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Results:1-10 of 854

The Priority Review Voucher: An Untapped Asset
  • Dilworth IP
  • USA
  • October 3 2018

Typically, we think of patents as the main tool that allows for product exclusivity in the pharmaceutical industry. However, exclusivity has a


PTAB Upholds GILENYA Method of Treatment Patent, Prompting New ANDA Litigation
  • Jones Day
  • USA
  • July 30 2018

In Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 (Jul. 11, 2018), the PTAB held that the claims of U.S. Patent No. 9,187,405 were not


FDA Issues Final Guidance on Biosimilar Labeling, Sticking with Generic Model
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • July 30 2018

Earlier this month, FDA issued final guidance on the labeling of biosimilar products. The final guidance continues the approach adopted in FDA’s March


Washington Healthcare Update - May 21, 2018
  • McGuireWoods LLP
  • USA
  • May 21 2018

On May 17, the Energy and Commerce Committee held the second of its opioid legislation markups, clearing 32 bills. The previous markup reported out 25


ITC Institutes Investigation Based on Allegation of Drug Sales Without FDA Approval
  • Jones Day
  • USA
  • May 17 2018

Normally, it is the FDA that monitors the improper distribution of drugs. But, as it turns out, the International Trade Commission ("ITC") might be


FDA Publishes List of Drug Companies Accused of Hindering Generic Entry: Antitrust Implications
  • Wilmer Cutler Pickering Hale and Dorr LLP
  • USA
  • May 17 2018

Today, as part of the Trump Administration's stated goal to lower drug prices, the Food and Drug Administration (FDA) published a list of


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.


Federal Court Dismisses CFAA Claims Against Former Executive, Allows CFAA and DTSA Claims Against Competitor in Pharmaceuticals Trade Secret Dispute
  • Seyfarth Shaw LLP
  • USA
  • April 18 2018

A recent decision from the Eastern District of Pennsylvania reinforces the importance of the timing of purported misconduct in alleged violations of


Drug Costs Targeted in Administration’s Fiscal Year 2019 Budget
  • Cooley LLP
  • USA
  • February 13 2018

Yesterday, the Administration released its Fiscal Year 2019 (FY19) Budget blueprint. The $4.4 trillion Budget blueprint includes several proposals


FDA’s Proposed New Pathway for Devices Referencing Drugs (DRDs)
  • Hogan Lovells
  • USA
  • January 19 2018

The Food and Drug Administration (FDA) may be closing in on solving one of its perennial regulatory problems, namely, the absence of a workable