by Chris Holman

As reported in posts by Dennis and Jason, the Supreme Court recently granted certiorari in Amgen v. Sanofi, marking the first time that the Court has taken up patent law’s enablement requirement since enactment of the Patent Act of 1952. The claims at issue are directed to a genus of functionally-defined molecules having therapeutic utility, i.e., monoclonal antibodies defined in terms of binding specificity. For the sake of brevity, I will refer to claims of this type as “chemical genus claims.”

A few days later, on November 7, the Supreme Court denied certiorari in Juno v. Kite, a case challenging the Federal Circuit’s interpretation of the written description requirement. The claims struck down for lack of adequate written description in Juno are strikingly similar to the claims that were invalidated under the enablement requirement in Amgen, being directed towards nucleic acids encoding chimeric T cell receptors (for use in Car T-cell therapy), comprising, inter alia, a functionally defined “binding element,” as exemplified by a single-chain antibody variable fragment (‘‘scFv’’).

The scope afforded to chemical genus claims under 35 USC § 112(a)’s enablement and written description requirements has been hot topic recently (at least in certain quarters). Professors Lemley, Seymore, and Karshtedt (it is so sad that he is no longer with us) published an article in 2020 entitled The Death of the Genus Claim, which asserts that “the law has changed dramatically in the last thirty years, to the point where it is nearly impossible to maintain a valid genus claim.” Amgen’s successful petition for certiorari relies heavily on Death, and its authors filed an amici curiae brief in support of Amgen’s petition.

While Death clearly raises some valid concerns regarding the challenges inventors face in trying to secure effective patent scope for inventions of this type, in my view it is an overstatement to say that chemical genus claims are “dead.” I responded to Death in a two-part article arguing, for example, that the case law identified in Death provides scant support for its assertion that the standard for compliance with the enablement and written description requirements has become significantly more stringent in recent years. Christopher M. Holman, Is the Chemical Genus Claim Really “Dead” at the Federal Circuit?: Part II, 41 Biotechnology Law Report 58 (2022); Christopher M. Holman, Is the Chemical Genus Claim Really “Dead” at the Federal Circuit?: Part I, 41 Biotechnology Law Report 4 (2022).

I also point out that relatively broad chemical genus claims continue to survive § 112(a) challenges in the district courts and at the Federal Circuit.  See, for example, Ajinomoto Co. v. Int’l Trade Comm’n, 932 F.3d 1342 (Fed. Cir. 2019); Bayer Healthcare LLC v. Baxalta Inc., 989 F.3d 964 (Fed. Cir. 2021); Plexxikon Inc. v. Novartis Pharmaceuticals Corp., Case No. 17-cv-04405-HSG, Document 565, July 22,2021 (N.D. Cal.).

Section 112(a)’s enablement and written description requirements, sometimes referred to as the “adequate disclosure requirements,” constitute U. S. patent law’s primary non-prior art-based limitations on claim scope. Although Supreme Court has in the past indicated that it views the patent eligibility doctrine as playing an important role in preventing patent claims from broadly “preempting” abstract ideas and natural phenomena, more recently the Court’s patent eligibility decisions have focused on the sufficiency of “inventive concept,” as opposed to claim breadth per se.  Absent such limitations, under a regime in which claim scope would only be limited by the prior art, an inventor could potentially secure patent claims encompassing huge swaths of yet-to-be invented technologies.

Hypothetically, for example, the inventor of the first practical method for communicating at a distance using electricity, e.g., the telegraph, might have ended up with a patent claim encompassing all means of communicating at a distance using electricity, e.g., the internet. The inventor of a rudimentary, barely functional electric light bulb could, assuming it was the first lightbulb, potentially have obtained a patent claim encompassing all lightbulbs, including far superior lightbulbs produced by subsequent inventors. While I have simplified the facts quite a bit, the gist of these examples have been the subject of actual Supreme Court decisions. O’Reilly v. Morse and Consol. Elec. Light Co. v. McKeesport Light Co..  Not surprisingly, in both cases the Supreme Court struck down the patent claims as overly broad, invoking what we would today refer to as the enablement requirement.

More pertinent to the facts of Amgen v. Sanofi, the inventor of the first antibody capable of recognizing a particular antigen could potentially obtain a patent encompassing all antibodies capable of recognizing that antigen. For example, an inventor who has succeeded in producing a mouse monoclonal antibody that binds to a particular human protein (useless as a human therapeutic) could in principle obtain a patent claim encompassing all monoclonal antibodies that bind to that particular human protein, even a fully humanized antibody that functions as a safe and effective biologic drug, e.g., AbbVie’s blockbuster Humira, or the accused product in Amgen, Praluent.  Again, the gist of this example comes from an actual Federal Circuit decision, Noelle v. Lederman, wherein the claims at issue were struck down under the written description requirement.

The Federal Circuit has invoked both the written description and enablement requirements as doctrinal tools for policing claim scope. Although as a formal matter the written description requirement focuses on whether the inventor has demonstrated “possession” of the full scope of the claim, while the enablement requirement asks whether the scope of the claim is “commensurate” with the scope of disclosure, as a practical matter the two requirements have been applied in a manner that is largely redundant, albeit with a few distinctions of arguable significance discussed later in this post. In my article responding to Death, for example, I point out that the Ariad factors that the Federal Circuit has identified as relevant to assessing compliance with the written description requirement are, in substance, virtually identical to the Wands factors used in the enablement inquiry. If anything, the written description requirement has been seen as the more stringent of the two, particularly in the context of biotechnology – the written description requirement has often been referred to as a  “super-enablement” requirement.

And in fact, prior to Amgen, the Federal Circuit has tended to invoke the written description requirement, rather than the enablement requirement, in striking down monoclonal antibody genus claims. See, for example, Noelle v. Lederman, 355 F.3d 1343, 1349 (Fed. Cir. 2004)(disclosure of mouse monoclonal antibody specific for mouse antigen (CD40CR) did not provide adequate written description for claim encompassing any monoclonal antibody capable of binding the human analog of the CD40CR antigen); Centocor Ortho Biotech v. Abbott Laboratories, 636 F.3d 1341(Fed. Cir. 2011)(disclosure of previously characterized antigen (human TNF-alpha) and mouse antibodies to the antigen did not provide adequate written description for claim encompassing fully human monoclonal antibodies capable of binding to a specific neutralizing epitope of the antigen); AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285 (Fed. Cir. 2014)(disclosure of about 300 antibodies falling within the scope of the claim did not provide adequate written description for a claim reciting neutralizing human antibodies capable of specifically binding human interleukin-12 (IL-12)).

Of course, given the redundancy of the doctrines, a claim struck down as overly broad for lack of enablement is highly likely to be invalid for lack of adequate written description, and vice versa. In Amgen, for example, the jury found Amgen’s claims not invalid under the enablement and written description requirements, but on a motion for JMOL the district court overruled the jury and found that, as a matter of law, the claims are invalid under both the enablement and written description requirements. In Amgen, the Federal Circuit decided the issue based on a failure to comply with the written description requirement, rendering the enablement issue moot, but in the past the Federal Circuit has been more inclined to find claims of this type invalid for failure to comply with the written description requirement.  See the examples provided above, as well as the Juno decision.

Thus, one of the big elephants in the room with respect to the grant of certiorari in Amgen is that the question for review appears to focus solely on the enablement requirement. Even if the Supreme Court lowers the bar for compliance with the enablement requirement, the ruling would presumably have no direct impact on the written description requirement, which has conventionally been thought of as imposing an even higher bar for the sort of claim at issue in the case, e.g., functionally defined chemical genus claims.

Sanofi raised this point in its Opposition brief, arguing that any ruling by the Supreme Court would not be dispositive of the case because, if the Supreme Court overturns the enablement verdict, the Federal Circuit would likely still find the claims invalid for lack of adequate written description. Sanofi points out that Amgen’s own amici, i.e., Professors Lemley, Seymore and Karstedt, concluded in Death that the Federal Circuit had “strongly suggested” that the claims were not only invalid under the enablement requirement, but also the written description requirement.

Indeed, the Federal Circuit has on occasion explicitly noted that a claim’s compliance with the written description and enablement requirements generally rise and fall together. For example, in Idenix v. Gilead, a recent case involving claims analogous to those at issue in Amgen, the jury also found the claims to be not invalid under the enablement and written description requirements. The district court overturned the jury verdict with respect to enablement, but denied a motion for JMOL with respect to written description. On appeal, the Federal Circuit affirmed the district court’s holding that the claims were invalid for lack of enablement, but reversed its denial of JMOL for failure to meet the written description requirement, finding the claims invalid under both doctrines.

Under the Federal Circuit’s current interpretation of the written description and enablement requirements, I think it would be highly unusual for the court to find claims of the type at issue in Amgen invalid for lack of enablement but not for lack of adequate written description. In fact, when the district court decision in Idenix v. Gilead initially came out, finding the claims invalid under the enablement requirement but not under the written description requirement, I thought it was so striking that I wrote an article about it.   Christopher M. Holman, Enablement Invoked as a ‘‘Super-Written Description Requirement’’ to Overturn $2.5 Billion Jury Verdict, 37 Biotechnology Law Report 63 (2018). So I was not at all surprised when the Federal Circuit reversed and explicitly found the claims invalid under both the enablement and written description requirements, even though the Federal Circuit could have chosen not to address the written description issue as moot in light of the enablement ruling, as it did in Amgen.

In retrospect, I wonder if it might have been better for the Supreme Court to take up the issue of adequate disclosure in a case like Idenix, where the Federal Circuit explicitly addressed both the enablement and written description requirements in the context of the same chemical genus claims. As Jason intimated in his blog post, while it is relatively easy to point out the shortcomings in the Federal Circuit’s current § 112(a) jurisprudence, it is much harder to come up with an effective alternative. I have to think that it will be particularly difficult for the Supreme Court to make a positive contribution to the law of adequate disclosure without also taking into account the written description requirement.

Although the written description requirement has long been used to police the claiming of new matter, it only took on the role of policing claim scope as what is in essence an alternate enablement requirement in 1997 when the Federal Circuit decided UC Regents v. Eli Lily, creating what I refer to as the “Lilly written description requirement” (so as to distinguish it from the “traditional written description requirement” used prevent the claiming of new matter). Early on, the Lilly written description requirement seemed to impose a much higher threshold than enablement, particular for biotechnology inventions, hence its characterization as a “super-enablement requirement.” But it seems to me that at this point in time the standards for compliance with the written description and enablement requirements have become for the most part indistinguishable, as illustrated by the redundancy of the Ariad and Wands factors, and the paucity (or, to my knowledge, the absence) of any judicial decisions (upheld on appeal) explicitly finding a claim invalid under the Lilly written description requirement but not invalid for lack of enablement, or vice versa.

Nonetheless, Federal Circuit precedent has carved out some clear differences between the written description requirement and enablement, although as a practical matter it is not clear to me how significant those differences are.  For example, the Federal Circuit treats the written description requirement as a question of fact, and the enablement requirement as a question of law based on underlying factual findings.  In its petition for certiorari, Amgen also asked the Court to rule that enablement, like written description, is a question of fact, but the Court declined to take up that question. In principle, a decision by a jury (or judge in a bench trial) should be afforded more deference with respect to a question of fact, which might explain why in Amgen and Idenix the district courts overturned the juries’ enablement decisions, but not their written description decisions. However, it seems to me that when case reaches the Federal Circuit the formal distinction between question of fact and “question of law based on underlying factual findings” has little practical effect.  See, for example, Centocor Ortho Biotech v. Abbott Laboratories, 636 F.3d 1341(Fed. Cir. 2011)(overturning jury decision finding claim encompassing fully human monoclonal antibodies not invalid for failure to comply with the written description requirement).

Another difference between the two doctrines has to do with the admissibility of evidence.  In the Federal Circuit’s first decision in Amgen v. Sanofi (the grant of certiorari is with respect to the Federal Circuit second decision in the case), the court held that the district court had committed legal error by improperly excluding post-priority date evidence of antibodies falling within the scope of the claim, including the accused product (Praluent). The district court based its decision to exclude the evidence on a 1977 decision of the Court of Customs and Patent Appeals, In re Hogan, which the Federal Circuit has interpreted as prohibiting, in the context of the enablement inquiry, admission of “post-priority-date evidence proffered to illuminate the post-priority-date state of the art.”  Without questioning the continuing vitality of Hogan, the Federal Circuit held that, in the context of the written description inquiry, post-priority-date evidence is admissible to show that a patent fails to disclose a representative number of species, explaining that Hogan is silent with respect to evidence of this type. Thus, it seems that under some circumstances post-priority-date evidence illustrating the structural and functional breadth of a chemical genus claim could be admissible for purposes of a written description challenge but not a challenge for lack of enablement.

by Dennis Crouch

In re Apple, — F.4th — (Fed. Cir. Nov 8, 2022)

The Federal Circuit has again ordered Judge Albright to halt pending litigation until he decides Apple’s motion to transfer venue on grounds of inconvenience under 28 U.S.C. 1404(a).  In particular, the court (1) vacated the scheduling order; and (2) directed Judge Albright to postpone fact discovery and “any other substantive proceedings.”

Aire Technology sued Apple for infringement back in October 2021.  In April 2022, Apple filed its motion to transfer.  At that point, the parties conducted some amount of ‘venue discovery’ that was completed around the end of June 2022.  However, instead of ruling on the motion, Judge Albright  told the parties he would postponed ruling for another 7-8 months while fact discovery in the case was ongoing.  Apple then petitioned for writ of mandamus, arguing that delay created a critical injury to the tech giant’s convenience that deserved immediate remedy. And, the Federal Circuit has complied–ordering the district court to go ahead and decide the transfer motion.

In this situation, I have tremendous sympathy for Judge Albright’s ruling.  Albright had previously noted problems with Apple’s venue declarant, Mark Rollins who “frequently and repeatedly submitted unreliable and misleading declarations to this Court.”  Scramoge Tech. Ltd. v. Apple Inc., 2022 WL 1667561 (W.D. Tex. May 25, 2022) (finding Rollins to be not credible).  Even without these particular problems with a 30(b)(6) declarant, my experience is that the witnesses and evidence arguments made in the 1404(a) context at the pleading-stage are notoriously unreliable because they do not reflect the actual evidence/witness issues that become clear around the end of discovery.  Further, parties treat the Section 1404(a) factors as a scorecard or checklist in ways that are often divorced from the interests of justice.

This mandamus is particularly about delaying a transfer decision while the case is developed.  I see little harm in that delay.  Discovery in federal courts is a nationwide endeavor. Evidence is exchanged electronically; parties go to the location of witnesses to conduct discovery; and discovery disputes needing court intervention are ordinarily resolved over the phone (or Zoom).  Thus, there would not be much difference for the parties during this period in terms of litigating in N.D. Cal. vs W.D. Tex.–with the one exception that Judge Albright  remains the judge if the case stays in W.D. Tex.  It is clear that this final Albright-factor underlies Apple’s true purpose in filing these motions and mandamus actions: to escape from Judge Albright.  Of course, that true reason is not justified under the law and so is never mentioned.

One key benefit of an early transfer would be to permit the new district court to get up-to-speed on the issues in the case and begin exerting their own style of case management.  That said, N.D.Cal. judges ordinarily defer the whole discovery process to a magistrate judge and thus rarely become involved.  The Federal Circuit cited some precedent about how an early transfer avoids double-work by two district courts. However, it is not clear how that precedent is applicable in this situation.

In its decision, the Federal Circuit did not delve into the particular issues, but rather focused on prior precedent that “entitles parties to have their venue motions prioritized.”  Id.

by Dennis Crouch

As Jason Rantanen posted, the Supreme Court has granted certiorari in Amgen v. Sanofi, agreeing to hear its first patent case in two terms.  The case has the potential of shaking up disclosure doctrine in a big way.  In particular, Amgen argues that the Federal Circuit incorrectly created two separate requirements from overlapping textual portions of Section 112(a): Written Description and Enablement.  Truthfully, having two separate and distinct requirements reflects an incoherent textual analysis of the statute. Over the past several years, both of these doctrines have increasingly focused on a “full scope” disclosure that makes it virtually impossible to include broad claims, especially genus claims with functional limitations as Amgen did in this case.   More to come. . .

By Jason Rantanen

On Friday, the Supreme Court granted certiorari on two petitions raising intellectual property issues, including the closely-watched enablement Amgen v. Sanofi.  The other case is a Abitron Austria GmbH v. Hetronic International, a trademark dispute involving extraterritoriality issues.

Over the past few years, the Federal Circuit has issued a series of enablement decisions, including Amgen v. Sanofi, that rely on a lack of enablement to hold that functionally defined genus claims are invalid. (Dennis’s post on Amgen is here.) This has been a topic to watch at the Federal Circuit, and two major law professor articles, one written by Mark Lemley and Jake Sherkow and the other co-authored by Dmitry Karshtedt, Sean Seymore, and Mark Lemley, have pointed out the problems with the Federal Circuit’s approach to genus claims, especially in the context of inventions such as antibodies. Karshtedt, Seymore and Lemley filed an amicus brief supporting en banc rehearing at the Federal Circuit (PatentlyO post here) as well as one supporting Amgen’s petition for certiorari.

The claim in Amgen illustrates this point. It claims the genus of antibodies that bind to a particular region on a specific protein. Here is a representative claim of Amgen’s Patent No. 8,829,165:

1. An isolated monoclonal antibody, wherein, when bound to PCSK9, the monoclonal antibody binds to at least one of the following residues: S153, I154, P155, R194, D238, A239, I369, S372, D374, C375, T377, C378, F379, V380, or S381 of SEQ ID NO:3, and wherein the monoclonal antibody blocks binding of PCSK9 to LDLR.

The problem is that there isn’t just one antibody that meets this requirement – rather, it encompasses potentially millions of currently unknown antibodies. The Federal Circuit held that the claims were far broader than the associated disclosure, requiring undue experimentation to identify undisclosed embodiments encompassed by the claims. Amgen petitioned the Supreme Court for review, extensively citing the Karshtedt/Seymore/Lemley article.  

On Friday, the Supreme Court granted certiorari on Question 2 of the Amgen petition, which focuses on the “full scope” and “undue experimentation” aspects of the of 112(a) jurisprudence. This was after the Solicitor General had recommended against certiorari.

Here’s the question that the Court granted cert on:

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,’ ” Pet. App. 14a (emphasis added).

This will be the first time that the Supreme Court has addressed the enablement requirement in a very long time.  Those decisions used the pre-1952 version of the patent law statute, Rev. Stat. § 4888. Generally, however, it was very similar to the current 35 U.S.C. § 112(a). For example, as applied in Consol. Elec. Light Co. v. McKeesport Light Co., 159 U.S. 465 (1895) (a/k/a The Incandescent Lamp Case), it required:

“a written description of the device, and of the manner and process of making constructing, compounding, and using it in such full, clear, concise, and exact terms as to enable any person skilled in the art or science to which it appertains or with which it is most nearly connected to make, construct, compound, and use the same.”

To me, the issue of full scope enablement is one of the most challenging problems in patent law. Many patent law scholars have written about it, including myself, and I still haven’t seen a real solution. But I’m sure that much more will be said before and after the Court issues its decision.

Sadly, as I wrote about last week, Professor Karshedt passed away just a few days ago, and we’ll miss his insights on the case as it moves through the Supreme Court.

Here’s a link to the docket on ScotusBlog for those who would like to read more.

Google LLC v. Sonos, Inc., No. 20-cv-06754, 2022 U.S. Dist. LEXIS 197728 (N.D. Cal. Oct. 31, 2022) [GoogleSonosDiscovery]

Google sued back in 2020 seeking a declaratory judgment that several Sonos networked-speaker patents are invalid or not infringed.  Trial is set for May 2023.  The parties had a prior development agreement and in a recent discovery request, Google asked for a R.30(b)(6) corporate witness deposition regarding Sonos’ “understanding of the scope” of a prior agreement between the parties.  Sonos refused to provide the witness – arguing that the discovery request improperly sought Sonos legal theories (including contract interpretation) and trial strategy.  Google moved to compel discovery, but that request has been denied by Magistrate Judge Ryu.

Judge Ryu concluded that Sonos’ “understanding of” its contract implicated questions of law (since contract interpretation is a question of law rather than a question of fact).   Even though Google limited its request to discover “facts,”the request was also very much about Sonos’ interpretation of the contract.  The discovery request here seeking a party deponent is also different from an ordinary request for documents because a 30(b)(6) deposition allows 7 hours of questions that allows for more substantial development of legal theory as opposed to just sending over a set of responsive documents.  The court did not attempt to distinguish the deposition discovery here from interrogatories and requests for admission regarding legal contentions that are a regular practice in patent litigation.

In re PersonalWeb Techs., LLC Patent Litig., No. 18-md-02834-BLF, 2022 U.S. Dist. LEXIS 197706 (N.D. Cal. Oct. 31, 2022) [PersonalWebDiscoveryOrder]

Amazon won this litigation against PersonalWeb and also awarded more than $5 million in attorney fees to Amazon for 10,000 attorney hours.  Since 2021, Amazon has bene trying to get banking and investor records from PersonalWeb for enforcement purposes.

In this recent decision, Amazon is seeking discovery from PersonalWeb’s former attorneys, the Stubbs Alderton Law Firm. Of course, that information is likely privileged and/or work product. But, PersonalWeb apparently did not timely respond to the discovery requests directed to its counsel and so, according to Magistrate Judge Susan Van Keulen, has waived its privilege.

PersonalWeb’s failure respond to discovery directed to its counsel, followed by its failure to argue in the Joint Statement that it had not waived objections, cannot now save its privilege claims.

Id.

by Dennis Crouch

Arthrex, Inc. v. Smith & Nephew (Supreme Court 2022)

The Supreme Court issued a major opinion in this case back in 2021, holding  that the IPR scheme was unconstitutional because it placed administrative patent judges in the role of entering final decisions that were unreviewable by any superior executive officer.  United States v. Arthrex, Inc., 141 S. Ct. 1970 (2021).  The Court’s solution was to add a layer of review by the USPTO Director who has gone through the process of Presidential appointment and Senate confirmation. Id.  This is a process that we now call “director review.”  The point of this whole process created at our nation’s founding was an attempt to hold the President politically accountable for the actions of the administration.

Back on remand, the USPTO faced a slight problem. Director Iancu had resigned and President Biden had not yet nominated a successor or even an acting-director authorized by the Federal Vacancies Reform Act (“FVRA”).  Rather, then Commissioner for Patents Drew Hirshfeld stepped in to perform the duties of the USPTO Director but without any Presidential imprimatur.  As a reminder, the Commissioner is not nominated by the President nor confirmed by the Senate. Rather, the Commissioner is appointed by the Secretary of Commerce (just like the PTAB judges). Hirshfeld reviewed the PTAB’s Arthrex decision, and denied the petition for director review.

Now the case is headed back to the Supreme Court with Arthrex arguing that, just like the PTAB judges, Hirshfeld lacked authority to speak for the agency at this level.

Despite this Court’s instructions, Arthrex was not able to seek review by any presidentially appointed, Senate-confirmed principal officer. Nor was Arthrex able to seek review even by an Acting Director. The Director’s position was vacant, and the President had not appointed an Acting Director pursuant to the FVRA. Instead, Arthrex’s petition was denied by the Commissioner for Patents, an inferior officer appointed by the Secretary of Commerce, who purported to exercise the Director’s powers under an internal PTO organization plan. As a result, this case now presents a new important question of federal law: whether the Commissioner’s exercise of authority was consistent with the FVRA.

Arthrex motion for extension.  Arthrex has asked for a 60-day extension for filing its opining petition.  That petition has been granted and so the brief is due Jan 8, 2023.

Jeffrey Lamken (MoloLamken) is representing the patentee.