, and RPL37A) for normalization rather than OAZ1 alone as required by claim 1.
Detailed Summary
This case concerns European Patent EP 3 346 403, titled 'Data processing, analysis method of gene expression data to identify endogenous reference genes.' The patent was originally owned by Albion, Inc. and Gencurix, Inc. In May 2024, the Claimant, GXD-Bio Corporation (a Korean company), acquired the patent through a Patent Purchase Agreement and became the sole registered owner in Austria, Belgium, France, Germany, Italy, Luxembourg, and The Netherlands. The patent claims priority from KR 20060134883 of 27 December 2006, with a filing date of 27 December 2007 and grant publication on 17 June 2020.
Claim 1 of the patent defines a method for quantifying expression level of a target gene in a FFPE (formalin-fixed, paraffin embedded) tissue sample of human breast cancer tissues, comprising: (1) synthesizing cDNA from RNA of a subject; (2) performing real-time PCR to amplify the target gene and Endogenous Reference Gene OAZ1 using a pair of primers and/or probes with the cDNA serving as a template; and (3) normalizing an expression level of the target gene to that of the endogenous reference gene OAZ1.
The Defendants include Myriad International GmbH, Myriad GmbH, Myriad Service GmbH, Myriad Genetics GmbH (Switzerland), Myriad Genetics S.A.S. (France), Myriad Genetics B.V. (Netherlands), Myriad Genetics S.r.l. (Italy), and Myriad Genetics Inc. (USA), along with Eurobio Scientific (France). Defendant 8 (Myriad Genetics Inc.) developed the 'EndoPredict' test, a multi-gene expression test for ER positive/HER2 negative breast cancer that predicts recurrence risk. Defendants 1-7 are European subsidiaries that used, offered, or supplied the test in the relevant territories. In 2024, Defendant 8 sold and transferred its entire EndoPredict business to Defendant 9 (Eurobio Scientific), which took over the European business effective 1 August 2024.
The EndoPredict Test-Kit contains primers and probes for amplifying eight target genes (BIRC5, RBBP8, UBE2C, IL6ST, AZGP1, DHCR7, MGP, STC2) and three reference genes (CALM2, OAZ1, RPL37A) by RT-PCR. The method involves providing an FFPE breast cancer tissue sample, performing RNA isolation, analyzing the sample using the Test-Kit and PCR platform, and uploading data to the EndoPredict Report Generator (EPRG) to produce the EPclin Risk Score. The expression levels of target genes are normalized to the average expression level of all three reference genes (CALM2, OAZ1, RPL37A), not to OAZ1 alone.
The Claimant argued that the Defendants directly infringed claim 1 by performing the claimed method steps, and that the Test-Kit constituted indirect infringement. The Defendants countered with a revocation action, arguing the patent lacked novelty and inventive step over prior art including WO 2008/078969, and that the claimed subject-matter was excluded from patentability. The Claimant submitted three auxiliary claim requests to amend the patent.
The Local Division Munich revoked the patent, finding that the EndoPredict test does not realize all features of claim 1. The court held that claim 1 requires normalization of the target gene expression level to OAZ1 alone, whereas the EndoPredict test normalizes to the average of three reference genes (CALM2, OAZ1, and RPL37A). The court noted that CALM2 and RPL37A were identified in the patent description as 'candidate reference genes' but were not selected as 'guide genes' because their expression stability was insufficient. The court also found that the Test-Kit was not suitable and intended for use in a method where normalization is carried out using OAZ1 alone, ruling out indirect infringement as well.
As a result, the court revoked European Patent EP 3 346 403 with effect to Austria, Belgium, France, Germany, Italy, Luxembourg, and The Netherlands, dismissed the application to amend the patent, dismissed the infringement action, and ordered the Claimant to bear the costs of both the infringement action and the counterclaim for revocation. The value in dispute was set at EUR 1,000,000 for the infringement action and EUR 1,500,000 for the counterclaim for revocation.
Practitioner Note
This case demonstrates the evidentiary and procedural standards applied in patent matters before Munich (DE) Local Division. Understanding the court's reasoning in GXD-Bio Corporation vs Myriad International GmbH and Others is valuable context for structuring arguments or assessing risk in similar proceedings.
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