Alan Klein, partner in the Trial Practice Group of Duane Morris LLP, wrote the above-titled article for this month's INNsight newsletter at GenericsWeb. The following is excerpted from the article:
Patent litigation settlement agreements between brand and generic drug manufacturers are receiving increased scrutiny in the United States Congress with the introduction of legislation with bipartisan support. The proposed Bills seek to curtail such agreements and get generic drugs to market faster and end what critics have complained are “pay for delay” deals benefiting both brand patent holders and generic drug company challengers. As noted below, however, there is a flip side to this controversy which the generic drug industry has highlighted in its public responses to this legislation. Opponents point to the risks of litigation and to the broader benefits accruing to consumers, health insurance companies and government third-party payors from such settlement agreements.
The Preserve Access to Affordable Generics Act, introduced last January in the current Congressional term, would establish a presumption that such patent suit settlement agreements are anticompetitive if the generic first filer receives anything of value or agrees to limit or forego research, development, manufacturing, marketing or sales of the generic drug for any period of time.
A second Bill introduced earlier this month, titled the Fair and Immediate Release of Generic Drugs Act (the “FAIR Generics Act”), would prevent brand drug companies from so-called “parked exclusivities” – providing generics which are not first-to-file with the right to market a generic equivalent of the brand drug during the first filer’s 180-day exclusivity period.
Read the full INNsight article here.