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Coherus' Humira formulation patent challenge rejected by PTAB

Dan Stanton

By Dan Stanton+

09-Nov-2016
Last updated on 09-Nov-2016 at 13:55 GMT2016-11-09T13:55:51Z

Image: iStock/belchonock
Image: iStock/belchonock

The rejection of a petition against a Humira formulation patent is problematic for Coherus but may not affect other adalimumab biosimilar developers, an analyst says.

The US Patent Trial and Appeal Board (PTAB) has struck a blow to Coherus’ biosimilar candidate CHS-1420 after rejecting an inter partes review (IPR) filed against a Humira formulation patent in May this year.

The company had looked to overturn a formulation patent on AbbVie’s monoclonal antibody - the 9,114,166 (‘166) patent , entitled ‘Formulation of Human Antibodies for Treating TNF-α Associated Disorders’ – but on Monday the PTAB denied review of Coherus’ petition.

“While we are disappointed by this outcome it is important to note that our longstanding strategy has been to develop and preserve multiple options pursuant to adalimumab formulation intellectual property,” Coherus CEO Denny Lanfear said in a statement.

“There are additional scientific and legal approaches available to address the various formulation intellectual property challenges, and all of the arguments raised in our IPR petition remain available in a District Court proceeding.”

Coherus’s share price dropped 20% following the decision.

Patent maze

AbbVie has pledged to defend its bestselling drug against competition and is looking to keep biosimilars at bay until at least 2022 in the US through an extensive maze of patents .

However, while the news strikes a blow to Coherus’ molecule other adalimumab developers may not be affected, according to Evercore ISI analyst John Scotti.

“Biosimilars do not necessarily need to have the same formulation as the reference product (so theoretically biosimilars can design around formulation patents), but they are required to have the same dosing regimen (which is covered by methods patents), and ABBV's 2022 guidance of US Humira biosimilar entry is predicated on their methods patents holding up in Court,” he said in a note.

“The IPR on the ‘166 may not be important for all potential Humira biosimilar filers because they may have different formulations and it's unclear whether they infringe,” he added, but notedthe decision “incrementally increases confidence in ABBV's IP position.”

AbbVie has previously been successful in its patent litigation, rebuffing patent challenges from Amgen in January .

Amgen has since seen its Humira biosimilar, Amjevita, approved in the US but said during its most recent financials it is unlikely to launch the product at risk, i.e. while litigation with AbbVie is still ongoing.

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