Hatch-Waxman paragraph IV issues
-->Generic manufacturers not satisfied waiting until patents expire have the option of trying to prove that an existing patent is invalid. The company that successfully challenges a patent is allowed six months before other generic firms are allowed to compete. A new strategy is to seek settlements from patent holding companies in lieu of patent prosecution. <--
Under paragraph IV, the ANDA filer can certify to invalidity or noninfringement. In one of the old omeprazole cases, noninfringement was the only issue. On multiple patents, the ANDA filer may state that he is waiting the composition of matter patent out, and assert invalidity of a more specific polymorph patent.
The "new" strategy of the first generic company cutting a deal with the proprietary company has been under scrutiny by the FTC (recall the Cardizem case, for example). Also, in the omemprazole case, the various generics cut deals, because the winner did not have sufficient production capacity.
Friedman also wrote:
By 2006, almost 200 patents covering $36 billion in US pharmaceutical sales will expire. When a pharmaceutical patent expires, manufacturers can lose a majority of their market share overnight.
With traditional pharmaceuticals, a generic company files an abbreviated new drug application (ANDA) with the FDA. This approval process takes 2-5 years, and one of the requirements is that the generic pharmaceutical be bioequivalent to the brand-name original. The current definition of bioequivalent is that the generic and brand-name pharmaceuticals must have the same amount of active ingredient in a patients blood over a period of time. While this arrangement is satisfactory for many traditional pharmaceuticals, biological compounds are not as easy to quantify. Biologically produced compounds are subject to minor modifications that are not always easily detected in traditional screens. Subtle differences in pH, ionic strength or temperature of the conditions used to produce a biological pharmaceutical can result in inactive products or products with unwanted activities. Both the FDA and Health Canada are working on additional regulations for generic forms of biological pharmaceuticals.