James B. Monroe

Lead counsel for Otsuka at trial and on appeal in Hatch-Waxman litigations against several companies seeking to market generic copies of Abilify®, which had sales of over $5.2 billion in 2011 alone. Following a month-long trial, district court ruled in favor of Otsuka on all issues, Federal Circuit affirmed, and Supreme Court denied cert, thus maintaining patent and regulatory protection for Abilify® in the United States from 2010-2015.

Lead counsel for Horizon in Hatch-Waxman patent infringement litigations against several companies seeking to market generic copies of Vimovo^®.  District court ruled in favor of Horizon, and appeal now pending. 

Lead counsel for Elan at trial and on appeal in Hatch-Waxman litigation involving Andrx’s efforts to market generic copies of Naprelan®. District court found in favor of Elan on all issues, including a finding of willful infringement, and the parties ultimately settled an at-risk launch damages case in a confidential settlement involving significant payments to Elan.

Lead counsel for Pronova at trial and on appeal in Hatch-Waxman patent litigation against three companies seeking to market generic versions of Lovaza®.  District court found in favor of Pronova on all issues, including patent infringement, validity, and enforceability.

Lead counsel in defending Elan at district court and in two appeals with respect to Classen’s infringement allegations regarding Elan’s Skelaxin® portfolio.  District court granted summary judgment of non-infringement in favor of Elan. Federal Circuit affirmed, and Supreme Court denied cert.  Also successfully represented Elan in related reexamination proceedings before the U.S. Patent and Trademark Office (USPTO).

Represented Aventis in patent infringement action asserting infringement against Baxter’s Advate® product for treating hemophilia. Case successfully resolved through a confidential arbitration trial, resulting in award to Aventis of the highest damages amount available under parties’ arbitration agreement.