By Noel Courage
BIoSIMILarS
biosimilar
biosimilar biosimilar biosimilar patent enforCement in Canada
T
here is much interest in developing lower-cost biosimilar (subsequent entry) copies of biologic drugs, such as filgrastim and erythropoietin, for the Canadian market. Brand name companies that have spent huge amounts of time and money pioneering these biologic drugs are keen to hold onto their exclusive markets as long as possible. Canada has a specialized litigation option available to protect certain patented drugs on the market. The process may block a second-entry drug that is referencing a patent owner’s clinical trial data. This unique Canadian system is informally called the “NOC Regulations.”1 It requires
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generic and biosimilar drug companies to establish freedom-to-operate (clearance) with respect to certain patents as a precondition to market authorization. This is in sharp contrast to conventional Canadian patent enforcement litigation that typically begins only after marketing authorization is granted. In comparison, the U.S. has created its own specialized and complex biosimilar litigation process, which is beyond the scope of this article. This article will review the NOC Regulations as well as conventional patent litigation options that apply in proceedings involving biosimilars.
Health Canada Opens the Door to Biosimilars A biosimilar is a complex drug, such as a protein drug, that can be approved for sale on the basis that it is chemically similar to an innovator biologic drug already on the market.2 This standard for market approval is less strict than bioequivalence, which applies to conventional generic pharmaceutical drugs. For instance, showing biosimilarity allows biosimilar manufacturers to rely largely on the innovator drug’s clinical data, thereby dramatically reducing the time and expense otherwise required to obtain market authorization. Health Canada approves drugs for marketing by issuing a marketing
