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Amgen v. Adello: A Blind Biosimilar Infringement Lawsuit
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • April 9 2018

Last month, Amgen sued Adello Biologics, a US-based biosimilar maker, for patent infringement under the Biologics Price Competition and Innovation Act


Win or Go Home? Standing to Appeal PTAB Decisions Upholding Patentability to the Federal Circuit Before Submitting a Biosimilar Marketing Application
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • April 6 2018

Biosimilar developers have been aggressive in filing petitions for inter partes reviews (IPRs) of biologics patents before the Patent Trial and Appeal


FDA Authorizes First Direct-to-Consumer Test for BRCA Gene Mutations
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • March 22 2018

On March 6, 2018, the U.S. Food and Drug Administration (“FDA”) authorized, with special controls, the first direct-to-consumer test to detect the


PTAB Holds Indian Tribes Don’t Offer an Out from IPR
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • March 9 2018

In a highly anticipated decision on the Saint Regis Mohawk Tribe’s motion to terminate inter partes review proceedings, the Patent Trial and Appeal


Claims Against Sanofi for Improper Orange Book Listings and Sham Litigation Dismissed
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • January 22 2018

On January 10, 2018, in In re Lantus Direct Purchaser Antitrust Litig., the District Court for the District of Massachusetts dismissed the antitrust


FDA Approves the First Gene Therapy to Treat an Inherited Disease
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • January 3 2018

On December 19, 2017, FDA approved the gene therapy Luxturna (voretigene neparvovec-rzyl), developed by Spark Therapeutics, to treat children and


2017 Biosimilar Approvals in Europe
  • Patterson Belknap Webb & Tyler LLP
  • European Union
  • December 21 2017

The European biosimilar market has expanded at record pace in 2017. The EMA approved marketing of sixteen biosimilar products referencing seven


US Biosimilar Approvals Soar in 2017
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • December 18 2017

Marketing approval for US biosimilars has taken off in 2017. FDA has approved five biosimilar products this year, increasing the number of approved


Federal Circuit Affirms Apotex Bench Trial Win in Neulasta Biosimilar Suit
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • November 21 2017

On November 13, The Federal Circuit issued a decision affirming a district court judgment that Apotex did not infringe Amgen’s recombinant protein


Amgen and Genentech Break New Ground in Avastin Biosimilar Dispute
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • October 26 2017

Amgen and Genentech have become embroiled in a novel procedural dispute relating to Mvasi, Amgen’s biosimilar of Genentech’s Avastin (bevacizumab). On