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Patent Law Keyed to Adelman
Regents of the University of California v. Eli Lilly & Co.
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Plaintiff's patent in this case involves DNA genetic recombination technology, which produces human insulin. Healthy people produce insulin in vivo by way of the terminal enzymatic cleavage of preproinsulin (PPI) to yield proinsulin (PI), a single amino acid chain. The patent's application was based upon the determination of the PI and PPI cDNA sequences found in rats. The patent specification mentions that the cDNA is part of the invention, provides only a general method for producing human insulin cDNA, and provides a description of the human insulin A and B chain amino acid sequences encoded by cDNA. Plaintiff sued Defendant for infringement and Defendant argued that the patent was invalid. The district court ruled that the claims of the patent were invalid because the specification did not provide sufficient written description of the cDNA. Plaintiff appealed.
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