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New Arguments in Momenta On Standing to Appeal IPR Loss Before Filing a Biosimilar Application
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • September 12 2018

In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., No. 17-1694 (Fed. Cir. argued Dec. 5, 2017), BMS challenges Momenta’s standing to appeal

FDA advisory committee meeting materials were “printed publications” after notice of meeting and link to location of materials were published in the Federal Register
  • Winston & Strawn LLP
  • USA
  • September 4 2018

This was an appeal from a final decision of the Patent Trial and Appeal Board (PTAB) finding patent claims relating to a drug distribution system for

Printed Publication Status Based on Public Accessibility
  • McDermott Will & Emery
  • USA
  • August 30 2018

Addressing public accessibility of prior art, the US Court of Appeals for the Federal Circuit affirmed a Patent Trial and Appeal Board (PTAB)

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month, we highlight significant developments in May 2018, including a stunning reverse payment decision at the FTC, draft guidance from the FDA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