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Food, Dietary Supplement & Cosmetics Regulatory Update Vol. IV, Issue 1
  • Jones Day
  • European Union, United Kingdom, USA
  • February 16 2017

On January 20, 2017, the Trump Administration issued a memorandum "for the Heads of Executive Departments and Agencies" requesting the "regulatory


PTAB Institutes Separate IPR Proceedings Filed by Codefendants, Finding that the Later IPR Proceeding Was Not Barred by 35 U.S.C. 325(d)
  • Jones Day
  • USA
  • January 30 2017

On January 19, 2017, the PTAB instituted inter partes review of U.S. Patent No. 8,822,438 (“the ’438 patent”) filed by Wockhardt Bio AG (“Wockhardt”


PTAB Upholds Sloan Kettering’s Cancer Immunotherapy Patent
  • Jones Day
  • USA
  • January 26 2017

By Galina Steinberg-Tatman, Ph.D. And Cary Miller, Ph.D. On December 16, 2016, the PTAB issued a Final Written Decision in case IPR2015-01719


Regulatory Developments Life Sciences Companies Should Expect in the New Presidential Administration
  • Jones Day
  • USA
  • January 20 2017

2017 and beyond promises to be a time for continued evolution and uncertainty for life sciences companies doing business in the United States. In


21st Century Cures ActFebruary 11, 2017, Deadline for Company Disclosure of Expanded Access Programs
  • Jones Day
  • USA
  • January 17 2017

The landmark 21st Century Cures Act1 ("Cures Act"), which was signed into law by President Obama and became effective on December 13, 2016


PTAB Invalidates Multiple Claims of Patent for Treating Anemia with Iron Carbohydrate Complexes and Denies Motion to Amend Claims
  • Jones Day
  • USA
  • January 13 2017

On January 4, 2017, in a Final Written Decision in IPR2015-01490, the PTAB found 17 claims of a patent directed to methods of treating iron disorders


What Impact Will the New Trump Administration Have on State Attorney General Activity?
  • Jones Day
  • USA
  • January 10 2017

Some state Attorneys General are already expressing their intention to challenge the new Trump Administration ("Administration") as it moves to


PTAB Institutes IPR Proceedings Against Mayne Pharma’s Antifungal Formulation Patent
  • Jones Day
  • USA
  • January 6 2017

The PTAB instituted an IPR on claims of Mayne Pharma International Pty Ltd.’s (“Mayne”) U.S. Patent No. 6,881,745 B2 covering formulations of azole


Routine Trial-and-Error Approach to Protein Formulation Is Not Sufficient to Establish Obviousness Absent a Reasonable Expectation of Success in Achieving the Claimed Formulation
  • Jones Day
  • USA
  • January 5 2017

On December 22, 2016, in a final written decision in IPR2015-01537, the PTAB rejected an obviousness challenge brought by Momenta Pharmaceuticals, Inc


Idenix Pharmaceuticals wins $2.54 billion infringement verdict
  • Jones Day
  • USA
  • December 21 2016

The global law firm Jones Day represented Idenix Pharmaceuticals, LLC (Idenix), a subsidiary of Merck & Co (NYSE: MRK), known as MSD outside the