EU LAWS HIT US GENERICS SECTOR

Because of changes to the patent laws in the European Union, strengthening them to cover both the compound and the production process, US generic drugmakers say they have lost their ability to produce inexpensive equivalents of compounds which are soon to lose patent protection.

In the past, the USA's generic drugmakers relied on loose patent laws in Europe to obtain alternative-source samples of products, according to Ira Breskin writing in the US Journal of Commerce. This meant they could develop the products and gain US Food and Drug Administration approval before the patent expired, and generics companies were thus able to get into the market the moment a brand-name drug lost its US protection.

US generics firms get almost all their raw materials from independent European companies, notably in Italy and Spain, as US suppliers are not a viable option because brand-name companies have tied up US production, she reports.