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Exclusivity safeguard for biotech

Twelve-year protection from generic competition for biotech drug firms

The US Senate Health, Education, Labor and Pensions Committee has approved an amendment to protect biotech drugs firms from generic competition for 12 years.

Patient groups had lobbied for much less time to elapse before cheaper drugs could be marketed. The Obama administration had pushed for seven years. Those who supported the 12-year amendment said a shorter timeframe would curb innovation and leave the US unable to compete with companies in the EU.

Biologics were not included in the 1984 Act, which enabled the FDA to approve generic versions of medicines, because manufacturers argued that competitors would not be able to duplicate complex drugs made from living cells. However science has now moved on.

If a pharmaceutical product developed by traditional research methods reaches the market with less than 14 years to run on a 20-year patent, the company can apply for an extension to ensure that generic copies cannot be brought to market. Biotech companies had argued that their drugs are more expensive and time-consuming to produce than regular drugs, and therefore need an even longer period of market exclusivity.

However, given the current climate of reform and push for patient access to cheaper drugs, Jim Greenwood, president of the Biotechnology Industry Organization, seemed satisfied with the ruling. He said in a statement: "A minimum of 12 years of data exclusivity establishes a fair and reasonable period to ensure continued biomedical innovation and provide the benefits of competition."

Although the Committee has passed the amendment, there will be more attempts to shorten this period of patent protection as it moves through Congress.

14th July 2009

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