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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMA USA, INC.,
`Petitioner,
`
`v.
`
`HORIZON PHARMA USA INC., and
`NUVO PHARMACEUTICALS (IRELAND)
`DESIGNATED ACTIVITY COMPANY,
`Patent Owners.
`____________
`
`Case IPR2018-00272
`Patent 9,393,208 B2
`____________
`
`Held: June 14, 2019
`____________
`
`
`
`
`Before MICHELLE N. ANKENBRAND, TONI R. SCHEINER, and
`DEBRA L. DENNETT, Administrative Patent Judges.
`
`
`
`
`
`
`Case IPR2018-00272
`Patent 9,393,208 B2
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`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`BRANDON M. WHITE, ESQUIRE
`AUTUMN NERO, ESQUIRE
`Perkins Coie
`700 13th Street, N.W.
`Washington, D.C. 20005
`
`
`
`ALAN POLLACK, ESQUIRE
`Windels Marx Lane & Mittendorf
`150 John F. Kennedy Parkway
`Short Hills, NJ 07078
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`SUSAN KRUMPLITSCH, ESQUIRE
`Cooley Godward Kronish LLP
`3175 Hanover Street
`Palo Alto, CA 94304
`
`
`
`
`The above-entitled matter came on for hearing on Friday, June 14,
`
`2019, commencing at 9:00 a.m., at the U.S. Patent and Trademark Office,
`600 Dulany Street, Alexandria, Virginia.
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`
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`Case IPR2018-00272
`Patent 9,393,208 B2
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`P R O C E E D I N G S
`- - - - -
`JUDGE ANKENBRAND: You can be seated. Give us a
`
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`minute to get situated. Is the court reporter ready?
`
`
`THE REPORTER: I am.
`
`
`JUDGE ANKENBRAND: Okay. Let's go on the record. Good
`morning everyone. We have today our final hearing in IPR 2018-00272
`between Petitioner Mylan Pharmaceutical and joined Petitioner Dr. Reddy's,
`and Patent Owners Horizon Pharma USA Inc., and NUVO Pharmaceuticals
`(Ireland) Designated Activity Company. I'm Judge Ankenbrand. I'm joined
`today by Judge Scheiner to my right, and by Judge Dennett who is appearing
`remotely in Austin.
`
`
`Counsel, can you please introduce yourselves and let us know
`who will be presenting today. We'll start with Petitioner.
`
`MR. WHITE: Good morning, Your Honor. Brandon White, Perkins
`Coie. I'll be presenting today. Also with me is my colleague, Autumn Nero
`and Rhea Stumming (phonetic).
`
`JUDGE ANKENBRAND: Okay. Thank you. Good morning, and
`for Patent Owner – oh sorry, I forgot about Dr. Reddy’s.
`
`MR. POLLAK: Alan Pollak with Windels Marx Lane & Mittendorf
`on behalf of Petitioner Dr. Reddy's.
`
`JUDGE ANKENBRAND: All right. Thank you. And for Patent
`Owner.
`
`MS. KRUMPLITSCH: Good morning, Your Honor. My name is
`Susan Krumplitsch from Cooley LLC on behalf of Patent Owner Horizon,
`and with me are my colleagues Tom Blinka and Ellen Scordino.
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`MR. GRITTON: Good morning. I'm Jeff Gritton from Baker Botts
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`on behalf of Patent Owner NUVO Pharmaceuticals.
`
`
`JUDGE ANKENBRAND: All right. Thank you and good
`morning. It's good to have everyone here and we appreciate everyone
`making the effort to be here today. We set forth our procedure for today's
`hearing in the Hearing Order but just to remind everyone about the way the
`hearing will work, each party will have 45 minutes of total time to present
`arguments. Since Petitioners have the burden of showing unpatentability
`they'll go first, so Mr. White you'll proceed first followed by Ms.
`Krumplitsch and I guess Mr. White, would you like to reserve any time for
`rebuttal?
`
`MR. WHITE: Yes, ten minutes please.
`
`JUDGE ANKENBRAND: Ten minutes. Okay. Let me set the time.
`Objections are only to be made during your own argument time with one
`exception. I don't think there's anything -- is there anything in the docket
`that's under seal?
`
`MS. KRUMPLITSCH: Your Honor, there are a few exhibits that are
`under seal but I don't believe that will be discussed.
`
`JUDGE ANKENBRAND: Okay. So that would be the only
`exception, if someone began to discuss something that was filed with a
`Motion to Seal and provisionally sealed then you can stand up and object,
`but other than that objections are just made during your own argument time.
`One more thing before we begin. Keep in mind that Judge Dennett will not
`be able to view anything that you project onto the screen so when your refer
`to a demonstrative or an exhibit please state for the record the slide number
`if it's a demonstrative and if it's an exhibit the exhibit number and page
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`number that you're referring to. Of course it's also important for the clarity
`of the transcript.
`
`Also because our microphones have limitations Judge Dennett won't
`be able to hear you if you stray too far from the podium so just keep that in
`mind. I'll try to give everyone a warning when you're reaching the end of
`argument time. I don't always remember but there is a light bar up here and
`the clock is behind me so you'll be able to know if you're reaching the end or
`if you've gone into your rebuttal time, Mr. White, and I think Ms.
`Krumplitsch, I'll ask you when you get up to speak but there's time for a
`brief surrebuttal as well. Does anyone have questions? Counsel for
`Petitioner.
`
`MR. WHITE: No, Your Honor.
`
`JUDGE ANKENBRAND: For Patent Owner?
`
`MR. KRUMPLITSCH: No, Your Honor.
`
`JUDGE ANKENBRAND: All right. So the last thing I'd like to
`remind the parties is that this hearing is open to the public and a full
`transcript of the hearing will be made part of the record. So with that, I
`think we're ready to begin. Mr. White, I'll start the clock when you start
`your argument.
`
`MR. WHITE: So good morning, Your Honors. Brandon White of
`Perkins Coie on behalf of Mylan. Looking at slide 3 in our demonstratives
`the ’208 patent, claim 1 is a long claim and it claims essentially three things;
`a.m., p.m., twice daily dosing of a combined Naproxen and Esomeprazole
`formulation, 500 milligrams of Naproxen, 20 milligrams of Esomeprazole,
`two doses that were known in the art and FDA approved, and then the bulk
`of the claim -- about two thirds of the claim -- as shown in pink on slide 3
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`are PK/PD limitations, Cmax, Tmax, AUC, we submit these are the inherent
`result of taking the Naproxen/Esomeprazole formulation twice per day.
`
`The problem with this claim from a prior art perspective is the ’285
`patent. Years before this patent was ever filed, Dr. Platchetka filed the ’285
`patent, ultimately issued as a patent. The ’285 patent disclosed the
`formulation that's recited in the claim 1 of the ’285 patent. It disclosed in
`the claim Esomeprazole and Naproxen in a single formulation. The doses
`that were used in that formulation were well known in the art, Naproxen 500
`milligrams twice per day as a follower (phonetic) half-life, is FDA approved.
`It was one of the most commonly used drugs for pain relief. Esomeprazole
`versus Nexium was approved at 20 to 40 milligram doses, again a widely
`used drug and they're used here for the exact purposes they were used in the
`prior art.
`
`Patent Owners make a few points, just briefly as way of introduction,
`make a few points, one, that the ’285 patent does not teach twice daily
`dosing. When a person of skill in the art is reading a prior art reference it's
`not for anticipation purposes, it's not just what is expressly disclosed, what
`the person of skill in the art can reasonably infer from that disclosure. A
`person of skill in the art by 2008 understood that Naproxen when given for
`pain relief was dosed twice per day at 500 milligrams, that's because of its
`half-life. So that was well known in the art. When the person of skill in the
`art reads the ’285 patent they would understand that Naproxen be given
`twice per day.
`
`The inherent limitations PK/PD recitation take up about two thirds of
`the claim, I don't think there's any actual dispute in this case that those are
`the actual and necessary result that occur when the 500 milligram Naproxen
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`20 milligram Esomeprazole formulation is administered to patients twice per
`day. Dr. Platchetka admits that. There's no real dispute that that's the result.
`Patent Owners have some disputes though with what the law requires but I
`think it's pretty common ground that --
`
`JUDGE ANKENBRAND: If that's the results then are these actually
`limitations of the claim that deserve patentable weight?
`
`MR. WHITE: Yes, I think they are limitations of the claim. The fact
`that they're inherent doesn't get rid of and doesn't make them not part of the
`claim. This was the contribution from Ault, Sostek, and Orlemans, and Dr.
`Platchetka wasn't necessarily aware of these. It's not as if it's a non-
`limitation where you might have a statement of intended purpose that like
`you've read out of the claims. These are requirements of the claim.
`
`JUDGE ANKENBRAND: What about the fact that the claim targets
`something? How are those requirements of the claims? It's just a target so
`it's not an exact number, so the claims simply require you to target
`something. They don't actually require you to hit that number, do they?
`
`MR. WHITE: They don't, and that's part of the District Court's
`problem with the indefiniteness issue is you know it requires a target, you
`don't have to necessarily achieve it and a person of skill in the art might not
`know for infringement purposes whether if you target it and don't achieve it
`are you inside or outside the claim. For the purposes here, the prior art is
`inside of the ranges so we think that anticipates or at least renders obvious
`those claims.
`
`And again, because it relates to a number of issues in the case,
`particular the 102(e) issues, I think it's important to note at the outset these
`PK/PD limitations came from the PN400 study. That was the study where
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`Ault, Sostek and Orlemans had administered Dr. Platchetka's formulation
`and they measured the blood serum levels of the drugs and its human
`patients. From that study, those three named inventors --
`
`JUDGE ANKENBRAND: Are you on a particular slide?
`
`MR. WHITE: I'm on slide 16.
`
`JUDGE ANKENBRAND: Thank you.
`
`MR. WHITE: From that PN400 study, that's where the PK/PD
`limitations take up about two thirds of the claim derive. Patent Owner's
`arguments are largely, their main arguments are I would call technical or
`procedural arguments starting with the request that this proceeding be
`terminated because of the District Court's indefiniteness decision. The
`Board's previously addressed that in denying their Motion to Terminate and
`we think that decision was correctly decided and should stand. We won't
`rehash those arguments here unless Your Honors have any questions.
`
`Turning to slide 9. Patent Owner makes two threshold arguments
`about the grounds in this case both related to the ’285 patent. The first one
`is whether or not the ’285 patent is 102(e) prior art. The issue there boils
`down to whether the ’285 patent is by another with respect to the ’208
`patent.
`
`If we look at the ’285 patent and the ’208 patent there's no question on
`the face of both patents and we're looking at slide 12. There's no question on
`the face of those patents there are different inventors. They are by another.
`Dr. Platchetka is the only named inventor on the ’285 patent. Dr. Platchetka
`and three others, Ault, Orlemans and Sostek, are the named inventors on the
`’208 patent. Even the evidence introduced in this case by Patent Owner
`suggests that Ault, Orlemans and Sostek were the ones who came up and
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`uncovered the PK/PD limitations from the PN400 study so we think they are
`properly inventors. Petitioners think what's not of record in this case --
`
`JUDGE ANKENBRAND: But can you invent something that's
`inherent, an inherent property in administering the drug?
`
`MR. WHITE: I certainly think that's not an invention. They are the
`ones who discovered it and revealed what those properties were. They did
`the study and made this contribution to this claim.
`
`JUDGE ANKENBRAND: I guess I'm having a hard time squaring
`this argument with your inherency argument because if Dr. Platchetka was
`the one who discovered the dosage form and this is just simply an inherent
`property of administering the dose, then what are the contributions of the
`other inventors or how is this by another?
`
`MR. WHITE: These values, apparently Dr. Platchetka was not aware
`of these values. It's Ault, Orlemans and Sostek who provided these values
`for purposes of the patent. If you look at the ’208 patent I think if you
`discount the PK/PD limitations there is essentially nothing left. All the
`figures go away. The sole example I think spans from columns 24 to 46
`disappears. That's the clinical trial of the PN400 study. Most of the
`background is gone. There's really nothing left but the disclosure of the ’285
`patent. If that's the case I think there are a whole host of issues, that's double
`patenting. That's an improper extension of this patent, and of course the
`’285 patent has already been held invalid by the Federal Circuit so even if
`Dr. Platchetka is not an inventor on that patent as well, it's already been
`invalidated. If you look even at what Patent Owner has --
`
`JUDGE SCHEINER: Excuse me, I'm sorry. I'm just not sure that
`answers the question about the different inventive entity. If you do strip
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`away all of the pharmacokinetic data, then you're left with Dr. Platchetka's
`contribution; isn't that correct?
`
`MR. WHITE: I think the fact -- that's correct -- but I think the fact
`that these are inherent values, they still derive from the work of Ault, Sostek
`and Orlemans. That was not Dr. Platchetka's contribution.
`
`JUDGE SCHEINER: Is it your position that it's because the claim
`reads targeting those amounts and therefore you'd have to know about them
`in order to target them? Is that your position or simply that those values
`exist when the dosage form is administered?
`
`MR. WHITE: I think those values exist. They're in the claims. These
`are the recitations that Patent Owner argued during prosecution give
`patentability to these claims. They continue to argue that these recitations
`give patentability to the claims. That's the only reason this patent issued was
`these recitations. The fact that they're inherent for the formulation, that may
`invalidate the patent but that doesn't mean that they are no longer limitations
`of the claim.
`
`JUDGE SCHEINER: Okay. I think I understand your position.
`Thank you.
`
`MR. WHITE: I think the evidence in this case that was introduced by
`the Patent Owners kind of reinforces that point. Throughout their briefing
`they discuss the contribution Dr. Platchetka then met with Ault, Orlemans
`and Sostek, they worked together on the clinical trial. You know, that's their
`evidence that they introduced through the depositions of those three
`inventors.
`
`I think what's interesting too is what's not of record in this case. There
`is no declaration from any of the inventors stating who invented the subject
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`matter of these claims. There's no request to correct inventorship. In the
`Riverwood case there was at least a request to correct inventorship. That
`hasn't occurred here because I think that would create some double patenting
`issues. There's no argument that subject matter that Ault, Orlemans and
`Sostek invented was somehow deleted during prosecution like we see in the
`Riverwood case. There's not even a suggestion that the inventors would
`agree with attorney's arguments that they're not inventors on this, so we're
`really left with no evidence from the inventors and attorney argument as to
`three of the four inventors not being inventors.
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`If we turn to the second threshold issue, the 103(c) issue. Patent
`Owners are trying to have that this is 102(e) art. That there was a
`(indiscernible) --
`
`JUDGE DENNETT: Pardon me. What slide number (indiscernible) -
`-
`MR. WHITE: Slide 18. So the issue is if this is 102(e) art and it was
`
`subject to a common joint research agreement, it may be excluded under
`103(c) only with respect to the obviousness grounds.
`
`JUDGE ANKENBRAND: Patent Owner is not making an argument
`under 103(c)(1) are they?
`
`MR. WHITE: I don't think so.
`
`JUDGE ANKENBRAND: Okay. And I'll ask them the same
`question but I just wanted to know your understanding this is all about
`103(c)(2). Okay.
`
`MR. WHITE: So looking at slide 19, I think the issue with 103(c) to
`boils down to the fact that the joint research agreement that we have filed by
`Patent Owners, there's no explanation of where this agreement came out
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`(indiscernible) not sure it's authenticated but setting that issue aside, it's an
`agreement between AstraZeneca AB and Pozen -- Pozen was the former
`patent owner in this case. NUVO replaced them -- it's an agreement between
`AstraZeneca AB. To the extent there is any AstraZeneca entity identified in
`the chain of the ’208 patent, it's in a priority application and identifies
`AstraZeneca Pharmaceuticals LP. There's nothing whatsoever in the record
`to identify any relationship between AstraZeneca AB other than the joint
`research agreement appears to be a Swedish company. AstraZeneca
`Pharmaceuticals LP is a Delaware company. AstraZeneca AB, the party to
`the joint research agreement appears nowhere in the ’208 prosecution
`history. We have nothing to suggest there's a relationship between those
`companies such that AstraZeneca Pharmaceuticals LP would get the benefit
`of the agreement. They're a subsidiary of AB, we're just left to assume that
`any AstraZeneca reference is a reference to all of them and I don't think
`that's the case.
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`JUDGE ANKENBRAND: Does that matter anyway under
`103(c)(2)(c) where the application for the patent has to disclose or is
`amended to disclose the names of the parties of the joint research
`agreement?
`
`MR. WHITE: Well I think that's the second reason why it does not
`apply to the ’208 patent, nowhere it lists any AstraZeneca entity. If the only
`place we see the AstraZeneca entity is an earlier, the provisional application
`584. But it's the second reason why the 103(c) issue would not apply.
`
`Those kind of threshold issues aside, turning to the merits. So we
`have three grounds: anticipation based on the ’285 patent, obviousness based
`on the ’285 patent and then obviousness based on the ’285 patent plus two
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`references that disclose PK/PD limitations for Naproxen and then on that
`result.
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`So if we start, looking at slide 25. On slide 25 we see claims 1 and 4
`of the ’285 patent. This is the formulation recited in claim 1 of the ’208
`patent. Esomeprazole, Naproxen in a therapeutically effective amount, a
`person of skill in the art would understand that therapeutically effective
`amount of Esomeprazole. The acid reduction agent would be 20 or 40
`milligrams, those were the FDA approved doses. A person of skill in the art
`would understand Naproxen is FDA approved at 500 milligrams and that
`was given twice per day at that dose because of its half-life. Those ranges
`fall within the ranges recited in claim 4, 200 to 600 milligrams of Naproxen
`and 5 to 100 milligrams of Esomeprazole. When a person of skill in the art
`reads this claim they would immediately envision the 500 milligram, 20
`milligram formulation, those were the FDA approved doses for both of those
`commonly used drugs. If you were going to combine them into a combined
`dosage form, Naproxen really drives the dosing decision. It needs to be
`dosed twice a day because of its half-life. Esomeprazole because it was
`approved for 20 and 40 milligrams if you're going to give it twice a day, as
`Drs. Mayersohn and Metz testified, you would then give Esomeprazole 20
`milligrams which would be roughly equivalent to a 40 milligram FDA
`approved dose, both of which would going to be safe, efficacious. A person
`of skill in the art would immediately seeing the claims of the ’285 patent
`have the formulation recited in claim 1 of the ‘208 patent.
`
`JUDGE ANKENBRAND: Where do these two claims on slide 25
`show the dosing twice a day?
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`MR. WHITE: There is no express disclosure twice daily dosing in the
`
`claims of the ’285 patent. I think that goes back to my point I made earlier
`when a person of skill in the art reads the prior art it's not what's expressly
`disclosed but what they can infer from that disclosure. The person of skill in
`the art knew that Naproxen was dosed at 500 milligrams twice per day. That
`was the FDA approved dose for pain relief with Naproxen. It was not given
`in a single daily dose because of its half-life. To maintain efficacy a person
`of skill in the art would read that and understand that Naproxen needed to be
`given twice per day.
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`JUDGE ANKENBRAND: Is there any disclosure in the ’285 patent
`about twice a day dosing?
`
`MR. WHITE: Yes. All of the examples, and they again don't
`necessarily relate to Naproxen plus Esomeprazole. They're different -- it's
`Naproxen with different acid inhibitors, Omeprazole in one case, so
`examples 6, 9 and 10, where the drugs are given and they're given twice per
`day and that's because it's the Naproxen driving the dosing decisions.
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`JUDGE ANKENBRAND: Is there an example in the ’285 patent of
`the Naproxen and the Esomeprazole?
`
`MR. WHITE: No, there is no express example of that combination.
`So we would submit that because the formulation is obvious, or is
`anticipated by the ’285 patent, the PK/PD limitations are similarly
`anticipated. They are the inherent result of giving this drug. You can't
`patent a known formulation simply by reciting the known or the inherent
`PK/PD values by giving the drug and measuring the blood levels. That does
`not impart patentability to an otherwise known formulation, and for those
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`reasons we would submit that claim 1 of the ’208 patent is anticipated by the
`claims of the ’285 patent.
`
`So Patent Owner disagrees with our position obviously and so this is
`not anticipated. If the claims of the ’285 patent don't anticipate the claims of
`the ’208 patent, I think it's a very strong basis for an obviousness position.
`Your questions about the twice daily dosing, if there's not an express
`disclosure of twice daily dosing in the ’285 patent a person of skill in the art
`wouldn't interpret what is expressly disclosed in the ’285 patent is required
`by daily dosing. A person of skill in the art would at least reasonably expect
`or be motivated and have a reasonable expectation of success of giving
`Naproxen twice per day because that was the FDA approved dose, 500
`milligrams twice per day. When a person of skill in the art, they're
`considering the formulation in the ’285 patent, they're going to know they
`need to give it twice a day to maintain efficacy.
`
`JUDGE ANKENBRAND: And you said earlier that's the only FDA
`approved dose?
`
`MR. WHITE: No. Naproxen's widely used for a number of purposes,
`so there are multiple doses for different purposes. For purposes of pain
`relief, the 500 milligram dose -- and that's largely what this drug is used for,
`for arthritic conditions -- but for pain relief the FDA approved dose is 500
`milligrams twice per day, and because the dosage form is either expressed in
`the prior art or obvious in view of the prior art --
`
`JUDGE ANKENBRAND: Are you on a particular slide?
`
`MR. WHITE: Yes, slide 34.
`
`JUDGE ANKENBRAND: Thanks.
`
`MR. WHITE: Okay, sorry.
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`JUDGE ANKENBRAND: Just try to remember for Judge Dennett,
`
`please.
`
`MR. WHITE: Certainly. I mean the case law tells us that an obvious
`formulation cannot become non-obvious simply by administering to a
`patient and claiming the result in serum concentrations. That's what's in the
`Par Pharms case on slide 34 and a number of others as well, and that's also
`what we see here. I don't think there's much of a dispute as to the factual
`background of this patent. Dr. Platchetka had this formulation and Drs.
`Ault, Orlemans and Sostek conducted a clinical trial and determined what
`the AUC, the Cmax and Tmax were for this drug to be administered twice
`per day. Those became imported and became the PK/PD limitations of
`claim 1 of the ’208 patent, and that's exactly what you can't do. You cannot
`extend the life of, essentially extend the life of the ’285 patent for years by
`later filing a patent application on that exact formulation with just the result
`you see here on concentrations from the administration of the drug.
`
`So turning to ground 3, so ground 3 I think just adds upon the
`obviousness basis of ground 2 based on the ’285 patent alone. So with
`ground 3 we have the EC Naprosyn label, the label that describes how
`Naproxen was approved and used and we have --
`
`JUDGE ANKENBRAND: You're on slide?
`
`MR. WHITE: We're on slide 45.
`
`JUDGE ANKENBRAND: Thank you.
`
`MR. WHITE: And the Howden 2005 reference which presents data
`on Omeprazole, the racemic mixture of which Esomeprazole is one of the
`enantiomers. There is a dispute whether or not the EC Naprosyn label is
`prior art. The date on the label is September, 2007. The testimony from Dr.
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`Metz is that the person of skill in the art had access to this label by that time.
`Naproxen was a widely used drug, it's well known in the art. Even if the
`date the EC Naprosyn label is as late as September, 2007, that's the year
`before the provisional date of September, 2008, Patent Owner has tried to
`swear behind the EC Naprosyn label to September, 2007 date by claiming a
`date of invention and this is looking at slide 46. So Patent Owner has tried
`to antedate that reference claiming a conception and reduction to practice at
`the conclusion of the PN400 study. So again, they're relying on the PN400
`study as conception and reduction to practice as part of the invention.
`
`The problem with that antedating argument is that they use the date
`that's the end of the study. In the study itself it's clear that none of the
`samples were analyzed until the study was completed. There's no evidence
`of when the sample were analyzed, when they became aware of what the
`study revealed, what the Cmax, Tmax, AUC and other values measured in
`the study for any of the formulations, so just simply completing the study
`did not tell the inventors anything about the actual data, the actual result of
`the study. We don't know when the studies were analyzed. There's no
`evidence of that so we really can't presume when that study was concluded
`so I think that attempt to antedate the EC Naprosyn label fails on that ground
`alone, and that's really the only evidence they have of an earlier date of
`invention.
`
`So looking at ground 3, what the EC Naprosyn label and what the
`Howden 2005 reference tell the person of skill in the art is basically what we
`argued was either obvious or inherent in grounds 1 and 2. The EC Naprosyn
`label has actual data, the actual PK/PD data for Naproxen. The Howden
`reference has actual PK/PD data for Omeprazole. Now that's not
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`Esomeprazole, that is the racemic mixture of which Esomeprazole is one
`enantiomer. Dr. Mayersohn explains that in his declarations why that
`provides a target to the skill in the art because we expect Esomeprazole
`possibly to have a higher value, a higher area to the curve, but they would be
`similar values. So when you have the ’285 formulation in the prior art and
`then you look to actual data in terms of the label and the articles in humans
`of both of those drugs, those targets become apparent to the person of skill in
`the art.
`
`I want to just conclude briefly with the secondary considerations
`arguments. I don't think the secondary considerations arguments save this
`patent. They are essentially ten years too late. If you look at the secondary
`considerations date they advance, they're really directed to the ’285 patent.
`
`JUDGE DENNETT: Can I get the slide number, please?
`
`MR. WHITE: Yes, slide 56. The secondary considerations don't
`show a long felt need for combined dosage forms for patients would be more
`compliant with their treatment. That was in the prior art, that was in the
`’285 patent. Was there skepticism? I think their evidence of skepticism is
`one internal email from AstraZeneca employees suggesting that -- we're
`looking at slide 60 -- one internal email from AstraZeneca employees
`suggesting that maybe the formulation of Omeprazole might not be or may
`be some (indiscernible) and actually suggesting that Esomeprazole should be
`used. I don't think that's skepticism. It's certainly not skepticism that was
`for patentability.
`
`If you look at slide 59, the issue of long felt need for a combined
`dosage form. A combined dosage form with Naproxen and a variety of PPIs
`were well known in the art. A whole host of those types of formulations
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`were disclosed in both the ’907 and the ’285 patents in various locations. So
`we would submit that none of those secondary issues are for patentability
`here, and unless Your Honors have any further questions I'll save the rest of
`my time.
`
`JUDGE SCHEINER: I don't at the moment.
`
`JUDGE ANKENBRAND: I don't. Judge Dennett, do you have any
`further questions?
`
`JUDGE DENNETT: Nothing at the moment. Thank you.
`
`JUDGE ANKENBRAND: All right.
`
`MS. KRUMPLITSCH: I'm ready to proceed.
`
`JUDGE ANKENBRAND: Okay. Did you want to save some time
`for rebuttal, Ms. Krumplitsch?
`
`MS. KRUMPLITSCH: Yes. Let's say 15 minutes, please.
`
`JUDGE ANKENBRAND: All right. Whenever you're ready you
`may begin.
`
`MS. KRUMPLITSCH: Good morning, Your Honors. I'm actually
`going to rely mostly on my talking to you and not so much on the slides but
`I'll try to remember to identify the slide numbers that we are looking at.
`
`Now Petitioners complain that Patent Owners are relying on mere
`procedural arguments to defeat the petition but they misstate our arguments.
`For clarity, Patent Owners argue first that the proceeding should be
`terminated because a District Court concluded that the claims are indefinite.
`
`JUDGE ANKENBRAND: Didn't we already address that issue?
`
`MS. KRUMPLITSCH: You did in your ruling on that motion,
`however Petitioners have identified no legal support for the proposition that
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`a claim can be indefinite when you are dete
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