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Results:1-10 of 17

FDA advisory committee meeting materials were “printed publications” after notice of meeting and link to location of materials were published in the Federal Register
  • Winston & Strawn LLP
  • USA
  • September 4 2018

This was an appeal from a final decision of the Patent Trial and Appeal Board (PTAB) finding patent claims relating to a drug distribution system for


Cumberland Pharmaceuticals v. Mylan Institutional LLC, Nos. 2016-1155 and 2016-1259 (Fed. Cir. Jan. 26, 2017)
  • Winston & Strawn LLP
  • USA
  • January 3 2017

FDA request for study does not amount to derivation where study request did not clearly encompass all elements of the later issued claims


Amgen Inc. v. Apotex Inc
  • Winston & Strawn LLP
  • USA
  • August 29 2016

Amgen Inc. brought an action against Apotex Inc. under the Biologics Price Competition and Innovation Act (BPCIA) alleging that Apotex’s marketing of


U.S. Supreme Court unanimously upholds generic drug makers’ right to correct inaccurate brand patent descriptions
  • Winston & Strawn LLP
  • USA
  • April 18 2012

In its first-ever case construing the Hatch-Waxman Act’s provisions governing competition between generic and brand-name drug makers, the United States Supreme Court on Tuesday handed a major victory to the generic drug industry.


IRS concludes attorney fees related to generic drug patent infringement lawsuits must be capitalized
  • Winston & Strawn LLP
  • USA
  • January 24 2012

In a recent Chief Counsel Memorandum (“CCM”), the Internal Revenue Service (the “IRS”) concluded (contrary to an established industry custom) that attorney fees incurred for investigatory patent research and to defend actions for patent infringement in connection with the filing of abbreviated new drug applications (“ANDAs”) were not deductible and instead must be capitalized.


Astrazeneca LP v. Apotex, Inc.
  • Winston & Strawn LLP
  • USA
  • November 9 2010

If a drug's product label includes instructions that could cause some users to perform the patented method, then courts may find that the manufacturer had an affirmative intent to induce infringement.


Teva Pharmaceuticals USA Inc., v. Eisai Co., Ltd.
  • Winston & Strawn LLP
  • USA
  • October 21 2010

A subsequent ANDA filer has a legally cognizable interest in when the first filer's exclusivity period begins, such that delay in triggering that period qualifies as "injury-in-fact" for the purposes of Article III.


When a commercial product meets all of the claim limitations, a comparison to that product may support a finding of infringement
  • Winston & Strawn LLP
  • USA
  • August 10 2010

The district court entered a judgment that the accused infringer’s Abbreviated New Drug Application (ANDA) product would not infringe the asserted claims of the patent-in-suit.


Louis J. Weber III
  • Winston & Strawn LLP