Second wave of biosimilar cases sharpens patent counsel focus

Lisa Ferri is featured in this article.

Lisa Ferri, global co-chair of Mayer Brown’s IP practice and life sciences group in New York, says there probably won’t be as many disputes as there were around five years ago in the wake of the first wave of biologics.

But she and others argue that the US will experience, or is already experiencing, a second wave of biosimilar patent litigation.

Ferri at Mayer Brown points out that innovator companies are trying to protect their market share. If a biosimilar is coming to market, they’ll take the issue seriously, and settlement may be an option.

She adds that disputes that have played out so far have dragged on for a while.

“But oftentimes as more biosimilars file challenges, the originator companies have to at least consider settlement in order to preserve their market,” she says.

Ferri at Mayer Brown says a lot of originator companies in past disputes have asserted secondary patents such as those covering manufacturing processes, formulations and devices, rather than antibody compound patents.

“These patents contributed to what a lot of people call patent thickets,” she says.

Ferri at Mayer Brown says that if a pharmacist or a doctor can prescribe a biosimilar for any use, the fear is that the biosimilar will carve out a patented use, but doctors or pharmacists will prescribe it anyway.