Federal Circuit: “The Doctrine of Equivalents Applies ONLY in Exceptional Cases”

Amgen Inc. v. Sandoz Inc. (Fed. Cir. 2019)

Amgen sued Sandoz for infringing its U.S. Patents 6,162,427 and 8,940,878. Both patents relate to Amgen’s biologic products (filgrastim and pefilgrastim) used as treatments for neutropenia. The lawsuit here is unique because it was filed under Biologics Price Competition and Innovation Act (“BPCIA”).  As an add-on to Hatch-Waxman, the BPCIA defines submission of an FDA biosimilar application (aBLA) as a form of patent infringement.  See 35 U.S.C. § 271(e)(2)(C) (defining submission of an aBLA as an act of patent infringement).

The ‘472 patent claims a “method of treating a disease” by giving a patient Filgrastim/Pegfilgrastim prior to chemotherapy in order to stimulate stem-cell growth.   After treatment with Filgrastim, the claims require “administering to the patient a disease treating-effective amount of at least one chemotherapeutic agent.”  The idea here appears to be that the Filgrastim will stimulate stem-cell growth so that stem cells will survive harsh cancer treatment.

In this case, Amgen argued that its “disease treating-effective amount of … chemotherapeutic agent” would not necessary require that the chemotherapy drug treat the underlying disease — rather, Amgen argues that the drug could be used to further mobilize stem cells.  Both the district and appellate courts rejected this claim construction proposal — noting that the focus of the claims is “treating a disease” and construing the claim otherwise does not make sense:

As an initial matter, the preamble of claim 1, as construed, arguably precludes Amgen’s construction. The district court construed the preamble, “[a] method of treating a disease requiring peripheral stem cell transplantation,” as requiring that the stem cell transplant be incorporated as a component of a method of treating an underlying disease, such as cancer, Claim Construction Order, 2016 WL 4137563, at *5–6, and Amgen does not dispute that construction on appeal. The claimed method therefore must be performed to treat an underlying disease. As the claim itself states, the “disease treating-effective amount” of a chemotherapeutic agent does precisely that.

The court suggests here that if Amgen had not wanted to claim treatment of an underlying disease, it should have drafted different claims. “Had Amgen simply wanted to claim a method of mobilizing stem cells, in any context, it could have done so.”

The ‘878 patent is not a method of treatment but instead directed to a multi-step method of preparing purified biologic products.  This begins with growing cells that express the protein of interest and ends with eluting the protein from a separation matrix such as ion exchange resin.

In its claim construction, the district court held that the claims required separate steps of “applying a refold solution”; washing the solution; and eulting the protein.  That construction eliminated infringement since Sandoz process only requires one step — applying the refold solution without washing or eluting.  On appeal, the Federal Circuit argued that Sandoz’ approach is effectively the same — and that its claims should be read as functional requirements rather than actual process steps.

The Federal Circuit sided with the accused infringer — holding that each step in the method is a separate process step that must be done in a particular order.  Most notably, the court noted (1) the fact that the patentee had sequentially listed its steps a-g; and (2) the washing and eluting steps are “consistently described in the specification as separate steps performed by different solutions.”

Doctrine of Equivalents: The claim construction here naturally raises a doctrine of equivalents question, which the Federal Circuit also rejected:

Amgen argues that Sandoz’s one-step, one-solution process is insubstantially different from the claimed three-step, three-solution process because it “achieves the same functions (washing and eluting), in substantially the same way (binding protein preferentially compared to contaminants, and then raising salt concentration to reverse protein binding) to achieve the same result (protein purification).”

The Federal Circuit found, however, that the one-step approach offered by Sandoz, “does not function in the same way as the claimed process.”  In particular, the court focused-in on the notion that doctrine of equivalents is handled on an element-by-element level. Here, since each claim step is a separate step occurring in sequence – it would be improper to say that that a single-step approach is the equivalent. The court explains:

The doctrine of equivalents applies only in exceptional cases and is not “simply the second prong of every infringement charge, regularly available to extend protection beyond the scope of the claims.” Duncan Parking Techs., Inc. v. IPS Grp., Inc., 914 F.3d 1347, 1362 (Fed. Cir. 2019) (“[T]he doctrine of equivalents cannot be used to effectively read out a claim limitation . . . because the public has a right to rely on the language of patent claims.” )

Although I follow the court’s line of thinking on claim construction, but the court’s limit of the DOE to “exceptional cases” seems to be a major step without precedential backing. 

35 thoughts on “Federal Circuit: “The Doctrine of Equivalents Applies ONLY in Exceptional Cases”

  1. 5

    Without commenting on the wisdom of having DOE, and giving the panel the benefit of the doubt, I did not think they were quietly attempting to state a new substantive rule of law on when a patentee can resort to DOE. Indeed, if the panel was trying to limit circumstances in which a patentee can raise DOE to “exceptional circumstances”, such as special equitable considerations, that would be contrary to prior precedent.

    From Warner-Jenkinson:

    Relying on Graver Tank’s references to the problem of an “unscrupulous copyist” and “piracy,” petitioner would require judicial exploration of the equities of a case before allowing application of the doctrine of equivalents. To be sure, Graver Tank refers to the prevention of copying and piracy when describing the benefits of the doctrine of equivalents. That the doctrine produces such benefits, however, does not mean that its application is limited only to cases where those particular benefits are obtained.

    Warner-Jenkinson Co. Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 34, 117 S. Ct. 1040, 1051 (1997).

    Accord

    Seymour v. Osborne, 78 U.S. (11 Wall.) 516, 557, 20 L. Ed. 33 (1870) (“Patentees, therefore, are entitled in ALL cases to invoke to some extent the doctrine of equivalents, but they are never entitled to do so in any case to suppress all other substantial improvements . . . Bonâ fide inventors of a combination are as much entitled to suppress every other combination of the same ingredients to produce the same result, not substantially different from what they have invented and caused to be patented, as any other class of inventors. All alike have the right to suppress every colorable invasion of that which is secured to them by their letters patent, and it is a mistake to suppose that this court ever intended to lay down any different rule of decision.” – emphasis added – finding infringement under the doctrine of equivalents)

    Hilton Davis Chemical Co. v. Warner-Jenkinson Co. Inc., 62 F.3d 1512, 1521-22 (Fed. Cir. 1995) (en banc) (“[T]he Supreme Court’s cases on the doctrine of equivalents foreclose a holding that the doctrine is a matter of equity to be applied at the court’s discretion. . . .The trial judge does NOT have discretion to choose whether to apply the doctrine of equivalents when the record shows no literal infringement.”), aff’d in relevant part, rev’d in part on other grounds, 520 U.S. 17, 34-35 (1997).

    I read the statement as an observation by the panel that, as a practical matter, it requires exceptional circumstances to successfully prove infringement under the doctrine of equivalents. Indeed, as support for the “exceptional circumstances” characterization and as an example of a limiting restriction on application of DOE, the panel goes on to quote a recent opinion, Duncan, stating the substantive rule that DOE “cannot be used to effectively read out a claim limitation … because the public has a right to rely on the language of patent claims.”

    Rather than announcing a new rule of law, I saw the “exceptional circumstances” language to be similar to the catchy statement that DOE is not a “talisman” to get to a jury in every case where literal infringement cannot be proven. Schoell v. Regal Marine Indus., Inc., 247 F.3d 1202, 1210 (Fed. Cir. 2001) (“The doctrine of equivalents is not a talisman that entitles a patentee to a jury trial on the basis of suspicion; it is a limited remedy available in special circumstances, the evidence for which is the responsibility of the proponent.”).

    These likely are quotable phrases accused infringers will use in briefs in defending against DOE assertions to impress upon the court the gravity of determining when the facts support a finding on infringement under DOE. But it does not set a new substantive legal standard for when infringement will be found under DOE. Indeed, while analyzing the DOE issues under the traditional “insubstantial difference” standard and the “way” prong of the function/way/result rubric, the opinion contains no attempt at a substantive discussion as to what is or is not an “exceptional circumstance” that would bear, substantively, upon whether infringement lies under DOE.

    1. 5.1

      Excellent post, Bob.

  2. 4

    the court’s limit of the DOE to “exceptional cases” seems to be a major step

    I don’t follow. Between the Supreme Court and the CAFC, the DOE is going to be available to plaintiffs in very rare and highly unusual circumstances (primarily because you can’t capture embodiments that could have been claimed, e.g., which were disclosed or taught in the art, but which weren’t claimed). That’s more true now than ever before because pretty much every skilled application drafter is aware that reliance on the DOE for infringement is an extremely poor bet. The result is that we focus on expressly disclosing valuable variations and we make sure that we have enabling support for those variations (and preferably a genus).

    In spite of all this, I agree with Lode Runner (in comments below) that the best result for the patent system would be to eliminate the doctrine entirely. All it does is introduce unnecessary uncertainty into the system, at the public’s expense.

  3. 3

    As Greg DeLauss pointed out, the concept that DOE is an exception, not the rule, dates back in Federal Circuit law to London v. Carson, 946 F.3d 1534 (Fed. Cir. 1991). But I wouldn’t consider a paragraph in a nearly three-decades-old panel decision to be a particularly firm ground on which to build a major doctrinal shift in patent law.

    But if this case begins the steady decline of the doctrine of equivalents, then let it die, and good riddance. As even the London case recognized three decades ago, the doctrine of equivalents is utterly inconsistent with the “public notice” doctrine, which provides that the claims and other intrinsic evidence provide a vital function of giving competitors and the public notice of the scope of the claimed invention. The “public notice” doctrine is probably one of the biggest contributions the Federal Circuit has made in the development of patent law. It’s one of the few areas that they have consistently gotten right.

    And I cannot imagine anything more irreconcilable with the public notice doctrine than D0E.

    1. 3.1

      [I]f this case begins the steady decline of the doctrine of equivalents, then let it die, and good riddance.

      To be really fair to the CAFC, thet tried en banc to more or less kill off D of E entirely in Hilton Davis Chemical Co. v. Warner-Jenkinson Co, 62 F.3d 1512 (Fed. Cir. 1995) and then again in Festo v. Shoketsu Kinzoku Kogyo Kabushiki, 344 F.3d 1359 (Fed. Cir. 2003). Both times the SCotUS refused to let the CAFC quite put this sorry end of the law out of its misery. Pity.

      Perhaps the third time is the charm. As you say, it would be all of the best if D of E would just disappear from U.S. law.

    2. 3.2

      I wouldn’t consider a paragraph in a nearly three-decades-old panel decision to be a particularly firm ground on which to build a major doctrinal shift in patent law.

      How “major” is this “shift”? As Paul points out below, D of E is undeniably already “exceptional” as an empirical matter. To say that the law should treat it as “exceptional” is rather akin to passing a statute requiring the sun to rise in the east and set in the west. Perhaps it is unnecessary, but it barely a “shift” at all, let alone a “major shift.”

      1. 3.2.1

        I would add that treating D of E as “exceptional” is unnecessary dicta to this case. The court could have simply relied upon Warner-Jenkinson Co. v. Hilton Davis Chemical Co., 520 U.S. 17 (1997) eliminating the “all elements” interpretation of the doctrine.

        As Justice Thomas writing for the majority stated (at 29): “There can be no denying that the doctrine of equivalents, when applied broadly, conflicts with the definitional and public-notice functions of the statutory claiming requirement. … Each element contained in a patent claim is deemed material to defining the scope of the patented invention, and thus the doctrine of equivalents must be applied to individual elements of the claim, not to the invention as a whole. It is important to ensure that the application of the doctrine, even as to an individual element, is not allowed such broad play as to effectively eliminate that element in its entirety. So long as the doctrine of equivalents does not encroach beyond the limits just described, or beyond related limits to be discussed infra this page and 31-34, 39, n. 8, and 39-40, we are confident that the doctrine will not vitiate the central functions of the patent claims themselves.”

        1. 3.2.1.1

          [T]reating D of E as “exceptional” is unnecessary dicta to this case.

          I think that this is correct. The “exceptional” nature of D of E was not part of a rule necessary to reach this holding. The line was intended more as an exhortation than a binding precedent.

          Still and all, as Paul has already noted, as a sheer matter of empirical fact the D of E is exceptional. There are very few cases where the patentee prevails on a D of E theory, but where the patentee could not have prevailed on a literal infringement theory.

        2. 3.2.1.2

          Just a little “tongue in cheek,” but does

          Each element contained in a patent claim is deemed material to defining the scope of the patented invention…

          really still hold if Courts are going to be applying “Gist” to “get at” what is “really” being claimed (and themselves NOT giving “materiality” to each element)?

          1. 3.2.1.2.1

            …take the Alice case itself directly: you had claims stipulated by both sides to be firmly in the Machine statutory category being deemed by the Court (through the “Gist” mechanism) to be “really” only “Abstract” in apparent violation of each element being given its materiality.

            The nature of “directed to” is much more egregiously violative of the views being expressed (against DoE) to cabin the reach of patent holders.

            The existence of DoE arises because language is simply known to be imperfect. The doctrine has known and reasonable limits on its application.

            Yet even this little bit of “pro-patent” piece is being denigrated all the while there is a much larger elephant being ignored (apparently because the larger elephant also goes against the patent holder).

            1. 3.2.1.2.1.1

              there is a much larger elephant being ignored

              Indeed, the absurdity of patenting logic simply because it’s written in a language that computers understand is a huge and destructive “elephant” within our patent system.

              But it won’t be ignored for much longer. Wait and see.

              Everything else you wrote is silly and pointless.

              1. 3.2.1.2.1.1.1

                Indeed, the absurdity of patenting logic simply because it’s written in a language that computers understand is a huge and destructive “elephant” within our patent system.

                Being purposefully dishonest is unbecoming of anyone, Malcolm — even you.

                Utility of the Useful Arts and having claims being in at least one of the statutory categories is the sum total of what is necessary for patent eligibility.

                All else is muckery.

            2. 3.2.1.2.1.2

              Was thinking along similar lines anon . . .

              So here’s the deal: Let’s swap abolishing the non-statutory DoE for abolishing the non-statutory exceptions to 101.

              What’s not to like?

              1. 3.2.1.2.1.2.1

                Let’s swap abolishing the non-statutory DoE for abolishing the non-statutory exceptions to 101.

                From your lips to God’s own ears…

      2. 3.2.2

        Whenever the Federal Circuit explicitly puts its thumb on the scales in one direction or another with respect to a particular issue, that easily qualifies as a pretty major “shift” in the law. Here, saying that the doctrine is limited to “exceptional” cases provides a huge gloss that will affect every situation in which the doctrine is invoked, similar to how the “clear and convincing” standard dictates impacts in a large number of invalidity trials.

        It doesn’t matter that, as an empirical matter, only the exceptional cases are ones in which infringement cases built on DoE do not fail. But whenever the court says that any doctrine should be used “rarely,” “in exceptional cases,” “sparingly,” whatever the term may be, that causes a huge ripple. In this case, that statement may lead to fewer assertions of DoE in future cases, and more skepticism of DoE cases by district courts. Again, this is a good thing.

        1. 3.2.2.1

          [S]imilar to how the “clear and convincing” standard dictates impacts in a large number of invalidity trials.

          This seems a strange example to use to undergird your point. My sense is that one can count on one hand the number of cases in which the difference between “clear & convincing” and “more likely than not” actually makes a difference to the outcome.

          1. 3.2.2.1.1

            I suppose on that one hand is the Supreme Court case of i4i….

          2. 3.2.2.1.2

            With respect, Greg, having interviewed jurors after verdicts, and watched lots of mock trials with mock juries, the C&C burden makes a big difference in the results of those cases where the patented subject matter falls outside the jury’s direct knowledge and experience. This includes stuff like semiconductors, medical devices, more complex software, or just about anything remotely technical.

            The general rule is, if the jury does not intrinsically understand the technology based on knowledge and experience they had before they were impaneled (and almost any plaintiff’s lawyer would boot any prospective juror that did), by the time of verdict, those jurors will almost never be able to feel that abiding level of clarity and one-sidedness that the C&C standard requires.

            Lay juries simply don’t understand the technology well enough to get to that level of confidence, no matter what the presentation at trial. This is because, of course, the jury will have heard conflicting testimony from both sides’ experts, and the jury will have understood maybe half of it (if that). This situation makes it really hard to say that the presentation was one-sided or that the defendant “clearly” showed invalidity. I’ve even seen cases where the plaintiff’s invalidity expert essentially impoded at trial by making key damning substantive admissions that should have doomed the case, and the invalidity case still failed. That’s because the juries didn’t even appreciate that said implosions had occurred.

            Yea, in cases involving simpler technologies that the jury can directly understand like skateboards, exercise equipment, plastic containers, sprinkers, or other simple mechanical inventions, the C&C standard may matter less because the jury will have some basic underlying knowledge with which to evaluate the evidence. But there are fewer and fewer of those cases being tried these days, and most cases today involve technologies outside the jury’s knowledge and experience and, in those cases, C&C can be outcome determinitive.

            1. 3.2.2.1.2.1

              Excellent post LR.

              As you may recall, Greg has had a pre-disposition AGAINST the presence and level of the presumption of validity for like forever.

              This extends back even to a time when he may have actually engaged others that do not share his selective views (or were even [gasp] critical of Greg’s views).

              Sadly, Greg employs the “politeness-as-a-smokescreen-for-not-engaging” mechanism, and the weaknesses of his positions (here, lack of appreciation for the existence and level of the presumption of validity) go uncorrected.

            2. 3.2.2.1.2.2

              [H]aving interviewed jurors after verdicts, and watched lots of mock trials with mock juries, the C&C burden makes a big difference in the results of those cases where the patented subject matter falls outside the jury’s direct knowledge and experience.

              I have never interviewed a single juror in my life, so I will naturally defer to your experience on this point. I am not sure, however, that the unwillingness of jurors to find anticipation (or lack of written description support, or whatnot) in complicated technology areas really shows that the c-&-c standard makes a difference. If the jurors find something confusing, they are equally well supposed to say “tie goes to the patentee” under a “more likely than not” standard. In other words, the unwillingness of jurors to go for invalidity arguments in cases with complicated tech is not really the sort of test that distinguishes between “c&c makes the difference” and “c&c does not make the difference.”

              1. 3.2.2.1.2.2.1

                You really don’t understand the differences in the levels, do you?

                How the F did you get through law school?

  4. 2

    For those following patent law internationally, this is a point of significant interest. England did not recognise any doctrine of equivalents until it flipped, very recently, in a Supreme Court drug molecule decision (as to whether potassium is “equivalent” to the claimed sodium). As a consequence, an enquiry into infringement by equivalent has become mandatory in the courts of England, a second prong just as big, nasty and sharp as the first prong. England is now in line with Germany on the DoE.

    See the link below for an example, the Mishan case, in which the subject matter is an unbelievably simple invention in the field of garden watering hoses (a growing field, of course, in which wealthy people will spend almost as much money as on their own bodily health). Indeed, the invention is so simple to grasp, that in blogs like this, each and every reader can have a legitimate opinion on infringement (whether or not by equivalent) and validity:

    link to patentblog.kluweriplaw.com

    Mishan is undergoing two oppositions at the EPO, and one at the UK Patent Office and has already been adjudicated in the UK High Court and at the UK’s CAFC. The Mishan patent family is well-populated, especially in the USA. The closest art is American. The Mishan story is set to run and run.

    1. 2.1

      an enquiry into infringement by equivalent has become mandatory in the courts of England

      An unfortunate development.

      1. 2.1.1

        Really? Some suggest that, with this development, England has become the most sympathetic jurisdiction in Europe, for patent owners.

        Mind you, England has also long enjoyed a reputation for being Europe’s most obliging, for those petitioners seeking revocation of a patent.

        I guess the patent judges of England subscribe to the view that the over-riding objective is to do justice between the parties: swiftly enforce the good patents; strike down the bad ones, and no messing.

        1. 2.1.1.1

          Really?

          Yup.

          England has become the most sympathetic jurisdiction in Europe, for patent owners.

          Yawn

          1. 2.1.1.1.1

            LOL. Got me there, MM. Who cares? Indeed!

          2. 2.1.1.1.2

            Yawning in regards to “sympathy for patent owners” is bad enough.

            This being met with (apparent) delight — instead of the derision it deserves — is rather telling.

            Cognitive dissonance and someone celebrating someone else’s cognitive dissonance…

            It really is a shame that people don’t understand the plain fact that patents are a good thing.

            1. 2.1.1.1.2.1

              A man sees what he wants to see, and disregards the rest (as Paul Simon once observed).

              I took it that i) MM was reminding me that, for readers here, England is no longer a jurisdiction of any importance and ii) I should never forget that.

              All the same, it is interesting (for those with world-wide patent interests) that, at a time when Europe cranks up the value of a DoE, the USA winds it down. What goes around comes around, as patent drafters well know.

              1. 2.1.1.1.2.1.1

                A critical thinker sees more.

                Please try to see more.

  5. 1

    [T]he court’s limit of the DOE to “exceptional cases” seems to be a major step without precedential backing.

    What do you mean “without precedential backing.” They cited precedent, including precedent that goes back at least a few decades. London v. Carson Pirie Scott & Co., 946 F.2d 1534, 1538 (Fed. Cir. 1991) (“Application of the doctrine of equivalents is the exception, however, not the rule, for if the public comes to believe… that the doctrine of equivalents is simply the second prong of every infringement charge…, then claims will cease to serve their intended purpose”).

    We have, in other words, been living with the “only exceptional cases” rule for D of E for a while now. This does not seem one of the more problematic aspects of patent law really.

    1. 1.1

      Re “..the court’s limit of the DOE to “exceptional cases” seems to be a major step without precedential backing.” Even if that were the case, the number of patent infringement suits in modern times in which DOE has been successfully asserted and sustained on appeal is so small as to deserve the word “exceptional” on that basis alone.

      As for Europe, is not claim construction in EPO patent countries by definition a cross-breed of central definition claiming and metes and bounds claiming?

      1. 1.1.1

        [T]he number of patent infringement suits in modern times in which DOE has been successfully asserted and sustained on appeal is so small as to deserve the word “exceptional” on that basis alone.

        Good point. As an empirical matter, the D of E really is the exception much more than the rule.

      2. 1.1.2

        Paul, in a word, YES.

        The Protocol on the interpretation of Article 69 EPC declared that the scope of protection of the claim of a European patent is neither metes and bounds nor central claiming but, rather, something in between that delivers BOTH fair protection for the inventor AND legal certainty for the affected public. National courts in EPC-land decide how to implement the Protocol. UK (metes) avers, just like we did already. Germany (central) avers, just like we did already.

    2. 1.2

      I would respectfully disagree, Greg, that the doctrine of equivalents “does not seem one of the more problematic aspects of patent law really.” It injects an enormous amount of uncertainty and cost into infringement proceedings. It makes it harder for competitors to obtain patent clearance of their products, even in cases where the non-infringement seems clear, because the doctrine of equivalents is utterly unpredictable in its application.

      I agree that DoE doesn’t make much difference in the end results, though. Juries do not like DoE for many of the same reasons that they don’t like obviousness, and most infringement cases that depend just on DoE fail (where it’s not just a backup to an asserted literal theory). But DoE is kryptonite to summary judgment or any other kind of early resolution of infringement disputes.

      1. 1.2.1

        I would respectfully disagree, Greg, that the doctrine of equivalents “does not seem one of the more problematic aspects of patent law really.”

        My apologies for my own unclarity, but you appear to have misunderstood me. I am not saying that the doctrine of equivalents in unproblematic. My contention, rather, is that treating the doctrine of equivalents as exceptional is unproblematic.

        Better still would be to efface D of E from the patent law landscape (except where it is provided in statute). If we are to have extrastatutory D of E, however, then it is best that it be confined to a class of “exceptional” aspects of patent law, cabined into a suffocatingly narrow confine.

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