DR.REDDY)S
`
`Dr. Reddy's Laboratories, Inc.
`
`1 07 College Road East
`Princeton, NJ 08540
`
`Tel: (609) 375-9900
`Fax: (877) 445-3741
`
`www.drreddys.com
`
`VIA CERTIFIED MAIL(cid:173)
`RETURN RECEIPT REQUESTED
`
`TO:
`
`Chief Executive Officer
`Galderma Labs L.P.
`14501 N. Freeway
`Ft. Worth, TX 76177
`
`FROM:
`
`Dr. Reddy's Laboratories, Ltd.
`Dr. Reddy's Laboratories, Inc.
`
`DATE:
`
`June 22,2015
`
`i
`
`NOTICE OF PARAGRAPH IV CERTIFICATION RE DR. REDDY'S
`LABORATORIES, LTD. AND DR. REDDY'S LABORATORIES, INC.'S
`DOXYCYCLINE CAPSULES 40MG; U.S. PATENT NOS. 7,211,267;
`7,232,572; AND 8,603,506
`
`RE:
`
`Dear Sirs:
`
`Pursuant to § 505(b)(3)(B) ofthe Federal Food, Drug and Cosmetic Act ("the Act") and
`
`§ 314.52 of Title 21 of the Code of Federal Regulations ("C.F.R."), please be advised that Dr.
`
`Reddy's Laboratories, Ltd.
`
`("DRL") has
`
`filed a patent certification pursuant
`
`to
`
`§ 505(b)(2)(A)(IV) ofthe Act and§ 314.50(i)(1)(i)(A)(4) of Title 21 of the C.F.R. in support of
`
`their New Drug Application ("the DRL NDA'') Number 208286 with respect to doxycycline
`
`capsules, 40 mg ("the Proposed DRL Doxycycline Product"). We understand that Galdenna
`
`EXECUTION VERSION Ashley Notice Lctt~r
`
`1
`
`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
`
`

`
`Gal derma Labs L.P.
`June 22, 201S
`Page2
`
`Labs L.P. ("Galderma") is the assignee of U.S. Patent Nos. 7,211,267 ("the '267 Patent");
`
`7,232,S72 ("the 'S72 Patent"); and 8,603,S06 ("the '506 Patent") (collectively "the Ashley
`
`Patents"). We also understand that Galderma is the holder of approved Application
`
`No. NOS080S under§ SOS(b) of the Act (New Drug Application or "NDA") in connection with
`
`doxycycline capsules, 40mg (ORACEA ®).
`
`DRL provides the following information:
`
`(1)
`
`(2)
`
`(3)
`
`( 4)
`
`The U.S. Food and Drug Administration ("FDA") has received the DRL NDA
`submitted by DRL with respect to doxycycline capsules, 40 mg;
`
`The DRL NDA number is 208286;
`
`The established name of the proposed drug product, as defined in§ 502(e)(3) of
`the Act, is doxycycline;
`
`ingredient of the Proposed DRL Doxycycline Product
`The active
`C22H24N208, HCl, ~ C2HSOH, Yz H20, also known as:
`
`is
`
`2-Naphthacenecarboxamide, 4-(dimethylamino)1, 4,4a,S, Sa, 6, ll,12a-octahydro-
`3,S, 10, 12, 12a-pentahydroxy-
`6-methy1-1, 11-dioxo-,
`monohydrochloride,
`compound with ethanol (2: 1 ), monohydrate, [4S-(4a,4aa,Sa,6a,12a)] (or)
`
`4-(Dimethylamino)-1,4,4a,5,5a, 6, 11,12a-octahydro- 3,5,10, 12,12a-pentahydroxy-6-
`methyl-1,11-dioxo-2 naphthacene carboxamide monohydrochloride, compound with
`ethyl alcohol (2: 1), monohydrate (or)
`
`Hydrochloride hemiethanol hemihydrate of (4S,4aR,5S, 5aR,6R,12aS)-4-
`3 ,S, 10, 12, 12a-pentahydroxy-6-methyl-1, 11-dioxo-
`( dimethylamino )-
`1,4,4a,S,Sa,6,11, 12a-octahydrotetracene-2-carboxamide
`
`All of which are commonly known as doxycycline hyclate; the strength is 40 mg
`per capsule; the dosage form is a capsule and the route of administration is oral;
`
`(5)
`
`The U.S. Patent Numbers and expiration dates, as known to DRL, of the patents
`alleged to be invalid, unenforceable or not infringed are:
`
`U.S. Patent No. 7,211,267 entitled "Methods Of Treating Acne," issued on
`May 1, 2007, which is listed in the Orange Book as expiring on AprilS, 2022;
`
`EXECUTION VERSION Ashley Notice Letter
`
`2
`
`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
`
`

`
`Gal derma Labs L.P.
`June 22, 2015
`Page3
`
`U.S. Patent No. 7,232,572 entitled "Methods Of Treating Rosacea," issued on
`June 19, 2007, which is listed in the Orange Book as expiring on AprilS, 2022;
`and
`
`.U.S. Patent No. 8,603,506 entitled "Methods Of Treating Acne," issued on
`December 10, 2013, which is listed in the-Drange Book as expiring on AprilS,
`2022.
`
`(6)
`
`(7)
`
`The information detailed in this letter and the attached memorandum is supplied
`for the sole purpose of efficiently addressing all patent-related issues relating to
`the above-referenced statutes and regulations, and neither DRL nor its attorneys
`waive any attorney-client privilege or attorney work product immunity
`concerning the subject matter of this communication; and
`
`DRL reserves its right to supplement this letter and the attached memorandum
`detailing the factual and legal basis for DRL's assertion of invalidity,
`unenforceability and/or non-infringement ofthe Ashley Patents should subsequent
`investigations reveal additional grounds for asserting. invalidity, unenforceability
`and/or non-infringement.
`
`DRL is seeking approval from the FDA to market and sell the Proposed DRL
`
`Doxycycline Product, which will be indicated for treatment of patients with rosacea. DRL is
`
`certifying with the FDA pursuant to § 505(b)(2)(A)(iv) of the Act and 21 C.F.R.
`
`§ 314.50(i)(1 )(i)(A)( 4)
`
`("Paragraph IV Certification") that the Ashley Patents are invalid,
`
`unenforceable and/or will not be infringed by the manufacture, use, sale, offer to sell in the
`
`United States or importation into the United States of the Proposed DRL Doxycycline Product
`
`for which DRL has submitted its application.
`
`Offer of Confidential Access: In addition to and not in lieu of the limitations contained
`
`in 21. U.S.C. § 355(c)(3)(D)(i)(III) (as amended December 8, 2003) DRL hereby offers
`
`conditional access to only those portions of the DRL NDA that, in DRL's judgment, are needed
`
`by Galderma to determine whether an action under Section 355 should be filed within 45 days of
`
`EXECUTION VERSION Ashley Notice Letter
`
`3
`
`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
`
`

`
`Galderma Labs L.P.
`June 22, 2015
`Page4
`
`the receipt of this letter. Access to the information is and shall be limited to only those attorneys
`
`acting as outside counsel for Galderma that are needed to evaluate the information for that
`
`purpose and such persons who are to have access shall be identified to DRL's counsel,
`
`William L. Mentlik of Lerner David, Littenberg, Krumholz & Mentlik, LLP, 600 South A venue
`
`West, Suite 300, Westfield, NJ 07090, before access is granted. Such persons so identified shall
`
`agree in writing that the information can only be used for the purpose of determining whether to
`
`file suit within the 45-day period. Those persons receiving access to the DRL NDA materials
`
`shall not engage, formally or informally, directly or indirectly in: any work before any patent
`
`office, including the United States PTO, relating to doxycycline; or in any counseling, litigation
`
`or other work before or involving a regulatory agency, including the United States FDA, relating
`
`to doxycycline. The DRL NDA and any tangible form of information derived from a review of
`
`the DRL NDA shall be destroyed, with notice to DRL's counsel, within 45 days of receipt of this
`
`letter or upon the filing of an action against DRL, whichever is earlier.
`
`Pursuant to 21 C.F .R. § 314.95( c )(7), DRL authorizes the following agent to accept
`
`service of process:
`
`William L. Mentlik
`Lerner David, Littenberg, Krumholz & Mentlik, LLP
`600 South A venue West
`Westfield, New Jersey 07090
`
`EXECUTION VERSION Ashley Notice Letter
`
`4
`
`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
`
`

`
`Gal derma Labs L.P.
`June 22, 2015
`Page 5
`
`Attached hereto is a memorandum setting forth DRL' s detailed factual and legal basis
`
`supporting its Paragraph IV Certification.
`
`Dr. Reddy's Laboratories, Inc. on behalf of Dr.
`Reddy's Laboratories, Ltd.
`
`B~~--
`
`Lee Banks, Esq.
`Vice President, Intellectual Property
`Dr. Reddy's Laboratories, Inc.
`107 College Road East
`Princeton, NJ 08540
`
`EXECUTION VERSION Ashley Notice Letter
`
`5
`
`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
`
`

`
`VIA CERTIFIED MAIL(cid:173)
`RETURN RECEIPT REQUESTED
`
`TO:
`
`Chief Executive Officer
`Gal derma Labs L.P.
`14501 N. Freeway
`Ft. Worth, TX 76177
`
`FROM:
`
`Dr. Reddy's Laboratories, Ltd.
`Dr. Reddy's Laboratories, Inc.
`
`DATE:
`
`June 22, 2015
`
`RE:
`
`FACTUAL AND LEGAL BASIS FOR DR. REDDY'S LABORATORIES,
`LTD. AND DR. REDDY'S LABORATORIES, INC.'S ASSERTION OF
`INVALIDITY, UNENFORCEABILITY AND/OR NON-INFRINGEMENT
`OF U.S. PATENT NOS. 7,211,267; 7,232,572; AND 8,603,506
`
`Dr. Reddy's Laboratories, Ltd. ("DRL") has filed a patent certification pursuant to
`
`§ 505(b )(2)(A)(IV) of the Federal Food, Drug and Cosmetic Act ("the Act") and
`
`§ 314.50(i)(1)(i)(A)( 4) of Title 21 of the Code of Federal Regulations, in support of their New
`
`Drug Application ("the DRL NDA") Number 208286 with respect to its proposed doxycycline
`
`capsules, 40mg1 ("the Proposed DRL Doxycycline Product"). We understand that Galderma
`
`Labs L.P. ("Galderma") is the assignee of U.S. Patent Nos. 7,211,267 ("the '267 Patent");
`
`7,232,572 ("the '572 Patent"); and 8,603,506 ("the '506 Patent") (collectively "the Ashley
`
`Patents"). We also understand that Gal derma Labs L.P. ("Gal derma") is the holder of
`
`Application No. N050805 under § 505(b) of the Act (New Drug Application or "NDA'') in
`
`connection with doxycycline capsules, 40mg (ORACEA ®).
`
`1 The Proposed DRL Doxycycline Product includes doxycycline hyclate. 46.16mg doxycycline hyclate is
`equivalent to 40mg doxycycline monohydrate.
`
`41 04913 _l.docx
`
`6
`
`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
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`

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`Gal derma Labs L.P.
`June 22, 2015
`Page 2 of42
`
`I.
`
`INTRODUCTION
`
`As of the date of this letter, the Electronic "Approved Drug Products with Therapeutic
`
`Equivalence Evaluations"
`
`("Orange Book")
`
`lists
`
`the Ashley Patents
`
`for doxycycline
`
`capsules, 40mg (ORACEA ®). According to the Orange Book, the expiration date for the
`
`Ashley Patents is April 5, 2022.
`
`DRL is seeking approval from the FDA to market and sell doxycycline capsules, 40mg
`
`for the treating at "papules and pustules" of rosacea prior to the expiration of the Ashley Patents.
`
`DRL certified with the FDA pursuant to 21 C.P.R. § 314.50(i)(1)(i)(A)(4) ("Paragraph IV
`
`Certification") that the Ashley Patents are invalid, unenforceable and/or will not be infringed by
`
`the manufacture, use, sale, offer to sell, or importation into the United States of the Proposed
`
`DRL Doxycycline Product for which DRL submitted its application. This memorandum details
`
`the factual and legal basis that supports DRL's Paragraph IV Certification with respect to the
`
`Ashley Patents.
`
`II.
`
`LEGAL BACKGROUND
`
`A. Infringement
`
`The test for infringement of a patent is stated in 35 U.S. C. § 271(a) as follows:
`
`(a) Except as otherwise provided in this title, whoever without authority makes, uses,
`offers to sell, or sells any patented invention, within the United States or imports into
`the United States any patented invention during the term of the patent therefor, infringes
`the patent.
`
`"Infringement analysis involves a two-step process: the court first determines the
`
`meaning of disputed claim terms and then compares the accused device to the claims as
`
`construed." Wavetronix LLC v. EIS Elec. Integrated Sys., 573 F.3d 1343, 1354 (Fed. Cir. 2009).
`
`4J049l3_l.docx
`
`7
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`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
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`

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`Galderma Labs L.P.
`June 22, 2015
`Page 3 of42
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`"A claim term is construed according to its ordinary and customary meaning as understood by a
`
`person of ordinary skill in the art at the time of the invention." !d. at 1355 (citing Phillips v.
`
`AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en bane)).
`
`Infringement is a question of fact. "To prove infringement, the patentee must show that
`
`an accused product embodies all limitations of the claim either literally or by the [doctrine of
`
`equivalents]." Amgen Inc. v. F. Hoffman-LaRoche Ltd., 580 F.3d 1340, 1374 (Fed. Cir. 2009).
`
`"If any claim limitation is absent from the accused device, there is no literal infringement as a
`
`matter of law." !d.
`
`If a claim is not literally infringed, it still may be infringed under the "doctrine of
`
`equivalents." Graver Tank & Mfg. Co. v. Linde Air Prods., 339 U.S. 605, 608-09 (1950). Under.
`
`this doctrine, a product that does not literally infringe the express terms of a patent claim may
`
`nevertheless be found to infringe the claim if there is an "equivalence" between the elements of
`
`the accused product and the elements of the invention as recited in the patent claims. !d. The
`
`doctrine of equivalents reaches those who "make unimportant and insubstantial changes and
`
`substitutions in the patent," which add nothing, while avoiding the literal scope of the claims. !d.
`
`at 607. In 1997, the Supreme Court of the United States confirmed the viability of the doctrine
`
`of equivalents and stated that the doctrine must be applied on an element-by-element basis, and
`
`not to the invention as a whole. Warner-Jenkinson Co. v. Hilton Davis Chern. Co., 520 U.S. 17,
`
`29 (1997). For each claim element literally absent from the accused product, the patentee must
`
`demonstrate that the corresponding feature of the accused product or process is equivalent to the
`
`claimed element. !d. "To prove infringement, the patentee must show that the accused device
`
`4l04913_l.docx
`
`8
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`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
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`

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`Galdenna Labs L.P.
`June 22, 2015
`Page 4 of42
`
`meets each claim limitation, either literally or under the doctrine of equivalents." Liquid
`
`Dynamics Corp. v. Vaughan Co., 355 F.3d 1361, 1367 (Fed. Cir. 2004).
`
`Courts have set forth different tests for assessing equivalency. Some courts look to the
`
`substantiality of the differences between the pertinent feature of the accused product and the
`
`claimed feature.
`
`If the differences are merely insubstantial, the accused device or method
`
`infringes under the doctrine. Wavetronix, 573 F.3d at 1360.
`
`Other courts use a
`
`"function-way-result" test. Graver Tank, 339 U.S. at 608; Abbott Labs. v. Sandoz, Inc., 566 F.3d
`
`1282, 1296 (Fed. Cir. 2009). Under that test, an accused product or process may infringe under
`
`the doctrine of equivalents if it performs substantially the same function in substantially the same
`
`way to achieve substantially the same result. Graver Tank, 339 U.S. at 608. The Supreme Court
`
`has stated that the particular linguistic framework used to assess equivalency is less important
`
`than whether the test assists the essential inquiry under the doctrine; i.e., whether or not the
`
`accused product or process contains elements identical or equivalent to each claimed element of
`
`a patented invention. Warner-Jenkinson, 520 U.S. at 40; Siemens Med. Solutions USA, Inc. v.
`
`Saint-Gobain Ceramics & Plastics, Inc., 637 F.3d 1269, 1279 (Fed. Cir. 2011). However, if an
`
`accused device completely lacks an element corresponding to a claim limitation, the accused
`
`device cannot infringe the claim under the doctrine of equivalents. See Warner-Jenkinson, 520
`
`U.S. at 24. This is sometimes referred to as the "all elements rule," discussed below.
`
`Prosecution history estoppel limits a patentee's ability to recover under the doctrine of
`
`equivalents. Where subject matter is surrendered during prosecution, prosecution history
`
`estoppel prevents the patentee from "recaptur[ing] in an infringement action the very subject
`
`matter surrendered as a condition of receiving the patent." Festa Corp. v. Shoketsu Kinzoku
`
`4l049l3_l.docx
`
`9
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`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
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`

`
`Gal derma Labs L.P.
`June 22, 2015
`Page 5 of42
`
`Kogyo Kabushiki Co., 535 U.S. 722, 734 (2002). Moreover, the patentee cannot deliberately
`
`narrow the scope of the claims during prosecution before the PTO to exclude a particular
`
`element and therefore distinguish over the prior art, and then assert, after issuance of the patent,
`
`that the excluded element is the equivalent of what is claimed. See Intervet Inc. v. Me rial Ltd.,
`
`617 F.3d 1282, 1290-92 (Fed. Cir. 2010).
`
`B.
`
`Invalidity
`
`As with infringement, the first step in any invalidity analysis is to "determine the
`
`meaning and scope of each claim in suit." Lemelson v. Gen. Mills, 968 F.2d 1202, 1206 (Fed.
`
`Cir. 1992).
`
`Before a piece of prior art can "anticipate" a patent under the previous version of 35
`
`U.S.C. § 1022
`
`, every feature of the claim must be found, either expressly or under principles of
`
`inherency, in a single prior art reference or prior art activity. Bettcher Indus., Inc. v. Bunzl USA,
`
`Inc., 661 F.3d 629, 641 (Fed. Cir. 2011).
`
`In addition, a patent may not be valid even though the invention is not anticipated.
`
`Specifically, a patent is invalid if the differences between the subject matter sought to be
`
`patented 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. 35 U.S.C. § 103. Obviousness under 35 U.S.C. § 103 is a question oflaw based
`
`on the underlying factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 17-18
`
`(1966); see MySpace, Inc. v. GraphOn Corp., 672 F.3d 1250 (Fed. Cir. 2012).
`
`2 Since these patents were filed prior to institution of the provisions of the American Invents Act ("AlA"), validity is
`analyzed under the pre-AlA law, including the pre-AlA version of35 U.S. C. §102.
`
`4!04913_l.docx
`
`10
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`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
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`

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`Gal derma Labs L.P.
`June 22, 2015
`Page 6 of42
`
`The obviousness inquiry is one of law based on four factual predicates: (1) "the scope
`
`and content of the prior art," (2) the "differences between the prior art and the claims at issue,"
`
`(3) "the level of ordinary skill in the pertinent art," and (4) "secondary considerations" such as
`
`"commercial success, long-felt but unsolved needs, failure of others, etc." KSR Int'l Co. v.
`
`Telejlex Inc., 550 U.S. 398, 406-07 (2007) (citing Graham v. John Deere Co., 383 U.S. 1, 17-18
`
`(1966)); 35 U.S.C. § 103(a). KSR reaffirmed that "[t]he combination of familiar elements
`
`according to known methods is likely to be obvious when it does no more than yield predictable
`
`results." KSR, 550 U.S. at 416. The Supreme Court also instructed "any need or problem known
`
`in the field of endeavor at the time of the invention and addressed by the patent, can provide a
`
`reason for combining the elements in the manner claimed." Id. at 420. "Common sense teaches,
`
`however, that familiar items may have obvious uses beyond their primary purposes, and in many
`
`cases a person of ordinary skill will be able to fit the teachings of multiple patents together like
`
`pieces of a puzzle." Id. Finally, the Court held that "[w]hen there is a design need or market
`
`pressure to solve a problem and there are a finite number of identified, predictable solutions, a
`
`person of ordinary skill has good reason to pursue the known options within his or her technical
`
`grasp." !d. at 421.
`
`"Motivation to combine may be found in many different places and forms." Par Pharm.
`
`Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1197 (Fed. Cir. 2014) (citing Allergan, Inc. v. Sandoz,
`
`Inc., 726 F.3d 1286, 1292 (Fed. Cir. 2013)). Thus, for example, a challenger is not limited to the
`
`same motivation that the patentee had. See id. (citing Alcon Research, Ltd. v. Apotex Inc., 687
`
`F.3d 1362, 1369 (Fed. Cir. 2012), cert denied, 133 S. Ct. 1736 (2013)).
`
`41049l3_l.docx
`
`11
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`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
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`

`
`Galderma Labs L.P.
`June 22, 2015
`Page 7 of42
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`When related to the claimed subject matter, objective indicia of nonobviousness,
`
`commonly referred to as "secondary considerations," such as commercial success, long-felt but
`
`unsolved need, failure of others, etc., must always be considered (and have been considered in
`
`this analysis) before a legal conclusion of nonobviousness or obviousness under § 103 is
`
`reached. See Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538-39 (Fed. Cir. 1983). For
`
`objective evidence of secondary considerations to be accorded substantial weight, its proponent
`
`must establish a nexus between the evidence and the merits of the claimed invention. W. Union
`
`Co. v. MoneyGram Payment Sys., Inc., 626 F.3d 1361, 1372-73 (Fed. Cir. 2010). However, an
`
`invention may be held obvious even where commercial success exists or is assumed to exist.
`
`See, e.g., Agrizap, Inc. v. Woodstream Corp., 520 F.3d 1337, 1344 (Fed. Cir. 2008).
`
`Although the presumption of validity accorded to issued patents has long been a fixture
`
`of common law, this presumption may be weakened or dissipated where the evidence in an
`
`infringement action was never considered by the PTO. Microsoft Corp. v. i4i Ltd P 'ship, 131
`
`S. Ct. 2238, 2246, 2250-51 (2011). Thus, "the jury may be instructed to evaluate whether the
`
`evidence before it is materially new, and if so, to consider that fact when determining whether an
`
`invalidity defense has been proved by clear and convincing evidence." !d. at 2251. "[I]f the
`
`PTO did not have all material facts before it, its considered judgment may lose significant
`
`force .... [a]nd, concomitantly, the challenger's burden to persuade the jury of its invalidity
`
`defense by clear and convincing evidence may be easier to sustain." Id; see also Sciele Pharma
`
`Inc. v. Lupin Ltd., 684 F.3d 1253, 1260 (Fed. Cir. 2012) ("While the ultimate burden of proof
`
`does not change, new evidence not considered by the PTO 'may carry more weight"'). Thus, "it
`
`may be harder to meet the clear and convincing [evidence] burden when the invalidity contention
`
`4104913_l.docx
`
`12
`
`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
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`

`
`Gal derma Labs L.P.
`June 22, 201S
`Page 8 of 42
`
`is based upon the same argument on the same reference that the PTO already considered" and "it
`
`could be reasonable to give more weight to new arguments or references that were not explicitly
`
`considered by the PTO." Sciele, 684 F.3d at 1260-61.
`
`In addition, "the fact that a skilled
`
`examiner passed upon that very reference during prosecution may be a factor in determining
`
`whether the challenger has met the clear and convincing evidence burden." Abbott Labs. v.
`
`Syntron Bioresearch, Inc., 334 F.3d 1343, 13S7 (Fed. Cir. 2003).
`
`III. THE ASHLEY PATENTS
`
`The
`
`'267 Patent was originally filed on AprilS, 2002, as U.S. Application
`
`No. 10/117,709 and claimed priority to
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`two provisional applications: 60/32S,489 filed
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`September 26, 2001 and 60/281,916 filed AprilS, 2001. The 'S72 and '506 Patents were filed
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`subsequent to the '267 Patent, claiming priority to the '267 Patent as continuation applications,
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`and thus the specification of each of the Ashley Patents should be substantially identical.
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`As discussed in further detail below, the claims of the Ashley Patents are quite similar to
`
`one another, and as such, they will be discussed together where feasible. For instance, all of the
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`claims of the Ashley Patents are method claims for treating either acne or symptoms of rosacea,
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`which are common to both rosacea and acne. And the Ashley Patents define rosacea as merely
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`one of a number of forms of acne.
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`('267 Patent col.4 11.26-4S.) Further, each of the claims
`
`requires the absence of a bisphosphonate compound.
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`IV. NONINFRINGEMENT ANALYSIS AS TO THE '267 PATENT
`
`A. Claim Construction
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`The first step in both patent infringement and validity analyses is to construe the claims
`
`to the extent any limitations have a meaning and scope that may not be self-evident. Markman v.
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`41 04913 _l.docx
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`13
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`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
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`

`
`Gal derma Labs L.P.
`June 22, 2015
`Page 9 of42
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`Westview Instruments, Inc., 517 U.S. 370, 384 (1996). While in certain situations where the
`
`claim terms are clear and unambiguous, there may be no need to interpret them, interpretation of
`
`a claim term focuses on a consideration of the intrinsic evidence, which includes the claims
`
`themselves, the specification, and the file history. Phillips v. AWH Corp., 415 F.3d 1303 (Fed.
`
`Cir. 2005) (en bane). However, where appropriate, extrinsic evidence, including technical
`
`dictionaries, learned treatises and even the testimony of experts, can be considered.
`
`Id
`
`at 1317-18. Generally, however, the use of extrinsic evidence is limited to situations where the
`
`intrinsic evidence is insufficient. In general, however, extrinsic evidence may be considered less
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`reliable than intrinsic evidence. !d. at 1318-19.
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`Here, the claimed tetracycline compound of the claims of the '267 Patent is intended to
`
`. treat the lesion count of acne and must be: (1) of a sub-antibacterial amount; and (2) of an
`
`amount that reduces lesion count resulting from acne. This amount is recited as being 10-80% of
`
`the antibacterial effective amount. The plain and ordinary meaning of this claim language
`
`suggests that the amount of tetracycline must be less than an antibacterial amount.
`
`1.
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`"Acne"
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`The preamble of independent claim 1 recites a "method of treating acne," including
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`administering a tetracycline compound in an amount that reduces lesion count. The specification
`
`of the '267 Patent defines "acne" as:
`
`A disorder of the skin characterized by papules, pustules, cysts, nodules, comedones,
`and other blemishes or skin lesions. These blemishes and lesions are often accompanied
`by inflammation of the skin glands and pilosebaceous follicles, as well as, microbial,
`especially bacterial, infection.
`
`For the purposes of this specification, acne includes all known types of acne. Some
`types of acne include, for example, acne vulgaris, cystic acne, acne atrophica, bromide
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`41049l3_l.docx
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`14
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`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
`
`

`
`Galderma Labs L.P.
`June 22, 2015
`Page 10 of42
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`acne, chlorine acne, acne conglobata, acne cosmetica, acne detergicans, epidemic acne,
`acne estivalis, acne fulminans, halogen acne, acne indurata, iodide acne, acne keloid,
`acne mechanica, acne papulosa, pomade acne, premenstral acne, acne pustulosa, acne
`scorbutica, acne scrofulosorum, acne urticata, acne varioliformis, acne venenata,
`propionic acne, acne excoriee, gram negative acne, steroid acne, nodulocystic acne and
`acne rosacea. Acne rosacea is characterized by inflammatory lesions (erythema) and
`permanent dilation of blood vessels (telangectasia).
`
`('267 Patent col.4 11.26-45.)
`
`Acne rosacea is an antiquated term used for rosacea. Example 38 of the '267 Patent
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`summarizes a study where acne, specifically lesions such as papules and pustules, were studied
`
`during treatment using 20mg doxycycline hyclate, administered twice daily.
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`(Jd. col.20 1.4 to
`
`col.211.10.)
`
`Thus, the specification establishes the plain and ordinary meaning of acne: "acne" should
`
`be defmed as a general disorder of the skin characterized by papules, pustules, and other lesions.
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`In other words, the specification designates "acne" as a genus encompassing a multitude of
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`species.
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`Activity throughout prosecution leads to a similar conclusion. For example, the
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`applicants submitted a declaration from Dr. Theobald on May 25, 2005, where he discussed a
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`study concerning the use of doxycycline in the treatment of lesions of patients suffering from
`
`acne rosacea. (Theobald Decl. 2, May 25, 2005, '267 Patent Prosecution) The declaration uses
`
`"acne rosacea,"
`
`'rosacea" and "acne" interchangeably when discussing this study. (Id.)
`
`Similarly, in a response to an office action, the applicants made the statement that it was "known
`
`before the present invention that tetracycline antibiotics were useful for treating acne, including
`
`acne rosacea." (Resp. 8, Sept. 1, 2006.) As such, the prosecution history also supports the plain
`
`41 049l3 _J.docx
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`15
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`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
`
`

`
`Galderma Labs L.P.
`June 22,2015
`Page 11 of42
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`and ordinary meaning of 'acne" in the '267 Patent as a general term for skin disorders involving
`
`lesions.
`
`The extrinsic evidence also suggests this same definition. Specifically, the Orange Book
`
`listing for Oracea® includes the '267 Patent. Thus, Galderma is affirmatively representing that
`
`the '267 Patent, directed toward a method of treating acne, covers the Oracea® product- a
`
`product only approved for the treatment of papules and pustules of rosacea. Further, the Orange
`
`Book lists the '267 Patent with use code U-925, i.e., "treatment of only inflammatory lesions
`
`(papules and pustules) of rosacea."
`
`(Emphasis added.) As such, Galderma, in listing the
`
`'267 Patent as to the Oracea® product, is representing that the ordinary and customary meaning
`
`of the term "acne" encompasses specific forms of acne, including at least rosacea and its papules
`
`and pustules.
`
`Accordingly, the term "acne" should be construed as a genus, broadly covering a general
`
`disorder of the skin characterized by papules, pustules, and other lesions, including disorders
`
`such as rosacea.
`
`2.
`
`"Sub-Antibacterial Amount"
`
`The plain and ordinary meaning of this claim element suggests that the amount of
`
`tetracycline compound administered should be below ("sub") the amount considered to display
`
`antibiotic properties ("antibacterial amount").
`
`The specification provides various examples of what should be considered an "antibiotic
`
`dose," including doses of at least 50mg/day of doxycycline. ('267 Patent co1.5 11.47-49.) The
`
`specification also describes 'non-antibiotic doses" of20mg/twice a day, and 30-60mg/day, which
`
`4104913 _l.docx
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`16
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`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
`
`

`
`Gal derma Labs L.P.
`June 22, 2015
`Page 12 of 42
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`"maintains a concentration in human plasma below the threshold for a significant antibiotic
`
`effect." (Jd col.S ll.53-55, 58-62.) These various ranges provided by the specification, on their
`
`face, are insoluble- specifically, the initial statement that any dose of 50mg or more would be
`
`considered an antibiotic dose, followed by the subsequent statements that a dose of up to 60mg
`
`would not be an antibiotic dose.
`
`The prosecution history focused on this limitation but did not offer much in the way of
`
`clarification. Specifically, early in prosecution, the examiner objected to the claim language
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`"substantially no antibiotic activity," stating that this limitation was not defined in the
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`specification, and further, that if this limitation encompassed any antibiotic activity, it would be
`
`encompassed by the prior art.
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`('267 Prosecution Interview Summary, Sept. 29, 2004; Resp.,
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`Sept. 10, 2004.) In response, the applicant amended the claim to instead recite "an antibiotic
`
`tetracycline compound in an amount that is 10-80% of the antibiotic amount," which was
`
`originally presented in original dependent claim 3.
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`(Resp., Sept. 10, 2004.) Since the
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`-specification often lists multiple antibiotic amounts, this adds little clarity. For example,
`
`antibiotic amounts of doxycycline are recited as 50, 75 or 100mg. But, using the amended claim
`
`language, 80% of the 1 OOmg antibiotic dose is still 80mg. If this is supposedly sub-antibiotic, as
`
`per the claim amendment, it is still the same as a dose specifically defined as antibiotic, i.e.,
`
`75mg.
`
`Subsequent to the above, the claim limitation "sub-antibacterial amount that reduces
`
`lesion count" was added to independent claim 1 in response to an office action rejecting the
`
`claims and multiple interview discussions between the applicant and the examiner.
`
`(Resp.,
`
`May 25, 2005.)
`
`4104913_Ldocx
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`17
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`Galderma Laboratories, Inc. Ex 2005
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01778
`
`

`
`Galderma Labs L.P.
`June 22, 2015
`Page 13 of 42
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`Perhaps most useful in resolving this inconsistency, however, is the claim construction
`
`ruling as to this limitation by the United States District Court for the District of Delaware.
`
`Research Found of State Univ. v. Mylan Pharms., Inc., 809 F. Supp. 2d 296, 313-15 (D. Del.
`
`2011), aff'd in part, vacated in part, and remanded, No. 2012-1523, 2013 U.S. App. LEXIS
`
`16284. As determined by the court, and as affirmed by the Federal Circuit, the claim limitation
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`"sub-antibacterial amount" should be construed to mean "an amount that does not significantly
`
`inhibit the growth of microorganisms." Id, 809