Shaping the Future of Patent Law: The Amgen v. Sanofi Decision and Bite-Sized Monopolies

by Dennis Crouch

“The more one claims, the more one must enable.”

In a unanimous opinion delivered by Justice Gorsuch, the Supreme Court has affirmed the Federal Circuit’s decision invalidating Amgen’s functionally claimed genus of monoclonal antibodies. The Court held that Amgen’s patent claims were invalid due to a lack of enablement, as they failed to provide adequate guidance for making and using the claimed antibodies.

The case in question is Amgen Inc. v. Sanofi, 22-157, — U.S. — (2023) (21-757_k5g1).

Amgen’s patents cover monoclonal antibodies created by Amgen researchers which aid in reducing blood levels of low-density lipoprotein (LDL), also known as “bad cholesterol.” These antibodies inhibit the operation of a naturally occurring protein known as PCSK9, which degrades LDL receptors and contributes to high cholesterol levels. Amgen’s original patent covered antibodies having particular amino acid sequences, but later its competitor Sanofi patented another antibody with a different sequence from those disclosed and began competing.   Amgen was then able to obtain the broader patents at issue here that are not tied to any particular antibody structure or amino acid sequence. Rather, the claims cover an “entire genus” of antibodies capable of binding to specific amino acid residues on PCSK9 and consequently inhibit PCSK9 activity. Amgen subsequently sued Sanofi for infringement, prompting a defense from Sanofi challenging whether these broader claims were sufficiently enabled.

The Patent Act requires that patent applicant describes the invention in explicit terms to enable any person skilled in the art to make and use the invention. 35 U.S.C. 112. Sanofi characterized the methods Amgen provided for generating additional antibodies as merely a trial-and-error process, claiming that Amgen’s patents failed the enablement requirement as they sought exclusive use over potentially millions more antibodies than the company had taught how to produce. Although a jury sided with the patentee Amgen, the district court and the Federal Circuit agreed with Sanofi’s contention, ruling that Amgen did not meet the enablement requirement as a matter of law.

The enablement requirement is a crucial aspect of the patent “bargain”: an inventor is granted limited protection from competition in exchange for publicly disclosing their new technology. The Supreme Court, in its decision, referenced previous cases such as Morse, Incandescent Lamp, and Holland Furniture, as establishing the requirement that if a patent claims an entire class or genus of processes, machines, or compositions of matter, the specification must enable a person skilled in the field to make and use the entire class. In simpler terms, it follows the elementary school principle: If you bring cookies to share, bring enough for everyone.

If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class. In other words, the specification must enable the full scope of the invention as defined by its claims.

The more one claims, the more one must enable. See §112(a); see also Continental Paper Bag Co. v. Eastern Paper Bag Co., 210 U. S. 405 (1908) (“[T]he claims measure the invention.”).

Amgen v. Sanofi.

In this case, Amgen sought exclusivity for the entire class of functional antibodies, not just the 26 antibodies expressly disclosed.  Although Amgen also provided a “roadmap” for discovering more antibodies, the court found that those approaches were insufficient “research assignments” rather than a clear process for creating the additional antibodies. The Supreme Court ruled that these disclosures did not fulfill the enablement requirement as per the Patent Act, as they simply described Amgen’s trial-and-error method without providing sufficient information for skilled scientists to make the entire class of claimed antibodies.

The Supreme Court did agree with Amgen that functional/genus claims should not be held to a stricter standard of enablement. In other words, there is “one statutory enablement standard.” Nonetheless, the general principle remains that broader claims necessitate more enablement, and all claims must be enabled to their “full scope.”

The outcome of the Amgen v. Sanofi case, while significant, may not come as a surprise to those familiar with the evolution of patent law. In recent years, there has been a growing emphasis on promoting innovation and competition by limiting the scope of patent monopolies. This approach recognizes that patents should strike a balance between incentivizing inventors to disclose their inventions and ensuring that the public can freely build upon existing knowledge. Rather than granting broad and far-reaching patent rights, the trend has been towards encouraging more focused and narrowly tailored claims. This shift reflects a recognition that patents are more palatable when they offer bite-sized protection rather than providing a singular and overpowering monopoly. The ruling in the Amgen v. Sanofi case aligns with this approach, reinforcing the notion that patents should enable the creation and use of the claimed inventions while still allowing for competition and further advancements in the field.

84 thoughts on “Shaping the Future of Patent Law: The Amgen v. Sanofi Decision and Bite-Sized Monopolies

  1. 11

    After 20 years, it is gratifying to know I was doing my job properly rejecting bogus patent applications that were clearly not enabled despite the resistance of management at the USPTO. Honestly, an enablement rejection is a rare thing because most patent practitioners will provide more than sufficient technical content. (I remember seeing specs of more than 1000 pages thinking this is a real invention and must be properly respected as such.) They didn’t even bother teaching examiners how to make enablement rejections back when I went through examination training. I hope the Patent Academy will start teaching it now given the clear endorsement of the US Supreme Court, but honestly…I don’t count on it. Wow, the Supreme Court did something right for a change.

    1. 11.1

      Will USPTO Examiners (including Jr at 11) be inspired by this Decision to question enablement? No, says Paul Morgan at 9.2, unless the MPEP is amended to force it.

      Of course Paul’s right. Given the ever-increasing pressure on Examiners to work more “productively”, the pressure on them not to question enablement is also ever-higher, despite this Decision. Don’t even think of it, Jr, because for sure you’re on a hiding to nothing. As ever in life, the old maxim applies: don’t start something you can’t finish.

      Or might Examiners increasingly do it anyway, just to get onto the wrapper statements from the Applicant that can be challenged, if ever it comes, years later, to an inter Partes dispute. I don’t know. Tell me somebody.

      1. 11.1.1

        Or might Examiners increasingly do it anyway, just to get onto the wrapper statements from the Applicant that can be challenged, if ever it comes, years later, to an inter Partes dispute. I don’t know. Tell me somebody

        MaxDrei,

        Notwithstanding this case dealing with granted patents, the controlling case law FOR the whose burden AND that level of burden, during prosecution that BINDS examiners has not changed.

        Also notwithstanding the apparent malinformed view that somehow it is the “official” patent office dissuading examiners from making proper rejections under 35 USC 112, it is the aforementioned case law aspects that simply making a rejection that is proper (and thus, would stick) to be NOT simple.

        Thus, merely “getting into the record” will likely have the opposite effect that you are thinking of, as examiners (by and large – certainly not all of them) are
        L
        A
        Z
        Y
        and will not do the necessary work to back up an initial rejection and then you have the applicant’s 112 position “made stronger” (at least, this is a stronger position to be argued post-grant).

        1. 11.1.1.1

          Not sure it is that USPTO Examiners choose not to do the work “necessary” to make good a non-enablement objection to allowance. Rather, I was thinking that they, lacking laboratory facilities and a research budget, are (even if they really really wanted to) simply not in a position to do the “work” that is necessary. What types of “work” did you have in mind, I wonder.

          1. 11.1.1.1.1

            When it comes to US practice — despite how embarrassingly long you have been posting here — your guess is quite wrong as usual.

            As I indicated, it is case law that has set the level of the burden, and that level has nothing to do with any such laboratory / scientific equipment or research budget.

      2. 11.1.2

        The USPTO examiners do their job. The PTAB does its job. The Court of Appeals for the Federal Circuit does its job. The Supreme Court of the United States does its job. But you know that.

        1. 11.1.2.1

          My pal shifty, to pretend that each or any of these entities are doing their jobs well is pretty PollyAnna.

          Why do you think there is so much consternation in the innovation protection environment?

  2. 10

    “In recent years, there has been a growing emphasis on promoting innovation and competition by limiting the scope of patent monopolies.”

    I like how you just flat-out acknowledge patents are monopolies. Lots of pro-patent types bristle at that (accurate) characterization.

    1. 10.1

      Can you please use a smaller picture of yourself? You are not a good looking person.

      1. 10.1.1

        The thing that I like is that sh 1t-eating grin, and how undeserved it is.

        It makes a great poster boy of how NOT to be.

          1. 10.1.1.1.1

            You really do not see the grin…?

            I am not the one insulting everyone by including that mug in a post – you’ve aimed at the wrong person. All I am doing is trying to make lemonade from the provided lemons.

  3. 9

    How to reconcile the view espoused here with the one on the Quinn Watchdog blog? Did an earthquake just happen, or was it a figment of somebody’s over-heated imagination?

    My thought: the law didn’t change but perhaps what will change is the level of attention, determination and zeal with which the USPTO, from now on, will devote to enablement issues, when examining ambitious claims in the unpredictable arts. Is that perhaps what is so troubling, to the minds of some patent practitioners?

    1. 9.1

      What will happen is that we will see a case like Williamson but more restrictive that cites to Amgen.

      What the judges will do is limit the POSITA or put a lot of requirements on the “any person skilled in the art” to limit what that “any” means.

      This case is the dream of Lemley who has been pushing on 112 to further limit patents. My guess is that about 20 percent of information processing patents will be deemed worthless after the CAFC gets their hands on this holding.

      1. 9.1.2

        This case is the dream of Lemley who has been pushing on 112 to further limit patents.

        Just for the record, Mark Lemley filed an amicus brief in support of the patentee in this case. I am sure that there are important interests that wanted to use this case to limit patents, but Prof. Lemley was not on their side here.

        My guess is that about 20 percent of information processing patents will be deemed worthless after the CAFC gets their hands on this holding.

        Interesting. That is almost a falsifiable hypothesis. There are still two points that need to be specified if you want real credit for making a prediction and seeing it verified.

        First, you also need to specify a time horizon (e.g., “…20 percent of information processing patents [litigated in the next five years] will be deemed worthless…,” or some such).

        Second, is that “20 percent” over and above the existing rate at which information processing patents presently fail in litigation. I believe, for example, that it is already the case post-Alice that 60% of information processing patents fail when litigated (if I am misremembering the statistics, I hope that someone will correct me). Sixty percent is, obviously, already greater than twenty percent, so the in that sense the prediction is already correct (there are already 20% of information processing patents that are “worthless” when asserted). Do you mean that the number will increase an additional 20 percentage points (such that 80% will fail post Amgen where only 60% failed post-Alice but pre-Amgen)?

        In any event, I will also contribute a falsifiable hypothesis. I predict that when an argument is made in an information processing case that cites to Amgen v. Sanofi, the CAFC will distinguish the holding here as relating to the unpredictable arts. In other words, I predict that this precedent will have little to no effect on information processing patents (which will continue to fail under Alice, to be sure). I doubt that even 1% of information processing patents that fail in the next 10 years will see Amgen v. Sanofi cited along the way to their failure.

        1. 9.1.2.1

          The note from Greg in regards to distinguishing between unpredictable and predictable arts calls to mind several thoughts…

          a) a long time ago (in a galaxy far far away), an anti-patent Slashdot/TechDirt pundit quipped that ALL software solutions are mathematically equivalent (for a specific ‘functionality’ as I might add for context). This — most likely to the chagrin of this gentleman (P0iR, IIRC), leads to Greg’s view and makes computing patents stronger.

          b) I am amused that Malcolm’s typical disdain for computing, and attempts to make his preferred arena of patenting “to be better” falls to the opposite of how the term “unpredictable” is utilized. Logically, a more grown-up area of endeavor is considered to be more maturely developed – and predictable. Things unpredictable are typically thought of as LESS mature or “grown-up.”

          c) at the risk of appearing to invite the inanity of Random, I am wondering how his typical conflation of the different sections of the patent act will absorb this decision.

          1. 9.1.2.1.1

            “ Logically, a more grown-up area of endeavor is considered to be more maturely developed – and predictable.”

            It’s not the “art” that’s “grown up”. It’s the patent practice as it relates to that art, and the behavior of practitioners (applicants in particular) within that art as compared to the infantile squalling we get endlessly from the “instruct a computer to apply logic to data” arts.

            This is not a new point. This is me reminding you once again that applying ancient “logic” in new contexts is the absolute lowest form of “innovation”. Animals do it.

            1. 9.1.2.1.1.1

              This is a hilarious post MM (Prophet) given that half the country is currently terrified that the innovations in the “instruct a computer to apply logic to data arts” are going to destroy humanity and overtake human intelligence in the next few years.

              But OK. Good to have a First Amendment. Notice I am not defaming you.

            2. 9.1.2.1.1.2

              Utter nonsense from Malcolm, as he
              h
              a
              t
              e
              s
              the Art AND the people who would provide innovation protection in that Art.

              For his (incredulous) assertion of “lowest form,” it is quite literally the MAIN form of the fifth Kondratiev wave.

              As noted, Malcolm has no grasp of the tech.
              Also as noted, Malcolm is ALWAYS free to take me up on my invitation for him to abstain from any form of innovation that he would deign to deny patent protection to. As such — to him — is such a “low form,” he should be able to do that quite easily (and yet,
              he
              just
              doesn’t
              do
              it – cue the Dr Strange strut)

        2. 9.1.2.2

          I know Lemley was on the other side of this one as he pushes, generally, for stronger pharma patents and weaker information processing patents. But he has been pushing on 112 for a long time to weaken information processing patents.

          It is good you are making a prediction. Thank you. So, I think we can boil our predictions down to whether or not the CAFC does as you say:

          >I predict that when an argument is made in an information processing case that cites to Amgen v. Sanofi, the CAFC will distinguish the holding here as relating to the unpredictable arts.

          Or uses Amgen to invalidate information processing claims.

          Verifiable.

      2. 9.1.3

        “My guess is that about 20 percent of information processing patents will be deemed worthless after the CAFC gets their hands on this holding.”

        Let’s hope so. The more patents are invalidated, the weaker is patent law, the better, since patent law is a monstrous abomination and a huge impediment to innovation and prosperity. The patent system is unjust and should be immediately and completely abolished (same with the copyright system).

        I’ve believed this ever since I passed the patent bar in 1994.

        1. 9.1.3.1

          Kinsella is a strong opponent of intellectual property,[7] arguing that patents and copyrights should not form part of a proper libertarian law code.[8]

        2. 9.1.3.2

          It’s been a while since the poster boy of cognitive dissonance appeared on these pages.

        3. 9.1.3.3

          If you don’t welcome intellectual property rights then you are welcome to amend the US Constitution. Good luck with that.

          1. 9.1.3.3.1

            Unlike Mr. Kinsella, I do not wish to abolish the patent laws. That said, the U.S. Constitution merely authorizes the Congress to enact patent laws—it does not affirmatively mandate that there be patent laws. A mere act of Congress would suffice to achieve Mr. Kinsella’s goal. An amendment is not necessary.

            1. 9.1.3.3.1.1

              Although abolishing patent or copyright law might be a violation of treaty obligations under international law, e.g. the Berne Convention requires the US to have municipal copyright law with certain minimum protections. So to abolish patent or copyright law it would be best to also have the US exit certain treaties, e.g. GATT/WIPO, Paris Convention, PCT, Berne, and so on. Abolishing copyright law, for example, is something Congress can do and it would have an effect, even if it meant the US is now in breach of international law. I.e., the government has the right, under US law, to violate international law.

              1. 9.1.3.3.1.1.1

                Why is it that innovation is so closely tied to patents?

                Why does China want patents?

                What is the best paper to read that suggests that patents and copyrights don’t promote innovation and creativity?

                1. Just because a person invents, being given a Patent then denying it through CAFC or stealing one from the person doesn’t stop the financial train. It just gives the inventor ownership. And then that will define who is on first. Let the Commerce Dept. tax the merchandise made the way they tax luxury items. Stolen Patents such as 5,560,312 and 5,832,857 along with the Trademark and Copyrights that went with the stolen Patents will also have to find another way to tax them also. As for family fraud and felonious crimes that is not a Girdisn Knot. They are both separate.

                2. “Why is it that innovation is so closely tied to patents?”

                  this is a vague question, and loaded. I mean in today’s world, given patent law, when there is innovation, companies try to patent it. When you create an original work, you also automatically get a copyright. This doesn’t mean that IP law is necessary for creativity of innovation just that when you have IP law it becomes part of the business landscape and people take it into account.

                  “Why does China want patents?”

                  This makes no sense. The US and the west have pushed the rest of the world to adopt US-style IP law. We constantly accuse China of stealing American IP (which is nonsense) and pressure them to crack down on IP infringement. What are you talking about?

                  “What is the best paper to read that suggests that patents and copyrights don’t promote innovation and creativity?”

                  See link to c4sif.org

                  link to stephankinsella.com

                3. Sarah Mcpherson: “Just because a person invents, being given a Patent then denying it through CAFC or stealing one from the person doesn’t stop the financial train. It just gives the inventor ownership. And then that will define who is on first. Let the Commerce Dept. tax the merchandise made the way they tax luxury items. Stolen Patents such as 5,560,312 and 5,832,857 along with the Trademark and Copyrights that went with the stolen Patents will also have to find another way to tax them also. As for family fraud and felonious crimes that is not a Girdisn Knot. They are both separate.”

                  This is utterly incoherent. It is impossible to “steal a patent”. It is not even correct to describe patent infringement as “theft”–the Supreme Court has made this clear. see link to c4sif.org or link to falkvinge.net

                4. We constantly accuse China of stealing American IP (which is nonsense)…

                  Hang around here for any length of time and you will frequently be reminded of the White Queen’s boast of believing sux impossible things before breakfast. I know that it is nonsense to speak of China “straling” IP, and you know it, and I dare say that deep down more than half the people around here also know it. Nevertheless, most would rather chew off their own right hand than admit as much.

                  This is utterly incoherent. It is impossible to “steal a patent”.

                  Oh, my sweet summer child…

                5. >>this is a vague question, and loaded.

                  It is a vague question, but I don’t think it is loaded. It is the case that almost all innovation has occurred under a patent system and that not having a patent system seems to doom societies not to innovate.

                  Plus, I think you don’t understand how companies work. The reason so many companies invest in R&D is that they are afraid of losing market share by being excluded from using features on their products or selling new products because of patents.

                  Plus, the biggest benefit of a patent system, in my opinion, is disclosing what you have invented. The alternative is trade secrets and binding people to corporations with contracts.

                  When read and think about your arguments and others like you, it always comes to my mind that it is instant gratification argument. I think innovation would for a few short years be better if all patents and copyrights (what is your position on trade secrets?) were to go away tomorrow. But then all companies would start to keep everything secret. Ask yourself why did Rome fall? Why did emperors have faucets and, yet, they weren’t commonly adopted and the technology was lost. Why did alloys take so long to develop?

                  The fact is that there is demonstrably–objective evidence and facts–that support a patent system. Consider a simple example, it takes a person 10 years to develop a new plough, but the benefit that person gets from the plough is only 1 month. But, if 12 million people use the plough, then it will save one million years. The patent is a form of capital to develop the plough. A promise that if you come up with something that benefits others that you will be rewarded.

                  >This makes no sense. The US and the west have pushed >the rest of the world to adopt US-style IP law.
                  This is not the reason. I actually have friends of some of the top-ranking Chinese officials in charge of the patent system. The reason–and the public reason–for the Chinese to develop a patent system is to create innovation in China. That is one of their top priorities as a nation and they are trying to use patents to achieve that.

                  >We constantly accuse China of stealing American IP >(which is nonsense) and pressure them to crack down on >IP infringement.
                  So, copying books and movies is not IP theft? Stealing the engineering specifications for the F-16 is not IP theft?

                  I think you would have to tell us your position on Trade Secrets to make sense of what you are saying.

                6. There is another flavor to consider:

                  What is a person’s view towards personal property?

        4. 9.1.3.4

          Have you ever helped an applicant to protect their innovation, Kinsella?

          If so, did you apprise the client of your fervent disdain for the very work product you were to deliver?

          1. 9.1.3.4.1

            To follow up on my previous reply — do you think someone who pays a tax lawyer to help them navigate the tax system is upset their lawyer things the income tax should be abolished? Do you think someone facing jail time for drug possession is upset that their defense attorney thinks the drug war is evil and that all drugs should be legalized?

            1. 9.1.3.4.1.1

              How is this a follow-up to your previous reply? Mine is a first question to you on this topic.

              And yes, if I were a tax attorney and felt the way you do about patents towards taxes, I would be ethically compelled to inform my client. Your example of a defense attorney is to the opposite point, and does not fit your situation.

              So, answer the questions:
              Have you ever helped an applicant to protect their innovation, Kinsella?

              If so, did you apprise the client of your fervent disdain for the very work product you were to deliver?

    2. 9.2

      Max, I do not think non-revolutionary decisions like this Amgen Inc. v. Sanofi sustaining a CAFC decision on functionally-defined generic claims covering a number of possible species, and enablement, will have much effect on PTO applications or post-grant proceedings [as opposed to infringement suits] unless broadly interpreted in an MPEP amendment?

    3. 9.3

      The « patent bargain » should make a lot of sense for patent practitioners since the informative content of published patents and applications is key for effective searches, in addition to the policy objective of disseminating technical information to the public. This justifies the enablement requirement.

      The enablement requirement may be favorable to patent applicants/owners when it can be used to challenge a prior art document devoid of enabling disclosure. See EPO decision T 2916/19 of 19 April 2023 in which the prior document failed to disclose a production method for specific polymers and was not considered part of the prior art applicable for novelty.

      1. 9.3.1

        Your view runs smack into the fact that much prior art (that of granted patents) will have a presumption of validity as to being enabled.

        (this admits to an invocation of the topic of how to treat science fiction)…

        1. 9.3.1.1

          Prior art is presumed enabling (MPEP 2121). But the presumption is rebuttable.
          As to patent documents as prior art, these days examiners tend to prefer citing US published applications than the equivalent granted patents. Is that because published applications have broader claims ?

          The enablement issue is a typical feature of the “unpredictable arts”. This is not limited to pharma/chemical cases, we see it today in IA cases if training datasets are not disclosed.

          1. 9.3.1.1.1

            Why cite A publications rather than granted patents? Because they have an earlier publication date and contain at least as much, and perhaps more, disclosure than the granted patent.

            That what is disclosed is also enabled is a presumption for all prior disclosures, isn’t it, not just patents. That the presumption is less rebuttable when the prior art is a granted patent (as opposed to ,say, an peer-reviewed Paper published in a top science periodical) is news to me, and an interesting thought.

            1. 9.3.1.1.1.1

              That what is disclosed is also enabled is a presumption for all prior disclosures, isn’t it, not just patents.

              Most definitely not — and this is exactly what I hinted at in my initial post in this sun-thread: science fiction certainly discloses that which is not enabled (hence the name).

            2. 9.3.1.1.1.2

              Yes, all prior art is presumed to be enabled. There is no distinction in either case law or lived experience between the presumption of enablement accorded to granted patents cited as prior art and to published applications cited as prior art.

              1. 9.3.1.1.1.2.1

                This is not true.

                Mere publication is lacking the very thing that earns the presumption of enablement (per case law): having BEEN examined — and deemed to pass — 35 USC 112.

                1. Greg should know that the MPEP is not law and (shockingly) gets case law WRONG.

                  Here, it is written as an attempt to make it easier — but experienced practitioners quite readily note the avenue of replying without evidence and the “plain on its face” understanding that merely being a publication does NOT garner the presumption that a granted patent has in regards to enablement.

                  Greg’s post is MISinformation.

                2. Greg property is the operative word. That is why Sotelo was removed. I am sure his argument never saw the light if day. Although he sent me his amendments that stated I accepted what he took away from me. But, we know 5,560,312 and 5,832,857 are counterfeit. And piracy and espionage are real. Greg they even sunk my boat. Do you know if Elizabeth Rice ( I think that was her name) even did a deep dive into what went on with my Telephone Co in Wisconsin. I know AT&T did.

    4. 9.4

      The way to “make sense” of the difference is to understand that Big Gene’s blog is just a super bloated pack of reactionary simpletons wailing into the wind every time the Supreme Court finds against the patentee. In comparison, this blog isn’t quite as bloated.

      Does that help?

  4. 8

    After listening to the 2 hour oral argument, I was struck by the complete absence of discussion on the actual therapeutic utility of the antibodies. This opinion also ignores the clinical context from which all pharma inventions arise.

    It’s frankly bizarre that there’s no mention of whether POSAs could “use” any or all of these antibodies in a nearly decade-old case on enablement. The point of an antibody is to give it to someone to treat a disease. It has no value otherwise–who really cares if it binds to/blocks some receptor? I kept thinking someone would eventually raise this point, and the Federal Circuit’s senseless aversion to the concept of efficacy, but it never happened.

    1. 8.1

      Lots of antibodies are made for only research purposes. They don’t have to be given to patients to be useful. Studying competitive binding between an antibody and another molecule is the first example that comes to mind; there are lots of others.

      1. 8.1.1

        Yes I’m sure they’re “useful” as research objects in some sense, but that doesn’t mean they meet the statutory utility requirement. Brenner squarely held that a molecule doesn’t meet the utility bar simply because it’s useful as a research tool.

        1. 8.1.1.1

          I think it depends on the claim and what is meant by “research tool”. But the thankfully defunct “antibody exception” once allowed applicants to identify an antigen and then broadly claim “An antibody that binds to the antigen” without any deposit or any description of having created a single such antibody (at least, the PTO allowed it). Those claims are no longer valid.

          What was interesting about the “antibody exception” was that it was at least recognized expressly as a judge-made “exception” to 112 that was completely outside the laws being applied to other chemicals. That is in contrast to the “software exception” where both judges and practitioners are still living in denial about what is going on.

          1. 8.1.1.1.1

            “In denial” in what sense? Both judges and practitioners seem well aware that information processing claims mostly fail when asserted. There are, to be sure, bitter disagreements about whether this should be the case, but I do not see a lot of disagreement about whether it is the case.

            1. 8.1.1.1.1.1

              From Greg’s LATimes “e”gg:

              But it quickly garnered criticism both for going too far in weakening the state’s environmental protections and not far enough because it limits proposed reforms to select projects.

            2. 8.1.1.1.1.2

              “In denial” about the fact that there is no structure being disclosed, just a function and what is being claimed is logic instructions (an abstraction). The denialists go so far as to suggest that there can be “sufficient structure” even when an algorithm (!) is the only novel element described, and even when the “algorithm” is described in general terms.

              The reality is that the CAFC just invented an exception to the uncontroversial rule that abstractions (like logic and instructions) are excluded from the patent system. This was done without ever using the word “exception”. Instead, a completely fabricated baloney assertion was made to the effect that logical operations carried out by a computer are “the essence of electronic structure.”

              The same could have been done with antibodies, of course. Antibody binding to antigen is the essence of biomolecular structure! Everybody knows it, right? If you don’t, then you know nothing about technology, etc etc.

  5. 7

    Kevin Noonan says that today’s decision extends the status quo. That seems right to me. Everything that we thought that we knew about enablement law last year, we still know. Nothing is overturned here.

    1. 7.1

      Wow — that “n” IS actually an Easter Egg, and while not pertinent to this thread, will likely be the subject of a near-future thread (Kagan rebuttal to Sotomayor majority in the Warhol case).

      That certainly should not be so hidden.

    2. 7.3

      Did you read all the way through Noonan’s piece?

      The last paragraph is quite opposite the title of [merely] extending the status quo.

      1. 7.3.1

        Note – I am referencing an email alert and NOT the link to PatentDocs that Paul provides.

  6. 6

    The lock analogy is not on point. The search for antibodies meeting the claim requirements is not random. The area on the target to which the antibody must bind is provided — 15 amino acid residues. The method for preparing antibodies that bind to the area on the target is provided.

    What was not shown (nor could it be), was that one can set out and say “I want to prepare an antibody that binds to 14 out of 15 amino acids in the sweet spot,” and do so without undue experimentation. First, such is not necessary. The number of amino acids bound by an antibody does not correlate with its blocking ability. Second, because of that, one of ordinary skill in the art would not approach the problem from that perspective. But I think the Court got hung up on this to meet the “full scope of the claim.”

    After reading the transcript of the oral argument, I think everyone was struggling with the technology.

    1. 6.1

      “The area on the target to which the antibody must bind is provided — 15 amino acid residues. The method for preparing antibodies that bind to the area on the target is provided.”

      Okay, well then why aren’t the claims obvious? I don’t believe that Amgen characterized PCSK9 for the first time, and the method for preparing antibodies is definitely not new.

      1. 6.1.1

        Because the area on the target that, if bound by antibodies, blocks binding of the target to the receptor, was identified.

        PCSK9 has over 692 amino acids. It is a globular protein. Amgen identified 15 of those as the sweet spot for antibody binding to inhibit its activity. THAT is why.

        1. 6.1.1.1

          The art was aware that PCSK9 had been found to be associated with LDL cholesterol levels, and characterizing the receptor presumably only required standard techniques of biology.

  7. 5

    If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class. In other words, the specification must enable the full scope of the invention as defined by its claims.

    Seems like there may be a revival of the reverse doctrine of equivalence. The claim scope may be fine but a new invention may mean that your specification does not “enable the full scope of the invention” such as a method. I wonder if that sentence includes the phrase “at the time of the invention.” If not, then we are in the territory of the reverse doctrine of equivalence.

    1. 5.1

      I also think that “enable the full scope of the invention” is a pandora’s box in combination of the CAFC judge’s willfully ignoring that functional language is used to include all known solutions.

      I think this holding could be abused like Alice’s holding to invalidate almost any claim by simply ignoring how people of ordinary skill in the art would interpret the claim terms.

      1. 5.1.2

        “all known solutions” at the time of invention or “all known solutions” now and forever?

  8. 4

    This opinion is going to make functional claims and genus claims very difficult to support going forward. It is hard (impossible) to disclose all methods by which a specific function can be carried out, and, especially in chemistry, it is just as hard to ensure that all possible species in a broad genus of molecules can be reasonably made.

    Whether you like this opinion or not, it was nice to see that it was relatively clean and clearly written. I’m sure that people will find ways to argue regarding the exact manner by which to interpret this decision, but it is going to be a lot less difficult than many other patent cases.

  9. 3

    This could have been a lot worse. Mostly, this opinion reads like a history lesson on past enablement opinions. I do not see that the Court is expanding the force of any doctrines or calling any CAFC precedents into question. We will have to see what the CAFC does with this new SCOTUS precedent, but it looks to me like we dodged a bullet here.

    1. 3.1

      Not sure what the 0bsess10n is that Greg has with Yglesias, perhaps it’s the Lemming Left Script of the Day feature…

  10. 2

    I’m not inclined to invest in a new invention, if someone can copy it and change one little thing. If they aren’t gonna have to pay me for the essence of my cookies which I discover, then I’m not going to develop them.

    1. 2.1

      This decision does not affect the Doctrine of Equivalents. Small, de minimus, changes are often covered there. Also, that “one little thing” may or may not be part of the claim scope, so it could easily be irrelevant.

        1. 2.1.1.1

          Only amendments related to patentability and the prior art. Many amendments don’t implicate the DoE at all. Lots of examples at the Fed. Circuit of amendments that didn’t invoke Festo.

  11. 1

    Meanwhile, the Court ducked the §230 issue in Gonzalez v. Google. We will have to wait for a resolution on that point.

    1. 1.1

      Ditto / a rather nausea-inducing propaganda FOR Soros…

      Greg would do well to simply stop drinking the Kool-Aid.

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