Impact of KSR v. Teleflex on Pharmaceutical Industry

For the past 30 years, Cal has been a litigation analyst serving the investment community. He is member of the New York Bar and a graduate of Northwestern law School. www.litigationnotes.com.

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By Cal Crary:

We do not believe that too much guessing is needed to see what the new patent environment will be like, since we already have the benefit of Chief Judge Michel’s March 23, 2007 decision in the Norvasc case, in which he identified the likely changes in the court’s obviousness jurisprudence. . . . A few of the principles reflected in Judge Michel’s opinion are as follows:

  1. routine testing to optimize a single parameter, rather than numerous parameters, is obvious;
  2. an approach that is obvious to try is also obvious where normal trial and error procedures will lead to the result;
  3. unexpected results cannot overcome an obviousness challenge unless the patentee proves what results would have been expected;
  4. a reasonable expectation of success does not have to be a predictable certainty but rather it can be an expectation that can be satisfied by routine experimentation; and
  5. motivation can be found in common knowledge, the prior art as a whole or the nature of the problem itself.

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[T]here are certain types of patents in the pharmaceutical industry that will have to be looked at, or looked at again, in light of the Supreme Court’s opinion. We happen to believe that enantiomer patents are especially vulnerable, at least in cases in which the technology to separate them was available in the public domain at the time the separation was made. However, we do not believe that the courts will permit a massive extermination of drug industry patents or that a meat-axe approach to them will be used. Rather, we think the Supreme Court’s only demand is that common sense be injected into the determination of what a person of ordinary creative skill in the art would do. The primary examples of enantiomer patents that we regard as vulnerable include Forest Labs’ Lexapro, Bristol-Myers’ Plavix, AstraZeneca’s Nexium and Johnson & Johnson’s Levaquin. We think that all four of these drugs are especially vulnerable now, in light of the new, broader scope of obviousness. In the case of Levaquin, Mylan Labs lost at the district court level in a case that it should have won, even under the law as it existed at the time, and then it was affirmed by Judge Pauline Newman, a pro-industry Federal Circuit judge, in a non-precedential decision without opinion. In a new case, if obviousness is in the mix and if Judge Newman is avoided on appeal, then Levaquin will be a generic drug.

Forest Labs’ Lexapro: Forest won this case before Judge Joseph Farnan, a strongly pro-patentee judge in the U.S. District Court in Delaware, and is scheduled to defend the decision in the Federal Circuit on May 9, 2007. Since the lower court gave no meaningful analysis of the obviousness issues, we think that a reversal in light of KSR would be reasonable to expect so as to give the lower court a chance to consider these issues again. We plan a report on the case later this month.

Bristol-Myers’ Plavix: The district court trial is over, post-trial briefs have been submitted and the case is under submission to the district court judge, who will probably be influenced by the Norvasc decision, in which obviousness invalidated the patent where there were a relatively small number of options to try. AstraZeneca’s Nexium: This slow-moving case in New Jersey is in the pre-trial phase, but is subject to the fundamental problem that separation of the enantiomers of omeprazole is likely to be considered obvious.

Procter & Gamble’s Actonel: Trial of this case was completed before Judge Farnan in Delaware last November, and the post-trial briefs were submitted in January of this year. Teva’s fundamental argument is premised on obviousness, and therefore it would have had little chance of winning prior to the KSR and Norvasc decisions. That said, we think that Judge Farnan is unlikely to change his pro-patentee bias, but a Teva win could come out of the Court of Appeals.

11 thoughts on “Impact of KSR v. Teleflex on Pharmaceutical Industry

  1. In an attempt to get the thread back on track, with respect to pharmaceutical inventions the Edison invention paradigm (invention through mindless labor-intensive repetition leading to improvement) still dominates. Businesses thrive based on luck and their skill in identifying which problems are amenable to solution through brute force, albeit efficiently executed.

    The determination of the obviousness of these inventions begs the question (actually the question is hardly ever raised): who is the “inventor”? For example, when asking the question, “Which genetic marker is most closely linked to Disease Y,” who is the inventor? The guy who selects the robust group of subjects whose genes are analyzed? Or the guy who puts the DNA in the machine for sequencing? Or the guy who runs the data in the machine through the computer which looks for significant associations between the gene and the disease? Or is it the CEO who recognized that the problem could be solved and protected with a patent?

  2. link to en.wikipedia.org

    Many people refer to Edison’s work as the first incandescent light bulb with high resistance, a small radiating area, and a commercially and uninhibitally but still useful lifetime. In other words his application for patent was presented as the only design suitable for use by large energy companies like the one he owned and ran. However, the US Patent Office ruled on October 8, 1883 that Edison’s design was based on the prior work of William Sawyer and his application was thus invalid. Edison had already lost an earlier patent dispute in British court when it was found that Joseph Swan received a patent in 1878 for the same bulb that Edison tried to claim as his own in the US in 1879. [8]

  3. The point about Edison’s light bulb experiments was that (a) he did not know whether any of the materials he tested would work because a satisfactory incandescent lamp had never been made before, and (b) he did not know what was the material which could be made to work. It was true blue-sky research with nothing to guide him. Very much like the experimentation carried out by Big Pharma even today when they are looking for new active compounds.

    Sorry, Jim, but if you had put Edison on the witness stand, he would not have given answers like those in the Norvasc case because the problem that faced him was orders of magnitude more difficult than the problem in Norvasc, and because he was a pioneer, not a routine developer. He would have protested indignantly against the postulated line of questioning and the facts would have been on his side.

    Edison was an empirical researcher, and when he started out empirical research was pretty much all that there was. His major discoveries included sound recording, the carbon microphone (of key importance for the telephone), alkali batteries and the Edison effect which pointed the way to diode and triode valves. Many of his patents, I think, would have stood up. On the way he pioneered research laboratories with groups of inventors working together, as is commonplace today.

    It is not fair to compare Edison to Tesla, who came later and had the maths necessary for systematic as opposed to empirical research. Without Edison there could have been no Tesla.

  4. “Where KSR refers to “a finite number of identified, predictable solutions”, the key word is “predictable”.

    Don’t discount the impact of the term, “finite”. If you have ten choices to consider versus 10,000,000, that’ll make a difference, regardless of whether it is predictable that one will work.

    Also to be considered will be the extent to which the “discovery” was one which actually required some diligence and creativity versus merely sweat. As was pointed out here several months ago (by way of a lengthy article on the history of 103) the obviousness regime was put in place at the behest of the pharma industry which was not engaged in typical problem-solving so much was it was engaged in pure discovery along the lines of “mining.”

    If everyone knows that a mutation in Gene X is involved in Disease Y, what purpose is served by granting a monopoly on the first person who discovers that mutation simply by throwing a blood sample on an Affymetrix chip?

    And the crucial question in every case will be: how broad are the claims? It’s not ususual for applicants to demonstrate two or three of the ten thousand choices and then attempt to claim the genus. That practice was ALWAYS a set-up for invalidity down the road, particularly when the patentee tried to hose a well-heeled defendant who had done at least as much work to identify a novel compound which allegedly fell within the scope of the genus.

  5. I can see Edison on the stand now:

    Q.: And one of the reasons why you chose these various materials is because you expected that you would be able to make a filament of them, correct?

    Edison: There was an expectation, but that wasn’t guaranteed.

    Q.: And when you chose these materials, you believed that if you could, in fact, make a filament out of them, these might provide a durable light bulb, correct?

    Edison: Indeed.
    ———————-

    Kevin Noonan hit the nail on the head: When a scientist tries to solve a problem with a particular material or procedure, it’s always with the expectation that it *might* work — why else do the experiment? And these expectations are based on the known properies of the material or the known consequences of the procedure.

    An enantiomeric drug invention involves trial and error, to find out whether or not all the desired activity does in fact reside in a single isomer. Asking the question is obvious, and there is a bookshelf full of teaching and suggestion and motivation to separate the isomers and test them — but it’s never obvious what the answer will be.

    The holding in KSR may have given us the Person Having Ordinary Skill And Creativity In The Art, but it will still have to be balanced against the principle that an “Edisonian” invention, arrived at by trial and error methods, is nonetheless patentable. Where KSR refers to “a finite number of identified, predictable solutions”, the key word is “predictable”.

  6. Edison “invented” the light bulb by trying one metal filament after another and patented the one that worked best commercially. If you have 1,000 different strips of metal representing all known possible metal strips and run current through each one to find out which one will be the best commercially, one of them will be the best commercially. It was obvious to try all known possible metal strips and the outcome of one of them being the best commercially was inevitable and obvious. Edison would not have received a patent on his light bulb under KSR.

  7. “I wonder how many of Edison’s 1093 US patents would hold up under the KSR regime — given that many of his inventions were a matter of trial and error.”

    I’m not sure why it matters. Seriously. Who cares whether Edison’s patents would hold under KSR or not?

    My guess is that many of Edison’s patents were, in fact, anticipated but the PTO lacked the ability to find the art.

    But since we’re on the subject, I wonder if historians have looked at how many of Edison’s patent applications were actually granted? How many interferences did Edison win or lose?

    I don’t want to bag on Edison — he was a visionary of sorts and a genuine freak — but from what I’ve learned about the history of motion pictures and phonographs, at least, Edison’s contributions to those fields were hardly the paradigm-shifting strokes of genius that most Americans imagine them to be. Compared to, e.g., Einstein, Edison was a chimpanzee.

  8. In the larger debate of what is obvious, it may be good to remember a quote from one of America’s most beloved inventor.

    “Genius is one percent inspiration, ninety-nine percent perspiration.” – Thomas Alva Edison, Harper’s Monthly (September 1931)

    I wonder how many of Edison’s 1093 US patents would hold up under the KSR regime — given that many of his inventions were a matter of trial and error. Would they have been “obvious to try”?

    Consider this quote from Tesla who was an employee of Edison:

    “His [Edison’s] method was inefficient in the extreme, for an immense ground had to be covered to get anything at all unless blind chance intervened and, at first, I was almost a sorry witness of his doings, knowing that just a little theory and calculation would have saved him 90 percent of the labor. But he had a veritable contempt for book learning and mathematical knowledge, trusting himself entirely to his inventor’s instinct and practical American sense.”

  9. I’m not intimately familiar with the details of these enantiomer patents (hey, I’m a chemist, not a lawyer) but I am aware of the power and unpredictability of enantiomers in the human body. A classic example that everyone can understand is the chemical called carvone. One enantiomer smells/tastes like spearmint, the other smells/tastes like caraway. (Pretty cool, huh?)

    Would this be helpful in proving non-obviousness?

  10. One quibble with the analysis. It seems to me that enantiomer patents, such as those protecting Nexium, will remain non-obvious provided that there was no understanding in the art that one enantiomer was expected to be more active than the other, and no drug having similar chemistry was known in the art that had been shown to have differential activity. In this case, we are in actual “obvious to try” land where the KSR language will not render a single enantiomer claim obvious. This is because, although there will be only two “choices” for the skilled artisan to make, the question of whether the two enantiomers can be separated is not trivial, and (under my hypothetical) there is no expectation either way of successfully showing differential activity. Unless “it might work” is enough, these claims should remain valid under KSR.

  11. In relation to the pharmaceutical industry, the Norvasc case is plainly seminal, and much in KSR affirms what the CAFC said in Norvasc.

    We should NEVER forget that courts decide cases according to the evidence. In Norvasc there was the following gem:

    Q. And one of the reasons why you chose these various salts [sic], or suggested these various salts [sic], is because you expected that they would be able to make a salt of them, correct?
    A. There was an expectation, but that wasn’t guaranteed.
    Q. And when you chose these salts . . . you believed that if you could, in fact, make an amlodipine salt out of them, these might be a cure for the problems you were having with maleate, correct?
    A. Indeed.

    With that on the transcript, the patent has joined the living dead, a mere zombie awaiting the formality of judicial execution.

    I don’t think we need formal rules – it all depends on the facts of the case and every case is different. But you need to find an expert who sincerely believes that he can stand in the witness box and defend the patent under cross-examination. There has to be a real argument for patentability and the invention cannot have been ob via (by the wayside).

    Big pharma will, of course, continue to apply for enantiomer patents, salt patents and other formulation patents and defend them vigorously. A year of further life at the end of the patent term is worth $ billions. But the judges know that, and know that there is a need to distinguish between real invention and simply trying it on.

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