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Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC
  • Knobbe Martens
  • USA
  • July 16 2018

References were sufficiently accessible to the public to constitute printed publication prior art even if they were not searchable or indexed because

When is There Standing to Appeal a PGR Final Written Decision?
  • Marshall Gerstein & Borun LLP
  • USA
  • July 5 2018

In Altaire Pharm., Inc. v. Paragon Biotek, Inc., Case No. 2017-1487 (Fed. Cir. May 2, 2018), the Federal Circuit reversed in part a PGR final written

Hatch-Waxman and BPCIA Developments in May 2018
  • Morrison & Foerster LLP
  • USA
  • June 6 2018

This month, we highlight significant developments in May 2018, including a stunning reverse payment decision at the FTC, draft guidance from the FDA

A Petitioner’s Dilemma in Post-Grant Reviews
  • K&L Gates
  • USA
  • June 5 2018

Post-grant reviews ("PGRs") can only be filed within a nine-month window starting from the issuance of the patent, but standing to appeal to the

Litigation Spotlight Update: Epogen Litigation Status in Face of Retacrit Regulatory Approval
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • May 22 2018

As we recently covered, May 15, 2018, saw the FDA granting approval to Hospira (now a Pfizer subsidiary) for its Retacrit injection, a biosimilar to

Jurisdiction for “Late Listed” Orange Book Patent and Injunction Based on Induced Infringement by Drug Label
  • Oblon
  • USA
  • April 25 2018

As reported earlier, the Federal Circuit in Vanda Pharm. Inc. v. West-Ward Pharm. Int’l. Ltd. held that jurisdiction exists under 35 U.S.C

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

Deference, Discovery and District Court Findings
  • McDermott Will & Emery
  • USA
  • March 28 2018

Giving deference on discovery issues and non-infringement findings, the US Court of Appeals for the Federal Circuit affirmed a non-infringement

Which Patent Trial and Appeal Board Trial Decisions Cannot be Appealed?
  • Banner & Witcoff Ltd
  • USA
  • March 26 2018

The U.S. Court of Appeals for the Federal Circuit heard oral arguments on March 6, 2018, in the appeal of Altaire Pharmaceuticals, Inc. v. Paragon