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` Paper 17
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` Entered: February 22, 2016
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`Trials@uspto.gov
`571-272-7822
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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
`
`
`
`Before TONI R. SCHEINER, LORA M. GREEN, and
`JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.
`
`SCHEINER, Administrative Patent Judge.
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
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`IPR2015-01718
`Patent 8,945,621 B2
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`I. INTRODUCTION
`The Coalition for Affordable Drugs VII LLC (“Petitioner”) filed a
`Petition (Paper 1, “Pet.”) on August 12, 2015, requesting an inter partes
`review of claims 1–16 of U.S. Patent No. 8,945,621 B2 (Ex. 1001, “the ’621
`patent”). Pozen Inc. (“Patent Owner”) filed a Preliminary Response (Paper
`15, “Prelim. Resp.”) on November 23, 2015. We have jurisdiction under
`35 U.S.C. § 314, which provides that an inter partes review may not be
`instituted “unless . . . there is a reasonable likelihood that the petitioner
`would prevail with respect to at least 1 of the claims challenged in the
`petition.”
`Upon consideration of the information presented in the Petition and
`the Preliminary Response, we are persuaded that Petitioner has established a
`reasonable likelihood that it would prevail in its challenges to claims 1–16 of
`the ’621 patent. Accordingly, we institute an inter partes review of those
`claims.
`
`A. Related Proceedings
`Petitioner represents it is unaware of any judicial or administrative
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`matters involving the ’621 patent. However, Petitioner represents that the
`’621 patent is listed in the Food and Drug Administration’s Orange Book for
`Vimovo®, and Petitioner has filed other Petitions for inter partes review
`involving patents also listed in the Orange Book for Vimovo®, including
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`IPR2105-01241, IPR2015-01344, and IPR2015-01680. Pet. 2–3; see also
`Paper 7 (listing four district court matters involving Patent Owner).
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`B. The Asserted Grounds of Unpatentability
`Petitioner asserts the challenged claims are unpatentable on the
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`following grounds. Pet. 4–5, 10–52.1
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`References
`
`Basis
`
`Claims Challenged
`
`Plachetka,2 Graham,3 and
`Goldstein4
`Plachetka
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`§ 103(a)
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`1–16
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`§ 103(a)
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`1–16
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`C. The ’621 Patent (Ex. 1001)
`According to the ’621 patent—titled “METHOD FOR TREATING A
`PATIENT AT RISK FOR DEVELOPING AN NSAID-ASSOCIATED ULCER”—the
`
`
`1 Petitioner supports its challenges with the Declaration of Leon Shargel,
`Ph.D., R.Ph., executed August 12, 2015 (“Shargel Declaration”) (Ex. 1003).
`2 U.S. Patent No. 6,926,907 B2, issued August 9, 2005 to Plachetka
`(“Plachetka”) (Ex. 1004).
`3 David Y. Graham et al., Ulcer Prevention in Long-term Users of
`Nonsteroidal Anti-inflammatory Drugs, 162 ARCH. INTERN MED. 169–175
`(2002) (“Graham”) (Ex. 1005).
`4 Jay L. Goldstein et al., Ulcer Recurrence in High-Risk Patients Receiving
`Nonsteroidal Anti-Inflammatory Drugs Plus Low-Dose Aspirin: Results of a
`Post Hoc Subanalysis, 26 CLINICAL THERAPEUTICS 1637–1643 (2004)
`(“Goldstein”) (Ex. 1006).
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`cumulative incidence of gastroduodenal ulcers (GDUs) with conventional
`non-steroidal anti-inflammatory drug (NSAID) use has been reported to be
`as high as 25–30% at 3 months and 45% at 6 months versus 3–7% for
`placebo, and at any given time, the incidence of upper gastrointestinal (UGI)
`ulcers in NSAID users has been estimated to be as high as 30%. Id. at 1:25–
`30. Further according to the ’621 patent, “[t]he risk factors associated with
`an NSAID user developing UGI ulcers include: age ≥ 50 years, history of
`UGI ulcer or bleeding, or concomitant aspirin use.” Ex. 1001, 1:30–32.
`The ’621 patent discloses a pharmaceutical formulation comprising
`immediate release esomeprazole (an acid inhibitor, specifically a proton
`pump inhibitor (PPI)), and enteric-coated naproxen (an NSAID). Id. at
`1:48–50. According to the ’621 patent:
`[T]he pharmaceutical formulation comprising immediate
`release (IR) esomeprazole magnesium and enteric-coated (EC)
`naproxen has been found to reduce the incidence of ulcers in
`patients at risk for developing NSAID-associated ulcers when
`compared to EC-naproxen. Such a formulation has also been
`found to reduce the incidence of ulcers in patients taking low
`dose aspirin (LDA) who are at risk for developing NSAID-
`associated ulcers when compared to EC-naproxen. Furthermore,
`patients taking this new formulation of IR esomeprazole and EC-
`naproxen were able to continue treatment longer than patients
`taking EC-naproxen.
`Id. at 1:48–58. “The term ‘low dose aspirin’ [LDA] refers to dosages
`of aspirin that are ≤ 325 mg.” Id. at 5:9–10.
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`D. Illustrative Claim
`Petitioner challenges claims 1–16 of the ’621 patent, of which claims
`1, 8, 15, and 16 are independent. Claim 1, reproduced below, is illustrative.
`1. A method of reducing the incidence of NSAID-associated
`gastric ulcers in patients taking low dose aspirin who are at risk
`of developing such ulcers, wherein the method comprises
`administering to said patient in need thereof a pharmaceutical
`composition in unit dose form comprising:
`(a) 20 mg of esomeprazole, or pharmaceutically
`acceptable salt thereof, in a form and route sufficient to
`raise the gastric pH of said patient to at least 3.5 upon the
`administration of one or more of said unit dosage forms,
`and
`(b) 500 mg of naproxen, or pharmaceutically acceptable
`salt thereof;
`wherein said unit dose form provides for coordinated
`release of the esomeprazole and the naproxen,
`wherein at least a portion of said esomeprazole, or
`pharmaceutically acceptable salt thereof, is released
`independent of the pH of the surrounding medium,
`wherein the unit dosage form releases less than 10% of
`the naproxen or a pharmaceutically acceptable salt thereof after
`2 hours when tested using the USP Paddle Method in 1000 ml
`of 0.1N HCl at 75 rpm at 37º C.+/-0.5º C.,
`wherein said pharmaceutical composition in unit dose
`form reduces the incidence of NSAID-associated ulcers in said
`patient and wherein administration of the unit dose form is
`more effective at reducing the incidence of the NSAID-
`associated ulcers in patients taking LDA than in patients not
`taking LDA who are administered the unit dose form.
`Ex. 1001, 26:61–27:20 (emphasis added).
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`II. ANALYSIS
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`A. Claim Construction
`We determine that no claim term requires express construction for
`purposes of this Decision.
`
`B. Claims 1–18—Asserted Obviousness over Plachetka,
`Graham, and Goldstein
`1. Plachetka (Ex. 1004)
`Plachetka teaches that NSAIDs are effective agents for controlling
`pain, but their administration can lead to the development of gastroduodenal
`lesions, e.g., ulcers and erosions, in susceptible individuals. Ex. 1004, 1:22–
`26. According to Plachetka,
`Attempts to develop NSAIDs that are inherently less toxic
`to the gastrointestinal tract have met with only limited success.
`For example . . . cyclooxygenase-2 (COX-2) inhibitors show a
`reduced tendency to produce gastrointestinal ulcers and erosions,
`but a significant risk is still present, especially of the patient is
`exposed to other ulcerogens . . . In this regard, it appears that
`even low doses of aspirin will negate most of the benefit relating
`to lower gastrointestinal lesions.
`Id. at 2:31–40.
`Plachetka discloses a “method for reducing the risk of gastrointestinal
`side effects in people taking NSAIDs for pain relief and for other conditions,
`particularly during chronic treatment.” Id. at 3:3–6. Plachetka’s method
`involves administering a pharmaceutical composition in unit-dose form “that
`combines: a) an agent that actively raises intragastric pH to levels associated
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`with less risk of NSAID-induced ulcers; and b) an NSAID . . . specifically
`formulated to be released in a coordinated way that minimizes the adverse
`effects of the NSAID on the gastroduodenal mucosa.” Id. at 3:8–13.
`According to Plachetka, “[t]his method has the added benefit of being able
`to protect patients from other gastrointestinal ulcerogens whose effect may
`otherwise be enhanced by the disruption of gastroprotective prostaglandins
`due to NSAID therapy.” Id. at 3:12–17.
`Specifically, Plachetka discloses administering “a pharmaceutical
`composition in unit dosage form suitable for oral administration . . .
`contain[ing] an acid inhibitor present in an amount effective to raise the
`gastric pH of a patient to at least 3.5” (id. at 3:18–22), and an enteric-coated
`NSAID “in an amount effective to reduce or eliminate pain or inflammation”
`(id. at 3:39–41).
`Plachetka’s preferred acid inhibiters are H2-blockers, such as
`famotidine, cimetidine, ranitidine, ebrotidine, pabutidine, lafutidine, and
`loxtidine. Id. at 3:32–34. “Other agents that may be effectively used
`include proton pump inhibitors such as omeprazole, esomeprazole,
`pantoprazole, lansoprazole or rabeprazole.” Id. at 3:36–38.
`Typical amounts for H2 blockers are: cimetidine, 100 to 800
`mg/unit dose; ranitidine, 50–300 mg/unit dose; famotidine, 5–
`100 mg/unit dose; ebrotidine 400–800 mg/unit dose; pabutidine
`40 mg/unit dose; lafutidine 5–20 mg/unit dose; and nizatidine,
`50–600 mg/unit dose. Proton pump inhibitors will typically be
`present at about 5 mg to 600 mg per unit dose. For example . . .
`omeprazole should be present in tablets or capsules in an amount
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`from 5 to 50 mg, with about 20 mg per unit dosage form being
`preferred. Other typical amounts are: esomeprazole, 5–100 mg,
`with about 40 mg per unit dosage form being preferred;
`lansoprazole, 15–150 mg, with about 30 mg per unit dosage form
`being preferred; pantoprazole, 10–200 mg, with about 40 mg per
`unit dosage form being preferred; and rabeprazole, 5–100 mg,
`with about 20 mg per unit dosage form being preferred.
`Id. at 7:2–18.
`The NSAID in Plachetka’s unit-dosage form “may be a COX-2
`inhibitor such as celecoxib, rofecoxib, meloxicam, piroxicam, valdecoxib,
`parecoxib, etoricoxib . . . [or] may be aspirin, acetaminophen, ibuprofen,
`flurbiprofen, ketoprofen, naproxen, oxaprozin, etodolac, indomethacin,
`ketorolac, lornoxicam, nabumetone, or diclofenac.” Id. at 3:41–47. “The
`most preferred NSAID is naproxen in an amount of between 50 mg and
`1500 mg, and more preferably, in an amount of between 200 mg and 600
`mg.” Id. at 3:48–50.
`Plachetka discloses several specific unit dosage forms in which an
`acid inhibitor is released from the unit dosage form immediately upon
`administration to a patient, while an enteric layer prevents release of the
`NSAID until the local pH is above about 4. For example, Plachetka
`discloses a unit dosage form with an enteric-coated naproxen core
`surrounded by an immediate-release layer of the H2-blocker, famotidine, and
`another dosage form with an enteric-coated naproxen core surrounded by an
`immediate-release layer of the proton pump inhibitor, omeprazole. Id. at
`8:14–67, 14:40–15:17.
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`2. Graham (Ex. 1005)
`Graham discloses the results of a prospective, double-blind, active-
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`and placebo-controlled study of the effectiveness of misoprostol (a synthetic
`prostaglandin) versus lansoprazole (a proton pump inhibitor) in preventing
`gastric ulcers in long-term NSAID users. Ex. 1005, 169. The criteria for
`study participants included “treatment with stable, full-therapeutic doses of
`an NSAID (with the exception of nabumetone or aspirin [≥ 1300 mg/d; low-
`dose aspirin for cardiovascular protection was permitted]) for at least the
`previous month.” Id. at 170. “Forty percent of the patients used ibuprofen,
`35% used naproxen, 32% used diclofenac, 22% used aspirin or aspirin
`combinations, 17% used piroxicam, and 34% used other NSAIDs” and
`“[p]atients could have taken more than 1 NSAID.” Id. at 171.
`
`According to Graham, “[p]roton pump inhibitors such as lansoprazole
`are superior to placebo for the prevention of NSAID-induced gastric ulcers
`but not superior to misoprostol, 800 µg/d.” Id. at 169. However, Graham
`concluded that proton pump inhibitors and misoprostol are clinically
`equivalent, when the poor compliance and potential adverse side effects
`associated with full-dose misoprostol are considered. Id.
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`3. Goldstein (Ex. 1006)
`Goldstein discloses a post hoc subanalysis of Graham’s study (see Ex.
`
`1005, discussed immediately above), “conducted to examine whether the
`efficacy of gastro-protective therapy [with misoprostol or lansoprazole]
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`against ulcer recurrence extends to patients taking concomitant nonspecific
`NSAIDs and low dose aspirin.” Ex. 1006, 1640, n.24. Goldstein’s
`“subanalysis included data from [seventy] patients in [Graham’s] intent-to-
`treat cohort who took aspirin at an amount ≤ 325 mg/d.” Id. at 1637. “The
`most frequently used nonaspirin NSAIDs were ibuprofen, naproxen, and
`diclofenac.” Id. at 1639. Goldstein concluded that “[c]otherapy with
`misoprostol or lansoprazole lowered the risk of ulcer recurrence in these
`high risk individuals.” Id. at 1641.
`
`4. Analysis
`Petitioner provides citations to Plachetka, Graham, and Goldman,
`
`purporting to show where the references disclose various limitations of
`independent claims 1, 8, 15, and 16. Pet. 13–19, 22–25, and 28–33. We
`have reviewed the citations, and are persuaded that Petitioner has shown
`sufficiently, for purposes of this decision, that the limitations of these claims
`are taught or suggested by references, with the possible exceptions discussed
`below.
`Petitioner contends essentially that an ordinary artisan, appreciating
`“the problem of patients developing gastric ulcers when taking both LDA
`and another NSAID as disclosed by Plachetka,” and also being aware of the
`reduced incidence of gastric ulcers in patients taking both LDA and another
`NSAID who were also administered lansoprazole, as disclosed by Graham
`and Goldstein, would have had a reason to administer Plachetka’s
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`coordinated unit dosage form to patients in need of NSAID therapy and at
`risk of developing gastric ulcers, including those patients taking low dose
`aspirin in addition to another NSAID. Pet. 11 (citing Ex. 1004, 2:35–40).
`Petitioner contends that “the results disclosed by Graham and Goldstein
`would indicate that the compositions disclosed in Plachetka could be used
`for treating patients on an LDA regimen to achieve the predictable result of
`lower gastric ulcer incidence.” Id. at 12.
`
`Patent Owner acknowledges that the ordinary artisan “would have
`appreciated the problem of patients developing gastric ulcers when taking
`both LDA and another NSAID.” Prelim. Resp. 12 (citing Pet. 11; Ex. 1004,
`1:35–40). Patent Owner further acknowledges that Goldstein discloses “for
`patients taking NSAIDs with LDA, that administration of misoprostol or
`lansoprazole reduced the risk of gastric ulcer compared to placebo.” Id. at
`14 (citing Ex. 1006, Abstract).
`At this stage of the proceeding, having considered Petitioner’s and
`Patent Owner’s arguments and observations with respect to this aspect of the
`challenged claims, we are persuaded that Petitioner has shown sufficiently
`that an ordinary artisan would have had a reason to administer Plachetka’s
`coordinated unit dosage form to patients in need of NSAID therapy and at
`risk of developing gastric ulcers—including those patients taking low dose
`aspirin in addition to another NSAID—in order to lower the incidence of
`gastric ulcers.
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`Moreover, on this record, we are persuaded that Petitioner has shown
`sufficiently that the ordinary artisan would have had a reason to administer a
`coordinated release unit dosage form comprising an enteric-coated naproxen
`core surrounded by an immediate release layer of esomeprazole. The record
`before us at this time indicates that Plachetka teaches that naproxen is a
`preferred NSAID in its combination NSAID/acid inhibitor unit dosage
`forms, and esomeprazole is one of a relatively small number of suitable acid
`inhibitors presented as essentially as interchangeable for purposes of
`formulating the unit dosage forms. Moreover, Plachetka discloses ranges for
`the acid inhibitors and NSAIDs that encompass the amounts required by the
`claims. Pet. 18; Ex. 1004, 3:36–38, 48–50, 7:2–18.
`As for the limitation “wherein the unit dosage form releases less than
`10% of the naproxen . . . after 2 hours when tested using the USP Paddle
`Method in 1000 ml of 0.1N HCl at 75 rpm at 37º C. +/-0.5º C.” (the “Paddle
`Method clause”), on this record, it appears that this property would be a
`natural result when testing of a dosage form comprising 500 mg of enteric-
`coated naproxen and 20 mg of esomeprazole. See Pet. 16; Ex. 1001, 26:61–
`27:13. At this stage of the proceeding, Patent Owner does not contest this
`point. Prelim. Resp. 18–22.
`As for Petitioner’s contentions with respect to the limitations recited
`in dependent claims 2–7 and 9–14, we have reviewed the Petition and the
`cited art and are persuaded that Petitioner has shown sufficiently that these
`limitations are taught or suggested by the art relied on. For example, claim 2
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`depends from claim 1 and requires that “the risk is associated with chronic
`NSAID treatment,” and Petitioner points out that “Plachetka discloses ‘a risk
`of gastrointestinal side effects in people taking NSAIDs . . . particularly
`during chronic treatment.’” Pet. 20 (citing Ex. 1004, 3:3–6). Similarly,
`claim 4 depends from claim 1 and specifies that the “patient is treated for a
`disease or disorder selected from osteoarthritis, rheumatoid arthritis,
`ankylosing spondylitis, and a combination thereof,” and Petitioner notes that
`Plachetka discloses “methods of treating a patient for . . . osteoarthritis or
`rheumatoid arthritis.” Id. (citing Ex. 1004, 4:18–23).
`
`Nevertheless, Patent Owner contends that the cited art does not teach
`or suggest the final clause of the independent claims (the “final wherein
`clause”). That is, Patent Owner contends that the cited art would not have
`led the ordinary artisan to expect that administering the specific unit dose
`form of the challenged claims to patients taking an NSAID and LDA would
`be “more effective at reducing the incidence of the NSAID-associated ulcers
`in patients taking LDA than in patients not taking LDA who are
`administered the unit dose form,” as required by each of the challenged
`claims. Prelim. Resp. 12 (emphasis added). Specifically, Patent Owner
`contends:
`There is no indication that a POSA would have found obvious a
`reduction in the incidence of NSAID-associated gastric ulcers in
`patients taking LDA compared to patients not taking LDA as a
`result of the administration of a unit dose form providing
`coordinated
`release of 500 mg of naproxen, or a
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`pharmaceutically acceptable salt thereof, and 20 mg of
`esomeprazole, or a pharmaceutically acceptable salt thereof.
`Id. at 17. According to Patent Owner, “neither Graham nor Goldstein
`reports data for a group of study participants taking NSAID and lansoprazole
`but not LDA” and “[n]either reference makes any effort to compare patient
`populations taking LDA with those not taking LDA.” Id. at 14. In addition,
`Patent Owner contends that the references would not have taught the
`ordinary artisan “anything regarding the effect of the use of naproxen and
`esomeprazole, let alone the use of a unit dosage form providing the
`coordinated release of 500 mg delayed release naproxen and 20 mg
`immediate release esomeprazole, as claimed in the ‘’621 patent, on patients
`on an LDA regimen.” Id.
`
`We agree with Patent Owner that Petitioner has not established that
`Plachetka, Graham, and Goldstein teach or suggest that “administration of
`the unit dose form is more effective at reducing the incidence of the NSAID-
`associated ulcers in patients taking LDA than in patients not taking LDA
`who are administered the unit dose form,” as required by each of
`independent claims 1, 8, 15, and 16 (emphasis added).
`Although Petitioner asserts that “Plachetka in view of Graham and
`Goldstein discloses this limitation” (Pet 17 (citing Ex. 1033 ¶ 82)), neither
`Petitioner, nor Petitioner’s witness, Dr. Shargel, identifies sufficiently the
`basis for this assertion. For example, according to Petitioner,
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`Graham and Goldstein disclose that 6.25% of patients taking a
`combination of 15 mg of lansoprazole and an NSAID with LDA
`have gastric ulcers, while 23% of patients taking a combination
`of 15 mg of lansoprazole and an NSAID without LDA have
`gastric ulcers. . . . Similarly, Graham and Goldstein disclose that
`0% of patients taking a combination of 30 mg of lansoprazole
`and an NSAID with LDA have gastric ulcers, while 17% of
`patients taking a combination of 30 mg of lansoprazole and an
`NSAID without LDA have gastric ulcers.
`Pet. 17–18 (citing Ex. 1003 ¶ 83). Paragraph 83 of Dr. Shargel’s declaration
`is virtually identical to the Petition. Neither Petitioner nor Dr. Shargel
`identifies the basis for these purported results, much less the basis for the
`conclusion that an ordinary artisan “would have understood that a
`combination of lansoprazole and naproxen was more effective at reducing
`the incidence of the NSAID-associated ulcers in patients taking LDA than in
`patients not taking LDA.” Id. at 18 (citing Ex. 1003 ¶ 83). “Expert
`testimony that does not disclose the underlying facts or data on which the
`opinion is based is entitled to little or no weight”—accordingly, we are not
`persuaded by these conclusory and unsupported statements by Petitioner or
`Dr. Shargel. See 37 C.F.R. § 42.65(a).
`
`Nevertheless, an underlying issue—not yet addressed on this record—
`is whether or not the “final wherein clause” of the independent claims is
`entitled to patentable weight. As the Court of Appeals for the Federal
`Circuit has stated, “[a] ‘whereby’ clause that merely states the result of the
`limitations in the claim adds nothing to the patentability or substance of the
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`claim.” Texas Instruments, Inc. v. U.S. Int’l Trade Comm’n., 988 F.2d 1165,
`1172 (Fed. Cir. 1993). See also, Minton v. National Ass’n of Securities
`Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003) (“the term ‘efficiently’
`[in the whereby clause] on its face does not inform the mechanics of how the
`trade is executed. . . . Rather the term ‘efficiently’ is a laudatory one
`characterizing the result of the executing step.”). Although the challenged
`claims use the word “wherein,” rather than the word “whereby” as in the
`claims in Texas Instruments and Minton, the effect is the same if the clause
`merely states the result of the method steps and does not further inform the
`mechanics of the method or the structure of the dosage form administered.
`Cf. Griffin v. Bertina, 285 F.3d 1029, 1034 (Fed. Cir. 2002) (finding that a
`“wherein” clause limited a method claim because the clause gave “meaning
`and purpose to the manipulative steps”). Again, this issue has not yet been
`addressed at this stage of the proceeding.
`Accordingly, on the record as it presently stands, we are persuaded
`that there is a reasonable likelihood that Petitioner would prevail in its
`challenge of claims 1–16 on the basis of obviousness over Plachetka,
`Graham, and Goldstein.
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`C. Claims 1–16—Asserted Obviousness over Plachetka
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`1. Analysis
`Petitioner alternatively contends that
`Plachetka recognizes that NSAID “administration can lead to the
`development of gastroduodenal lesions, e.g., ulcers and erosions,
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`in susceptible individuals.” . . . Plachetka also recognizes that
`“[a]ttempts to develop NSAIDs that are inherently less toxic to
`the gastrointestinal tract have met with only limited success.”
`. . . This limited success is due, in part, because even a patient’s
`LDA regimen (e.g., chronic treatment with LDA for
`cardiovascular prophylaxis) may negate most of the lower
`gastrointestinal lesion benefits of less toxic NSAIDs. . . .
`Accordingly, Plachetka discloses that its invention is directed to
`“a new method for reducing the risk of gastrointestinal side
`effects in people taking NSAIDs for pain relief and for other
`conditions, particularly during chronic treatment.” . . . Based
`on the foregoing, a POSA would have understood Plachetka to
`disclose claim 1’s “method of reducing the incidence of NSAID-
`associated gastric ulcers in patients taking low dose aspirin who
`are at risk of developing such ulcers” because Plachetka
`identified the problem of adverse effects of chronic LDA usage
`on NSAID administration . . . and indicated its invention was
`directed at methods of addressing that problem. (Ex. 1003, ¶ 163.
`See Ex. 1004, col. 1, ll. 11-19 and col. 3, ll. 1-6.)
`Pet. 33–34 (citing Ex. 1004, 1:11–19, 1:23–25, 2:31–33, 2:35–40, 3:1–6; Ex.
`1003 ¶ 163).
`Essentially, Petitioner contends that the particular unit dosage form
`required by the challenged claims would have been obvious over Plachetka’s
`disclosure that esomeprazole in amounts between 5 and 100 mg is suitable
`for the immediate release layer of its dosage form, while enteric-coated
`naproxen in amounts between 200 and 600 mg is preferred for the core of
`the dosage form—and that it would have been obvious for the ordinary
`artisan to administer the dosage form to patients in need of NSAID therapy,
`and also taking LDA, given Plachetka’s recognition of “the problem of
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`adverse effects of chronic LDA usage on NSAID administration.” Id. at 34–
`36 (citing Ex. 1003 ¶¶ 163, 164, 166, 168, 170; Ex. 1004, 2:35–40, 3:19-36,
`39–59, 4:18–20, 6:6–11, 7:7–13, 21:46–22:17).
`More importantly, however, Petitioner contends in this ground that the
`“Paddle Release” and “final wherein” clauses of the challenged claims
`reflect nothing more than the natural result of the obvious combination of
`elements explicitly disclosed by Plachetka. Pet. 40. That is, Petitioner
`contends that these clauses reflect the inherent result of an obvious
`combination.
`Patent Owner contends that “Plachetka provides no rationale for the
`use of 20 mg esomeprazole combined with 500 mg naproxen for the
`treatment of patients taking LDA as recited in the claims of the ’621 patent.”
`Prelim. Resp. 22. On this record, however, Petitioner reasonably contends
`that the ordinary artisan would have had a reason to combine any of the
`various acid inhibitors and NSAIDs, in amounts within the ranges taught by
`Plachetka, in a unit dosage form for immediate release of the acid inhibitor
`and controlled release of the enteric-coated NSAID—and also would have
`had a reason to administer the unit dosage form to a patient in need of
`NSAID therapy, whether or not the patient was taking LDA.
`As for Petitioner’s assertion that the “Paddle Method” and “final
`wherein” clauses represent the inherent result of an obvious combination, the
`Federal Circuit states in PAR Pharmaceutical, Inc. v. TWI Pharmaceuticals,
`Inc., 773 F.3d 1186 (Fed. Cir. 2014) that “inherency may supply a missing
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`claim limitation in an obvious analysis.” Id. at 1194–95 (citing Santarus,
`Inc. v. PAR Pharm., Inc., 694 F.3d 1344, 1354 (Fed. Cir. 2012); In re Kao,
`639 F.3d 1057, 1070 (Fed. Cir. 2011)). However, “the concept of inherency
`must be limited when applied to obviousness, and is present only when the
`limitation at issue is the ‘natural result’ of the combination of prior art
`elements.” Id. at 1195. We further note, however, that the court in PAR
`emphasized that the limitation at issue in Kao “add[ed] nothing of patentable
`consequence,” and in Santarus, “neither party disputed that the blood serum
`concentrations claimed . . . were expected in light of the dosages disclosed in
`the prior art.” Id. On the record before us, Petitioner reasonably contends
`that both the Paddle Method and “final wherein” clause limitations would
`have naturally resulted from using the recited pharmaceutical composition.
`Pet. 37–40.
`
`Here, to overcome any information before us indicating obviousness
`(including obviousness by inherency), Patent Owner contends that it
`provides evidence showing surprising and unexpected results of the claimed
`methods of the ’621 patent (i.e., the final wherein clause), as presented in the
`specification and the file history of the ’621 patent, a declaration submitted
`during prosecution of a continuation application claiming the benefit the
`’621 patent, as well as post-filing date scientific publications. Prelim. Resp.
`9 (citing Ex. 1002 Part A, 27, 66, 78, 95–101, 104–107), 23–29 (citing Ex.
`1001, 17:21–44, Tables 3, 5; Ex. 2002, 1505; Ex. 2004, 465, 470; Ex. 2005,
`1; Ex. 2007, 1–2). Patent Owner contends that “Petitioner’s blunt
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`characterization of the data presented in the specification as ‘expected’
`simply fails to overcome the Patent Owner’s convincing and overwhelming
`evidence supporting the surprising and [un]expected results of the claimed
`methods.” Id. Based on the record before us and the state of the case at this
`time, however, we determine that the issue of whether secondary
`considerations, including surprising and unexpected results, overcomes a
`possible showing of obviousness is an issue for trial.
`Moreover, as discussed above in connection with the previous ground,
`an underlying issue—not yet addressed on this record—is whether or not the
`“final wherein clause” of the independent claims is entitled to patentable
`weight. If the final “wherein” clause is entitled to patentable weight and/or
`any challenged claims otherwise appear obvious, we note that evidence of
`secondary considerations—in this case, unexpected results—must be taken
`into account, and may or may not be sufficient to confer patentability upon a
`showing of obviousness. See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348,
`1372 (Fed. Cir. 2007) (“[W]e hold that even if Pfizer showed that
`amlodipine besylate exhibits unexpectedly superior results, this secondary
`consideration does not overcome the strong showing of obviousness in this
`case. Although secondary considerations must be taken into account, they
`do not necessarily control the obviousness conclusion.”).
`Accordingly, on the record as it presently stands, we are persuaded
`that there is a reasonable likelihood that Petitioner would prevail in its
`challenge of claims 1–16 on the basis of obviousness over Plachetka.
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`III. CONCLUSION
`For the foregoing reasons, we are persuaded that the Petition
`establishes a reasonable likelihood that Petitioner would prevail in showing
`claims 1–16 of the ’621 patent are unpatentable under 35 U.S.C. § 103(a).
`We emphasize, however, that we have not made a final determination with
`respect to the patentability of any claim.
`
`IV. ORDER
`
`Accordingly, it is:
`
`ORDERED that, pursuant to 35 U.S.C. § 314(a), an inter partes
`
`review is instituted as to claims 1–16 of the ’621 patent on the following
`grounds of unpatentability:
`1.
`Claims 1–16 under 35 U.S.C. § 103(a) as obvious over
`Plachetka, Graham, and Goldstein; and
`2.
`Claims 1–16 under 35 U.S.C. § 103(a) as obvious over
`Plachetka; and
`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(c) and
`
`37 C.F.R. § 42.4, notice is hereby given of the institution of a trial, which
`commences on the entry date of this Decision.
`
`
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`For PETITIONER:
`Jerry C. Harris, Jr.
`Amy E. LaValle
`WICK PHILLIPS GOULD & MARTIN, LLP
`CFAD.IPRs@wickphillips.com
`
`For PATENT OWNER:
`Stephen M. Hash
`Margaret J. Sampson
`Jeffrey S. Gritton
`BAKER BOTTS LLP
`stephen.hash@bakerbotts.com
`margaret.sampson@bakerbotts.co
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