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Results: 1-10 of 1,739

A U.S. Perspective on Global Strategy
  • Sterne Kessler Goldstein & Fox PLLC
  • USA, Taiwan
  • April 13 2018

In December 2017, the Taiwan Pharmaceutical Affairs Act has been amended to harmonize generic approval process with prevailing international norms

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

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

Additional Discovery of Clinical Trial Data in Inter Partes Review
  • Baker & Hostetler LLP
  • USA
  • March 30 2018

In Apotex, Inc. et al. v. Novartis AG (IPR 2017-00854, paper 47 dated Feb. 5, 2018), petitioner Apotex sought, and was granted, discovery of a Phase

Deference, Discovery and District Court Findings
  • McDermott Will & Emery
  • USA
  • March 28 2018

Giving deference on discovery issues and non-infringement findings, the US Court of Appeals for the Federal Circuit affirmed a non-infringement

The I-O Movement: Priming the Immune System to Fight Cancer - Part I: Chimeric Antigen Receptor T (CAR-T) Cell Technology
  • Dilworth IP
  • USA
  • March 27 2018

This is the first article in a Series focused on current trends in immuno-oncology (I-O) and immunotherapy. Since the latter are becoming household

Rituxan Patent Spared by Failure to Establish Product Label as “Printed Publication”
  • Marshall Gerstein & Borun LLP
  • USA
  • March 26 2018

A patent relating to a method of treating rheumatoid arthritis using rituximab recently survived its fourth IPR challenge. Celltrion, Inc. v. Biogen

Which Patent Trial and Appeal Board Trial Decisions Cannot be Appealed?
  • Banner & Witcoff Ltd
  • USA
  • March 26 2018

The U.S. Court of Appeals for the Federal Circuit heard oral arguments on March 6, 2018, in the appeal of Altaire Pharmaceuticals, Inc. v. Paragon

FDA Authorizes First Direct-to-Consumer Test for BRCA Gene Mutations
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • March 22 2018

On March 6, 2018, the U.S. Food and Drug Administration (“FDA”) authorized, with special controls, the first direct-to-consumer test to detect the