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Materiality Part III: It Is Not Enough That The Government Could Refuse PaymentThe Question Is Whether The Government Would Refuse Payment
  • Sheppard Mullin Richter & Hampton LLP
  • USA
  • April 16 2018

In Part II of our series, we discussed government knowledge. When the government knows of a claim’s falsity, but nevertheless pays the claim, the


Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
  • Ropes & Gray LLP
  • USA
  • April 12 2018

The rules regarding truthful, non-misleading communications by medical product manufacturers have long been unclear. In recent years, there have been


Deeming Regulations Litigation UpdateAnti-Tobacco Groups Challenge the FDA’s Extension of Deadlines for Premarket Review Submissions
  • Troutman Sanders LLP
  • USA
  • April 9 2018

In connection with FDA Commissioner Scott Gottleib’s July 2017 announcement regarding a new comprehensive nicotine strategy, the FDA gave


Judge Stark (D. Del.) Holds Generic Label is Insufficient to Prove Induced Infringement
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • April 9 2018

Following a seven-day trial last year, a jury found that Teva willfully induced infringement of claims of U.S. Patent


Amgen v. Adello: A Blind Biosimilar Infringement Lawsuit
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • April 9 2018

Last month, Amgen sued Adello Biologics, a US-based biosimilar maker, for patent infringement under the Biologics Price Competition and Innovation Act


Win or Go Home? Standing to Appeal PTAB Decisions Upholding Patentability to the Federal Circuit Before Submitting a Biosimilar Marketing Application
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • April 6 2018

Biosimilar developers have been aggressive in filing petitions for inter partes reviews (IPRs) of biologics patents before the Patent Trial and Appeal


When Parallel Claims Are Neither Claims Nor Parallel
  • Reed Smith LLP
  • USA
  • April 5 2018

This is not new. PMA devices should have broad preemption against product liability claims. Not just from the express preemption provisions of the MDA


District court finds patent covering Cephalon’s wakefulness improving drug Nuvigil, valid in ANDA litigation
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • April 4 2018

The U.S. District Court for the District of Delaware ruled in favor of Finnegan clients Cephalon Inc., Cephalon France, and Teva Santé SAS, finding


S.D. Fla. Dismisses Supplements Case for Lack of Standing
  • Reed Smith LLP
  • USA
  • April 4 2018

We recently read an editorial in The New York Times advocating lawsuits as a means of regulating an industry. Politicians are gripped by paralysis -


My Lawyer Said It Was OK: ‘Scully’ and Defending Based on Reliance on Counsel
  • Morvillo Abramowitz Grand Iason & Anello PC
  • USA
  • April 3 2018

Good faith reliance on counsel can be a critical line of defense for the accused in white-collar referred to as the "involvement of counsel" defense