‘Gaming the System’: How Many Years Without Competition is Too Many?

Regulatory NewsRegulatory News | 27 July 2018 |  By 

AbbVie CEO Richard Gonzalez drew a line in the sand early Friday by declaring that none of the deals to keep US competition for its mega-blockbuster Humira (adalimumab) off the market until 2023 is “gaming the system.”

But how does one define “gaming" the system?

Biologics in the US are supposed to enjoy 12 years of exclusivity -- AbbVie's Humira, which brought in more than $5 billion in sales in this latest quarter, is likely to enjoy more than 20 years on the market with no competition.

AbbVie has been able to extend its competition-less years with Humira with a fortress of patents extending to 2034. But is AbbVie wrong to use the IP and legal systems to its advantage? And should that be considered “gaming”?

Jacob Sherkow, professor of law at the Innovation Center for Law and Technology at New York Law School, told Focus he agreed with Gonzalez, as when the rules are designed to be anti-competitive, as they are with biopharmaceuticals, “gaming the system with respect to that is hard. It’s hard to put a pin on what that means…reverse payment patent settlements, that’s gaming the system, but having a lot of patents, that just doesn’t seem to be gaming the system…they’re using the patents for what they’re good for.”

As far as the deals to bring biosimilars to market in the US, AbbVie has made two deals with Mylan (their first biosimilar comes to market 31 July 2023) and Amgen (31 January 2023).

By contrast, the EU will see Humira competition beginning 16 October 2018, and at least five biosimilars for Humira are set to hit the market. Though comparing the EU and US is difficult because their patent and exclusivity systems differ, Sherkow noted how Europe has had more experience with biosimilars and in substituting them for their reference products. He also said he thought Congress should mandate FDA to develop a real Purple Book, which is the biosimilar version of the Orange Book.

“In an age where some bad guys are drug developers, it seems like there’s a story about every drug developer being a bad guy, and that’s just not necessarily true,” Sherkow added.


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