Category: District Court

  • By Kevin E. Noonan — Earlier this month, Judge Paul Crotty, U.S. District Court Judge for the Southern District of New York handed down rulings in two separate cases related to the biosimilars law (the Biologics Price Competition and Innovation Act, or BPCIA) and how the Act's dispute resolution provisions (also called the "patent dance")…

  • By Kevin E. Noonan — In Genetic Technologies Ltd. v. Laboratory Corp. of America Holdings, yet another district court (actually, a magistrate judge) has succumbed to the siren song, or drank the Kool-Aid, or (fill in your favorite Apocalyptic metaphor here) of applying the Supreme Court's Mayo v. Prometheus decision in ways not required by…

  • By Kevin E. Noonan — While the rest of the patent world was focused on Supreme Court opinions (issued and pending) and Congressional action vel non on threats like patent trolls, the consolidated Multi District Litigation between Myriad Genetics and several defendants over BCRA 1 and 2 genetic testing has been proceeding apace in the…

  • By Kevin E. Noonan — The old adage "Be careful what you wish for" comes to mind regarding Myriad Genetics' motion to the Judicial Panel on Multidistrict Litigation under 28 U.S.C. § 1407, that cases relating to the company's BRCA gene patents be consolidated in the District of Utah.  By year-end 2013, the litigation scorecard…

  • By Kevin E. Noonan — In a 106-page opinion, U.S. District Court Judge Robert J. Shelby on Monday denied Myriad Genetics motion for preliminary injunction in Myriad Genetics v. Ambry Genetics.  Characteristic of its aggressive defense of its patent rights, the motion was, as the District Court noted, for "extraordinary" relief and thus not routine…

  • By Kevin E. Noonan — Gene-by-Gene, Inc. was one of the first direct-to-consumer (DTC) genetic diagnostics companies to announce that it would offer BRCA1/BRCA2 testing after the Supreme Court's decision last June that certain of Myriad Genetics' claims (those that encompassed isolated genomic DNA) were invalid for reciting patent-ineligible subject matter.  And Gene-by-Gene was one…

  • By Donald Zuhn — Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories.  For 2013, we identified fourteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners…

  • By Kevin E. Noonan — It is often to a patentee plaintiff's strategic advantage to file suit in the district in which it resides, to obtain whatever "home court" advantage may attach to that venue.  Myriad's choice of filing its post-Supreme Court opinion patent infringement lawsuits reflects this strategy, as does declaratory judgment plaintiffs Counsyl,…

  • By Kevin E. Noonan — The very latest company targeted by Myriad Genetics for offering a genetic diagnostic test encompassing the human BRCA 1 and BRCA 2 genes is LabCorp (Laboratory Corporation of America), located in Burlington, North Carolina.  Myriad sued LabCorp on Tuesday in the District of Utah, Central Divisions (Case No. 2:13-cv-01069-BCW; complaint).  Myriad's…

  • By Kevin E. Noonan — Things are getting worse for genetic diagnostics company 23andMe.  On the heels of receiving a Warning Letter from the FDA over its Personal Genomic Services (PGS) test (see "FDA Threatens Agency Action Against 23andMe Over Personal Genetic Testing"), on Wednesday the company was named in a class action lawsuit in…