Secondary Patents Not an Issue for Biosimilars in Europe, Study Notes

The main hurdle preventing biosimilars from coming to market is the primary patent on the originator product, not supplementary patents, according to a European study. Investigators also found that product exclusivity extensions, which are customary in Europe, delay the market entry of competitor products.

A patent protects the intellectual property of pharmaceutical manufacturers, guaranteeing them market exclusivity for a set number of years to recoup their drug development costs. Pharmaceutical corporations routinely get secondary patents for tweaks to those drugs to extend their exclusivity, but the study of biosimilar litigation in Europe found that secondary patents were not sufficient to delay the market entry of biosimilars for 9 top-selling monoclonal antibodies.

“Except for 1 patent on trastuzumab where the decision to reject the patent was overturned in appeal, biosimilar developers have won all identified opposition and national patent litigation cases. This indicates that some patents on trastuzumab were seen as a real hurdle for biosimilar entry, but that biosimilar developers can challenge these patents and win,” the authors wrote.

In the United States, patents are often considered formidable barriers to biosimilar market entry, and the multiple patent filings over individual products are known as patent thickets. Limits on patent litigation have been sought to improve access to these lower-cost medicines. In Europe, the authors of this new study suggest, some patent barriers may be more illusory than real.

To read the rest of the story visit The Center for Biosimilars.