Trials@uspto.gov
`571-272-7822
`
` Paper: 73
`Entered: March 9, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`COALITION FOR AFFORDABLE DRUGS (ADROCA) LLC,
`Petitioner,
`
`v.
`
`ACORDA THERAPEUTICS, INC.,
`Patent Owner.
`
`Case IPR2015-01850 (Patent 8,440,703 B2)
`Case IPR2015-01853 (Patent 8,007,826 B2)
`Case IPR2015-01857 (Patent 8,663,685 B2)
`Case IPR2015-01858 (Patent 8,354,437 B2)1
`
`Before JACQUELINE WRIGHT BONILLA, Vice Chief Administrative
`Patent Judge,
`LORA M. GREEN and SUSAN L. C. MITCHELL, Administrative Patent
`Judges.
`
`MITCHELL, Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318 and 37 C.F.R. § 42.73
`
`1 Because resolution of issues common to all four inter partes reviews
`resolves the outstanding disputes between the parties with respect to all
`challenged claims of the four patents at issue, we exercise our discretion to
`issue a single Final Written Decision to be entered in each case.
`
`
`571-272-7822
`
` Paper: 73
`Entered: March 9, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`COALITION FOR AFFORDABLE DRUGS (ADROCA) LLC,
`Petitioner,
`
`v.
`
`ACORDA THERAPEUTICS, INC.,
`Patent Owner.
`
`Case IPR2015-01850 (Patent 8,440,703 B2)
`Case IPR2015-01853 (Patent 8,007,826 B2)
`Case IPR2015-01857 (Patent 8,663,685 B2)
`Case IPR2015-01858 (Patent 8,354,437 B2)1
`
`Before JACQUELINE WRIGHT BONILLA, Vice Chief Administrative
`Patent Judge,
`LORA M. GREEN and SUSAN L. C. MITCHELL, Administrative Patent
`Judges.
`
`MITCHELL, Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318 and 37 C.F.R. § 42.73
`
`1 Because resolution of issues common to all four inter partes reviews
`resolves the outstanding disputes between the parties with respect to all
`challenged claims of the four patents at issue, we exercise our discretion to
`issue a single Final Written Decision to be entered in each case.
`
`
`
`Case IPR2015-01850 (Patent 8,440,703 B2)
`Case IPR2015-01853 (Patent 8,007,826 B2)
`Case IPR2015-01857 (Patent 8,663,685 B2)
`Case IPR2015-01858 (Patent 8,354,437 B2)
`
`
`
`I. INTRODUCTION
`This is a Final Written Decision in four inter partes reviews
`IPR2015-01850, IPR2015-01853, IPR2015-01857, and IPR2015-01858.
`IPR2015-01850 involves review of claims 1–52 of U.S. Patent No.
`8,440,703 B2 (Ex. 1001, “the ’703 patent). As this case is representative of
`the dispositive issues in all four inter partes reviews, we will refer to the
`papers in IPR2015-01850 unless otherwise indicated.
`Coalition for Affordable Drugs (ADROCA), LLC (“Petitioner”), filed
`a Petition (Paper 2, “Pet.”) on September 2, 2015, requesting an inter partes
`review of claims 1–52 of the ’703 patent. Patent Owner, Acorda
`Therapeutics, Inc. (“Patent Owner”) filed a Preliminary Response (Paper 10,
`“Prelim. Resp.”) on December 14, 2015. On March 11, 2015, we instituted
`trial on the following grounds:
`
`Reference(s)
`
`S-12
`S-1 and Hayes3
`
`Basis
`§ 103
`§ 103
`
`Claims Challenged
`1–7, 10, 11, 26–33, 44–46, 52
`8, 9, 12–21, 34–41, 47–49
`
`
`2 Acorda Therapeutics, Inc., Registration Statement under the Securities Act
`of 1933 (Form S-1) (Sept. 26, 2003) (“S-1”) (Ex. 1003).
`3 Keith C. Hayes et al., Pharmacokinetic Studies of Single and Multiple Oral
`Doses of Fampridine-SR (Sustained-Release 4-Aminopyridine) in Patients
`With Chronic Spinal Cord Injury, 26 CLIN. NEUROPHARMACOLCOY 185–92
`(2003) (“Hayes”) (Ex. 1005).
`
`2
`
`
`
`
`Case IPR2015-01850 (Patent 8,440,703 B2)
`Case IPR2015-01853 (Patent 8,007,826 B2)
`Case IPR2015-01857 (Patent 8,663,685 B2)
`Case IPR2015-01858 (Patent 8,354,437 B2)
`
`
`Reference(s)
`S-1 and Juarez4
`
`Basis
`§ 103
`
`Claims Challenged
`22–25, 42, 43, 50, 51
`
`Paper 14 (“Dec. Instit.”), 21. As discussed in more detail below, every
`instituted ground in all four inter partes reviews relies on S-1, either alone or
`in combination with other references.
`Subsequently, Patent Owner filed a Response (Paper 34, “PO Resp.”),
`and Petitioner filed a Reply (Paper 43, “Reply”).5
`Petitioner filed a Motion to Exclude (Paper 56) certain of Patent
`Owner’s exhibits and testimony by Dr. Gregory K. Bell. Paper 56, 1, 15.
`Patent Owner filed an Opposition to the Motion to Exclude (Paper 60), and
`Petitioner filed a Reply (Paper 64).6
`
`
`4 Haydee Juárez et al., Influence of Admixed Carboxymethylcellulose on
`Release of 4-Aminopyridine from Hydroxypropyl Methylcellulose Matrix
`Tablets, 216 INT’L J. PHARM., 115–25 (2001) (“Juarez”) (Ex. 1006).
`5 Both Patent Owner and Petitioner filed the Response and Reply,
`respectively, as confidential with accompanying motions to seal. See Papers
`28, 29, 44, 45. Because we do not need to refer to any confidential
`information in our Final Written Decision, we will reference the public
`versions of the Response and Reply.
`6 Petitioner and Patent Owner filed Objections to Evidence, see Papers 35,
`47, and Patent Owner filed Observations regarding the Cross-Examination
`of Dr. Fairweather, Dr. Pleasure, and Ms. Distler, to which Petitioner filed a
`response, see Papers 58, 63, respectively (public versions). We have
`reviewed these papers and will give the evidence the appropriate weight in
`light of these observations and objections. We do not need to refer to any
`confidential information in our Final Written Decision.
`3
`
`
`
`
`Case IPR2015-01850 (Patent 8,440,703 B2)
`Case IPR2015-01853 (Patent 8,007,826 B2)
`Case IPR2015-01857 (Patent 8,663,685 B2)
`Case IPR2015-01858 (Patent 8,354,437 B2)
`
`
`A final hearing was conducted on January 19, 2016. Paper 68 (“Tr.”).
`We have jurisdiction under 35 U.S.C. § 6. Petitioner bears the burden of
`proving unpatentability of the challenged claims, and that burden never
`shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner must establish
`facts supporting its challenge by a preponderance of the evidence. See 35
`U.S.C. § 316(e); 37 C.F.R. § 42.1(d). This Final Written Decision is issued
`pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`For the reasons that follow, we determine that Petitioner has not
`demonstrated by a preponderance of evidence that claims 1–52 (“the
`challenged claims”) are unpatentable on the instituted grounds.
`
`A. Related Proceedings
`The parties identify a number of judicial matters involving the patents
`
`in the four inter partes proceedings at issue in this Final Written Decision,
`including, among others, Acorda Therapeutics, Inc. v. Mylan Pharm. Inc.,
`No. 1:14-cv-00935 (D. Del); Acorda Therapeutics, Inc. v. Mylan Pharm.
`Inc., No. 1:14-cv-00139 (N.D. W. Va.); Acorda Therapeutics, Inc. v. Accord
`Healthcare Inc., No. 1:14-cv-00932 (D. Del.); and Acorda Therapeutics Inc.
`v. Mylan Pharm. Inc., Case 15-124 (Fed. Cir.). Pet. 2–3; Paper 5, 3–5. The
`parties also identify Case No. IPR2015-00817, previously denying inter
`partes review of U.S. Patent No. 8,007,826 patent, as well as Case No.
`
`4
`
`
`
`
`Case IPR2015-01850 (Patent 8,440,703 B2)
`Case IPR2015-01853 (Patent 8,007,826 B2)
`Case IPR2015-01857 (Patent 8,663,685 B2)
`Case IPR2015-01858 (Patent 8,354,437 B2)
`
`IPR2015-00720, previously denying inter partes review of U.S. Patent No.
`8,663,685. Pet. 3; Paper 5, 2–3.
`
`B. The ’703 Patent (Ex. 1001)
`The ’703 is directed to a sustained release oral dosage of an
`aminopyridine pharmaceutical composition that can be used to treat
`individuals affected with neurological disorders. Ex. 1001, 1:14–16. The
`most preferred aminopyridine is 4-aminopyridine (“4-AP” or “fampridine”).
`Id. at 1:35–41, 2:29–32. According to the ’703 patent, its pharmaceutical
`composition can be used to treat spinal cord injury, multiple sclerosis
`(“MS”), Alzheimer’s disease, and amyotrophic lateral sclerosis (“ALS”). Id.
`at 2:23–27. The composition is said to maximize therapeutic effects while
`minimizing side effects. Id. at 1:17–18.
`In one embodiment of the ’703 patent, the composition is
`administered to patients with MS to increase their walking speed. Id. at
`3:65–4:3. The composition is administered twice daily in an amount of less
`than about 15 milligrams of aminopyridine, preferably about 10 to 15
`milligrams of aminopyridine. Id. at 4:1–5. In other embodiments, the
`composition is said to improve lower extremity muscle tone and lower
`extremity muscle strength in patients with MS. Id. at 4:6–19. The ’703
`states that in responsive patients (approximately 37%), “treatment with
`fampridine at doses of 10–20 mg produced a substantial and persistent
`improvement in walking.” Id. at 29:23–26.
`5
`
`
`
`
`Case IPR2015-01850 (Patent 8,440,703 B2)
`Case IPR2015-01853 (Patent 8,007,826 B2)
`Case IPR2015-01857 (Patent 8,663,685 B2)
`Case IPR2015-01858 (Patent 8,354,437 B2)
`
`
`D. Illustrative Claim
`The ’703 patent contains fifty-two claims, all of which are challenged
`by Petitioner. All fifty-two claims are directed to methods of improving
`lower extremity function in an MS patient in need thereof. Claims 1 and 2
`are the only independent claims. Claims 1 and 2 are illustrative of the
`challenged claims and are reproduced below:
`1. A method of improving lower extremity function in a human
`multiple sclerosis patient in need thereof comprising orally
`administering to said patient a sustained release composition of
`less than 15 milligrams of 4-aminopyridine twice daily for a time
`period of at least two weeks, wherein the amount of said 4-
`aminopyridine administered to said patient in each said
`administering step is the same over said time period.
`
`2. A method of improving lower extremity function in a human
`multiple sclerosis patient in need thereof comprising orally
`administering to said patient a sustained release composition of
`10 milligrams of 4-aminopyridine twice daily for a time period
`of at least two weeks.
`Id. at 29:55–67.
`
`II. ANALYSIS
`A. Claim Construction
`In an inter partes review, claim terms in an unexpired patent are
`interpreted according to their broadest reasonable construction in light of the
`specification of the patent in which they appear. 37 C.F.R. § 42.100(b);
`Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142–46 (2016)
`6
`
`
`
`
`Case IPR2015-01850 (Patent 8,440,703 B2)
`Case IPR2015-01853 (Patent 8,007,826 B2)
`Case IPR2015-01857 (Patent 8,663,685 B2)
`Case IPR2015-01858 (Patent 8,354,437 B2)
`
`(concluding that 37 C.F.R. § 42.100(b) “represents a reasonable exercise of
`the rulemaking authority that Congress delegated to the Patent Office”).
`Under that standard, claim terms generally are given their ordinary and
`customary meaning, as would be understood by one of ordinary skill in the
`art in the context of the entire disclosure. In re Translogic Tech., Inc., 504
`F.3d 1249, 1257 (Fed. Cir. 2007).
`Petitioner asserts constructions for the following claim terms, “less
`than 15 milligrams,” “release profile,” “matrix,” “improving walking,” and
`“initiating treatment.” Pet. 18–19. Patent Owner contends that Petitioner
`has failed to provide an explanation as to why the identified claim terms
`require construction and why the Board should depart from the
`plain and ordinary meaning of the terms. Prelim. Resp. 17, n.4.
`In the Institution Decision, we agreed with Patent Owner and
`determined that it was unnecessary to construe explicitly the claim terms for
`purposes of the Institution Decision. See Dec. Instit. 6 (citing Wellman, Inc.
`v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim
`terms need only be construed ‘to the extent necessary to resolve the
`controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200
`F.3d 795, 803 (Fed. Cir. 1999))). We also determine here that we need not
`construe expressly any claim term in order to issue a Final Written Decision
`regarding the patentability of the challenged claims.
`
`7
`
`
`
`
`Case IPR2015-01850 (Patent 8,440,703 B2)
`Case IPR2015-01853 (Patent 8,007,826 B2)
`Case IPR2015-01857 (Patent 8,663,685 B2)
`Case IPR2015-01858 (Patent 8,354,437 B2)
`
`
`B. The Asserted References
`1. S-1 (Ex. 1003)
`S-1 is an Acorda prospectus SEC filing that describes Acorda’s initial
`public offering of common stock and Acorda’s desire to list their common
`stock on the Nasdaq National Market. Ex. 1003, 27. S-1 describes Acorda
`as a late-stage biopharmaceutical company dedicated to identification,
`development and commercialization of therapies that improve neurological
`function. Id. at 5. Acorda’s therapies are focused on treating people
`suffering from spinal cord injury, multiple sclerosis and related disorders of
`the nervous system. Id. S-1 states that Fampridine-SR is Acorda’s lead
`product candidate and that laboratory studies have shown that fampridine
`improves impulse conduction in nerve fibers that have been damaged, such
`as in the case of MS. Id. at 6. Fampridine-SR was developed by and
`manufactured for Acorda by Elan. Id. at 34.
`Fampridine-SR is described as suitable for twice daily dosing for both
`SCI (spinal cord injury) and MS. Id. at 34. S-1 states that it is believed that
`Fampridine-SR represents a “fundamental shift in the treatment of both SCI
`and MS because it may improve neurological function rather than only
`treating the symptoms or slowing the progression of these diseases.” Id.
`
`
`7 We cite exhibit page numbers as indicated by Petitioner on the bottom
`right of Exhibit 1003, rather than page numbers designed in S-1 itself.
`8
`
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`
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`Case IPR2015-01850 (Patent 8,440,703 B2)
`Case IPR2015-01853 (Patent 8,007,826 B2)
`Case IPR2015-01857 (Patent 8,663,685 B2)
`Case IPR2015-01858 (Patent 8,354,437 B2)
`
`Specifically, S-1 teaches that fampridine is able to block exposed myelin
`potassium channels in MS patients, thereby permitting the axons in nerve
`fibers to transmit nerve impulses again. Id.
`S-1 states that clinical trials of Fampridine-SR have demonstrated
`improved neurological function in people with chronic SCI or MS. Id. at 6.
`S-1 states that eight clinical trials have been conducted with Fampridine-SR
`for SCI and six clinical trials for MS. Id. S-1 further states that in Phase 2
`clinical trials, treatment with Fampridine-SR has been associated with a
`variety of neurological benefits in people with SCI or MS. Id. S-1 also
`states that Acorda was conducting a late Phase 2 clinical trial in people with
`MS for the improvement of walking speed. Id. According to S-1, Acorda
`has performed clinical trials of Fampridine-SR in chronic SCI and MS to
`establish the “pharmacokinetics, safety, and optimal dosing of the drug, as
`well as to assess its efficacy.” Id. at 34. S-1 states that clinical trials of
`Fampridine-SR therapy have shown “a statistically significant improvement
`in walking speed and leg strength” in MS patients. Id. at 35.
`S-1 describes the design and results of a clinical trial designated
`“MSF201” as follows:
`In 2001, we completed a double-blind Phase 2 clinical trial
`of Fampridine-SR in Multiple Sclerosis, MS-F201. The clinical
`trial was designed to determine the optimal dose level of
`Fampridine-SR and to evaluate possible ways in which to
`measure the effect of the drug on symptoms of the disease,
`including motor strength, timed walking, and self-reported
`9
`
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`Case IPR2015-01850 (Patent 8,440,703 B2)
`Case IPR2015-01853 (Patent 8,007,826 B2)
`Case IPR2015-01857 (Patent 8,663,685 B2)
`Case IPR2015-01858 (Patent 8,354,437 B2)
`
`
`fatigue. The clinical trial involved a total of 36 MS subjects in
`four major academic MS research centers. A total of 25 subjects
`received Fampridine-SR in doses increasing from 10 mg to 40
`mg twice per day over eight weeks of treatment, and 11 subjects
`were given placebo over the same period. This treatment period
`was preceded by a series of baseline evaluations over the course
`of four weeks to allow the subjects to become adjusted to the
`clinic visits and allow the various measurements to stabilize. A
`one week blinded treatment with placebo preceded the first drug
`administration to look for potential placebo effects on the various
`outcome measures.
`The clinical trial demonstrated that doses up to 25 mg
`twice a day were well tolerated, and were associated with
`statistically significant improvements in walking speed and leg
`muscle strength. Most of the improvement in strength and
`walking speed was apparent within the first three weeks of the
`Fampridine-SR treatment, at doses from 10 to 25 mg twice a day.
`Id. at 37.
`S-1 also describes a current late Phase 2 clinical trial, “MS-F202,”
`that was designed, based on extensive consultations with expert MS
`neurologists and the FDA, to provide support for an NDA for the use of
`Fampridine-SR in MS. Id. The MS-F202 trial was designed to “compare
`three doses of 10, 15 and 20 mg, twice per day, and assess their relative
`safety and efficacy over a treatment period of 12 weeks.” Id. at 37. The
`primary endpoint of the MS-F202 trial involved timing subjects completing
`a 25 foot walk. Id. The trial enrolled approximately 200 subjects in 24
`
`10
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`Case IPR2015-01850 (Patent 8,440,703 B2)
`Case IPR2015-01853 (Patent 8,007,826 B2)
`Case IPR2015-01857 (Patent 8,663,685 B2)
`Case IPR2015-01858 (Patent 8,354,437 B2)
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`major MS centers in July 2003 and was to conclude by the end of March
`2004. Id.
`
`2. Hayes (Ex. 1005)
`Hayes is entitled “Pharmacokinetic Studies of Single and Multiple
`Oral Doses of Fampridine-SR (Sustained-Release 4-Aminopyridine) in
`Patients With Chronic Spinal Cord Injury.” Ex. 1005, 1. Hayes states that
`“[t]wo studies were conducted to determine the pharmacokinetics and safety
`profile of an oral, sustained-release (SR) formulation of fampridine
`(fampridine-SR, 10–25 mg) administered as a single dose (n = 14) and twice
`daily for 1 week (n = 16) in patients with chronic, incomplete SCI,” i.e.,
`spinal cord injury. Id. at 1, Abstract.
`
`Hayes discloses that “[c]linical trials have confirmed that
`administration of fampridine results in symptomatic improvements in
`patients with SCI and multiple sclerosis.” Id. at 1 (citations omitted). Hayes
`discusses its “first study [that] evaluated single oral doses of fampridine-SR
`(10 mg, 15 mg, 20 mg, and 25 mg) in 14 patients with SCI,” and its “second
`study [that] examined multiple oral doses (10 mg, 15 mg, 20 mg, and 25 mg,
`twice daily, each given for 1 week) of fampridine-SR in 16 patients with
`SCI.” Id. at 2.
`
`In relation to the second study, Hayes discloses that 16 patients
`“received doses of orally administered fampridine-SR tablets at each dose
`level (10, 15, 20, and 25 mg) twice daily for 6 consecutive days and then
`
`11
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`Case IPR2015-01850 (Patent 8,440,703 B2)
`Case IPR2015-01853 (Patent 8,007,826 B2)
`Case IPR2015-01857 (Patent 8,663,685 B2)
`Case IPR2015-01858 (Patent 8,354,437 B2)
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`once daily on the seventh day,” and “[d]osing at each level was performed in
`an ascending manner over 4 weeks with no intervening washout period.” Id.
`Thus, at one point, patients received 10 mg of Fampridine-SR tablets twice
`daily for six days as part of this study.
`
`In relation to a number of measured pharmacokinetic parameters in
`the second study, as presented in Figure 1B and Table 3, Hayes states that
`“[s]teady state was achieved by day 5 (4 days of fampridine-SR dosing) after
`twice-daily administration of fampridine-SR.” Id. at 4. Figure 1B presents
`the mean fampridine plasma concentration versus time over 24 hours for
`each dosage, including 10 mg, given twice daily. Id. at 5. Table 3 presents
`the “Mean (±standard deviation) pharmacokinetic parameters of fampridine-
`SR after multiple-dose administration” for each dosage, including 10 mg
`given twice daily. Id. at 7. Such parameters for the 10 mg dosage twice
`daily dosage include: Cmaxss, ng/mL of 32.2 ± 8.9, Cminss, ng/mL of 14.0 ±
`4.4, Cavss, ng/mL of 20.8 ± 5.7, and tmax, h of 2.7 ± 1.0. Id.
`3. Juarez (Ex. 1006)
`Juarez describes the use of mixtures of polymers to achieve a variety
`
`of release properties. Ex. 1006, 1. In particular, Juarez describes testing the
`matrix release behavior of tablets of 4-aminopyridine with hydroxypropyl
`methylcellulose (“HPMC”). Id. at 2. Juarez states that the purpose of the
`HPMC matrix is to “prolong delivery with zero-order kinetics to maintain a
`
`12
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`Case IPR2015-01850 (Patent 8,440,703 B2)
`Case IPR2015-01853 (Patent 8,007,826 B2)
`Case IPR2015-01857 (Patent 8,663,685 B2)
`Case IPR2015-01858 (Patent 8,354,437 B2)
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`constant in vivo plasma drug concentration, and with this to maintain a
`constant pharmacological effect.” Id. at 2.
`C. Asserted Obviousness over S-1
`Petitioner challenges claims 1–52 of the ’703 patent as rendered
`obvious over S-1, either alone or in combination with Hayes or Juarez. Pet.
`20. In support, Petitioner provides a detailed explanation, as well as a claim
`chart, as to how each claim limitation is taught. Id. at 30–60. Petitioner also
`relies on the Declarations of Scott Bennett (Ex. 1016), an academic librarian,
`and Dr. Samuel J. Pleasure, a Professor of Neurology (Ex. 1023), and James
`Polli, a Professor of Pharmaceutical Sciences (Ex. 1044). See generally,
`Pet. 11–56.
`A patent claim is unpatentable under 35 U.S.C. § 103(a) if the
`differences between the claimed subject matter and the prior art are such that
`the subject matter, as a whole, would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said
`subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`(2007). The question of obviousness is resolved on the basis of underlying
`factual determinations including: (1) the scope and content of the prior art;
`(2) any differences between the claimed subject matter and the prior art;
`(3) the level of ordinary skill in the art; and (4) objective evidence of
`nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`
`13
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`Case IPR2015-01850 (Patent 8,440,703 B2)
`Case IPR2015-01853 (Patent 8,007,826 B2)
`Case IPR2015-01857 (Patent 8,663,685 B2)
`Case IPR2015-01858 (Patent 8,354,437 B2)
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`
`In that regard, an obviousness analysis “need not seek out precise
`teachings directed to the specific subject matter of the challenged claim, for
`a court can take account of the inferences and creative steps that a person of
`ordinary skill in the art would employ.” KSR, 550 U.S. at 418; see
`Translogic, 504 F.3d at 1259.
`
`1. Level of Skill
`Petitioner’s declarants, Drs. Pleasure and Polli, testify that a person of
`ordinary skill in connection with the ’703 patent would have had an M.D. or
`Ph.D. in neuroscience or a related field with an understanding of
`pharmacokinetics and at least some experience in providing drug therapy to
`MS patients. Ex. 1023 ¶ 16, Ex. 1044 ¶ 13. Additionally, Drs. Pleasure and
`Polli testify that a person of ordinary skill in the art would have had access
`to a person having an advanced degree in pharmaceutics or pharmaceutical
`formulation, specifically oral sustained release formulations, or at least five
`years of experience in formulating sustained oral release drug products and
`may work as part of a multi-disciplinary team. Ex. 1023 ¶¶ 16–17; Ex. 1044
`¶¶ 13–14. Patent Owner does not dispute this recitation of the level of
`ordinary skill in the art. See Ex. 2042 ¶ 68 n.5. We adopt the level of
`ordinary skill in the art identified by Drs. Pleasure and Polli as it is
`consistent with the prior art of record. See Okajima v. Bourdeau,
`261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating level of ordinary skill in the
`art may be reflected by the prior art of record); In re GPAC Inc.,
`14
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`Case IPR2015-01850 (Patent 8,440,703 B2)
`Case IPR2015-01853 (Patent 8,007,826 B2)
`Case IPR2015-01857 (Patent 8,663,685 B2)
`Case IPR2015-01858 (Patent 8,354,437 B2)
`
`57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA
`1978).
`
`2. Decision on Institution
`In our Decision on Institution, we determined that S-1 is a printed
`publication based on the evidence of record at the institution stage.
`Specifically, we stated that there was sufficient evidence of record before us
`“to demonstrate that a person of ordinary skill in the art would have been
`aware of Acorda’s clinical trials and would have monitored and sought
`information about such studies by looking for and accessing statements and
`publications by Acorda and its researchers.” Dec. Instit. 14. We also noted
`that Acorda would have an opportunity at trial to provide further evidence
`concerning its S-1document. Id.
`
`Turning to the merits of the asserted challenges based on the record at
`the institution stage, we determined that, based on the teachings of S-1 in
`light of Dr. Pleasure’s testimony, that “one of ordinary skill in the art would
`have combined the known elements 10 mg dosage, twice daily for more than
`2 weeks, in an MS patient for the stated purpose of improving lower
`extremity function, including improvement in walking speed and muscle
`strength.” Id. at 17. As to the challenges combining the teachings of S-1
`and Hayes or Juarez, we concluded on the record at institution that
`Petitioner has provided sufficient and credible evidence to
`demonstrate that one skilled in the art would have combined the
`
`15
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`Case IPR2015-01850 (Patent 8,440,703 B2)
`Case IPR2015-01853 (Patent 8,007,826 B2)
`Case IPR2015-01857 (Patent 8,663,685 B2)
`Case IPR2015-01858 (Patent 8,354,437 B2)
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`references for the purpose of forming a polymeric delayed
`in vivo plasma
`release
`tablet with 4-AP
`to maintain
`concentrations (S-1 and Juarez) and the purpose of achieving
`Hayes’ extended release profile with 4-AP (S-1 and Hayes).
`Id. at 20.
`We also specifically stated that “[f]or purpose[s] of this Decision we
`need not determine whether the ’703 patent is entitled to priority benefit of
`the provisional application as the S-1 prospectus is statutory prior art under
`either effective filing date.” Id. at 12, n.2.
`During trial after institution, Patent Owner presented evidence that
`S-1 could potentially qualify as prior art only under 35 U.S.C. § 102(a), but
`not § 102(b), and because S-1 corresponds to the inventors’ own work, S-1
`does not qualify as prior art against the ’703 patent under § 102(a) either.
`See PO Resp. 1–22. In this Final Written Decision, we will first address the
`status of S-1 as prior art under § 102(a) or (b).
`
`3. Petitioner’s Arguments Regarding Prior Art Status of S-1
`Petitioner asserts that at least claims 1–30 and 32–52 are not entitled
`to the benefit of the filing date of the provisional application to which the
`’703 claims priority. Pet. 10. The ’703 patent claims the benefit of
`provisional application No. 60/560,894, filed on April 9, 2004 (“the
`Provisional”). Ex. 1001 ¶ 60.
`Petitioner offers three reasons why the Provisional does not provide
`support for claims 1–30 and 32–52. Pet. 10–17. First, Petitioner asserts that
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`Case IPR2015-01850 (Patent 8,440,703 B2)
`Case IPR2015-01853 (Patent 8,007,826 B2)
`Case IPR2015-01857 (Patent 8,663,685 B2)
`Case IPR2015-01858 (Patent 8,354,437 B2)
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`claims 1–30 and 32–52 all require that 10 mg or less than 15 mg of 4-AP be
`administered twice daily, and that the claimed time period for administration
`for all of these claims is “at least two weeks” or “more than two weeks” (i.e.,
`the so-called “two-week limitations”). Pet. 11. Petitioner refers to Example
`11, including a graphically depicted Study Design, presented in the
`Provisional and concludes “the disclosure of a 12-week ‘treatment period’ to
`improve lower extremity function in MS patients does not adequately
`disclose to a POSA that the challenged claims’ two-week limitations were
`necessarily present from the Provisional’s disclosure.” Id.
`Petitioner notes that graphically depicted Example 11 Study Design
`has five time periods that include a “2-week upward titration (10/15 mg bid
`or placebo)” followed by a “12-week stable treatment period.” Pet. 11–12.
`Petitioner further explains that there is no disclosure of “any data for the first
`two weeks of the 12-week treatment period” because data is provided only
`for Visit 4 at the end of the upward titration period and not again until
`Visit 7, which appears to take place no earlier than week 4 of the 12-week
`treatment period. Id. at 12 (citing Ex. 1023 ¶¶ 41–42). Petitioner concludes
`that “[a]s a result, this disclosure is not a full, clear, concise, and exact
`disclosure of the challenged claims’ two-week limitations—and ‘a POSA
`would not immediately discern that the Provisional necessarily disclosed the
`two-week limitations based on reviewing the Provisional.’” Id. (citing Ex.
`1023 ¶¶ 43, 36).
`
`17
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`Case IPR2015-01850 (Patent 8,440,703 B2)
`Case IPR2015-01853 (Patent 8,007,826 B2)
`Case IPR2015-01857 (Patent 8,663,685 B2)
`Case IPR2015-01858 (Patent 8,354,437 B2)
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`Petitioner asserts also that the two-week limitations are not met during
`the two-week upward titration period. Pet. 12–14. Noting that the current
`explanation for the upward titration period in the ’703 patent is absent from
`the Provisional, Petitioner’s declarant states: “At best, a POSA would have
`understood this disclosure to mean that the ‘2-week upward titration’ period
`involved administering SR 4-AP BID at a dose of 10 mg for some portion of
`the 2-week period, follow[ed] by an upward dose of 15 mg for the remaining
`portion of the 2-week period, to ensure patients do not have an adverse
`reaction.” Pet. 13 (quoting Ex. 1023 ¶ 47). Therefore, Petitioner concludes
`that the “two-week limitations” were not necessarily present in the
`Provisional’s disclosure because the claims require administering the same
`dose of 4-AP for at least two weeks or more than two weeks, not for some
`portion of the two weeks. Id. at 14.
`Regarding Petitioner’s second reason as to why the Provisional does
`not provide support for claims 1–30 and 32–52, Petitioner asserts that the
`Provisional’s single data point other than the 15 mg dosing data point in the
`12-week period, i.e., a 10 mg dosing, is insufficient to disclose the full scope
`of the claimed range of “less than 15 milligrams,” which would encompass
`from “between 0 and 15 mg.” Pet. 15.
`Finally, for claims 14–15 and 35–36 that require a CavSS range of 15
`ng/ml to 35 ng/ml in MS patients receiving 10 mg (or less than 15 mg) 4-AP
`BID, Petitioner asserts the Provisional does not provide adequate support for
`
`18
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`Case IPR2015-01850 (Patent 8,440,703 B2)
`Case IPR2015-01853 (Patent 8,007,826 B2)
`Case IPR2015-01857 (Patent 8,663,685 B2)
`Case IPR2015-01858 (Patent 8,354,437 B2)
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`the full scope of claimed range because it only discloses CavSS ranges of 15.1
`ng/ml to 26.5 ng/ml in Table 7. Id. at 16 (citing Ex. 1007, 45). Petitioner
`again notes that the description for the claimed CavSS ranges in the ’703
`patent are absent from the Provisional. Id.
`Based on this analysis, Petitioner posits that:
`The S-1 constitutes prior art under 35 U.S.C. §§ 102(a) and
`(b) because it was printed and made publicly available at least as
`early as September 30, 2003—more than one year before the
`earliest effective filing date of April 8, 2005 (for claims without
`provisional priority). (Ex. 1004-9; see generally, Ex. 1003).
`Even assuming arguendo that the priority date is April 9, 2004,
`the S-1 would still qualify as prior art against all claims under 35
`U.S.C. § 102(a).
`
`Pet. 23.
`
`Petitioner asserts further that S-1 was publicly available as early as
`2000 because a person of skill would have known that Acorda was
`investigating 4-AP for treating multiple sclerosis and would have been
`motivated to monitor and seek information about Acorda’s studies, such as
`Acorda’s publically available S-1 filing. Id. 24–26.
`
`4. Patent Owner’s Arguments Regarding Prior art Status of S-1
`Patent Owner asserts that Petitioner’s challenges fail because S-1
`cannot be asserted against the claims of the ’703 patent. The claims of the
`’703 patent, Patent Owner argues, are entitled to the benefit of the
`Provisional’s filing date, which disqualifies S-1 as prior art under § 102(b)
`19
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`Case IPR2015-01850 (Patent 8,440,703 B2)
`Case IPR2015-01853 (Patent 8,007,826 B2)
`Case IPR2015-01857 (Patent 8,663,685 B2)
`Case IPR2015-01858 (Patent 8,354,437 B2)
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`against the ’703 patent. PO Resp. 1. In addition, according to Patent
`Owner, because S-1 is the work of the named inventors of the ’703 patent,
`and not “by others,” it cannot be asserted against the claims of the ’703
`patent as prior art under § 102(a). Id. Also, Patent Owner asserts that S-1
`does not qualify as a printed publication. Id.
`As to Patent Owner’s argument that the ’703 patent is entitled to the
`benefit of the Provisional’s filing date, Patent Owner refers to Example 11 of
`the Provisional, asserting
`Because patients in the ‘10 mg bid’ dosing arm received the 10
`mg big dose throughout the ‘2-week upward titration (10/15 mg
`bid or placebo)’ phase of the study, the reported ‘significant
`difference . . . at up-titration’ shows that the inventors
`possessed therapeutically effective abbreviated treatment
`periods comprising, for example, two weeks of 4-AP dosing at
`10 mg bid.
`Id. at 5–6.
`Patent Owner also asserts that Table 7 of t
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