Ajinomoto Co., Inc. v. U.S. Int’l Trade Comm’n, 597 F.3d 1267 (Fed. Cir. 2010) (LOURIE, Newman & Linn) Ajinomoto03082010
MAJOR ISSUES: best mode requirement; concealment of element of preferred embodiment relating to non-novel claim limitations; claimed methods of cultivating lysine; failure to disclose preferred host cells
COMMENT. The “best mode” requirement, in its present form, has been justly criticized as a trap for the unwary and as providing a distracting defense to enforcement of otherwise high quality patents. Federal Circuit decisions have limited the requirement’s scope, but this case shows that the requirement still has teeth.
CULTIVATING GENETICALLY ALTERED BACTERIA TO PRODUCE L-LYSINE. Two patents claimed cultivating genetically altered bacteria to produce an amino acid (L-lysine). U.S. Pat. No. 5,827,698. USPatNo5827698 U.S. Pat. No. 6,040,160. USPatNo6040160
In a Section 337 proceeding, the United States International Trade Commission (ITC) determined that the two patents were invalid for violating the best mode requirement because the patent owner failed to disclose preferred host strains the inventors used in cultivating lysine from the bacteria. The court affirmed.
The patent owner argued that the ITC erred by applying the best mode requirement to “overall lysine production” and, instead, should have limited it to claimed inventions: the genetic mutations to the ldc gene (‘698 patent) and dapA gene (‘160 patent). The argument lacked merit.
The patent owner argued that the ITC erred by applying the best mode requirement to “overall lysine production” and, instead, should have limited it to claimed inventions: the genetic mutations to the ldc gene (‘698 patent) and dapA gene (‘160 patent). The court disagreed. The best mode requirement does not require disclosure of “every preference,” but it does require disclosure of a preferred embodiment. The requirement is limited to the claimed invention, but that invention includes all the claim limitations, not just novel or innovative aspects or features. Here, the claim limitations included a host strain and its cultivation as well as the novel genetic modifications.
The ITC correctly held that the best mode disclosure requirement included the inventor’s preferred host strains. The claims at issue were methods of cultivating host strains to produce lysine, not merely the specific mutations in the host strains. The patent owner argued that the ITC’s ruling conflicted with best mode’s “two-way” street. It cited Eli Lilly & Co. v. Barr Labs., 251 F.3d 955, 964-67 (Fed. Cir. 2001), which held that the best mode does not extend to unclaimed, non-novel subject matter. However, there is no conflict. As the patent owner argued, it cannot exclude others from cultivating strains without the claimed ldc or dapA mutations. But it also cannot exclude others from using the novel mutations absent a bacterium host and its cultivation.
CROSS REFERENCES. On the best mode disclosure requirement and its relation to the claimed invention, see Chisum on Patents 7.05[e]; Chisum Patent Law Digest 2340.