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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

U.S. FDA Approves First Biosimilar to Neulasta
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • June 29 2018

Earlier this month, the U.S. FDA announced approval of Mylan’s Fulphila biosimilar to Neulasta (pegfilgrastim). Neulasta was developed by Amgen and

Lower Court’s Factual Finding Given Deference in “Close Case”
  • McDermott Will & Emery
  • USA
  • June 28 2018

The US Court of Appeals for the Federal Circuit affirmed the district court's finding that a skilled artisan would have had no reasonable expectation

FTC Says Hatch-Waxman Suits Not Immune from Antitrust Scrutiny
  • Vinson & Elkins LLP
  • USA
  • June 26 2018

The Federal Trade Commission (“FTC”) has sought permission to file an amicus brief in a pharmaceutical patent case, urging a district court to reject

Senator Hatch’s New Legislation Would Eliminate IPR Challenges by Generics and Biosimilar Makers
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • June 18 2018

Generics and biosimilar makers have increasingly used inter partes reviews (“IPRs”), proceedings made possible by the America Invents Act, to

FDA Draft Guidance on Meetings Regarding the Development and Review of Biosimilar or Interchangeable Products
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • June 12 2018

On May 31, 2018, FDA issued draft guidance on Formal Meetings Between the FDA and Sponsors or Applicants of Biosimilar User Fee Act (BsUFA) Products

Deeming Regulations Litigation Update-Case Transferred, Appointments Clause Briefing Scheduled
  • Troutman Sanders LLP
  • USA
  • June 11 2018

There has been new activity in two of the three Deeming Regulations challenges filed by vapor-industry plaintiffs represented by the Pacific Legal

PTAB Tech Center 1600 Round-up: Week of June 4-8, 2018
  • Perkins Coie LLP
  • USA
  • June 11 2018

Other than quickly granting Petitioner’s unopposed motion to dismiss with prejudice in (Decision Entered June 6, 2018), during the week of June 4, the

FDA Commissioner Plans to Create a Fast Track Approval Pathway for Certain Gene Therapies
  • Knobbe Martens
  • USA
  • June 7 2018

During a speech on May 22, 2018 at the Alliance for Regenerative Medicine's Annual Board Meeting, Food and Drug Administration (FDA) Commissioner

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