Dual-Purpose Communications and Privilege

by Dennis Crouch

The NY IP Law Association (NYIPLA) recently filed an amicus brief in the pending  anonymous Supreme Court case captioned In re Grand Jury, 21-1397 (2022).  The case focuses on the scope of attorney client privilege, especially with regard to dual-purpose communications.

Petitioner is a law firm specializing in international tax and had provided tax law advice to an expatriation client and also prepared individual tax returns for the client.  Later, the US Gov’t began a criminal tax investigation of the client and subpoenaed the law firm to provide Grand Jury testimony and evidence.  The law firm resisted, but both the district court and Ninth Circuit Court of Appeals ordered compliance.  In prior precedent, the courts have ruled that preparation of a tax return is a non-legal function, and thus, communications for that purpose are not privileged.  However, advice regarding tax planning and tax controversies is legal advice and thus communications are privileged. The attorney-client communications in this case thus fall under the category of dual-purpose communications where some aspect of the communications are privileged and other aspects are not privileged.

The lower court approach was two-fold. First, the court concluded that dual-purpose communications are entirely protected only when the primary purpose of the communication involved seeking legal advice.  Using that test, the court found that some of the communications were not privileged because they were primarily associated with tax return prep.  Thus, the law firm was ordered to deliver the documents.  Still, the court did not run entirely roughshod over attorney-client privilege. Rather, the second part of the lower court approach that any portions of the communications that contain attorney-client privileged material can be redacted.  Still, the law firm doesn’t want to disclose the communications at all and suggests that communications should entirely protected when the legal advice was “one of [its] significant purposes.” The Supreme Court recently agreed to hear the case with oral arguments set for January 2023.

Question Presented: Whether a communication involving both legal and non-legal advice is protected by attorney-client privilege where obtaining or providing legal advice was one of the significant purposes behind the communication

[Petition]. In its responsive briefing, the U.S. Government reframed the question as follows:

Whether the district court permissibly denied petitioner’s general claim of attorney-client privilege over communications, related to the preparation of a tax return, that did not have obtaining legal advice as their primary purpose, while instructing that all legal advice contained in the communications be redacted

[Gov’t Opposition].  The “significant purpose” test comes from a 2014 D.C. Circuit decision by Judge Kavanaugh, who is now a member of the Supreme Court. In re Kellogg Brown & Root, 756 F.3d 754 (D.C. Cir. 2014).

In their Amicus Brief, NYIPLA argues that the situation faced by the tax lawyers here is also prevalent for IP attorneys because IP lawyers are often experts in both the law and in the relevant field of the IP. For example, many patent attorneys also hold advanced degrees in a particular technical field and regularly use that knowledge in providing advice.  Likewise, many patent attorneys (especially in-house counsel) develop extensive knowledge of the firm’s business activities and goals and integrates those into their analysis.  According to the briefs, the 9th circuit rule “which requires courts to balance the legal and nonlegal aspects of a communication to determine its predominant purpose, hamstrings IP attorneys and clients.”   Irena Royzman (Kramer Levin) is counsel of record for the NYIPLA brief.

 

 

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Cross-Border Inventing

by Dennis Crouch

The chart below highlights an important trend in patenting: increased joint-inventorship where the inventors reside in different countries.  The top (blue-circle) series looks generally at cross-border joint-inventing while the lower (orange-square) series reports a subset where at least one of the inventors has a US residence.

One important caveat here is that the inventor’s permanent residence does not necessarily mean that the inventors where physically distant since one or more inventors may have been temporarily on location.  Further, residence is typically designated at the time the patent application is filed, and inventors may have moved in the interim between inventing and their US filing.  The rise in cross-border inventing also correlates with the rise in joint inventorship.  From 2005 to 2022, the average number of inventors per patent rose from 2.5 up to over 3.   If we reach back to 1985, most US patents listed only one inventor. By 2005, only 37% of utility patents were single inventor endeavors.  Today, the figure is down to 26%.

 

Disclaimer: Now and Later

by Dennis Crouch

The Federal Circuit’s decision in CUPP Computing v. Trend Micro includes a big discussion on treatment of disclaimers.  The patentee (CUPP) filed the appeal after the PTAB issued its final written IPR decisions finding the claims of three mobile device cybersecurity patents to be unpatentably obvious. IPR2019-00764, -00765, -00767.

In the IPR, CUPP was seeking a narrow construction of its claims in order help it skirt the prior art.  The claims all require a “security system processor” that is “different than” from the mobile device processor.  During prosecution, CUPP distinguished prior art that included both processors using the same motherboard as not “different.”  Later during the IPR, CUPP argued that this distinction meant that the two processors must be “separate and remote” from one another.  During the IPR, CUPP also expressly disavowed claim coverage where the security system processor is embedded in the mobile device.  Despite these arguments, the PTAB gave the claims a broad construction that allowed for both processors to be embedded next to one another.  This interpretation meant that the prior art killed the claims.

On appeal, the Federal Circuit has affirmed on this point.  First, as to the original prosecution.  The court concluded that the statements were not a clear disavowal of scope.  The court noted that the statements could be reasonably interpreted in more than one way and thus failed to meet the high burden of prosecution disclaimer.

The doctrine of prosecution disclaimer precludes patentees from recapturing through claim interpretation specific meanings disclaimed during prosecution. However, a patentee will only be bound to a disavowal that was both clear and unmistakable.

Slip Op. (quotation marks, alterations, and citations omitted).

As to disavowal during the IPR, the Federal Circuit has previously held the PTAB is not required to accept a disavowal of scope during an IPR.  However, that prior decision was non-precedential. VirnetX Inc. v. Mangrove Partners Master Fund,
Ltd., 778 F. App’x 897, 910 (Fed. Cir. 2019).  Here, the court makes the ruling binding:

The Board concluded that it could ignore this disavowal in construing the claims. We agree. . . . The Board is not required to accept a patent owner’s arguments as disclaimer when deciding the merits of those arguments. A rule permitting a patentee to tailor its claims in an IPR through argument alone would substantially undermine the IPR process. . . .

If patentees could shapeshift their claims through argument in an IPR, they would frustrate the Patent Office’s power to “revisit” the claims it granted, and require focus on claims the patentee now wishes it had secured.

Slip Op. (citations removed).

The court goes on to make a some what powerful extension of issue preclusion doctrine:

To be clear, a disclaimer in an IPR proceeding is binding in later proceedings, whether before the PTO or in court. We hold only that a disclaimer is not binding on the PTO in the very IPR proceeding in which it is made, just as a disclaimer in a district court proceeding would not bind the district court in that proceeding. This follows from the adjudicatory nature of IPR proceedings as contrasted with initial examination.

Id. Truthfully, it is difficulty to this aspect of the court’s decision as it relates to preclusion law in general.  But, perhaps the court is simply saying that if the disclaimer had been successful during the IPR, then it would be binding before a subsequent tribunal.

= = =

Also note that all this law of prosecution disclaimer is made-up law by the judges based upon their preferred policy arguments.  The statute does discuss disclaimer under Section 253, but this is disclaimer of a claim as a whole. “[A] patentee … may disclaim any complete claim . . . Such disclaimer shall be in writing and recorded.”

Prosecution Delays and Patent Term Adjustment on the Rise Again

by Dennis Crouch

In the standard case, a US utility patent will expire 20 years from its effective filing date.  But, there are several circumstances that might alter the patent term. As a consequence, only a minority of patents fit the standard.  One circumstance involves unduly delayed patent prosecution that results in “patent term adjustment” or PTA under 35 U.S.C. 154(b).  The two chart below show PTA awards over the past 17 years.  Of some importance here — over the past 18 months PTA has been steadily creeping-up.  This is generally an indication that the prosecution process has slowed down.

These numbers will likely continue to rise as indicated by the USPTO’s delays in issuing an initial office action rejection — only about 30% of cases are receiving a first office action within the 14 months allotted by Congress.  I’ll note here that the PTA does not ‘cost’ the USPTO anything in terms of up-front money and, may make it more likely that the patentee will pay the issue and back-end maintenance fees.

Minerals Separation v. Hyde, 242 U.S. 261 (1916)

by Dennis Crouch

Almost all the briefs filed in Amgen v. Sanofi cite to the 1916 Supreme Court decision in Minerals Separation v. Hyde, 242 U.S. 261 (1916). It is an interesting little case that primarily focuses on obviousness (i.e., “invention”), but also touches upon inventorship and sufficiency of disclosure.  In Amgen, the Supreme Court is tasked with reconsidering the law of enablement, and so it is this final issue that is most relevant.

Mined ore is typically a mixture of metals and various non-metallic gangue (often quartz).  Although folks had figured out various ways to separate the two, the solutions were not yet cost effective.  One form of separation was based upon the knowledge that certain oils tended to attach only to the metal.  Various prior patents used this law of nature to either cause the metal to float to the top of a liquid mixture or otherwise sink to the bottom.  But, those prior processes required a lot of oil; were not cost effective; and thus did not succeed in the marketplace.  Our patentees in this case are a trio of London metallurgists who developed their own approach of “froth flotation.”  They mixed in a very small amount of oil (0.5% of ore weight) into the powdered ore and then vigorously shook the mixture.  The shaking caused the oil to form air bubbles that rose to the top in a froth form.  And, because of the affinity between the oil and the metal, the metal power and flakes would line the surface of the frothed bubbles.  U.S. Pat. No. 835,120 (1906).

On the enablement issue, although the patentee had conducted tests on various oils and acids; agitation levels; addition of heat; etc, it was also clear that the method required refining for each different type of ore.  In particular, a user would need to conduct preliminary tests to figure out the amount of oil and level of agitation that works best.  The patent itself admitted that “in the concentration of any particular ore a simple preliminary test is necessary to determine which oily substance yields the proportion of froth or scum desired.’’

The Supreme Court considered this issue, but found the disclosure sufficient.

The composition of ores varies infinitely, each one presenting its special problem, and it is obviously impossible to specify in a patent the precise treatment which would be most successful and economical in each case. The process is one for dealing with a large class of substances and the range of treatment within the terms of the claims, while leaving something to the skill of persons applying the invention, is clearly sufficiently definite to guide those skilled in the art to its successful application, as the evidence abundantly shows. This satisfies the law.

Minerals Separation, 242 U.S. at 270-271.  In the same paragraph, the court also included a sentence on claim definiteness, using the same language of reasonable certainty that the Court later reiterated in Nautilus: “the certainty which the law requires in patents is not greater than is reasonable, having regard to their subject matter.”

The district court had also decided the case in favor of the patentee, concluding that “a range of quantities that leaves something to the judgment of the operator is all that can be described, and is sufficiently definite.”  Minerals Separation v. Hyde, 207 F. 956 (D. Mont. 1913), rev’d, 214 F. 100 (9th Cir. 1914), rev’d, 242 U.S. 261 (1916).  The issue does not appear to have been briefed to the Supreme Court, but the court addressed it anyway.

Both the District Court and the Supreme Court cite to Mowry v. Whitney, 81 U.S. 646 (1871).  In that case, Justice William Strong explained that a patent is not awarded simply for the act of invention. Rather, the inventor must also “teach the public how to practice it.”  Still, the court went on to explain that the specification is directed to those of skill in the art. Thus, disclosures insufficient the general public may still be sufficient to teach those already knowledgeable. “[I]t may leave something to their skill in applying the invention, but it should not mislead them.” Id.  In Mowry, the court concluded that the patent was valid despite “vague and uncertain directions” as to the amount of heat to add as part of a casting process.

But it is obvious that only vague and uncertain directions could have been given respecting the extent to which the heat is necessary to be raised. It must differ with the difference in the progress of cooling which has taken place before the wheels are removed from the moulds. . . . That, in the nature of things, must be left to the judgment of the operator.

Id.  In Minerals Separation, the Supreme Court also cited to Ives v. Hamilton, 92 U.S. 426 (1875).  In Ives the patent introduced a mechanism to impart a rocking motion a reciprocal saw being used in a saw mill.  The patentee used a “curved guide” but did not describe the exact nature of the curve.  In the case, the Supreme Court sided with the patentee and found the disclosure sufficient:

The complaint made by the defendants, that the patent is defective in not stating the nature of the curve for the guides, whether that of a circle or of some other figure … [is] not sufficient to affect its validity. Any good mechanic acquainted with the construction of sawmills, and having the patent and diagram before him, would have no difficulty in adopting the improvement, and making suitable curves.

Id.  The statutory text at the time was codified in R.S. Sec. 4888. The text is remarkably similar to the language found today in Section 112(a).  It required the the patentee to file:

a written description of the [invention or discovery], 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; and in case of a machine, he shall explain the principle thereof, and the best mode in which he has contemplated applying that principle, so as to distinguish it from other inventions; and he shall particularly point out and distinctly claim the part, improvement, or combination which he claims as his invention or discovery.

R.S. Sec. 4888 (1910).

After Granting Certiorari In Enablement Case, Supreme Court Declines Opportunity To Address Written Description

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.

Venue Transfers Without Delay

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.

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An Enabling Written Description

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. . .

 

Rethinking enablement: Court grants cert in Amgen v. Sanofi

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.

Patentees Can Still Win in the US

Provisur Technologies, Inc. v. Weber, Inc., Docket No. 5:19-cv-06021 (W.D. Mo. Feb 22, 2019)

 

A jury has sided with Provisur and issued a $10 million verdict against its  food-processing machinery competitor Weber Maschinenbau. This is about half what Provisur requested.

The patents cover various various high-speed slicers, conveyors, and packaging equipment.  I spent a summer working on the line of a bacon packing factory and know how critical it is to have machinery that is speedy and safe, and works well even with variable inputs and poorly trained handlers.

Following a nine-day trial, an eight-member jury found claims from three of the four asserted patents infringed.  The Judge in the case is Stephen Bough, a 2014 Obama appointee.  In cases like these, Judge Bough generally seats a six-member jury with two alternates. (Under FRCP 48, the jury needs to have at least six jurors in order to render a verdict in civil cases). 

The jury also found the infringement willful. The patentee will likely use that willfulness verdict to request punitive damages.   In post-verdict motions, the defendant will likely renew its motion for Judgment as a Matter of Law. A key question is raised in the pre-verdict JMOL motion was whether the patentee is entitled to rely upon an Entire Market Value Rule to calculate damages rather than an apportionment approach.  The patentee also indicated in its pre-trial brief that it planned to also seek injunctive damages.  That equitable issue is decided by a judge rather than jury.

One interesting aspect of the verdict is that the jury was authorized to to decide the case on either literal infringement or under the doctrine of equivalents (DOE).  The verdict form did not, however, require the jury to distinguish between the two. Thus, the verdict can be upheld on either ground. I have included the jury instructions on DOE below.

The patentee was represented by Willkie Farr & Gallagher on a team led by Craig Martin.  Sterne Kessler represented the defendants.  This appears to be one of several ongoing patent battles between the two parties in US court, the PTAB, and abroad.

Two Discovery Disputes

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.

Distributing Cases in W.D.Tex.

On July 25, 2022, W.D.Tex. Chief Judge Garcia issued a unique order regarding assignment patent cases filed in Waco Texas federal court.  Prior to that order, all Waco cases were assigned to Judge Albright.  Many accused infringers complained that Albright was taking cases to trial to quickly and after some political pressure Judge Garcia issued this new order that going forward any patent actions filed in Waco will be distributed randomly to one of twelve W.D.Tex. Judges.

Since that date, 234 patent cases have been filed in W.D.Tex.  One surprise from looking at the judicial assignments — about 1/3 of these new cases have been assigned to Judge Albright. It appears that the court may be making an exception to the rule when new cases are closely related to already pending cases, but I have not seen any public statement on that front.  Of the other 11 judges, all have received at least one new case, with most having 9-11 patent cases to handle.  The new randomness appears to also create a delay in case assignment.  About 25% of the cases have not yet been assigned to any judge — most of these are cases filed in October.

Arthrex back at SCT: Does Director Review Require a Director?

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.

Prior Narrow Definition Does Not (Necessarily) Limit Claim Scope in Family Member

Finjan LLC v. ESET LLC, — F.4th — (Fed. Cir. 2022)

Finjan’s patents claim a system for checking downloadable files for security concerns.  Back in 1996 when Finjan filed its original provisional application, the focus was on applets or other small downloadable programs.  But downloadables today are much bulkier.  Here, the claims require a number of operations on “a downloadable” and the parties have debated throughout the litigation how to construe that term.

The district court’s approach was a bit convoluted.

  • Construction: The district court first narrowly construed the term as limited only to “small downloadables.” Although the asserted patents do not appears to require smallness, the patents do incorporate-by-reference a family member that particularly defines downloadable as “applets” and as “small executable or interpretable application program[s] which [are] downloaded.”
  • Invalidation: Later, the district court reviewed that construction and concluded that the term “small” is a term of degree without any limiting theory and therefor is invalid as indefinite.

(more…)

Guest Post – All Together Now: The Innovator Diversity Pilots Conference (November 18, 2022 at Santa Clara University and online)

By: Colleen V. Chien, Professor of Law, Santa Clara University School of Law and Margo A. Bagley, Asa Griggs Candler Professor of Law and Associate Dean for Research, Emory Law School and Hieken Visiting Professor in Patent Law, Harvard Law School (visiting Fall 2022) 

Link for more Information and to Register for the Conference

Growing the percentage of Americans of all backgrounds participating in the innovation system is not only the right thing to do, it is also critical to global economic competitiveness for the United States. But currently,  while women represent over 50% of the workforce and 27% of STEM workers, they comprise only 13% of inventors, according to the USPTO’s influential Progress and Potential report.  A growing number of stakeholders are actively experimenting with ways to narrow these and other innovator-inventor gaps* in participation and diversify the profession. We invite you to participate in our inaugural Innovator Diversity Pilots Conference, which will build on efforts like the USIPA Increasing Diversity in Innovation Pledge, signed by over 50 leading companies, USPTO Council for Inclusive Innovation (CI2), IPO Diversity in IP Toolkit, and Santa Clara Diversity in Innovation Best Practices Guide, to foster a community of practice, bolster the evidence base for what works, and inform policy and regulatory efforts to promote diversity and inclusion in innovation and invention.

Our focus on piloting – temporarily introducing new practices to learn from them – and rigorous research methods like field experiments to evaluate effectiveness underscores that the work of diversity and inclusion is hard and requires not only a focus on results, but also iteration, refinement, humility, and collaboration.

Featuring keynote remarks by USPTO Director Kathi Vidal and Professor John List (author of the Voltage Effect), the event is co-organized by the USPTO and co-sponsored by the law schools of Santa Clara University and Emory University, the Intellectual Property Owners Association, the US Intellectual Property Alliance, the National Academy of Inventors, the Institute for Progress, the Association for University Technology Managers, Meta, the Institute for IP and Social Justice, and Schwegman Lundberg & Woessner.

This year’s all-day event will take place on Friday November 18, 2022 in-person at Santa Clara University and on-line. Remote participation is free and the program will feature the following sessions:

  • The Why and How of Diversity Piloting – the case for diversity in innovation and rigorously piloting ways of advancing it, presented in part by leading economist and MacArthur Fellow Heidi Williams.
  • Getting People off the Bench – Learning from Doing – companies, researchers, and the USPTO will report on diversity nudges, affinity groups, and other practices for engaging and developing diverse talent.
  • Getting the Data and Tools Needed to Make Progress – how data and tools can be used, in privacy-respecting ways, to advance diversity in innovation and invention.
  • Innovator Diversity Policy Pilots – initiatives at the university, agency, state, and federal, levels to develop and use evidence to advance broad-based economic growth through greater participation and inclusion in innovation and inventing.

Fireside Chat with USPTO Director Kathi Vidal“USPTO Diversity Initiatives Changing the Innovation Ecosystem”

  • Let’s Pilot Together – conference participants will draw upon research, their experience, and the proceedings to “pitch” the USPTO and other sponsoring organizations with their ideas for piloting regarding, for example, attribution practices at the Office, mentorship, and adapting the diversity pledge to the academy.
  • Diversity in the Profession and Pipeline – discussion of existing and emerging initiatives and approaches like the Council for Inclusive Innovation (CI2), Patent Pipeline Program, LEAP, and the Mansfield Rule for supporting diversity in the legal profession and beyond.

Background resources and background materials are available here. We have designed the day to be informative, educational, and interactive. We hope you will join us, online or in-person.

*The Gender Innovator-Inventor Gap (source: Redefining Progress and the Case for Diversity in Innovation and Inventing

Link for more Information and to Register

Updated to reflect additional co-sponsors.

Dmitry Karshtedt

By Jason Rantanen

George Washington University Law School Professor Dmitry Karshtedt has passed. Dmitry was a remarkable scholar, wonderful colleague, and incredible friend. We often had different ways of thinking about patent law, and I always hoped that some day we might have time to write something together. Sadly will never happen. The world was more with Dmitry and less without him.

Professor Karshtedt received an A.B from Harvard and a PhD from UC Berkeley, both in chemistry. After a few years working as a chemist for a semiconductor startup, he went to law school, receiving his JD from Stanford Law School in 2011. He worked for a short time at Wilson Sonsini in Palo Alto before clerking for Judge Kimberly Moore on the Federal Circuit. He joined GW Law in 2015 after a fellowship at Stanford and received tenure in 2020.

Professor Karshtedt’s work was wide-ranging. He is named as an inventor on 13 patents, is the first-named author on five scientific publications, and spoke at dozens of conferences and presentations.  His legal scholarship was deep and contemplative, and includes two articles published in the Iowa Law Review. His most recent work with Mark Lemley and Sean Seymore, The Death of the Genus Claim, 35 Harv. J. L. & Tech., is cited extensively in petitions for certiorari before the Supreme Court.

But more importantly, Dmitry was a wonderful colleague who contributed to every conference and workshop he attended. If you emailed him anything, whether a short question or a draft paper, he would always reply with a thoughtful response, including in depth comments on your work–comments that always made it better. I and many others had many wonderful conversations with Dmitry both over email and in person. I cannot speak personally about his teaching, but if it was any reflection of his professional interactions it must also have been terrific.

I have so many memories of Professor Karshtedt, but for now will end with a link to a PatentlyO guest post that he wrote just last year, in which he reconceptualized the framework for how courts should think about nonobviousness – an approach that will continue to influence my own thinking and make me sad for else might have been.

Guest Post by Prof. Dmitry Karshtedt: Nonobviousness and Time

 

Schedule-A Example

Here is a new example of a Schedule-A case filed in the Northern District of Illinois.

Dyson Tech. Ltd. v. Persons listed on Schedule A, Docket No. 1:22-cv-05946 (N.D. Ill. Oct 27, 2022).

DysonAnonComplaint.  The list of defendants is apparently in Schedule-A, but that document was filed under seal.  The complaint alleges that the defendants are all counterfeiters who operate in “foreign jurisdictions with lax intellectual property enforcement systems” such as “the People’s Republic of China.” They are selling products in the US via online stores such as eBay, AliExpress, Alibaba, Amazon, Wish.com, Walmart, Etsy, and DHgate. The justification for the under-seal filing is similar to that of sealed warrants or sealed indictment in criminal cases.  In particular, the patentee has indicated that it plans to seek a TRO in a way that will preserve evidence:

If Defendants were to learn of these proceedings prematurely, the likely result would be the destruction of relevant documentary evidence and the hiding or transferring of assets to foreign jurisdictions, which would frustrate the purpose of the underlying law and would interfere with this Court’s power to grant relief. Once the temporary restraining order has been served on the relevant parties and the requested actions are taken, Dyson will move to unseal these documents.

MotionToSeal.

Dyson’s patent here is U.S. Design Patent No. D853,642 and appears to cover its “Airwrap” product.  [$699 on Amazon]. According to RPX, the patentee here has already sued 1,000+ defendants for infringement even before this actions.