EU action on pharma patent 'pay-to-delay' settlements - a legal opinion; US FTC also to review the subject

The European Commission yesterday launched a probe over patent settlements made between drug companies and generics manufacturers and whether their use is preventing consumers from accessing cheaper medicines, activities that have been dubbed 'pay-to-delay' (The Pharma Letter January 12).

While the Commission has not named the parties involved, several key market players have come forward and said they have been approached, including the UK-based majors AstraZeneca and GlaxoSmithKline, Switzerland's Novartis and Roche, and France's Sanofi-Aventis. Generics manufacturers also approached include Niche Generics (part of Unichem) and Isreal's Teva. Also, just a week earlier, the Commission revealed it is investigating Denmark's Lundbeck (TPL January 7).

Taking an external view of the situation, Gareth Williams, a partner at intellectual property law firm Marks & Clerk, comments: 'Today's investigation is a logical step in progressing the Commission's agenda to ascertain whether or not there are unnecessary, anti-competitive delays in generic drug manufacture. There can often be as much commercial incentive for generic companies to restrict competition as there is for major pharmaceutical companies - everyone is in business to turn a profit.