Court: Pepcid Complete Generic Does not Provide “Immediate Relief” and Therefore Does not Infringe

by Dennis Crouch

This case provides an example of the all-elements-rule of infringement.  Here, the patentee failed to prove that the accused infringer each-and-every element of the claimed invention.  Here, the failed element was providing “immediate relief” after administration of the generic Pepcid Complete  

Brigham & Women’s Hospital, Inc., v. Perrigo Company (Fed. Cir. 2019) (non-precedential)

Brigham’s U.S. Patent 5,229,137 covers a method of treating heartburn using H2-blockers and antacids. Both ingredients were known in the art to provide relief with antacids having a immediate-but-fleeting action and  H2-blockers providing slower but sustained relief.  The invention here is to use both drugs at once and – surprise – the result is “immediate and sustained relief.”

The asserted claims are directed to a “method of providing immediate and sustained relief” by providing an effective amount of antacid and H2-blocker “for providing the human with immediate and sustained relief from pain, discomfort and/or symptoms associated with episodic heartburn.”  The claims go on to require that “the immediate and sustained relief” of the combined treatment must last longer “than when the human is orally treated with only the antacid” and must be more immediate “as when the human is orally treated with only the histamine H2 -receptor antagonist.”

The specification also particularly defines the term: “immediate and sustained relief:”

It means herein immediate, temporary and sustained relief which starts within about 5-10 minutes following ingestion of the active ingredients and continues and remains constant for at least about 4-6 hours after ingestion of the active ingredients.

Johnson & Johnson exclusively licensed the patent and listed it in the Orange Book listing for Pepcid Complete.  However, when Perrigo filed its generic ANDA and Paragraph IV certification, J&J chose not to file suit, but rather sued on a different listed patent and lost.  At that time, the ‘137 patent was also removed from from the FDA Orange Book listing. (I don’t know why).

In the present case, the Massachusetts jury sided with the patent holder — finding the patent enforceable and infringed and awarding $10 million in past damages (the patent expired in 2012).  However, in a post verdict decision the district court rejected the jury verdict — holding instead that no reasonable jury could have found infringement based upon the evidence presented.

Looking here at the infringement analysis, the patentee argued that the accused product included the same ingredients as Pepcid Complete, which is covered by the patent claims.  In this copy-cat situation, however, the decision maker has to be careful to focus on the patent claims, not simply compare the copied products.  Here, the district court considered the clinical evidence presented at trial and found that it “did not demonstrate that Pepcid Complete provided immediate relief from episodic heartburn.”  In particular, the evidence showed relief within 15 minutes, but not the 5-10 minutes required by the definition of immediate.

On appeal, the Federal Circuit has affirmed. Although the patentee presented evidence of very rapid change in esophageal pH after taking the drug (within 5-10 minutes), the court found that a change in esophageal pH does not directly correlate with immediate relief of episodic heartburn.

At most, the study suggests that Pepcid Complete might provide immediate and sustained relief; such speculative data, however, cannot sustain Brigham’s burden of proof.

A related study did show fairly-rapid action, but the shortest period measured was 15 minutes.

There is no dispute that adequate relief first measured at 15 minutes after administration is a parameter different from relief starting 5–10 minutes after administration. . . . As Studies 110 and 127 did not measure the result that Brigham claimed in the ’137 patent, we agree with the district court that they do not support the jury verdict. . . . Because only speculation supports Brigham’s contention that data showing adequate relief at 15 minutes implies that relief started within 5–10 minutes, it cannot sustain the jury verdict.

I’ll also note that the the inventor of the ‘137 patent (Wolfe) participated at trial as an expert witness.  Wolfe testified that he took the Perrigo product and that it worked on him within five to ten minutes.  On appeal, the Federal Circuit rejected that statement as “uncorroborated, conclusory, and interested testimony … insufficient to carry Brigham’s burden of proof and to sustain the jury verdict.”

 

28 thoughts on “Court: Pepcid Complete Generic Does not Provide “Immediate Relief” and Therefore Does not Infringe

  1. 5

    I guess this seems like the right outcome. I’d like to see if this was an issue in prosecution and also probably read the specification to see if the 5-10 minutes was limited to some embodiments. That would tell us if this is importation of a limitation or viewed in light of the specification.

    Didn’t see comments how it plays out with the presumption of validity. Does the definition of immediate used mean the claim is invalid? Or should the presumption of validity allow “immediate” to be more expansive?

    1. 5.1

      I’d like to… read the specification to see if the 5-10 minutes was limited to some embodiments.

      This was my thought as well. As it happens, the specification includes (col. 3, ll. 8–12) an explicit definition to the effect that “the term ‘immediate relief’ means that relief obtained from pain, discomfort and/or symptoms associated with episodic heartburn which occurs within about 5–10 minutes following ingestion of the active ingredients or an antacid.” In other words, not only was this not limited to specific embodiment, but the patentee could not have been more clear that this sense of “immediate” was meant to apply as the court applied it. Like yourself, I agree that this looks like the CAFC reached the right outcome here.

      Does the definition of immediate used mean the claim is invalid?

      Not following you here. Why should the definition affect the validity of the claim. I see nothing on this record to indicate that this definition makes the claim less novel, more obvious, or less fully enabled.

      The problem here for the patentee is not that there is evidence of a product lying within their claim scope that does not function. Rather, the problem is that the patentee (who has the burden to establish infringement) could not be bothered to produce actual evidence that Perrigo’s product works.

      That does not mean that Perrigo’s product does not work (indeed, Dr. Wolfe’s anecdotal evidence suggests that Perrigo’s product does work). Rather, the problem was just that J&J never bothered to do any—you know—actual tests on Perrigo’s product.

      If they cannot be bothered to do the work to generate evidence, they can hardly be surprised when the court holds that they have not met their burden to establish infringement.

      1. 5.1.1

        It also may mean that the patentee’s own product would not “infringe” (or more correctly, is not covered by the patent itself; thus allowing exact copies to be made without there being infringement).

        I think this more likely than not testing the competitor’s product – and would also point to why it may have been voluntarily removed from the Orange Book.

      2. 5.1.2

        >Does the definition of immediate used mean the claim is invalid?

        Maybe there are different mixtures or amounts, but the point is that maybe the claim is not enabled with the construction of immediate as 15 minutes. Do any of the P’s product work within 5-10 minutes? If not, then the claim would not be enabled or immediate should be interpreted to mean 15 minutes so as to keep the claim valid.

        1. 5.1.2.1

          Do any of the P’s product work within 5-10 minutes? If not, then the claim would not be enabled

          A product has nothing to do with whether a claim is enabled.

          1. 5.1.2.1.1

            Why do you say things like that, anon? It is just cheap shot that is not even correct. Try to read what other people write and think at least a few seconds before firing off a response.

            My point is clear. And –of course—the products have something to do with. If one of there products does work “immediately” then the claim is enabled assuming it meets the other elements.
            And clearly one can call it product as it would have had to have been tested to show enablement. Please try work on reading and trying to understand what people write.

            1. 5.1.2.1.1.1

              Get a hold of yourself (yet again).

              What a company puts out there as there product may – and critically – may not – have anything to do with a patent they have (from start or bought or whatever).

              CLEARLY.

              Given that plain fact then, a product and its inherent characteristics will have NO control over whether or not a claim is enabled.

              Such is entirely a function of the application. Whether or not an application is appropriately written, written for an existing product, written for a product not yet even made (with constructive reduction to practice as opposed to actual reduction to practice) ALL inform the point at hand.

              Your point is wrong.

              The fact that there MAY be a product to which an application is attempted to be written to cover does NOT tell you — one way or another — whether the actual writing of the application has been sufficient to cover the eventual claims – which IS the legal point at hand.

              You are simply wrong to want to make a physical product BE determinative of whether the specification enables a claim.

              Stop trying to blame others when you say something wrong.

              1. 5.1.2.1.1.1.1

                anon, read what people write. I am obviously using product to include not just commercial products but compounds made by the company. My point is pretty clear and you are going off with some narrow definition of product and acting supercilious.

                1. Night Writer,

                  I have read what you have written and what you have written is plainly wrong from a legal standpoint.

                  Maybe YOU should stop and do a little reading first.

                  You want to make some type of point that is simply off base from a legal standpoint.

                  That you want to characterize my correction as to disregard it won’t fly.

                  Deal with the reality of the law as it is – as I present the correction to you.

                  This is NOT a matter of MY being superior – it is a matter that you need to put your (attempted) point into the proper legal context.

                  You just cannot use a product when what you are talking about is a legal document. You help no one with such nonsense.

                2. anon, what are you talking about? You think trials and products are not related to enablement?

                3. Enablement is a legal question of the four corners of the patent application.

                  Certainly, products (trials and such) MAY be brought to bear as indicative of what is within those four corners.

                  And just as certainly, a company’s products (trials and such) MAY be disconnected from what is within those four corners.

                  Here, the patentee may well have a product that simply does not fit the claim (as laid out AND supported/enabled BY the application).

                  That only means that the product is not covered by the particular claims of the patent.

                  Such does NOT mean that the product is indicative that enablement of the claims has not been provided.

                  You seem to have forgotten a basic premise in patent law: the patent is a legal document, and not an engineering document.

                  Much like your other points for which I have reminded you (the reminder being that your points are NOT made as you may think them to be made), here too, you react p00rly when faced with critical thinking.

                  Instead of lashing out, I suggest that when you are faced with a post that is critical of your desired Ends, that YOU take a moment, read the point, understand the point, and when you realize that the point is valid, is cogent, and will not go away, that you thank the person, reflect and make your position stronger by incorporating that point.

                  Or, you can chose to act like Malcolm (and v0m1t back some inane denigrations), or like Greg, Paul, or Random (and take an inte11ectually cowardly non-engagement path).

                  The choice, as ever, is yours.

                  (just don’t expect me to be overly “polite” and ignore your plain errors)

                4. anon, no. That is not how it works. You need to take a vacation. You attacked my post on some ridiculously narrow definition of product (when obviously I was referring to evidence of trials and products), and now you are back pedaling and not even correct.

                5. Sorry Night Writer, but I call B$ on your “that’s not how it works.”

                  My posts reflect exactly how it works.

                  YOU only perceive “an attack” because you do not like what I say. You have placed your pride (your feelings) above reason – and you act just like Malcolm acts in regards to someone pointing out to you a cogent point of law.

                  some ridiculously narrow definition of product (when obviously I was referring to evidence of trials and products),

                  I have made no such “narrow definition,” let alone a ridiculously narrow one.

                  and now you are back pedaling and not even correct.

                  I have not back pedaled at all – my posts (ALL of them) remain correct and I remain consistent in what I have said. Further, I am absolutely correct in what I have said – and you have provided ZERO points of fact or law to counter what I have said.

                  The lady (that would be you) doth protest too much, methinks.

                6. Malcolm,

                  Feel free to join the dialogue with a meaningful (you know, on point) comment. Like maybe something about the law…

  2. 4

    im·​me·​di·​ate | \ i-ˈmē-dē-ət , British often -ˈmē-jit\

    Definition of immediate
    1a : occurring, acting, or accomplished without loss or interval of time : INSTANT
    an immediate need
    b(1) : near to or related to the present
    the immediate past
    (2) : of or relating to the here and now : CURRENT
    too busy with immediate concerns to worry about the future
    2a : existing without intervening space or substance
    brought into immediate contact
    b : being near at hand
    the immediate neighborhood
    3 : being next in line or relation
    the immediate family
    4a : acting or being without the intervention of another object, cause, or agency :

    The plain and ordinary meaning of immediate, when the effect is not instant, is that the effect will be near to.

    In the case of pain relief, the difference between five minutes and 10 minutes and 15 minutes (if the effect is not instant) is likely not material to doctors or patients and all three of those time frames could easily be considered immediate in this context. This decision seems arbitrary to me.

    1. 4.1

      The patentee defined the term in the specification and likely relied upon the definition during prosecution.

      Dictionary definitions are pretty much beside the point under these circumstances.

    2. 4.2

      If I am in enough stomach pain to take something for it, immediate means as soon as I swallow it. 15 minutes later is not immediate. Neither is 5 or 10 minutes for that matter.

  3. 3

    What about laches? The initial ANDA was filed in 2004 and this suit wasn’t brought until 2013. Seems like it would be reasonable to suggest that the patent owner (who obviously knew about the infringing product) didn’t bring this case within a reasonable amount of time.

    1. 3.1

      Laches is no longer a defense against patent infringement. The SCotUS got rid of it two years ago. SCA Hygiene v. First Quality Baby Prods., 137 S. Ct. 954 (2017).

  4. 2

    Dennis, nowhere in your post do you reprint the claim(s) at issue.

    1. 2.1

      1. A method of providing immediate and sustained relief from pain, discomfort and/or symptoms associated with episodic heartburn in a human, said method comprising:

      orally administering to a human together or substantially together an antacid in an amount effective to substantially neutralize gastric acid and a histamine H2 -receptor antagonist in an amount effective to substantially inhibit or block gastric acid secretion for providing the human with immediate and sustained relief from pain, discomfort and/or symptoms associated with episodic heartburn, the immediate and sustained relief provided lasting longer in duration than when the human is orally treated with only the antacid and the immediate and sustained relief provided being faster than and lasting at least about as long in duration as when the human is orally treated with only the histamine H2 -receptor antagonist.

      1. 2.1.1

        P U.

        It’s unfortunate this claim wasn’t invalidated.

      2. 2.1.2

        Doesn’t this claim two laws of nature or naturally occurring processes?

        Antacids neutralize acids.

        Histamine H2 -receptor antagonists antagonize Histamine H2 -receptors.

        Doesn’t this just claim the abstract idea of taking medicine to address a medical condition?

        You could put the pill in a rolled up piece of paper and push it into your mouth with a pencil couldn’t you? Therefore it could be done with pencil and paper! Mental Steps!

        101 – 3-ways

        NEXT!

        1. 2.1.2.1

          Maybe everything humans do is nothing but a law of nature. Maybe inventing is a law of nature. Actually, under the logic of the SCOTUS it is.

          1. 2.1.2.1.1

            As I quipped previously, show me anything that is a violation of the laws of nature.

    2. 2.2

      Atari –

      He does that a lot. In future, you can copy the patent number and paste it into the search box here : link to patents.google.com

  5. 1

    Another case of Big Pharma and a patent without actual possession (of claimed utility)…?

Leave a Reply

Your email address will not be published. Required fields are marked *

You can click here to Subscribe without commenting

Add a picture