PricewaterhouseCoopers LLP has released its “2012 Patent Litigation Study,” which shows that the 4,105 patent lawsuits filed in 2011 marked a high point and a 22-percent increase from the previous year. Biotechnology cases have increased significantly since 1995-2000, when 40 were filed, with 112 filed during the 2006-2011 period. The study also showed a high correlation between patent cases filed and patents granted by the U.S. Patent and Trademark Office. Other findings include that (i) median damages awarded in the most recent fiveyear period (2006-2011) are less than half the median award between 2001 and 2005; (ii) median damage awards for non-practicing entities continue to outpace those of practicing entities, a trend that began in 2001; (iii) the largest historical awards are rarely upheld on appeal; and (iv) “reasonable royalties are the predominant measure of damages; price erosion is rare.”

This year’s report includes a section on ANDA (abbreviated new drug application)-related filings, that is, litigation resulting “from a generic drug manufacturer’s filing with the Food and Drug Administration an ANDA paragraph IV certification, which effectively challenges a brand drug manufacturer’s patent(s).” The number of court rulings in ANDA litigation increased to 70 in 2006-2011 compared to 16 in 1995-2000. As the study notes, “the economic ramifications of ANDA litigation are significant due to the potential for lost patent protection of highly profitable brand name drugs. In addition, the first generic filer of a successful patent challenge is awarded a period of exclusivity in the generic drug market.” The report also shows which are the favored ANDA federal district courts, historical success rates and top ANDA litigants.