Regardless of the reasons for the decision's implementation, it still carries significant implications for the pharmaceutical and health-care industries. The rule proposed by the Bush administration is intended to "limit drug makers to seeking a single 30-month delay [or stay'] before a generic competitor can be introduced after a patent expires- (1). The Federal Trade Commission came to the conclusion last spring that the big pharmaceutical firms were taking unfair advantage of the 30-month stay granted to them by 1984 Hatch-Waxman Act by using it indiscriminately, and in many cases multiple times. .
The Hatch-Waxman provision, which was intended to sanction competition in the pharmaceutical industry, provides the bigger brand-label firms with "up to 30 months of additional patent protection while [patent] litigation proceeds- (7). It seems now that brand-name pharmaceuticals have been abusing this privelage "increasingly to fend off competition and keep generics out of consumers' hands, sometimes for years- (5).
In several instances the big firms have used the 30-month shield a number of times, thus stalling the arrival of generic brands on pharmacy shelves for several years. To do so, the brand name pharmaceutical companies will often formulate their patent lawsuits around such inconsequential issues such as "packaging claims- or irrelevant assertions of Intellectual Property Rights (IPR) protection (5). .
One IPR based patent infringement lawsuit in which major drug label AstraZeneca actually recently prevailed dealt with its "blockbuster purple pill- Prilosec. The controversy was merely over whether or not competing generic firms could market the drug using a different type of "sub-coating layer [which] is inserted between the core of the drug's active ingredient- to protect it from "harsh stomach acids during digestion- (2). Apparently the generic knock-offs' modifications to the drug were not broad enough to avoid a patent infringement ruling by the court.