Competition and success in the pharmaceutical industry is often defined by a winning patent strategy that most effectively addresses generic market entry. For both branded and generic drug manufacturers, this patent strategy centers around the Hatch-Waxman statutory scheme and associated abbreviated new drug application (ANDA) litigation. The Orange Book patent(s) protecting a company's branded product and a generic's Paragraph IV patent challenges to those patent(s) are the respective lifebloods of these competitors. The Hatch-Waxman Act, enacted in 1984 and amended in 2003, encouraged early entry of generic drug products and corresponding Orange Book patent challenges, thereby elevating the importance of patent strategies while ostensibly providing greater business certainty through early and expedited litigation.
Litigation, however, is an inherently uncertain process, and competition is an ever-evolving one. Since Hatch-Waxman's enactment more than 25 years ago, changes in the legal landscape (statutory amendments, obviousness/inequitable conduct jurisprudence, and so on) have compounded this uncertainty and caused Hatch-Waxman litigants on both sides to constantly rethink and adapt their strategies. So, too, have changes in the competitive landscape. For instance, over the years, the scope and prevalence of ANDA lawsuits has steadily increased. This increase has been driven by the expansion of both the number of generic manufacturers (including branded companies who have started generic businesses of their own) and the "size" of the products subject to such challenges. No longer are branded-generic ANDA battles reserved for "blockbuster" drugs. Drug products with annual sales well below $100 million are increasingly subject to ANDA challenges from one or more generics. Similarly, the 2009 Biologics Price Competition and Innovation (BPCI) Act has expanded the branded-generic patent battleground into the realm of so-called biologics, such as recombinant proteins, antibodies, and the like, by introducing a litigation framework for follow-on biologics (FOBs).