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In Generics, An Update on Reform

The new Medicare Act, while aimed at expanding health insurance coverage to include drug benefits, also includes some changes that wiill impact the intricate and highly evolved way generic companies go about challenging patents on brand-name drugs. Specifically, it strengthens an incentive companies have to be first to file a patent challenge, known as 180-day marketing exclusivity. Second, it limits the number of times a brand name company can get a delay on launch of a newly approved generic.

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....

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