UK High Court rules innovator Akebia can launch anaemia drug

The UK High Court has declared five of seven patents covering an anaemia drug as invalid. The court found patents EP 14 63 823, EP 22 98 301, EP 16 33 333, EP 23 22 153, and EP 23 22 155 invalid for insufficiency.

The court also ruled one patent, EP 22 89 531, valid on the grounds of obviousness. However, the judge ruled the patent would not be infringed if Akebia launched a new product. A final patent was subject to a settlement agreement by all parties. All pharmaceutical companies involved are innovators.

Scientifically signficant

In December 2018, Akebia and licence partner Otsuka filed six revocation proceedings against US biotechnology Fibrogen. The proceedings were to clear the way for Akebia to launch its own version of a drug for anaemia. Astellas, the Fibrogen licensee in the UK, counter-claimed for infringement. Astellas argued that Akebia’s actions constituted an infringement of its patents.

The drug in question works by affecting the body’s oxygen sensor. This means the body reacts as it would in a low oxygen environment, such as up a mountain, by making more red blood cells. Its discovery won the Nobel Prize 2019.

Multinational company GSK was also involved in the proceedings. It sought revocation of two of the patents in challenge, and a declaration of non-infringement by its product by the courts. However, this strand of the case settled beforehand. The remaining three parties then went to trial over questions of infringement and equivalence. London boutique firm Powell Gilbert represented GSK.

It is not yet clear if Fibrogen will ask the court if it can appeal the decision.

Innovator process

Akebia and Otsuka, Fibrogen and Astellas all used firms experienced in conducting litigation for innovators in complex pharmaceutical cases. The pharmaceutical team at Hogan Lovells’ London office was the counsel of choice for Akebia. The case concerning the anaemia drug is the first time Akebia has instructed Hogan Lovells in patent litigation. The firm has previously worked with the innovator on regulatory cases. Hogan Lovells has represented other innovators against GSK, for example Merck Sharp & Dohme.

Carpmaels & Ransford acted for Fibrogen. The 15-year relationship between Carpmaels and Fibrogen means the firm is responsible for the prosecution of patents in issue, as well as defending the patents in the EPO opposition proceedings. The patent attorneys at Carpmaels have been responsible for the EPO proceedings for a long time. Currently, these opposition proceedings remain ongoing both at Opposition Division level and Board of Appeal level. Carpmaels’ patent attorneys advised during the litigation aspects of the High Court case.

UK patent attorney firm Potter Clarkson acts for Astellas, albeit with a mixed team of solicitors and patent attorneys.

For Fibrogen
3 New Square: Justin Turner, Thomas Mitcheson, Joe Delaney, Thomas Lunt
Carpmaels & Ransford (London): David Wilson, Daniel Wise (partners); Richard Newell, Jennifer Antcliff, Aled Richards-Jones, Craig Lumb

For Akebia
11 South Square: Piers Acland, Iain Purvis, Anna Edwards-Stuart
Hogan Lovells (London): Stephen Bennett, Dan Brook (partners); Stella Wong, Helen Poulson; Ethan Plumb, Hannah Collins (trainees)

For Astellas
3 New Square: Justin Turner, Michael Conway, Kathryn Pickard
Potter Clarkson: Nick McDonald, Oliver Laing (solicitors), Tony Proctor, David Carling (patent attorneys) (all partners)

UK High Court, London
Richard Arnold (presiding judge)