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What Are the Top Hatch-Waxman and BPCIA Developments for October 2018?
  • Morrison & Foerster LLP
  • USA
  • November 6 2018

This month we highlight a new law requiring notification to the Federal Trade Commission and Department of Justice of biosimilar litigation

Yeda Research and Development Co., Ltd. v. Mylan Pharmaceuticals Inc. & Teva Pharmaceuticals USA, Inc. v. Sandoz Inc.
  • Knobbe Martens
  • USA
  • October 15 2018

Non-prior art evidence may be considered when evaluating the knowledge, motivations, and expectations of a POSITA regarding the prior art. In addition

Post Grant Proceedings: Recent Developments & Precedential Proceedings
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • September 5 2018

The overall institution rate continues to decline and is at 61 in FY2018. Overall, the institution rate remains higher for electricalcomputer and

Tribal Sovereign Immunity Does Not Bar IPRs
  • Morrison & Foerster LLP
  • USA
  • August 20 2018

The Federal Circuit affirmed the PTAB's decision that tribal sovereign immunity did not bar IPRs against patents owned by the Saint Regis Mohawk tribe

Federal Circuit Affirms Tribal Sovereign Immunity Does Not Apply to IPR
  • Marshall Gerstein & Borun LLP
  • USA
  • August 9 2018

The Federal Circuit recently affirmed the PTAB’s decision that tribal immunity cannot be asserted in an IPR (Saint Regis Mohawk Tribe v. Mylan Pharma

Native American Tribes’ Patents Not Immune from Challenge in the Patent Trial and Appeal Board
  • Ladas & Parry LLP
  • USA
  • July 27 2018

On July 20 in Saint Regis Mohawk Tribe, Allergan, Inc. v. Mylan Pharmaceuticals Inc., a panel of the U.S. Court of Appeals for the

The Federal Circuit Finds Tribal Sovereign Immunity does not Apply in IPR
  • Knobbe Martens
  • USA
  • July 24 2018

On July 20, 2018, the Federal Circuit held that tribal sovereign immunity is not available as a defense in IPR. Allergan Pharmaceuticals owned

Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc.
  • Knobbe Martens
  • USA
  • July 23 2018

Generic drug manufacturers petitioned for IPR of Allergan’s patents relating to the dry eye treatment Restasis. The Board instituted the IPR, but

Federal Circuit Holds that Tribal Sovereign Immunity Does Not Bar Inter Partes Review
  • Fredrikson & Byron PA
  • USA
  • July 20 2018

In a closely-watched case, the United States Court of Appeals for the Federal Circuit held today that a Native American tribe may not assert sovereign

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