According to a news source, at least one major pharmaceutical company has filed a complaint before the International Trade Commission (ITC) seeking an exclusion order to block the importation of a generic version of one of its patented drugs. Legal commentators reportedly indicated that recourse to the ITC is often undertaken by companies as a “strategic counterstrike to other litigation,” but this option is evidently rarely used in the pharmaceutical sector. It may not become a common strategy either, because such disputes may not meet the ITC’s requirement that a product, at least in part, be made abroad. The ITC’s speed in resolving patent cases may also be viewed as a potential negative from the perspective of a brand-name manufacturer seeking to extend the life of its patents. See The Blog of Legal Times, March 17, 2011.
Meanwhile, legal challenges to existing pharmaceutical patents are reportedly said to be “increasing with the rapidity of a centrifuge.” Only 81 such lawsuits were filed in 2005, but more than 230 were filed in 2010. Most of the challengers are generic drug makers, that, if successful, become the exclusive provider of the generic version of the drug for six months. According to a news source, a winning generic firm can take over as much as 65 percent of the branded drug’s market in the first two months. Thus, a $2 million investment in litigation can return some $60 million in additional revenue during the ensuing six-month period. With a 70-percent success rate, the litigation explosion is easy to understand. Ultimately, the question raised by this pharmaceutical patent tug of war is whether government regulations have failed to correctly balance the goals of fostering innovation and preserving competition in the business. See CNNMoney.com, March 11, 2011.