32 thoughts on “More Patently-O TidBits

  1. 32

    Metoo and Malcolm:

    I am sorry, but I missed your logic.

    Let’s say Pfizer discovers a new chemical compound and patents it. They develop a composition of a specific salt of the compound (just for laughs we’ll pick maleate), and perform animal and human trials to the tune of $1e9. Finally after 15 years they market a product that saves lives. Just before the patent term runs out they patent a different salt (just for laughs we’ll pick besylate) which, as Metoo says, is less effective and unsafe but can be patented.

    So what?

    Pfizer has a patent for an unsafe and ineffective drug which they hang on the wall while the generic companies sell the off-patent original composition.

    If, on the other hand, the new salt is just as safe and effective as the old salt, but is also more pourable and stable, reducing manufacturing and storage costs, why shouldn’t Pfizer make a profit? No one is forcing you to buy Pfizer’s besylate, you can always buy Dr. Reddy’s maleate.

    It would be strange if the judges decided an obviousness issue, as Metoo hints, to punish Pfizer for not doing something useful like being talented as Jordin and instead trying to get rich by improving a drug.

    And Malcolm, who would expect that a besylate salt would taste better than a maleate salt to salamanders? That is definitely non-obvious and according to US law should be patented. No one is forcing you to purchase the veterinary composition. You can always buy the off-patent generic maleate salt.

  2. 31

    “While one may be able to effectively argue that, from a public policy standpoint, most of the focus should be on efficacy when it comes to patentability, those public policy arguments are not for the CAFC to consider.”

    They would be out of bounds, perhaps, if the application made no reference to the efficacy of the composition. I trust that it is not the case.

    Nobody except a desperate drug company with a crap patent wants the standard for the patentability of a human therapeutic to be that “it unexpectedly tastes better to salamanders kept in blue aquariums.” Such games make a mockery of the obviousness standard.

    “quite a bit of research is directed to developing new pharmaceutical products which can: (1) quickly receive FDA approval; (2) can be effectively marketed; and (3) can be patented.”

    This is true. Note what is missing: improved effectiveness and safety. The sad fact is that “effective marketing” usually means ignoring the fact that the drug is less effective and less safe than what is already on the market.

    The patenting is not necessary to protect/reward the “invention” but rather to keep copycats from riding off the marketing efforts in the event the drug product “takes off.”

    In other industries, trademarks and branding accomplish the same goals.

  3. 30

    step back – at first I misunderstood your point re Judge Newman and her understanding of science. But I get it. Judge Newman and Judge Lourie have the strongest science backgrounds of anyone on the CAFC – both have Ph.Ds, and both worked in chemistry research early in their careers. Of course it is probably no coincidence that both of them dissented in Pfizer v. Apotex on the question of rehearing en banc. The third dissent was Judge Radar. Based on his CAFC bio, he decidedly does not have any scientific training or experience (BA in English). However, his dissent did focus heavily on the unpredictability of pharmaceutical research and other science-related factors.

    One other factor to consider is that quite a bit of pharmaceutical “research” is not necessarily directed to finding new and more effective drugs. Rather, quite a bit of research is directed to developing new pharmaceutical products which can: (1) quickly receive FDA approval; (2) can be effectively marketed; and (3) can be patented. Improved efficacy and/or safety is not a prerequisite to any of these 3 things. As effective/safe as an existing pharmaceutical product will often suffice, or in some cases almost as effective yet cheaper will work. Some companies will even skip the FDA approval step for certain pharmaceutical products they deem to be “grandfathered” (so-called DESI drugs). If they are able to patent the pharmaceutical product, then all they need to do is market it to the doctors. The patent protection keeps out the generics. So, being able to base patentability on “unexpected results” which are unrelated to drug efficacy is very important to the pharmaceutical industry. For that reason, the Pfizer v. Apotex case should cause concern for pharmaceutical companies since the panel focused its “unexpected results” inquiry on efficacy (“therapeutic value”) and arguably ignored (or gave less weight to) other unexpected results not related to efficacy. While one may be able to effectively argue that, from a public policy standpoint, most of the focus should be on efficacy when it comes to patentability, those public policy arguments are not for the CAFC to consider. Nevertheless, it is not out of the realm of possibility that it played at least a small role in the panel’s decision.

  4. 29

    Step back, thank you for your comment.

    Re: “I respectfully suggest crossing the word “patents” from your statement about the Supremes and Newman J. and replacing it with “science”.”

    How about this:
    Even combined, the Supremes know less about science and patents than Judge Newman.

    Re: “… what is the difference between an ordinary “artisan” and an ordinary “inventor”?”

    Don’t get me started — I have been giving thought for many years to inventing, e.g.:
    (i) How do flashes of genius come about?
    (ii) How is it that some people can think up new ideas or combine two or more things in a new way, and some people can only repeat what they have learned?
    (iii) Can one’s talent to invent be enhanced?

    I think of inventing as a talent or craft that can be productive in many disciplines. Inventors can sometimes even invent things in arts in which they are not skilled.

    Re: “American competency in matters of science and innovation” is diminishing.

    I fear you are right, but I am not competent to agree.
    However, I do see our patent system taking one hit after the other, and that cannot be good for innovation. I suspect big business interests and their lobbies are at the core of such corruption –- the sellout of the peoples’ interest in favor of greed and power.

  5. 27

    Alan – I suspect that Judge Newman’s dissent was written before KSR came out. In fact, only one of the dissents cites KSR, and Judge Lourie merely cited for the following: “Chemical and pharmaceutical compounds often can be found to be prima facie obvious, as they are based on prior work that could reasonably suggest them.” Also, I wonder how much KSR did actually play a role in the en banc decision – albeit behind the scenes. The first en banc hearing or rehearing at the CAFC on the issue of obviousness and combining references will be a very significant case. It is possible that some of the judges decided that Pfizer v. Apotex was not the best case for that. Even if the vote on rehearing took place prior to KSR, I would be surprised if the CAFC judges were not re-polled after the KSR decision.

  6. 26

    “Even combined, the Supremes know less about [[patents]] SCIENCE than Judge Newman.”

    Ordinary Inventor,

    (Good screen name BTW, what is the difference between an ordinary “artisan” and an ordinary “inventor”? Hmmm…)

    I respectfully suggest crossing the word “patents” from your statement about the Supremes and Newman J. and replacing it with “science”.

    What you are witnessing is just the tip of the melting iceberg regarding American competency in matters of science and innovation. The old guard, of which Newman is one of the last surviving members, is quickly dissipating away into the fog of history while a new, improved generation is taking over.

    This new, improved generation of humans has it all figured out. Somewhere out there, are a bunch of high-school rejects and geeks who can be goaded into doing all the hard hard science while the cool guys (and/or their iPod crusted girl friends) get to sit back on the bench of power, don black robes, proclaim themselves Masters of the Universe, and pontificate about how “obvious” and easy every advancement in technology is.

    After all, when you want the latest in “technology”, you simply drive over to Circuit Metropolis (or some other smoking high, tech store) and “buy” the latest greatest gadget. It’s easy. It’s all easy. It’s all obvious.

    One day in the very near future, the cool ones will wake up with a bad headache. Their Hummers will cease their hummings. Their power tools will halt and refuse to further empower a high-on-the-bench style of life. The cool ones will scratch their heads and have not a clue as to why it happened. Why did the innovation machine stop turning? Where is the Easy button to press and make it go again?

    The cool will be the ones who had unwittingly killed the innovation goose. But they will also be the ones who are too dumb, too arrogant to know it. Magnesium versus manganese. It all sounds the same to me. That’s sound logic.

  7. 24

    Can anybody confirm the following?

    The PTO has trended toward busting applicant’s balls for at least a few years, long before KSR.
    And at least some of the Examiners seem far less than qualified.

  8. 23

    You missed the salient fact that KSR did nothing constructive for our patent system, quite the contrary–KSR is gobbledygook.
    Even combined, the Supremes know less about patents than Judge Newman.

  9. 22

    There’s a reason Newman is always dissenting, she’s always wrong.

    Maybe she doesn’t read Supreme Court decisions. Her dissent in Pfizer states that “obvious to try” is long discredited. Maybe in the past, but didn’t KSR refute that position or at least allow for an argument on that basis?

    A revision of an old saying: The only patent that isn’t invalid is a patent in which Newman (or Rader) writes the opinion.

  10. 21

    T: Lesson learned, next time send Face to argue (especially if the board has a female member).

  11. 20

    Mr. T is nevertheless thankful to the Board for pointing out that his driver’s license had expired, and for eventually letting him in the building with an expired one. Can’t drive the team’s van legally without that!

  12. 19

    Mr. T is upset. He argued at a PTO oral hearing yesterday. The Board brought up KSR (obviously, we had prepared arguments in the brief before KSR). They asked if KSR would have any bearing on the case. It appeared the Board had already made up their minds on this one, and they viewed the prior art very broadly without strict TSM. In the past, Mr. T beleived his approach would have been successful(otherwise, he would not have appealed). Mr. T feels like a fool! Pity me!

  13. 18

    djf: Maybe you are right, I’ll see if I can get around to study Mangold in detail (as well as Pfizer).

    It is just that chemistry labwork is so unpredictable and so complex that even results of “standard experimentation” from a limited group (even “just” the 14 lanthanoids) isn’t obvious.

    I feel bad for the poor scientist who spent years acquiring expertise so that he could spend a year of his life making the product just to be told by the judges that his work isn’t worthy of recognition.

    My gut feeling is that Mangold should get to keep the patent on erbium oxide dopant. If the erbium oxide is as good as anything, the monopoly is worthless. If it has a significant advantage, they deserve the patent.

    But you are right, Pfizer sounds even worse.

  14. 17

    “What am I supposed to tell my clients after the denial of rehearing here – that even though they’ve got objective evidence of non-obviousness, if they ever get as far as the CAFC it’s a crapshoot, depending on who they are and the mood of the judges that hear their case?”


    Yes, that is what you should tell your clients.

    The entire legal system relies on human beings to act as the final “decision-makers” (be they a judge, a jury member or some other form of adjudicator).

    Human beings are inherently irrational. (We are not Vulcans.) We have our good days and our bad days. We have our pride and our prejudices. It always has been a crap shoot.

    As the lawyer in the joke said when told that justice had prevailed at trial level, “Then we’ll have to appeal”. As long as you have money, you can keep shopping around for a different outcome. Even if the US Supreme Court rules against you, you can still “appeal” to Congress (i.e. with generous campaign contributions). Thank goodness we don’t live in a corrupt country and justice always prevails.

  15. 16

    Erez, I don’t find Mangold “terrifying”. The board basically said, “You picked a species (erbium oxide as a dopant) out of a fairly narrow, previously disclosed genus (metals and non-metals, particularly transition metals), and the use of erbium oxide as dopant was known in other contexts. So your claims are prima facie obvious; give us some evidence they’re not”. Based on the facts as presented in the board’s decision – and I admit to not yet having looked at the application file history – it seems that had the applicant brought forth some objective evidence of non-obvious, the board might have reached a different conclusion. There’s nothing new in requiring that – that’s just applying Graham. That’s why, even before cert was granted in KSR, in situations similar to this one, I told my clients that they’d better be prepared with objective evidence of non-obviousness to fend off 103 rejections like those proferred by the examiner in Mangold.

    What’s scary to me is the CAFC’s denial of en banc rehearing in Pfizer. Judges Rader and Lourie hit the nail on the head: there was objective evidence of non-obviousness of the besylate salt (better handling properties as a bulk material than the known maleate salt), certainly enough to support affirmance of the district court’s decision (or rather, to thwart reversal), and the panel focused too narrowly on what constituted non-obviousness (looking at the therapeutic properties rather than the bulk handling properties). One wonders if there wasn’t simply an anti-big pharma bias at work here, since, after all, this was a second generation patent that covered Pfizer’s no. 2 product, and the panel decision was issued a few days before the patent would have expired. What am I supposed to tell my clients after the denial of rehearing here – that even though they’ve got objective evidence of non-obviousness, if they ever get as far as the CAFC it’s a crapshoot, depending on who they are and the mood of the judges that hear their case?

  16. 15

    Thanks stepback, ex parte Mangold is terrifying.

    The BPAI is saying that in chemistry you can better keep trade secrets than file for a patent.

    It seems that this was a very wrong decision.

  17. 14

    Is anyone aware of any cases where a court has vacated a trial date, granted a new trial, granted JMOL, etc. in view of KSR?

  18. 13


    Take a look at this one:
    Decided: May 21, 2007

    link to des.uspto.gov

    How about the next level of argument, namely, that it is obvious to substitute any element for another because they are all members of the atomicly stable portion of the Periodic Table? Remember, manganese and magnesium kind of sound alike according to the US Supreme Court.

  19. 12

    Sounds pretty normal to me. I think much ado about nothing has pretty much been confirmed as to KSR. The PTO is using the same standard it always has (which begs the question of whether they were following the law BEFORE KSR cam down, but…) – and Rader says the Fed Circuit is sticking to Azla and In Re Kahn.


  20. 11

    I have done a quick check on Board opinions issuing since 5/8/07. For about 75% of the appeals, the position of the Examiner has been affirmed. For about 25% of the appeals, the position of the Examiner has been reversed.

  21. 10


    Your summary of BPAI opinions is incorrect. There have been many post-KSR BPAI opinions that reversed obviousness rejections: Ex parte Kalliokulju; Ex Parte Nolte; and Ex Parte Bodin just to name a few I’ve seen in the last few days.

    Can you identify any BPAI opinions that you think broadly applied KSR to affirm rejections that would not have been affirmed under TSM? Can you even identify a post-KSR BPAI opinion that you disagree with? The cases that actually make it to the BPAI are so crummy it is hard to find reasons to disagree with the BPAI (clear examiner errors rarely make it to the BPAI).

  22. 9

    stepback, has the BPAI affirmance rate gone up since KSR?

    I think it would be arguably irresponsible of BPAI not to cite KSR when discussing obviousness. KSR is the latest, most authoritative word on the subject, and if BPAI didn’t cite it, one might wonder if they were aware of it.

  23. 8

    I like to peek in on once in a while on what the USPTO Board of Appeals (BOPAI) is doing lately.

    Here is what it looks like recently when you summarize the recent decisions by the BOPAI on examiner rejections:


    You get the picture.
    Many of these decisions make direct citation to KSR to justify why the Examiner has produced a prima facie case of obviousness and why the Applicant has not successfully rebutted it.

    Of course Rader J. will probably never see these cases appearing on his radar screen. To the folk down in the trenches where the first battles take place, KSR is having an immediate and big impact.

  24. 7

    Yet again, you are right on point, “so far no one’s proposed anything better [than TSM].”

    Great or not, could it be that TSM, not too rigid, is as good as it gets?

    It is darn near impossible to separate obviousness from subjective thinking. That is why an objective test is most helpful to determine obviousness — evidence that speaks to obviousness or evidence that speaks to non-obviousness — because invention by its very nature tends to make the non-obvious obvious.

  25. 6

    From KSR:

    “In the years since the Court of Customs and Patent Appeals set forth the essence of the TSM test, the Court of Appeals no doubt has applied the test in accord with these principles in many cases. There is no necessary inconsistency between the idea underlying the TSM test and the Graham analysis. But when a court transforms the general principle into a rigid rule that limits the obviousness inquiry, as the Court of Appeals did here, it errs.”

    * * *

    “We note the Court of Appeals has since elaborated a broader conception of the TSM test than was applied in the instant matter. See, e.g., DyStar Textilfarben GmbH & Co. Deutschland KG v. C. H. Patrick Co., 464 F. 3d 1356, 1367 (2006) (“Our suggestion test is in actuality quite flexible and not only permits, but requires, consideration of common knowledge and common sense”); Alza Corp. v. Mylan Labs., Inc., 464 F. 3d 1286, 1291 (2006) (“There is flexibility in our obviousness jurisprudence because a motivation may be found implicitly in the prior art. We do not have a rigid test that requires an actual teaching to combine . . .”). Those decisions, of course, are not now before us and do not correct the errors of law made by the Court of Appeals in this case. The extent to which they may describe an analysis more consistent with our earlier precedents and our decision here is a matter for the Court of Appeals to consider in its future cases. What we hold is that the fundamental misunderstandings identified above led the Court of Appeals in this case to apply a test inconsistent with our patent law decisions.”

    It looks as though the Supreme Court held that TSM is fine, as long as it’s not applied too rigidly.

    The broader implication may be that the CAFC (and other interested parties) should continue to think about how to apply 103(a). TSM isn’t great, but it’s not inconsistent with Graham, and so far no one’s proposed anything better.

  26. 5

    I think he meant that the legal reasoning and conclusions didn’t change, the cite and quote might have been added in just to show that the opinion was in line with KSR.

  27. 4

    KSR was no great change, because the CAFC changed its jurisprudence and approach between the granting of cert in KSR and the Supreme Court’s decision.

  28. 3

    Look at it this way, it is going alot better between the SC and FC this time – remember Festo? That is good news for all.

  29. 2

    By my count, 2 cites of KSR, and a use of language taken directly from KSR.

    Rader J.’s comment “…did not require one iota of change.” is obviously not meant to be taken literally. The real issue is how much it changed, which is anyone’s guess–but it doesn’t really seem especially interesting to consider. At least not for me.

  30. 1

    The comment that the CAFC’s first post-KSR opinion was written before the Supreme Court ruled, and nothing was changed after KSR issued, is very, very hard to believe.
    Esp., since the CAFC quoted and cited KSR in their ruling.

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