Patent Docs lays out Myriads arguments against its two opponents asking that the courts uphold its request for an injunction that would prevent Ambry and Gene-by-Gene from offering genetic testing for the BRCA1 and BRCA2 mutations.
Myriad claims that it is highly likely that it win the case on its merits and it will suffer irreparable harm if the injunction is not issued. Its main arguments cover these points:
- Its primers and oligos used in testing are synthetic and therefore patent eligible according to the Supreme court decision (AMP v. Myriad)
- Its method claims are directed toward specific lab processes that utilize knowledge of the BRCA1 and BRCA2 genes to develop previously unkown techniques. Therefore would meet criteria defined in Mayo to be patent eligible
- Its claims cannot be considered routine and well understood. With BRCA they found a brand new biomarker for a new indication (hereditary breast and ovarian cancer)
- Myriad can likely prove infringement by Ambry and Gen-by-Gene
- Myriads claims are not anticipated by prior art. They conceived and recited their claims prior to the earliest dates cited by defendants
- The discovery of the BRCA genes was not obvious and this is evidenced in part by all the other skilled practitioners in the art who failed even with the same information available to Myriad
- Myriad followed an uncoventional path to idnetify and the BRCA2 gene
Myriad asks for the injunction and says it will suffer irreparable harm from price erosion that cannot be readily compensated, and will also suffer reputational harm. They also say that they satisfy the public interest in having BRCA testing and that is evidenced by their extensive contributions to the field.
We await the court's decision. And this will continue on for years with this and other cases to define the field of play. Myriad did win the battle of the briefs -- 140 pages to 109 pages -- that could be enough to prevail.
Posted by Bruce Lehr Oct 10th 2013.