Pharma LItigation Study - Generic Challenges are Many, Successes Few

RBC Capital Markets released a very interesting study on patent litigation in the pharmaceutical industry by analyzing more than 370 cases filed over the last 10 years.  The study concludes that there is "very little downside and huge upside" for generics to take brand manufacturers to court, but also noting that"while patent challenges by generics are extremely common, winning is not."

Highlights from the study:

• Patent challenges remain on the rise with a record 65 new first-to-file lawsuits in 2009, up from 51 in the prior year and more than double the number just three years ago.

• Over the last decade, the overall success rate for the generic drug industry is 48% for cases that have gone to trial. However, the success rate increases to 76% when settlements are included. Over half of all cases are settled or dropped.

• The top three courts by volume -- NJ, DE and SDNY -- accounted for 69% of all decisions. These courts have a combined success rate of just 36% for generics. However, just over half of the cases in these three courts get settled or dismissed.

• Four courts have never ruled against a generic -- C.D. Cal., E.D.N.Y., D. Minn. and ED Mo.

• The top five judges by volume accounted for 31% of the total decisions.  These five judges ruled in favor of generics only 33% of the time. The total success rate, however, including settlements is 75%.

• Last year saw six "at-risk" launches, up from four in the last few years.  Teva remains the most likely to go at-risk with 12 of the 28 at-risk launches since 2002.

• The number of settlements in 2009 reached an all-time high of 54, up from 45 in the prior year. Settlements occur on average 47% of the time withTeva accounting for nearly one-third of all settlements. On the innovator side, Glaxo and Novartis have settled the most.

• 25 authorized generics launched in 2009, compared to 18 in the prior year. However, more products are launching without an AG than in prior years.

Read/download a copy of the 24-page report here (link), courtesy of Amlaw Daily