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Rewriting Life

Blood Feud

In biotech, one drug can make a company. For Amgen of Thousand Oaks, Calif., the nation’s largest biotech firm, that drug is the anemia treatment erythropoietin (EPO). The best-selling protein racked up $2 billion in revenues for Amgen in 1999 and is paying for the 87,000-square-meter (285,000-square-foot), state-of-the-art laboratory the company is building in the heart of Cambridge, Mass.

But just a few blocks away, at Transkaryotic Therapies (TKT), some clever Cambridge competitors are set to challenge Amgen’s pre-eminence with a version of EPO they believe gets around Amgen’s suite of patents. If successful, TKT’s “end-around” could lead to additional knockoffs of some of the world’s largest-selling biotech pharmaceuticals.

In the early 1980s, Amgen was first to discover and patent the gene that encodes the EPO protein. To manufacture EPO, Amgen adds a copy of the gene to rodent cells growing in culture. TKT’s strategy calls for using human cells instead; latent copies of the EPO gene are turned on in human cells grown in the lab, bypassing Amgen’s patents on the gene and its production method.

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Amgen originally hauled TKT into court in 1997. But TKT sidestepped the legal challenge thanks to a loophole that immunizes companies from patent infringement suits while testing a drug. Now that TKT and its partner, the French-based drug firm Aventis, have finished studies in patients and are preparing to seek FDA approval to market its version of EPO, the parties are set to meet Amgen in a Boston courtroom this April.

Robert Frank, an attorney with Boston’s Choate, Hall & Stewart who represents TKT, says the case will be significant not only because of the money at stake, but also because it will test just how well-defended the patents that undergird biotech’s pioneering companies really are. TKT is betting that it’s found a chink in their armor. After EPO, TKT has secrecy-shrouded plans to take on six more of the top drugs in the worldwide $15 billion protein-therapy market.

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