In a decision this month (IPR2013-00308), the Patent Trial and Appeal Board (PTAB) has ruled against Stanford University’s patented method for detecting Down’s syndrome and other chromosomal defects, finding all of the challenged claims 1-13 invalid. The Stanford patent, U.S. Patent Number 8,296,076, is licensed to Verinata Health Inc., and is the subject of patent infringement litigation initiated by Verinata and Stanford against Ariosa Diagnostics in 2012 (Verinata Health Inc. et al. v. Ariosa Diagnostics Inc. et al., case no. 3:12-cv-05501, N.D. California). (Verinata is now owned by genetic instruments maker, Illumina, which acquired it in 2013 for over $350 million dollars.) The remaining two claims of US Patent 8,296,076, independent claim 14 and its dependent claim 15 directed to a “method of testing for an abnormal distribution of chromosome in a sample comprising a mixture of maternal and fetal DNA,” were not challenged in the IPR2013-00308.
In two other recent decisions in October, 2014, Verinata’s own IP survived challenges by Ariosa. In final decisions on IPR 2013-00276 and IPR2013-00277, the PTAB decided that Ariosa had failed to meet its burden of showing by a preponderance of evidence that the claims of U.S. Patent Number 8,318,430 were invalid, representing a rare outcome where all of the challenged claims in a IPR proceeding were successfully defended. The Verinata ‘430 patent is the subject of separate pending litigation in the Northern District of California between Verinata and Ariosa (Illumina, Inc. v. Ariosa Diagnostics, Inc., case no. 3:14-cv-01921, N.D. California).
The two infringement suits claim that Ariosa infringes the Stanford and Verinata patents by selling its Harmony prenatal test, which uses sequencing technology to find fetal DNA in maternal blood. Shortly after each of the infringement suits were filed, Ariosa went to the USPTO and sought inter partes review (IPR) of two patents asserted in the infringement action. At this point, Ariosa is time barred from bringing additional IPR proceedings to challenge the patents-in-suit because the America Invents Act, which established the new post-grant proceedings, prohibits challenges by defendants in infringement actions unless their petitions for review are filed within one year of commencement of the litigation.
Both of the patent infringement cases are likely to continue (unless the parties settle) despite the invalidity ruling on the Stanford patent at the U.S. Patent Office. Claim construction hearings on both patent suits are scheduled to begin in December, 2014.
Interestingly, the federal district court judge who is hearing both cases has bucked a growing trend by opting not to stay the underlying civil actions when the IPR petitions were filed. Even after trials for inter partes review on both patents were instituted by the PTAB in January 2014, Judge Susan Illston refused to stay the cases, noting that the IPR proceedings were unlikely to resolve all of the validity issues because the losing party at the patent office would be able to appeal to the Federal Circuit. “[U]nder the new procedures, it may still be years before the inter partes review is truly final,” according to Judge Illston.