trials@uspto.gov
`571-272-7822
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`IPR2015-01718, Paper No. 39
`February 17, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`COALITION FOR AFFORDABLE DRUGS VII, LLC,
`Petitioner,
`
`v.
`
`POZEN INC.,
`Patent Owner.
`____________
`
`Case IPR2015-01718
`Patent 8,945,621 B2
`____________
`
`Held: November 16, 2016
`____________
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`
`
`
`
`BEFORE: TONI R. SCHEINER, LORA M. GREEN, and
`JACQUELINE BONILLA, Administrative Patent Judges.
`
`
`The above-entitled matter came on for hearing on Wednesday,
`November 16, 2016, commencing at 1:00 p.m., at the U.S. Patent
`and Trademark Office, 600 Dulany Street, Alexandria, Virginia.
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`571-272-7822
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`IPR2015-01718, Paper No. 39
`February 17, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`COALITION FOR AFFORDABLE DRUGS VII, LLC,
`Petitioner,
`
`v.
`
`POZEN INC.,
`Patent Owner.
`____________
`
`Case IPR2015-01718
`Patent 8,945,621 B2
`____________
`
`Held: November 16, 2016
`____________
`
`
`
`
`
`BEFORE: TONI R. SCHEINER, LORA M. GREEN, and
`JACQUELINE BONILLA, Administrative Patent Judges.
`
`
`The above-entitled matter came on for hearing on Wednesday,
`November 16, 2016, commencing at 1:00 p.m., at the U.S. Patent
`and Trademark Office, 600 Dulany Street, Alexandria, Virginia.
`
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`
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`AMY E. LAVALLE, ESQ.
`
`JERRY C. HARRIS, JR.
`
`Wick Phillips
`
`3131 McKinney Avenue
`
`Suite 100
`
`Dallas, Texas 75204
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`Case IPR2015-01718
`Patent 8,945,621 B2
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
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`ON BEHALF OF PATENT OWNER:
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`SAMONEH KADIVAR, ESQ.
`MARGARET J. SAMPSON, ESQ.
`Baker Botts LLP
`98 San Jacinto Boulevard
`Suite 1500
`Austin, Texas 78701-4078
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`Case IPR2015-01718
`Patent 8,945,621 B2
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`
`P R O C E E D I N G S
`- - - - -
`JUDGE SCHEINER: Good afternoon. Please be
`
`seated.
`
`Okay. Let's take care of a little housekeeping first. We
`are here in the matter of IPR2015-01718, and I believe that each
`side will have 45 minutes to present their case. I typically don't
`use the thing, so I'll write down the times when we start. And we
`have no motion to amend in this case. Is that correct? That is
`correct.
`
`So after we do introductions, Petitioner, you'll start, and
`you'll have 45 minutes, and you can reserve time, if you like, and
`the burden will be on you to establish patentability. Then, Patent
`Owner, you will have 45 minutes to present your response. Then
`we will shift back to you, assuming that you're going to -- do you
`know whether you want to reserve?
`MS. LAVALLE: I do plan to reserve some time, yes.
`JUDGE SCHEINER: Okay. So why don't we start
`with the introductions. Petitioner first, please.
`MS. LAVALLE: Yes, Amy LaValle for Petitioner,
`Coalition for Affordable Drugs VII, LLC, and with me is my
`partner Jerry Harris.
`THE COURT: Thank you.
`For Patent Owner?
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`Patent 8,945,621 B2
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`MS. SAMPSON: Margaret Sampson from Baker Botts
`here on behalf of Patent Owner, Pozen and Horizon, and with me
`is Sammy Kadivar, an associate at Baker Botts.
`JUDGE SCHEINER: Thank you.
`Okay, let's see, am I forgetting anything? I guess not.
`All right. Let's -- why don't we hear from Petitioner
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`first.
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`MS. LAVALLE: Thank you, Your Honor.
`JUDGE SCHEINER: And we are starting right about
`1:00. I'm sorry, did you say -- how much time did you want to
`reserve?
`MS. LAVALLE: I think about 15 minutes.
`JUDGE SCHEINER: Okay. So we will go until about
`1:30, unless we ask you a lot of questions, and then we'll give you
`some extra time.
`MS. LAVALLE: Right. It may not even take 30
`minutes for me, just depends on the questioning.
`JUDGE SCHEINER: I like the sound of that.
`MS. LAVALLE: Yeah.
`JUDGE SCHEINER: Okay. Whenever you're ready.
`We have your demonstratives, electronic copies of your
`demonstratives, so...
`MS. LAVALLE: Would you like a hard copy?
`JUDGE SCHEINER: Actually, I would, because I
`sometimes take notes on them. If you have them, yes.
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`Patent 8,945,621 B2
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`MS. LAVALLE: I do.
`JUDGE SCHEINER: It is not, you know, a
`requirement certainly, but --
`MS. SAMPSON: Would you like Patent Owner's
`demonstratives?
`JUDGE SCHEINER: Sure. I'm faster at taking notes
`with a pen than I am on the screen, so...
`Thank you.
`MS. LAVALLE: Okay, I will go ahead and get started.
`I want to try to make this presentation short so that I can save
`some time for rebuttal, but I also think this case is simple. The
`'621 patent is one of at least nine patents listed in the Orange
`Book that is directed to the pharmaceutical product Vimovo. The
`earliest Vimovo patent listed in the Orange Book that is also
`directed to Vimovo, which is an NSAID and an acid inhibitor in a
`unit dose form, is U.S. Patent Number 6,926,907, which is the
`prior art reference that we refer to as Plachetka. That is the
`primary prior art reference of our grounds one and two in this IPR
`proceeding.
`Just some background, Plachetka issued as the '907
`patent in August 2005, about four years before the earliest
`priority date of the '621 patent that we are challenging here today.
`Despite the fact that both Plachetka and the '621 patent are
`directed to Vimovo and they share one named inventor, John
`Plachetka, the two patents are not in the same patent family. The
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`Patent 8,945,621 B2
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`'621 patent does not claim priority to Plachetka. Because the '621
`patent somehow issued over Plachetka, it improperly extends the
`patent protection for Vimovo by over eight years. That's what
`this --
`
`JUDGE GREEN: But we don't have an anticipation
`challenge over Plachetka, right? It's obviousness.
`MS. LAVALLE: That's correct. Our ground two is a
`103 obviousness challenge, but I'll be honest, we contemplated
`doing a 102 anticipation ground in that place, and because really
`we have a single reference, Plachetka, that --
`JUDGE GREEN: I know, but the interplay of
`unexpected results and secondary considerations and inherency is
`different under an anticipation than under obviousness, correct?
`MS. LAVALLE: Right.
`JUDGE GREEN: So it kind of complicates the issue.
`MS. LAVALLE: It does. It does. And we went with
`obviousness because the '621 patent in the preamble contemplates
`giving the product to patients that are also on a low-dose aspirin
`regimen, and just because Plachetka does not explicitly instruct
`that the unit dose form be administered to patients on a low-dose
`aspirin regimen, we felt that a 102 analysis was a little too
`stringent and felt that this was more of a 103 obviousness --
`JUDGE SCHEINER: Is there any real dispute on the
`record that it would have been obvious to give that combination
`to someone who's also on a low-dose aspirin regimen?
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`MS. LAVALLE: Not in my mind. I mean, I think the
`Patent Owner has argued in their response that some of the prior
`art teaches away from giving that combination to patients also on
`a low-dose aspirin regimen, but to us that's not what the prior art
`teaches at all. In fact, it contemplates that patients -- some
`patients may need to be on a low-dose aspirin regimen for
`cardiovascular --
`JUDGE SCHEINER: As well as another NSAID,
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`right?
`
`MS. LAVALLE: Right. Although there are risks, the
`benefits would outweigh the risks for some patients.
`JUDGE SCHEINER: Okay. Sorry to interrupt you.
`Please continue.
`MS. LAVALLE: Oh, no problem. So I have already
`skipped to slide number 2 here, and I wanted to start the
`presentation on slide 2 just to quickly provide an overview of the
`'621 patent. The cover page of the '621 patent is shown here to
`put things into perspective. The title of the patent and the abstract
`tell you really everything you need to know about this patent.
`The title tells you that this patent is directed to a method
`for treating a patient at risk for developing an NSAID-associated
`ulcer, and the abstract tells you that the method for treating a
`patient at risk for developing an NSAID-associated ulcer is by
`administering a pharmaceutical composition in unit dose form
`comprising of naproxen and esomeprazole, and, indeed, here I
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`Patent 8,945,621 B2
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`have highlighted that there are 16 method claims and no drawings
`because the focus of this patent is not to teach how to make the
`pharmaceutical composition in unit dose form. That is the
`point -- that is not the point of this patent. That is a point of the
`prior art, Plachetka. This patent, in our opinion, adds nothing
`other than to disclose the natural results of taking Vimovo.
`JUDGE SCHEINER: In someone who's also taking
`low-dose aspirin?
`MS. LAVALLE: Correct.
`JUDGE SCHEINER: Okay.
`MS. LAVALLE: Turning to slide 3, I have highlighted
`the filing date of this patent and the related patent data to
`highlight the fact that the '621 patent was not filed until June
`24th, 2010, and it claims an earliest priority date of June 25th,
`2009, and it is, as I said earlier, is not related to Plachetka.
`Plachetka is not identified here in the related patent data because
`Plachetka issued as the '907 patent in August 2005, about four
`years before the earliest priority date here of the '621 patent.
`Turning to slide 4, I've noted here that the '621 patent
`has four independent claims, claims 1, 8, 15, and 16, and each of
`the independent claims are directed to a method of treating
`patients taking low-dose aspirin using the commercial
`embodiment of this patent, Vimovo. Specifically, that
`commercial embodiment is a combination of 500 milligrams of
`naproxen and 20 milligrams of esomeprazole in unit dose form.
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`Patent 8,945,621 B2
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`
`I highlighted the final "wherein" clause of claim 1 here
`on this slide. All four of the independent claims have this same
`final "wherein" clause, verbatim, and I will be talking about this
`clause throughout the presentation.
`Turning to slide 5, I provide here an overview of the
`three issues that I plan to cover in this presentation. These are the
`three reasons why we believe that the '621 patent is directed to
`unpatentable subject matter.
`First, the final "wherein" clause of the independent
`claims is not entitled to any patentable weight, and that is as a
`matter of law.
`JUDGE BONILLA: Just to clarify on that, I realize that
`we did bring it up in the decision to institute, but that's not an
`argument that you made in the petition. Is that correct?
`MS. LAVALLE: In our mind, we did, as sort of falling
`under the inherency argument of our ground two. By arguing that
`this limitation, this "wherein" clause is inherent in the prior art,
`we were essentially arguing that it added nothing; it added no
`patentable subject matter --
`JUDGE SCHEINER: It flows naturally from the steps
`that are --
`MS. LAVALLE: Exactly, and --
`JUDGE BONILLA: But that's not the same thing as it
`having no patentable weight, right?
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`MS. LAVALLE: It's not, but a lot of the case law is
`sort of overlapping in this area. I mean, you see the same
`language, you know, if it's just the natural result flowing from,
`you know, something that already existed in the prior art, you --
`some courts are -- or case law decisions call that inherent, some
`might call that -- it's just not entitled to patentable weight.
`However you get there, to us, it doesn't -- it doesn't
`matter. We wanted to address both since you raised it in your
`institution decision, but we feel like the law is consistent in this
`case, and either way, that "wherein" clause really adds nothing.
`So that's really the first point I wanted to cover.
`And then ground one is the second reason in our mind
`that claims 1 through 16, all claims, are obvious over Plachetka,
`and that's in view of Graham and Goldstein. So to the extent that
`that final "wherein" clause should be given any patentable weight,
`it's our argument that it was disclosed and obvious in view of the
`prior art.
`JUDGE SCHEINER: Okay. So can we look at where
`that was discussed in the petition?
`MS. LAVALLE: Our ground --
`JUDGE SCHEINER: The evidence for that, that that
`final "wherein" clause was actually disclosed --
`JUDGE BONILLA: Or suggested.
`JUDGE SCHEINER: -- or suggested.
`MS. LAVALLE: In the prior art?
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`JUDGE SCHEINER: Yes.
`MS. LAVALLE: So I --
`JUDGE SCHEINER: Assuming for the moment that
`that clause does have patentable weight.
`MS. LAVALLE: Okay.
`JUDGE SCHEINER: Okay.
`MS. LAVALLE: So I know that we have a section in
`our petition covering that final "wherein" clause, and for that we
`cite our expert declaration.
`JUDGE SCHEINER: Right, but that --
`JUDGE BONILLA: I'm looking on page 17 to 18 of
`your petition, and you cite paragraphs 82 and 83 of
`the declaration.
`MS. LAVALLE: That's correct. That's as deep as we
`got on the petition.
`JUDGE SCHEINER: Okay.
`MS. LAVALLE: And so what we did, seeing that that
`was an issue that you raised in your institution decision, is came
`back into the reply and pointed specifically to where the support
`for that is in the expert declaration.
`JUDGE SCHEINER: Well, there's a difference
`between us raising the issue of whether the final clause has
`patentable weight and us criticizing the evidence for or lack of
`identification of the evidence of the prior art teaching that clause,
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`Case IPR2015-01718
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`and it's questionable whether that's a -- whether a reply is the
`proper --
`JUDGE BONILLA: Your position seems to be in your
`petition that even if we give it patentable weight, that it was
`suggested in the art, and I --
`MS. LAVALLE: Exactly.
`JUDGE BONILLA: -- and, I mean, one of the issues
`we have is we're looking at the support for that in the petition,
`and it looks like the support you have there is the dec that you
`cite, but the -- when we look at paragraph 83, for example, there
`doesn't seem to be citation to anything. We're not exactly clear
`where that information comes from in paragraph 83 in the
`declaration that you cite.
`MS. LAVALLE: Right. We did our best to clear that
`up in our reply. We rely on the expert's opinion. His summary is
`there in paragraphs 83 and 84. The reply points to an Appendix
`B as well where he did --
`JUDGE SCHEINER: Right, but that was not in the
`petition, correct?
`MS. LAVALLE: That's correct, yes.
`JUDGE SCHEINER: Okay. I just wanted to verify
`where we are on that, because --
`MS. LAVALLE: Right. Well, I -- what we're doing is
`relying on our expert's opinion, and so --
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`JUDGE SCHEINER: No, I understand, but I just
`wanted to make sure there wasn't something that we missed in the
`petition.
`MS. LAVALLE: Right, right.
`So I've covered our first two reasons why we believe
`that the patent is directed to unpatentable subject matter. Our
`third reason is our asserted ground two in the petition, and that's
`that Plachetka alone renders claims 1 through 16 obvious. All
`three of these reasons are related to the -- are related because they
`all focus on that final "wherein" clause of the independent claims.
`So on the next slide, slide 6, I thought we should take a
`minute and look at the background of the final "wherein" clause
`and see where this language came from. As the Patent Owner
`explains in its response, the inventors discovered that the
`administration of the claimed unit dose form results in a greater
`reduction in the incidence of gastric ulcer in patients also taking
`low-dose aspirin than in those patients that are not taking
`low-dose aspirin, but these results of taking the claimed unit dose
`form were not part of the original claim language.
`During prosecution, the examiner rejected the
`independent claims under 102 and 103 over Plachetka, the
`primary reference in our grounds one and two. The applicants
`argue that a post-filing reference, a study published by Angiolillo,
`which is Patent Owner's Exhibit 2003, demonstrated unexpected
`results that overcame the examiner's rejections. The examiner
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`agreed that the post-filing reference, Angiolillo, demonstrated an
`unexpected result that maintained the claimed rejections because
`the claims were not commensurate in scope with that unexpected
`result.
`
`Accordingly, the examiner entered an amendment
`adding the final "wherein" clause to render the claims
`commensurate in scope with the demonstrated unexpected results.
`JUDGE BONILLA: If we assume that the "wherein"
`clause that we're talking about doesn't have patentable weight, is
`the fact that there's unexpected results still relevant to our
`analysis?
`MS. LAVALLE: To me they are not truly unexpected
`results. If -- if --
`JUDGE BONILLA: But let's just say for the sake of
`argument that we decide the "wherein" clause has no patentable
`weight and we decide that the unexpected results are unexpected.
`Is that valid in our analysis in relation to the claims?
`MS. LAVALLE: I don't think so, because I believe the
`invention could only be what is patentable, and so that clause
`comes out of the analysis entirely. That clause shouldn't have any
`patentable weight for lots of reasons. I mean, one is that it -- I
`mean, not that 101 is even an issue here in this IPR, but we could
`look at 101.
`The natural results of any human natural process are not
`patentable, and so the fact that you get unexpected results by a
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`human body doing something -- and we don't even know how it
`happens, it's just in a black box -- that happening is not patentable
`and shouldn't be a factor in a nonobviousness analysis.
`JUDGE SCHEINER: So is it -- would it be your -- is it
`fair to say that there's nothing in that latter clause that requires
`any refinement of any of the steps that are already recited in the --
`in the claim?
`MS. LAVALLE: I don't see any further refinement.
`When I look at -- when I read the language of the final "wherein"
`clause, it's literally stating just results of what happens when a
`human body ingests the unit dosage form. It's --
`JUDGE SCHEINER: The precise unit dosage form
`that's recited in the claims?
`MS. LAVALLE: In the claims. And that precise unit
`dosage form is in Plachetka as well.
`JUDGE BONILLA: And your position is if you follow
`the steps, you will necessarily, in every case, get that result.
`MS. LAVALLE: That's what is claimed, and that's
`what the studies show. That's what the prior art shows. That's
`what our Graham and Goldstein studies show.
`JUDGE SCHEINER: Or at least for a cohort of people
`taking low-dose aspirin.
`JUDGE BONILLA: Can we run through that a little
`bit, why you think it is necessarily the case that if you follow
`those steps, that you necessarily get to the "wherein" clause? I
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`think you pointed out you got into a little bit more detail in the
`reply.
`
`MS. LAVALLE: I don't think I understand your
`question.
`JUDGE BONILLA: So your position is that if you
`follow the steps of the claim, that the "wherein" clause about the
`fact that it works better if you give the low-dose aspirin --
`MS. LAVALLE: Right.
`JUDGE BONILLA: -- that that is inherent, that that's
`your position, that that is inherent, the necessary results. It would
`be your burden to show that it was necessarily occurring, because
`you have to show that the element was there.
`MS. LAVALLE: Yes.
`JUDGE BONILLA: So I was wondering if you could
`run through it with me, your data or your evidence that it really is
`inherently there, if you follow all the other steps.
`MS. LAVALLE: Right. Well, the data is in the '621
`patent itself, in the specification. I think it was Example 1 or one
`of the examples in the specification shows the study and the
`results, and then the Patent Owner's own evidence and part of the
`prosecution file history, the later study by Angiolillo, which I said
`was Exhibit -- I think it's 2003? Yes, Patent Owner's Exhibit
`2003, that is the data from -- from a study that came after the
`filing, but it shows the same thing.
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`And it's our position that Graham and Goldstein,
`although the acid inhibitor was different in that case, it was
`Lansoprazole, it shows the same trend as well. So it's really just
`showing a natural result. You could say it's an obviousness
`reference. It's making this claimed invention obvious in view of
`the prior art, but it's also just additional evidence for what is a
`natural human body result.
`If I turn to the next slide, I believe I already started
`talking about this, but I just wanted to point out -- and we go
`through this in our reply, that the final "wherein" clause recites
`the natural results of administering the claimed unit dosage form
`to a patient and that it doesn't add any -- anything to the
`pharmaceutical composition. There is no additional active
`ingredient added, so there's -- it's still just the naproxen and the
`esomeprazole, and it doesn't add a step to the claimed process.
`Administering was already there. It's -- it's not adding an
`additional method, step or process step to the treatment.
`So -- and also the final "wherein" clause does not
`describe any functionality. It's not explaining what is happening
`in the human body to make these results occur. It's just literally
`telling us what the results are when patients, who are also on
`low-dose aspirin, take the unit dose form.
`JUDGE GREEN: But can't you argue that the
`"wherein" clause relates back to the preamble, that this is
`something that happens in patients who are already on low-dose
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`aspirin regimens, and so to that extent it does relate to the
`preamble of the claim?
`MS. LAVALLE: It is a corollary to the preamble, and,
`I mean, in our mind, the preamble doesn't have any patentable
`weight either.
`JUDGE GREEN: But it is identifying patient
`populations who you're administering to, correct?
`JUDGE SCHEINER: Yes.
`MS. LAVALLE: It is.
`JUDGE GREEN: So to a certain extent -- I mean, the
`method doesn't -- if we take away the preamble and all we have is
`administering the dosage form and you're kind of -- the preamble
`in this case I think breathes life into the method because it
`informs you who you are going to administer this dosage form to,
`correct?
`MS. LAVALLE: Correct. And this is why we went
`with the 103 obviousness ground for Plachetka, because
`Plachetka did not explicitly disclose administering the unit
`dosage form to patients who are also on the low-dose aspirin
`regimen, but it was obvious in reading Plachetka, which discusses
`patients being on low-dose aspirin, that that's a possibility, that a
`certain population of patients who are on the unit dose form may
`also be on low-dose aspirin. It just did not directly say you
`must -- if you're on low-dose aspirin, you must also take this
`low-dose form. It allowed it; it didn't exclude that possibility.
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`Slide number 8 is the start of my summary for ground
`one. We've been talking about this already, but Plachetka is the
`primary reference for this ground one. I think it's undisputed, if
`you read through the Patent Owner's response, that Plachetka
`expressly discloses all of the limitations of claims 1 through 16,
`all the dependent claims, and all of the elements of the
`independent claims, except for that one final "wherein" clause.
`And it's undisputed that Plachetka discloses Vimovo or
`another name for that is PN400. The '621 patent specification
`uses the name PN400 for that product, but it is the same product
`as Vimovo. I confirmed this with Patent Owner's expert,
`Dr. Johnson, at his deposition, and, indeed, he testified that
`Plachetka is directed to Vimovo, and Dr. Johnson further testified
`that PN400 is -- which is the product disclosed in the '621 patent,
`is another name for Vimovo. The dosages are exactly the same.
`The composition, the unit dose form, everything is there except
`for that final "wherein" clause.
`So turning to slide number 9, still focusing on ground
`one, we assert that the final "wherein" clause is disclosed by
`Plachetka in view of the Graham and Goldstein studies. Like
`Plachetka, esomeprazole, and like Plachetka's -- I'm sorry,
`Plachetka's esomeprazole and NSAID combination, Graham
`discloses a similar combination. Instead, it is Lansoprazole and
`NSAID.
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`Graham tested and analyzed that combination, and
`Goldstein further analyzed Graham's results, this study. There
`were -- there is one co-author on the two papers. They had access
`to the actual study when writing Goldstein. It wasn't merely
`someone who came back later and read Graham and then decided
`to do a second paper.
`And our expert, Dr. Shargel, analyzed the results of
`Graham and Goldstein and testified in his declaration that the
`administration of an acid inhibitor with an NSAID is more
`effective at reducing the incidence of NSAID-associated ulcers
`when patients are also taking low-dose aspirin than in patients not
`taking low-dose aspirin. That is our evidence. It's expert witness
`opinion evidence.
`JUDGE SCHEINER: But were the underlying facts
`identified in the petition and in this portion of the declaration that
`he's identified in the petition? That's an issue, though, that we
`have.
`
`MS. LAVALLE: Right. So I think it's a logistical issue
`more than -- I -- relying on expert opinion evidence, so we relied
`on his ultimate opinion, and he formulated that opinion by
`creating his entire declaration and reviewing the materials. And
`in -- and within the materials that we attached, including his
`Appendix B, it's exactly --
`JUDGE SCHEINER: Which was not cited in the
`petition, correct?
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`MS. LAVALLE: It is not literally cited. We cited his
`conclusion.
`JUDGE SCHEINER: Okay.
`MS. LAVALLE: And I might add that he wasn't cross
`examined on that conclusion. That evidence, that opinion
`evidence stands. It wasn't objected to. He wasn't cross examined
`on it. It's there. His conclusion is there, and that's what we rely
`on.
`
`So turning now to slide 10, this is what I'm talking
`about when I mentioned Appendix B and what Dr. Shargel
`actually did in his analysis, which is -- which formed the basis of
`his ultimate expert opinion, he decided to make his own table,
`taking numbers from both Graham and Goldstein papers, to
`identify which patients were suffering from gastric ulcers.
`And so if we focus here on the yellow highlighted
`numbers, the Lansoprazole 15-milligram column, 6.25 percent of
`patients taking the combination of 15 milligrams of Lansoprazole
`and an NSAID, while on low-dose aspirin, had gastric ulcers. On
`the bottom row under that, a greater percentage, 23 percent of
`patients taking a combination of 15 milligrams of Lansoprazole
`and an NSAID, while not on low-dose aspirin, had gastric ulcers.
`And the same trend is shown in the Lansoprazole
`30-milligram title. Zero percent of patients taking a combination
`of 30 milligrams of Lansoprazole and an NSAID, while on
`low-dose aspirin, had gastric ulcers.
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`JUDGE SCHEINER: I'm sorry. Were those patients
`actually -- are there any assumptions here about which patients
`were on low-dose aspirin --
`MS. LAVALLE: No.
`JUDGE SCHEINER: -- or just the percentage of
`patients? They knew specifically which patients in that first
`study were on --
`MS. LAVALLE: Right. They knew specifically.
`Goldstein had access to the study, had access to the numbers on
`low-dose aspirin, and which ones weren't. This table is not
`published in Graham or Goldstein, but the numbers that form the
`percentages are. We have a little asterisk by the numbers that
`come from Graham, a single asterisk, and two asterisks by the
`numbers that come from the Goldstein paper, and then doing
`math we could determine the percentages and numbers of the --
`of the numbers that have three asterisks there.
`JUDGE GREEN: Now, is there anything in Graham or
`Goldstein that would suggest that one should do these types of
`calculations? I mean, it seems like to a certain extent this is a
`little bit of hindsight in that you're looking at what they're
`claiming and saying, oh, if we go back and massage their
`numbers, we can see that this is what happened, but there is no
`suggestion actually in the references that you should have done
`this, that you should have made this table or done these
`calculations.
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`MS. LAVALLE: The authors did not set out with a
`hypothesis to say that we expect that patients that are both on the
`low-dose aspirin and taking the nonaspirin NSAID and taking the
`acid inhibitor will have fewer incidence of gastric ulcers than
`those who are not on the low-dose aspirin. No, that is not in the
`stated hypothesis, but that is in the actual results.
`JUDGE GREEN: No, but -- I understand but this seems
`to be more evidence of inherency than it does to be -- that the
`references would have suggested the "wherein" clause.
`MS. LAVALLE: Right, yes. And I agree that it is
`evidence of inherency, but if you -- if you take a look at the title
`of Goldstein, and I -- actually, I have that right here, I think.
`What Goldstein set out to do is -- the title of his paper is "Ulcer
`Recurrence in High-Risk Patients Receiving Nonsteroidal
`Anti-Inflammatory Drugs, Plus Low-Dose Aspirin: Results of a
`Post Hoc Subanalysis."
`So he wanted to take a deeper look at what's happening
`with patients that are also on low-dose aspirin and getting the
`treatment with a nonaspirin NSAID and an acid inhibitor.
`JUDGE SCHEINER: But he didn't reach the -- didn't
`realize what was actually happening?
`MS. LAVALLE: He didn't publish it, whether he did or
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`not.
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`JUDGE SCHEINER: Well, fair enough.
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`MS. LAVALLE: Yeah. Yeah, he didn't. That's
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`correct.
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`JUDGE SCHEINER: But -- so he set out to look at
`whether there was a difference one way or the other, I suppose --
`MS. LAVALLE: Um-hum.
`JUDGE SCHEINER: -- but didn't come to this --
`MS. LAVALLE: But the title of the paper is what led
`Dr. Shargel -- and I would argue would lead anyone of skill in the
`art -- to this paper, and that's why this is an obviousness analysis,
`is, you know, what is rele
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