Regents of the University of California v. Eli Lilly & Co.

Brief Fact Summary. The University (Plaintiff) brought suit against Eli Lilly & Co. (Defendant) claiming infringement.  Defendant argued claiming that the patent was invalid due to specifications that failed to provide a sufficient written description of the subject matter.

Synopsis of Rule of Law. Claims for a DNA sequence will be considered invalid if they fail to provide a sufficient written description of the subject matter of the DNA itself with information regarding its relevant structure or physical characteristics, such as sequence information indicating which nucleotides constitute human cDNA.

Facts. 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.

Issue. Are claims 1, 2, and 4 to 7 invalid because a sufficient written description was not provided?

Held. (Lourie, J.)  Yes.  The claims are invalid because a sufficient written description was not provided.  For the written description of a DNA to be adequate it must be more than just a statement that it is part of the invention with a reference to a possible method of isolating it; there must be a description of the DNA itself.  In Claim 5, the claimed microorganism requires human insulin-encoding cDNA.  Example 6 provides only a general method to obtain human cDNA, but not a written description of the cDNA encoding human insulin, which is required to provide a written description of Claim 5’s subject matter.  Information related to cDNA’s relevant structure or physical characteristics is necessary.  The patent needs to include sequence information showing which nucleotides constitute human cDNA.  The specification therefore does not provide a written description of the invention of Claim 5.  The patent specification provides only a general method for producing human insulin cDNA and a description of the human insulin A and B chain amino acid sequences encoded by cDNA.  Therefore, Claim 5 is invalid as it does not provide an adequate written description.  In addition, the remaining claims are also invalid because a description of rat insulin cDNA is not a description of the broad classes of vertebrate or mammalian insulin cDNA.  An invention involving chemical genus requires a written description with a precise definition, such as by structure, formula, or chemical name of the claimed subject matter sufficient to tell it apart from other materials.  Regarding claims to genetic material, a generic statement such as “vertebrate insulin cDNA” or “mammalian insulin cDNA,” is not adequate on its own as a written description of the genus because it does not distinguish the claimed genus from others, except by function.  Therefore, one skilled in the art cannot visualize or recognize the identity of the members of the genus.  A definition by function is not enough to define the genus, because it is only an indication of what the gene does, not what it is.  Therefore, naming a substance generally known to exist, without the knowledge as to what the substance consists of, is not a description of that substance.  A definition of a cDNA requires a kind of specificity achieved by means of the recitation of the sequence of nucleotides that make up the cDNA.  A description of a genus of cDNAs may be achieved by reciting the sequence of nucleotides the cDNA is comprised of.  A description of a genus of cDNAs may be achieved by means of a representative number of cDNAs falling within the scope of the genus or a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus.  Claims 1, 2, 4, 6 and 7 are therefore also invalid for failing to provide an adequate written description.  Affirmed.

Discussion. The strict description requirement as set forth in this case and the obviousness test as set forth in In re Deuel, 51 F.3d 1552, 34 U.S.P.Q.2d 1210 (Fed. Cir. 1995) are unique to U.S. patent law.