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29 April 2019Americas

LSPN 19: Humira litigation may prompt more antitrust scrutiny

The six antitrust class-action lawsuits that have been brought against AbbVie could result in more scrutiny of settlement agreements between the innovator and the biosimilar manufacturer, with potential antitrust complications.

This is according to Meg Ives, partner at Choate Hall & Stewart in Boston, who was speaking at the  Life Sciences Patent Network in Boston last week.

In early April, LSIPR  reported that AbbVie was facing six class-action lawsuits which claimed that the company had illegally stopped competition for its arthritis treatment  Humira (adalimumab).

AbbVie was accused of creating an exclusionary ‘patent thicket’, by securing more than 100 patents “designed solely to insulate Humira from any biosimilar competition in the US for years to come”.

The first suit, filed by a grocery workers’ union, also alleged that AbbVie had entered into illegal market division agreements with the other defendants in a concerted effort to delay biosimilar entry in the US until at least 2023.

AbbVie has entered into settlement and licensing agreements over Humira biosimilars with seven companies, including Pfizer, Sandoz and Mylan.

Ives explained: “The biosimilars had a choice. Do I engage in years of expensive litigation in the hopes of invalidating 50 to 80 patents and thousands of claims or be reasonable and try to negotiate a settlement. The majority in the Humira cases have reached a settlement.”

Under the agreement, the biosimilars could launch if they had approval in Europe in 2018, but in the US they couldn't’ launch before 2023.

“Both sides of the patent dispute have been very public that this is a completely rational settlement agreement,” said Ives, before adding that litigation like this has caught the attention of legislators.

Ives said that it’s likely that there’s going to be motions to dismiss the antitrust cases cases, and if that happens, the motions to dismiss are likely to be granted.

“It’s not really for the legislature to decide what number of overlapping pants would be acceptable. It is very interesting times in respect of settlement agreements,” she added.

Ives also believes that any pending settlement agreements, there may be more Federal Trade Commission review and scrutiny.

“There’s a real question whether this will delay the potential settlement of these cases,” added Ives. “But given the likelihood of additional scrutiny and potential lawsuits from third parties, it’s definitely going to upset some of the timelines on when these cases might get solved.”

Bifurcated strategy

Atsuko Polzin, vice president of IP at Scholar Rock, a clinical-stage biopharmaceutical company focused on the treatment of diseases in which protein growth factors play a fundamental role, also spoke on the panel.

“It used to be rosy, but the last year and a half, things have changed and basically gone upside down,” said Polzin. “Now we have a bifurcated strategy. We can’t have the same strategies in the US and Europe.”

Polzin cited the Amgen v Sanofi decision, a case which the US Supreme Court refused to review in January 2019. The US Court of Appeals for the Federal Circuit altered the standard for sufficiency of written description in antibody cases.

“Pre-Amgen, the key case we had constantly relied upon was Noelle v Lederman, which was extremely pro-patentee. It said we should be entitled to get patent protection for antibodies as long as you can define the antigen,” said Polzin.

She said that, in Amgen, the Federal Circuit rejected the “newly characterised antigen” test as a means of satisfying the written description requirement.

Rolando Medina, partner at Choate Hall & Stewart in Boston, chaired the “Biologics and Biosimilars” panel.

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