Amgen v. Sanofi – Next Steps

In Amgen v. Sanofi, the Supreme Court has been asked to review Federal Circuit precedent on the enablement doctrine found in 35 U.S.C. § 112(a).   Although still uncertain, the case has a strong chance of being granted certiorari.  Most recently, the Supreme Court requested that the US Solicitor General file a brief in the case indicating the views of the U.S. Gov’t. That filing will likely come in December 2022.

The statute requires the patentee to provide “a written description of the invention, and of the manner and process of making and using it [sufficient] to enable any person skilled in the art … to make and use the same.”  The petition asks two particular questions:

  1. Whether enablement is “a question of fact to be determined by the jury” Wood v. Underhill, 46 U.S. (5 How.) 1, 4 (1846), as this Court has held, or “a question of law that [the court] review[s] without deference,” as the Federal Circuit holds.
  2. Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. § 112, 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.’ ”

The invalidated patents here are likely worth >$100 million.


20 thoughts on “Amgen v. Sanofi – Next Steps

  1. 2

    It is too bad that this blog does not have an (active) ethical section, as it would be of interest to address the ethics (or lack thereof) of excessive spin in “questions presented” that spin out some merely desired narrative that is divorced from the proceedings below.

    1. 2.1

      If the cert petition “questions presented” are not properly raised in this case, or would not change the outcome, then the opposing party brief, if any, or the requested US Solicitor General’s brief, should so note.

      1. 2.1.1

        …unless of course the other side ALSO engages in such frolics.

        Sorry Paul – but I have just seen TOO MANY “questions posed” that engage in shameful frolics of such spin as to induce tornado warnings.

        When it gets to a point that no one bats an eye, something needs be done.



          Tthe Court sets its own question for review if it grants cert. And in any event, as Paul stated, in an adversarial system such as ours, the other side will frame the question in a way that favors it. Far from being unethical to frame questions in a way that is helpful to your client, that’s called good lawyering. If a party frames a question in an illogical or unsupportable way, the other side will have no problem pointing that out. Finally, just because you don’t like someone’s argument doesn’t mean that someone is unethical. In any event, without taking any position on the ultimate merits of the petitioner’s framing of the argument, it does not seem to me to be clearly untethered to facts nor does it seem to be frivolous on its face.


            Sorry but no – when the framing goes too far, it IS unethical.


            This is just not a matter of my liking anyone’s argument or not.


              I agree with Litig8tor. Also, these Questions Presented seem reasonable in this case. What is it about these questions that you find misleading?


                meh – it is less that these in particular are WAY over the top egregious and my comments started out more as an indictment to the “Ethics” side of the blog (last post there: August 13, 2021 – more than TEN months ago).

                But to IGN0RE the fact that WAY too much liberty is taken with spin is just not acceptable. When the “question asks” can fairly be said to NOT reflect the case below (for whatever reason), then enough is enough.

  2. 1

    I would love to see the discrepancy resolved between 112(a) enablement being a question of law and 112(a) written description being a question of fact. That said, one should never wish for the SCOTUS to take a patent law question. One has to go way back to find a patent case where they left the law better than they found it. Here’s hoping that cert is denied.

    1. 1.1

      “112(a) enablement being a question of law and 112(a) written description being a question of fact” also strikes me as illogically flipped, especially in view of Markman, but that is not likely to be dealt with in this cert petition.
      Those who would cheer 112(a) enablement being flipped to a question of fact [because that would make it a jury decision] should consider that this would also make it a fact issue for IPR decisions [much harder to challenge under the APA].

      1. 1.1.1

        Why is the Federal Circuit quick to overturn juries but slow to overturn bureaucrats? That strikes me as un-American.


          Why is the Federal Circuit quick to overturn juries but slow to overturn bureaucrats?

          It is not clear to me that this is the case. The CAFC reverses district court judgments more often than it reverses PTAB judgments, but it is not clear to me what fraction of those district court judgments constitute jury verdicts. Do you know of data that speak to this point?

          link to


          Of course, the CAFC is not “quick” to overturn anyone. The CAFC affirms completely the overwhelming majority of decisions whose appeals it is tasked to decide. It completely affirms district court judgments ~70% of the time, and PTAB decisions ~80% of the time. In other words, complete affirmances in patent cases are more than twice as likely as even partial reversals, regardless of the origin of the appeal.


            Greg, the Court of Appeals should NOT be “quick” to reverse. Are you suggesting that they should ? Any litigator worth is salt is going to do everything to win at the trial level (/PTAB) and anyone that talks about winning the appeal should be fired.


              Are you suggesting that they should [be “quick” to reverse]?

              Definitely not. I agree that one should expect most district judges and APJs to reach a correct conclusion most of the time. It should hardly be surprising that reversal on appeal is a relatively rare outcome. I was merely responding to Mr. Malone’s assertion that the CAFC is quick to overturn juries.”

    2. 1.2

      There was never a truer statement: “One has to go way back to find a patent case where they left the law better than they found it.” (I personally can’t think of any patent law case where the SC left the law better than when they found it, at least not for prosecution issues. But I could be, often am, wrong.)

      1. 1.2.1

        lol – such humility….

        But I too would love to see someone posit a pro-innovation decision of the Supremes that left the law better than when they found it.

      2. 1.2.2

        Probably United States v. Adams, 383 U.S. 39 (1966) is the most recent such case that I can remember. The category “cases in which the SCOTUS improved patent law relative to the status quo ante” is not a large genus.


          Greg, many thanks for the Adams tip. I see that the final words read “We conclude that the patent is valid”. I don’t expect to see that formulation again, any time soon.

    3. 1.3

      I’m with you. This case has very little to do with the patents around Repatha, an antibody drug no one really cares about. Rather, this case is about “Dupixent” a life-changing medication for tens of millions who fought atopic dermatitis and/or asthma their entire lives. Amgen tried to develop an IL4/IL-13 combination antibody and failed so they want a piece of Sanofi/Regeneron profits. Now it may be fair to ask whether the scope of a patent claim under 112(a) should read on work successfully (in terms of a life-changing treatment) carried out by others and not by the patentee. I have not reviewed or considered the claims at issue, but there is more at stake than just the games we play as patent attorneys. Amgen says the claims are enabled, and perhaps, they are valid and read on Praulent, but Amgen will certainly not stop there. They’re looking for a bigger pay day down the road in a different litigation matter.

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