Amgen V Transkaryotic Therapies: The Legal Battle Over Recombinant Erythropoietin

Tuesday, October 18, 2011 - 6:30pm

The patent infringement lawsuit between Amgen and Transkaryotic Therapies (TKT) over recombinant erythropoietin, a multibillion dollar biologic, is one of the most famous intellectual property cases in biotechnology. The patent protection of Amgen’s first blockbuster product, Epogen, was threatened by TKT's comparable product Dynepo.  A seven year legal battle ensued, spanning continents, with separate rulings and differing holdings in both the US and the UK.  Epogen is a recombinant human erythropoietin that was manufactured in CHO host cells; Dynepo was manufactured from an endogenous erythropoietin gene upregulated in a human cell line by an exogenous promoter.  In both countries, TKT was taken to court by Amgen for patent infringement, however in the UK, TKT cross-appealed for patent revocation and a declaration of non-infringement.  After a series of appeals, the UK’s highest court held that TKT did not infringe on Amgen’s patent and in fact declared Amgen’s patent to be invalid due to insufficiency. By contrast, the US court system found that TKT in fact infringed on two of Amgen’s patents, while only declared one of five patents to be invalid.   Recombinant gene-based technologies pose unique challenges for patent interpretation.  As the first major case of its kind, Amgen v TKT set a precedent regarding the extent to which patent claims can offer sufficiently broad coverage to be useful while still remaining legally valid. The impact of the judges' findings moved well beyond the erythropoietin industry to set a roadmap for effective patent strategy for biologics for the years to come. 

Team iDEA Tech

Presented by Team iDEA Tech

Location: Instructional Centre, Room 335.
All welcome!