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A Twist On The Old One-Two Punch
  • Reed Smith LLP
  • USA
  • November 2 2018

Not terribly long ago, we had a series of poststoo many to linkthat recounted court decisions rejecting efforts to impose liability on a generic

Taking the Medicine
  • VdA
  • Portugal
  • October 31 2018

Portugal's new Medicine Act has come into effect at a time of good health for Portugal's life sciences sector

CMS considers linking Medicare drug payment rates to international prices
  • Hogan Lovells
  • USA
  • October 30 2018

On October 25, 2018, the Centers for Medicare & Medicaid Services (CMS) issued an Advance Notice of Proposed Rulemaking (ANPRM) describing a potential

First Circuit Rejects Certification of Class that Included Members Who Had Not Suffered Any Injury
  • Troutman Sanders LLP
  • USA
  • October 29 2018

In its decision, United Food & Commer. Workers Unions & Emplrs. Midwest Health Bens. Fund v. Warner Chilcott Ltd., 2018 U.S. App. LEXIS 28920, issued

Teva Sues FDA Alleging Unlawful Interpretation of the Definition of “First Applicant”
  • Seyfarth Shaw LLP
  • USA
  • October 24 2018

The FDA Reauthorization Act of 2017 (FDARA) created a new type of 180-day exclusivity for ANDA applicants applying for approval of certain drugs

Highlights of the USMCA
  • Miller Thomson LLP
  • USA, Mexico, Canada
  • October 11 2018

On September 30, 2018, the United States, Mexico and Canada reached a new trade agreement, the United States-Mexico-Canada Agreement (“USMCA”). This

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

How often will the FTC use its recently reaffirmed authority to compel disgorgement?
  • K&L Gates
  • USA
  • September 6 2018

The U.S. District Court for the Eastern District of Pennsylvania recently granted the Federal Trade Commission’s (“FTC”) request to compel a branded

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

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