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Results: 1-10 of 101

Venue Over An ANDA Defendant: D. Del. Weighs In
  • Fish & Richardson PC
  • USA
  • October 9 2017

In light of the Supreme Court's TC Heartland decision, courts around the country have been grappling with venue-related challenges in patent cases


The Amgen v. Sandoz Disclosure Disputes Continue
  • Fish & Richardson PC
  • USA
  • July 27 2017

A theme emerging in biosimilar litigation is when - and how much - discovery is available to reference product sponsors. The Supreme Court in Amgen


SCOTUS Unravels Some of the BPCIA Enigma But Questions Remain
  • Fish & Richardson PC
  • USA
  • June 13 2017

Reference product sponsors (RPSs) and biosimilar manufacturers were hoping the Supreme Court of the United States would clarify two aspects of the


How Soon Can A Biosimilar Applicant Be Sued for Patent Infringement?
  • Fish & Richardson PC
  • USA
  • April 24 2017

Biosimilar manufacturers proceeding under the abbreviated approval pathway laid out in the Biologics Price Competition and Innovation Act ("BPCIA"


First Biosimilar Monoclonal Antibody in Oncology Granted EU Approval: Implications for the U.S. Market
  • Fish & Richardson PC
  • USA, European Union
  • March 14 2017

Recent developments in Europe may augur a new push for oncology biosimilars in the United States. On February 22, 2017, the European Commission


Rituxan Patents Resurface at the PTAB
  • Fish & Richardson PC
  • USA
  • March 10 2017

Two patents related to methods of treating rheumatoid arthritis (RA) patients with rituximab have been brought before the PTAB for a third time - with


Biosimilar Litigants Square Off Before the Supreme Court
  • Fish & Richardson PC
  • USA
  • February 16 2017

Last week, Sandoz filed its opening Supreme Court brief, asking the Court to determine (1) whether notice of commercial marketing under Subsection


FDA Final Guidance on Nonproprietary Names of Biological Products
  • Fish & Richardson PC
  • USA
  • February 3 2017

In January, 2017, the FDA released a final guidance document outlining its rules for giving nonproprietary names to biological products. The issue has


Biosimilars: What to Expect in 2017
  • Fish & Richardson PC
  • USA
  • January 23 2017

2016 was a record year for the development of biologics in the United States. Below, we summarize a few key biosimilar developments to keep an eye on


The First Amendment Does Not Protect All Off-Label Drug Promotion
  • Fish & Richardson PC
  • USA
  • December 23 2016

FDA is considering making off-label promotion easier, consistent with recent case law. The drug and biologics industry is also proposing an ease up