Thread by @SterneKessler

Good morning! Will Milliken here. I’m a director in Sterne Kessler’s Trial and Appeals Group and co-chair of the firm’s Appellate Practice. I’ll be providing real-time analysis of today’s #SCOTUS argument in #Amgen v. Sanofi.
#AppellateTwitter #SCOTUSLive 1/

The #Amgen case concerns the standard for the patent-law requirement of "enablement," found in section 112 of the Patent Act. 2/

Under the enablement requirement, a patent must contain enough information to allow—or “enable”—people of ordinary skill in the relevant field to reproduce what the inventor claims to have invented. 3/

If you have joined me for one of my previous #SCOTUS argument live-tweets, welcome back! #SCOTUSLive 4/

If you’re tuning in for the first time, welcome! 5/

First, some lawyerly disclaimers, which are both important and necessary so they keep letting me have the password to the firm Twitter account. These tweets are intended to convey general information only, and should not be construed as a legal opinion or legal advice. 6/

All trenchant observations and incisive critiques are attributable to the firm; any inaccuracies, dumb comments, glaring typos, or bad jokes are attributable solely to me. 7/

If you would like to listen to the arguments in real time, you can access a live stream from the #SCOTUS website: supremecourt.gov/oral_arguments… 8/

The argument will begin at approximately 10am this morning and likely last for 90 minutes or so. 9/

It’s worth noting that we have the pandemic to thank for being able to listen to these arguments live (and live-tweet them!). When the Court moved from in-person arguments to telephonic ones as a result of the pandemic, it made live audio available. 10/

#SCOTUS arguments are now in-person and open to the public again, but—to the delight of nerds like me—real-time audio remains available. (Sadly, the in-person format means we are unlikely to hear any more mid-argument toilet flushes.)
#AppellateTwitter #SCOTUSLive 11/

Each advocate will have about two uninterrupted minutes in which to speak, and then the Justices will begin asking questions. Once the advocate’s time has expired, each Justice has an opportunity to question the attorney individually. 12/

The seriatim questioning proceeds in order of seniority, starting with the Chief Justice and ending with Justice Jackson. 13/

Now, to the #Amgen case, which concerns patents on monoclonal antibodies that reduce LDL (“bad”) cholesterol. Amgen and Sanofi market competing such therapies. Amgen’s is called Repatha, and Sanofi’s is called Praluent. 14/

The patents claim a group—or “genus”—of antibodies. The genus is defined functionally, by the antibodies’ ability to bind to a particular region of a specific protein called PCSK9 and block it from binding to LDL receptors. 15/

The #Amgen patents disclose 26 specific examples of antibodies that fall within this genus, and they also disclose routine ways that people skilled in the field could make other antibodies falling within the genus. 16/

But the patent doesn’t describe ALL antibodies in the genus (nor could it, as a practical matter—the number of antibodies that potentially satisfy the claims’ functional limitation is extraordinarily large, in the millions). 17/

The question presented is, essentially, whether these claims are enabled. 18/

I’m using the wiggle-word “essentially” for a reason here. The question presented is not “clean” in the sense that the parties seem to disagree about what the question presented actually is. 19/

A jury found the claims enabled, and then both the district court and the Federal Circuit disagreed, saying #Amgen's patents do not allow a skilled artisan to “reach the full scope” of the claimed embodiments without undue experimentation. 20/

Amgen says that the #FederalCircuit required the patents to enable a skilled artisan to “cumulatively identify and make all or nearly all embodiments of the invention without substantial time and effort.” And Amgen says this standard is legally wrong. 21/

Amgen also says this cumulative-effort standard is bad policy. In the antibody context, for example, Amgen argues, if patentees are forced to claim inventive antibodies narrowly by their structural features… 22/

...patent protection for antibodies will be illusory, because potential copyists could make minor structural changes to the claimed antibodies that will not alter their function and yet take them outside the claims. 23/

Sanofi and the U.S. Solicitor General (appearing as amicus curiae) do not appear to defend a “cumulative-effort” standard, but they say that the Federal Circuit did not in fact apply such a standard. 24/

Instead, Sanofi and SG say the Federal Circuit correctly held that the claims are not enabled because there are many antibodies that (i) fall within the scope of the claims but (ii) a person skilled in the field would not be able to make without undue experimentation. 25/

Sanofi and the SG say that broad functional genus claims like Amgen’s are harmful to innovation because they allow patentees to foreclose innovation within an entire genus of potential therapies that the patentee has not fully enabled. #SCOTUSLive #AppellateTwitter 26/

Sanofi points out, for example, that Pfizer developed and sought to patent a PCSK9 antibody but had to discontinue its program because of disappointing clinical results. 27/

What if Pfizer had claimed the entire genus of PCSK9 antibodies? Sanofi asks. In that case, Sanofi argues, no one else would have been able to innovate in this space, and the public would be left with a single therapy that didn’t work. 28/

Given the disagreement about what exactly the Federal Circuit held (and thus what exactly #SCOTUS is reviewing), I would expect a fair number of questions regarding the scope and meaning of the lower court decision. 29/

I also would not be surprised to hear some questions about whether and to what extent the enablement inquiry is a factual one, such that the jury verdict in Amgen's favor gets some deference. 30/

Federal Circuit precedent holds that enablement is a question of law that implicates underlying questions of fact. Amgen petitioned for cert on the issue of whether it’s ultimately a question of law or fact, but SCOTUS denied review of that issue. 31/

Nonetheless, I think the factual-versus-legal nature of the question may play a significant role here. 32/

If enablement is more towards the factual end of the spectrum, then the jury’s implicit rejection of Sanofi’s argument that there are a bunch of embodiments that couldn’t be made based on the patent’s guidance could loom large. 33/

In contrast, if enablement is closer to a pure question of law, the jury verdict doesn't help Amgen as much. 34/

In all events, the ultimate decision here has the potential to have a major impact on patent law, especially in the pharmaceutical and biotech spaces. 35/

The #SCOTUS opinion may provide significant guidance about whether and to what extent functional genus claims like Amgen’s can comply with section 112's enablement requirement. 36/

Notably, this is only the second time #SCOTUS reviewed a question about section 112 since the modern Patent Act was adopted (and the other case concerned definiteness, not enablement). So any guidance the court provides has the potential to be very significant. 37/

We will begin shortly! A final caveat. Oral argument is not a perfect indicator of how #SCOTUS is leaning. (Sometimes, it’s not even a good indicator.) So take any prognosticating you hear—including from yours truly—with ample grains of salt.
#AppellateTwitter #SCOTUSLive 38/

And we're off. First up is Jeff Lamken, counsel for Amgen. #SCOTUS 39/

Lamken starts out by describing Amgen's invention, which says provides a "roadmap" that allow skilled artisans to make the claimed antibodies "every time." And he says no one has identified any antibodies that can't be made using the roadmap. 40/

He says enablement should be a rule of "reasonableness," which Amgen has satisfied here. 41/

J. Thomas asks what the invention is. Lamken says it's a class of antibodies with a specific binding profile. Thomas asks how big that class is relative to the examples disclosed in the patents. Lamken says there are probably about 400. 42/

Lamken acknowledges that other variations could be made using a technique called conservative substitution, but says those wouldn't be considered distinct antibodies. 43/

J Sotomayor asks, if it's so easy to make all these variations, why didn't you list all 400 in your patent? 44/

Lamken says it doesn't matter, because skilled artisans are just looking for antibodies that have the claimed binding profile--they don't care about exhausting the genus. 45/

J Gorsuch asks if Lamken agrees with the "undue experimentation" standard. Lamken says yes. 46/

J Gorsuch then asks if Lamken accepts the Federal Circuit's so-called "Wands" factors that it uses for analyzing enablement. Lamken says they can be useful, but they shouldn't constitute a rigid "checklist." 47/

J Gorsuch: do you agree that broader patents require more for enablement? Lamken says maybe, but not necessarily. 48/

CJ Roberts asks about the "reasonableness" requirement Lamken is emphasizing. Lamken says enablement should look at what is actually important to those of skill in the art. 49/

CJ Roberts: well how long does it have to take for the amount of experimentation to be unreasonable? Lamken responds with the classic lawyer refrain: it depends. 50/

Lamken then starts describing how one would go about finding additional antibodies that work by using the anchor antibodies disclosed in the patent and then screening additional ones. He says this is "just what antibody scientists do"--not undue experimentation. 51/

J Jackson asks, wouldn't the undue experimentation analysis need to be applied to every species in the genus? Lamken says it needs to be applied to each category within the genus, but not necessarily each species. 52/

J Jackson asks how many categories there are here. I think Lamken is suggesting that there is actually only one, because all that matters is that the antibody have the binding ability recited in the claim. 53/

J Kagan: Do the parties now all agree on the appropriate legal test? And so are we just arguing about how it should be applied? 54/

This is getting to the issue I identified in my preview--what exactly is the legal question #SCOTUS is being asked to review? 55/

Lamken identifies a few (in my view) relatively minor points of disagreement, but in essence says, the Federal Circuit decision can be read to impose a cumulative-effort test, and the resulting uncertainty is very damaging. 56/

J Gorsuch: what if we conclude that the Federal Circuit is applying the correct legal test? Lamken: we need at least a remand. J Barrett: but why? 57/

Lamken suggests that, to prevail, Sanofi needed to present evidence of an actual claimed embodiment that wasn't enabled and to show that this actually mattered to skilled artisans. He says the CAFC didn't hold Sanofi to that requirement. 58/

He keeps coming back to the cumulative-effort standard and how that has to be wrong, but I get the sense at least some of the Justices think this is a straw man and that the Federal Circuit did not apply that standard. 59/

He also says that the analysis must focus on what's "reasonable" from the perspective of a skilled artisan--i.e., would the skilled artisan actually care that there is a given embodiment that can't be made using the guidance in the patent? 60/

Lamken argues that Amgen had the first PCSK9 binding antibodies and that it taught those in the field how to make other ones. So it was entitled to a patent on the broad class, notwithstanding Sanofi's hypothesis that there might be unenabled examples out there somewhere. 61/

Lamken's time is up, and the seriatim questioning begins. J Thomas again says he's not understanding what exactly the invention is--it's not the 26 antibodies described in the spec but also it's not the millions of potential candidates. So what is it? 62/

Lamken responds with the functional definition from the patent, but Thomas seems uncomfortable with that. He seems to want a more structural definition. 63/

Lamken analogizes to a patent on a steam engine, and Thomas responds that no, this seems more like a patent on the concept of using steam pressure. 64/

Lamken says allowing genus patents like this promotes innovation because it incentivizes others to look at other categories of solutions instead of making insignficant alterations to what the patentee already did. And he cites some examples of that happening in this field. 65/

J Kavanaugh brings up some baking analogies from the SG's brief. Lamken says baking isn't a great analogy in the antibody context because of the way antibodies are generated. 66/

He emphasizes that antibody screening is very routine--skilled artisans have been doing it since at least the Wands decision itself, in 1988. #SCOTUSLive #AppellateTwitter 67/

He also says that there would be no good reason for a patent to have to list out all the possible embodiments in this context--this patent is already 380 pages long. 68/

J Jackson asks, if you are saying that there are around 400 that work, where do the references to "millions" of embodiments come from? Lamken says you would get to the "millions" by conservative substitution. 69/

J Jackson: are you claiming those too? Lamken: yes, doing conservative substitution is completely routine. Skilled artisans wouldn't even really consider these distinct antibodies. 70/

Next up is Paul Clement, on behalf of Sanofi. #SCOTUSLive #AppellateTwitter 71/

Clement argues that enablement is the "heart" of the patent quid pro quo--i.e., you get a limited monopoly in exchange for disclosing your invention to the world so others can make and use it. 72/

Clement says that under the "undue experimentation" standard, which Amgen concedes applies here, the patent here is not enabled because, among other things, Amgen disclosed no antibodies that bind to all of the residues recited in the patent. 73/

Clement takes issue with Lamken's argument that conservative substitution will not meaningfully alter the function of the antibodies. Clement says this is inconsistent with Amgen's own expert testimony. 74/

Clement also says that the cumulative-effort test is not a proper standard standing alone, but a cumulative-effort inquiry can be relevant in certain circumstances. 75/

J Gorusch asks if Clement agrees with the "reasonableness" aspect of Lamken's test; he says yes, it's the flip side of undue experimentation. 76/

J Gorsuch: so if the parties basically agree on the law, what is there left for us to do here? Clement, to laughter, says the court could just "DIG" (i.e., dismiss the case as improvidently granted). 77/

Clement also says that it can't be enough to say that the claims enable skilled artisans to make claimed antibodies "every time," because that actually rewards undue breadth (the broader your claims are, the more likely you will fall within them "every time"). 78/

A couple of times, Clement has emphasized an amicus brief by Sir Gregory Winter, a Nobel-prize winning molecular biologist, which he says shows that Sanofi's view of the science is correct. 79/

Clement also suggests that functionally defined antibody claims like this are really an attempted end-run around #SCOTUS's prohibition on patenting natural phenomena. #AppellateTwitter 80/

Clement: it's no accident that Amgen's best cases are process-patent cases. Mechanics routinely tweak processes all the time to accomplish a desired result. 81/

But it's weird to claim a genus of compositions of matter and then require the public to essentially replicate the inventor's work to find other compositions in the genus. 82/

Clement offers an example: if I want to find a 15-binder that satisfies the functional results recited in the claim to see if it works better than Amgen's 7-binder, I have to go through all the steps Amgen did anew to find that. 83/

J Kagan asks Clement to address an amicus brief by Professor Mark Lemley--why is he wrong that the Federal Circuit's current approach to genus claims is harmful to innovation? 84/

Clement seems to acknowledge that the current doctrine may preclude functional genus claiming in the antibody context, but he says this is a good thing. The different embodiments in Amgen's claims are not fungible. 85/

So we want to incentivize those in the art to develop different embodiments that accomplish the same function but potentially do so in different ways. Clement cites as an example Pfizer's antibody, which accomplishes the claimed function but failed in clinical trials. 86/

J Jackson: shouldn't some amount of experimentation be OK? Clement: yes, the test is undue experimentation, not no experimentation. 87/

But if you claim a lot, you have to enable a lot. 88/

Clement keeps coming back to what he says are disagreements between him and Lamken "on the facts," which I interpret to be a suggestion that this is just a factbound dispute that implicates the particulars of the science and so isn't appropriate for #SCOTUS to be wading into. 89/

Counsel for the government, Colleen Sinzdak, is now up. #AppellateTwitter 90/

She begins by emphasizing that the "recipe" for an antibody is the amino acid sequence. And Amgen has not given that "recipe" for all the antibodies within the genus. She says it "really is that simple." 91/

She says that Amgen's "reasonableness" test is "dangerous" because we don't actually know if the variations Amgen says a skilled artisans wouldn't care about make a meaningful difference. 92/

She also says that the solution to Amgen's worry about people copying via insubstantial changes is the doctrine of equivalents. 93/

Amgen's response, she says, is that they can't rely on the doctrine of equivalents. But the reason they cannot rely on DOE is because the other competing antibodies are meaningfully different from Amgen's, which she says supports her point that the claims are not enabled. 94/

A theme in her argument so far is that #SCOTUS should not be creating "new rules" for new technologies. The same law that applied to patents on the lightbulb should apply here. 95/

J Gorsuch asks for SG's position on the "reasonableness" requirement. Sinzdak says that there is always room for reasonableness, but most of those concerns are taken care of by the DOE. 96/

And she also suggests that the knowledge of the person skilled in the relevant field can supply a little bit of wiggle room. 97/

Sinzdak agrees with Clement that the cumulative-effort inquiry can be relevant but is not appropriate as a standalone standard. 97/

Sinzdak turns to some "factual" points. She says Lamken's 400 number is "misleading" and that it's not clear to her based on the record that a skilled artisan using Amgen's roadmap could obtain Sanofi's antibody. 98/

I've said this a few times, but I am again struck by how fact-dependent this dispute seems, which is not typically what you see at #SCOTUS. 99/

Sinzdak confirms that the US and Sanofi are, essentially, fully aligned on the merits. #SCOTUSLive #AppellateTwitter 100/

J Thomas asks a question about the relationship between the enablement inquiry and the scope of the claim. She says it is "often" the case that broader claims require more because you need to enable a skilled artisan to make any given claimed embodiment. 101/

Sinzdak suggests that allowing broad genus claims like this might actually dis-incentivize scientists from conducting further investigation into the structure-function relationship. 102/

J Sotomayor: If we don't DIG, what would you want us to say? Sinzdak: You could DIG. But if you don't, you can make clear that Amgen's theory that certain embodiments can be dismissed as "not mattering" is wrong. 103/

J Kavanaugh: wouldn't it be useful for #SCOTUS to just express agreement with the Federal Circuit, which would settle the matter vis-a-vis the courts and make clear that if there needs to be a change it must come from Congress? Sinzdak: Yes. 104/

Lamken opens his rebuttal by saying, there is no evidence of any claimed antibody that couldn't be made using the roadmap in the patents. 105/

He says, there a lot of factual disputes here, but that's why we have trials and juries. 106/

(Which, again, sort of suggests to me that this may be more of a sufficiency-of-the-evidence case, not a case implicating some major disagreement about the proper legal test.) 107/

Re: DOE, Lamken says that DOE is not an answer because if you claim an antibody by its amino-acid sequence, an antibody that differs even a little bit from that sequence wouldn't infringe under DOE. 108/

Lamken is given a minute to address the DIG suggestion. He says that as long as the Federal Circuit's decision is the law, it will disincentivize companies from bringing therapies like Amgen's to market. So #SCOTUS needs to step in. 109/

And that's a wrap. As expected, a singificant amount of the questioning focused on what exactly #SCOTUS can or should say in this opinion, given that the parties seem to largely agree on most aspects of the legal standard. 110/

Thanks for joining us this morning. Stay tuned for further analysis from Sterne Kessler up to the time of #SCOTUS's decision and beyond. #AppellateTwitter 111/end