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Why Amgen vs. TKT Matters

This article was originally published in Start Up

Executive Summary

Amgen's patent infringement lawsuit against Transkaryotic Therapies is probably the most important of its kind, and not merely because the product Amgen is trying to protect, erythropoietin, is the company's--and the biotech industry's--biggest revenue generator. This lawsuit, although not yet decided, already offers some valuable lessons both in developing a patent portfolio and defending a patented product.

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TKT: Victory At Last

The recent UK appeals court decision that TKT does not infringe Amgen's erythropoeitin patent doesn't mean much commercially for either group. But it could pave the way for stricter interpretation of biotech patents in the UK and the rest of Europe.

TKT: Bloodied But Unbowed

Amgen was the winner of a late January decision involving its patent dispute with Transkaryotic Therapies Inc. over erythropoietin. Its stock rose about 15% in the three days after the ruling, while TKT's shares slid 40% that week. The judge ruled that TKT's process doesn't infringe Amgen's patent, but the product that TKT makes using that process does. The decision is on appeal. TKT argues that its method is a next-generation protein production technology, but if the decision stands, the company will have to take its first shot at something other than EPO.

Why Clinical Trials Fail Unexpectedly

Is there an explanation for the recent spate of biotech Phase II and Phase III clinical trial failures? It's almost impossible to give general reasons for specific clinical failures. Several hypotheses, borrowed from the tenets of behavioral finance, however, may help explain some recent, unanticipated later-stage setbacks. They may also support other studies that suggest that small biotech companies fail more often in clinical development than their larger biotech and pharma brethren.


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