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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`ACRUX DDS PTY LTD. & ACRUX LIMITED,
`Petitioner,
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`v.
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`KAKEN PHARMACEUTICAL CO., LTD. and VALEANT
`PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner.
`____________
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`Case IPR2017-00190
`Patent 7,214,506 B2
`____________
`
`Record of Oral Hearing
`Held: January 26, 2018
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`Before ERICA A. FRANKLIN, SUSAN L. C. MITCHELL, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
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`Case IPR2017-00190
`Patent 7,214,506 B2
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
`E. ANTHONY FIGG, ESQUIRE
`AYDIN H. HARSTON, Ph.D.
`Rothwell Figg IP Professionals
`607 14th Street, N.W.
`Suite 800
`Washington, D.C. 20005
`
`ON BEHALF OF PATENT OWNER:
`JOHN D. LIVINGSTONE, ESQUIRE
`JEFFREY M. JACOBSTEIN, ESQUIRE
`Finnegan, Henderson, Farabow, Garrett & Dunner, LP
`271 17th Street, N.W.
`Atlanta, Georgia 30363-6209
`
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`The above-entitled matter came on for hearing on Friday, January
`26, 2018, commencing at 9:34 a.m., at the U.S. Patent and Trademark
`Office, 600 Dulany Street, Alexandria, Virginia.
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`Case IPR2017-00190
`Patent 7,214,506 B2
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`P R O C E E D I N G S
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`JUDGE MITCHELL: Well, good morning, everyone. We
`have a final hearing this morning in IPR2017-00190. I'd like to get
`appearances on the record starting with Petitioner.
`MR. FIGG: Good morning, Your Honor. My name is Tony
`Figg. With me at counsel table is Aydin Harston and my partner, Lisa
`Phillips, sitting behind me. We're with Rothwell Figg and we're here for
`the Petitioner Acrux.
`JUDGE MITCHELL: Great. Thank you.
`And for Patent Owner.
`MR. LIVINGSTONE: Good morning, Your Honors. I'm John
`Livingstone from Finnegan, Henderson, Farabow, Garrett & Dunner on
`behalf of Patent Owner. At counsel table with me today is my colleague,
`Jeffrey Jacobstein. I've also got Barbara Rudolph, Tony Hartmann,
`Ashley Winkler, Naoki Yoshida also from Finnegan, and we've got four
`representatives from Kaken Pharmaceuticals from Tokyo, Japan.
`JUDGE MITCHELL: Great. Thank you and welcome.
`We did set forth the -- oh, go ahead.
`MR. FIGG: I'm sorry, Your Honor. I neglected to introduce
`Ms. Shannon Lynch who represents Argentum who was joined as a
`Petitioner to this case.
`JUDGE MITCHELL: Great. Thank you and welcome.
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`We did set forth sort of the procedure in our order and I know
`you gentlemen are familiar with that for how to handle the oral argument,
`but I'll go over just a few things as reminders.
`Each party has 45 minutes of time to present the argument for
`their case. It's important for the clarity of the record -- it's nice that we
`have everybody on the bench here and we're not -- nobody is remote, but
`still for the clarity of the record, you know, make sure you refer to the
`slide number or any exhibits, just so when we go back and look at the
`hearing transcript we know exactly what you're talking about.
`Petitioner has the burden of showing unpatentability of the
`challenged claims and on its Motion to Exclude Evidence, so Petitioner
`will go first. The Petitioner may reserve time for rebuttal on its main
`case and on the Motion to Exclude. Patent Owner will then have the
`opportunity to present its response. You can -- Patent Owner, you do
`have the burden on your Motion to Exclude, so only for the Motion to
`Exclude. If you choose to, you can observe some rebuttal time.
`And I think with that being said, Petitioner, would you like to
`reserve time for rebuttal?
`MR. FIGG: Yes, Your Honor. I would like to reserve about 20
`minutes for rebuttal.
`JUDGE MITCHELL: Great.
`MR. FIGG: May I begin?
`JUDGE MITCHELL: One quick moment while I get your time
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`set up.
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`MR. FIGG: Your Honor, we have paper copies of our
`demonstratives for members of the Board, if that would be helpful.
`JUDGE MITCHELL: Great. Yes, I would love it. Thank you.
`MR. FIGG: And while he's passing them out, I'd like to
`apologize in advance. Like everyone in America, I'm coming off of a
`cold, so I'm coughing and my ears are stopped up. I can't -- so I may ask
`you to repeat things, I apologize.
`JUDGE MITCHELL: Sure.
`MR. FIGG: Your Honor, may I begin?
`JUDGE MITCHELL: Sure. Oh, sure, yes.
`MR. FIGG: The topical use of efinaconazole for the treatment
`of fungal infections of the nails was a logical and obvious result of a
`confluence of technologies in the late 1990s. Oral antifungals were
`available and were effective with cure rates approaching 40 percent.
`Those drugs are still today considered the gold standard for
`onychomycosis therapy, but those drugs were accompanied by
`undesirable systemic side effects, and so there was a motivation to
`develop topical treatments for onychomycosis that would avoid those
`side effects.
`The prior art described a number of topical formulations that
`were effective in delivering the active antifungal to the infected site.
`They included gels and lacquer formulations. Several were approved in
`Europe and the United States. And as Patent Owner's own expert's
`contemporaneous publications acknowledged, they were safe and
`effective. They avoided the systemic side effects of the oral drugs and
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`they were easier to use, but they were not as effective as people would
`have liked, so there was an interest in improving them.
`In the 1990s researchers at Kaken discovered a new azole
`antifungal, efinaconazole, also referred to as KP-103 or a compound
`minus 40. It was described in the literature as having a broad spectrum
`of antifungal activity with potent activity against species T. rubrum and
`T. mentagrophytes, which caused 90 percent of the onychomycosis
`infections. Those microorganisums are keratinophilic, meaning they
`infect tissues that contain keratin, like the nail, the hair and the stratum
`corneum or the horny layer of the skin.
`The prior art described efinaconazole as retaining a high level
`of activity in keratin-containing tissues and unlike other antifungals it
`was not inactivated by keratin. It didn't bind strongly to keratin, so it was
`able to distribute throughout the keratin-containing tissues.
`Now, in view of this confluence of technologies, it was obvious
`to use efinaconazole for the topical treatment of onychomycosis and a
`POSA would have had at least a reasonable expectation of success,
`particularly in view of the breadth of the claims at issue here, the '506
`patent claims and their modest requirements for therapeutic efficacy or
`activity.
`Kaken recognized the value of its new antifungal drug. They
`patented it as a novel composition of matter. They also patented
`compositions and methods of using it for treating fungal infections called
`mycoses. The question now is whether it was obvious to use this known
`triazole antifungal in well-known topical application methods. We
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`submit that it was and I'll explain our bases here this morning and do my
`best to answer any questions that the Board might have.
`My colleague, Mr. Livingstone, here is a very fine lawyer and
`I'm sure he's going to make a good presentation in which he is going to
`present us with arguments that the art was unpredictable, the prior art
`topical products were not effective, that onychomycosis was a difficult to
`treat disease. He will extol and I suspect he will exaggerate the benefits
`of Patent Owner's commercial product, Jublia, but I would ask that the
`Board keep a few points in mind.
`First, Patent Owner wants to make this case about whether it
`was obvious to develop an FDA-approved commercial product or to cure
`advanced stages of onychomycosis, a goal that even today is rarely
`achieved, but it's the claims in the patent that frame the obviousness
`inquiry.
`Patent Owner's case depends on its improper attempt to use
`extrinsic evidence to narrow the patent's express definitions of the claim
`terms "nail" and "onychomycosis," and these were the definitions that
`were applied by the Board in the Institution Decision.
`Second, Patent Owner's own expert correctly acknowledged
`that the '506 patent claims cover the treatment of any form of
`onychomycosis, including superficial forms and early stages of the
`infection involving the skin components of the nail.
`Third, obviousness requires only a reasonable expectation of
`success, not absolute predictability. And, again, that expectation is
`measured against what is claimed, not against a commercial product. A
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`POSA would have expected efinaconazole to have at least the
`effectiveness required by the claims. We submit it would have been
`expected that it would have greater activity than that. But given its very
`desirable properties, there would have been at least a reasonable
`expectation of success.
`If we can go down to the slides. I'm referring to slide 2.
`This IPR was instituted based on the Board's determination that
`there was a likelihood that Petitioners would prevail in proving that one
`or more of the claims of the '506 patent are unpatentable. There were six
`grounds for institution. The primary references, JP '639, the '367 patent
`and the Hay article described effective topical therapy of onychomycosis
`with antifungal compounds, many of which were azole antifungal
`compounds.
`The secondary references, the Kaken Abstracts and the Ogura
`article, described efinaconazole and its properties and I will explain, as I
`go through today, those properties would have strongly directed a POSA
`toward using this drug for treating onychomycosis.
`If I can go to slide 3.
`The claims of the '506 patent are very broad. As the Board
`determined in the Institution Decision, the patent expressly defines the
`terms "nail" and "onychomycosis." The claims are not limited to any
`particular type, stage or severity of onychomycosis. The claims
`encompass the use of efinaconazole in any type of pharmaceutical
`formulation.
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`Now, there really are three ways of looking at obviousness in
`this case. The first is it was obvious to use efinaconazole for treating
`infections of the skin components of the nail as that term is defined.
`Second, it was obvious to use efinaconazole to treat superficial forms of
`onychomycosis called white superficial onychomycosis or WSO. And,
`third, it was a person of ordinary skill also would have been motivated to
`use efinaconazole to treat even more advanced stages of the disease,
`because the drug would have been expected to penetrate the nail plate.
`In the interest of time I'm going to focus on these first two
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`points.
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`If we can go to slide 6.
`JUDGE MITCHELL: Mr. Figg, can I ask you a question?
`MR. FIGG: Yes, ma'am.
`JUDGE MITCHELL: If we just find on your first point that the
`KP-103 -- I can't pronounce the name, I'm sorry, so I'll stick with KP-103
`-- is useful in treating a skin disorder, then do you win on that point?
`MR. FIGG: I believe we do, yes.
`JUDGE MITCHELL: Okay.
`MR. FIGG: Slide 6 is a 1998 publication by Patent Owner's
`expert, Dr. Elewski, and it identifies five different types of
`onychomycosis.
`And if we can go to the next slide, slide 7.
`The most common type of onychomycosis is a form called
`distal subungual onychomycosis or DSO. It's also sometimes called
`DLSO, which stands for distal lateral subungual onychomycosis.
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`Kaken Exhibit 2010 is a 1998 publication by Dr. Elewski. It
`describes DSO as an invasion of the nail bed and the underside of the nail
`plate. It begins with the infection of the stratum corneum of the
`hyponychium, a skin structure at the tip of the finger where the finger and
`the nail meet -- where the nail meets the skin.
`It would have been obvious to use efinaconazole for treating the
`early stages of DSO considering its broad potent antifungal activity, its
`weak keratin binding, the lack of inactivation of the drug by keratin and
`its retention of activity in keratinized tissues, all properties that were
`described in the Kaken Abstracts and the Ogura reference.
`If we skip forward to slide 12, we see that Kaken Exhibit 2008,
`an 1999 publication, explains -- and I'm referring to the middle of the
`slide here -- explained that topical treatment was suitable for treating
`WSO or they call it SWO, white superficial onychomycosis, and early
`DLSO. In fact, Jublia, the commercial product, was FDA approved
`based on studies in patients with mild to moderate DSO. And I would
`refer the Board to Exhibit 2055, page 9, for that point and I also Dr.
`Elewski's testimony.
`Now, if we can go to slide 8.
`Another form of onychomycosis whose treatment is
`encompassed by the claims is white superficial onychomycosis or WSO.
`As Dr. Elewski explains in her 1998 publication, Exhibit 2010, WSO
`occurs when fungi invade the superficial layers of the nail plate. It's an
`infection on the surface of the nail. She testified that its treatment is
`fairly simple. You can scrape it off or you can put any topical antifungal
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`on it. Petitioner's, expert, Dr. Weinberg, agreed with Dr. Elewski's
`testimony on this point and said the same was true in 1999.
`So it would have been obvious to have treated WSO, a form of
`onychomycosis encompassed by the claims by the topical application of
`an effective amount of efinaconazole, a known potent antifungal
`compound. And as we saw previously on slide 12, Exhibit 2008, also
`said that topical therapy was suitable for treating white superficial
`onychomycosis.
`If we can go to slide 17.
`JUDGE MITCHELL: Can I ask you, on slide 12, and you don't
`have to go back, that particular reference was after the critical date.
`MR. FIGG: Which one?
`JUDGE MITCHELL: The reference on slide 12 to which you
`were referring that it was proper for treatment of SWO and DLSO.
`MR. FIGG: Slide 12 was after? I don't think so, Your Honor.
`It was a 1999 publication.
`JUDGE MITCHELL: Okay. Thank you.
`MR. FIGG: So going to slide 17, I'd like to turn briefly to
`claim construction.
`So as the Board noted in the Institution Decision, the Petitioners
`have relied on express definitions of nail and onychomycosis as set forth
`in the patent. Those express definitions can't be changed by expert
`testimony or extrinsic evidence.
`And if we go to slide 18.
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`The Board noted in its Institution Decision that under the
`broadest reasonable interpretation the term "nail" includes the
`eponychium and hyponychium, which are skin structures.
`If we go to slide 19.
`The Patent Owner would like to rewrite those definitions now
`to mean deeper parts of the nail plate and the nail bed. In other words,
`they would like to limit the claims to advanced stages of onychomycosis.
`During her deposition, Dr. Elewski acknowledged that the opinions and
`conclusions in her declaration were based on her rewriting and narrowing
`of the definition of nail provided in the patent. She also admitted that the
`term "onychomycosis" is not limited to any subtype or stage and it
`includes DSO, PSO, which is proximal subungual onychomycosis, as
`well as SWO.
`If we can go to slide 20.
`In the Patent Owner's Response, Patent Owner argued that the
`Board did not construe the term "onychomycosis." We believe that's
`incorrect. The Board found that the term is defined in the '506 patent as a
`kind of superficial mycosis which is caused by invading and proliferating
`in the nail of human or animal, and the Board emphasized there that the
`definition of onychomycosis incorporates and depends on the defined
`term "nail" which includes skin structures. And so onychomycosis
`includes the infection associated with the skin structures of the nail.
`If we go to slide 10.
`We present excerpts here from a 1995 publication by Dr.
`Elewski, Exhibit 1502. Here, she acknowledged in this scientific
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`publication that topical antifungal drugs, amorolfine, ticonazole and
`ciclopirox, had excellent safety profiles and had greatly improved the
`prognosis of onychomycosis. She concludes in this paper that because of
`these therapies, onychomycosis is no longer considered incurable.
`If we go to slide 12.
`Several effective topical onychomycosis therapies were
`available before the '506 patent was filed. And as shown on this slide,
`Kaken Exhibit 2057 which is a 2015 publication, but it reviews the
`history of the products and their regulatory histories, it indicates Loceryl,
`a five percent amorolfine topical lacquer, was approved in the U.K. in
`1991 and numerous other countries. Penlac, an eight percent ciclopirox
`topical, was approved in Europe in the early 1990 and in the U.S. in
`1999.
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`The article summarizes that topical treatment is suitable for
`SWO, white superficial onychomycosis, and early DLSO. Exhibit 1503
`shows that amorolfine and ticonazole were both approved in the U.K., a
`country that requires proof of safety and efficacy for regulatory approval.
`If we go back to slide 11.
`Exhibit 2009 is a 1999 publication entitled Management of
`Onychomycosis and it summarizes various drugs that were described as
`appropriate for topical therapy.
`This is not on the slide, but at page 1 of that exhibit it states
`"Topical application based on novel active substances or vehicles are
`available and cure is feasible for a majority of cases." We see at the
`bottom of this exhibit that topical therapy is identified as being
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`appropriate for white superficial onychomycosis and distal subungual
`onychomycosis, DSO.
`If we go to slide 23.
`This IPR was instituted on all six grounds proposed by the
`Petitioners.
`If we go to slide 25.
`The primary references, JP '639 and the '367 patent and the Hay
`article, each describe topical formulations for delivering antifungal
`agents to the nail. JP '639 discloses a topical lacquer that's said to have
`excellent releasability of the antifungal and high permeability of the
`keratinous layers. Thus, it is described as being effective for delivering a
`variety of antifungals, most of which are azole compounds and the like.
`The '367 patent is a Pfizer patent and it describes topical gel
`formulations of the antifungal compound ticonazole and it describes them
`as being effective for treating onychomycosis.
`The Hay article reports a clinical study with 28 percent
`ticonazole topical solution and he points out that six patients, 22 percent
`of his cohort, achieved complete remission. He concluded that it was
`possible to obtain clinical and micrological cures of onychomycosis
`using topical therapy alone.
`If we go to slide 24. I'm sorry, slide 34.
`Reference 11 cited in this article in Exhibit 1503 is the Hay
`publication that is one of the primary references. The ticonazole product
`was sold as Trosyl by Pfizer in the U.K. and was reported to have cure
`rates from 20 percent to 70 percent.
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`Now, if we go to slide 28.
`Patent Owner has emphasized that, well, efinaconazole is a
`triazole. However, Patent Owner's expert admitted that the broad
`formula in the description of the invention as well as the formula in
`Claim 1 of the '506 patent includes both imidazoles and triazoles. And,
`moreover, as pointed out on this slide, in a 1995 publication, Exhibit
`1502, Dr. Elewski touted multiple advantages of triazole antifungals over
`other azoles.
`If we go to slide 29.
`Patent Owner would like the Board to conclude that because
`Loceryl, the amorolfine product, was not approved by the FDA, it was
`ineffective, even though it was approved in the U.K. and numerous other
`countries.
`On cross examination Dr. Elewski admitted that this argument
`was based on pure speculation. There is no evidence in the record and
`she certainly didn't know whether an application had even been
`submitted. If it wasn't submitted, why. If it was submitted, why wasn't it
`approved. We all know there are many reasons a pharmaceutical
`company might decide not to pursue a product and the lack of FDA
`approval here, particularly given that this product was approved in the
`U.K. and I think 91 other countries, is probative of nothing.
`Slide 38 refers to the Institution Decision and the Board pointed
`out that the secondary reference, the Kaken Abstracts, show that
`efinaconazole was effective at least with respect to the skin in treating
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`fungal infections and that the '506 claims encompass treating the skin
`structures associated with the nail.
`And if we go to slide 40.
`The Kaken Abstracts disclose that efinaconazole designated
`KP-103 has a broad spectrum of antifungal activity. It's highly potent
`against T. mentagrophytes, a species that causes onychomycosis.
`Now, Patent Owner argues that the Kaken Abstracts show that
`efinaconazole was not much more potent than -- or was not more potent
`than other tested antifungals and, therefore, they argue that there would
`have been no reason to use it. But what Patent Owner overlooks or
`glosses over is that this -- the point of these references was to emphasize
`that unlike most antifungals, efinaconazole retained its activity in the
`presence of keratin and that it maintained its activity in the keratinized
`horny layer where the fungi reside.
`I would refer the Board to the summary in this Exhibit 1015.
`That is hardly a summary that is directing POSAs away from
`efinaconazole. It's describing efinaconazole as a new antifungal having
`very desirable characteristics and properties, and a person skilled in the
`art knowing these properties would have understood the value of this
`drug and the topical treatment of onychomycosis, particularly forms of
`the disease that are encompassed by the claim like white superficial
`onychomycosis and early stage DSO.
`JUDGE MITCHELL: Mr. Figg, let me ask you this: So for the
`efinaconazole, does it have very similar properties to the ticonazole that
`was used in what you're terming the primary references?
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`MR. FIGG: Ticonazole is an imidazole, so it's got two
`nitrogens in the heterocyclic ring. They are both antifungal agents, but
`the advantage of efinaconazole that's demonstrated by the Kaken
`references and the Ogura article are that it maintains its activity in
`keratinized tissues and it doesn't bind strongly to keratin, which means
`it's able to be distributed throughout those keratinized tissues. So it was
`an improvement.
`We don't dispute that use of efinaconazole was an improvement
`over these earlier topicals. That's what people were looking for. The
`Kaken Abstracts told us it was going to be an improvement. So the
`improvement that we see was not unexpected. It was one that was
`expected and that would have motivated people to use that drug.
`JUDGE MITCHELL: Well, how do you address Patent
`Owner's argument that, you know, in looking at the affinity for the
`keratin layer, what the efinaconazole has, would have actually taught
`away? You wouldn't have looked to that because it wasn't -- it didn't
`have the affinity for the keratin other ones did.
`MR. FIGG: If we look at that argument and we look at Dr.
`Elewski's testimony on which it is based, all of the references on which
`they rely for that point dealt with drugs for the systemic treatment, oral
`drugs for the systemic treatment of efinaconazole. And as Dr. Elewski
`acknowledged on cross examination, when you're administering an oral
`drug, you do want that drug to target the tissue where the infection
`occurs. I asked her a hypothetical, if you're developing a drug for
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`treating the spleen, it would be nice to have a drug that targets tissues in
`the spleen.
`And the reason for that, of course, is that the drug is very dilute
`when it's distributed through the whole body, but if it targets the infected
`tissue, it is concentrated there and that's why keratin affinity was a
`desirable property for oral drugs. But as has been explained in our expert
`reports, strong keratin binding which was seen with these prior art drugs
`would be recognized as a disadvantage because that would prevent the
`drug from actually penetrating the keratinized tissues and would prevent
`it from being distributed throughout those tissues and the -- that was
`made very clear in the Kaken Abstracts.
`They were not talking about keratin binding as an undesirable
`property. They were talking about low keratin binding as a very
`desirable property. Because in the horny layer of the skin and the nail
`and the hair, it's not going to inactivate the drug as it did with these prior
`art topical drugs.
`JUDGE MITCHELL: Do you have a cite to the expert report?
`Sorry to put you on the spot.
`MR. FIGG: I'm sorry, Your Honor?
`JUDGE MITCHELL: Do you have a cite to your expert report
`where your expert is discussing what you just said? And that's fine if you
`get it later.
`MR. FIGG: I'll get it and give it to you in rebuttal.
`I just wanted to mention -- if we go to slide 44 -- the fact that
`the efinaconazole had a very broad spectrum of antifungal activity is
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`reported -- which is reported in the Kaken Abstracts and Ogura was
`known to be a desirable property for onychomycosis therapy, and that's
`emphasized in this 1995 article, Exhibit 1502, published by Dr. Elewski
`and also in Exhibit 2077, another article published in the late 1990s.
`Your Honor, unless you have further questions, I'd like to
`reserve the remainder of my time.
`JUDGE MITCHELL: Sure. Thank you.
`MR. FIGG: Okay. Thank you.
`MR. LIVINGSTONE: Your Honors, while we get the
`computer switched around, we have some hard copy demonstratives.
`Would you like us to pass them up?
`JUDGE MITCHELL: Oh, great. Yes. Thank you.
`MR. LIVINGSTONE: While we're getting these technical
`issues figured out, we will reserve five minutes of our time for our
`Motion to Exclude.
`JUDGE MITCHELL: Okay.
`MR. LIVINGSTONE: All right. Your Honors, may it please
`the Board. There are four fundamental flaws with Petitioners'
`obviousness allegations. First, as you heard Mr. Figg discuss claim
`construction just a minute ago, they push for a claim construction of the
`term "onychomycosis" that is divorced from the intrinsic record and the
`way that those of skill in the art and, indeed, the experts in this case
`understand, use and define that term.
`The record makes clear that the term "onychomycosis" requires
`an infection of at least the nail plate. That's important because the second
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`flaw is that the only data in the prior art related to efinaconazole is skin
`data. There was no data in the nail plate.
`Petitioners cannot point to anything showing that those of skill
`in the art believe the efficacy of an antifungal in skin could be correlated
`or translated to efficacy in an onychomycotic model. In fact, the
`overwhelming evidence is to the contrary.
`Third, Petitioners repeatedly chant this mantra of four or five
`different properties that efinaconazole has to support their alleged
`motivation for picking it out of the vast array of antifungals that were in
`the art, but they can show no prior art recognition that the combination of
`those properties was advantageous for the topical treatment of
`onychomycosis. In fact, they got that mantra from post-invention articles
`by people often associated with the molecule, trying to figure out the
`source of efinaconazole's surprising efficacy.
`And even if there was a motivation to choose efinaconazole,
`there would be no reasonable expectation of success because all of the
`experts agree to determine whether a compound would work in nail you
`have to test it there. And the fourth fundamental flaw and perhaps the
`most powerful is the real-world objective story of this molecule.
`Kaken disclosed the drug's properties in the Kaken Abstracts in
`1996, all of the properties that were emphasized, as Mr. Figg notes, in
`those abstracts are out there in the art. They tried to license the
`compound. Nobody would bite. Indeed, the record shows that no one,
`not even Kaken, recognized efinaconazole's potential as a topical
`treatment for onychomycosis until Kaken ran the appropriate tests years
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`later and that those in the art objectively ignored efinaconazole and its
`properties is telling. Because at the time of the invention, those in the art
`were searching for a topical treatment.
`If we look here at demonstrative 3 at the bottom here, this is a
`1999 article that says effective topical therapy directly applied to the nail
`plate would be an attractive alternative with the additional benefit of
`complete absence of systemic side effects and drug interactions. So the
`goal was clear. And with that goal in mind, those in the art who were
`charged with finding a topical never looked at efinaconazole. They never
`recognized its properties and they never went forward with it.
`Now, as often happens in these case and proceedings, the Board
`is faced with a Petitioner that has some expert and the Patent Owner that
`has some experts and you have to figure out who you should listen to.
`Just let me tell you real quickly why I think you should listen to our
`expert.
`
`Dr. Boni Elewski is a doctor at the Ohio State University
`College of Medicine or she got her M.D. back in '78. She is and was at
`the time of the invention a world-leading expert in onychomycosis. She
`has decades of experience treating patients and evaluating new treatments
`in the clinic.
`If you go to slide 11.
`At the time of the invention, right at the time of the invention
`she wrote a seminal review article here that Mr. Figg has quoted called
`Onychomycosis: Pathogenesis, Diagnosis, and Management, and her
`opinions here today are consistent with her contemporaneous
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`observations of the level o
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