EFPIA Proposes Process to Ease Early Resolution of Patent Disputes

Brand drugmakers in Europe are calling on the European Commission to implement a system to help resolve patent disputes before the launch of a generic drug, a move they say would address inefficiencies in the current patent litigation system.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has proposed a three-step process in which:

1. At least one year before loss of exclusivity, the innovator company would be required to release details of certain patents to let generic companies assess the risks of early entry;
2. Medicines agencies would be required to disclose information about generics makers’ applications to let innovators assess whether the generic might infringe its intellectual property rights; and
3. After the filing of a generic application, innovators could initiate infringement proceedings.

The proposal comes as the European Commission reports that brand and generic firms increasingly are settling patent issues out of court. The number of patent settlements jumped to 146 in 2013, compared with an annual average of 24 settlements from 2000 to 2008, said the EC report.

Companies, in most cases, are able to solve their disputes in a manner that typically is considered unproblematic from a competition law perspective, it concluded.

For example, settlements that included payments by brand firms to generics firms to delay generic entry represented just 8 percent of the total settlements in 2013, a decrease from 22 percent during the 2000 to 2008 period. Settlements that didn’t include payments accounted for 47 percent of the total in 2013, down from 51 percent the prior year, but up significantly from 26 percent during 2000 to 2008 period.

Read the EC report here: www.fdanews.com/12-14-EC-Report.pdf. — Jonathon Shacat

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.