On November 4, 2022, the Supreme Court granted cert in Amgen Inc. v. Sanofi, a patent infringement case that involves the application of the statutory enablement requirement of Section 112 of the patent laws to what is referred to as a "genus claim" as it applies in the context of pharmaceutical applications. The two patents in dispute relate to antibody drugs that reduce low-density lipoprotein (“LDL”) cholesterol.
The Court is set to hear oral arguments in the case on March 27. Specifically at issue is "whether enablement is governed by the statutory requirement that the specifications teach those skilled in the art to 'make and use' the claimed invention, or whether it must instead enable those skilled in the art 'to reach the full scope of claimed embodiments' without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial 'time and effort.'"
Robert Rando, an intellectual property attorney who filed an amicus brief in the case, joined us to break down the arguments.
As always, the Federalist Society takes no position on particular legal or public policy issues; all expressions of opinion are those of the speaker.
Jack Derwin: Hello, and welcome to this Federalist Society virtual event. My name is Jack Derwin, and I’m Associate Director of the Practice Groups here at The Federalist Society. Today, we’re excited to host a Courthouse Steps discussion on yesterday’s oral arguments in Amgen Inc. v. Sanofi, featuring Mr. Robert Rando.
Rob is a Partner with Greenspoon Marder LLP’s Intellectual Property Department, where he focuses his practice on patent and other intellectual property infringement disputes—which you’ll see is perfectly relevant for today’s discussion. Rob has more than 30 years of civil litigation experience at the trial and appellate levels and has served as counsel of record on a number of Amicus briefs—including 1 in the case we’re discussing today—filed on behalf of the New York Intellectual Property Law Association, of which Rob is president elect.
In the interest of time, I’ll keep it there, but you can view Rob’s full bio at fedsoc.org. After his presentation, we’ll go to audience Q&A. So please enter any questions into the Q&A function at the bottom right of your Zoom window. Finally, I’ll note that, as always, all expressions of opinion on today’s program are those of the guest speaker joining us.
With that, Rob, the virtual floor is yours.
Robert J. Rando: Thank you, Jack, and good afternoon. I would also like to thank The Federalist Society for the opportunity to discuss this case with those of you attending the webinar.
The Amgen v. Sanofi case is a patent-infringement case involving the scientific invention concerning patent genus claims in the monoclonal antibody space as it related to the drugs that reduce LDL cholesterol. It is an important and interesting case for a couple of reasons.
How the justices rule in this case will have a huge impact on whether the incentive to invest in and innovate within the U.S. patent system for these types of potentially life-saving drugs will continue. It will also impact patent-enablement issues in the other arts as well. And it presents issues regarding the question of statutory interpretation with respect to the plain language of the patent enablement statute, as well as consideration of the Court’s relevant precedent.
However, that being said, there was not much attention paid to its variance with and lack of support in the plain language of the governing patent enablement statute, nor regarding the Supreme Court's precedent. But I'll get into that a little later. Before we get to those issues and the party’s arguments and the oral argument this week, some background on the case.
On November 4, 2022, the Supreme Court granted cert in Amgen Inc. v. Sanofi. It is a patent-infringement case involving the application of statutory enablement requirement of Section 112 of the patent laws for what is referred to as “genus claims” as it applies in the context of pharmaceutical applications. The two patents in dispute relate to antibody drugs that reduce LDL cholesterol. The human body normally relies on LDL receptors in the liver to remove LDL cholesterol from the bloodstream. A naturally occurring protein, PCSK9, binds to and causes the destruction of the LDL receptors leading to higher levels of LDL cholesterol. I will call it P9 for convenience in the purpose of this discussion.
The patented invention is for a technology that relies on antibodies that bind to that protein, inhibiting it from binding to the LDL receptors, and leaving them free to extract cholesterol from the bloodstream. Respondent Sanofi developed Praluent—the first FDA-approved P9
Antibody, and petitioner Amgen developed Repatha, another FDA-approved P9 antibody. These antibodies differ in amino acid sequence and where they bind to P9.
Amgen obtained the two patents that broadly claimed the genus of all antibodies that bind to certain amino acids on P9 a first function and block its binding to LDL receptors a second function. The common specification for the patents discloses that Amgen used a trial-and-error method to generate and screen antibodies that meet the claim language. Using this process, Amgen identified numerous antibodies that meet the claim language. But the specification discloses only the amino acid sequences of about two dozen of these antibodies. The specification also provides the three-dimensional structure of only two of those antibodies.
At trial, respondent introduced evidence that the claims had a scope that could cover millions of antibodies and that given the unpredictability of antibody science, a person skilled in the art would have to test every single antibody generated by Amgen’s disclosed methods to determine whether it had the necessary functional properties and was then encompassed by the claims.
At a first jury trial, the defendants conceded infringement, and the jury found the patents valid. On appeal, the Federal Circuit affirmed in part, reversed in part, dictated in part, and remanded. They did it all. On remand, the jury found two of five asserted claims invalid for lack of adequate written description but found the three remaining claims valid. The District Court granted respondent’s motion for JMOL as to enablement—concluding that under the Federal Circuit's long-established multi-factor test for evaluating enablement in the case of In re Wands, Amgen's patents require undue experimentation and are not enabled.
The Wands case factors are the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claims. On a second appeal, the FED circuit unanimously affirmed the district court, observing that enablement is a question of law reviewed without deference—although that determination may be based on underlying factual findings which we review for clear error.
Considering the Wands factor, the Court determined that undue experimentation was necessary to enable the full scope of Amgen's double function claims. Further, the evidence established that the relevant field of science was unpredictable. Under these facts, the Court explained, “No reasonable jury could conclude that anything but substantial time and effort would be required to reach the full scope of the claimed embodiments.”
Weighing the Wands factor, the Court concluded an undue experimentation would be required to practice the full scope of the claims. In support of its full-scope requirement, the Federal Circuit cited to its earlier opinions in the past decade. In its petition for cert, Amgen argued that, in this case, the Federal Circuit applied a recent Court-made “hurdle” to enablement—that is, for genus claims, like Amgen’s—and ruled that it is not enough that the patent meet the statutory requirement to teach skilled artisans to make and use the invention as per the plain language of the statute.
Instead, the Federal Circuit required that the specification allows skilled artisans to reach the full scope of claimed embodiments—that is, to cumulatively identify and make all or nearly all possible variations of the invention without substantial time and effort. Further, Amgen asserted that there was no dispute, that their patented invention—monoclonal antibodies that dramatically reduced levels of bad cholesterol—was a breakthrough.
There was no dispute the patents enabled skilled artisans to make and use the antibodies. It could make the 26 antibodies identified in the patent by amino acid sequence, and could make other antibodies within the claim by following the patent’s step-by-step roadmap, which employs methods routine in the antibody arts.
As Amgen pointed out in their petition, no one—neither respondents, nor their experts, nor the Court—identified either one actual embodiment that could not be made following the patent's disclosures. So the question to be reviewed by the Court is whether enablement is governed by the statutory requirement, that the specification teach those skilled in the art to make and use the claimed invention, or whether it must instead enable those skilled in the art to reach the full scope of claimed embodiments without undue experimentation—that is, to cumulatively identify and make all or nearly all embodiments of the invention without substantial time and effort.
The party's arguments in their briefs: Amgen made several arguments. They argued that the Federal Circuit's full-scope standard defies the text, precedent, history, and policy; that the Federal Circuit's full-scope standard is not supported under Section 112; that the Supreme Court precedence refute the Federal Circuit's test, as centuries of enablement practice refute this full-scope test; that the Federal Circuit's full-scope standard defies patent law policy and is harmful to innovation; and that the plain language statutory make a new standard [inaudible 09:27] govern and the statute provide the practical test; and that the make and use statutory standard fully addresses concerns about overbroad claims.
Needless to say, Sanofi disagrees with Amgen. And they argued in their brief, “Federal Circuit’s enablement standard is faithful to Section 112's text and the Supreme Court precedence and was properly applied in this case, that Section 112 and the Supreme Court decisions require enablement of the full scope of a claim without elaborate experimentation, that the Federal Circuit in general in the decision below requires no more than statutory text, and is consistent with the Supreme Court decisions that Amgen is proposing the establishment of a new enablement standard, and Amgen mischaracterizes the decision below. And to the extent Amgen is proposing a new enablement standard, it’s that it conflicts with statutory text, settled, present, and long-standing practice. And Amgen’s claims are not enabled under any viable test for enablement.”
In its reply, Amgen argued the Federal Circuit applied the full-scope test. The Court should restore the make-and-use standard—Section 112, “Provide the practical standard of reasonableness.” Sanofi has specified an undisclosed embodiment standard is not supported, Sanofi cannot prevail under its own tests, and that the government's arguments fail, and that genus claims promote rather than stifle innovation.
I'll pause here to note that while there are always opposing arguments in every case, the diametrically opposed interpretation of the facts in the [inaudible 11:10] case is quite remarkable. And then the government amicus arguments—Section 112(a)— is, “Enablement requirement is not satisfied if a person skilled in the art must undertake undue experimentation in order to make and use the invention. Petitioners’ claims fail under 112(a) because undue experimentation would be required to make and use the claimed antibodies.”
I will also note that, in addition to the SG brief that was invited by the Court, there were approximately 30 other amicus briefs in the case—roughly, evenly split between in support of petitioner Amgen or neither party and those in support of respondent Sanofi.
Now, before I get into the oral argument, a few general observations. The justices were very active in their questions. And it is interesting to note that they did not focus on or appear to be persuaded by or concerned with the plain language of the statute and the statutory interpretation issue. Similarly, the issue of the Court's precedence did not appear to be a significant concern to the justices.
In fact, the questions from the justices were mostly focused on the factual issues—and for some of them, trying to understand the science in, albeit, a general manner. The justices, especially Justice Gorsuch, focused attention on whether the parties were in agreement on the law and, if not, what the differences were. And in fact, Justice Gorsuch posited that this case might be fact-bound and inquired of the petition of whether a remand with clarification of the law was in order.
The focus on the facts invoked a suggestion by the respondent that perhaps a dig—that is, a dismissal as improvidently granted—would be appropriate. And that was addressed further by the government and the petitioner's rebuttal.
Okay, the oral argument. For petitioner Amgen Inc., Jeffrey Lampkin represented Amgen, Paul Clement represented Sanofi, and Colleen Sinzdak—assistant to the DOJ Solicitor General—represented the government.
Petitioner's argument: So Mr. Lamken opened up with a description of the invention. He stated that Amgen invented a new class of antibodies that lower cholesterol that bind to a small spot on PCSK9—the sweet spot—and thereby block that protein from binding to and destroying LDL receptors that remove cholesterol. He went on that Amgen had in hand 384 examples of such antibodies. He framed the case as concerning the requirement that patents enabled skilled artisans to make and use the invention.
He then articulated several points that support his reading of the statute and how the make-and-use enablement requirement is satisfied by Amgen’s patent and the reasons why the Federal Circuit ruling should be reversed.
First, he said the road map in Amgen's patents allow skilled artisans to easily make those antibodies every time using two new anchor antibodies that cover the entire sweet spot, so skilled artisans can be certain to make all the claim’s antibodies—including defendant’s examples. Second, the Federal Circuit never identified a single actual antibody that's in the claim that cannot be made or require undue experimentation. Instead, it invokes something that no one will defend that is even relevant here—the cumulative effort to make all or some large group of an invention potentially a myriad of variations.
He characterized the Supreme Court relevant precedent as reflecting the statutes “pragmatic booths-on-the-ground focus on enabling skilled artisans who want to practice the invention on a concrete action making and using the invention.” He argued that the patent satisfied the law when sufficiently definite to guide artisans’ successful application of the invention where there is some practical way of putting them into operation requiring reasonableness with due regard to the patent subject matter.
He pointed out that to overturn the PTO issuance of these patents and the two verdicts upholding them, two things must be shown. One, at least, have evidence of some variant of the invention, some category that requires what the Court has called “painstakingly experimentation.” And two, if that is identified, show why it matters to skilled artisans since by its plain language, the statute is about skilled artisans seeking to make and use the invention and reasonableness rather than “theoretical far corners never shown to affect the ability to do so.”
Justice Thomas then asked what the invention is. Petitioner responded, “It's the class of antibodies that bind to a particular spot.” Justice Thomas then focused on the number of disclosed antibodies and asked if it only -- if only 26 were invented. Petitioner responded, “That was incorrect” and that the patent states that Amgen had 384 but that there are only 26 specified by the amino acid structure.
Justice Thomas then asked whether the process only produced a higher number of antibodies. Petitioner responded that it will produce every antibody within the claims and that there was no evidence that there was a particular antibody that was harder to make that, for some reason, you would expect it more difficult to come out of that. Justice Thomas then said, “So you don't know how many there are?”
Petitioner responded no and told him that there were likely about 400 identified specific reasons related to the antibody science to support the conclusion. So we see Justice Thomas was trying to flesh out the species and the genus claim. Justice Sotomayor then asked why all 400 were not made. Petitioner explained that the science to meet the enablement requirement was sufficiently enabling with the 26 specified.
Justice Gorsuch then asked whether petitioner agreed that a patent fails the enablement test if it would force a person skilled in the art to undertake undue experimentation to produce the claimed invention. And the petitioner agreed. Justice Gorsuch then asked whether petitioner accepted the Wands factors, thinks that they are useful, and if the Court should endorse them.
Petitioner responded that the Wands factors can be useful in particular cases when properly applied but that the problem with the Wands factors are that they became -- become something of a checklist abstracted, and therefore, replacing the ultimate statutory standard. Justice Gorsuch went on and asked whether the broader the patent, the more difficult it is to prove enablement.
After some back and forth, petitioner stated that broader and harder are not necessarily synonymous. Narrow claims can be harder, and it’s hard to say that in every art for every circumstance that broader maybe -- make it more difficult.
Chief Justice Roberts—excuse me for a moment—then asked for a clarification of petitioner’s reasonableness standard. The petitioner stated that you always look at it from the perspective of the skilled artisan, and you have to ask two questions: Is there something here that takes undue experimentation—what this Court calls “painstaking experimentation” to make—and if you can find something that might be concrete enough?
And then the next question is, does it matter? Does it somehow impede the skilled artisan from reasonably practicing their full scope of the invention? Justice Sotomayor interjected and asked petitioner to explain the process, and petitioner described it in some detail. Justice Jackson, who was quite active in this oral argument, then asked petitioner why whether finding one species required undue experimentation it would not be non-enabling on whether it should apply to every species.
Petitioner responded that it would not have to apply to every species, if you find undue experimentation to make a particular species. The next question is whether it matters to the skilled artisan or is it just an outlier. And if you have the one-off, that doesn't mean anything to the skilled artisans. You're not going to invalidate the patent.
Petitioner went on to explain the genus distinction in terms of it being a category and that when you're enabling, the question is, can a skilled artisan using the instruction you have make the various embodiments -- make the various variants without undue experimentation? And if you find one that takes undue experimentation, the next question is, does that matter? Does it really meaningfully impede somebody—the skilled artisan, the guy who cares, in his words—from doing it?
Judge Kagan then jumped in and returned to the question of what the parties don't agree on at this point with respect to the applicable principles of law. They should’ve pointed to the government's proposed requirement that you have a structure that unifies your genus. And petitioner disagreed with that proposal and explained why it could not be sustained under the law in the context of an invention that's biological in nature.
Justice Gorsuch then asked if there were any other disagreements on law and, if not, why this case isn't just a fact-bound dispute. Petitioner responded that it was not fact bound and that the Court needed to clarify the law. Justice Sotomayor then asked Petitioner to respond to a quote from the Federal Circuit opinion that whether it is appropriate to look at the amount of effort needed to obtain embodiments outside the scope of the disclosed examples.
Petitioner responded that a single embodiment—not plural embodiments—would be appropriate. Justice Alito then asks questions concerning whether there was something unique about the Federal Circuit's decision in this case or had it been applying essentially the same approach to the enablement of antibody genus claims since around 2004. And the petitioner then described the history of the treatment of those cases.
Justice Thomas returned to his initial inquiry as to what the invention is. Then the petitioner analogized to the James Watt steam engine and pointed out that it is the category or genus of the antibodies that is being claimed. Petitioner also pointed out that this case is a 112(a) enablement case rather than a 112(b) claimed invention case.
Justice Kavanaugh then asked whether the petitioner accepted the Federal Circuit precedent in Wands and the SCOTUS precedence. Petitioner responded that the Supreme Court precedence are all accepted but that the Wands factors may be appropriate in a given case but that they have been abstracted to replace the actual statutory text of Section 112. Justice Jackson then asked about the species in terms of these numbers: the 26, the 384, and the millions. The petitioner explained that the enablement is provided for the skilled artisan to practice the invention and described how it was done.
Now, before I get into the respondent’s argument, a couple of observations regarding the questions by the justices that were posed to the petitioner. They focused on what is claimed in the invention—and although not asking specifically, understanding the genus species distinction with respect to what is enabled and what is planned. They focused on whether there is any disagreement regarding the applicable law or legal standard, and a general understanding of the science, and whether this case is really a fact-bound case.
Now, for the respondent argument. Mr. Clement opened up by stating, “Section 112 sets forth the heart of the patent bargain. The more you claim, the more you need to enable. If you claim a lot and enable a little, the public gets shortchanged, and the patent is invalid.” Respondent went on to say that the Federal Circuit has long enforced that basic principle by requiring the patentee to enable the full scope of the patent without undue experimentation.
Respondent then pointed out that under the full-scope test based upon the antibody science, the patent is not enabling. Respondent stated that Amgen overclaimed and under enabled, rendering the patent invalid. Respondent also stated that the Court has long applied this same principle in Morse, in Lamp, and in Holland Furniture.
Justice Thomas asked what was being claimed and to expand on “the more you claim, the more you have to enable.” Respondent explained that the full scope of the claim was millions of antibodies—not just 384. And he also stated that the road map is a road map for trial and error. Justice Gorsuch asked whether there is a point of agreement with respect to cumulative effort, that it should not -- and that it should not be dispositive. And the respondent agreed.
Justice Gorsuch then asked whether respondent agreed that there has to be a reasonable enablement and that, in every instance, it just needs to be reasonable. Respondent agreed and stated that it was just maybe the flip side of undue experimentation. At this point, Justice Gorsuch then asked, “If we agree on the law, what's left for this Court?” to which respondent replied, “Nothing, except maybe a DIG.”
Justice Kagan then asked whether there was any other point of law where there was disagreement. Respondent described what he characterized as the inadequacy of the roadmap, which Justice Kagan asked whether that was really a disagreement on the law or legal standard. The respondent stated that it was a disagreement on the law standard -- legal standard, explaining that petitioner’s view of how the roadmap functions within the enablement requirement was not correct.
Justice Alito then asked, “What was the relevance between time and effort?” Respondent replied that they are both relevant and agreed with petitioner and that they’re both sort of relevant evidence. It gets to the ultimate inquiry, which is, is there undue experimentation? Justice Jackson asked for a distinction between routine and undue experimentation. Respondent replied with an analogy to paint mixing for a particular color.
Justice Sotomayor also focused in on the undue experimentation issue with respect to time and asked for a description of the process and if it is computerized. Respondent described it in terms he understands. Justice Gorsuch asked whether the 384 were enabled. And respondent said no because Amgen had not disclosed the amino acid sequence for them.
Justice Kagan asked the respondent to address Professor Lemley’s amicus brief concerning his very strong view that antibody genus claims are valuable and that the Federal Circuit's test is going to pretty much wipe them out across the board. She then asked, “Why is it that Professor Lemley is wrong in your view? Respondent disagreed that the Federal Circuit precedent would foreclose all genus claims. And when asked by Justice Kagan whether he thought that even if most of these genus patents were invalidated that would be okay, respondent replied yes, and that functional genus claims are terrible, and they “retard the science.”
Justice Jackson expressed her concern that there are some fields where there is a degree of unpredictability or randomness and that the respondent’s view on this would mean that we would not be able to have patents where some experimentation was required. Respondent replied that the test should be undue experimentation and that it should not be zero tolerance or no experimentation.
Justice Jackson then asked whether there was any clear and convincing evidence that the road map is not certain to make all of the claims antibodies. Respondent replied, “There was not any, but it might take an infinite amount of time to get them.”
Now, for the government argument. Ms. Sinzdak, on behalf of the government amicus, is focused on the science and the lack of enablement of the species for all of the claimed antibodies of the genus. She also pointed to the doctrine of equivalence—relevant to the issue and relevant to Professor Lemley's concern. She also stated that the genus claims could stifle innovation.
Justice Gorsuch asked whether reasonableness should be considered in terms of the full enablement standard. Amicus replied that a little reasonableness could be considered with a caveat that what does or does not matter to a skilled artisan should not play a role. Justice Gorsuch then asked about cumulative effort. And the response was that amicus agreed that it could be relevant but not dispositive.
Chief Justice Roberts asked whether there was anything Mr. Clement said with which the government disagreed. Amicus responded no. The Chief Justice then asked about the less reliable doctrine of equivalence and its potential adverse impact on investment decisions. Amicus responded by addressing what the patent claims or does not claim and did not directly address the doctrine of equivalence issue in that context.
Justice Thomas asked about the relationship between the enablement inquiry in acclaimed inventions. Amicus responded that she agreed that the more that is claimed can require more enablement. Justice Sotomayor asked for an opinion on whether the court should DIG the case. The response was that the Court could and that there was nothing that the Federal Circuit said that was wrong.
The petitioner’s rebuttal. Petitioner addressed the arguments by responding, reiterating much of its opening argument and its brief arguments. However, the petitioner was allowed time to respond to the issue of a DIG as follows: “This case, you should make no mistake, has incredible impacts. We have two decisions now from the PTAB—both characterizing it as a cumulative effort to make all the embodiments test. Nobody can invest billions of dollars with this decision out there. Nobody can invest billions of dollars if it’s irrelevant. There's a legal dispute about the relevance of that cumulative effort test, and this Court should address it and excise it from the law.”
I will stop there and answer any questions, if I can.
Jack Derwin: Thanks so much, Rob. And as I noted at the outset, you can submit questions via the Q&A function. That should be at the bottom right of your Zoom window. It looks like we have one in here already, so we can get right to it.
The question is, “Why did the Court grant cert on Amgen's 112(b) issue but not on Juno's 112(a) issue?”
Robert J. Rando: I’m not sure that that’s -- I think it was [inaudible 31:04] on 112(a).
Jack Derwin: All right. So as we wait for more questions to filter in, I guess, not to put you on the spot necessarily, but we talked about this a little bit in the green room. Any cold-hard predictions for the case?
Robert J. Rando: Well, as much as I hate prognostications, I'll do it. Based on the questions, it does not appear that this case will break down long, strict, ideological lines right and left. It appears that Justice Gorsuch wants to target how, if at all, the legal standard needs to be clarified.
Justice Thomas seems persuaded that the claims are overbroad. Justice Jackson appears to be willing to accept the petitioner’s argument for reasonableness and the undue experimentation. Chief Justice Roberts also seems to be on board with the reasonableness argument.
Justice Alito appears to want to understand the Federal Circuit history with these antibodies genus claims—to view them in the context of the recent decision as a departure or a continuum. Justice Sotomayor seemed focused on understanding the science and the process in order to determine whether the claims were overbroad. Justice Kavanaugh also seemed interested in the investment in innovation policy issues, as well as the agreement on the legal standard.
Justice Barrett focused on the evidentiary issue and also a question of why a remand would be necessary. And finally, Justice Kagan is also focused on whether there are any differences between the parties regarding the legal standard, as well as the Lemley concern.
As for the outcome in this case, I'll take a shot. While I would not discount a DIG—especially after what happened in this term within In re Grand Jury—it seems unlikely because the implications for a ruling in this case, while no less consequential in the attorney-client privilege involved in In re Grand Jury, can vastly change the landscape for investment, innovation, and whether patent disclosure or trade secrets will be favored by vendors.
That being said, as I view the oral arguments and the justices’ questions -- which, by the way, unlike in some oral arguments before the Court, I did not discern any question by any of the justices that seemed targeted to each other. It appears that a reversal remand could be in the offering based in large part on Justice Gorsuch’s questioning and suggestion, as well as the several justices, including Justice Jackson, Alito, Roberts, Kagan, and Kavanaugh.
Now, while that sounds like a 6-3 decision for remand, I'm not sure that the decision would include a dissent, other than Justice Thomas and possibly Sotomayor. Also, there may not be an agreement on a reversal remand, in which case it could be a plurality decision in the case. And if Justice Thomas authored the opinion, it can come out very differently.
So with that prognostication, I think I’ve covered all the bases. So maybe, however it works out, I might seem right.
Jack Derwin: That's a good approach. You touched on it a little bit in your answer there, but we have another question here: “Do you have any more thoughts on the implications of this case for the pharmaceutical industry generally?”
Robert J. Rando: Well, sure. I think there’s credence to be had with respect to how much investment is necessary when trying to investigate these antibodies with genus claims. So I don't think having to reach that ultimate space will be good for the pharmaceutical industry in terms of investment. And I will say that if there are alternatives to what the Court may decide. I'll reference the amicus brief that was filed by the NYIPLA, in which I participated.
We have proposed a solution that’s kind of a compromise where genus claims—in the full scope of the genus claims—they would be allowed at prosecution, but they would be tested at the infringement stage based on claim construction for the full scope of the claim. So if it catches enough justices’ attention, you never know. But I think that's a real long shot. Hopefully, that answers your question.
Jack Derwin: All right. Once again, you can submit questions using the Q&A button. That should be at the bottom right of your Zoom window. We have a clarification on that first question. It's a clarifying question. “Why do you think that the Court chose to address enablement in Amgen but not a written description in Juno?
Robert J. Rando: It may very well be that it caught their attention in terms of the implications of the ruling with respect to monoclonal antibodies and the advancement in that science.
Jack Derwin: All right. A final call here for any questions for Rob before we wrap up. All right. Any closing thoughts, Rob?
Robert J. Rando: Although I offered my prognostication, I will say that there really -- it wasn't a lot for reading the tea leaves from the oral argument in terms of the questions other than— as I said in the beginning—the justices seemed very invested in understanding the science, at least on a basic level. And we're really trying to find -- I think, trying to find how and why the Federal Circuit has gotten it wrong.
I was surprised that the justices did not focus on statutory interpretation, the plain language of the enablement provision, or even their own -- the Court's own precedence. Now, I could also be surprised by the opinion when it comes out. And maybe that will have some influence on what they decide. Hopefully, I've provided some insight here.
Jack Derwin: We did get one more question. “Did it come up how much time and money it would take to make the 300 some embodiments?”
Robert J. Rando: I'm pretty sure that the petitioner had identified, I believe, it was 2.6 billion invested. And I don't know that that was for the 384. I apologize. I did know that, but I don't have that handy right now.
Jack Derwin: No problem at all. And I believe, with that, we will wrap up. Thanks again, Rob, for taking the time to join us today. That was fantastic. I think our audience really appreciated it.
Robert J. Rando: Well thank you. I appreciate being invited to do it.
Jack Derwin: And thank you to our audience for tuning in to today's program. You can check out our website, fedsoc.org, or follow us on all the major social media platforms at FedSoc to stay up to date. With that, we are adjourned. Thank you