The S. San Francisco-based biotech, now fully owned by Swiss drugmaker Roche after agreeing in March on a buyout price of $46.8 billion, has fought off four patent office rejections to Cabilly II since September 2005. The company has also defended the patent in a Supreme Court lawsuit brought by MedImmune (Nat. Biotechnol. 26, 846, 2008). A quick look at the revenue—and future revenue—from Cabilly II makes clear why Genentech so adamantly pursued the validation of the patent: the royalty revenue far exceeds the legal costs of defending it. In 2008 alone, Cabilly II generated at least $237 million for the company. “It's not even close in terms of whether it was worth it for Genentech,” says Clark.
The patent office initially rejected Cabilly II on grounds of obvious-type double patenting—the method was not novel but a variant of previous patents including the Cabilly I patent issued in 1989. But Genentech argued that in Cabilly I, to produce a functional immunoglobulin molecule, the host cell is transformed with either an immunoglobulin heavy chain or light chain separately, whereas in Cabilly II, the host cell is inserted with DNA sequences encoding both heavy and light chains. To make this clear, Genentech had to amend 11 of Cabilly II's claims but “in a way that does not affect the commercial importance of the patent,” according to Genentech.
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