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.
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Biotech and would-be biogenerics companies are battling to shape the future of generic biologics. The FDA, along with established biotech and drug companies, has opposed the concept of biogenerics, insisting the compounds are too complex to be reproducible in a reliable fashion. Challengers insist that the science is advanced enough to make such products feasible and are pumping significant time and money into bringing them to market.
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.
Following its failed 1993 IPO, TKT embarked on a strategy to develop and market through a larger partner competing versions of top-selling protein drugs. The company's first target: EPO, which currently generates more than $3.3 billion for Amgen annually. EPO and other protein drugs still have several years of patent protection left, but TKT believes it's found a way around those patents with a production process called gene activation.