ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Jeff, no one has mentioned the data on 18,000 patients. But I believe that Abbvie and Dr Snabes have the 5 years of data on 3656 patients to support the new claims. It would be consistent with the followup obligation to the patients as per FDA SPA.

I also think Abbvie is sensing an urgency to get Libigel moving. Especially if the UK High Court trial that start today goes against Abbvie. It could hit PPS hard and they need something to counter with and stabilize PPS.

Samsung Bioepis-AbbVie Humira patent trial in UK to start Monday


It looks like Abbvie claiming they have a strong defensible patent portfolio to defend Humira is going to have to put all their card on the table. If they lose Humira Biosimilars hit the shelves in the EU in 2018.

AbbVie had argued that a trial was unnecessary as it had already offered to give up its rights to the patents in dispute, clearing the way for the complainants to market their biosimilars in the future, according to the judge’s note.

However, the UK High Court dismissed AbbVie’s request to suspend the trial, as Justice Carr appears to have recognized the validity of the complainants’ arguments.

“The judge at trial may well conclude that AbbVie has consistently adopted a policy of publicly expressing its confidence in its Humira patent portfolio, and its intention to enforce it against competition from biosimilars, while at the same time shielding patents within the portfolio from scrutiny by the court,” Carr said.

“It may be considered that AbbVie is ‘willing to wound and yet afraid to strike’ and that the time has come to put its professed confidence in its ability to prevent biosimilar competition to the test,” he added.

JMHO