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23 April 2020Big PharmaRory O'Neill

Akebia prevails over Fibrogen in UK patent suit

Massachusetts-based pharmaceutical company  Akebia has had five  Fibrogen patents for an anaemia treatment invalidated at the English High Court.

The  judgment, issued by Lord Justice Richard Arnold on Monday, April 20, resulted from a lawsuit brought by Akebia for the cancellation of six Fibrogen patents.

Akebia brought the suit to clear the way for vadadustat, the company’s anaemia drug which stimulates production of hemoglobin and red blood cells.

The patents cover the treatment of anaemia with inhibitors of the hypoxia inducible factor-prolyl hydroxylase enzyme (HIF-PHIs)

Astellas Pharma, which exclusively licensed the IP from Fibrogen, filed a counterclaim against Akebia for infringement of the patents.

In September 2019, Astellas obtained a marketing authorisation in Japan for the first oral HIF-PHI product, roxadustat.

Astellas has pitched the drug as a potential blockbuster (generating sales of $1 billion or more annually), and hopes it will achieve that status by 2023.

Vadadustat, Akebia’s HIF-PHI product, is currently in phase III clinical trials. Akebia would have been blocked from bringing the drug to market by the Fibrogen patents, but this obstacle has now been removed with the English High Court ruling.

Dividing the six patents into Families A and B, Arnold ruled that two of the Family A patents contained “uncertain” claims, and were “invalid for insufficiency”.

Arnold did not invalidate one of the Family A patents, but held that it was not infringed by vadadustat.

All of the Family B patents, meanwhile, are obvious in light of an international patent application from Family A filed in 2003, the judge ruled.

Arnold also took the opportunity to comment on the order in which each side called their expert witnesses.

“Less helpfully, the medicinal chemists were called before the nephrologists. The logical order would have been the other way around,” Arnold said.

He added: “This is a problem which I have encountered before. I appreciate that the availability of experts can make scheduling their testimony in the logical order difficult, but I would urge legal teams to do their utmost to try to ensure that this is done.”

Akebia was represented by a team from  Hogan Lovells, including partners Stephen Bennett and Dan Brook, as well as Stella Wong (counsel) and Helen Poulson (associate). Fibrogen was represented by  Carpmaels and Ransford (David Wilson, partner), and Astellas by  Potter Clarkson (Nick McDonald, partner).

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