There are certain “patent-eating” monsters that lurk nowhere else but in America. One created by the “duty of disclosure” obligation is “inequitable conduct” which devours patents like a Tyrannosaurus Rex. There’s also a stealthier but ravenous patentivour that is as deadly as a velociraptor in Jurassic Park. It’s called the “best mode” requirement of 35 U.S.C. § 112, first paragraph.
The latest victim of the “best mode” patentraptor was a foreign patent applicant in Ajinomoto Co., Inc. v. International Trade Commission. In the end, Ajinomoto was unable to outrun the “best mode” patentraptor. And like the sequels to Jurassic Park, there are likely to be future instances where this patentivour devours other U.S. patents, including those of foreign applicants who may even be ignorant of this patent monster. But ignorance of the “best mode” patentraptor is equivalent to not being aware that the bioengineered dinosaurs were multiplying in dangerous numbers in Jurassic Park.
In Ajinomoto, not one but two patents were consumed by failure to satisfy the “best mode” requirement. What was even more startling was that Judge Newman, considered by many to be very “pro-patent,” was unwilling to slay this patentivour in this instance.
Similar to part of the story line in Jurassic Park, the two patents in Ajinomoto, U.S. Pat. No. 5,827,698 (the ‘698 patent) and U.S. Pat. No. 6,040,160 (the ‘160 patent), were about producing the essential amino acid, lysine. As an essential amino acid, animals, like the dinosaurs in Jurassic Park, cannot synthesize lysine, but must instead obtain it by consuming foods which contain it. The microorganism Esherichia coli (better known as E. coli) can produce lysine but only in limited quantities because of two inhibitory mechanisms: (1) “feedback inhibition” triggered by lysine production itself; and (2) lysine decarboxylases which breakdown extra lysine produced into a non-nutritive byproduct.
Also like the bioengineered Tyrannosaurus Rex and velociraptors of Jurassic Park, the ‘698 and ‘160 patents involved bioengineered E. coli strains to combat these two inhibitory mechanisms. The ‘160 patent addressed the first mechanism (“feedback inhibition”) by creating in the E. coli strain at least one of two mutations in the gene (dapA) encoding a biosynthetic enzyme (dihydrodipicolinate synthase or DDPS) to remove the “feedback inhibition” imposed by excess lysine and thus produce greater amounts of lysine. The ‘698 patent addressed the second mechanism (lysine decarboxylases) by creating mutations in the lysine decarboxylase gene (Idc) to provide an E. coli strain that reduced or eliminated lysine decarboxylase activity.
So far so good. What eventually caused the ‘698 and ‘160 patents to be consumed by the “best mode” patentraptor were the following disclosures and omissions:
a. The ‘698 patent described a two-step process for producing the mutant Idc host strain. The first step subjected the native (“wild”) E. coli strain to selection to identify a strain (called WC196) having lysine productivity. In the second step, the mutant Idc gene was inserted in the identified WC196 strain to create the Idc mutant strain. But what the ‘698 patent neglected to describe was the actual strain used by the inventors which had two other gene alterations: (i) prior to the first step, insertion of a variant lysC (a gene encoding an enzyme in the lysine biosynthesis pathway) in the wild-type (W3110) strain, the resulting modification being identified as the WC80 strain; and (ii) after the first selection step which resulted in the strain WC80-196, insertion of sucrose utilization genes in the E. coli to permit the resulting strain to use sucrose as a carbon source. This host strain (identified as WC80-196S) was the one into which the Idc mutation was inserted in the second step.
b. The ‘160 patent identified two host strains (B-399 and W3100(tyrA) into which the mutant dapA was introduced. But what the ‘160 patent neglected to do, even though known before the filing of the Japanese application from which the ‘160 patent claimed priority, was that the inventors characterized a different strain (AE-70) as their best lysine producer.
In April 2006, Ajinomoto (the owner of the ‘698 and ‘160 patents) filed a complaint under section 337 of the 1930 Tariff Act (19 U.S.C. § 1337) with the International Trade Commission (ITC) to prevent alleged improper importation and sale of lysine feed products made using the methods of the ‘698 and ‘160 patents. In fact, the collective respondents (GBT) admitted infringement. But the “best mode” patentraptor reared its ugly head as the Administrative Law Judge (ALJ) found no violation of section 337 because the ‘698 and ‘160 patents were invalid for failing to satisfy this requirement based on the disclosures/omissions noted above.
When the ITC didn’t disturb the ALJ’s finding of no violation of section 337, Ajinomoto appealed. But the “best mode” patentraptor became an insurmountable obstacle to getting the Federal Circuit panel to reverse. In fact, Ajinomoto didn’t contest that the disclosures/omissions noted above had occurred. Instead, Ajinomoto argued that these disclosures, and especially omissions, didn’t relate to the “innovative aspects” of the claimed invention, thus there was no “best mode” violation.
Ajinomoto’s argument fell on deaf Federal Circuit ears. In fact, Judge Lourie (writing for the Federal Circuit panel) said that Ajinomoto “misstate[d] the law” as relating the “best mode” requirement only to vague “innovative aspects,” and not the claimed invention as a whole. That included disclosing in the ‘698 and ‘160 patents the inventors’ preferred host strains (i.e., WC80-196S and AE-70) which the inventors admitted they had neglected to do. In fact, the undisclosed the WC80-196S was the “only bacterial strain that the inventors used to practice the claimed invention” of the ‘698 patent.
Ajinomoto relied upon (unsuccessfully) four other Federal Circuit cases to argue that the “best mode” requirement hadn’t been violated by the omissions in the ‘698 and ‘160 patents. The first was the 1987 case of Christianson v. Colt Industries Operating Corp. which held that the “best mode” requirement didn’t extend to the production details for use of the claimed parts in a particular weapon, namely an M-16. In fact, Judge Lourie distinguished Christianson as claiming only the specific rifle parts, not the rifles themselves. Contrary to what Ajinomoto asserted, the ‘698 and ‘160 patents covered more than just the isolated mutations (Idc or dapA) but instead cultivating E. coli strains containing those mutations. That made the preference for cultivating those particular strains relevant to the “best mode” for carrying out the claimed invention “regardless of whether the mutations could be used in other bacteria, and thus that the preferred bacterium had to be disclosed.”
Judge Lourie similarly rejected Ajinomoto’s reliance upon the 2007 case of AllVoice Computing PLC v. Nuance Communications, Inc., the 1996 case of Zygo Corp. v. Wyko Corp., and the 2002 case of Bayer AG v. Schein Pharmaceuticals, Inc. because “the claims as construed did not cover the embodiment alleged to have been concealed.” In AllVoice, the claimed invention was construed as excluding the undisclosed updating and maintaining functionalities present in the patentee’s commercial embodiment. Similarly in Zygo, the patent on an interferometer system was held not to violate the “best mode” requirement because of an undisclosed commercial embodiment with packaging. In Bayer, the patent on the antibiotic ciprofloxacin was held not to violate the “best mode” requirement based on an undisclosed process for making an unclaimed starting material because the undisclosed and “unclaimed process did not materially affect the claimed antibiotic.” By contrast, Judge Lourie characterized the cultivating host strain in Ajinomoto as “claimed rather than unclaimed subject matter, and thus the inventors’ preferred host strain had to be disclosed to comply with the best mode requirement,” citing the 1996 case of United States Gypsum Co. v. National Gypsum Co. (best mode violation for concealing preferred expanded perlite for making claimed joint compound) and the 1990 case of Chemcast Corp. v. Arco Industries Corp. (best mode violation for concealing the preferred material for making the claimed locking portion of a grommet).
Judge Lourie’s opinion also disagreed with Ajinomoto’s contention that the ITC found that the inventors concealed the method for creating the host strain into which the Idc mutation was introduced. Instead, the ITC had found that the inventors had concealed the identity of the preferred host strain, and “specifically that the other genetic alterations, including the lysC variant and the sucrose utilization genes, had been introduced (by whatever method) into the only host strain used to practice the claimed invention.” In addition, and contrary to what Ajinomoto asserted, the “best mode” requirement “cannot be satisfied by the deposit of a non-preferred strain.” Instead, as observed by Judge Lourie, the “inventors could not, consistent with the best mode requirement, claim the cultivation of a bacterium containing an Idc mutation while simultaneously keeping from the public the identity of the one and only bacterium that they used to practice that cultivation,” again citing the Chemcast case.
Ajinomoto’s final “hail Mary” argument (and only for the ‘160 patent which claimed priority to a PCT application) was that even if the best strain was “concealed” as of the original Japanese filing date, that only meant Ajinomoto couldn’t rely upon that Japanese filing date, but could instead rely upon the PCT application filing date. But Judge Lourie agreed with GBT and the ITC that Ajinomoto waived its right to rely on this PCT application filing date by not raising this issue in pre-trial briefs.
In the end, Ajinomoto, and especially the ‘698 and ‘160 patents, did not prevail. The message is now clear: be aware or be eaten by the “best mode” patentraptor.
© 2010 Eric W. Guttag