Allergan v. Sandoz: The Thin Line of Nonobviousness

By Jason Rantanen

Allergan, Inc. v. Sandoz Inc. (Fed. Cir. 2013) Download Allergan v Sandoz
Panel: Dyk (dissenting-in-part), Prost (author), O'Malley

Allergan illustrates how thin the line between obvious and nonobvious can sometimes be.  Allergan owns several patents relating to its COMBIGAN combination ophthalmic drug treatment: Patent Nos. 7,323,463, 7,642,258, 7,320,976, and 7,030,149.  Representative claim 1 of the '463 patent states:

1. A composition comprising about 0.2% timolol by weight and about 0.5% brimonidine by weight as the sole active agents, in a single composition.

Sandoz sought to market a generic version of COMBIGAN, triggering Allergan to file suit under 35 U.S.C. § 271(e)(2)(A) alleging infringement of its four patents.  Sandoz stipulated to infringement of most of the asserted claims following claim construction and the district court subsequently found that all of the remaining asserted claims were not invalid after a bench trial.  Sandoz's appeal focused primarily on the district court's nonobviousness ruling. For purposes of the appeal, the asserted claims of the '463, 258, and '976 patents were treated as a single group (I'll refer to these collectively as the '463 claims, since that's how the court refers to them) with claim 4 of the '149 patent treated separately.

The '463 claims – obvious: On appeal, the court unanimously reversed the district court's determination that the claims of the '463 patent were nonobvious.  Both timolol (a beta blocker) and brimodine (an alpha2-agonist) were commercially available in their claimed concentrations at the time of the invention and were used to treat opthalmic conditions.  The primary prior art reference, DeSantis, expressly taught serially administering both a beta blocker, such as timolol, with a brimodine in a fixed combination.  It also provided "an express motivation to combine alpha2-agonists and beta blockers in order to increase patient compliance."  Slip Op. at 8.

So where did the district court go wrong?  First, the Federal Circuit held that it committed clear error by finding that "“while patient compliance may have created a need for fixed combination products, it did not motivate a person of skill in the art to develop fixed combinations with a reasonable expectation of success, because the FDA did not consider improving patient compliance as a factor in its approval decision.” Id. at 9, quoting district court.  While FDA approval may be relevant to the motivation inquiry:

There is no requirement in patent law that the person of ordinary skill be motivated to develop the claimed invention based on a rationale that forms the basis for FDA approval. Motivation to combine may be found in many different places and forms; it cannot be limited to those reasons the FDA sees fit to consider in approving drug applications.

The CAFC also concluded that the district court erred by over-relying on the recognized unpredictability in the formulation carts.  While unpredictablity is also relevant to the obviousness inquiry, it can be overcome simply by establishing that there was a reasonable probability of success.  Furthermore, Allergan's challenges in developing its commercial COMBIGAN product were not particularly probative of the obviousness inquiry because the relevant inquiry is whether a person of ordinary skill in the art would have a reasonable expectation of success in developing the claimed invention, not COMBIGAN (which contains many elements in addition to those embodied in the claims). 

In addition, the Federal Circuit concluded that the district court's factual findings on teaching away were insufficient to overcome the motivation provided by DeSantis and that the secondary considerations of nonobviousness did not weigh heavily in this analysis. 

Claim 4 of the '149 patent – nonobvious: While the full panel agreed on the obviousness of the '463 claims, it split over claim 4 of the '149 patent. Claim 4 states:

4. A method of reducing the number of daily topical ophthalmic doses of brimondine administered topically to an eye of a person in need thereof for the treatment of glaucoma or ocular hypertension from 3 to 2 times a day without loss of efficacy, wherein the concentration of brimonidine is 0.2% by weight, said method comprising administering said 0.2% brimonidine by weight and 0.5% timolol by weight in a single composition.

The underlined language is essentially the same as claim 1 of the '463 patent.  Central to the majority's conclusions was thus its treatment of the italicised language as a claim limitation: even though the creation of a single composition of 0.2% brimonidine by weight and 0.5% timolol by weight was obvious, administering it twice a day instead of three times a day without loss of efficacy was not.

The majority reached this because it was understood at the time of the invention that when brimonidine is dosed twice per day as opposed three times per day there is a loss of efficacy in the afternoon (the "afternoon trough") and Sandoz did not identify any "evidence in the prior art that would allow us to conclude that the addition of timolol to brimonidine dosed twice per day would eliminate the afternoon trough issue."   Slip Op. at 13.  Furthermore, even though it was "true that the prior art shows concomitant administration of brimonidine and timolol was dosed twice per day," that was insufficient to establish the obviousness of claim 4 because "this art does not show that there was no loss of efficacy associated with that treatment, let alone an elimination of the afternoon trough."  Id. at 14.

Judge Dyk's dissent:   Writing in dissent, Judge Dyk would have found Claim 4 invalid.  Judge Dyk's disagreement highlights the issue of whether a claim can nonobvious if it is drawn to an unknown – but inherent – property of an obvious invention.  "While a new and nonobvious method of using an existing (or obvious) composition may itself be patentable, [] a newly-discovered result or property of an existing (or obvious) method of use is not patentable."  Slip Op. at 18 (internal citations omitted).

In Judge Dyk's view, claim 4 includes only a single limitation (in this case, a step): "applying a fixed combination of 0.2% brimonidine and 0.5% timolol twice a day."  Given the prior art, [t]he method of applying a fixed combination of 0.2% brimonidine and 0.5% timolol twice a day would therefore have been obvious over the prior art." Id. at 19. 

This did not end the nonobviousness inquiry for the majority, however.  "The majority’s outcome appears to rest, therefore, on the notion that claim 4 was not obvious because it claims the result of twice-a-day dosing—avoiding “a loss of efficacy in the afternoon.”  Id., quoting Maj. Op. 13.  This is not a limitation: "[a]voiding a “loss of efficacy” is not a separate step, but rather a result of the claimed method. []. We should recognize in this case, as we did in Bristol-Myers Squibb, that '[n]ewly discovered results of known processes directed to the same purpose are not patentable.' Bristol-Myers Squibb, 246 F.3d at 1376."  Slip Op. at 19 (internal citations omitted).  

Consequences: It's worth noting that even though it prevailed in establishing the obviousness of the asserted claims of the '463 patent, Sandoz still cannot market its generic version of COMBIGAN: "The ’258, ’976, and ’149 patents each expire on April 19, 2022. Because we concludd that claim 4 of the ’149 patent is not invalid, the Appellants will be unable to enter the market until that date. Accordingly, we find it unnecessary to address the claims of the ’258 and ’976 patents."  Slip Op. at 15.

70 thoughts on “Allergan v. Sandoz: The Thin Line of Nonobviousness

  1. anon–

    Although I disagree entirely in principle, practically speaking the result would be the same, using a 101 utility-based analysis.

  2. Is there a tag that can be removed, that is responsible for the strikethrough?

  3. Thought exercise for the day – Pretend MM and the Fed Circuit make differing statements about what the state of the law is. Whose statement represents the actual state of the law?

    For whatever else you can’t take away from this case, this case is at least a good reminder that you need to argue not only why your client wins on the technical merits of the law, but also why the world is a better place if the Court finds for your client. The technical merits show the Court how to find for your client, but the other arguments are why they want to. In a close case, that can be the difference, and help them stare into the clouds and see the distinction in your claim 4.

  4. What I do not understand is why the FC did not address the claims in the ‘258 and ‘976 patents?

    Perhaps the parties stipulated as to how those patents would rise or fall depending on the outcome with the ‘149 claims (e.g., maybe they are obvious in view of the ‘149 claims or they were terminally disclaimed).

    If Alcon takes claim 4 to SC and the claim is held to be invalid, then what? Does Sandoz enter market at risk?

    See above.

  5. What I do not understand is why the FC did not address the claims in the ‘258 and ‘976 patents?

    If Alcon takes claim 4 to SC and the claim is held to be invalid, then what? Does Sandoz enter market at risk?

  6. But can you fix your broken tag that is crossing through the names and posts times?

    I don’t know what you broke there.

  7. LOL – now this is better – at least you are showing a little originality.

    Mind you, your input on patent law matters is about the same, but at least you play the jester in a less political manner.

  8. Thanks for proving my point. Can we see how great I am by you once more cutting and pasting my comment?

  9. Love that cut and paste.

    Can we see it again to show how much of a dooche you are?

    Thanks in advance!

  10. Anytime you want to say something relevant to patent law and not earn my personal attack, go ahead.

  11. Nice examiner move, McCracken – when all else fails, employ a mindless cut and paste.

    Thank you for conceding.

  12. Noble? Too cynical Malcolm. A high Quality EPC use claim rewards (and so promotes) the progress of useful arts and so adds to the General welfare. I concede that, as a side effect, these use claims enrich chemical patent attorneys, especially when these’s a big fight with the EPO whether to let them through, but I don’t see that as the decisive issue whether or not to permit them as a class to exist.

    Society has an interest in promoting investment in research how to run ic engines more economically. If you were bald you might be glad if somebody were to discover that Aspirin is a cheap cure.

    Nevertheless, thanks for the regular injections of levity and wit. They are very welcome.

  13. Anytime you want to say something relevant to patent law and not earn my personal attack, go ahead.

  14. Mirroring exactly what I say rather loses its effect when it applies to you, but not to me.

    I am not the one QQ’ing about “personal attacks.”

    Your “attacks” are as feeble as your reading comprehension, and thus, impugn you rather than do any damage to me.

    Words of advice: Put. The. Shovel. Down.

  15. Anytime you want to say something relevant to patent law and not earn my personal attack, go ahead.


  16. Who infringes? You have the burden of proof. Off you go: prove the infringement. Can you? Perhaps you can. Do you have the budget? Can you intimidate anybody enough to get them to stop prescribing X as a baldness cure, or cough up a royalty? Good luck.

    But perhaps the infringer has a defence? What might that be? I dunno.

    Your “body aches” is not an easy case for me because I cannot distinguish whether fever can come with or without body aches. Is it a genuine second use or just an inseparable aspect of the known first use. This is one tiny aspect of how pharma patent attorneys earn their crust in Europe.

    Is there a more noble calling on God’s grey earth?

  17. If the claim is reducing from 3 to 2 doses a day, why can’t Sandoz market it for only 2 doses a day (and not 3) as that wouldn’t be infringing?

    Great question. There is a boring answer:

    link to patentdocs.org

    After a claim construction determination, the lower court granted summary judgment of non-infringement as to claims 1-3 of the ‘149 patent, and the parties stipulated to infringement of the remaining claims. After a bench trial, the District Court found all of the claims nonobvious over the prior art. The defendants appealed.

  18. Re-posting from above with some edits for clarity:

    Bob: 2. If the claim requires a result (no loss of effectiveness) and if the result is NOT inherent in the claimed steps (2 a day dosing of 2 drug combo), the method is NOT obvious even if performing the claimed steps (2 a day dosing 2 drug combo) would have been obvious

    That’s ridiculous, of course. If the “required result” is not inherent to the claimed steps, and the claimed steps are in the prior art, then the claim is plainly missing a step. Think about it. I disclose a method of administering 2.675 aspirin tablets a day to treat baldness. You’re saying that you can get a claim over my disclosure by reciting only the same step (administering 2.675 aspirin tablets a day and reciting some “non-inherent result” that you discovered? So what does one need to do differently from the prior art to infringe your claim? See the result? Think about the result?

    The CAFC got it right in Bristol Myers Squibb. And by “right” I mean “Supreme Court Will Approve 9-0 Right”. When you tack on a “new result” to a method in the prior art, you are (ready for this? you should be!) effectively claiming the result itself. And that result … that’s called a “phenomonen of nature”.

    So is the claim obvious or is it ineligible? It’s anticipated, of course, if you ignore the new recited “result”. If you don’t ignore it, then chances are it’s non-obvious. But who cares? It’s dead as a doornail under Prometheus.

    As to whether claim 4 can be easily tanked under 101, I expect so provided that you don’t hire some cr-ppy “Supreme Court attorney” to brief your cases for you. You’ll want a real patent lawyer.

  19. It’s nice that you are still waiting.

    I’m still waiting too for the day that you realize that this is a patent blog.

  20. I like this case for the Attention it requires on the interplay of issues of fact and law.

    I have always explained to Clients that, in real cases, the hard part is Fixing the Facts. Once the Facts are settled, the issues of law cease to be puzzling.

    Not here though. Instead, omnishambles. The issues of law are i)what does claim 4 mean, ii) is its subject matter eligible, iii) new or not, iv)obvious or not. I’m left dissatisfied and disappionted by the way These issues were handled.

  21. Anytime you want to say something relevant to patent law and not earn my personal attack, go ahead.

  22. 2. If the claim requires a result (no loss of effectiveness) and if the result is NOT inherent in the claimed steps (2 a day dosing of 2 drug combo), the method is NOT obvious even if performing the claimed steps (2 a day dosing 2 drug combo) would have been obvious.

    That’s ridiculous, of course. If the “required result” is not inherent to the claimed steps and the claimed steps are in the prior art, then the claim is plainly missing a step. Think about it. I disclose a method of administering 2.675 aspirin tablets a day to treat baldness. You’re saying that you can get a claim over my disclosure by reciting only the same step (administering 2.675 aspirin tablets a day and reciting some “non-inherent result” that you discovered? So what do differently from the prior art infringe your claim? See the result? Think about the result?

    The CAFC got it right in Bristol Myers Squibb. And by “right” I mean “Supreme Court Will Approve 9-0 Right”. When you tack on a “new result” to a method in the prior art, you are (ready for this? you should be!) effectively claiming the result itself. And that result … that’s called a “phenomonen of nature”.

    So is the claim obvious or is it ineligible? It’s anticipated, of course, if you ignore the new recited “result”. If you don’t ignore it, then chances are it’s non-obvious. But who cares? It’s dead as a doornail under Prometheus.

    As to whether claim 4 can be easily tanked under 101, I expect so provided you don’t hire some cr-ppy “Supreme Court attorney” to brief your cases for you. You want a real patent lawyer.

  23. Anytime you want to say something relevant, instead of your usual personal attacks, go ahead.

  24. Who said anything about me beinga Republican?

    By the way, I am not.

    And you still are irrelevant.

    So you have that and a comprehension problem going for you.

  25. Well, it’s kinda hard to practice patent law when the end-time comes in. It’s not that hard to grasp, even for a Republican like you.

  26. Bob: “Whether the result, mentioned in the claim preamble, is or is not a limitation may be disputed (it appears to me to breathe life and meaning into the body of the claim and so should be a real limitation), we should still be able to agree on the two different legal results under the two different possibilities.”

    Again, a wonderful illustration of precisely why this should have been decided on 101 and NOT on 103, because there is only a single possible legal result (see logic above).

  27. IMO: “To me this case represents the thin line between unexpected results and inherent properties, and demonstrates how obviousness can turn on how the properties of a claimed invention are characterized.”

    Which illustrates precisely why it should have been decided on 101, NOT on 103.

  28. I think that you should have better things to do, evenif you are contemplating what the end-time will bring.

    Relevancy?

  29. Would Dyk’s analysis still hold if the preamble had been recited as a step in the claim, i.e., would such a step still be dismissible as an inherent result of following the prior art even though it was concedely unexpected?

  30. Another illustration of why the preamble should ALWAYS be considered limiting.

    Except it is not another illustration of such.

    But you do have a pretty soapbox IBP.

  31. EG I too stand corrected. I must have jumped to the conclusion you are EE because of your proximity to Gene Quinn on the Watchdog blog. Sorry.

    And thanks for adding to the dialogue on use Claims. I’m sorry others are not prompted to join in.

  32. Ned–

    Yes, I now remember having read that.

    Perfect! My response would be that the asserted utility is therefore not credible.

    Another illustration of why the preamble should ALWAYS be considered limiting.

    If it is not, the only step recited by this claim is “administering A and B in a single composition”, and the obviousness analysis would proceed on that basis, with the resulting conflicting conclusions that we see both from the CAFC, and on this board.

    If it is, then the invention is wholly inoperative and therefore lacks credible utility. 101 fail.

    From MPEP 2107, “An invention that is “inoperative” (i.e., it does not operate to produce the results claimed by the patent applicant) is not a “useful” invention in the meaning of the patent law. See, e.g., Newmanv.Quigg, 877 F.2d 1575, 1581, 11 USPQ2d 1340, 1345 (Fed. Cir. 1989); In re Harwood, 390 F.2d 985, 989, 156 USPQ 673, 676 (CCPA 1968) (“An inoperative invention, of course, does not satisfy the requirement of 35 U.S.C. 101 that an invention be useful.”). ”

    The logical premise upon which the statement of asserted utility rests is that administering A and B OTHER than in a single composition requires dosing thrice daily.

    According to the majority’s opinion, this logical premise is untrue. As a matter of logic, no assertion of utility that relies upon an untrue premise can be considered to be credible.

    The “invention” is therefore inoperative within the meaning of 35 USC 101.

    This case should never have been decided on the grounds of the wishy-washy, pseudo-quasi understanding of obviousness that the court believes it has, but in fact does not.

    Another missed opportunity, stemming from the court’s fundamental lack of understanding of patent law, likely stemming from their fundamental lack of rigor, or the impossibility of their meeting adequate performance goals due to something like untenable time constraints.

    This is not too much to ask, IMO. It is part of the bedrock of patent law, one of the few areas of law with which the court deals.

  33. To me this case represents the thin line between unexpected results and inherent properties, and demonstrates how obviousness can turn on how the properties of a claimed invention are characterized.

    If administration of the combination product provided benefits that were unexpectedly superior over what was know for administration of the individual compounds, then both the compostion and method claims should be nonobvious, even if there was motivation to formulate the combination product and regardless of whether the preamble in the method claim is given patentable weight. If the majority is correct that the combination product did not have superior properties over what was expected from the prior art, then both the method claims and composition claims should be considered obvious.

    The majority’s statement “Whether or not that combination
    also solved problems associated with the afternoon
    trough, we find the motivation to make the combination
    was real” makes no sense. Secondary considerations are only relevant if a prima facie of obviousness is established, which requires some form of motivation to arrive at the claimed subject matter (or rationale per KSR). Moreover, how could there be “real” motivation to arrive at the composition but not administer it for the same therapeutic purposes as the individual components?

  34. Ned,

    Caveat, I don’t prosecute patents and this is way outside my technical area. That said, based on how this claim is drafted, I’d think the Examiner should be able to assume the “without loss of efficacy” is not a limitation but just an inherent result. Then the applicant can come back and establish that it isn’t inherent and is a limitation (or better yet, redraft the claim to positively make a limitation, as Dyk might have been in the majority in a different panel). Some might object that this conflicts with established burdens of proof during prosecution though, but I’m not sure.

    I don’t think that conflicts with this case since there are major differences between the examination of a patent and then validity of an already issued patent — burdens of proof, etc.

    Otherwise, as you say, I don’t see what else the Examiner could do with his limited time and resources.

  35. Anonymous, while we deal here with an issued patent, in the PTO the examiner does not have the resources to show that dosing twice a day using the two separate compositions at the same time produces the same results as dosing twice a day with the two compositions combined into one tablet.

    How does he demonstrate that the effect is the same.

  36. IBP, the majority opinion states that the prior art showed that twice daily doses of the two compositions taken together was known and actually done.

    Now if I understand the law, if the exact compositions is known, a patent cannot be had for the same composition by stating a new property since discovered.

    I also thought the law was the same regarding methods. If the prior art shows the method steps claimed were old, just how can one repatent the old method upon discovery of an inherent property of that method?

  37. Scientist, EG is referring to the extinct “Swiss form” of claim under the 1973 original EPC in which methods of therapy were ineligible for patenting. The ban was circumvented by a claim of the form:

    Use of molecule X in the manufacture of a medicament for treating disease B.

    EG, you are software/business methods, right? Nevertheless, before you write any more about whether or not MD is or is not correct, you might want to acquaint yourself with the differences between EPC 1973 (Swiss claims rampant) and EPC 2000 (Swiss claims extinguished).

  38. Scientist,

    A very interesting and insightful question. Body aches often accompany fever (e.g., flu), but not necessarily. For example, if the second inventor simply stated on his bottle of Advil (ibuprofen) to use it to treat pain (e.g., body aches due to something other than illness) and/or inflammation, the first inventor would be very hard-pressed to make out a plausible case for infringement, even under a contributory or inducing infringement theory.

    As MD points correctly points out, second indication drug claims are not allowed in Europe. Instead, for such second indications, Europe (as well as other countries such Australia which don’t allow second indication or any sort of medical treatment claim) use what are called “Swiss-style” (looks somewhat like a process claim for making the drug but also with “method of treatment”-like language) which can only be infringed by the manufacturer of the drug, not the doctor who prescribes it or the patient who uses it.

  39. Scientist, a typical EPO “2nd medical use” claim is of the form:

    Use of molecule X to treat condition B.

    Suppose X is an aspirin-type molecule. The molecule is old and its use to alleviate headaches is notoriously old. There is a patent in force for its use for blood thinning.

    Now suppose you discover that it alleviates male pattern baldness. That is “condition B” in the claim.

    You own that claim.

    Who infringes? You have the burden of proof. Off you go: prove the infringement. Can you? Perhaps you can. Do you have the budget? Can you intimidate anybody enough to get them to stop prescribing X as a baldness cure, or cough up a royalty? Good luck.

    But perhaps the infringer has a defence? What might that be? I dunno.

    Your “body aches” is not an easy case for me because I cannot distinguish whether fever can come with or without body aches. Is it a genuine second use or just an inseparable aspect of the known first use. This is one tiny aspect of how pharma patent attorneys earn their crust in Europe.

  40. MD, thank you for your insightful answer. I am not sure how one would utilize EP law in practice. Let me give you an example to illustrate my question. Advil (Ibuprofen), which we know reduces fever, but also body aches, and some what even cough.

    First Inventor patent: Advil to reduce fever.
    First Inventor commercializes Advil

    Second Inventor: Advil to reduce body aches?

    Can the second Inventor sue first Inventor for infringement?

  41. Scientist, I like your question because it exposes a gulf of difference between the USA and Europe as to which unobvious contributions to the state of the art are patentably new.

    Back in the 1980’s, the original “second non-medical use” claim at the EPO was EXXON: friction-reducing additive. Exxon found out (to their surprise) that a known fuel additive (that was being used to inhibit corrosion) was also reducing friction in the engine. So they patented “use of the additive to reduce friction”. The claimed subject matter was found to be NOT old and not obvious either.

    For the patent jurisprudence of the USA and the UK this was an affront. In the UK it is no longer controversial. Patents are to flush out new and non-obvious contributions to the art that promote the progress. Exxon did that then, and Allergan has done that here.

    I have a feeling that the majority has some sympathy with EPO law but the minority not. Let the debate continue.

  42. I would appreciate some discussion between methods/use vs composition being patentable. Please see arguments from the transcript of Myriad. Is it for composition or for use?

    JUSTICE KAGAN: General Verrilli, could I understand what you said, because I think it might be a little bit different from Mr. Hansen and I just want to understand your position. You said that a company can’t get a — a patent on the thing, but can get it on the uses. So, if I find this plant, let’s say, in the Amazon and I can’t get a patent on the thing itself, but can I get a patent when I discover that if you eat this plant it has therapeutic effects?

    (little bit deleted in between for space)

    GENERAL VERRILLI: Yes, you certainly can, and that illustrates the difference. That patent is just for the use; it doesn’t tie up all other potential uses of the substance and that’s the key.

  43. 1. If the claim requires a result (no loss of effectiveness) and if the result is inherent in the claimed steps (2 a day dosing of 2 drug combo), the method is obvious IF performing the claimed steps (2 a day dosing 2 drug combo) would have been obvious.

    2. If the claim requires a result (no loss of effectiveness) and if the result is NOT inherent in the claimed steps (2 a day dosing of 2 drug combo), the method is NOT obvious even if performing the claimed steps (2 a day dosing 2 drug combo) would have been obvious.

    3. If the claim does NOT requires a result (preamble is not a limitation), the method is obvious IF performing the claimed steps (2 a day dosing 2 drug combo) would have been obvious (regardless of whether the result is or is not inherent in the claimed steps).

    4. The method is NOT obvious if performing the claimed steps (2 a day dosing 2 drug combo) would NOT have been obvious (regardless of whether the result is or is not a limitation and regardless of whether the result is or is not inherent in the claimed steps).

    As the majority says in footnote 1, it is not clear from the record if the result is inherent in the claimed steps. Judge Dyk apparently disagrees, but that is a fact question (and, of course, we here can disagree on this fact, but should agree on the two different legal results under the two different possibilities).

    Whether the result, mentioned in the claim preamble, is or is not a limitation may be disputed (it appears to me to breathe life and meaning into the body of the claim and so should be a real limitation), we should still be able to agree on the two different legal results under the two different possibilities.

  44. My problem with claim 4 has to do with not correctly reciting the method that is alleged to be unobvious. As far as the preamble goes about permitting reduction of the dosage from 3 to 2 times a day, that’s simply a statement of “intended use” and in my view entitled to no validity weight (the Federal Circuit is also all over the map as to when the preamble has any validity weight). Instead, the “body” of the claim should have been written as follows: “said method comprising administering said 0.2% brimonidine by weight and 0.5% timolol by weight in a single composition no more than twice daily to the patient in need thereof.” That captures what the essence of is “unique” about this method, if anything.

    My problem Dyk’s “inherent property” argument is that it doesn’t address how does someone of “ordinary skill in the art” know beforehand that this combination of brimondine and timolol is more efficacious when given twice daily versus thrice daily. They don’t, and that’s the only “reed” the patentee has for patentability, even if it is a slim one.

    P.S. Jason, I love your title for this post!

  45. I’m not in pharma so perhaps my questions below are naive. Tell me if they are.

    Claim 4 is directed not to a method of dosing but to a method of reducing. My questions on that claim are:

    1. Is it usual to claim such methods of reducing?

    2. What physical activities are involved in the step of reducing? It strikes me as a purely mental step.

    3. But never mind that. When is the concrete reducing step performed; in making the pill, in packaging the pill, in prescribing the pill, in swallowing the pill or in ALL of these activities equally? I suppose the pill presser is a direct infringer of the reducing method and that’s why reducing rather than dosing is claimed.

    4. Suppose the claim had been directed to a method of dosing. Would it make any difference to the majority? Or was it only the admirable, beneficial and efficaceous step of “reducing” that saved it from being found obvious?

    5. This would be a fascinating claim to litigate in Europe. Indeed, I fancy it has been. Does anybody know the corresponding EPO patent number, please?

  46. “Although I don’t know what the compounds do”

    They apparently put more inches on the federal circuit’s literary pen is.

  47. Now forgetting to take your medicine one out of three times a day is patentable. The fed seems to have sunk to a new low.

  48. While I applaud Judge Dyk for being right again, I’m also aware that this ruling conveniently makes my job easier as a prosecutor.

    My kudos to Judge Dyk for being correct; my thanks for the majority for being… …in the majority.

  49. Jason — I think you need to discuss the majority’s response to the dissent in footnote 1. Your write-up is a little misleading. The majority may be wrong (I’m not sure), but footnote 1 at least makes them sound slightly reasonable. According to the majority, it’s not just an inherent result of the claimed step:

    “The evidence of record does not establish that the
    dose reduction “from 3 to 2 times a day without loss of
    efficacy” limitation is an inherent property or a necessary
    result of the administration of 0.2% brimonidine and 0.5%
    timolol in a single composition. Of course, it may be true
    that the mere administration of 0.2% brimonidine and
    0.5% timolol twice daily in any fixed combination formulation inherently produces the claimed result. Alternatively, it may also be true that only certain fixedcombination formulations produce this result. On the
    present record, we cannot draw a conclusion in favor of
    either proposition.”

  50. I don’t understand this case at all. If the claim is reducing from 3 to 2 doses a day, why can’t Sandoz market it for only 2 doses a day (and not 3) as that wouldn’t be infringing?

  51. Research by David C. Barker of the University of Pittsburgh and David H. Bearce of the University of Colorado uncovered that belief in the biblical end-times was a motivating factor behind resistance to curbing climate change.

    “[T]he fact that such an overwhelming percentage of Republican citizens profess a belief in the Second Coming (76 percent in 2006, according to our sample) suggests that governmental attempts to curb greenhouse emissions would encounter stiff resistance even if every Democrat in the country wanted to curb them,” Barker and Bearce wrote in their study, which will be published in the June issue of Political Science Quarterly.

  52. Ned,

    You are jumping the gun on the Monsanto case. It has not yet been finally adjudicated.

    And I love the fact that you glibly ignore (here) that your beloved MoT was met in Prometheus.

    Oh well, as I have said:
    Bilski: MoT not required
    Prometheus: MoT not sufficient

    Speaking about the number of times that someone must be hit over the head….

  53. As always, Malcolm, you explain the fundamental problem with patenting information in a very clear manner.

    What was discovered here was that two doses per day would work just as well as three. Taking two doses was known or obvious for other reasons. Thus, the PTO gave us a patent on the new information, where knowledge of the effectiveness of 2 vs. 3 is required to infringe.

    But patent infringement is supposed to be without regard to mens rea. It appears the Feds don’t understand what they are doing. First they approve Prometheus. Next Monsanto (where knowledge of that the seeds one is planting are patented seems to be a requirement for proof of direct infringement). Now this.

    How many time does one have to hit them over the head until they get it?

  54. I am surprised that you did not try to blame this on Kappos.

    You are slipping.

    Spending too much time with Francis and Keeping It Real, perhaps?

  55. The preamble should ALWAYS be considered limiting!

    Unless, of course, it is not to be considered limiting.

    Hmm, which of the two statements accords with actual law?

  56. claim 4 recites a property of the claimed method, so it is improper to give it any patentable weight.

    Absolutely true. And basic stuff, as Dyk points out. The really absurd part is the majority’s reasoning with respect to claim 4 contradicts the very principle they relied on to find the other claims obvious! Specifically: Motivation … may be found in many different places and forms. The cited motivation does not need to be the same motivation as that which “inspired” the alleged inventor.

    Here, there was demonstrated motivation in the prior art to dose twice daily — the only step recited in the claimed method. For the purpose of evaluating obviousness, it doesn’t matter that a different motivation to dose twice daily was identified by the applicants. Whether it was “lowering dosage” or “raising dosage” or “creating additional stomach space for shiny, grape-flavored candies” is irrelevant.

    Consider the outcome here: individual A who has never taken the drug before reads the literature and takes two doses (it’s obvious, after all). No infringement. Everything’s cool.

    Then, one day, individual A takes three doses. It works okay. But he decides that he can’t afford three doses. Can he return to two doses? Nope – not without infringing the patent.

    What are the labels of this unpatentable composition supposed to say? “Take two doses daily unless you are already taking three doses, in which case consult your attorney first.” Give us a break already. When the Federal Circuit can’t get the simple stuff right, we have big problems.

  57. The preamble should ALWAYS be considered limiting!

    And this is a great example of how a specific, substantial, and credible assertion of utility is critical in a patent application.

    Although I don’t know what the compounds do, or how “efficacy” is defined, I assume it to be something like the maintenance of a particular circulating level of a compound. No, “maintaining efficacy” is not a method step, and yes, a method claim is composed of steps–so how could the preamble possibly be considered limiting if it includes no steps?

    Because, and to the extent that it actually does, it permits interpretation of the remainder of the claim steps.

    In this case, are there different ways of “administering said 0.2% brimonidine by weight and 0.5% timolol by weight in a single composition”? Of course there are–there are different administration schedules, twice daily, and thrice daily being 2 possible such schedules.

    Would going from thrice a day to twice daily have any specific, substantial, and credible utility? Potentially, IFF it could be shown that there was some deficiency that actually resulted from the thrice daily requirement, that was ameliorated or eliminated by moving to a twice daily requirement.

    For instance, it could have been shown that patients dosing twice daily would forget less often than those dosing thrice daily.

    Or, it could have been shown that less of the active ingredients were actually used while dosing twice daily, as compared with dosing thrice daily.

    Or, it could have been shown that the variability in the circulating levels was lessened when dosing twice daily, as compared to dosing thrice daily.

    Were anything like these actually evidenced in the trial, or in the appeal? Or is a minimum dosing schedule generally considered to be a well-established utility in these arts?

    If so, then and only then should an obviousness analysis be conducted.

    I would say that if the utility was well-established, but had not yet been actually achieved or implemented, that that would be evidence of non-obviousness.

  58. While as a prosecutor who often deals with new uses of old products, I will definitely use this case, I have to admit that the majority’s position makes no sense with respect to claim 4. Dyk has it exactly right: claim 4 recites a property of the claimed method, so it is improper to give it any patentable weight.

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