Proving Non-Obviousness with Ex-Post Experimental Evidence?

by Dennis Crouch

The Federal Circuit has rejected BMS’s petition for en banc rehearing in its chemical compound obviousness case. However, four additional opinions either concurring or dissenting show that the court does not speak with one-mind on the issue. Obviousness is the central patentability doctrine and thus, even small modifications to the doctrine can have important systemic impacts. En Banc Denial Opinions.  The patent in question – if valid – is worth hundreds of millions of dollars and so we can expect a petition for writ of certiorari to the Supreme Court.

In Bristol-Myers Squibb Company v. Teva Pharmaceuticals USA, Inc., the Federal Circuit panel affirmed a lower court finding that BMS’s patent covering the Hep-B drug entecavir is invalid as obvious. Patent No. 5,206,244. Judge Chen drafted the original opinion that was signed by Chief Judge Prost and Judge Plager.  Prof Rantanen covered the original decision here.

The obviousness approach for newly invented chemical compounds typically involves identifying the closest analog compound (lead compound) and then determining whether it would have been obvious to create that new compound based upon the lead prior art.  Here, the basic holdings of the Federal Circuit were: (1) affirming that “those of ordinary skill in the art would have selected 2′-CDG, a carbocyclic analog, as a lead compound for further development efforts;” (2) affirming that the same PHOSITA would have been motivated to modify the lead compound; and (3) holding that the secondary indicia of non-obviousness were insufficient to transform the obviousness determination.

In its petition for rehearing, BMS presented two primary arguments:

  • That the court improperly refused to consider post-invention discoveries regarding the invention and prior art that showed significant differences between the two.  In particular, the appellate panel found it irrelevant that the lead-prior art compound is highly toxic to humans since – at the time of the invention – the compound was generally regarded as safe.
  • With regard to objective indicia of non-obviousness – that the court improperly separated the analysis on a property-by-property basis (finding each merely difference-in-degree) rather than looking at the alleged dramatic (difference-in-kind) impact of the drug when considered as a whole.

In his opinion discussed below, Judge Taranto sets the stage:

In short, the Bristol-Myers compound, which is a novel molecule, is dramatically different from the prior-art compound in providing practical human benefits: one provides such benefits, the other does not. But that difference was identified only after Bristol-Myers filed for its patent, because the prior-art compound, not having been tested in animals or humans, was not then known to be toxic.

A number of Amici supported the petition, including BIO, Pfizer, Eli Lilly, PhRMA, IPO, and Merck.

The basic issue here is that pharmaceutical companies regularly perform tests to compare their newly-invented drug treatment to the prior art in order to prove that the two are quite different.  However, as a general matter, those tests are performed after the invention and application is already on file.  The companies then have a major concern that this decision will deny the relevancy of those objective but ex post results.

The trouble for the patentee in this case is the statute — that expressly calls for considering what was known by PHOSITA at the time of the invention (pre-AIA; in future we the time is at the effective filing date of the patent application).  Under the statute it seems that post-filing information should only be relevant to showing what PHOSITA would have been thinking back at the critical date.

Although the entire court did not explain its reasons for denying the rehearing, Judges Dyk (joined by Judge Wallach) and Judge O’Malley wrote separate opinions concurring in the denial.

Judge Dyk:

This case presents a question of obviousness, in particular whether evidence postdating the invention can be used to establish unexpected results. The panel holds that it cannot be considered in the circumstances of this case. That position is correct. It is mandated by the statute, which provides that an invention is not patentable if it “would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C. § 103 (emphasis added).

The patent applicant’s discovery of unexpected results at the time of the invention can help to establish that the invention would not have been obvious to another skilled person. But hindsight bias must be avoided in determining obviousness. And under longstanding Supreme Court authority, the pertinent knowledge is that possessed at
the time of the invention.

You will note that Judge Dyk cites the new-103 rather than pre-AIA 103(a), but that does not significantly change the point he is making here.

Judge O’Malley:

I write to assuage Bristol-Myers Squibb Co.’s (“BMS”) and the amici’s1 fears that this panel decision has rewritten the test for obviousness for pharmaceutical patents. In my view, the concerns expressed are unjustified and mischaracterize the opinion. This case does not forge new ground or set down immutable principles. It simply decides that, on the record before it, the district court did not err in finding the asserted claim of the ’244 Patent invalid as obvious. . . .

Our case law clearly allows the consideration of later discovered differences between the prior art and the invention. . . . These differences inform the obviousness analysis and thus can be considered when assessing what was understood by one of skill in the art at the time of the invention and what expectations may have been reasonable. . . . Like all evidence of objective indicia, the point of considering later-understood evidence regarding the properties
of the invention is to guard against hindsight bias by assessing claims of a motivation to combine as of the time of invention in light of later surprises or developments.

Judge Newman dissented from the denial with an opinion joined by Judges Lourie and Reyna.  Judge Newman, inter alia, walks through the lengthy list of cases that where ex post evidence was relied upon to prove non-obviousness and sees the panel decision here as a major departure.

Judge Taranto’s dissent basically argues that the panel decision was sloppy and, because it can be read in the extreme way suggested by the petitioner, that it should be modified.

76 thoughts on “Proving Non-Obviousness with Ex-Post Experimental Evidence?

  1. 14

    MM, if this decision would be limited to its facts, it would not be a problem. That is, limited to a holding that a valid, proven and KSR-supported “obvious to try” 103 rejection should be based on what was obvious to try at the time of the patentees invention, and not changed by a latter discovery that the cited prior art was not as good as a POSITA at the time of the patentees invention would have thought.
    However, there will be some examiners and defense counsel that will try to use this case to argue that all post-invention date evidence should be excluded from supporting patent application or patent unobviousness.

    1. 14.1

      there will be some examiners and defense counsel that will try to use this case to argue that all post-invention date evidence should be excluded from supporting patent application or patent unobviousness.

      Yes that will happen, just like there were some applicants and patentees who used Newman’s decision in Knoll to argue that *any* post-filing evidence of unexpected results is permissible to prove the non-obviousness of an otherwise obvious compound “period.”

      I’m sure you agree, Paul, that your “some Examiners and defense counsel” argument cuts both ways. People who have no other alternative and who are desperate to succeed will always try to pull out some snippet from some case somewhere and argue that the “the law” mandates the result they are seeking.

      The goal here is to arrive at a reasonable rule that doesn’t promote the inevitable shenanigans of the sort I indicated. Chen’s decision was well-written, well-supported, and it looks like he reached the right result. If other judges strive to emulate his efforts there then I think we’re heading in the right direction. The wrong direction, in my opinion, is more decisions like Knoll and Genetics Institute which really do seem to offer a system-corroding loophole through which applicants can stake out huge chunks of prima facie obvious territory in their patent filing and then, years later, “rescue” a paticular species with some “unexpected” data that nobody — least of all the applicant — knew about.

    2. 14.2

      Paul,

      I understand what you are saying. To put another way the opinion is saying a that when a court addresses an invalidity attack against a claim of a U.S. patent, the court must return to the moment in time in which the claim was filed and only consider the factual evidence available to a person of skill at that particular point in time, i.e., the filing date. If that is the case, then the opinion does significantly alter how a chemical practitioner must counsel his/her client.

      I agree with Taranto, the facts around the timing of the post-filing evidence is significant, and further discussion by the court is warranted. Is the opinion saying the a court negate post-filing evidence submitted in the form of a 132 Declaration during the initial examination of the claim also suspect? Should the examiner also not consider such evidence stating that the evidence is untimely? I refer to Taranto’s statement

      “Even if the panel merely rejected the particular post-filing evidence here as insufficient, it is significant (for how the decision will be invoked as precedent) that the panel did not give any case-specific reasons for doing so except timing: the discovery of the prior-art compound’s toxicity post-dated the invention. The panel decision seems highly likely to be viewed as addressing the timing-of evidence question—whether generally or in this context. And that question is worthy of further attention.”

      This opinion significantly impacts the type of post-filing evidence that can be submitted in a 132 Declaration to rebut a prima facie of obviousness. This opinion is the “KSR” of chemical practice – it is that significant, and likely change how I think about drafting a compound case.

  2. 13

    Why not? According to the nonsense of Wands, ex post commercial acceptance is fine too. In fact, many kinds of hindsight provide acceptable fuel for the fire. Burn baby burn till it’s all burned down.

  3. 12

    “[E]very property of a claimed compound need not be fully recognized as of the filing date of a patent application to be relevant to nonobviousness.” Slip Op. at 29. In other words, “evidence of unexpected results may be used to rebut a case of prima facie obviousness even if that evidence was obtained after the patent’s filing or issue date.” Id. Genetics Institute, LLC v. Novartis Vaccines and Diagnostics, Inc. (Appeal No. 2010-1264), (Fed. Cir., decided August 23, 2011).

    1. 12.1

      jc: In other words, “evidence of unexpected results may be used to rebut a case of prima facie obviousness even if that evidence was obtained after the patent’s filing or issue date.” Id. Genetics Institute, LLC v. Novartis Vaccines and Diagnostics, Inc. (Appeal No. 2010-1264), (Fed. Cir., decided August 23, 2011).

      Obviously that’s from the Newman/Lourie dissent to the denial of a re-hearing in this case.

      The Genetics Institute case they are citing is the wrongly-decided Lourie-penned case that the CAFC majority is plainly trying to minimize. Either that or the majority is simply hoping that the Supreme Court will step in and inform the dissenters accordingly, or at least send a little message with a cert denial.

      The bit about “[E]very property of a claimed compound need not be fully recognized as of the filing date of a patent application to be relevant to nonobviousness” is alleged supported by another recent Federal Circuit case, Knoll Pharm. Co. v. Teva Pharms. USA, Inc., 367 F.3d 1381, 1385 (Fed. Cir. 2004) where post-filing evidence of unexpected evidence was allowed (Dennis noted the “inherent contradiction” of the statute when he reported on Knoll). That decision was written by — surprise! — Judge Newman (Archer and Prost concurring).

      Here is the money quote from that case, which vacated a district court’s summary judgment of obviousness and remanded: There is no requirement that an invention’s properties and advantages were fully known before the patent application was filed, or that the patent application contains all of the work done in studying the invention, in order for that work to be introduced into evidence in response to
      litigation attack.

      Two points about this quote. First, there is no citation in Knoll to back it up.

      Second, there is no dispute about the first part of the quote, i.e., “There is no requirement that an invention’s properties and advantages were fully known before the patent application was filed, or that the patent application contains all of the work done in studying the invention…” Nobody’s going to argue with that. The last part of the quote — the controversial part — is interesting because on its face it says only that additional “work [done in studying the invention]” — work that was not disclosed in the patent application — can be introduced into evidence to support non-obviousness.

      The problem is that Newman’s proposition as stated in Knoll is a far, far cry from the proposition that a composition that is prima facie obvious as of its filing date can be turned into a non-obvious composition by the post-filing “discovery” of some “unexpected property” of the composition. That proposition, if unchecked, turns our understand about how our patent system is supposed to work on its head.

      Note again: we’re not talking about a case where some unexpected properties were disclosed in the application as filed while some other suspected useful properties were not disclosed or some unexpected valuable details were omitted (perhaps because they were deemed insufficiently robust as of the filing date). We’re talking about the situation where there are no unexpected results in the application as filed because the applicant was not aware of any such results. It’s a critical point.

  4. 11

    Was this a jury or a bench trial? Sounds like relevant, probative and objective evidence that a jury should have been entitled to consider. As you all know, the standard to JNOV a jury is a higher burden than reversing or sustaining a bench trial. I assume this was a SJ motion granted by the lower court? Wherein as a matter of law – CAFC is saying post application discovery of non-obviouness is not – admissible evidence? Sort of at odds with evidence of commercial success – which by definition is after the conception date of the invention. That is black letter – Graham non-obvouness rebuttal evidence.

    1. 11.1

      Wherein as a matter of law – CAFC is saying post application discovery of non-obviouness is not – admissible evidence?

      That’s not what the CAFC is saying.

      1. 11.1.1

        Actually, “iwasthere”, your comment is pretty close to what the CAFC is saying. I initially read it as saying that evidence of unexpected results can’t be presented post-filing — that goes too far.

        But post-filing *discovery* of unexpected results … why in the world would we allow that? What’s the point of a filing date anyway?

        As with subject matter eligibility, it’s important to look at the inevitable repercussions of not putting reasonable limitations on what can be submitted post-filing. If post-filing *discovery* of unexpected results is permitted, then applicants can simply file on all the obvious compounds that they intend to subsequently test or that they assume will be tested by others. Then the applicant waits — keeping the application pending — until the compound with the “unexpected” (and valuable) property is identified. Then the applicant specifically claims that compound and submits the post-filing evidence.

        Does that seem like a good way to “promote progress”? Or is it promoting something else entirely?

    2. 11.2

      Sort of at odds with evidence of commercial success – which by definition is after the conception date of the invention. That is black letter – Graham non-obvouness rebuttal evidence.

      Note that in the case of “commercial success”, the courts have been very keen to cabin the use of that “factor” to those instances where there is a clear “nexus” between the evidence of success and the claims (i.e., the claims that were disclosed on the filing date). In many (most) cases, the “nexus” doesn’t exist and the alleged “success” isn’t the result of the claimed improvements to the prior art but other factors, e.g., marketing.

      In contrast, the dissenting judges on the Federal Circuit seem to believe — and some have allowed — that unexpected results obtained after the filing date can be probative even where the applicant had no clue about the unexpected results. It isn’t even clear that the applicant needs to What’s the “logic” there? How does allowing applicants to previously unknown evidence of unexpected results of a compound — years after their filing date in some cases — promote progress?

      Lastly, while the Supreme Court did invent the Deere factors (and oddly enough I don’t recall any complaints about a “Constitutional crisis” when they did so — go figure), they never said, as far as I know, that each factors was to be treated equally for all purposes or that courts could not place restrictions/guidelines on how the factors were treated in different circumstances.

  5. 10

    Wasn’t this basic point made long ago in In re Davies, 177 USPQ 381 (C.C.P.A. 1973)? In order to rely on unexpected differences in a property, the application must disclose the property at issue.

    1. 10.1

      I think the differing contexts makes Davies not so much on point.

      Here the patentee argues that the skilled person would not have used the prior art molecule as a starting point to arrive at their patented molecule, and so they are not obvious.

      They’re not quite claiming (a la Davies) that their molecule has the unexpected result of being non-toxic. When they developed their molecule, the were shooting for non-toxic and the starting point molecule was also believed to be non-toxic.

      It’s just that, as it turns out, the starting point molecule was later found out to be toxic.

  6. 9

    How can some of these Fed. Cir. judges say that evidence of unobviousness after the “invention” date [I think they meant filing date] cannot be used, when evidence of facts not in existence at the time of filing, such as commercial success and long felt need, CAN be used to establish non-obviousness. That is Sup. Ct. case law – Graham v. John Deere, 383 US148 (1966). It seems quite inconsistent with the logic expressed by some of the judges here? Nor does it make sense. Especially under the AIA, it is essential to file applications as soon as possible, not waiting to file years later after extensive testing.

    1. 9.1

      Sorry didn’t see your post. That is my exact question too above. It sure sounds like even assuming the evidence is otherwise admissible under the federal rules of evidence – CAFC is excluding it as a matter of law? That sounds wrong on it’s face.

    2. 9.2

      How can some of these Fed. Cir. judges say that evidence of unobviousness after the “invention” date [I think they meant filing date] cannot be used

      The judges are not proposing so broad a restriction.

      In any event, if you have trouble with the “logic” that would restrict reliance on post-filing submissions of “unexpected results” where those results were neither contemplated nor disclosed by the applicant as of the filing date, I’d love to know what you think about the “logic” underlying the use of “commercial success” or “licensing” as a factor for evaluating the obviousness of an invention at the time of filing.

      1. 9.2.1

        Hmm…. never argued commercial success myself, but your question got me wondering.

        Can it be correct to say that commercial success of the thing today can be indicative of obviousness at the time of filing (say, 3 years ago), if the commercial success today as measured today shows what was lacking in the marketplace 3 years ago?

  7. 8

    hindsight reasoning arguments need to go both ways. Its most often used to argue against findings of obviousness but to be fair it needs to be recognized when its used to defend nonobviousness as well. The toxicity is a fact that wasnt available at the time of the invention and clearly wouldnt have dissuaded anyone at that time. I dont think this changes anything about obviousness and those crying foul are just greedy for overreaching patent rights.
    As for secondary considerations in general, the courts wont be “chucking” any of them. If anything is consistent in patent law it is that each case is decided on its own facts and the courts have always been adverse to establishing per se rules. That is why software patents are still alive afterall. Call it the benefit of the doubt. Commercial success has always been a weak argument because it invites so much weasling from the business majors who think that making money is the only useful art. But the courts wont axe it categorically since it is potentially relevant for revealing what actually motivates ordinary persons.

    1. 8.1

      edstirling,

      Do you think that “inherency” should go both ways as well?

      Not sure why you would label anyone “greedy for overreaching patent rights,” unless you are resting on your conclusion and want to throw around labels. Also, your notion of “weasling” is out of place. What exactly do you think motivates ordinary persons that use the patent system in the first place? What is the first rule for any business – to stay in business (outside of non-profits, of course). You cannot stay in business unless you make money.

  8. 7

    Overly broad, trivial patents can have a tremendous value due to their blocking effect. I other words: value is not a meaningful indicator.

    1. 7.1

      I do not think that anything that can be labeled “overly broad” can also be labeled “trivial,” do you? Especially as you immediately say that they can have tremendous value…

      Maybe I do not understand what you mean by trivial. Is that a code word for something?

  9. 6

    But that difference was identified only after Bristol-Myers filed for its patent, because the prior-art compound, not having been tested in animals or humans, was not then known to be toxic.

    This decides the issue, because “was not then known” means “was not then known to the public“. The court isn’t going to incentivize applicants not to disclose failings of their machines. This is the exact same issue as the judicial exceptions – even if Congress intended the law to be this way they lack the authority to make patents rules that impede invention.

    Patent attorneys/judges can be so special sometimes.

    1. 6.1

      I am also bothered by the possible negative consequences. An inventor who widely guesses that a compound is toxic before anyone else, and starts working on a way to make the compound less toxic would have to delay his/her invention (or now his/her filing) until the rest of the profession (the public) realizes that the compound is toxic. This is not exactly promoting the progress of Sciences and Useful Arts, is it?

      1. 6.1.1

        An inventor who widely guesses that a compound is toxic before anyone else, and starts working on a way to make the compound less toxic would have to delay his/her invention (or now his/her filing) until the rest of the profession (the public) realizes that the compound is toxic.

        I don’t follow this at all. If you want to patent a less toxic but otherwise arguably obvious compound, all you need to do is (1) identify the compound and (2) provide some data showing that the compound is less toxic.

        That doesn’t seem like too much to ask.

        And I almost forgot: I’m “guessing” that every new compound is less toxic than every existing compound. Does that mean I’m the rightful inventor of every new compound that matches my guess? Of course it doesn’t. That’s not how the patent system works.

        1. 6.1.1.1

          If you want to patent a less toxic but otherwise arguably obvious compound, all you need to do is (1) identify the compound and (2) provide some data showing that the compound is less toxic.

          Is that not what the patentee has done in this case?

          1. 6.1.1.1.1

            I don’t believe BMS knew the prior art compound was more toxic at that time. Later testing (after filing on the new compound) showed the prior art compound to be more toxic than the new compound.

            Going back to your prior question at 6.1, I agree with MM’s take. It’s not that the discoverer (of both the new compound, and the problem/toxicity in the old compound) need wait until the public catches on. They can just provide the proofs/data in their application.

            But again, in this case, I don’t believe they had the data at the time. They created the data later, once the question of obviousness of the new compound in view of the old/lead compound was raised.

            1. 6.1.1.1.1.1

              Maybe BMS did not know the base compound was toxic, maybe it knew but did not have proof yet, and maybe it had just lucky guess. But obviousness does not involves what the patentee knew privately or did not know. I think this is why the patent was found invalid, and would be found invalid regardless whether the patentee had data or not.
              Possibly, if BMS had published data regarding the toxicity of the base compound, and made the invention after the publication, it could have obtained a patent.

              1. 6.1.1.1.1.1.1

                Possibly so. But let’s say they learned of the lead compound’s toxicity while developing the claimed new compound. I still think publishing the data (of the lead compound’s toxicity) in the patent app itself and using it to offset/distinguish the new claimed compound could assist in overcoming obviousness attacks.

                On the one hand you have the usual routine in pharma cases of selecting the closest predicate as “lead” and arguing why the differences in the new compound are or are not inventive in view of what the skilled person knows of that lead compound. Nothing changes in this regard.

                But you balance the above analysis against the idea that identification of a problem unknown to the skilled person, and solving that problem, is also an inherently inventive act.

                That’s why I think in a scenario where the inventors themselves recognize the (e.g.) toxicity in a lead compound, and provide that new data in the app for their new compound, on balance could have gone a long way toward supporting inventiveness.

                1. Recognizing that such “could” assist is one thing, but is such required to be shared?

                  After all, such a discovery of toxicity itself cannot be claimed, and such information may be deemed to be something not to be shared for valid business reasons (why let the competition piggyback off of your work?).

                  Further, the claimed aspect related to the toxicity is – in a very real sense – already shared. The issue of inherency is in play with any such characterisitcs of the item at the time of filing.

                  Is it not fair that the concept of inherency works both ways? If an applicant can lose based on inherency (known or not), why then can an applicant not win based on the same concept?

                2. I agree with you. I would have understood this decision of invalidating the claim(s) better if it had been on the ground of the inventor not possessing the invention (for example not describing that the invention solved the toxicity of the base compound). It is more difficult for me to buy the obviousness argument.

        2. 6.1.1.2

          And I almost forgot: I’m “guessing” that every new compound is less toxic than every existing compound. Does that mean I’m the rightful inventor of every new compound that matches my guess? Of course it doesn’t. That’s not how the patent system works.

          But this issue solves itself, because if it is not in fact less toxic, then it is not in fact non-obvious. If a patent issues due to the non-obviousness being in an untrue assertion, the patent is invalid.

  10. 5

    “Judge Taranto’s dissent basically argues that the panel decision was sloppy and, because it can be read in the extreme way suggested by the petitioner, that it should be modified.”

    That is always a real concern and should be taken srsly.

    Also, the case seems to be simply an instance of filing before ensuring non-obviousness. Sure, they made the compound but they had no reason to think it non-obvious at filing other than just tossing it to the office for an entitlement. It’s just irresponsibility really. And the statute specifically appears to command against taking that late evidence into account.

  11. 4

    Judge Newman seems correct that this appears to depart from the general tenor of past cases, and I agree that such departures from precedent really should be heard and decided en banc (not that anyone on CAFC listens to me).

    That said, I agree with the outcome. To the extent later data contradicts what the field-skilled person at the time of the invention knew (as in this case), it should not (should never have been) available for use in formulating arguments of non-obviousness.

  12. 3

    The practical and cynical result: in-house counsel will kindly suggest to the research scientists that they create an email chain or slide show where in passing they say something like, “We have serious concerns about the toxicity and efficacy of the lead compound, and if not for this particular insight and innovation, we probably would not seek to work with this lead compound.” There is your nugget of teaching away evidence for non-obviousness to present to a jury.

    1. 3.1

      Better choose that scientist carefully because if he/she gets on the stand he/she is likely to be grilled at length about how that slide came to be created.

      Some scientists are really great actors and perform well under such circumstances. But most of them are terrible. That’s why they became scientists and not actors. Or lawyers.

      1. 3.1.1

        MM said : “Some scientists are really great actors and perform well under such circumstances. But most of them are terrible. That’s why they became scientists and not actors. Or lawyers.”

        What does acting have to do with lawyers?

        1. 3.1.1.1

          From the lawyers I have known, they tend to have a great stage presence, that goes a long way toward reinforcing their arguments.

        2. 3.1.1.2

          What does acting have to do with lawyers?

          Sounds like a joke question, but I’m going to assume it’s serious and give you one of many serious answers:

          link to americanbar.org

          Advocates have much in common with actors. For actors and lawyers, the key to a winning performance is not what they say but how they say it. The key to great advocacy, like great acting, is authenticity. Drawing from experience is a basic element of the contemporary actor’s craft. In method acting, the actor reads the script with an eye toward understanding the character, then assimilates the character into his or her own emotional makeup and life experience. Even though the character and the story are fictional, the actor’s performance is based on his or her own truth. It is the truth of the actor’s performance that conveys the truth of the story and induces the audience to believe and become involved in it.

          Great trial lawyers employ this same authentic approach. Trials, regardless of the nature of the issues at stake, always have an emotional component. Lawyers must somehow find ways to appeal to the fact-finders on an emotional level. Instead of simulating emotions by playing the “role” of the angry, disappointed, grieving, or frustrated lawyer, good advocates, like good method actors, bravely allow the jury to see that they are human beings who feel what the facts of the case really cause them to feel. Instead of adopting a courtroom demeanor, such lawyers recognize that they are engaged in a real human drama and that the judge and the jurors are real human beings who react to evidence as real human beings. Authentically sharing or even anticipating their reaction is effective advocacy.

      2. 3.1.2

        Sure, but you can still get a sincere and accurate statement that isn’t egregiously leading.

        In-House: “Would it be fair to say there are concerns or problems with the lead compound? Or even suspicions that don’t have supporting data yet?”

        Researcher: “Sure. But you can say that about almost anything we look at.”

        In-House: “Okay, regardless we should articulate what the specific concerns are and put in on the record, internally. Maybe bounce it off of other groups for feedback.”

        You prompt a legitimate statement out of the scientist, and if on the stand one day, the scientist can honestly say the generated evidence was based on a question from a lawyer, but not demanded by the lawyer and not using legal wording.

        1. 3.1.2.1

          Can you add a comment to help a reader from Europe who has difficulty seeing how such evidence has any relevance to the issue of what was obvious to that legal fiction the PHOSITA. Seriously, if the app as filed is silent as to any toxicity issue, why should any weight at all be given to such evidence?

          1. 3.1.2.1.1

            If you’ve reached the point in a case where you can or need to rely on extrinsic evidence as opposed to just intrinsic evidence (i.e. the spec), a statement like this is easy for a jury to digest as “oh, this is teaching away from use of the lead compound, which means it wasn’t obvious to do or try”, as opposed to whatever you get from an expert witness or technical dictionary.

            1. 3.1.2.1.1.1

              Again very helpful, thanks. Amazing, what can make the decisive difference, in finely balanced cases. Troubling though. While you,re about it, why not just ask the named inventor, was it obvious?

      3. 3.1.3

        LOL How true. While there are exceptions, the only witnesses in patent litigation worse than scientists/engineers are salespeople. No matter how hard you try, in depositions, regardless of the question asked, scientists always seem to go out of their way to give the answer they think the deposing attorney wants to hear, while salespeople give the answer that they think their counsel wants to hear. I’ve been in depositions of engineers where you could probably ask one question and get everything you need just by staring at the deponent and continuing to nod your head in agreement as they go on, and on, and on, when a simple “yes” would have been fully responsive.

  13. 2

    Dennis: Under the statute it seems that post-filing information should only be relevant to showing what PHOSITA would have been thinking back at the critical date.

    I don’t think I agree with this particular expression of the issue.

    First, it’s not just 103 that compels restrictions on the use of post-filing submissions but also considerations of fairness to the public (including the applicant’s competitors).

    Second, post-filing submissions also seem reasonable if a question is raised (e.g., by the Examiner) about the veracity, reproducibility or meaning of data submitted in the original application. Maybe that’s encompassed in your statement about ‘what PHOSITA would have been thinking” but, if so, it wasn’t entirely clear to me.

    Judge Newman, inter alia, walks through the lengthy list of cases that where ex post evidence was relied upon to prove non-obviousness and sees the panel decision here as a major departure.

    Some of the cases in that “lengthy list” were undoubtedly wrongly decided and undoubtedly some of them were cases that were either written by one or more of the dissenters here or endorsed by them. I’m surprised none of them were taken to the Supreme Court earlier because the general proposition that applicants can submit, after the filing date, newly obtained and previously undescribed evidence demonstrating the non-obviousness of a chemical compound is, in my humble opinion, completely bats. The primary concern is that it creates a playground for post-filing mischief where applicants can file upon reams of distinct structures and then create or find the necessary evidence for patentability later. In this way, an applicant can not only poison the well (with disclosures in the spec that prevent others from obtaining patents) but also drink the water (when a valuable property of a compound in the well-poisoning disclosure of the pending application is discovered by a third party and specifically claimed by the patent applicant years after filing).

    I don’t think there’s any question about where the Supreme Court will come out so I look forward to a petition for cert. If nothing else, that might inspire the Supreme Court to start reconsidering the factual and logic support for one or more of the other “secondary factors” that are part of the current obviousness regime (and which aren’t found in the statute).

    1. 2.1

      If nothing else, that might inspire the Supreme Court to start reconsidering the factual and logic support for one or more of the other “secondary factors” that are part of the current obviousness regime (and which aren’t found in the statute).

      Which ones are you concerned about in particular? Outside of the chemical area, I’m not aware of any of the secondary considerations playing any significant role in determining patentability.

      1. 2.1.1

        Which ones are you concerned about in particular?

        Licensing and commercial success as “evidence” of non-obviousness.

        I’m not aware of any of the secondary considerations playing any significant role in determining patentability.

        Unexpected results play a significant role in determining patentability of chem/bio inventions. That’s always going to be the case.

        In contrast, licensing and commercial success play a significant role in driving up costs associated with defending against information-processing patents wielded by NPEs who (i) first seek out “weak” targets who are more likely to take licenses, then (ii) sue commercially successful entities. Given the rate at which such patents are invalidated as obvious when they are challenged by third parties, the probative value of licensing and commercial success in that context is close to zilch.

        Without any positive data supporting the relationship between licensing/commercial success and the legal question of obviousness, the reliance on these particular “factors” by courts achieves nothing except to raise the costs for defendants. (as an aside, it’s not clear to me how often the PTO is presented with such evidence to rebut a prima facie case of obviousness — perhaps someone from the PTO can chime in here).

        1. 2.1.1.1

          Although as you mention the “secondary considerations” are not in the statute, they are in the supreme court’s own caselaw. So if you get your wish (e.g., if they chuck “commercial success”, which you mention above, other others from Deere), it’ll only be through reversing their own precedent….

          …I just don’t see that happening.

          1. 2.1.1.1.1

            I agree it’s going to require some work. And it does to be the case that consideration of the licensing/commercial success factors hardly ever change the result. In part that’s because those factors have already been chipped away at by the courts; in part it’s because judges probably avoid writing decisions that seem to suggest that the licensing/commercial success was a key to their determination that the claims were non-obvious.

            I do think defendants should start routinely (but considerately) attacking the erroneous presumptions and logic underlying those particular factors (when patentees bring them up), in addition to challenging “nexus” and the data straight on. I don’t think any members of this Supreme Court are deeply invested in keeping those factors alive.

            1. 2.1.1.1.1.1

              The presumptions are not erroneous – by definition.

              Presumptions can be overcome and it does make sense to counsel defendants to attack presumptions where such considerations make sense. But this is not new advice.

              But just because a presumption is – or can be – overcome does not mean that the presumption is not a presumption, that it is an “erroneous presumption.” I think the language you choose to use plays too much on the emotional trigger of “erroneous,” implying that the presumption was somehow simply wrong to be there in the first place, that it is unfair to even require the presumption to be rebutted by defendants.

              1. 2.1.1.1.1.1.1

                ” implying that the presumption was somehow simply wrong to be there in the first place”

                He wasn’t implying it, he’s been expliciting exactly that all along in this thread.

      2. 2.1.2

        Btw, DanH: I somehow missed the “outside of the chem area” clause when I initially read your comment. Sorry about that.

    2. 2.2

      From O’Malley’s concurrence in the denial for rehearing en banc:

      [BMS] argue that no medicinal chemist could have had a reasonable expectation of success from use of 2’-CDG as a lead compound because they could not have known if any modification to it would be safe for human use.

      As the district court pointed out, BMS did not question the reasonableness of a skilled artisan’s expectation on these grounds until its reply brief before the trial court and, thus, arguably waived that argument. Bristol-Myers
      Squibb Co., 923 F. Supp. 2d at 674 n.36.

      And, the district court rejected the merits of BMS’s argument, finding that the level of 2’-CDG’s cytotoxicity was not known at the time of the invention and that tentative concerns about the toxicity did not stop researchers from using 2’-CDG as a starting point.

      As the district court said, “the best indication that any such tentative references to possible toxicity did not stop the medicinal chemist from selecting 2’-CDG as a lead compound in the late 1980s and 1990, in light of its positive benefits, is the fact that researchers were actually treating and using 2’-CDG as a lead compound during the relevant time period.” Id. at 662. Indeed, BMS’s own expert, Dr. Bud Tennant, testified that, during his experiments investigating the effects of 2’-CDG against the woodchuck hepatitis virus—which occurred after entecavir’s invention—he was surprised to find 2’-CDG was toxic. Id. at 623–24.

    3. 2.3

      MM, had they filed a CIP disclosing the unexpected toxicity — assuming no other prior art but the prior application assignable to the same company, would that CIP be valid?

        1. 2.3.1.1

          Why would it take out the lead compound? If you were looking for an improved drug to do X, and had a known but now revealed to be toxic drug that did X, wouldn’t that drug remain a good starting point for further research? If anything it would seem to provide further motivation for a researcher to investigate alternatives to the lead compound, as opposed to abandon it.

          A different case would exist if the lead compound, and several other members of that class were found to be toxic, and there were other non-toxic alternatives that were in place. In that case proceeding with investigation into the toxic compound and discovering a non-toxic relative may be non-obvious.

          As a general comment though, doesn’t it seem odd that in the pharmaceutical field the patent reward is being granted to those researchers who don’t do the logical and obvious steps, and instead reward those researchers who do less obvious things and get lucky?

          That approach works in a field where there are thousands of people who will do the obvious research for competitive reasons. Where you have a regulatory environment that requires significant investment and time to produce a new product, it seems that there may be some obvious inventions out there that wont be brought to market, simply because they wont merit a patent monopoly.

        2. 2.3.1.2

          J, I’m still trying to figure this CIP out. If the earlier application is not prior art, and the CIP discloses the toxicity of the lead compound…

          Perhaps it might be better to abandon the earlier application entirely?

          MM, still awaiting your views.

          1. 2.3.1.2.1

            I agree with RH.

            The validity of the claim is considered as of the filing date of the claim. It doesn’t — and shouldn’t — matter how the post-filing evidence is presented.

            1. 2.3.1.2.1.1

              MM, then a fresh application, no CIP, with the unexpected property or new information about toxicity, etc., disclosed.

              Would it make one bit of difference if the claim compound were actually made prior to new information being developed or understood if it is disclosed in the application?

              When was the “invention” made.

              It would seem that even if the information is disclosed, if it were in fact discovered after the compound was made then its disclosure in the application might be irrelevant?

              Does the subtle change in 103 from when the invention was made to when the application was filed materially change this outcome?

              1. 2.3.1.2.1.1.1

                Ned, the issue presented by the appellants here only arises when the compound is prima facie obvious.

                It’s not a question of whether the structure of the compound itself was described as of the filing date. Nobody is disputing that. The issue is whether the prima facie case of obviousness of that compound under 103 can be rebutted by presenting new data that (1) didn’t exist and (2) was not predicted or was not predictable at the time of filing. If you ask me (or a majority of Federal Circuit judges), there’s a huge quid pro quo problem with allowing applicants to obtain composition patents in that manner.

                1. Okay – so of a lead compound is obvious to try, and actually was tried by many as the facts of this case revealed, and if the modifications employed by the inventors were typical, then the later discovery that the lead compound was toxic would not have undercut the initial choice of a lead compound.

                  I don’t know the facts of this case will permit the rule announced here to be extended much farther.

                  So let me ask you this, if this lead compound was obvious to try, and the modifications typical, but it is later discovered that rather than just curing the targeted disease, the resulting compound cures cancer, what then?

                  The cure for cancer outcome would be entirely unexpected. This would almost be like the discovery of the vulcanization of rubber.

                  The questions Taranto is asking are intriguing and thought-provoking, not so?

                2. Trying to reply to Ned’s comment about the compound unexpectedly curing cancer:

                  Let’s say (for the sake of argument) that the compound itself is obvious to make based on references that are not drawn to cancer. If the inventors then unexpectedly discover that the compound can cure cancer, then they have found a (fantastic) new use for an obvious compound. Their discovery is thus the method of using the compound to treat cancer, and they could pursue a patent on such methods – just not on the compounds themselves.

                3. RH, I don’t disagree that one can get a valid claim on the use of the new compound a cure cancer. The question I have is little more nuanced.

                  The debate seems to be whether one should wait to find the utility of the new compound so as to put that utility into the patent application so that one might argue unexpected results. But then I would ask in the case
                  where the cure for cancer was discovered after the obvious compound was made, why would putting the evidence into the patent application make any difference at all if the compound was obvious to try?

                  I don’t think the issue has anything to do with what’s in the patent application or what is not in the patent application. If the compound was obvious to try, no amount of unexpected results should make the compound patentable. In contrast, if the unexpected results discovered after the obvious compound is made render the obvious compound patentable, the question should be, why? And if it is sufficient to render an obvious to try compound patentable, why is the evidence limited to being in the specification?

                  This seems to suggest to me that something is very wrong with this case and the result of this case if unexpected results historically could be used to prove patentability of an otherwise obvious to try compound.

                4. MM, I am not convinced. See my most recent post in response to RH.

                  Unexpected results occur after a compound is made. If a compound is obvious to try, no amount of unexpected results should allow that obvious to try compound to be patentable. In contrast, if unexpected results would render an otherwise obvious to try compound patentable, it should make no difference whatsoever when that evidence is presented.

                5. I agree with Ned, there is something very wrong with this opinion. The opinion holds that it will be untimely to submit post-filing evidence of unexpected results in support of an otherwise obvious “to make” compound. I do not agree. Although I still believe that the opinion does not extend to data in a patent that demonstrates unexpected results, e.g., the non-toxicity of the claimed compound vs. the toxicity of a certain lead compound, the court comes very close to negating such data. Does the court ask us, the examiner, the APJ, the judge to go all the way back to the morning the scientist wakes up from a good night sleep and thinks out loud ‘you know what, I wonder if I modify this lead compound by simply making this one trivial modification’ is the compound at that point in time obvious even before the scientist has his/her first cup of coffee? One can certainly argue that the opinion extends to this point in time. This is the concern of Taranto. Moreover, one can argue that the compound is obvious even before the scientist puts his head to the pillow.

                6. Replying to Ned: “But then I would ask in the case where the cure for cancer was discovered after the obvious compound was made, why would putting the evidence into the patent application make any difference at all if the compound was obvious to try?”

                  If the claim is drawn only to the compound, then the evidence of unexpected results wouldn’t outweigh its obviousness because the evidence (drawn to the method of using it to cure cancer) wouldn’t be commensurate in scope with the claimed invention (just the compound).

                  I don’t think this opinion is saying that post-filing evidence is necessarily untimely. I think it’s saying that the basic property at issue must have been disclosed as part of the invention. This general principle has been around for a while – see In re Davies, 177 USPQ 381 (C.C.P.A. 1973). In this particular case, if the patentee wants to hold up evidence of unexpectedly different toxicity, then the original application ought to have said something about toxicity in order to ensure that the public was apprised of the invention being about the compound’s toxicity. If the application didn’t say anything about toxicity, then any post-filing evidence they develop to compare to the prior art will have to be drawn to some other property that was discussed in the application.

                  To JBarrera: We need to consider obviousness at the time the invention is made. I’m not sure I followed your argument about when the scientist made the compound. But if there’s an obviousness rejection to make, then it’s going to be hard to get a patent on the compound itself. More likely, someone will have to seek a claim on a new use of the compound.

                7. RH, “at the time the invention was made” has been changed in the new statute to “before the effective filing date of the claimed invention.”

                  How does this change your analysis?

      1. 2.3.2

        How would the claims of the CIP differ from the claims of the parent application? The filing date is decided on a claim-by-claim basis, so if the claims of the CIP are the same as the claims of the parent application, then the statements regarding toxicity in the CIP’s disclosure would not affect the CIP’s claims’ filing date. Thus the statements in the disclosure do not establish what was known in the art at the time of the invention of the claimed compounds.

        1. 2.3.2.2

          If the claims do not differ, then do you really have a CIP?

          I think that the premise of the example being a CIP is that there is some dependency on the new matter.

      2. 2.3.3

        Yeah idk ned I thought about some of those situations myself but overall I don’t think there’s any way to get around this other than to wait to file your application until you have the data that would suggest it to be non-obvious.

  14. 1

    Although I will have to read the original opinion again, and have yet to read the opinions denying a rehearing, this case raises a very interesting issue in our 103 jurisprudence. The issue is whether the obviousness to make the compound for a particular purpose from a base compound given the level of skill and knowledge to modify the base compound to the claimed compound at the time of the invention trumps the obviousness of the compound (claim) as a whole, i.e., its structure and inherent properties, In re Papesch? I would think that Papesch controls, but the court majority thinks otherwise. The later unexpected results as secondary indicia, I believe, rebuts the prima facia case of obviousness to make the compound simply because the properties are so significantly different between the base compound and the claimed compound.

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