In Generics, An Update on Reform

The Medicare Act of 2003 is directed at expanding benefits to drug coverage for Medicare recipients, but it also contains some changes that will significantly impact the intricate and highly evolved way that generics companies go about challenging patents on brand-name drugs. Attorneys say it's too early to gauge the full impact of these modifications, but they are beneficial to generics companies and may lead to a decline in litigation in the field—if not between branded companies and generics, then among generics competitors. For branded companies, their effect appears to be mixed.

The law makes two key changes to the Hatch Waxman Amendment of 1984, which created the modern generic drug industry. Under that law, the first company to submit a complete...