Akebia Therapeutics Inc v Fibrogen, Inc

Akebia Therapeutics Inc v Fibrogen, Inc

The Family A patents are not obvious over Epstein, but all claims except claim 17A of EP 531 are invalid for insufficiency (lack of plausibility and undue burden); claim 17A is not infringed by vadadustat, including by equivalence. The Family B patents are obvious over WO 997 and, except for claim 36A of EP 333, are also insufficient. There is no real threat of infringement of the Family B patents by Akebia/Otsuka's vadadustat product.

Parties
Claimant/defendant: Akebia Therapeutics Inc; Claimant/defendant: Otsuka Pharmaceutical Company Limited; Defendant/claimant: FibroGen, Inc; Claimant/defendant: Astellas Pharma Inc
Jurisdiction
England and Wales
Judgment Date
20 April 2020
Procedural Posture
Patent Revocation and Infringement (cross Claim) / Judgment After Full Trial
Outcome
Most claims of the Family A and Family B patents are invalid for insufficiency and/or obviousness; claim 17A of EP 531 is valid but not infringed; no injunction or relief granted against Akebia/Otsuka.
Legal Topics
Patent Validity, Patent Infringement, Obviousness, Insufficiency, Indirect Infringement, Medical Use Claims, Equivalents Doctrine

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Parties

Akebia Therapeutics Inc

Claimant/defendant

Otsuka Pharmaceutical Company Limited

Claimant/defendant

FibroGen, Inc

Defendant/claimant

Astellas Pharma Inc

Claimant/defendant

Procedural Posture

Patent Revocation and Infringement (cross Claim) / Judgment After Full Trial

  1. 1 Whether the Family A and Family B patents are invalid for obviousness and/or insufficiency
  2. 2 Whether vadadustat infringes any valid claims of the patents, directly or by equivalence
  3. 3 Whether amendments to the patents are allowable

Ratio Decidendi

The Family A patents are not obvious over Epstein, but all claims except claim 17A of EP 531 are invalid for insufficiency (lack of plausibility and undue burden); claim 17A is not infringed by vadadustat, including by equivalence. The Family B patents are obvious over WO 997 and, except for claim 36A of EP 333, are also insufficient. There is no real threat of infringement of the Family B patents by Akebia/Otsuka's vadadustat product.

Court Disposition

Most claims of the Family A and Family B patents are invalid for insufficiency and/or obviousness; claim 17A of EP 531 is valid but not infringed; no injunction or relief granted against Akebia/Otsuka.

Orders

  • Declaration of invalidity of all claims in issue of EP 823 and EP 301 for insufficiency
  • Declaration of invalidity of all claims in issue of the Family B patents except claim 36A of EP 333 for obviousness and/or insufficiency