Best Mode Requirement Strikes Down Biotech Patent

Ajinomoto Co., Inc. v. International Trade Commission (Fed. Cir. 2010)

The ITC held that Ajinomoto's patents were invalid for failure to satisfy the best mode requirement of 35 U.S.C. 112. On appeal, the Federal Circuit affirmed.

The two asserted patents relate to methods of producing L-lysine using GM E. coli and include fairly broad claims. L-lysine is used in animal feed and is now a multi-billion-dollar market. The patent discloses one way to create the L-lysine producing E. coli. However, by the time they filed the patent application, the inventors had identified another, better strain. The evidence showed that Ajinomoto intentionally withheld that information.

The best mode doctrine requires that the inventor disclose the preferred embodiment of the invention and any preferences that materially affect properties of the claimed invention, but only to the extent that information is subjectively known by the inventor at the time the application was filed. There are four major caveats to the law of best mode. (There is no duty to supplement the best mode disclosure during prosecution). The scope of the required best mode disclosure is commensurate with the scope of the claims. [updated] This has been termed the "two-way street" of the best mode requirement: "the best mode requirement is a “two-way street,” for which a patentee’s obligations are no broader than the right to exclude." Thus, "the best mode does not extend to unclaimed, non-novel subject matter."

Here, Ajinomoto was tripped-up by the breadth of its claims. Ajinomoto's asserted claim recited the step of "cultivating a bacterium belonging the genus Escherichia . . . having mutation to desensitize feedback inhibition of L-lysine." It was easy then for the the court to hold that Ajinomoto should have recited its preferred host strain.

By defining the invention to include the host strains, we do not read the Commission’s decision as requiring the disclosure of any and all preferences related to the production of lysine, as Ajinomoto claims. The Commission simply defined the scope of the claimed invention to include “cultivating a bacterium” as recited by the asserted claims. Also, the Commission did not, as Ajinomoto asserts, require the disclosure of all subject matter having to do with the claim term “bacterium.” The Commission simply required the disclosure of the preferred and, for the ’698 patent, only bacterial strain that the inventors used to practice the claimed invention.

Ajinomoto unsuccessfully argued that this result was contrary to the precedent of Christianson v. Colt Industries Operating Corp., 822 F.2d 1544 (Fed. Cir. 1987), AllVoice, Zygo, and Bayer.

Patent Reform: The Patent Reform Act of 2010 would eliminate the invalidity defense of failure to satisfy the best mode and therefore would flip the verdict in a case such as this.

42 thoughts on “Best Mode Requirement Strikes Down Biotech Patent

  1. Well said, Gekko. Bravo!

    The bit you missed is that it is greed and the “evolutionary spirit” (love that one) that will bring our species to it’s evolutionary endpoint — which is to say extinction — and the other species along with it.

    The Founding Fathers, in their wisdom, saw that to promote science you reward greed. Alfred Nobel saw that, too. The Nobel Prize has done more damage to the species than all the TNT ever detonated.

    Not arguing with you, Gek. Just filling in some of the empty blanks. All I’m saying is that as patent lawyers, and agents, and examiners, we satisfy our own greed by promoting the greed of inventors. Our greed is parasitic to theirs.

  2. “Let’s just be sure we’re clear on one thing in this discussion and any other concerning patents — patents are about, and only about, greed.”

    The point is, ladies and gentleman, that greed, for lack of a better word, is good. Greed is right, greed works. Greed clarifies, cuts through, and captures the essence of the evolutionary spirit. Greed, in all of its forms; greed for life, for money, for love, knowledge has marked the upward surge of mankind. And greed, you mark my words, will not only save The Office, but that other malfunctioning corporation called the USA.

  3. Let’s just be sure we’re clear on one thing in this discussion and any other concerning patents — patents are about, and only about, greed.

    The inventor wants to get as much $$ as he possibly can while disclosing as little as possible, and the public wants to get as much disclosure as it possibly can while paying as little as possible. The old QPQ system optimized this mutual greed pretty well.

    But government has a monopoly on granting the monopoly, and so they can pretty much do it any way they want to. There is no Constitutional right to be treated equitably by the PTO or any other agency. The PTO has an obligation to the taxpayer to minimize the inventor’s end of the deal while maximizing the public’s.

    INANE thinks that if the deal is too stinky for the inventors, they won’t disclose. Mostly wrong. The inventors will do whatever is necessary to score the $$. If that means making a complete disclosure for rotten claims, that’s what they’ll do.

    Besides, in this environment all the wolves keep talking about the wonderful QPQ and the sheep keep eating it up. Most of the inventors don’t really understand. So it’s up to us practitioners and judges who run the show to keep dishing out the QPQ myth so our own incomes won’t suffer.

  4. What’s plenty?
    Does it matter bright boy?
    Good-N-Plenty – the more the merrier.

    Get as much Quo as you can grab before you give out any Quid.

    What’s not to love about this deal? What is Latin for “I’ve got mine?”

    Sinister – incompetent – who cares why?

    “they will stop disclosing altogether” – not a chance – look at the people lining up even though the Quid Pro Quo was changed. Recession? what recession? – There’s a backlog even though the Office has decided on record numbers of applications.

    Get while the gettings good.

  5. “As I have said – we got the quo- we got the real benefit, what else really matters?”

    What else really matters is getting inventors their patents. If you believe the comments on this board, that’s a pretty important concern for all of us, even if we have different approaches to the problem.

    If the patent system is seen to take applicants’ disclosures and give them nothing in return, they will stop disclosing altogether.

    I’m curious to hear how so many of these applicants are getting “stiffed”. What sinister motives do you see in the PTO that can’t be attributed to innocent administrative incompetence?

  6. But you both miss the fact that there are plenty out there that are published and then languish for years and get plainly stiffed.

    What’s “plenty”?

  7. Agonizing aegis
    Babel Boy
    Can’t catch-up
    Demoralized delivery

    “paying in advance” – lol especially if it is the other guy paying in advance and he is stiffed because there is no longer any reason to hurry, or to even bother with a quality examination.

    No, IANAE is right – I see nothing wrong with that at all.

    As I have said – we got the quo- we got the real benefit, what else really matters?

    Step right up, lay your money down.

    Mooo – money.

  8. “The publication issue is a red herring anyway, with your corresponding foreign applications getting published at 18 months as a matter of course.”

    It’s not a red herring. It’s the cause of the whole mess.

    Up to 1999 the American QPQ principle was equitable and served the country and its inventors very well for 200 years. Then Congress decided to scrap it as a step toward “global harmonization,” meaning, essentially, EPO harmonization.

    EU knows nothing, and could care less, about equitable conduct between governments and individuals. In the EPO system, you file your application, pay huge maintenance fees every year, have your invention disclosed to the world, wait 5 or 7 years for the first office action, and then get scr*wed — particularly if you are a non-EPO applicant. So the deal offered by the EPO is: you disclose everything and we’ll see.

    That is now the deal in the US, under the aegis of global harmonization.

  9. No one said that a patent “must” be given. No one is saying that BECAUSE the Office published, the applicant MUST have a patent.

    No, but it does say that if the claimed invention isn’t invalid under the statute a patent must be given. The quid pro quo is right there in the statute – disclose something that is a patentable invention and therefore presumptively of some value to the public, and you get a patent. Disclose something the public already knew, and you don’t get a patent, but you didn’t really disclose anything either. There’s no good reason why quid pro quo precludes one party paying in advance, especially when the real benefit to the public is having inventions disclosed while they’re still interesting to other researchers.

    The publication issue is a red herring anyway, with your corresponding foreign applications getting published at 18 months as a matter of course. The real issue here is the pendency time, for which the PTO still has no real answer.

  10. Oh IANAE, you crack me up, and I’ll even spot you in your game of moving the fence posts. And them’s some pretty special wheels you got hooked up to your fence posts – motorized and all.

    “would McDonald’s claim that you still had to pay because you received your part of the bargain?”

    No one said that a patent “must” be given. No one is saying that BECAUSE the Office published, the applicant MUST have a patent.

    Let’s see – yep – you even re-typed my word of “regardless”.

    Sweet.

    In fact – it plain don’t matter.
    quo: yes,
    quid: – who cares, the quo is already gotten.
    Reject them all – a bite and eww? – toss that one, there’s another one to bite and yum – reject that too, so what? – why pay for the milk when the cow’s giving it away?

    There are plenty of chicken heads out there just as there are plenty of yummy chicken mcnuggets. With the situation as is, its like giving away everything and then hoping that an honest person out there will decide to pay you. I have to tell ya, I haven’t seen that much honesty out there.

    Cranky today – no I think you missed my point – your scenario is like IANAE’s – publish them all and for those who didn’t deserve a patent – no harm , no foul. But you both miss the fact that there are plenty out there that are published and then languish for years and get plainly stiffed. Just some collateral damage folks – that’s all. So who cares if the Quid Pro Quo is all quacked up? People are suckers and they keep wanting patents. What’s the Latin for “there’s a sucker born every minute?”

    Babel’s on the ball with the OLD Quid Pro Quo.

  11. cranky: “I don’t think Babel Boy is complaining about publication because he thinks it’s making the backlog worse.”

    You’re right, crank, I wasn’t, but only because it hadn’t occurred to me.

    I think you’re missing the finer but more important point. Maybe you’re new and don’t remember how it used to work.

    When I used the term “invention”, I used it in the sense that the courts, statutes and patent attorneys normally do, which subsumes new, non-obvious and useful. I apologize for not reciting Section 101 for you.

    That’s my mistake, your mistake is in not understanding that there are two disclosures and only one was part of QPQ.

    The disclosure to the public is what is supposed to get you the monopoly under QPQ — that happened AFTER examination.

    The disclosure to the patent office was never a part of the QPQ. It was required in order for the analysis that leads to the QPQ deal. Once that analysis [examination] was completed, the QPQ was offered in the form of a Notice of Allowance. The applicant had no obligation to disclose anything to the public until that point and could cancel the whole thing up until he paid his issue fee.

    To summarize, the process to which the term QPQ properly applies is:

    1. inventor discloses to PTO subject matter [application];

    2. PTO evaluates the subject matter and determines if it’s patentable [examination];

    3. IF it is patentable, PTO offers the deal [notice of allowance based on the claims allowed];

    4. inventor accepts or rejects the deal [pays the issue fee or walks];

    5. IF inventor pays the issue fee, the PTO grants the patent [monopoly] and

    6. PTO publishes patent [disclosure of invention to public].

    As it is now in most cases the inventor is forced to disclose to the public BEFORE he is offered a monopoly on whatever claims survive examination; i.e. Step 6 precedes Step 4. That’s not a QPQ deal. It’s a bum’s deal.

  12. Who cares about the patent backlog or examination quality when the State already has the quo?

    Now here I see your point, I think. However, I dare say that “the State” isn’t particular interested in improved toilet paper holders or one-click shopping methods for its own sake. I find it hard to imagine that bureaucrats like 6 would be more motivated to provide speedy and thorough examination simply because the brilliant ideas in your disclosure won’t be published until they finish the job. I don’t think Babel Boy is complaining about publication because he thinks it’s making the backlog worse.

  13. Regardless of that state, the State already has taken the Quo.

    I think you’ve missed my point. If the disclosure wasn’t a real contribution, then there was no “Quo” for the State to take. The public already had the invention, what does the State want with your description of it?

    Besides, you know the deal going in – it’s in the statute, after all. The State is giving out limited monopolies on its terms – if you don’t like the terms, then by all means, keep your non-novel and/or obvious ideas secret. It’s not like you have a constitutional right to a patent ….

  14. Regardless of that state, the State already has taken the Quo.

    The State got the quo, took one bite, and said “eww, this is awful, I’m not paying a quid for this!”

    If you were the person who got the fried chicken head in your box of McNuggets, and you refused to pay for it, would McDonald’s claim that you still had to pay because you received your part of the bargain?

    If you don’t disclose a patentable invention, what you filed isn’t what the PTO ordered. Why should they pay?

  15. Quid sine quo. – ouch.

    cranky, I think you missed the point. Whether or not you have something worth earning the patent is not at issue. Regardless of that state, the State already has taken the Quo.

    Who cares about the patent backlog or examination quality when the State already has the quo?

  16. cranky If you disclose a BS invention, you haven’t performed your half of the deal.

    Yup. But you might get lucky and receive a patent anyway.

    Happens every Tuesday at 12:01.

  17. It’s like giving the car salesman $30,000, and then the car salesman decides whether or not he will give you the car. When the agreement requires one party to perform before the other elects whether or not to perform, it is not a QPQ agreement.

    Yeah, it’s just like that. Except that disclosing information is a lot different than handing over a pile of money. If I already had the information, you haven’t actually given me anything.

    You’ve mischaracterized the nature of the “QPQ”. The real version is this: inventor discloses invention that is actually a contribution to the state of the art (i.e., useful, novel, and non-obvious), and public gives inventor limited monopoly. If you disclose a BS invention, you haven’t performed your half of the deal.

  18. This opinion hinges, or course, on the quid pro quo principle, as Lourie rightly states. What he and the entire profession appear to miss is the point that there virtually is no quid pro quo agreement anymore.

    The PQP is hyped as: inventor discloses invention, public gives inventor limited monopoly. This logically means the converse: if the public does not give the monopoly, inventor does not disclose the invention.

    It used to be this way. In the old days (pre-1999) if the inventor got to the end of the examination and didn’t like the scope of the monopoly that was being offered, he could refuse the deal, refuse to disclose, and practice the invention as a trade secret or just sit on it. Public gets nothing; inventor gets nothing.

    But in today’s practice all but the small entity non-foreign filer is forced to disclose the invention prior to knowing what claims, if any, will be allowed. Consequently, the deal is now: inventor discloses invention in its entirety and public may or may not give the monopoly. Quid sine quo.

    It’s like giving the car salesman $30,000, and then the car salesman decides whether or not he will give you the car. When the agreement requires one party to perform before the other elects whether or not to perform, it is not a QPQ agreement.

    So QPQ is largely an American patent myth that won’t die. With the cards stacked against the inventor who is forced to publish, I would argue that they should conceal everything they possibly can.

  19. As well noted above, this decision is consistent with Fed. Cir. law. Perhaps best summarized by this case as a question of whether a concealed embodiment would be covered by the claims (see the last paragraph on page 13 of opinion on the Fed. Cir.’s website).

  20. Paul, we once lost and interference on best mode because we failed to disclose the exact measurements of a mechanical structure. This was not a case, IIRC, were the application disclosed any measurements, as the particular details of the measurements had nothing to do with enablement and were well within the skill in the art. Because of this, we were all surprised that the issue was even raised in the first place. But in the end, we lost.

    According to your analysis above, we were jobbed, and I would have to agree.

  21. It seems Ajinomoto’s bait-and-switch tactic was to initially rely on a foreign priority application, which lacked support for best mode, and then late in the proceeding rely on a later filed PCT/Nat’l Stage U.S. application claiming priority to the foreign applicaiton, which apparently had a stronger best mode argument for Ajinomoto. This tactic was good for purposes of preventing GBT from relying on prior art between the dates, but ultimately burned Ajinomoto due to a lack of best mode being provided in the foreign priority app. What I am wondering is, is there a duty to update the best mode, say from the time a foreign application is filed to the time when a U.S. application claiming priority to that foreign application is filed? In other words, when a better mode is discovered after the foreign app is filed, does the later-filed U.S. app have to disclose that better mode? (It seems that is what was occurring in this case.)

  22. Inventors will not disclose their best mode, but believe that the claims are broad/vague enough to cover their best mode. Then when they go to sue an infringer for making a device (according to the best mode) they will find out that their claims do not cover it.

  23. Ceasar, I have never suggested there is any such specific data, or even that it could ever be accurately quantified, much less suggesting that I fully agree with the views of either side of this specific legislative proposal. I am merely trying to present and discuss arguments from both sides on this important but widely ignored legislative issue, plus some background information.
    Especially since most of the patent reform legislation debates over the past four years were preocupied with highly controversial proposed amendments to the infringement damages statute. [Plus some continuing controversy over how viable the new one year grace period would really be.] Those damages debates damage has now been toned down to proceedural and gatekeeping changes. [Although why the (unknown as always) latest authors felt required to ramble on for at least 100 prolix new lines of new legislative language on that subject that could engender a lot of new litigation issues is puzzling to many.]
    So now hopefully other parts of this bill will get more serious discussions.

  24. Sorry, Paul, but there is no concrete evidence — other than so-called anecdotes — that suggest litigation costs outweigh the benefits of requiring a full disclosure by the inventors.

  25. I also think that the “best mode” situation is another example [akin to their "inequitable conduct" mess] of what happens when Fed. Cir. panels constantly fail to even cite, or sanction attorneys for not citing, much less follow, their EARLIEST decision on a legal issue, as required by their own [ignored] rules of stare decisis. Thus, an en banc decision on this subject has been needed for several years.

  26. If you have any interest in how the Fed. Cir. expanded “best mode” from a rarely raised issue into its present litigation mess, read their below, and later, decisions. Some seem to even confuse “best mode” with adequate “enablement.” Compare for example the 1986 Federal Circuit decision by Judge Rich in Hybritech Inc. v. Monoclonal Antibodies, Inc., 231 USPQ 81, 93-94, citing DeGeorge v. Bernier, 768 F.2d 1318, 1324, 226 USPQ 758, 763 (Fed. Cir. 1985) and In re Sherwood, 613 F.2d 769, 135 USPQ 311 (CCPA 1962), in contrast to the later Dana Corp. v. IPC Limited Partnership, 860 F.2d 415, 8 USPQ2d 1692 (Fed. Cir. 1988); Chemcast Corp. v. Arco Industries Corp. (Fed. Cir. 1990); and even worse subsequent CAFC decisions.
    Note also the critical article entitled “Throwing the Baby Out With the Bathwater?” published in the Fall 2005 ABA “IPL Section Newsletter,” pp. 8-14. Yet as this article notes, the ABA IPL Section had previously urged elimination of any “best mode” requirement by amending 35 USC 112 paragraph 1]. This article lists the numerous alleged statistical and public policy arguments against eliminating “best mode”, criticizes the adequacy and accuracy of the prior published analysis, and states in its conclusion on p. 12 that, unlike other proposed Patent Reform Act provisions: “The proposal to eliminate the best mode requirement has not been thoroughly discussed.“

  27. “I don’t see anything wrong with the holding in this case, as a matter of law or policy.”

    No big surprise here.

  28. Re: “If best mode is still a requirement during the application process, and the applicant intentionally withholds the information, wouldn’t that be inequitable conduct?”

    Yes indeed, but other commentators, and a literal reading, indicate that this proposed legislation would eliminate that as a defense as well.
    This bill language would expressly leave PTO disciplinary proceedings. But the prep and prosecution attorneys [subject to such proceedings] are unlikely to have known about the inventor’s concealment of their best mode and been stupidly willing to risk their licenses to participate. Such PTO disciplinary proceedings are not even available against unregistered inventors or assignees, and could not provide any relief for any infringers of the non-enabled claims.
    However, even when [or if] fully honestly debated, there are apparently many people who think that this defense elimination is a reasonable trade-off to eliminate a lot of costly litigation discovery over an issue that is so rarely successful.
    Remember that unless there is at least one operative, useful, embodiment that IS disclosed in the specification the patent, that patent is 112 dead for non-enablement without even needing to raise “best mode.”
    To put it another way, [as older cases did before subsequent CAFC panels messed it up], for a best mode violation the inventors had to have had two operative embodiments before filing and deliberately choose the worst one to disclose in their application.

  29. If best mode is still a requirement during the application process, and the applicant intentionally withholds the information, wouldn’t that be inequitable conduct?

  30. “The Patent Reform Act of 2010 would eliminate the invalidity defense of failure to satisfy the best mode and therefore would flip the verdict in a case such as this.”

    Which way is the better way?

  31. “(There is no duty to supplement the best mode disclosure during prosecution).”

    Could that be because you can’t.

  32. The reform would eliminate the best mode – but don’t you think the court would find other basis for invalidity (albeit via a much more expensive & tortured discovery as noted by Paul).

    Or – does the community think it is more likely that Ajinomoto would win if best mode is removed?

    wasn’t Ajinomoto part of the big Cargill lysine scandal of ~ ten years ago?

  33. Re: “The scope of the required best mode disclosure is commensurate with the scope of the claims.”
    The defendant certainly argued that here (based on one cited prior CAFC panel decision) but this decision did not expressly affirm that as far as I can see, and I recall other CAFC panel decisions to the contrary, not cited in this decision.

  34. Paul,

    I’m with you on “best mode.” What is really needed is a standard that punishes deliberate omission to keep the “gem embodiment” as a trade secret (not innocent omission); that’s the reason for the “best mode” requirement in the first place. The proposed provision in the so-called “patent law reform” is very odd, and almost meaningless. If they wanted to define an invalidating “best mode” offense as one where the inventor did what I described, that’s one thing. But making “best mode” a requirement without it being an invalidity defense in litigation is completely nonsensical.

  35. The timing of this decision is more than a little ironic and unfortunate. It directly coincides with the just-disclosed intended elimination as any patent litigation defense [even as inequitable conduct] [yet somehow still required for PTO filing] of any and all such 112 “best mode” non-disclosure violations [even deliberate, as here] in the latest S.515 patent reform “compromise” bill. One of the arguments in favor of that elimination is that it almost never occurs [hence the ironic coincidence], yet causes a lot of costly extra litigation discovery.
    {My personal view is that the real problem has been CAFC panel decisions greatly expanding this defense BEYOND deliberate non-disclosure [concealment, to keep as a trade secret] of a KNOWN clearly commercially superior enablement for what is being CLAIMED. That would seem to be correctable by a somewhat less draconian legislative solution?

  36. Consummate? I doubt it. What sort of a blog have I stumbled into here? Commensurate perhaps?

    DDC Says: Thanks Max.

Comments are closed.