Study suggests controversial patent review pathway is effective for biologics

A new study out of Harvard Medical School and West Virginia University suggests that fighting prescription drug patents through the US Patent and Trademark Office is an effective alternative to costly, drawn-out litigation.

While patent challenges have traditionally been argued in court, the creation of the Patent Trial and Appeal Board in 2012 opened a new pathway. That process is currently under scrutiny by lawmakers who introduced legislation last summer that would make it more difficult for patent challengers to win.

In a study published Friday in Nature Biotechnology, the academics argued for the strengthening of the USPTO’s review procedures, noting that the pathway “may help promote timely drug competition for the benefit of patients and the US healthcare system.”

The researchers reviewed PTAB challenges to more than 100 patents covering approved biologics since 2012. Of those, 43 patents were accepted for further review and 24 had…
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