Source: https://www.patentdocs.org/best_mode/
Timestamp: 2019-04-19 11:06:20+00:00

Document:
(b) collecting the L-lysine produced and accumulated in step (a), wherein the microorganism belongs to the species Escherichia coli.
15. A method of producing L-lysine, comprising: cultivating a bacterium belonging [to] the genus Escherichia which is transformed with a DNA coding for a dihydrodipicolinate synthase originating from a bacterium belonging to the genus Escherichia and having mutation to desensitize feedback inhibition of L-lysine, wherein the mutation is selected from the group consisting of [a mutation to replace the alanine residue at the 81st position and/or a mutation to replace the histidine residue at the 118th position] in a suitable culture medium, producing and accumulating L-lysine in the culture thereof, and collecting L-lysine from the culture.
The panel opinion notes that that both patents disclose certain E. coli strains for practicing the claimed inventions. In contrast to the specification of the '698 patent, however, the inventors actually induced two other undisclosed additional genetic alterations before the addition of mutant Idc. Similarly, in the '160 patent specification, the inventors described two host strains (B-399 and W3110 (tyrA)); however, the inventors neglected to include strain AE-70, a strain characterized by the inventors prior to the filing of the priority Japanese application as "their best lysine producer."
On April 25, 2006, Ajinomoto filed its complaint with the ITC, alleging that Global Bio-Chem Technology Group Company, Ltd., Chanchun Dacheng Bio-Chem Engineering Development Co., Ltd., Chanchun Baocheng Bio-Chem Development Co., Ltd., Chanchun Dahe Bio-Technology Development Co., Ltd., and Bio-Chem Technology (HK) Limited ("defendants") violated section 337 of the Tariff Act of 1930 as amended, 19 U.S.C. § 1337, through defendants' importation and sale of certain lysine feed products made according to the disclosed methods of the '160 and '698 patents. The ITC launched an investigation. Before trial, defendants admitted infringement of the patents-in-suit. However, the ITC ALJ's ruling found that the patents were invalid for multiple violations of 35 U.S.C. § 112's best mode requirement. The ALJ also concluded that both patents were unenforceable due to inequitable conducted related to the § 112 violations.
(1) concealing their preferred and only host strain, WC80-196S, via a misrepresentation of the steps actually performed to create a mutant Idc host strain; (2) concealing sucrose as their preferred carbon source, which materially affects achieving the claimed invention; and (3) submitting data associated with fictitious host strains in support of best mode.
With regard to the '160 patent, the ALJ concluded that the inventors had (1) purposely concealed their preferred host strain, AE-70; and (2) submitted fictitious data in support of their best mode.
The ALJ then considered the inequitable conduct issue and found that (1) the necessary materiality was established via the inventors' best mode disclosure violations; and (2) the intent to deceive was established through proof of the inventors' submission of fictitious data coupled with their concealment of the best mode; and, with respect to the '698 patent, (3) concealing the preferred carbon source. Ajinomoto petitioned the ITC for a review of the ALJ decision, but the ITC took no position on the ALJ's finding. Ajinomoto then appealed to the Court of Appeals for the Federal Circuit for review.
Writing for the majority, Judge Lourie cites to Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1330 (Fed. Cir. 2002) for the proposition that the best mode requirement "comprises part of the quid pro quo of the patent grant, prohibiting inventors from receiving the benefit of the right to exclude while at the same time concealing from the public preferred embodiments of their inventions." Judge Lourie also stated that "in order to satisfy the best mode requirement, an inventor must disclose the preferred embodiment of the invention as well as preferences that materially affect the properties of the invention." Bayer AG v. Schein Pharm., Inc., 301 F.3d 1306, 1319 (Fed. Cir. 2002). Judge Lourie then reiterated the two-prong inquiry for compliance with the best mode requirement. In the first "subjective" prong, the court must determine "whether, at the time the patent application was filed, the inventor possessed a best mode of practicing the claimed invention." United States Gypsum Co. v. Nat'l Gypsum Co., 74 F.3d 1209, 1212 (Fed. Cir. 1996). Judge Lourie noted the subjectiveness of the prong as it "focuses on the inventor's own personal preferences as of the application's filing date." In the second "objective" prong, if an inventor has a subjective preference for one mode over all others, the court must determine whether the inventor "concealed" the preferred mode from the public. Chemcast Corp. v. Arco Indus. Corp., 913 F.2d 923, 928 (Fed. Cir. 1990).
The Federal Circuit then addressed Ajinomoto's issues on appeal: whether the ITC made multiple legal errors in defining the scope of the claimed inventions and the scope of the best mode requirement. As its first argument, Ajinomoto claimed that the ITC erred in defining "best" in terms of "overall production of lysine" rather than in terms of the claimed invention. Ajinomoto supported its position with the argument that the ITC erroneously applied the best mode requirement to areas beyond the patents' innovative aspects (the claimed genetic mutations). Both the ITC and the defendants countered that the best mode requirement relates to the "claimed invention, not just to its 'inventive aspects,' as claimed by Ajinomoto. The CAFC agreed with the ITC/defendants' reasoning, concluding that nothing in Federal Circuit precedent limits the best mode requirement to "vague 'innovative aspects' or 'inventive features' of the invention." The Court also concluded that the ITC correctly included the obligation of the inventors to include their preferred host strains as the best mode. The Court reasoned that the ITC's definition of the method to include the host strains properly defined the scope of the claimed invention to include "cultivating a bacterium."
Ajinomoto also argued that the ITC's interpretation was erroneous because Ajinomoto's best mode obligations extended only to the claimed Idc and dapA mutations, without which Ajinomoto could not exclude others from cultivating lysine-producing strains. Central to Ajinomoto's position was its argument that because the two mutations could be used in any E. coli strain, the inventors had no obligation to disclose their preferred strain. In support of its position, Ajinomoto cited to numerous cases where inventors were found not to have concealed the best mode even where they had not disclosed their preferred embodiments. The Federal Circuit disagreed and distinguished the cited cases from the current case on the grounds that, in all of the cited cases, the asserted claims as construed did not cover the embodiment alleged to have been concealed. The Federal Circuit reasoned that, as Ajinomoto's host strain was "claimed rather than unclaimed subject matter," the inventors' were under an obligation to disclose their preferred strain. The Court also stated that Ajinomoto's claimed right to exclude competitors from practicing a method of producing lysine using bacteria with the disclosed mutations also obligated them to disclose the best bacterium for carrying out the invention, thereby satisfying the "two-way street" of the best mode obligation.
Ajinomoto also argued that, even if the best mode requirement did extend to disclosure of the preferred bacteria strains, the ITC erred in its application of the requirement with respect to the '698 patent. Specifically, Ajinomoto argued that the ITC erred in finding that the inventors were required to disclose the host strain into which they inserted the Idc mutation. Ajinomoto also stressed that the inventors' deposit of a strain containing the lysC variant and disclosure of said deposit within the specification satisfied their responsibilities under the best mode requirement. The ITC countered that the inventors "concealed the only bacterial strain altered to contain the patented Idc mutation, and thus the only embodiment of the invention, by failing to identify it in any way, either by name or by its method of creation." The Federal Circuit disagreed with Ajinomoto, stating that the ITC opinion found that the inventors improperly concealed the identity of the preferred host strain, not the method of creating the host strain. The Court also stated that the best mode requirement "cannot be satisfied by the deposit of a non-preferred strain. The Court noted that the strain deposited by the inventors lacked the sucrose utilization genes of the preferred embodiment and, therefore, was not the strain that contained the Idc mutation. The Federal Circuit conceded that the deposited strain contained the lysC variant; however the Court also concluded that this, in and of itself, was insufficient to satisfy the best mode requirement. The Court reasoned that as the specification contained no disclosure of the fact that the deposit contained the lysC variant, thereby precluding one having skill in the art from knowing of the alteration, the deposit "failed to enable one of skill in the art to practice the inventors' preferred embodiment and thus concealed the best mode."
Ajinomoto's final argument addressed its position that the ITC erred in invalidating claim 15 of the '160 patent. Ajinomoto stated that even if the inventors concealed the best host strain as of the filing date of the 1993 Japanese application, the only result is that the Ajinomoto cannot rely on that date for priority purposes under 35 U.S.C. § 120. Ajinomoto asserted that it could still claim priority to the November 24, 1994 PCT filing date, thereby necessitating a finding by the Court that the defendants had infringed the '160 patent, thereby violating § 337. The ITC and the defendants countered that Ajinomoto, by not raising the matter in its pre-trial brief as required under the ALJ's stated ground rules, had waived its right to rely on its PCT application's filing date. The ITC also argued that Ajinomoto's claim of priority from the 1993 benefited Ajinomoto by concealing its best mode's priority date from the public and limiting the prior art upon which the defendants could rely for their invalidity defenses. The Federal Circuit agreed with the ITC and the defendants, stating that "a patentee cannot, as Ajinomoto attempts here, reverse a finding of invalidity by unveiling after trial an alternative priority date on which it would now like to rely."
On Friday, the Court of Appeals for the Federal Circuit handed Pfizer a mixed decision on defendant Teva's appeal of a District Court judgment that Teva was liable for infringing a trio of Pfizer patents (U.S. Patent Nos. 5,466,823; 5,563,165; and 5,760,068) relating to the pain medication Celebrex® (celocoxib). While keeping Teva's generic celocoxib off the market for now, the Federal Circuit's ruling advances the date when the generic version of Celebrex® will become available by about 12 months.
Compound of claim 8 where the compound is [celocoxib], or a pharmaceutically-acceptable salt thereof.
A pharmaceutical composition comprising a therapeutically-effective amount of a compound and a pharmaceutically-acceptable carrier or diluent, said compound selected from a family of compounds . . . where the compound is [celocoxib], or a pharmaceutically-acceptable salt thereof.
A method of treating inflammation or an inflammation-associated disorder in a subject, said method comprising administering to the subject having or susceptible to such inflammation or inflammation-associated disorder, a therapeutically-effective amount of a compound . . . where the compound is [celocoxib], or a pharmaceutically-acceptable salt thereof.
The District Court found the asserted claims infringed, the claims of the '068 patent not invalid for obviousness-type double patenting, claim 9 of the '823 patent and claim 17 of the '165 patent not invalid for violation of the best mode, and the asserted claims not unenforceable due to alleged inequitable conduct.
The Federal Circuit, in a unanimous opinion by Judge Dyk (joined by Chief Judge Michel and District Judge Matthew Kennelly of the Northern District of Illinois, sitting by designation) reversed the District Court's determination that the claims of the '068 patent were not invalid for obviousness-type double patenting but affirmed Teva's failure to carry its burden of a best mode violation or inequitable conduct on the other asserted patents. The basis for the Federal Circuit's decision that the '068 patent was invalid for obviousness-type double patenting was that the designation of this patent as a "continuation-in-part" was not merely semantic but had substantive repercussions regarding whether the '068 claims were entitled to the "safe harbor" provisions of 35 U.S.C. § 121. These provisions entitle a divisional application filed as the result of a restriction requirement (a Patent Office determination that an applicant has filed claims directed to more than one invention) to be exempt from obviousness-type double patenting. These provisions illustrate a Congressional intention, from the legislative history of the 1952 Patent Act, to prevent the unfairness of forcing an applicant to be required to file a divisional application based on claiming "independent inventions" through restriction while permitting the original application to be used as "prior art" in a obviousness-type double patenting rejection. The Federal Circuit noted, however, that Congress also evinced the intention to restrict the safe harbor to divisional applications (which have an identical specification to the originally-filed application) and keep any claims in such a divisional application strictly within the bounds of what had been determined to be a separate invention. This intention meant, for example, that an applicant would not be able to include claims in a divisional that were within the scope of any claims previously elected for examination. In this way applicants would be precluded from inequitably increasing patent term while not being penalized for electing one invention and pursuing additional inventions in divisional applications.
The Federal Circuit found that the '068 application did not fall within the safe harbor because it was a continuation-in-part application, not a divisional. Such a "CIP" application by definition contains some of the disclosure of an earlier-filed application in addition to new disclosure. Because of this distinction, the Federal Circuit found that CIP applications could not fall within the safe harbor because they could encompass additional information (and patentable inventions) that were not a part of the original, restricted claims.
In this case, however, the CAFC has applied the rubric to the application rather than to the claims. A review of the claims of the '165 patent, as originally filed, shows that the application contains a claim (claim 29) that recites the same method as the '068 patent and a list of species of the generic formula, expressly reciting celecoxib. This claim was subjected to a restriction requirement and the applicants elected to forego prosecution of these method claims until filing the CIP application that resulted in the '068 patent. However, the specification of the '068 patent is much more extensive than the earlier-filed '823 and '165 patents; in particular, the '068 patent specifically discloses celecoxib synthesis, and contains biological data relating to the specificity of celecoxib for COX2 over COX1 (the biological basis for its advantages as an anti-inflammatory agent). Without specifying any rationale other than the noted distinction between divisional and CIP applications, it appears that these differences in the specification may provide additional support for the Federal Circuit's determination.
The CAFC upheld the District Court's determination that claim 9 of the '823 patent and claim 17 of the '165 patent (directed specifically to celecoxib) were not invalid for failure to satisfy the best mode requirement of 35 U.S.C. § 112, first paragraph. Teva contended that Pfizer's failure to disclose the COX2 specificity of the claimed compounds was a violation because it prevented the skilled worker from appreciating which of the disclosed compounds exhibited the specificity for COX2. In Teva's view, this failure of disclosure was significant, because the capacity to block the action of COX2, related to pain, while not inhibiting COX1, related to normal processes such as gastrointestinal integrity, was an important feature of the claimed invention. The Federal Circuit adopted the view of the District Court that Pfizer was under no obligation to disclose this distinction. (Presumably, this would not have been the case if the claim was to a method or included the COX enzyme specific limitations.) Disclosing how to make and use the compounds of the invention was enough to satisfy the best mode requirement. Interestingly, the CAFC noted that while Teva had raised the defense of invalidity against Pfizer's claims, it had not counterclaimed for a declaratory judgment of invalidity; thus, since claim 9 of the '823 patent and claim 17 of the '165 patent satisfied the best mode requirement and were infringed, it did not need to reach the "difficult issue" raised by the generic claims. This dicta from the Federal Circuit would seem to raise a caution for similar instances where generic claims are asserted.
(3) the applicant has not provided a credible explanation for the withholding.
Here, Teva's failure to establish or rebut the third prong was fatal to its inequitable conduct allegation.
As a consequence of the Federal Circuit's holding the '068 patent invalid, the expiration date for the remaining Orange Book listed patents is now May 30, 2014 (when pediatric exclusivity for the '165 patent expires) rather than June 2, 2015. Undoubtedly this means millions of dollars in revenue lost, especially since the '823 patent was deemed ineligible for patent term extension under 35 U.S.C. § 156.
Additional information regarding this case can be found at Patently-O and the Orange Book Blog.

References: § 1337
 § 112
 § 112
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 § 120
 § 337
 § 121
 § 112
 § 156