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Laboratory DNA analysis procedures patented by Johns Hopkins University were well known in the industry and are therefore invalid, Myriad Genetics said in four patent board filings ( Myriad Genetics, Inc. vs. Kinzler Vogelstein , P.T.A.B., No. IPR2017-01102, petition filed 3/16/17 ; Myriad Genetics, Inc. v. Kinzler Vogelstein , P.T.A.B., No. IPR2017-01105, petition filed 3/16/17 ; Myriad Genetics, Inc. v. Kinzler Vogelstein , P.T.A.B., No. IPR2017-01106, petition filed 3/17/17 ; Myriad Genetics, Inc. v. Kinzler Vogelstein , P.T.A.B., No. IPR2017-01107, petition filed 3/17/17 ).
Myriad told the Patent and Trademark Office’s Patent Trial and Appeal Board March 16 and 17 that four JHU patents, which are exclusively licensed by Esoterix Genetic Laboratories,, part of the Laboratory Corporation of America (LabCorp), are invalid as obvious or anticipated because of prior research publications. Esoterix is suing Myriad for patent infringement in the U.S. District Court for the Middle District of North Carolina, alleging that Myriad’s MyRisk Hereditary Cancer Test infringes the JHU patents that Esoterix licenses.
In February, Myriad reported second-quarter global revenues of $144 million for its MyRisk test. If the patent board determines that the four JHU patents are invalid, it could shake the foundations of Esoterix’s infringement suit against Myriad.
Myriad filed four petitions for inter partes review (IPR) with the PTAB. The IPR is a process created by the America Invents Act to allow third-party challenges of the validity of existing patents due to their lacking novelty by being anticipated under 35 U.S.C. § 102 and/or by being obvious under 35 U.S.C. § 103. If the PTAB grants Myriad’s petition, the challenge will go to trial unless the parties reach a settlement. Bloomberg BNA research has indicated that once an IPR petition is granted, patent owners will often settle with the challenger rather than go to trial.
In its four petitions, Myriad noted the claims it is challenging in the four JHU patents—U.S. Patent Nos. 6,440,706; 7,824,889; 7,915,015; and 8,859,206—recite a method that the JHU calls “digital PCR (polymerase chain reaction).” According to Myriad, digital PCR is a method for distributing a DNA sample into compartments so that each compartment contains, ideally, one or zero molecules of DNA from the sample, carrying out PCR in each compartment, and then analyzing the resulting amplified DNA molecules to determine how many compartments contain each different template DNA molecule.
“The steps comprising what the Patent Owner calls ‘digital PCR’ were well known in the art before the earliest possible priority date for the '889 patent,” Myriad wrote. “In the prior art, this method was often called ‘limiting dilution analysis’ or ‘limiting dilution PCR’ (LDPCR) because the sample is diluted down to the point at which some compartments will be ‘positive,’ i.e., contain a PCR-amplified product, and some will be ‘negative,’ i.e., contain no PCR-amplified product.”
Myriad added, “Patent Owner did nothing more than add a snappy name to the prior art method of LDPCR.”
According to Myriad, by 1994, Kary Mullis, the Nobel Prize-winning inventor of PCR, had edited a book on PCR that included a chapter on quantitative PCR, the use of PCR to quantitate amounts of nucleic acids in a sample. The Mullis chapter discloses and discusses the work of multiple groups of scientists at the time who were carrying out and publishing work involving LDPCR. The earliest priority date for any of the JHU patents is 1999, Myriad said. The petition also asserted that the contested claims were rendered obvious or anticipated by four prior research studies.
In 2015, Myriad sued LabCorp and other companies for infringement of its breast and ovarian cancer composition and method patents and later settled the claims ( 09 LSLR, 2/6/15 ).
Pattie Kushner, LabCorp’s vice president of global corporate communications, told Bloomberg BNA in a March 20 email, “When we first filed the lawsuit, we did so to hold Myriad accountable for infringing on, and to protect, our intellectual property. Beyond that, we will not comment further on the pending litigation and related proceedings.”
The petitions were filed by Quinn Emanuel Urquhart & Sullivan, New York.
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To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com
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