BIO 2017: Panellists talk Amgen Sandoz biosimilar battle

Earlier this month, the US Supreme Court handed down its decision in the biosimilars battle between Amgen and Sandoz, centring on the Biologics Price Competition and Innovation Act (BPCIA).

A session moderated by Bob Ramos, partner at Procopio, at the 2017 BIO International Convention, dived into the implications of this major decision.

In the dispute, the Supreme Court ruled that biosimilar applicants  (in this case, Sandoz) may provide notice to the manufacturer before obtaining a licence from the US Food and Drug Administration (FDA) for their biosimilars.

Amgen had argued that a biosimilar applicant must wait until its product is approved by the FDA before giving the 180-day notice of commercial marketing.

The Supreme Court also ruled that reference product sponsors (RPSs) couldn’t enforce the ‘patent dance’ through a federal injunction.

The patent dance allows parties to address any patent claims while an applied-for drug is being approved.

Dr Chuck Sholtz, vice president of IP at Coherus Biosciences, explained that the court had “side-stepped” the patent dance issue, and didn’t “opine on the legality” of it.

“I thought I knew what the goals of the BPCIA were, having embarked on the journey for Amgen, both as innovator and biosimilar,” explained Wendy Whiteford, vice president of law at Amgen.

Some of the goals, according to Whiteford, were to create a mechanism for lower barriers to entry, while also maintaining the incentives to innovation that patents provide.

Now however, she believes that it’s “pushing things to the advantage of the biosimilar applicant”.

“Where you have a choice by the biosimilar to make no disclosure, so it only provides notice, how do you know which patent you might be able to proceed on?” she questioned, adding that the “odds are essentially stacked against the innovator”.

“If you have a court that really knows what it’s doing, it will understand that no-one should have to work blind,” explained Faith Hochberg, former US District Judge, who added that judges would likely require the biosimilar applicant to produce the required information.

“I don’t think the Supreme Court really understands what it’s like to manage a case,” she said. “You learn by doing them over and over and they don’t have that benefit.”

Will this ruling encourage or discourage biosimilars from engaging in the patent dance? The answer is not so simple.

According to Sholtz, the decision will be made on a case-by-case basis.

Whiteford added that one benefit for a biosimilar from participating is the “limitations on remedies that may be realised to the benefit of biosimilar applicant by having gone through the process”.

Panellists were speaking in a personal capacity at the session “Biosimilars IP litigation: where we’ve been and where we’re heading”.

The 2017 BIO International Convention took place in San Diego from June 19 to 22.

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