Although Motivated to Try; No Reasonable Expectation of Success

by Dennis Crouch

Novartis Pharm. v. West-Ward Pharm. (Fed. Cir. 2019)

West-Ward (now known as Hikma) is seeking to make and sell a generic version of the Novartis chemotherapy drug everolimus (Afinitor).  After filing its Abbreviated New Drug Application (ANDA), Novartis sued, alleging infringement of its U.S. Patent 8,410,131.

Following a bench trial, the district court sided with the patentee – finding the claims enforceable – not obvious. Novartis Pharm. Corp. v. West-Ward Pharm. Int’l Ltd., 287 F. Supp. 3d 505 (D. Del. 2017).  On appeal, the Federal Circuit has affirmed.

The claims at issue are method-of-treatment claims with one step — “administering … a therapeutically effective amount” of everolimus.  The preamble of claim 1 indicates that the treatment is for “inhibiting growth of solid excretory system tumors.”  Dependent claims 2 and 3 add limitations that the treatment is for a kidney tumor or “advanced solid excretory tumor.”

At the time of the patent filing, the compound (everolimus) was already known as an mTOR inhibitor; and mTOR inhibiors were known to inhibit tumor growth. Everolimus a derivative of rapamycin and structurally similar to temsirolimus — both of which were already identified as chemotherapy treatments for similar cancer types.

The district court took this evidence and agreed that a person of skill in the art would have been motivated to pursue everolimus as a potential treatment for advanced solid tumors. However, the court’s opinion then seemed to contradict itself by saying that there was no motivation to combine the prior art.   The district court also found that everolimus was one of many different research paths and that the prior art was not sufficient to create “a reasonable expectation of success in using everolimus” to treat advanced kidney tumors.

On appeal, the Federal Circuit rejected the district court’s confusing motivation-to-combine analysis, but agreed ultimately that the claims were not proven invalid (with clear and convincing evidence).  In particular, the appellate panel agreed with the lack of reasonable expectation of success.

Truthfully, this doctrine confuses me.  The claims simply call for administering an effective amount of everolimus to treat a solid tumor; and the courts held that a person of skill in the art would have been motivated to pursue administration of everolimus as a potential treatment. In addition to this motivation, the courts also require clear and convincing evidence of a “reasonable expectation of success.”  You might divide these into “a reason to try” and “reason to believe that the attempt would be successful.”

A party seeking to invalidate a patent based on obviousness must prove “by clear and convincing evidence that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989 (Fed. Cir. 2009) (quoting Pfizer, Inc. v. Apotex, Inc., 480
F.3d 1348 (Fed. Cir. 2007)).

Another way to think about the doctrine here is that a creation that is “obvious to try” would still be patentable if the attempt was unlikely to succeed.  This situation comes up most often in situations involving many different potential solutions and it would be “obvious” to try each one until the solution is found.

Motivation to Combine: Regarding motivation to combine, the Federal Circuit particularly held that the district court had improperly required the patentee to prove that PHOSITA “would have selected everolimus over other prior art treatment methods.”  That heightened standard does not comport with the law and thus is not required.

I’ll note here that the district court’s approach was appropriate in the setup involving modification of a lead compound.  Precedent asks for an indication that the lead compound would have been selected over other potential lead compounds.  Here, however, the compound was already known and the only “new” element is giving an effective amount to a patient for the purpose of treating a particular illness.

The district court … appeared to apply or conflate the standard for these types of cases by requiring clear and convincing evidence that a person of ordinary skill “would have been motivated to select everolimus.” To the extent the district court required a showing that a person of ordinary skill would have selected everolimus over other prior art compounds, it erred. The proper inquiry is whether a person of ordinary skill would have been motivated to modify the prior art disclosing use of temsirolimus to treat advanced RCC with the prior art disclosing everolimus. This question was answered affirmatively when the district court found that a person of ordinary skill “would have been motivated to pursue everolimus as one of several potential treatment options for advanced solid tumors, including advanced RCC.”

Reasonable Expectation of Success: Despite a motivation to pursue treatment, the district and appellate court found that the claimed treatment would not have been obvious because the prior art did not show a sufficiently high “expectation of success.”

Note here that the requirement is an “expectation” of success — would PHOSITA have expected that the drug would work?  In this case, at the time of the invention, there was no clinical data on everolimus (as an anti cancer agent) and no completed trials for the other similar compounds (only phase I safety-focused data).  And, the district court noted that there had been many many past attempts to find a compound that works — most of them starting with some promise.   On appeal, the Federal Circuit found that the rebuttal evidence and arguments made by the patentee were sufficient to defeat an obviousness finding — giving deference to the district court factual findings.

The district court reviewed the [presented] evidence, determined that the molecular biology of advanced RCC was not fully understood, recognized the limitations in the temsirolimus phase I data, and found that such data did not provide a person of ordinary skill with a reasonable expectation of success. We hold that the district court did not err in its determination and affirm its conclusion that claims 1–3 of the ’131 patent would not have been obvious in view of the asserted prior art.

Non-Obviousness affirmed.

58 thoughts on “Although Motivated to Try; No Reasonable Expectation of Success

  1. 13

    Seeing as this is an older thread, this may be worth double posting (below, in context – and here, at the top):

    Just saw a Law 360 article from this week that attempts to parlay this “new” power of the individual State as a (re-powered) reason why Sovereign Immunity applies to any post grant mechanism.

    Worth reminding all that the current view is that Sovereign Immunity does NOT apply (and from the case concerned with Tribal Sovereign Immunity, the holding there did NOT differentiate between Tribal Sovereign Immunity and its kin of State Sovereign Immunity).

  2. 12

    Disappointing that Dennis lacks the courage to permit discussion of existential patent law issues.

    1. 12.1

      Where for now are you seeing restriction or cen sor ship?

  3. 10

    Let’s focus on distinguishing “motivation” as a word unto itself and the full legal phrase of “motivation to combine” by noting this phrase from the write-up:

    Here, however, the compound was already known and the only “new” element is giving an effective amount to a patient for the purpose of treating a particular illness.

    Tracking the difference between mere motivation for any singular item all on its own, who can succinctly provide the different aspect of the phrase motivation TO combine?

    In a case like this, is there truly ANY actual secondary item that is BEING combined?

    Or rather, is there taking that first item and merely doing something with that first item (completely absent any actual different second item?).

    Keep in mind that merely coming up with a new use of a known item MAY be patentable (See 35 USC 100(b)), but also keep in mind that the mechanism of “motivation to combine” may well be inappropriate in a situation where there really are NOT two separate items to be combined.

    If the confusion comes from attempting to use the wrong tool in the wrong situation, we should stop trying to say that the tool is confusing.

  4. 9

    Dennis, you say that you are confused by the two-elements required for satisfying the motivation to combine test, and identify those two elements as:
    “a reason to try” and “reason to believe that the attempt would be successful.”

    Here is a hypothetical: you have cancer that the doctors say is incurable and you are going to die soon. You have a reason to try anything as a remedy. Lord knows cancer patients have put up with every sort of proposed remedy and horribly noxious chemotherapy — they have a strong motivation to try things.

    One option is to apply latex paint all over your legs; you have a reason to try it: you want to cure your cancer.

    But you have no “reason to believe that the attempt would be successful.” Hence painting your legs with latex paint is unobvious. I have no idea if it is a cancer cure, but if it is, it sure is non-obvious.

    1. 9.1

      Nice example. I think in view of KSR too that the two prongs are reasonable.

    2. 9.2

      I wonder if the “reason to try” doesn’t subsume the “reason to believe that the attempt would be successful.”

      Do you have a reason to paint your legs without a “reason to believe that the attempt would be successful.” Probably not.

      1. 9.2.1

        The reason is to paint your legs is so you can see your racquetball better.

        1. 9.2.1.1

    3. 9.3

      This returns to a proper understanding of the phrase “motivation TO COMBINE” as contrasted with the word “motivation.”

      These carry different (albeit similar) meanings, and it is the lack of critical thinking and making sure that overlap is controlled that is a source of the “confusion.”

      But as I stated below,

      Outside of the actual context OF combining, motivation TO combine is simply an inappropriate mechanism.

      “Confusion” from trying to inappropriately use a vehicle is NOT confusion inherent in the vehicle.

    4. 9.4

      Your hypo suggests another interesting question, as to the effect of how specific versus generic as to what is claimed can the “motivation to try” be? E.g., what if painting your legs with some other kind of paint for the same or another medical benefit was in the prior art?

      1. 9.4.1

        I agree that if you change the facts, you may indeed change the conclusion.

        However, I do not agree if the suggestion is that the facts can be assumed without evidence.

    5. 9.5

      Quite so!

      Here is a link to a succinct tour d”horizon of the established (long-standing, uncontroversial) case law of the Boards of Appeal of the EPO, on the importance of distinguishing between a reasonable “expectation of success” and a mere “hope to succeed” (however strongly that hope is felt):

      link to epo.org

      Does that help? Not only in your hypo but also in pharma claim litigation, the facile and hindsight-assisted siren call (dog whistle?) “obvious to try” should always be treated sceptically.

      1. 9.5.1

        Thanks, Max. For once your EPO link made sense to an American. But it leads me to another series of questions:

        In the “obvious to try” or “reason to try” and accompanying inquiry about reasonable expectation of success, it seems to me that the effort required to “try” plays a role. If trying the modification or combination is easy to do with materials readily at hand, does that make the case for obviousness easier? Or, conversely, if “trying” would take extraordinary efforts and a very major investment, does that make it less obvious to try? Is there a sliding scale between how hard it is to try and how likely you expect success to be?

        1. 9.5.1.1

          There is a reason why the Act of 1952 added:

          Patentability shall not be negatived by the manner in which the invention was made.

          The view of “well, that seems easy enough” was recognized to be a trap.

          It would STILL be a trap if converted to be part of a duo-sliding scale mechanism.

        2. 9.5.1.2

          In haste, SVG. See the link below. In it there is another link, to the full text of the Decision. Hot off the press. Perhaps you will enjoy reading it. Hope so.

          link to eplaw.org

  5. 8

    OT, but it is interesting that the Apple anti-trust lawsuit is going to go forward.

    It feels more like the Scotus being legislators to me. They seem to feel that they know how to run the US economy and innovation engine. So now that they have enabled a few giant corporations to exist (if you don’t understand why it is the Scotus that has done this then it is supplemental reading). Now they are going to put some consumer protection controls on the corporations through their legislation.

    Incredibly the ego on the justices.

    1. 8.1

      How many attorneys are complicit in this in treating the Supreme Court as Supreme deities rather than lambasting them when they step beyond their role subservient to the Constitution?

      Let me again point out (without directly challenging you) that I have laid out a detailed multi-prong set of counterpoints expressly showing exactly what I am talking about as to how the Supreme Court has gone beyond their proper role as a portion of a three prong, checks-and-balances, system UNDER the Constitution.

      People of all political/philosophical persuasions (of the Left and of the Right) would do well to heed my words. My words are apolitical and are geared instead to the proper place of the Constitution and the Rule of Law regardless of political or philosophical persuasion.

  6. 7

    just shows that the litigators made a huge mistake by not doubling up on their 103 attack with a 112 Rasmussen/Galantamine squeeze

    reading the specification, there’s no experimental proof at the time of filing beyond some minor in vitro evidence (which the Circuit found was not indicative enough to demonstrate the likelihood of success)

  7. 6

    The sufficiency of the “reasonable expectation of success” to prove obviousness does not look controversial. However, I really wonder if the necessity of a “reasonable expectation of success” will survive a review by the Supreme Court, because 103 does not state that a patent for a claimed invention may not be obtained if, and only if, a person having ordinary skill in the art would have had, before the effective filing data, a reasonable expectation of success for the invention.

    1. 6.1

      Certainly, if the patentee’s lawyers were to present the case properly, the Supreme Court would uphold the CAFC’s case law on this point. On the other hand, I believe (and still believe) that the Court would have also upheld the CAFC’s Myriad decision if the patentee’s lawyers had properly presented the case. That just goes to show that no matter how much is riding on a case, sometimes the relevant party drops the ball.

      1. 6.1.1

        … I believe (and still believe)…

        Er, “I believed (and still believe)…” Mea culpa.

        1. 6.1.1.1

          I am not convinced Greg. Obviousness is a question of law. It has to involve some weighing. It cannot be subsumed by a question of fact, like the “Reasonable Expectation of Success.”
          Of course, the holding may merely be that, in this case, and in this case only, the failure to find a REoS is determinative.

    2. 6.2

      I think PiKa your comment needs to be contextualized with the KSR holding.

  8. 5

    I have the impression that the “motivation to combine” finding is replacing the factual inquiry about whether the prior art relied on is analogous. Both “motivation to combine” and the extent of the analogous art are treated as questions of fact. Also, in the Federal Circuit opinions, the object of the “motivation to combine” is often teachings or references, and rarely claim elements.

    1. 5.1

      PiKa, sounds right. (Of course Stoll is of such low quality it is hard to tell what such a person is thinking. Probably about her ego and how cool she looks in her new clothes.)

      1. 5.1.1

        My point is that the people they have appointed to the CAFC are anti-patent judicial activists and/or are so dismal that they cannot understand either patent or the technology. Some have serious personality issues like Stoll.

  9. 4

    you are twisting my point

    Pretty sure you’re twisting your own point, and also slicing your own baloney. Not sure why you bother but … there it is.

    1. 4.1

      Um… sure – I am twisting my own point….

      Do you even bother to realize how you sound?

      1. 4.1.1

        Some of his material is pretty funny. ‘Night Wiper’ and ‘Derpshirt’ are creative. I don’t think any Supreme Court justices will be assaulted on the street, but anything is possible….

        1. 4.1.1.1

          I don’t think any Supreme Court justices will be assaulted on the street, but anything is possible…

          Once Brett and Company decide that every other person in the country is basically a “birthing vessel” with inferior rights (exception for the rich, of course!) I think you’ll see quite a bit of justifiable violence. I have my bricks ready. The Supreme Court won’t be worth a hill of beans (and hopefully will be reduced to a hill of rubble).

          1. 4.1.1.1.1

            You — advocating violence — are the same one that ridiculous Night Writer for his stand on mere impeachment….?

            Stultifying.

        2. 4.1.1.2

          It is truly rare that Malcolm says anything funny or creative (albeit it has happened).

          Most times — like here — his blight is merely a smokescreen for him having nothing meaningful to say on the legal point at hand.

          It is one thing to be able to wield snark and sar casm that coats a cogent legal point (as I often do), and it is quite another to depend solely on ad hominem and put-downs without any meaningful legal points to be made (as is Malcolm’s modus operandi).

          It’s a bit of a Rorschach test to see who “enjoys” the blight that Malcolm brings. His anti-patent cognitive dissonance is a beacon to the moths of dullards that also dislike the notion of patents.

        3. 4.1.1.3

          OK Martin. You like calling me names like a kindergarten.

  10. 3

    Off-topic but nevertheless potentially interesting to some readers here, Gil Hyatt lost his Supreme Court appeal against the California Tax Board today.

      1. 3.1.1

        Goodness, thinking of long-shot petitions, I just learned this morning (how did I miss this?) that the crazy walnut oil application‘s cert. petition was shot down a few weeks after Prof. Crouch covered it on this blog. No great surprise, of course.

    1. 3.2

      (c) Stare decisis is “ ‘not an inexorable command,’ ” Pearson v. Cal-lahan, 555 U. S. 223, 233, and is “at its weakest” when interpreting the Constitution, Agostini v. Felton, 521 U. S. 203, 235. The Court’s precedents identify, as relevant here, four factors to consider: the quality of the decision’s reasoning, its consistency with related decisions, legal developments since the decision, and reliance on the decision. See Janus v. State, County, and Municipal Employees, 585 U. S. ___, ___–___. The first three factors support overruling Hall. As to the fourth, case-specific reliance interests are not sufficient to persuade this Court to adhere to an incorrect resolution of an important constitutional question. Pp. 16–17.

      The Repu k k ke judges signed on to this. All 4 of the “liberal” Justices did not. Here’s Breyer writing for the dissent:

      It is one thing to overrule a case when it “def [ies] practical workability,” when “related principles of law have so far developed as to have left the old rule no more than a remnant of abandoned doctrine,” or when “facts have so changed, or come to be seen so differently, as to have robbed the old rule of significant application or justifica-tion.” Casey, 505 U. S., at 854–855. It is far more dangerous to overrule a decision only because five Members of a later Court come to agree with earlier dissenters on a difficult legal question. The majority has surrendered to the temptation to overrule Hall even though it is a well-reasoned decision that has caused no serious practical problems in the four decades since we decided it. Today’s decision can only cause one to wonder which cases the Court will overrule next. I respectfully dissent.

      1. 3.2.1

        In other words, the “four factors” of when the Court will over-rule itself WERE met in this instant case (with result against Hyatt), which MAY presage the Court applying (and reaching a similar decision to over-rule itself) in a use of the Kavanaugh Scissors to cut the Gordian Knot of the mess of 35 USC 101.

        Here, the loss by Hyatt may presage a greater win for innovation protection.

        1. 3.2.1.1

          Except that 101 is a statute and it’s been interpreted by most of these same judges in a series of 9-0 decisions. Nice try, though.

          The bigger point is that the Repu k k es really don’t care about state decisis. As was already pointed out to you.

          1. 3.2.1.1.1

            “series of 9-0 decisions” is NOT one of the four Kavanaugh Scissor factors.

            You miss the bigger point here as to the framework of just when stare decisis will be “cared for” or not.

            Combine this with the other shear of the holding of the Schein case — just in case you want to actually engage in a legal discussion.

            1. 3.2.1.1.1.1

              You miss the bigger point here

              The bigger point is that you’re an i di 0t who is reliably wrong about pretty much everything. Not less than ten days ago I raised the issue of stare decisis and the view of the Repu k k ke majority regarding same and you pretended it was a “both sides” issue. Because you’re an id i 0t.

              Now additional evidence supporting my observation is put right in your face and you just dig deeper. Because you’re an id i 0t.

              “series of 9-0 decisions” is NOT one of the four Kavanaugh Scissor factors.

              LOL Lyin’ R@pin’ Brett is a prep school t u rd licker whose deplorable snarling mug will be roundly punched in, in public, before he croaks. Nobody cares about his “scissors” except to the extent it’s used to chop off his tiny useless nuts so they can shoved into Stolen Seat Neil’s mouth.

              1. 3.2.1.1.1.1.1

                All I see here is your emotional response of empty and ill-aimed ad hominem.

                Do you not realize yet that EVERY time you engage like this you only make my posts stronger?

                Try — instead of being enraged — being engaged (on the merits – in an inte11ectually honest manner).

    2. 3.3

      If it had been Trump instead of Hyatt Kavanaugh would be running around screaming stare decisis hoo hoo hoo.

      1. 3.3.1

        Of this has been Trump, do you think that the four liberal judges would have taken up the Kavanaugh position that you Kavanaugh abandoning?

        Malcolm’s prior quip if only one party afflicted with politics is absurd.

        As is your post here (not as absurd as Malcolm’s mind you, but still it is absurd as it misses the bigger picture to focus on the projective politic).

    3. 3.4

      Not actually off topic, because the Supreme’s latest and now 5-4 Gilbert Hyatt decision [number 3] is by the new conservative majority. Yet it admits that it is not following stare decisis in overruling a longstanding prior Sup. Ct. decision, and further admits that this decision is not specifically required in Constitution text and effectively is applying the “penumbra” theory supposedly despised by strict constructionist conservatives. I.e., those who think the Sup. Ct. will become much less “activist” with appointment of yet more conservative Jesuit school graduates, and follow more ancient Sup. Ct. patent case law that they think applies, may be in for surprises.
      [BTY, as understood, I think I might personally agree with this actual decision’s reportedly baring of private state court suits in one state against state governments in other states based on respect for state sovereign immunity based on other indications in the Constitution?]

      1. 3.4.1

        Besides the Law 360 article, I also saw a Greg Aharonian piece lambasting Justice Thomas for the items you mention, Paul.

    4. 3.5

      Just saw a Law 360 article from this week that attempts to parlay this “new” power of the individual State as a (re-powered) reason why Sovereign Immunity applies to any post grant mechanism.

      Worth reminding all that the current view is that Sovereign Immunity does NOT apply (and from the case concerned with Tribal Sovereign Immunity, the holding there did NOT differentiate between Tribal Sovereign Immunity and its kin of State Sovereign Immunity).

  11. 2

    Truthfully, this doctrine confuses me.

    ITS A GRODIN KNOT TIME FOR TEH CAVEMANLAW SISTERS TO JUSTIFY THE MEAN

    1. 2.1

      Your attempt at humor is noted.

  12. 1

    I posit that some of the possible professed confusion comes from the word “motivation” itself.

    I have noted for awhile now that the phrase “motivation to combine” should not be confused with the word “motivation.”

    Motivation – and and of itself – is ridiculously easy to find and actually quite divorced from the innovation hurdle of looking at a PHOSITA and that legal fiction combining various items that admittedly exist in the art.

    If we “allow” (or ‘confuse’) mere motivation to negate patentability, then nothing would be patentable except things that would come in two flavors:
    1) Flash of Genius, and
    2) Pure Serendipity.

    For either of these things, the very reason for having a patent system (innovation breeding more innovation) would not be promoted, as neither Flash nor Serendipity need be based on the shoulders of those that came before.

    1. 1.1

      the phrase “motivation to combine” should not be confused with the word “motivation.”

      Agreed that the term “combine” is not helpful in every context, and can make the analysis seem awkward.

      The motivation to try the recited compound for treating “solid excretory system cancers” was easily established in this case:

      Everolimus a derivative of rapamycin and structurally similar to temsirolimus — both of which were already identified as chemotherapy treatments for similar cancer types.

      To reach a conclusion of non-obviousness, what needs to be established next is that there wasn’t a reasonable expectation of success. This evidence could take a number of different forms. For example, the patentee could show that there are several hundred equally “structurally similar” compounds to the three compounds identified above and, of those compounds, only a tiny handful were identified as chemotherapy treatments. Another angle is to show that the results are achieved with recited dosages that are substantially lower than the other compounds, so that there are less side effects. Another angle would be to show that the recited compound and its structural similarity were recognized for a long time and yet nobody bothered to test it because the expectation of success was low relative to say, modifying the existing compounds (ideally corroborated with independent testimony). And so forth.

      1. 1.1.1

        Agreed that the term “combine” is not helpful in every context, and can make the analysis seem awkward.

        You have an odd way of agreeing with me, seemingly wanting to misapply the very point that I am applying.

        Outside of the actual context OF combining, motivation TO combine is simply an inappropriate mechanism.

        “Confusion” from trying to inappropriately use a vehicle is NOT confusion inherent in the vehicle.

        1. 1.1.1.1

          You have an odd way of agreeing with me

          Not nearly as odd as your response to that agreement.

          1. 1.1.1.1.1

            There is nothing odd in my response as that response notes specifically how you are twisting my point.

            Why would you find it “odd” that I note such?

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