ITC claim construction, written description, and finding of infringement by imported E. coli strains affirmed by Federal Circuit

Ajinomoto Co. et al. v. Int. Trade Commission (ITC) et al.

Docket No. 2018-1590, -1629 (ITC No. 337-TA-1005)
August 6, 2019

Brief Summary: ITC claim construction, written description, and finding that certain E. coli strains imported by CJ infringed Ajinomoto’s patent affirmed.

Summary: Ajinomoto appealed ITC decision (19 USC section 1337) that certain E. coli strains used to produce L-tryptophan and imported by CJ CheilJedang Corp. (“CJ”) infringed the claims of US 7,666,655 (the “earlier strains”), while others did not (the “later strains”), and the ITC’s claim construction. The ITC also found that the ‘655 patent is not invalid for lack of written description (WD). The ‘655 claims are directed to recombinant E. coli “wherein the aromatic L-amino acid production by said bacterium is enhanced by enhancing activity of a protein in a cell of said bacterium beyond the levels observed in a wild-type of said bacterium”, the protein being the product of the yddG gene (“consist[ing] of the amino acid sequence of SEQ ID NO: 2” in claim 9, or “encoded by the nucleotide sequence which hybridizes with the complement of the nucleotide sequence of SEQ ID NO: 1” in claim 15), the enhancement being achieved by transforming “the bacterium with a DNA encoding the protein”, “replacing the native promoter…with a more potent promoter”, or by introducing “multiple copies of the DNA encoding said protein into the chromosome of said bacterium”. The full ITC reviewed and affirmed the Administrative Law Judge’s (ALJ) construction of “replacing the native promoter…with a more potent promoter” to mean “removing the native upstream region of the yddG gene and inserting one of a class of promoters that controls expression of a different gene” and the finding of no infringement by the earlier strains, but reversed the ALJ’s finding of no infringement by the later strains. Ajinomoto argued that the “removing” limitation should “encompass[] mutagenesis of individual nucleotides within the native promoter”, but the FC panel found that “[t]he ordinary and customary meaning of the claim language provides support for the Commission’s claim construction” (e.g., “[t]he language…suggests, in ordinary parlance, an operation at the level of the entire promoter as a unit, not at the level of a single nucleotide”, “further reinforced by the most apt of the dictionary definitions”, “Ajinomoto has not shown a contrary common understanding…among relevant artisans”, “the claim language, though hardly establishing a plain meaning, supports the Commission’s construction”, “[t]he specification offers additional support” but “nowhere uses” “replacing” and “discusses mutagenesis…only in the context of…the yddG gene, not the promoter”, also supported by the prosecution history (e.g., amended to recite “replacing…instead of ‘by alteration of expression’” in response to WD and enablement rejections, no “clear and unmistakable disavowal or disclaimer” (Norian, FC 2005; Biogen, FC 2013 (surrender can be based on amendments made to overcome 112 rejections; “this is a case where the applicants surrendered more than may have been necessary”); Judge Dyk dissented from this conclusion). The FC panel also affirmed the Commission’s infringement determinations, namely, that “second later strain met the protein limitation” under DOE (e.g., “Ajinomoto did not surrender the protein produced by the codon-randomized non-E. coli yddG gene of CJ’s second strain” (Festo, FC 2003 (“Ajimomoto had rebutted the Festo presumption [of surrender] because the amendment was tangential to the equivalent”); Insituform, FC 2004; Univ. Cal., FC 2008; Intervet, FC 2010), “both…later strains met the resistance limitation” (e.g., “the claims require only that the protein ‘has the activity to make the bacterium resistant’ to L-tryptophan, not that the protein be the sole cause of the bacterium’s enhanced resistance”), and claim 20 is not invalid for lack of WD (e.g., “’655 patent discloses four examples of ‘potent promoters’”, “the genus of more potent promoters was already well explored in the relevant art”, known “correlation between structure and function” (Ariad, FC 2010; Boston Sci., FC 2011 (“no examples of macrocyclic lactone analogs”); Abbvie, FC 2014 (no evidence of representative antibodies)). Thus, the ITC’s decision was affirmed.

This entry was posted in Claim Construction, Doctrine of equivalents, Importation, Infringement, International Trade Commission, Prosecution History Estoppel, Uncategorized, Written description. Bookmark the permalink.

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