Aly Quoted on Proposed FDA Fixes to Prevent Blocking of Generic Drugs

Imron said a helpful action by the FDA would be to work with Congress to prevent innovator companies from blocking generics from entering the market by getting a lot of patents to form a so-called patent thicket, giving an example that “the agency could only list the first generation of patents in its Orange Book.”

On the FDA’s question to the USPTO about the time patent examiners spend on pharma patent applications, Imron suggested that removing quotas for patents on already FDA-approved drugs may support implementation of this policy. He pointed out that ”if these drugs have approval, there are probably already some patents that protect the products and therefore delays would not harm companies’ strategies like they would if they were launching brand new drugs.”

On the FDA’s offer to train examiners on the agency’s public information, Imron said the USPTO may not always know about FDA submissions including new discovered properties of existing drugs, so improved collaboration between the agencies could allow the FDA to “prevent companies from obtaining different versions of patents on what is basically the same drug product.”

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