Obviousness for Pharma/BIO

The new petition for writ of certiorari in MacDermid v. DuPont focuses on the central question of U.S. patent law – obviousness. In the case, the patent challenger asks that the Supreme Court reinvigorate the doctrine with flexibility – especially with regard to the ‘unpredictable arts.’  The question presented:

Whether the Federal Circuit has erred in holding that there “must” be a proven “reasonable expectation of success” in a claimed combination invention in order for it to be held “obvious” under 35 U.S.C. § 103(a).

It is a well known secret that both the USPTO and the Federal Circuit treat pharmaceutical and biotechnology obviousness cases differently than they do electronics, software, and mechanical inventions.  This has to be kept a secret though, because both are applying the same law and the same Supreme Court precedent.  The case here looks to rejoin the two — in a way that makes it easier to invalidate the pharma/bio patents.

Read the petition: MacDermid

65 thoughts on “Obviousness for Pharma/BIO

  1. I read the petition, and this is a bad case for whether a reasonable expectation of success is a good analytical element. While overheating was a problem in the art, and fan cooling a fairly common-sense solution, the Board was troubled by the risk of too much cooling that was not addressed. The Board finding that finding an amount of cooling sufficient to protect the plates from heat could be found by an ordinarily skilled artisan would seem to cover that, but maybe not. Cooling below a certain point and managing a temperature range are two different things. If anything, ignoring possible problems with the combination is the restricted analysis, i.e. the analysis petitioner is asking for. I think for certiorari asking for a less restricted analysis, you should at least offer a less restricted analysis not a differently restricted analysis.

    1. Obviously this is only my opinion, but I’ve now read the cert petition and also the PTAB decision, and I agree with what you say and I also think the petition only poorly reflects the PTAB’s positions…

      1. Re: “..for certiorari, asking for a less restricted analysis, you should at least offer a less restricted analysis not a differently restricted [or broader in some respect?] analysis.”

        That sounds like a replay of the bizarre upside down fact pattern in the Cuozzo Cert? [A kind of cert petition not doing the P. Bar any favors even if granted?]

        1. Mr. Morgan,

          I do not think that you grasped one possible nature of the Cuozzo cert (see my previous discussions on widening the coverage of land so that one may THEN narrow to a different section of land… Making the parcel of land larger such that one can move a claim from a swamp portion to a beachfront portion).

          You only seem stuck on “going from swamp to a larger parcel

  2. I’ve just started skimming the cert petition and so I’m not sure why Prof. Crouch posed this case as having any applicability to the bio/pharma/chem so-called “unpredictable” arts, unless it was just to say that it comes up more often in those arts.

    Anyway, involved here is really a mechanical apparatus and process invention. The patent involved in this McDermid/duPont case is US-6797454 (PTO link:link to patft.uspto.gov).

  3. I haven’t read the petition and I don’t recall the case so I’m not familiar with the specific facts of the instant case.

    But there is definitely a problem (multiple problems, more likely) with declaring arts to be “unpredictable” or not, and relying too heavily on that status.

    The major problem is that while many aspects of a particular art may be more “unpredictable” than other aspects, not all aspects are going to be “unpredictable.” As time goes by and knowledge increases and synthesis methods evolve, we can expect aspects of the art that were once “unpredictable” to become very predictable indeed. That has certainly happened in the so-called “chemical arts”.

    On the flip side, there are going to be aspects of so-called “predictable” arts that are not “predictable.” Every claim shouldn’t be treated the same just because it falls within some broadly defined “predictable art.”

    In the chem/bio context, I think both the courts and the PTO “get it”. Many examiners in chem/bio have a good understanding of what sort of result is/was “reasonably expected” and the entire field isn’t treated as if it was born yesterday. That’s not true, unfortunately, for the computer-implemented arts, where Examiners have routinely genuflected before ridiculous claim elements like “remote server” and “wireless” (not to mention a zillion abstractions laid on top of “data”) as if nobody ever contemplated or successfully implemented those modifications to a computer before the applicant.

    1. “I haven’t read the petition and I don’t recall the case so I’m not familiar with the specific facts of the instant case.” Shouldn’t you stop here? Why post when you know nothing?

      1. “I haven’t read the petition and I don’t recall the case so I’m not familiar with the specific facts of the instant case.” Shouldn’t you stop here?

        To please you? LOL

        I discussed the related issues of “unexpected results” and “unpredictability” independent of the facts of the case.

        Why post when you know nothing?

        If only you would ask yourself that question more often. In the meantime, here’s a kleenex. Dry those tears, PB. It’ll all be over soon.

        LOL

  4. The CellzDirect opinion published today. I thought that was a more interesting 101 case than Sequenom, as I wrote here earlier.

    The CAFC panel here (Prost, Moore, Stoll) vacated the district court’s summary judgment that the claims at issue were ineligible because they were “directed to a law a nature.”

    1. A method of producing a desired preparation of multi-cryopreserved hepatocytes, said hepatocytes being capable of being frozen and thawed at least two times, and in which greater than 70% of the hepatocytes of said preparation are
    viable after the final thaw, said method comprising:

    (A) subjecting hepatocytes that have been frozen and thawed to density gradient fractionation to separate viable hepatocytes from nonviable hepatocytes,

    (B) recovering the separated viable hepatocytes, and

    (C) cryopreserving the recovered viable hepatocytes to thereby form said desired
    preparation of hepatocytes without requiring a density gradient step after thawing the hepatocytes for the second time, wherein the hepatocytes are not plated between the first and second cryopreservations, and wherein greater than 70% of the hepatocytes of said preparation are viable after the final thaw.

    Note the major distinction between this claim and Sequenom’s claim: this claim isn’t a method of detecting a phenomenon using a prior art detection technique (per the panel here: “The existence and location of cffDNA is a natural phenomenon; identifying its presence was merely claiming the natural phenomena itself.”).

    1. Isn’t it directed to the natural law of survival of the fittest: i.e. to the DISCOVERY that if they could deal with freezing once, chances are they can deal with freezing a second time?

  5. Except any intellectually honest person (I know there are only a couple left) would say that Alice has overturned KSR.

    So, if the justices want to really address obviousness, they need to address the new laws they made in the Alice line.

    1. I will also disagree with your post here, Night Writer.

      I think you stretch this too far. I do “get” that you think that the effect of the Court’s (deliberate?) muddling of patent law is one that makes even the KSR decision a mess, but I think that the recent Royal mess is NOT meant by the Court to overrule the 103 decision.

      Yes, there might be an effect, and there certainly would be inte11ectual DIShonesty to say that there is NO effect, but the terminology you attempt to use is not the correct terminology.

      1. anon, in fact, KSR is overturned by Alice. It really is the right terminology. Any judge can use Alice to invalidate a claim rather than 103. That very fact means KRS is overturned by Alice.

        1. That is not what the legal term means.

          As I said, I “get” what you are trying to say, but the words you are using are just not correct.

  6. That the unpredictability of combining various of millions of possible chemicals is a valid part of a 103 test is no secret, and still logical, as long as, with modern science, it really still is unpredictable.

    1. If its unpredictable, then how do they come up with the chemicals? Infinite number of monkeys with an infinite number of test tubes? Clearly, there is a level of predictability….

      1. Actually, what some do isn’t too far from that. They make all these different chemicals and then run them through the water of zebra fish to see if the chemical affects the zebra fish.

          1. We were discussing predictability. My assertion is that Chemistry is predictable, else, what are the text books for and why did we have to learn about ionic and covalent bonds and energies of reaction and yadda yadda yadda.

            1. Funny, I was discussing 103.

              Are you trying to use “predictability” as some type of proxy for 103?

              I am pretty sure that the point that you are driving at is that you want to contrast how some people insist on treating 103 and the point here about “predictability” renders the use of 103 to obtain the per verse result that the only things patentable are the “Flash of Genius” or the complete “oopsie, how did I get that” types of things – which are completely against the express purpose of Congress in carving out the new section of law of 103 from that prior single pre-1952 paragraph.

              1. You were discussing? You weren’t even a part of the discussion. Paul made a post. I made a post in response and Night made a post in response to me. That’s when you chimmed in….

                1. …and my chiming in makes me a part of the discussion.

                  You might want to read the post that you responded to Les, as that post did include the notion of the law of 103.

                2. Night was responding in regard to my comment regarding an infinite number of monkeys, which had nothing to do with 103.

                  Maybe you should read the posts YOU are responding to.

                3. The entire chain (with the start as I mentioned) has to do with 103.

                  You want to “get upset” that you meant for your tangent to not be about 103….?

                  Lighten up Francis.

                4. Paul’s post mentions 103, to be sure. But YOU weren’t discussing it. Moreover, neither was I and neither was Night. Night and I were discussing predictability and alleged specialness of the chemical arts for their alleged unpredictability.

                5. For you to say that is was not discussing 103 – AND complain that I was discussing 103 (when you were discussing “predictability”) is utterly inane.

                  Maybe you want to stop and think for a second, Les.

                6. I’m not complaining about anything. Merely pointing out that at 5.1 and 5.1.1 people other than you were discussing things other that 103. At 5.1.1.1 you mentioned 103 in a two sentence post and said you didn’t understand the point. I then explained the point to you at 5.1.1.1.1.

                7. B$ Les.

                  You got in a tizzy about my “responding” and the thread “not being about 103, and YET – your very response at 5.1 WAS to a post with 103 (your post at 5.1.1.1.1.1.1 contradicts what you say in your last post, btw).

                  Then you went into a tizzy about my calling you out for going into a tizzy.

                  NOW you want to say that you “explained things”…

                  The only explanation from you that fits is an apology and an admission.

                  And then you can stop being an @$$, and read my first post and see that it fits the conversation.

                8. I was not and am not in a tizzy.

                  However, your use of dollar signs and at signs suggests you might be.

                9. The dollar signs are to avoid the filter – you were in a tizzy and oddly still refuse to recognize just how off you were.

                  But hey, the black and white here will not change with you wanting to plod on in being wrong, and does not change the fact that you have yet to own up to your blunders.

                10. Right, you wanted to use foul language as you are in a tizzy and you used the dollar signs and at signs to get your tizzy induced foul language through the filter.

                  I am not and was never in a tizzy at any point why posting under 5.0.

                  Any tizzy is in your head.

                11. Using course language does NOT equal “tizzy” my friend.

                  Some of us have some military background where that type of saltiness is de rigueur.

                  You whine pointlessly, then are busted for whining pointlessly, and all you can do is attempt some rather lame spin.

                  Once again, lighten up Francis.

                12. You were the one whining that Night had not paid sufficient respect to 103. I did not whine. I merely answered your rather rude post with a civil explanation.

                  Thanks for your service.

                13. Straight up prevarication does not work well for you Les.

                  First, I was not rude at all to Night Writer (let him complain if he thinks that I was being rude for bringing the discussion BACK to 103).

                  Second, You WERE in a tizzy and quite the snotty one at that: “You weren’t even a part of the discussion.” LOL – that’s some “civil explanation.” And to which I gave you a TRUE explanation, which sent you even deeper off the end, trying to disregard the FACT that the initiation of this sub-thread WAS about 103.

                  The plain black and white above is not something that you can change with your attempt at rewriting history.

                  Face it, Les – you are completely and absolutely in the wrong here.

                  “Service” that.

            2. Les, you need to go to work in a medicinal chemistry lab for a few months. I did it for 20 years, and I can tell you that the level of predictability in chemistry, although it improved greatly even over that short time period, is still far less than in any of the mechanical arts. On a single research project, me and about 25 other people each made approximately 200 new compounds a year, molecules that had never before existed, and tested them to see if they had our desired biological activity. This is after using the most advanced computer prediction tools and modeling software and batteries of screening tests on our enormous library of millions of previously synthesized compounds to try to hone in on the most likely structural elements. After a couple of years of that level of production, we might have some dim view of what sorts of chemical structures would be effective, and could begin honing in on something that might one day become a drug – after another ten years of increasingly resource-intensive research. Assuming, of course, that the structures we drew on paper could actually be synthesized. More often, we would exhaust our creativity without finding anything useful, and drop the project. Not quite an infinite number of monkeys, but the principle is the same. We avoid infinity only by creative insights into which compounds to attempt to synthesize next and what the biological results actually mean, some of the insights opening whole new vistas of research landscape and others leading to brilliantly useless dead ends that might take years to tease out.

              Sure, chemical reactions that were first discovered 100 years ago have become much more predictable and can be taught to and used by graduate students and even some undergrads, but the people who learned how to predict them and taught the rest of us earned and still earn well-deserved Nobel prizes for it. And yes, occasionally some perfectly predictable chemistry will give perfectly predictable analogs of known active molecules which have perfectly predictable biological activity. But that is by far the most unlikely outcome.

              Remember that heroin was first synthesized from morphine in an attempt to generate a non-addictive opioid painkiller. I would call the result unexpected. Thalidomide causing severe birth defects if administered as a mixture of stereoisomers but not if the active isomer is administered separately was unexpected. Synthesizing an active compound with desired biological activity and an acceptable safety profile is about the most unexpected research outcome that can be imagined, and is only achieved at the cost of thousands of other compounds being synthesized and dozens of research teams failing to achieve anything beyond another way not to solve the problem. Name one other industry that has to make so many prototypes to come up with even one working model.

  7. It’s a combination of old elements with no new function. A&P Tea and Sakraida control. Sakraida supplies the rationale and you don’t need a motivation. So what’s the rationality behind applying the reasonable expectation of success? RES goes towards the plausibility of a motivation, but a motivation isn’t in play here.

    1. You always need motivation.

      Always.

      Sometimes the motivation is excessively easy, but you do not get to eliminate any items just because you may feel that they are easy.

      And hey, I am “with you” on the whole mere aggregation thing – your views on 103 are still wrong though, notwithstanding my sharing your propensity towards mere aggregations.

      1. You always need motivation. Always.

        No, you always need a rationale as to why it is obvious. That the art would be motivated to make a modification is simply the most common example of that rationality being fulfilled. There are all sorts of things that people can do that lack an identifiable motivation and yet are entirely obvious.

        Take simple substitution for example. Suppose you swap element B in for element A. B is worse in every possible manner – it’s more expensive, it’s heavier, it causes the system to function poorly, etc. But element B is a recognized substitute for element A. The system that uses B is obvious, because recognition of equivalency is a rationale that the modification is an obvious modification. The fact that no one of skill would be motivated to work harder for a worse system is irrelevant, because the motivation is not necessary for the rationale that underpins an obviousness holding.

        Its an important distinction, because a reference that explicitly states “You definitely can use element B in place of element A for this, but it will create an inferior system” admits the equivilency but motivates away. Regardless of the motivation, the result is obvious subject matter because the substitution was posited, see In re Gurley 27 F.3d 551, MPEP 2145.

  8. The PTO is wise to divide up incompatible subject matter. The Supremes should support them in doing so.

    Ideally at some point Congress should catch up and divide chemicals and pharmaceuticals from the more widely abused subjects and provide for different standards and procedures. Until then, the informal norms will have to suffice and courts should defer.

    1. There are many areas of law where, in the abstract the standard is the same, but in practice it reflects realistic differences. In negligence law for example, you’re always dealing with a “reasonable person under the circumstances” – but the rub is always what those “circumstances” are and what they would prompt that “reasonable person” to do.

      1. There is no analogous “circumstances” to the higher level of law here though Ken.

        There is such an analogy when it comes to being within any art due to the legal nature of Person Having Ordinary Skill In The Art.

        But the PHOSITA angle is not in play in the immediate discussion.

    2. This debate comes long after there was the same debate amongst the different specialist Technical Boards of Appeal at the EPO. In the past, the chemical Boards resisted the notion that the Problem and Solution Approach (as applied for decades in engineering areas) was also fit for assessing obviousness in chem/bio.

      Then, at long last, the penny dropped so that now at the EPO the same Approach to obviousness works just as well for chem/bio as it does for engineering cases.

      As Max Planck pointed out:

      A new scientific truth does not triumph by convincing its opponents and making them see the light, but rather because its opponents eventually die, and a new generation grows up that is familiar with it.

      So it is also, with ways of assessing what claimed subject matter was “obvious”.

      1. Chem/bio IS engineering.

        Your use of terms is not standard for this discussion, and evidences more your odd “understanding” than anything else my friend.

    3. Abuses? I read that one of spanglburgs IPR para challenges was for the speckles in the tablet – as the pharma active compound had long expired.

  9. I have an idea for The Supremes: let’s water down the 103 test as the petitioner here proposes to do, then incorporate that lower standard into the conflated 101/103 analysis of Myriad/Mayo/Alice. Stop pharma patents now, because new drugs are a Bad Thing!

  10. Unpredictability vs Novel components is a policy decision on what type of activity you think patent law should promote. The law right now says both, the statute also does in its plainest meaning.

    If we don’t want massive amounts of rote experimentation to lead to patents, we should change the law to read that.

    Just my 2¢

    1. Alex,

      From a historical perspective, what do you understand the legal phrase of “Patentability shall not be negated by the manner in which the invention was made.” to mean? Why do you think that phrase was added?

      1. Anon, you points about the current SCOTUS overturning the ’52 Act – are becoming more and more evident with each incremental decision. And since as you noted above – the law on the books is already being intentionally ignored by SCOTUS – The only matter left is the strip jurisdiction from SCOTUS.

        1. Not just the current SCOTUS.

          The Court had grown accustomed to the addictive power of having a “common law” power (as had been allowed by an earlier Congress). That type of addiction is very difficult to overcome, and the Court has simply become more and more bolder (moving even from “implicit” to “explicit” re-writings of the words of Congress.

          Note as well that this “ease” of changing patent law has not been lost on “amici,” who very often beseech the Court to tread in the waters “best left for Congress.” (See Chakrabarty for the somewhat rare realization that the Court itself has very real limits).

      2. “Patentability shall not be negated by the manner in which the invention was made.” to mean? Why do you think that phrase was added?

        Tell everyone exactly what you think it means, “anon.”

        1. You first.

          (Here’s a hint: Alex’s comment impinges on the very thing that Congress says is not important. Here is another hint: ANY semblance of needing some type of “Flash of Genius” was something expressly that Congress was reacting against in the (so-called-merely-HAH) “codification” that happened in 1952.)

      3. Which is exactly why I said, “If we don’t want massive amounts of rote experimentation to lead to patents, we should change the law to read that.”

        You are tilting at windmills.

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