“If the generic company wins the patent challenge, the innovator loses its remaining market exclusivity for that product, while the generic manufacturer gains 180 days of market exclusivity and an average potential payoff of $60 million during that period. Graham added: “”The law is creating incentives to bring challenges on more and different types of drugs.””
Because of this, the researchers argue that a longer exclusivity period is required; the current 5-year period is not usually sufficient to recoup R&D costs. A 2007 report from The National Academies also supported this and explained that the US should at least double the duration of exclusivity to bring it closer to allowances awarded in the EU, Canada and Japan.
There has been a recent surge of Paragraph IV patent challenges by generic companies. Paragraph IV is a provision of the US Hatch-Waxman Act of 1984 that allows generic drugs manufacturers to challenge an innovator’s patents by claiming that either the patent is invalid or that the generic drug does not infringe the patent.
Veeda Clinical Research is a leading Indian CRO which caters to cost effective bio-equivalence studies for the Global Pharma and biotech industry in a major way. “