Hikma Pharmaceuticals USA Inc., et al. v. Vanda Pharmaceuticals Inc., No. 18-817

Hikma has petitioned the Supreme Court for review of this important eligibility case.  In its decision, the Federal Circuit drew a fine line between Vanda’s personalized medical treatment claims (adjudged eligible) and the methods found in Mayo and Ariosa (adjudged ineligible).  Question presented (long form):

This Court has repeatedly held that “natural phenomena[] and abstract ideas are not patentable” under Section 101 of the Patent Act. E.g., Alice Corp. Pty. Ltd. v. CLS Bank, Int’l, 573 U.S. 208, 216 (2014). Thus, “a process that focuses upon the use of a natural law” must also contain other elements or a combination of elements, sometimes referred to as an ‘inventive concept,’ sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself.” Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 72-73 (2012). Mayo, for example, invalidated a medical diagnosis method patent that was just “an instruction to doctors to apply the applicable laws when treating their patients.” Id. at 79.

In the decision below, a divided Federal Circuit panel did exactly what Mayo forbids: it exempted all patent claims that are drafted as reciting a method of medically treating patients from this analysis. Citing the ruling, the Patent and Trademark Office has directed its examiners that “(1) ‘method of treatment’ claims that practically apply natural relationships should be considered patent eligible under * * * the USPTO’s subject matter eligibility guidance; and (2) it is not necessary for ‘method of treatment’ claims that practically apply natural relationships to include nonroutine or unconventional steps to be considered patent eligible under [Section 101].”

The question presented is whether patents that claim a method of medically treating a patient automatically satisfy Section 101 of the Patent Act, even if they apply a natural law using only routine and conventional steps.

Read the Petition.

72 thoughts on “Hikma Pharmaceuticals USA Inc., et al. v. Vanda Pharmaceuticals Inc., No. 18-817

  1. 7

    IMHO there should not be a blanket exemption as exemplified by the following:

    Having discovered that autoimmune diseases are mediated by TNF alpha. The following claim should be ineligible under Alice:

    “A method of treating an autoimmune disease by inhibiting TNFalpha”

    By contrast, the following claims should at least not fall foul of Alice:
    “A method of treating an autoimmune disease said method comprising administering a TNFalpha inhibiting amount of DIS-252262 to a subject in need thereof.”

    1. 7.1

      Your second claim is merely window dressing and adds nothing “significantly more” than your first claim.

      I can easily see several Supreme Court Justices shooting down your statement, David.

    2. 7.2

      The following claim should be ineligible under Alice:

      “A method of treating an autoimmune disease by inhibiting TNFalpha”

      I am sure, as a practical matter, that this claim would presently be treated as ineligible under Mayo/Alice. I am less clear as to why it should be classed as ineligible. On the assumption that TNFα inhibitors are known in the art at the time of filing*, it seems to me that this claim should pass §101 (it is a useful process, thus fulfilling the utility and category eligibility requirements set out in the statute), but then fail §112 on written description / scope of enablement grounds (one has neither described nor enabled every possible means of inhibiting TNFα.

      * If TNFα inhibitors were not known in the art at the time of filing, then this claim should fail the §101 utility requirement, because a totally non-enabled claim has no use. In re Kirk, 376 F.2d 936, 942 (C.C.P.A. 1967).

      1. 7.2.1

        In re Kirk is a fun read – thanks for the cite!

      2. 7.2.2

        Greg: “A method of treating an autoimmune disease by inhibiting TNFalpha”

        I am sure, as a practical matter, that this claim would presently be treated as ineligible under Mayo/Alice. I am less clear as to why it should be classed as ineligible.

        First off, if there are no compounds known to possess the inhibitory property, then a claim like this has zero chance of getting out of the PTO. It’s not an enablement issue but a perfect example of a claim failing 112 under the written description prong. It’s indistinguishable from the situation presented in the CAFC’s seminal Ariad v. Lilly case, where Ariad’s claims covered the use of all substances that inhibited NF-κB activity but disclosed not a single example of any such substance, not even prophetically. I’m not aware of any controversy whatsoever about that result (but feel free to disagree).

        It’s also a slam dunk eligibility fail because the claim protects (i.e., grants ownership rights to) an abstraction, i.e., a functionality. It’s non-statutory on its face (and the scriveners attempt to claim the functionality as a “method” achieves nothing) because it plainly seeks to own the use of anything that “works”. That’s not permitted. That’s not “inventing”. You can call it “claiming a natural phenomenon” if you prefer but I’d simply call it what it is: an attempt to avoid describing any working compositions in structural terms while still claiming a degree of ownership in the use of all compositions with the desired functionality.

        The policy considerations are identical (the same considerations are behind many different sections of the patent statute): you are entitled to claims commensurate with the scope of the novel features that you disclose. So there should be no surprise when claims miserably failing 112 or 103 also miserably fail section 101. That’s to be expected, in fact. Feel free to complain about the policy, if you wish, but think carefully before you do so.

        1. 7.2.2.1

          My second paragraph above (beginning with “I am sure …”) should also be italicized. I’m quoting Greg.

        2. 7.2.2.2

          Your canards are aplenty (same ones, another day with the same dissembling)

  2. 6

    The question presented is whether patents that claim a method of medically treating a patient automatically satisfy Section 101 of the Patent Act, even if they apply a natural law using only routine and conventional steps.

    Well, the answer to that question is definitely “no” but it’s not clear to me that the PTO or the lower courts have plainly stated anything to the contrary. Merely labeling a method a “method of treatment” isn’t going to solve your eligibility problems. Even if your method does actually “treat” somebody, it won’t necessarily solve a claim’s eligibility problems if the “treating” steps as claimed are old in the art.

    For example, even if Prometheus’ ineligible claim had recited an additional step of actually administering a lower amount of the drug (instead of just thinking about doing that, as was the case for the claim at issue), if the administration of that lower amount of the drug was also in the prior art (which it was, by the way!), the claim would still be ineligible. In other words, you can’t obtain a patent on a claim that recites only the physically transformative treating steps in the prior art simply by adding a “non-obvious” step of thinking about (or writing about, or informing about) a particular number (e.g., a threshold value or a correlation) while performing the administration. The reason why that’s the case is that, as a health care provider, I have every right to think about whatever I want when I treat a patient as long as the treatment is safe and effective and legal. You can’t come at me with some patent and tell me what I can think or what I can’t think while I’m treating somebody, nor can you tell me what I can tell them about why I’m treating them.

    People who have difficulty understanding this really need to check themselves. Look in the mirror for a change instead of just jrking yourself off to patents 24-7.

    1. 6.1

      You are (again) confusing and conflating patent eligibility and patentability.

      That you seem completely unaware that such is what you are doing here — such is ONLY what you are doing here — says more about you than probably know (or care).

      Hint: that more about you is NOT a good thing.

      1. 6.1.1

        You are (again) confusing and conflating patent eligibility and patentability.

        Y0u are (again) reciting a tired script and stating a conclusion without providing any evidence. I’m not “conflating” anything.

        That you seem completely unaware that such is what you are doing here

        I know exactly what I’m doing here, Billy. I’m showing everyone what an incredible vapid j0 ke you are, along with the rest of your miserable jrk-off cohorts. I’ve been doing it for years and by the admission of your p@ thetic bff Night Wiper, I’m incredibly skilled at it.

        Win, win, win. And more winning to come.

        1. 6.1.1.1

          The Accuse Others is stultifying:

          Y0u are (again) reciting a tired script and stating a conclusion without providing any evidence.

          That’s exactly what YOU are doing.

          I’m not “conflating” anything.”

          Yes, that is exactly what YOU are doing.

          I know exactly what I’m doing here, Billy.

          No. No you do not. You may think that you do, and in your own “Legend in your own mind” way, you continue to “shine your own buttons,” but any notion that what you do in your mind has any bearing on reality is pure poppycock. What you have been doing for years is be a blight. As has been documented in the “let’s have a nice ecosystem” threads. That’s not a “skill,” leastwise, not one that a decent person would take delight in, as you do.

          1. 6.1.1.1.1

            “Y0u are (again) reciting a tired script and stating a conclusion without providing any evidence. ”

            That’s exactly what YOU are doing.

            You know, Billy, everyone can read my comment and see that you are l y ing.

            It’s time for you to do that f cking yourself thing again. Get started, please.

            1. 6.1.1.1.1.1

              Stay classy.

              Or not (and have this join your expunged posts.

              Speaking of expunged posts, tell me again who has the most expunged posts — more than anyone else — and more than everyone else combined…

              Yes, that would be you.

              Ever figure out why?

              Ever try?

  3. 5

    Where’s MM on this bio case? Too worried about his precious whamen’s march going up in flames because its antisemitic/too white and getting people killed?

  4. 4

    Cert denied.

    As. It. Should. Be.

    For the good of our Country, Congressional 101 reform + the forthcoming, promised additional PTO 101 guidance can’t come soon enough.

    1. 4.1

      Anyone in the Office know what the hold-up is with the new 101 guidance?

      1. 4.1.1

        I haven’t heard anything.

        I wouldn’t be surprised if some segment of the office was dragging their heels on implementing Iancu’s “practical application” test until someone can explain how Alice wasn’t a “practical application”.

        1. 4.1.1.1

          Thanks Ben,

          I am not certain that dragging heels on implementation is a consideration since there is nothing (yet) TO implement.

          Maybe the dragging is in how to word the direction so as to “appease” the Court while still actually enforcing the “real” law (the law as written by Congress and not the Court)….

        2. 4.1.1.2

          I wouldn’t be surprised if some segment of the office was dragging their heels on implementing Iancu’s “practical application” test until someone can explain how Alice wasn’t a “practical application”.

          I wouldn’t be surprised if I knew those people and wasn’t in contact with them on a regular basis on how to make sure that the test is never successfully implemented because it’s absurd and illegal.

          Iancu isn’t going to be around much longer anyway.

          1. 4.1.1.2.1

            I wouldn’t be surprised if I knew those people and wasn’t in contact with them on a regular basis on how to make sure that the test is never successfully implemented because it’s absurd and illegal.

            LOL – besides being the legend in your own mind, what you appear to be admitting to here is obstruction of justice based on your feelings.

            That may be one way for someone to reach out to the editors for your personal information (and believe me, the lack of objective editorial controls on this blog would remove any attempt of a “shield” by the editor and your information would be obtained.

            Maybe you want to think more before stating things like that you would obstruct the implementation of an executive branch director’s protocol based merely on what YOU deem to be absurd or illegal.

            1. 4.1.1.2.1.1

              ..or maybe you are just practicing your Internet Tough Guy routine….

            2. 4.1.1.2.1.2

              what you appear to be admitting to here is obstruction of justice

              Comedy gold.

              1. 4.1.1.2.1.2.1

                The “comedy gold” is in your apparent lack of ability to understand the implications of what you write:

                in contact with them on a regular basis on how to make sure that the test is never successfully implemented

                This may just be some of your “Internet tough guy” schtick (I’m infringing, come and get me, boasted pseudonymously), or you really may not understand the legal connotation of your ‘make sure not implemented’ comment, but either way, your comment is just not flattering for you as a supposed attorney.

                1. the legal connotation of your ‘make sure not implemented’ comment

                  What’s the “legal connotation” of that phrase, Billy? Tell everyone.

                2. Are you an attorney, Malcolm?

                  Do you really need someone to hold your hand in view of your (purported) active interference in preventing implementation of a law?

                  What do YOU think obstruction of justice entails?

                3. Are you an attorney, Malcolm?

                  Yes, that’s why I’m asking you perfectly reasonable follow-up questions, Billy.

                  And you aren’t answering them.

                  That’s just more evidence that you’re full of f king sh t, which everybody already knows.

                4. Your follow up is anything BUT perfectly reasonable – for the very reason that if you WERE an attorney, you would need not ask that follow up question at all.

                  The fact that you need not ask that at all is ALL the answer that you need (never mind how I did provide the additional “spoon-feeding” for you).

                  If you still have trouble with this, contact your malpractice carrier and ask them to explain this to you. Please feel free to send them the black and white of the direct text here.

  5. 3

    The petition has a clear invitation to the Court to reinstate its Flash of Genius mentality.

    Those that do not learn from history are doomed to repeat it.

    (maybe this time, Congress will take that [necessary] step and employ jurisdiction stripping of the non-original jurisdiction of patent appeals from the Supreme Court, and provide a reset [and non-browbeaten] lower Article III court to once again preserve a strong patent system)

  6. 2

    Please, let’s do even MORE to ensure that there’s no investment in medical advances. So that in the future we WON’T have treatments for cancers for which there is presently no treatment, so that we WON’T have faster and more accurate diagnoses of various conditions, and so that we WON’T have new life-saving devices and procedures. Because if we grant patents on those things, gosh darn it, someone might make a buck, so it’s better that those things never be developed than a pharmaceutical or medical device company make a profit and mankind benefit in the long run. But it’s ok for lawyers make their own quick buck trying to get SCOTUS to further f–k things up.

    The lawyers who filed this petition should be disbarred.

    1. 2.1

      Can’t agree more, but let’s appeal to the Vermont hippie – aka ‘social commons’ aka communist economics – and expect good results.

    2. 2.2

      So that in the future we WON’T have treatments for cancers for which there is presently no treatment, so that we WON’T have faster and more accurate diagnoses of various conditions, and so that we WON’T have new life-saving devices and procedures.

      Pretty sure “cure for cancer” and “change current dosage levels for people with this gene” aren’t the same thing, but yeah, I can’t think of any motivation someone would have for discovering a cure for cancer that doesn’t involve them getting monopoly profits in the United States of America. Everyone knows Medicine started in 1790 shortly after the first patent act was passed and has been at a standstill ever since Mayo was issued.

      Because if we grant patents on those things, gosh darn it, someone might make a buck, so it’s better that those things never be developed than a pharmaceutical or medical device company make a profit and mankind benefit in the long run.

      People turn profits on all sorts of things that aren’t subject to patent monopolies.

      Psst, by the way, if some other country publishes a patent and you have the internet (you do!) and are capable of reading (questionable?) you can know everything they know. That’s how patent publishing works. Now if only someone can get word to our doctors about these techniques.

      Maybe it’s the Americanness of our dollars that beats cancer. If I had the cure for cancer and my only options were to only take european money or throw it in a fire, you better believe I’m getting the lighter fluid.

      A lot of true lol at the people who actually think there’s no solution to this situation, as if society has no mechanism to entice beneficial information research and disclosure besides the grant of a patent.

      1. 2.2.1

        Random—do you have any experience in innovation and trying to fund creating new things? Any?

        1. 2.2.1.1

          Random—do you have any experience in innovation and trying to fund creating new things? Any?

          I invent software inventions without reducing them to practice constantly. I also have a five yeard old nephew that does, because he is also capable of naming things he’d like computers to do.

          1. 2.2.1.1.1

            The thought of software is not software.

            That you examine in this area is downright scary.

            1. 2.2.1.1.1.1

              The thought of software is not software.

              But thinking of things that computers can do is definitely “inventing”, at least according to some people who talk and act in a manner indistinguishable from you. And that’s what was being discussed, Billy.

              Here’s another thought: feel free to disagree with something that we are saying, for a change, instead of arguing about something that nobody is saying. Bonus points if you can actually explain the point of disagreement and your reasoning in direct English sentences without invoking Monte Hall or the World’s Simplest Set Theory.

              I’ll even tee it up for you. If thinking about a new piece of software in terms descriptive of the new functionality imparted to the programmable computer is not “inventing” software, then please tell everyone exactly what else needs to be described (that hasn’t previously been described) before it can properly be termed “inventing”. Go ahead. And don’t refer us to something else. Use your words, Billy. Like a grown-up.

              1. 2.2.1.1.1.1.1

                You are so very confused.

      2. 2.2.2

        I will agree with Random here – but only on a certain angle: the notion of “but for patents” is oft an overplayed one.

        Having a patent system is NOT just for those instances wherein “innovation would not happen without.”

        It is a mistake then to build an argument with that view as your foundation.

        That being said, removing the “[addition] of the fuel of interest to the fire of genius” cannot be a good thing.

        And this is where Random (and the other typical anti-patentists) never seem to be able to see themselves. Hiding behind labels such as “maximalists,” the naysayers never seem to be able to contemplate the “world” as they would have it.

        1. 2.2.2.1

          Random (and the other typical anti-patentists)

          Pretty sure that Random is not “anti-patent” in any meaningful sense. I’m not “anti-patent” in any meaningful sense either. Patents are important. In theory, they are perfectly reasonable legal tools for effecting reasonable policy choices.

          I’m definitely opposed to the use of patents as a means for “owning” “new” logic, “new” information, and/or “new” rules, and I’m opposed to patents that broadly grant rights to “newly discovered” naturally occurring phenomenon (e.g., newly described organisms and parts thereof). Pretty sure most normal people around the world would agree with me (at least, most normal people who are intelligent enough to understand the issues).

          I don’t see how this makes me “anti-patent.” It certainly makes me “anti-cwazypatent”. Proud to wear that label.

          1. 2.2.2.1.1

            Pretty sure that Random is not “anti-patent” in any meaningful sense. I’m not “anti-patent” in any meaningful sense either.

            I am more than sure that you are dead wrong in your views.

            Are you really that out of touch?

            Maybe we can have the Prof. Bring back DISQUS, and block the ultra-high security level and let you see the collection of your posts, and how more than 99% of them are anti-patent.

      3. 2.2.3

        I can’t think of any motivation someone would have for discovering a cure for cancer that doesn’t involve them getting monopoly profits in the United States of America. Everyone knows Medicine started in 1790 shortly after the first patent act was passed and has been at a standstill ever since Mayo was issued.

        I gather that your substantive point here is that “Chicken Little” is not a good look for people on my side of this argument. As it happens, I agree with that take, so I do not want to press back too hard against your argument. That said, your post betrays a lack of familiarity with the subject matter of which you are speaking.

        Firstly, ever since the advent of the Pure Food & Drug Act of 1906, the discovery of a new treatment is only one hurdle (and maybe not even the most difficult) to improving the lives of patients. Before one’s discovery can make any difference to patients in the U.S., one must first get the FDA’s permission to distribute and practice the therapy in the U.S. That is why, when you write that “if some other country publishes a patent and you have the internet… you can… get word to our doctors about these techniques,” you come across as somewhat naive about your subject matter. Sure, a U.S. physician can read an (e.g.) EP patent, but if the FDA has not approved the therapy described in that patent, then the U.S. physician’s ability to put that therapy into practice is compromised.

        If, for example, Amgen discovers a new monoclonal antibody (mAb), and the USPTO decides that this mAb is an ineligible “natural product,” then economics of taking the new mAb through FDA clearance is dubious, no matter how efficacious the mAb. The fact that this mAb is disclosed in some patent document somewhere is cold comfort to patients or physicians, because they will lack the wherewithal to produce useful quantities of this mAb. This advance in the knowledge common to the art will drop stillborn from the press.

        If I had the cure for cancer and my only options were to only take european money or throw it in a fire, you better believe I’m getting the lighter fluid.

        Secondly, the economics of the healthcare industry are very different from other industries. In software, or automotives, or kitchen appliances, people pay for the goods they consume with their own money. In healthcare, however, most of the spending is done by third-party payers (insurance companies in some countries, government spending in others). Various of these third-party payers impose various spending caps on what can be spent on different categories of care. The upshot of all this is that the U.S. market accounts for more than 50% of all profits that a company will end up making off of any given product. In other words, if one cannot extract monopoly rents off of one’s U.S. sales, then the overall value of the new discovery to the inventor is cut by approximately half. The economics of what sort of product is worth taking through regulatory clearance in the USFDA, EMA, JPMDA, etc. is very different in a world in which one does not have U.S. market exclusivity. It is quite possibly not worth the expense even to pursue regulatory approval in Europe or America if you do not have U.S. market exclusivity. Therefore, the idea that one might “take [E]uropean money” in lieu of American money is an illusion. One is not even permitted to make sales in Europe without prior clearance from the EMA, and the costs of seeking that regulatory approval are not economically viable if the costs of the requisite phase III studies cannot be recovered from monopoly rents in both the US and EU.

        1. 2.2.3.1

          Greg reveals (yet another) dirty secret:

          As a US citizen, I am forced to subsidize the actual costs (through the profit mechanisms) for other countries.

          IF actual citizens of other countries picked up their “fair” share of the profits, then my actual costs (borne through insurance or otherwise) would be dramatically different.

          This then would lean away from the mechanisms that Greg identifies.

          As Greg notes, these mechanisms do apply a peculiar “twist” to not only the Pharma patent efforts, not only the Pharma view of patents, but what ACTUALLY is developed and put into the market.

          Note as well that this art field is NOT one (like the computing arts) that provides for the “not-so-well-ALREADY-monied” innovators to provide disruptive innovation.

          One of the odd twists from this is the “taint” from Big Money against small-guy disruptive innovation (and policies that actively support this very beneficial philosophy).

          This too played out in the AIA “divide and conquer” approach, as well as the “general” anti-innovation, anti-patent propaganda against the very form of innovation MOST accessible to the non-wealthy, non-already-established.

          These are the types of important nuances one should take care to understand when one looks at the bigger picture of patent systems that are constructed (largely) to be agnostic to ANY ONE particular area of innovation.

          1. 2.2.3.1.1

            Anon, I agree it’s not fair that US taxpayers effectively subsidize drug development for the rest of the world. But it is what it is, and as Greg explained (and RG completely missed), undermining patent eligibility results in a situation where products that might otherwise have been worth developing are no longer worth developing, thus depriving everyone of those products. I’ve seen in this practice, but it’s a point that most people aren’t aware of – you can’t detect what’s not there.

            If there was no requirement to obtain FDA approval, the dynamics would probably be different…although with the kind of obscene damages awards given out by US juries, they might not be.

            Patents are not necessarily the only way to go in pharma. Simply giving market exclusivity for 12 years from FDA approval for a new drug would do it too. But lacking some promise of exclusivity to guarantee an adequate return on investment, new drugs, and to a lesser extent new medical devices and new diagnostic methods, there will be less development in those areas.

            1. 2.2.3.1.1.1

              You miss several of the points of my post with your (seemingly too eager) acceptance of “it is what it is.”

              Let me throw another point on the pile: the “Big Pharma” affect also plays out in the area of secondary markets and the attempts by Big Pharma to diminish the loss of protection due to the First Sale Doctrine.

              Look at how Pharma tries to use cross border controls and wants to extend patent protection for things that they themselves have already sold and put into the stream of commerce (albeit, at the artificially low prices in other non-US geographic zones).

              They will try to use a “bait and switch” “safety” argument, but that argument does not hold up to critical thinking when one realizes that the exhaustion doctrine is being applied to the very items that they themselves are putting into the stream of commerce.

              We should not meekly accept “it is what it is” without critical thinking and without recognizing the effects on patent law (and other social issues, which may be addressed better in other forums).

              Here, in this forum, my further points (which you seem to have glossed over) are directly related to the patent law issues that are often in play (and to which, a “divide and conquer” approach is evident in the larger mind-games and applications of propaganda aimed to shape the law).

            2. 2.2.3.1.1.2

              …but to reply to your point that “patents are not the only way to go,” such is universally true – and being universally true, misses the point that a pre-occupation with only one reason (and certainly not the only reason) why we have a patent system creates the fallacy in Random’s reply.

              The multitude of reasons why we have a patent system eviscerates the “we can use other mechanisms” point.

              It simply does not matter that we could use other mechanisms.

              We have chosen TO have a patent system. The choice is NOT a “but for cost” only choice.

              There is a real danger in getting caught up with the larger philosophies of why we have so chosen to have a patent system when one becomes entrained in the “thinking” of only one art field.

              As I point out (and not just here), many of the “arguments” and “logic” used in attacking software or business method types of innovation are at their core merely anti-patent “arguments” and “logic.”

              This is also why I am so adamant about the “Ends do not justify the Means” mantra.

              One of the huge propaganda points is the attempt to achieve a certain Ends of denting protection to innovation of a certain type. I can not accurately call this a certain art field, because computing (and thus, software) innovation actually spans MANY art fields. Suffice to say though, the desired Ends is to deny patent protection to that type of innovation.

              As is being done now (largely from the legislating from the Bench of the Supreme Court, infecting the CAFC and the Office), improper Means have been employed in order to reach the desired Ends.

              It is inevitable that the side effects, the flow into many art fields, will occur based on the improper means.

              What this does (as more improper means are piled on top, ever trying to reach a desired Ends), is to create a Gordian Knot of self-conflicting and impossible to square “Common Law” law writing from the courts.

              This can be seen directly in the writings of the Supreme Court alone.

              This can also be seen in the writings of the other Article III courts.

              This (sadly) can also be seen in the Office, as the executive agency attempts to use the Common Law law writing tools provided by the Supreme Court.

              ALL of these things are simply reflections of the larger issue that the score board is broken.

              1. 2.2.3.1.1.2.1

                …let me also point out that this has been played out previously in the historical basis that generated the Act of 1952 and Congress stripping from the Court the Common Law ability to set the meaning of the word “invention,” and opting instead to carve up a former single paragraph into the multiple sections of 101/102/103.

                The man who helped Congress do this (the man who wrote the laws that Congress passed), the jurist most in tune with this topic explained this in his writings way back in the 1961/1962 time frame (that jurist is Judge Rich). While certainly not the only word on the matter, what he had to say is an important word on the matter.

                It is no small accident that it was due directly to Judge Rich that the “scrivining” of the Court (from Benson and Flook) was pushed back, and cases such as Chakrabarty and Diehr sought to get back closer to the actual words of Congress.

            3. 2.2.3.1.1.3

              I agree it’s not fair that US taxpayers effectively subsidize drug development for the rest of the world.

              Two brief responses:

              (1) It is not really US taxpayers that are doing the subsidizing. It is US drug consumers. I suppose that there is a large overlap between those two categories, but there is nothing about paying taxes in the US that makes you to subsidize drug development around the world.

              (2) What exactly is “not fair” about this arrangement? We (US drug consumers) consent to pay the prices that we pay. There is no fraud or coercion involved.

              Meanwhile, there is nothing stopping us from using our government to institute statutory prices caps, just as other countries do. We simply choose—as a people and as a polity—not to do so.

              How is this less than fair?

              1. 2.2.3.1.1.3.1

                I agree that “taxpayers” was not the correct wording (and may attribute this to being a mere misnomer on AM’s part).

                There very much IS coercion of a sort: there is a concerted effort to not only make US consumers pay more (contribute more to the profit), there is a concerted effort to block the natural consequences of secondary markets that prop up artificial geographic market manipulations.

                It is more than a bit disingenuous to pretend that if US consumers were given an actual choice, that they would with NO hesitation choose a lower price. This is well reflected in the STRONG desire for a secondary market, even if that secondary market has to venture into being a black market.

                Your “answer” of government controls is a false flag. Such does not address the willfulness nor ability of Big Pharma to gouge US consumers in relation to prices that Big Pharma itself either sets or agrees to in other markets.

                To rally around other government’s policy decisions to force price caps does NOT remove the fact that Big Pharma still voluntary places its own products into the stream of commerce.

                Big Pharma could just as well refuse to sell into a market for which the local Sovereign has chosen to put in place price caps. The choice remains theirs. And part of their choice is their choice to “make up” their profit loss by charging more here (AND actively trying to deny secondary markets).

          2. 2.2.3.1.2

            Greg reveals (yet another) dirty secret:
            As a US citizen, I am forced to subsidize

            ROTFLMAO

            That’s a secret?

            Glibertarians never cease to amuse. Like nobody’s subsidizing “anon.” Too funny.

            1. 2.2.3.1.2.1

              Like nobody’s subsidizing “anon.” Too funny.

              What exactly is your point with this statement?

              Be clear.

              Then remember (with that self-professed ability of yours to recall EVERY post of mine in a four hour time span) that I have been more than clear that ALL of my posts satisfy the (buried) posting rules of this blog in that they are my personal — non-subsidized — views.

              Then take your mindless (glib) ad hominem and put away your favorite meme of Accuse Others.

            2. 2.2.3.1.2.2

              Are you “right here” again in your silence, Malcolm?

              Maybe address the points put to you so that we all can see that you actually are “right here” (and by “right here,” I mean more than your usual drive-by monologue Internet style shout down effect; maybe something like being inte11ectually honest in engaging with the conversation and addressing those points put to you).

            3. 2.2.3.1.2.3

              I am “sure” that you are still “right here,” but when that “right here” is NOT here (and engaging on the merits put to you), you are effectively NOT “right here.”

              You have effectively run away.

              As is your style (also known as the drive-by monologue, Internet shout down style).

          3. 2.2.3.1.3

            As Greg notes, these mechanisms do apply a peculiar “twist” to not only the Pharma patent efforts, not only the Pharma view of patents, but what ACTUALLY is developed and put into the market.

            These are the types of important nuances one should take care to understand when one looks at the bigger picture of patent systems that are constructed (largely) to be agnostic to ANY ONE particular area of innovation.

            But the patent LAW does not distinguish the standards by the area of implementation. And it is not like these well-monied organizations lack the ability to influence Congress on the issue.

            For example, if the FDA is a problem, there’s a simple (if politically difficult for Republicans) solution – you push the FDA into an international context, where each country funds it, and you allow every country to rule whether something is allowable based on the outcomes. That is, essentially what happens anyway, as everyone just follows what the FDA does, but it would spread the costs out to everyone. But that issue is separate and apart from whether the invention contains anything beyond the natural law.

            If natural laws are allowed, you would have all sorts of scientists claiming patents. Granted because many of types of science command less earning of money than medicine does, it may seem to be less important, but as I’ve pointed out before – it’s only because nobody has sought to patent the discovery of the location of oil that we haven’t had this problem be massively affecting consumers already.

            1. 2.2.3.1.3.1

              You seem to think that every patent is a nuisance to consumers.

              You fail to grasp that patents are by design both a carrot and a stick.

              Necessity is the mother of invention. Making it necessary brings the “stick” aspect.

              That you are involved in the patent system and lack this fundamental understanding is rather frightening.

            2. 2.2.3.1.3.2

              But the patent LAW does not distinguish the standards by the area of implementation.

              Not exactly true, given that often standards are to be provided in view of a Person Having Ordinary Skill IN THE ART, and the “area of implementation” most certainly is affected by THE ART.

              So while true that in a larger sense, the law is consistent in its meaning, it remains ALSO true that the application very much IS affected — and distinguished — by areas of implementation.

        2. 2.2.3.2

          Sure, a U.S. physician can read an (e.g.) EP patent, but if the FDA has not approved the therapy described in that patent, then the U.S. physician’s ability to put that therapy into practice is compromised.

          But as you point out, that burden exists whether the invention is patented or not. Someone looking to practice the discovery (and an inventor seeking to gain monopoly profits) has already factored in those costs. I could just as easily make the converse argument that with no patent you could spread the FDA cost out amongst several entities who seek to profit off of competitive treatment of patients.

          The upshot of all this is that the U.S. market accounts for more than 50% of all profits that a company will end up making off of any given product.

          That’s a great thing to highlight, because people everywhere get sick (in fact, I would assume more people get more sick of more things, except for maybe obesity, elsewhere in the world than people in the US), so you do correctly point out that the american consumer/patient essentially bankrolls the entire world’s medical advancements, allowing the rest of the world to freeload on the american consumer. You may see this as a benefit of the patent system. I do not.

          This ignores the fact that huge sums of money are lost in the motivation to be “first” – the person with the patent gets everything, everyone else gets nothing, so it is reasonable to spend money inefficiently in order to be slightly slightly faster.

          Regardless, the fact of the matter is that the patentee wants a patent for discovering a natural law. Once the natural law is disclosed, what to do is simplistic. The notion that we cannot use non-patent incentives to optimize current treatments is silly.

          1. 2.2.3.2.1

            Someone looking to practice the discovery (and an inventor seeking to gain monopoly profits) has already factored in those costs.

            I am not sure that I understand the point that you are trying to make here. By and large, R&D outfits do have these costs factored in, and the plan by which they expect to make good these costs depends on patents. Perhaps we are simply both agreeing here? The patent system is indispensable to the currently prevailing economic model by which healthcare innovation is distributed to the public in need thereof. I suspect (although I cannot formally prove it) that any attempt to remove the patent monopoly from this economic model and rework the other aspects accordingly would be one with a much lower (albeit non-zero) rate of innovation in healthcare technology.

            I could just as easily make the converse argument that with no patent you could spread the FDA cost out amongst several entities who seek to profit off of competitive treatment of patients.

            As a matter theoretical, you are quite correct. I am not much, however, for designing public policy around pure theory that never happens in practice. I am an in-house patent counsel for a pharma company.

            Here is something that I know from personal experience. My company is approached all the time by university scientists who believe that they have discovered some useful new therapeutic. Neither the individual scientist nor the university has the manufacturing or distribution infrastructure in place necessary to get these innovations into widespread circulation, so they come to my company (and other companies, of course), urging us to license their technology and commercialize it. One of our first questions is “what sort of IP is there around this discovery?”

            Sometimes (class A), the answer turns out to be that there is plausibly solid and enforceable IP. Some of the time we license that IP and take up the work of moving the technology through the FDA approval process.

            Sometimes (class B), however, the answer turns out to be that there is no IP, or that there is some IP filed only after the invention was disclosed in a paper/conference/poster session/etc. We never license that technology.

            In theory, you could imagine a charity taking up the expense of moving that class B technology through FDA clearance. Similarly, you could imagine a consortium of generic pharma companies pooling their resources to do the FDA clearance. Despite the fact that you could imagine this happening, it never does.

            In theory, one could imagine a human individual swimming across the Atlantic Ocean. In practice, this never happens. We inductively infer from the persistent lack of human individuals swimming the Atlantic that it is—in practical fact—impossible for a human individual to swim the Atlantic. In a similar fashion, we can inductively infer from the total lack of drugs on the market brought through the FDA process on the backs of charities or cooperative corporate endeveavors that it is—in actual practice—impossible to bring drugs to market on that economic model.

          2. 2.2.3.2.2

            [T]he american consumer/patient essentially bankrolls the entire world’s medical advancements, allowing the rest of the world to freeload on the american consumer. You may see this as a benefit of the patent system. I do not.

            I do not contend that it is a benefit of the U.S. patent system that it makes possible an arrangement by which the U.S. “bankrolls the entire world’s medical advancements.” That is nothing like a point that I have been making.

            I do contend that it is a benefit of the U.S. patent system that it makes possible technological progress in the healthcare industry. It is also the case that asymptotically all of the healthcare innovation is funded by the U.S. market. These two facts are only tangentially related. If you destroyed the U.S. patent system entirely, it would not lead to more of the world’s healthcare innovation being funded by ex-US sources. It would merely lead to a lower level of healthcare innovation overall.

            This ignores the fact that huge sums of money are lost in the motivation to be “first” – the person with the patent gets everything, everyone else gets nothing, so it is reasonable to spend money inefficiently in order to be slightly slightly faster.

            Sure. The current system is not perfect. I suspect that the current system is the best that is practically achievable (if “best” is measured in terms of “largest practically possible number of effective new treatments reaching patients”). This side of the eschaton, however, the “best” is often far short of the “perfect.”

            The notion that we cannot use non-patent incentives to optimize current treatments is silly.

            I agree that such a notion is silly. Is anyone on this thread advancing that notion? I will cheerfully consent to join you in deriding that person’s silly position.

            1. 2.2.3.2.2.1

              If you destroyed the U.S. patent system entirely, it would not lead to more of the world’s healthcare innovation being funded by ex-US sources.

              I do not necessarily think that there is much social utility to be had from shifting the percentage of healthcare innovation that is funded from the U.S. market. If, however, this were a goal that I supported, then I would suggest that much more would be achieved in this direction by ending the tax-free status of employer provided health insurance, than by any changes that one might make to the U.S. patent system.

            2. 2.2.3.2.2.2

              If you destroyed the U.S. patent system entirely, it would not lead to more of the world’s healthcare innovation being funded by ex-US sources. It would merely lead to a lower level of healthcare innovation overall.

              I suppose this is what I’d ask for more clarity on. Since the slippery slope of this argument would be if you entirely destroyed the world IP system it would lead to little to no healthcare innovation overall. Or more importantly (since the converse is generally true while slippery slope is not) – if we were to give more IP protection we would get even more healthcare innovation.

              In theory, you could imagine a charity taking up the expense of moving that class B technology through FDA clearance. Similarly, you could imagine a consortium of generic pharma companies pooling their resources to do the FDA clearance. Despite the fact that you could imagine this happening, it never does.

              Yes, so you see the irony here? The patent system exists to generate the disclosure. When the disclosure happens without the patent system, nothing occurs. When the patent issues, billions of dollars are put into effect. That shows that we are promoting the monopoly rather than the progress, an entirely @ss-backward situation.

              I suspect that the current system is the best that is practically achievable (if “best” is measured in terms of “largest practically possible number of effective new treatments reaching patients”)

              I find it difficult to believe that anyone could come to this conclusion. You’ve already demonstrated how valid drugs aren’t taken up because there is no profit in them. “No profit in them” shrinks both the amount and type of solutions that are sought if for no other reason than poor nations suffer from local diseases too.

              Please don’t misunderstand that as confusing “best” and “perfect”, as you say. It simply seems that if tomorrow we were to federalize all the ground level researchers and turn them around and re-task them we might not advance as far in certain sectors as we do now, but we almost assuredly would advance more overall. Nor does it make a lot of sense for multiple organizations to overspend to inefficiently try to reach first.

              You’re correct that I have an outsider (and perhaps unintelligent) perspective, but when two opponents spend inefficiently in order to not come in second, it seems the solution is either to remove the competition or lower the stakes (both between them and with respect to third parties) in order to force efficient expenditure. I recognize there is a small class of people for whom the extra time makes a difference, but they are dwarfed by the other classes who would benefit from efficient expenditures. The universe of possible advancements is not so small that the field lacks goals.

              1. 2.2.3.2.2.2.1

                Your “world view” is painfully Pollyanna Random.

                I can easily imagine that you lack any “real world” experience outside of your schooling and your government job as a bureaucratic examiner.

              2. 2.2.3.2.2.2.2

                [T]he slippery slope of this argument would be if you entirely destroyed the world IP system it would lead to little to no healthcare innovation overall.

                I can envision two equilibria that might plausibly emerge in a world without patents on drugs (or in which the patents were so short-lived or difficult to enforce as to be effectively no better than no patent at all):

                (1) Healthcare innovation slows to a level asymptotically approximate to zero.

                (2) Government takes over the healthcare sector entirely or almost entirely, achieving a level of healthcare service and innovation that is approximately equal to the level prevailing in modern Cuba or the pre-collapse Soviet Union (pretty good for state-of-the-art routine care; more innovation than scenario #1 above, but far less than the contemporary U.S. level of healthcare innovation).

                Or… if we were to give more IP protection we would get even more healthcare innovation.

                Gosh, this one is a big concept. My anecdotal impression is that we are seeing fewer start-ups in the diagnostic technology space over the last five years. I put this down to Mayo and its CAFC sequelae (Merial, Cleveland Clinic, Sequenom, etc). I think that if there were a statutory over-ride of Mayo, investment in diagnostic technologies would pick back up.

                I doubt that there is much more therapeutic innovation that could be squeezed out by making patents in this space easier to get or to enforce. I think that one probably could increase the rate of innovation in the therapeutic space by making patent terms longer (there are many therapies that never come to market because it would not be possible to recoup the investment capital during the ~8 years one gets between when the FDA approves the drug and when the patent expires).

                That is not to say, however, that I actually favor increasing patent term lengths. At the margins, medical innovation competes for capital and talent with clean energy innovation, biomaterials innovation, etc. If we jiggered the patent system to get more drugs, we would probably get less of other technologies that are more urgently necessary right now.

                1. (2) Government takes over the healthcare sector entirely or almost entirely, achieving a level of healthcare service and innovation that is approximately equal to the level prevailing in modern Cuba or the pre-collapse Soviet Union (pretty good for state-of-the-art routine care; more innovation than scenario #1 above, but far less than the contemporary U.S. level of healthcare innovation).

                  This is essentially what happens in the defense industry, and nobody suggests that defense innovation is approximately zero. The federal government grants money for development, monopolizes the innovative result for themselves, and produces embodiments. I don’t see the economics of researching a new weapons system (something that costs a lot of money, has large negatives for being second, and would not be undertaken absent the private monetary incentive) being that different from the economics of researching a new drug, with the notable exception that when we build an aircraft carrier Europe doesn’t necessarily get to freeload off it.

                  And personally I am not a huge believer in the American exceptionalism argument – as if people in Canada or Europe don’t get medical care – and that without american capitalism the entire world would descend into the dark ages. Everyone has an interest in being healthy, and the notion that the only thing allowing us to achieve that is the US patent system overinflates our self-worth.

                2. This is essentially what happens in the defense industry, and nobody suggests that defense innovation is approximately zero.

                  Sorry – but that is pure B$.

                  Why do you insist on talking about things that you CLEARLY lack any real knowledge in, Random?

                  You continue to crater your credibility with your Pollyanna feelings.

              3. 2.2.3.2.2.2.3

                The patent system exists to generate the disclosure. When the disclosure happens without the patent system, nothing occurs. When the patent issues, billions of dollars are put into effect. That shows that we are promoting the monopoly rather than the progress, an entirely @ss-backward situation.

                I do not follow your point here. The monopoly and the progress move in tandem. They are not working against each other. Can you please clarify your point, because I do not presently understand it.

              4. 2.2.3.2.2.2.4

                I suspect that the current system is the best that is practically achievable

                I find it difficult to believe that anyone could come to this conclusion. You’ve already demonstrated how… “[n]o profit in them” shrinks both the amount and type of solutions that are sought…

                Please note that I said “best that is practically achievable,” not “best that one can conceive.” I agree that the current system is far short of perfect. I agree that the points that you identify as deficiencies are deficiencies. If you think that something better is “practically achievable,” then you have a far more sanguine view than I have of what people can be motivated to do—in ordinary workaday circumstances—without a profit motive.

                I pray that your view is correct and that I am overly pessimistic. I see much evidence, however, for my view and scant little for yours.

              5. 2.2.3.2.2.2.5

                You’re correct that I have an outsider (and perhaps unintelligent) perspective…

                I never said that your perspective is unintelligent, and I never would say that. There are many unintelligent perspectives articulated around these parts, but yours are never among them. I said that your perspective on this particular subject appears uninformed and “naive.” Even your less informed musings, however, are manifestly intellligent and make an interesting contribution to the discussion.

                It simply seems that if tomorrow we were to federalize all the ground level researchers and turn them around and re-task them we might not advance as far in certain sectors as we do now, but we almost assuredly would advance more overall.

                I often wonder if we would not make more progress by federalizing science research. I used to favor that approach. My life experience has dissuaded me from that view. I do not know how old you are, but in the course of my life, I have lived through two particular episodes that have convinced me that federalizing healthcare would not accelerate progress.

                First, I am old enough to remember when HIV was a social hot button. Influential senators like Jesse Helms were able to see that many onerous reglations were put on federal funding for AIDS research. If it had been up to the government (rather than Burroughs-Wellcome) to move AZT through the FDA approval process, I very much doubt that it would have come to the market before ~2005.

                Second, I remember when the GOP congress raided the NIH budget in 2003 to pay for the Iraq war. Then, again, when the 2007 budget crunch hit, NIH and NSF funding were decimated (and still are not back up to pre-2007 levels in inflation adjusted dollars). In other words, a world in which we rely on the public sector to move healthcare innovations from lab to clinic to market is a world in which the progress of healthcare is—move than half the time—held in the hands of anti-science lunatics like Steve King and Lamar Smith. I have far more trust that the CEO of GSK will do what is best for patients than I have that Michelle Bachman will do so.

                1. I never said that your perspective is unintelligent, and I never would say that. There are many unintelligent perspectives articulated around these parts, but yours are never among them.

                  When “politeness” displaces reality, EVERYONE loses.

                  Greg loses credibility right along with Random (and that’s even given that Greg is in the industry that he is discussing!).

                  When you cannot call a spade a spade — and even worse, would never deign to do so, you artificially limit the value of the conversation.

                  Let me repeat: “Words,” wrote John Maynard Keynes, “ought to be a little wild, for they are the assault of thoughts on the unthinking.”

                2. held in the hands of anti-science lunatics like Steve King and Lamar Smith.

                  LOL – or insert the names of particular Justices and Judges, as they re-write the statutory law of Congress with their Common Law law writing…

  7. 1

    A hot New Years Eve topic Dennis?
    The chances for cert grant here may depend to some extent on how credible to the Court is this petition’s characterization of the decision below as a Fed, Cir. attempt to overrule [rather than distinguish] Mayo.
    Only the last paragraph starts with the applicable words “the question presented.” The decision below did not, of course, actually express the position that “patents that claim a method of medically treating a patient automatically satisfy Section 101 of the Patent Act, even if they apply a natural law using only routine and conventional steps.”
    [Also should the Sup. Ct. should take cert on Denials of preliminary 101 motions if that may become a moot issue if the patent claims are invalidated or held non-infringed?]

    1. 1.1

      My prediction: no chance that the Court takes cert. on this one.

      1. 1.1.1

        I agree with Greg.

        There are many much more deserving cases that have been refused cert.

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