On March 15, 2013, the U.S. Court of Appeals for the Federal Circuit agreed to consider en banc whether claim construction decisions made by district courts should be given deference on appeal. This action may have profound implications for biotech patents in the years ahead. The Federal Circuit’s standard for review of claim construction decisions, as stated in Cybor v. FAS Techs., is "as a purely legal question, [the court reviews] claim construction de novo on appeal including any allegedly fact-based questions relating to claim construction." The Federal Circuit granted the request to reconsider Cybor in response to Lighting Ballast Control LLC’s 2012 petition for a rehearing en banc in Lighting Ballast Control v. Philips Electronics North America.

That the Federal Circuit has ordered en banc review of Lighting Ballast is noteworthy, and marks a potentially important development for biotechnology patent litigants. According to a 2012 study by PricewaterhouseCoopers, biotechnology patent cases are on the rise: The number of court decisions in the biotechnology/pharma industry has increased nearly threefold, from 40 in the 1995–2000 timeframe to 112 between 2006 and 2011. (See 2012 Patent Litigation Study.) Indeed, the Cybor issue has been previously addressed in biotechnology cases and will remain an important issue in such matters going forward. For example:

  • In Merck v. Teva Pharmaceuticals USA (2005), a case involving bisphosphonate compounds, Judge Rader lamented the lack of deference given to the district court’s decision where the judge conducted a trial, analyzed the claims and arguments in detail, heard from expert and fact witnesses, and wrote a 75-page opinion, but was nonetheless reversed by the Federal Circuit.
  • In Amgen v. Hoechst Marion Roussel (2006), a case involving manufacture of recombinant DNA, six of the then-active Federal Circuit judges (Michel, Radar, Gajarsa, Linn, Dyk, and Moore) expressed a willingness to revisit Cybor in a denial of a petition for rehearing en banc.
  • In Retractable Technologies v. Becton, Dickinson (2011), a case relating to retractable syringes, three of the current Federal Circuit judges (Rader, Moore, and O’Malley) voiced concern about the lack of deference given to review of a district court’s claim construction decision under Cybor.