Nelson Quoted on Possible Shortcomings of Proposed Biologic Patent Transparency Act

Partner Kevin Nelson was quoted on how the recently proposed Biologic Patent Transparency Act, aimed at clarifying the biosimilar drug approval process and encouraging marketplace competition, may not “fulfill all the promises [lawmakers are] making.”

"I think there's a good chance this goes forward, but I hope they make the necessary changes in order to shore up the intent that they do have for this legislation,” Kevin said.

One of the changes the Senate bill would make to the current law is requiring biologic drug companies to list their products’ patents in the Food and Drug Administration’s (FDA) Purple Book. This is similar to the Hatch-Waxman Act’s requirement of traditional drugmakers to list their patents in the FDA’s Orange Book.

Though adding transparency would be "a good first step because it attempts to recreate one of the good parts of Hatch-Waxman," Kevin said the bill’s approach may need to be tweaked.

“The problem with the biosimilar pathway as compared to the Hatch-Waxman Act is that a company looking to go into it isn't sure of the patent barriers it's going to face,” Kevin said.

Instead of adding new requirements to the existing system, Kevin said a better approach might have been to simplify the exchange of patent information. "It could be a much, much easier and more streamlined process."

Another goal of the bill is to target methods that block competition such as “patent thickets” and “evergreening” by “restricting enforcement of patents that are issued after a biosimilar application has been submitted to the FDA."

However, Kevin said that the text of the bill may not support this claim because the only reference to a restriction on infringement claims comes in the section that limits suits when patents are not listed with the FDA, and doesn't say anything about a biosimilar application being filed.

"While the intent might be that lawsuits can't be filed, it's unclear that they've actually put in the proper wording and legal structure to prohibit those lawsuits," he said.

He added, "There's a little more work to do [on the bill], so hopefully they'll work it out in committee.”

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