Construing claims to avoid invalidity (and also infringement)

by Dennis Crouch

MedCo v. Mylan (Fed. Cir. 2017)

In this Hatch-Waxman dispute, the Federal Circuit has sided with the accused infringer Mylan and reversed a lower court’s judgment that Mylan’s proposed Bivalirudin formulation would infringe The Medicines Company (MedCo) U.S. Patent No. 7,582,727 (covering ANGIOMAX).  This decision appears to clear the way for Mylan’s generic launch. (An authorized generic is already being marketed by Sandoz).

Claim construction: Rather than focusing solely on individual dosages, the MedCo patents include a limitation for consistant “batches” of the active ingredient based upon various impurity level targets and a target pH that is “adjusted by a base.”  Although not expressly claimed, the patent describes an “efficient mixing” process used to ensure the consistency.  Mylan’s proposal would use a different process to ensure batch consistency and pH level – Thus, the issue is whether the claims – as properly interpreted – require efficient mixing.

We hold that [the] patents include a “batches” limitation that requires batch consistency, which, according to the patents in suit, is achieved through efficient mixing. . . . We further construe efficient mixing as defined by Example 5 of the patents’ specification.

To reach this conclusion, the court applied a canon of construing-for-validity: Here, the claim language require a particular impurity level but the court found that they could not simply apply to individual-batches since that is already taught by the prior art. “Such a construction would render the claims of the ’727 patent invalid in light of Medicines’ numerous pre-critical-date sales of ANGIOMAX® batches having Asp9 levels below 0.6 percent.”  Rather, the requirement that “the batches have a maximum impurity level” limitation must be construed to require cross-batch consistency — which requires that all of the batches be produced with the “same compounding process.”  Looking to the specification, the court found that the patentee had stated its “development of a compounding process for formulating bivalirudin that consistently generates formulations having low levels of impurities is desirable” and later discussed “the compounding process . . . of the invention” . . . “and as prepared by the new process of the present invention.”  When then further delving into the specification, it became clear that the compounding process discussed is the efficient mixing process.  The specification spells out that process in “example 5” and contrasts it with the non-efficient process of “example 4.” (Example 5 was the only embodiment of efficient mixing described). The court writes:

Although the specification provides that Example 5 is “non-limiting,” no other part of the patents’ written description sufficiently teaches the affirmative steps that constitute efficient mixing. In this circumstance, we think it entirely appropriate to limit the term “efficiently mixing” to the sole portion of the specification that adequately discloses “efficient mixing” to the public.

Once the efficient mixing limitation was read into the claims, it was accepted by the parties that the Mylan proposal would not infringe.

To spell out the results here. The appellate court reversed the district court’s decision based upon its revised claim construction.  The claims require “batches” of the active ingredient that “have a maximum impurity level.”  The court construed that term to require a consistent process for making all the batches, and then looked to the specification to note that the patentee intended to use an “efficient mixing” process as that consistent process since that was the type of process described in the specification; And then finally zeroed-in on the the “efficient mixing” process and required that it follow the particulars of “example 5” of the patent since that was the only detailed example given of efficient mixing.  With that narrowed claim construction, non infringement was easy.

Although the court does not state as much here, this appears to me a case that de novo review was critical in the appellate court’s analysis.


35 thoughts on “Construing claims to avoid invalidity (and also infringement)

  1. On scrolling through the decision the thought struck me that a court of appeal has its hands tied, to some extent. Does it pick up the ball where the court at first instance put it, or does it carry the ball back to the start line and start again. I suppose the former, unless that course offends the interests of justice.

    I mean, if the first instance is banging on about infringement Y/N, and is silent on validity, is it not problematic for the court of appeal to change horses in mid-stream, and decide the case on validity? Better (on balance) to close out the case on the thread: Infringement Y/N?

    Reminds me of the American SUV driver in Ireland, asking a local, leaning on his thumbstick, the way to Dublin. Answer: It’s complicated. Here is not a good place to start from.

  2. The article suggests that the Federal Circuit decision revived the largely discredited claim construction doctrine that claims should be construed, if possible, to preserve their validity. That doctrine has basically been reduced to a maxim of last resort that is almost never invoked. And for good reason; it’s a relic of the 1980s Federal Circuit that was overly protective of patents. More recent jurisprudence under Phillips, etc., correctly favors the public notice functions of the claims, and application of the intrinsic record, over policy maxims designed to favor one class of litigants over another.

    The Federal Circuit decision here did not revive the “construe for validity” doctrine, despite the misleading title of this article. The court certainly tried to avoid the invalidity issue through claim construction (including a footnoted misapplication of Cardinal), there is no suggestion that the analysis itself was tainted by the maxim of construing claims to preserve their validity. Court to the contrary seems to have gone out of its way to justify its narrow construction by invoking the standard SciMed approach of importing details from the specification where they are believed to be important to the claimed invention.

    1. importing details from the specification where they are believed to be important to the claimed invention.”

      Actually it is a little bit of both – construing to include in the claim the invention disclosed and avoiding the prior art.

      The claim term at issue, “wherein the batches have a maximum
      impurity level of Asp9-bivalirudin that does not exceed
      about 0.6% as measured by HPLC,” simply claims a result. The only invention disclosed is how to achieve this result. Claiming a result is the pith and essence of a “functional” claim.

      The courts have been construing claims to cover the corresponding structure, etc., since at least Westinghouse v. Boyden Power Brake. The Supreme Court effectively overruled Westinghouse in Halliburton when the Supreme Court held that there is a problem in claiming an invention functionally in that the apparent breath of the claim itself was a problem. The Supreme Court there announced such claims, functional at the point of novelty, we are invalid under section 112.

      But of course Congress provided for what we now know to be 112(f) as a fix – allowing claims in means plus function format. But, in my view, the policy of 112(f) is wrong and, for this reason, 112(f) should be limited to the use of “means for” without the recital of structure. In other cases, the claims should simply be held invalid. But, as we know, the Federal Circuit has gone in exactly the opposite direction, generally construing functional elements to include the corresponding structure.

      An interesting example of the phenomena of claiming a result is the patent in the Selden case that on its face appeared to cover any automobile with an internal combustion engine. The Second Circuit construed the claim to be limited to particular form of engine disclosed by the inventor Selden because the prior art had shown that internal combustion engines were known, the desire to incorporate them into automobiles was known, but it was not known how to build an engine small enough and with enough power to make the concept practicable. Thus to construe the claims broader than the particular engine disclosed would to render them invalid. But, limited to the particular engine disclosed, the court found the claims not to be infringed.

      In the present case, batches having the claimed property were known, but it was not known how to efficiently mix them so that all batches had the claimed property. By construing the claims to cover the corresponding “structure,” the Federal Circuit followed Westinghouse and did not follow Halliburton. In my view, the Federal Circuit is wrong in its policy and is pointedly not following Halliburton.

          1. The use of terms sounding in function is known to be permissible outside of 112(f).

            You know this Ned.

            Why do you persist in trying to portray the law to be something that it is not?

      1. Once again Ned – your view just does not jibe with the Act of 1952 (and Prof. Crouch’s own coined term of Vast Middle Ground.

        Why do you continue to advocate from a known false position?

        1. The 1952 act is silent on non-MPF functional claiming. Crouch’s work discusses the VMG, but does not say it was authorized by the 1952 act. You have never shown otherwise.

          1. I’m not even sure what this VMG described by Prof Crouch is; a link would be nice… but anon never delivers.

            Also, there are obviously types of functional claiming that are allowed, such as describing an interrelationship between two elements, e.g. the first element is able to freely rotate around the second element.

            Not sure why he brings it up, though. If anything, it appears to be an opinion of a law prof.

            1. How much effort did you expend on looking for the VMG, patent cat? You – as an examiner – should easily find it, given that it was the title of one of Prof. Crouch’s posts.

              Please don’t tell me that you are one of those examiners…

              1. You think it’s pertinent? Link it. I’m not a blog examiner.

                Otherwise, since you pretty much just say VMG over and over again, without any substantive discussion, I’m just going to assume it’s not as relevant as you think it is…

  3. Given the Federal Circuit’s emphasis on construing for validity, it occurs to me that this is a classic example of the so-called “Gillette defence.”*

    Since we used a device or method that was already known, if we are infringing, then the patent is suit is not valid.

    And if the patent is valid, then we are not infringing.

    *UK House of Lords, 1913, Gillette Safety Razor Co. v. Anglo-American Trading Co., UK patent 28,763 – 1902

  4. For someone crowing about “nuance,” you obviously are c1ueless.

    First, why would I be the one needing nuance if – as you state – “stated as much without equivocation“…?

    Second, it is apparently you that missed the nuance, given the difference in your own feelings about the “per se nature that you express towards software that is indeed is lacking across the board (and not “immune” as you attempt to spin here in reply).

    You are (completely unjustly) full – and thus, f001 – of yourself.

  5. Although Dyk fails to correctly invalidate these claims, the software people which simply claim undescribed algorithms which achieve a novel result should take notice. A lot don’t even have an Example 5 to fall back on. Just because the office can’t/won’t do its job on 112 doesn’t mean the Federal Circuit doesn’t at least recognize something is wrong, even if they can’t provide the right remedy in this case.

    Although functional limitations in patent claims are
    not per se objectionable even when the means-plus-function format is not invoked,6 they cannot be “so broad
    that [they] cause[] the claim to have a potential scope of
    protection beyond that which is justified by the specification
    disclosure.” Here, Medicines’ construction would
    expand the scope of [the function] to cover any [thing that achieves the function]. The patentee’s construction
    of [the functional language] thus attempts to claim all
    solutions to the identified [] problem, without
    describing the entire range of solutions to that problem.

    You might want to ask yourself if you can ever prove that you’ve described the entire range of solutions to a problem, especially when the manner in which the functionality is fulfilled (writing computer algorithms) is just mental logic. Can you inductively prove you’ve thought of all the ways to to attack a problem?

    This manifests in virtually every claim where the novelty is a command to generate a rule to control something rather than a claim to a rule itself. Nobody wants to claim a particular rule because it is not commercially valuable. It does not follow that because one rule is not valuable that one is entitled to all rules, whether you’ve thought of them or not.

    If you have a software claim and the novel feature is described in the claim as “a processor running code code which causes the processor to do AB[function X]DE”, then function X is going to make your claim invalid. I have issued (pursuant to office guidelines) hundreds of claims that are invalid in this manner. Though I can hardly blame them, as I’ve been making this argument for years now on this board and I still see people routinely push back on me on them. May those maintenance fees feed my children for many years to come.

    The only way to make it valid is to replace [function X] with the particularly posited series of steps which takes the output of B and transmutes it into the input for D. That is the only thing your client has invented. That may be easily designed around, but that’s because writing code isn’t very hard. The fact that your claim might not be commercially valuable is not the law’s fault, its the fact that your client’s invention is an insignificant increase (assuming it is an increase at all) over what anyone would come up with on their own.

    If I write bad or mundane fantasy fiction, I don’t get to avoid low sales of my book by summarily attaching the profits of everyone who writes fantasy novels. If I solve a common problem on a computer using mundane logic, my mundane logic can and should be designed around, which leads to my claim being small and worthless. Describing code not by the algorithm that it is but by the functional result of its running is (again) derided here (as it has been by courts greater than this one) as an attempt to make the small into something greater than it is.

    I hope to hear from anon on this thread. He who has long said that Halliburton was abrogated. Here’s a case that is explicit that it is not talking about means plus and making the exact same argument I always make and the exact same one that also-not-in-means-plus Halliburton made – that one cannot use functional language to dance around on his “ladders of abstraction” at will. A claim to novel functionality, outside of means-plus, is rarely supported by a specification, because rarely can one prove one has posited all of the ways of achieving the result.

      1. Hint: not two.

        Oh I agree, but they’re pretty much all pointing in the same way, and it’s not in your favor. There’s a reason I keep using the phrase “Scoreboard.”

        Hint: It’s because there’s some high value numbers, and they favor me.

        This just happens to be one where they explicitly talk about functional language outside of means-plus (the “optional claim format” favorite of yours) and raise exactly and explicitly the issue I always talk about – one solution attempting to support a claim to all solutions.

        1. Your reply is not responsive to my post not to the meaning of “rungs on the ladder of abstraction.”

          By referencing the broken scoreboard, you merely draw attention to the fact that you do not understand the issues with the broken scoreboard (in addition to not understanding the multiple rungs on the ladders of abstraction).

          You keep on missing the fundamentals – and here it is no different.

      2. None.

        The law requires you to claim what you disclosed. You get that and equivalents. You are not entitled to claim the equivalents.

        1. Seriously Ned – this is a rather well known term of art that you should know about (your answer of “none” is none-sensical).

  6. Wow, just wow.

    I know a lot of you don’t like to read older Supreme Court cases (which is kind of silly, because the court does and you’re kind of lawyers ‘n’ all), but this is Perkin’s Glue. And the patentee here is arguing for the exact same thing as was in Perkin’s Glue. And there (because the Supreme Court actually followed correct cannons of construction and don’t bend over backwards to save obviously improper claims) the claims were found indefinite.

    I have to believe that Dyk knows that bs is being sold in this opinion here, because Dyk directly points to the exact same issue that Perkin’s controls on three times, using substantially the same language:

    To illustrate, if a defendant using the same
    compounding process produced fifty batches each having
    an Asp9 level below 0.6 percent, each of those fifty batches
    would infringe. But the defendant would not know whether
    any of the batches infringed until all fifty batches had
    been produced…For an ongoing commercial com-
    pounding process, this approach cannot provide “reasonable
    certainty” regarding the scope of the asserted claims.

    and further:

    Medicines urges that reading the batches limitation to
    require “efficient mixing” would render the asserted
    claims of the ’343 patent—which already recite an “efficiently
    mixing” step—superfluous, and that the batches
    limitation extends to compounding processes that do not
    use efficient mixing…[But] Divorcing efficient mixing from the batches limitation
    would also have the impermissible result of “extend[ing]
    [Medicines’] monopoly beyond the invention” disclosed,
    and potentially to the prior art.4 Gen. Elec. Co. v. Wabash
    Appliance Corp., 304 U.S. 364, 371 (1938);

    and further:

    Medicines’ construction is problematic
    because it amounts to a mere recitation of the
    results obtained from “efficient mixing” rather than a
    definition of what the efficient mixing process is. Before
    the district court, Medicines “conced[ed] that its proposed
    definition . . . construes that term functionally—i.e., by its
    intended result.” Although functional limitations in patent claims are
    not per se objectionable even when the means-plus-function format is not invoked,6 they cannot be “so broad
    that [they] cause[] the claim to have a potential scope of
    protection beyond that which is justified by the specification
    Here, Medicines’ construction would
    expand the scope of “efficient mixing” to cover any way of
    mixing that achieves a compounding solution having an
    Asp9 level of less than 0.6 percent. The patentee’s construction
    of “efficient mixing” thus attempts to claim all
    solutions to the identified “impurities” problem, without
    describing the entire range of solutions to that problem.

    Medicines’ construction is therefore not permissible. See
    Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336,

    Perkin’s Glue is available for people to read. The CORRECT result of this situation is to not try and pretend that the product claim was not attempting to be a second product-by-process claim, but that the product claim (especially as argued) is overbroad and indefinite and should be struck altogether.

    Some might say that is a semantic difference because narrowing the ‘727 patent to the scope of the ‘343 patent has the effect of cancelling ‘727’s Claim 1. But that’s only because the ‘343 patent exists. The correct outcome is to tell lower courts and related interested parties (i.e. the patent office) the same thing that Perkin’s told them – the ‘727 claim should have never issued because it was indefinite. By saying the ‘727 claim isn’t indefinite, the Court allows people like Medicines to hold less-bold defendants for ransom with an invalid claim. They can say exactly what they said to the court here – look we have a product by process claim you might not infringe, but we have a product claim you do infringe.

    You don’t get cute to try and save bad claims. Medicines was arguing for a construction that made their claim invalid, they should have been granted it. This patentee isn’t doing anything different than most other bad applicants (and here my personal knowledge comes into play) – they give one example of doing something and explicitly try and claim all the ways of doing it:

    We conclude that one of ordinary skill in the art
    would rely on Example 5 to ascertain the metes and
    bounds of “efficiently mixing.” As the only embodiment of
    efficient mixing, Example 5 is “highly indicative of the
    scope of the claims.” Johns Hopkins Univ. v. CellPro, Inc.,
    152 F.3d 1342, 1355 (Fed. Cir. 1998).8 Example 5, however,
    is not merely the only disclosed embodiment of efficient
    mixing—it is the only description of efficient mixing in the
    in suit that casts light on what efficient mixing is
    and that enables one of ordinary skill in the art to achieve
    the objects of the claimed invention. Although the specification
    provides that Example 5 is “non-limiting,”
    e.g., ’727
    patent, col. 16 l. 6, no other part of the patents’ written
    description sufficiently teaches the affirmative steps that
    constitute efficient mixing.
    In this circumstance, we think
    it entirely appropriate to limit the term “efficiently mixing”
    to the sole portion of the specification that adequately
    discloses “efficient mixing” to the public.

    The Supreme Court has spoken time and again on this issue and the correct thing to do when someone teaches one way of doing something but claims all the results of usage is to invalidate the claim. See Morse, Perkin’s Glue, Halliburton.

    1. I just want to ask: (1) Did the defendant assert a 35 USC 112 (a) or (b) issue in the District Court, and (2) if so, did the defendant maintain the issue on appeal?

      Sorry, I didn’t have time to dig into the opinion.

      If not, then the outcome is what the judge should have done … point out the serious issues and resolve the case accordingly in an alternative way. If the issue was in contest, then the judge wrote a silly opinion when the proper course of action was to address the 35 USC 112 issues directly.

      Just saying, there on limits on the appellate courts. I don’t want justices/judges deciding issues not briefed before them – they are not district courts. In fact, district courts also shouldn’t do that – to a lesser extent.

      1. I just want to ask: (1) Did the defendant assert a 35 USC 112 (a) or (b) issue in the District Court, and (2) if so, did the defendant maintain the issue on appeal? If not, then the outcome is what the judge should have done … point out the serious issues and resolve the case accordingly in an alternative way.

        Is it? If the defendant doesn’t raise a defense is it the Court’s job to raise it for him? Why is it wrong to not raise 112b on its own, but proper to import a 112b analysis into the claim construction issue that was raised?

        Sure its unjust if the defendant has to pay for indefinite claims, but at least it is his own fault. You don’t go around creating bad law on claim construction because the defendant is not good enough to raise his own defense.

        It either should have been taken care of in a 112b context or not discussed at all, not raised under claim construction.

  7. Dennis, nice write up, but I think there was at least one other wrinkle worth mentioning: this patent, and its two brethren, were filed with non-publication requests in 2009, I think, and were the subject of requests for accelerated examination under the pre-AIA accelerated examination program. Requests for accelerated examination were rare at the time, largely because they required the applicant to conduct a search and provide an “examination support document”, which created concerns about later accusations of inequitable conduct (insufficient search, misrepresentation of search results or their relevance, etc.) This case illustrates another danger to applicants with the old program: as much as it looked at statements in the patent itself, the CAFC also looked at statements in the “examination support document” in construing the claims as product-by-process claims that included in the “efficient mixing” limitation.

    I found this case to be a textbook example of how “patent profanities” and excess verbiage in prosecution can come back to bite a patentee.

    BTW, I found it interesting at the time that there was both an accelerated examination request AND a non-publication request. The idea, evidently, was to get the patents granted before the original bivalirudin patent expired, but to keep the existence of the applications secret for as long as possible so as to allow competitors seeking FDA approval to proceed with production processes that might infringe, and not tip them off at an early stage. At the time, the fate of the original bivalirudin patent up in the air, TMC having missed the filing deadline for a patent term extension by one day; thanks to an injunction from a sympathetic judge in EDVa and some well-executed lobbying that resulted in the dog-ate-my-homework act as part of the AIA, that patent was eventually extended until 2015.

    1. Where is Malcolm and his “all Pharma patents are nothing but G-g-g-grifters, thus they all should be banned” mantra…?

      Oh wait, those “feelings” don’t count since Pharma is actually not concerned with Mega-Corp big money…


      1. I’m right here.

        For the record, I’ve never suggested that pharma is immune from the games that plague the s0 ftie w0 ftie arts. I have, of course, demonstrated that the opposite is true many times and stated as much without equivocation.

        But nuance is difficult for some people, particularly those with lower than average intelligence. Keep trying, “anon.”

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