Case 1:15-cv-00670-LPS Document 13 Filed 09/22/15 Page 1 of 27 PageID #: 222
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`GALDERMA LABORATORIES, L.P.; NESTLË
`SKIN HEALTH S.A.; and TCD ROYALTY SUB,
`LLC,
`
`
`
` Plaintiffs and
` Counterclaim Defendants,
`
`v.
`
`DR. REDDY’S LABORATORIES, LTD.; DR.
`REDDY’S LABORATORIES, INC.; and
`PROMIUS PHARMA, LLC,
`
`
`
`
`
`
`C.A. No. 15-670-LPS
`
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`
`Defendants and
`Counterclaim Plaintiffs,
`
`
`v.
`
`GALDERMA S.A.,
`
`
`
` Counterclaim Defendant.
`
`
`ANSWER TO COMPLAINT, ADDITIONAL DEFENSES AND COUNTERCLAIMS
`Defendants Dr. Reddy’s Laboratories, Ltd. (“DRL Ltd.”), Dr. Reddy’s Laboratories, Inc.
`
`(“DRL Inc.”) and Promius Pharma, LLC (“Promius”) (collectively “DRL” or “Defendants”) by
`
`their attorneys, as for their answer to the complaint of Galderma Laboratories, L.P.
`
`(“Galderma”), Nestlë Skin Health S.A. (“Nestlë”) and TCD Royalty Sub, LLC (“TCD”)
`
`(collectively “Plaintiffs”) states as follows:
`
`THE PARTIES
`Apart from the mailing address alleged in paragraph 1, which, based on
`
`1.
`
`information and belief, DRL admits is a known address of Galderma, DRL is without knowledge
`
`or information sufficient to form a belief as to the truth of the allegations of paragraph 1, and
`
`therefore denies them.
`
`Galderma Laboratories, Inc. Ex 2006
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01777
`
`

`
`Case 1:15-cv-00670-LPS Document 13 Filed 09/22/15 Page 2 of 27 PageID #: 223
`
`2.
`
`DRL is without knowledge or information sufficient to form a belief as to the
`
`truth of the allegations of paragraph 2, and therefore denies them.
`
`3.
`
`DRL is without knowledge or information sufficient to form a belief as to the
`
`truth of the allegations of paragraph 3, and therefore denies them.
`
`4.
`
`DRL denies that Promius is, in all circumstances, an agent of DRL Inc. and DRL
`
`Ltd., and, for purposes of this action, admits the remaining allegations of paragraph 4.
`
`5.
`
`DRL denies that DRL Inc. is, in all circumstances, an agent of DRL Ltd., and, for
`
`purposes of this action, admits the remaining allegations of paragraph 5.
`
`6.
`
`7.
`
`DRL admits the allegations of paragraph 6.
`
`NATURE OF THE ACTION
`Answering paragraph 7 of the complaint, DRL admits that Plaintiffs purport to
`
`allege claims of patent infringement arising under the Patent Laws of the United States, 35
`
`U.S.C. §§ 100 et seq., as well as the Declaratory Judgment Act, 28 U.S.C. §§ 2201-02, in
`
`asserting the patents-in-suit (collectively U.S. Patent Nos. 7,211,267; 7,232,572; 8,603,506;
`
`7,749,532; 8,206,740; 8,394,405; 8,394,406; 8,470,364; and 8,709,478), but DRL denies that
`
`Plaintiffs have a legally sufficient, valid, or meritorious claim against DRL under those
`
`provisions.
`
`JURISDICTION AND VENUE
`DRL admits that this Court purportedly has jurisdiction over the subject matter of
`
`8.
`
`this action under 28 U.S.C. §§ 1331 and 1338(a), but DRL denies that Plaintiffs have a valid or
`
`meritorious claim against DRL under those provisions.
`
`9.
`
`DRL admits the allegations of paragraph 9 as to DRL Inc.; DRL denies that this
`
`district is a proper venue for the present dispute with regard to DRL Ltd. or Promius; but DRL
`
`does not contest venue in this district for the purposes of this action.
`
`
`
`2
`
`Galderma Laboratories, Inc. Ex 2006
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01777
`
`

`
`Case 1:15-cv-00670-LPS Document 13 Filed 09/22/15 Page 3 of 27 PageID #: 224
`
`10.
`
`Answering paragraph 10 of the complaint, DRL admits that this Court has
`
`personal jurisdiction over DRL, Inc.; DRL denies that this Court has personal jurisdiction over
`
`DRL Ltd. or Promius, but DRL does not contest personal jurisdiction in this Court for the
`
`purposes of this action; DRL admits that it filed NDA No. 208286 with the U.S. Food & Drug
`
`Administration (“FDA”), and DRL admits that it is intending to commercialize, manufacture,
`
`use, and/or sell the DRL’s NDA Product before the expiration of the patents-in-suit, throughout
`
`the United States, including in the State of Delaware, following approval of DRL’s NDA Product
`
`by the FDA; DRL denies the remaining allegations of paragraph 10.
`
`11.
`
`DRL admits that Promius is a subsidiary of DRL Inc. and DRL Ltd., but denies
`
`that Promius is an agent of DRL Inc. and DRL Ltd. and thus denies the remaining allegations of
`
`paragraph 11.
`
`12.
`
`DRL denies that DRL Inc., in all circumstances, is an agent of DRL Ltd., but
`
`otherwise admits that DRL Inc. submitted DRL’s NDA No. 208286 to the FDA on behalf of
`
`DRL Ltd.
`
`13.
`
`14.
`
`DRL denies the allegations in paragraph 13.
`
`DRL is without knowledge or information sufficient to form a belief as to the
`
`truth of Plaintiffs’ assertion of an estimated potential of U.S. sales of DRL’s NDA Product and
`
`whether Promius may have any involvement in any such commercialization, and therefore denies
`
`the allegations of paragraph 14.
`
`15.
`
`16.
`
`DRL denies the allegations of paragraph 15.
`
`DRL admits that Promius is organized and existing under the laws of the State of
`
`Delaware. DRL otherwise denies the allegations of paragraph 16, but DRL does not contest
`
`personal jurisdiction over Promius for the purposes of this action.
`
`
`
`3
`
`Galderma Laboratories, Inc. Ex 2006
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01777
`
`

`
`Case 1:15-cv-00670-LPS Document 13 Filed 09/22/15 Page 4 of 27 PageID #: 225
`
`17.
`
`DRL denies the allegations of paragraph 17, but DRL does not contest personal
`
`jurisdiction over DRL Inc. and DRL Ltd. for the purposes of this action.
`
`18.
`
`DRL admits the allegations of paragraph 18 as to DRL Inc., but DRL denies the
`
`allegations of paragraph 18 as to DRL Ltd.
`
`19.
`
`DRL admits that Promius is a subsidiary of DRL Inc. and DRL Ltd., and DRL
`
`admits that Promius sells branded dermatologic pharmaceutical products, but denies that Promius
`
`is an agent of DRL Inc. and DRL Ltd. and thus denies the remaining allegations of paragraph 19.
`
`20.
`
`DRL denies that DRL Ltd. directs the operations, management and activities of
`
`Promius and DRL Inc. in the United States, and thus denies the allegations of paragraph 20.
`
`21.
`
`Answering paragraph 21 of the complaint, DRL denies that it can be deemed to
`
`have availed itself of the protections afforded by the Court by having asserted compulsory
`
`counterclaims in this judicial district in other, unrelated cases; DRL admits that it has asserted
`
`compulsory counterclaims in this jurisdiction; and otherwise admits the allegations of
`
`paragraph 21.
`
`THE PATENTS-IN-SUIT
`DRL is without knowledge or information sufficient to form a belief as to the
`
`22.
`
`truth of the allegations of paragraph 22, and therefore denies them.
`
`23.
`
`DRL admits the allegations of paragraph 23, but denies that the ‘267 Patent was
`
`duly and legally issued.
`
`24.
`
`DRL is without knowledge or information sufficient to form a belief as to the
`
`truth of the allegations of paragraph 24, and therefore denies them.
`
`25.
`
`DRL admits the allegations of paragraph 25, but denies that the ‘572 Patent was
`
`duly and legally issued.
`
`
`
`4
`
`Galderma Laboratories, Inc. Ex 2006
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01777
`
`

`
`Case 1:15-cv-00670-LPS Document 13 Filed 09/22/15 Page 5 of 27 PageID #: 226
`
`26.
`
`DRL is without knowledge or information sufficient to form a belief as to the
`
`truth of the allegations of paragraph 26, and therefore denies them.
`
`27.
`
`DRL admits the allegations of paragraph 27, but denies that the ‘506 Patent was
`
`duly and legally issued.
`
`28.
`
`DRL is without knowledge or information sufficient to form a belief as to the
`
`truth of the allegations of paragraph 28, and therefore denies them.
`
`29.
`
`DRL admits the allegations of paragraph 29, but denies that the ‘532 Patent was
`
`duly and legally issued.
`
`30.
`
`DRL admits the allegations of paragraph 30 insofar as TCD is listed as the current
`
`owner in the USPTO assignment database, but is without knowledge or information sufficient to
`
`form a belief as to the truth of the remaining allegations of paragraph 30, and therefore denies
`
`them.
`
`31.
`
`DRL admits the allegations of paragraph 31, but denies that the ‘740 Patent was
`
`duly and legally issued.
`
`32.
`
`DRL admits the allegations of paragraph 32 insofar as TCD is listed as the current
`
`owner in the USPTO assignment database, but is without knowledge or information sufficient to
`
`form a belief as to the truth of the remaining allegations of paragraph 32, and therefore denies
`
`them.
`
`33.
`
`DRL admits the allegations of paragraph 33, but denies that the ‘405 Patent was
`
`duly and legally issued.
`
`34.
`
`DRL admits the allegations of paragraph 34 insofar as TCD is listed as the current
`
`owner in the USPTO assignment database, but is without knowledge or information sufficient to
`
`
`
`5
`
`Galderma Laboratories, Inc. Ex 2006
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01777
`
`

`
`Case 1:15-cv-00670-LPS Document 13 Filed 09/22/15 Page 6 of 27 PageID #: 227
`
`form a belief as to the truth of the remaining allegations of paragraph 34, and therefore denies
`
`them.
`
`35.
`
`DRL admits the allegations of paragraph 35, but denies that the ‘406 Patent was
`
`duly and legally issued.
`
`36.
`
`DRL admits the allegations of paragraph 36 insofar as TCD is listed as the current
`
`owner in the USPTO assignment database, but is without knowledge or information sufficient to
`
`form a belief as to the truth of the remaining allegations of paragraph 36, and therefore denies
`
`them.
`
`37.
`
`DRL admits the allegations of paragraph 37, but denies that the ‘364 patent was
`
`duly and legally issued.
`
`38.
`
`DRL admits the allegations of paragraph 38 insofar as TCD is listed as the current
`
`owner in the USPTO assignment database, but is without knowledge or information sufficient to
`
`form a belief as to the truth of the remaining allegations of paragraph 38, and therefore denies
`
`them.
`
`39.
`
`DRL admits the allegations of paragraph 39, but denies that the ‘478 patent was
`
`duly and legally issued.
`
`40.
`
`DRL admits the allegations of paragraph 40 insofar as TCD is listed as the current
`
`owner in the USPTO assignment database, but is without knowledge or information sufficient to
`
`form a belief as to the truth of the remaining allegations of paragraph 40, and therefore denies
`
`them.
`
`41.
`
`DRL admits that the patents-in-suit are listed in the Orange Book for ORACEA®,
`
`but denies that they were properly listed pursuant to 21 U.S.C. § 355(b)(1) or any attendant FDA
`
`regulations.
`
`
`
`6
`
`Galderma Laboratories, Inc. Ex 2006
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01777
`
`

`
`Case 1:15-cv-00670-LPS Document 13 Filed 09/22/15 Page 7 of 27 PageID #: 228
`
`DRL’S NDA AND NOTICE LETTERS
`DRL admits that DRL Inc. submitted NDA No. 208286 to the FDA on behalf of
`
`42.
`
`DRL Ltd., and DRL admits that it is intending to engage in the commercial manufacture, use,
`
`sale, or offer for sale within the United States, or importation into the United States, of DRL’s
`
`NDA Product prior to the expiration of the patents-in-suit following approval of DRL’s NDA
`
`Product by the FDA. DRL denies the remaining allegations of paragraph 42.
`
`43.
`
`44.
`
`DRL admits the allegations of paragraph 43.
`
`DRL denies the allegations of paragraph 44, though DRL admits that ORACEA®
`
`is the listed drug which its § 505(b)(2) application references.
`
`45.
`
`DRL admits the allegations of paragraph 45 as to studies conducted under fasting
`
`conditions.
`
`46.
`
`47.
`
`48.
`
`DRL admits the allegations of paragraph 46.
`
`DRL admits the allegations of paragraph 47.
`
`DRL admits that Galderma received the Ashley and Chang notice letters on
`
`June 25, 2015, but denies that TCD received the Chang notice letter on June 25, 2015, as TCD
`
`received the Chang notice letter on June 23, 2015.
`
`49.
`
`50.
`
`DRL admits the allegations of paragraph 49.
`
`DRL admits that the Ashley and Chang notice letters included an OCA, which
`
`was conditionally accepted by Galderma in its letter of July 6, 2015. DRL denies that Galderma
`
`negotiated with DRL in an effort to agree on reasonable terms for the OCA, and denies the
`
`remaining allegations of paragraph 50.
`
`51.
`
`DRL admits the allegations of paragraph 51, however, notes that DRL offered
`
`reasonable terms under the OCA but Galderma refused to accept those terms.
`
`
`
`7
`
`Galderma Laboratories, Inc. Ex 2006
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01777
`
`

`
`Case 1:15-cv-00670-LPS Document 13 Filed 09/22/15 Page 8 of 27 PageID #: 229
`
`DRL’S INFRINGEMENT OF THE PATENTS-IN-SUIT
`DRL repeats and realleges its responses to the preceding allegations as if fully set
`
`52.
`
`forth herein.
`
`53.
`
`54.
`
`DRL denies the allegations of paragraph 53.
`
`DRL admits that DRL Inc. submitted NDA No. 208286 on behalf of DRL Ltd.,
`
`and DRL admits that it is seeking to engage in the commercial manufacture, use, sale, or offer
`
`for sale within the United States, or importation into the United States, of DRL’s NDA Product
`
`prior to the expiration of the patents-in-suit following approval of DRL’s NDA Product by the
`
`FDA. DRL denies the remaining allegations of paragraph 54.
`
`55.
`
`56.
`
`57.
`
`DRL denies the allegations of paragraph 55.
`
`DRL denies the allegations of paragraph 56.
`
`DRL denies the allegations of paragraph 57.
`
`ANSWER TO PRAYER FOR RELIEF
`
`DRL denies that Plaintiffs are entitled to any of the judgments and relief prayed for in
`
`paragraphs A through E of the complaint.
`
`ADDITIONAL DEFENSES
`
`DRL alleges and asserts the following additional defenses in response to the allegations
`
`contained in Plaintiffs’ complaint:
`
`First Additional Defense
`(Noninfringement)
`
`58.
`
`The manufacture, use, offer for sale, sale, or importation of the products described
`
`in DRL’s NDA No. 208286 do not and will not infringe (either literally or under the doctrine of
`
`equivalents), directly or indirectly (either by inducement or contributorily), any valid claim of
`
`any of the patents-in-suit.
`
`
`
`8
`
`Galderma Laboratories, Inc. Ex 2006
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01777
`
`

`
`Case 1:15-cv-00670-LPS Document 13 Filed 09/22/15 Page 9 of 27 PageID #: 230
`
`Second Additional Defense
`(Invalidity Of The Patents-In-Suit)
`
`59.
`
`The claims of the patents-in-suit are invalid under Title 35, United States Code,
`
`including, inter alia, §§ 101, 102, 103, 112, and/or for double patenting.
`
`Third Additional Defense
`(Collateral Estoppel)
`
`60.
`
`The manufacture, use, offer for sale, sale, or importation of the products described
`
`in DRL’s NDA No. 208286 do not and will not infringe (either literally or under the doctrine of
`
`equivalents), directly or indirectly (either by inducement or contributorily), any claim of at least
`
`the ‘267 and ‘572 Patents under principles of collateral estoppel, based on the construction of the
`
`claims of these patents in Research Found. of State Univ. v. Mylan Pharms., Inc., 809 F. Supp.
`
`2d 296, 313-15 (D. Del. Aug. 26, 2011), aff’d in part, vacated in part, and remanded,
`
`No. 2012-1523, 2013 U.S. App. LEXIS 16284 (Fed. Cir. Aug. 7, 2013) (“the Research
`
`Decision”), which was litigated to a final judgment adversely to Plaintiffs, as set forth more
`
`particularly in the counterclaims that follow.
`
`Fourth Additional Defense
`(Prosecution History Estoppel)
`
`61.
`
`The claims of the patents-in-suit are so limited as not to cover the manufacture,
`
`use, offer for sale, sale, or importation of the products described in DRL’s NDA 208286 due to
`
`the arguments, statements, representations, and/or amendments made by Plaintiffs to the United
`
`States Patent and Trademark Office during the prosecution of the respective applications leading
`
`to issuance of each of the patents-in-suit.
`
`
`
`9
`
`Galderma Laboratories, Inc. Ex 2006
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01777
`
`

`
`Case 1:15-cv-00670-LPS Document 13 Filed 09/22/15 Page 10 of 27 PageID #: 231
`
`Fifth Additional Defense
`(Safe Harbor)
`62. Manufacturing, using, selling or offering to sell within the United States, or
`
`importing into the United States, DRL’s NDA Product, solely for uses reasonably related to the
`
`development and submission of information under a federal law that regulates the manufacture,
`
`use, or sale of drugs, including the submission and prosecution of a New Drug Application under
`
`§ 505(b)(2), is not an act of infringement under the safe harbor provisions of 35 U.S.C.
`
`§ 271(e)(1).
`
`Sixth Additional Defense
`(Failure To State A Claim Upon Which Relief Can Be Granted)
`Each of Plaintiffs’ allegations of infringement of each of the patents-in-suit under
`
`63.
`
`35 U.S.C. § 271 fails to state a claim upon which relief can be granted.
`
`Seventh Additional Defense
`(Failure To Join A Necessary Party)
`Plaintiffs failed to name Galderma S.A., which, based on information and belief,
`
`64.
`
`is a “societe anonyme” organized and existing under the laws of Switzerland, having a principal
`
`place of business at Avenue Gratta Paille 2, 1018 Lausanne, Switzerland. Galderma S.A., also
`
`based on information and belief, is a successor company of Galderma and is now the owner of
`
`the patents-in-suit and/or the NDA No. 50-805 on ORACEA®.
`
`RESERVATION OF DEFENSES
`
`65.
`
`To the extent not already pled, DRL reserves the right to add additional defenses
`
`pending further investigation and discovery.
`
`WHEREFORE, DRL denies that Plaintiffs are entitled to any relief as prayed for in the
`
`complaint or otherwise and, accordingly, DRL respectfully prays for entry of judgment:
`
`A. Dismissing Plaintiffs’ complaint against DRL with prejudice;
`
`
`
`10
`
`Galderma Laboratories, Inc. Ex 2006
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01777
`
`

`
`Case 1:15-cv-00670-LPS Document 13 Filed 09/22/15 Page 11 of 27 PageID #: 232
`
`B. Finding that DRL has not infringed and is not infringing upon any valid claim of
`
`the patents-in-suit;
`
`C. Finding that each claim of the patents-in-suit asserted against DRL is invalid;
`
`D. Enjoining Plaintiffs and/or any of their successors and attorneys, and all persons
`
`in active concert or participation with any of them, from directly or indirectly asserting
`
`infringement against, or instituting any further action for infringement of the patents-in-suit
`
`against DRL, or any of its customers, agents, successors, and assigns;
`
`E. Finding that this case is exceptional and awarding DRL its reasonable attorney
`
`fees, expenses, and costs incurred in connection with this action pursuant to 35 U.S.C. § 285,
`
`Fed. R. Civ. P. 11, and/or other applicable law;
`
`F. Assessing the costs of this action against Plaintiffs; and
`
`G. Awarding to DRL such other and further relief as the Court may deem just and
`
`proper under the circumstances.
`
`COUNTERCLAIMS FOR DECLARATORY JUDGMENT
`Defendant-Counterclaim Plaintiffs Dr. Reddy’s Laboratories, Ltd. (“DRL Ltd.”) and
`
`Dr. Reddy’s Laboratories, Inc. (“DRL Inc.”) (collectively “DRL” or “Counterclaim Plaintiffs”)
`
`by
`
`their attorneys, hereby state
`
`their counterclaims
`
`for declaratory
`
`relief against
`
`Plaintiff-Counterclaim Defendants Galderma Laboratories, L.P. (“Galderma”), Nestlë Skin
`
`Health S.A. (“Nestlë”), and TCD Royalty Sub, LLC (“TCD”), and Additional Counterclaim
`
`Defendant Galderma S.A. (“Galderma S.A.”) (collectively “Counterclaim Defendants”) as
`
`follows:
`
`1.
`
`These Counterclaims seek, inter alia, a judgment declaring that the claims of U.S.
`
`Patent Nos. 7,211,267 (“the ‘267 Patent”); 7,232,572 (“the ‘572 Patent”); 8,603,506 (“the
`
`‘506 Patent”); 7,749,532 (“the ‘532 Patent”); 8,206,740 (“the ‘740 Patent”); 8,394,405 (“the
`
`
`
`11
`
`Galderma Laboratories, Inc. Ex 2006
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01777
`
`

`
`Case 1:15-cv-00670-LPS Document 13 Filed 09/22/15 Page 12 of 27 PageID #: 233
`
`‘405 Patent”); 8,394,406 (“the ‘406 Patent”); 8,470,364 (“the ‘364 Patent”); and 8,709,478 (“the
`
`‘478 Patent”) (collectively “the patents-in-suit”) are invalid and/or not infringed by DRL.
`
`THE PARTIES
`Counterclaim Plaintiff DRL Ltd. is an Indian corporation, with its principal place
`
`2.
`
`of business at 8-2-337 Road No. 3, Banjara Hills, Hyderabad, 500034, India.
`
`3.
`
`Counterclaim Plaintiff DRL Inc. is a New Jersey corporation, with its principal
`
`place of business at 107 College Road East, Princeton, New Jersey 08540.
`
`4.
`
`On information and belief, Counterclaim Defendant Galderma is a privately held
`
`partnership registered in the State of Texas, having a principal place of business at 14501 North
`
`Freeway, Fort Worth, Texas 76177.
`
`5.
`
`On information and belief, Additional Counterclaim Defendant Galderma S.A. is
`
`a “societe anonyme” organized and existing under the laws of Switzerland, having a principal
`
`place of business at Avenue Gratta Paille 2, 1018 Lausanne, Switzerland.
`
`6.
`
`On information and belief, Counterclaim Defendant Nestlë is a “societe
`
`anonyme” organized and existing under the laws of Switzerland, having a principal place of
`
`business at Avenue Gratta Paille 2, 1018 Lausanne, Switzerland.
`
`7.
`
`On information and belief, Counterclaim Defendant TCD is a limited liability
`
`company organized and existing under the laws of the State of Delaware, having a principal
`
`place of business at 222 Delaware Avenue, Suite 1200, Wilmington, Delaware 19801.
`
`NATURE OF THE ACTION
`This is an action for declaratory judgment of patent noninfringement and
`
`8.
`
`invalidity arising under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202, as well as
`
`the patent laws, Title 35, United States Code.
`
`
`
`12
`
`Galderma Laboratories, Inc. Ex 2006
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01777
`
`

`
`Case 1:15-cv-00670-LPS Document 13 Filed 09/22/15 Page 13 of 27 PageID #: 234
`
`JURISDICTION AND VENUE
`This Court has subject matter jurisdiction over the counterclaims asserted herein
`
`9.
`
`pursuant to 28 U.S.C. §§ 1331, 1338, 2201, and 2202.
`
`10.
`
`On July 31, 2015, Plaintiffs-Counterclaim Defendants filed in this Court a
`
`complaint for patent infringement, alleging that DRL infringes the patents-in-suit listed in the
`
`U.S. Food & Drug Administration’s (“FDA”) Approved Drug Products with Therapeutic
`
`Equivalence Evaluations (“Orange Book”). By filing this complaint, Plaintiffs-Counterclaim
`
`Defendants have consented to the personal jurisdiction of this Court.
`
`11.
`
`Upon information and belief, Galderma S.A. exists as a result of the recent
`
`acquisition of Galderma by Nestlë. Upon information and belief, Galderma is a predecessor
`
`entity to Galderma S.A.
`
`12.
`
`13.
`
`Upon information and belief, Galderma S.A. is a subsidiary of Nestlë.
`
`Upon information and belief, Galderma S.A. is the alter ego of Galderma, and as
`
`such, this Court has personal jurisdiction over Galderma S.A. for the same reasons as it has
`
`personal jurisdiction over Galderma.
`
`14.
`
`This Court also has personal jurisdiction over Galderma S.A. because, based upon
`
`information and belief, it directly or through its subsidiaries, affiliates or agents, develops,
`
`formulates, manufactures, markets, imports, and sells pharmaceutical products throughout the
`
`United States, including in the State of Delaware.
`
`15.
`
`Venue is proper in this district pursuant to 28 U.S.C. § 1391. By filing its
`
`Complaint, Plaintiffs-Counterclaim Defendants have consented to venue in this district.
`
`16.
`
`Plaintiffs-Counterclaim Defendants, and now including Galderma S.A., by their
`
`Orange Book listings and by their Complaint herein, have asserted and continue to assert that
`
`DRL is infringing patents listed in the Orange Book. DRL, by notice letters and this answer, has
`
`
`
`13
`
`Galderma Laboratories, Inc. Ex 2006
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01777
`
`

`
`Case 1:15-cv-00670-LPS Document 13 Filed 09/22/15 Page 14 of 27 PageID #: 235
`
`asserted and continues to assert that it does not infringe these patents and/or that they are invalid.
`
`Thus, an actual, concrete, ripe, and justiciable controversy exists between Counterclaim
`
`Defendants, on the one hand, and DRL, on the other hand, concerning infringement and validity
`
`of the patents-in-suit.
`
`BACKGROUND OF THE PARTIES
`Galderma is listed in the Orange Book as the alleged holder of NDA No. 050805
`
`17.
`
`for doxycycline capsules, for oral use, in 40mg dosage, which is sold under the trademark
`
`ORACEA®.
`
`18.
`
`Galderma asserted to the public that, inter alia, the patents-in-suit claim the
`
`ORACEA® product and/or a method of using such product, and that a claim of infringement can
`
`reasonably be made under these patents as these patents are listed in the Orange Book pursuant
`
`to 21 U.S.C. § 355(b)(1) and 21 C.F.R. § 314.53.
`
`19.
`
`The label for ORACEA®, as provided to the FDA on July 25, 2013 (“ORACEA®
`
`label”), recites that ORACEA® is “a tetracycline-class drug indicated for the treatment of only
`
`inflammatory lesions (papules and pustules) of rosacea in adult patients.”
`
`20.
`
`The ORACEA® label recites in section 11, “Description,” that ORACEA®
`
`capsules, 40mg, are “filled with two types of doxycycline beads (30 = mg immediate release and
`
`10 mg delayed release) that together provide a dose of 40 mg of anhydrous doxycycline.”
`
`21.
`
`The ORACEA® label recites in the “Warnings and Precautions” section that
`
`“[b]acterial resistance to tetracyclines may develop in patients using ORACEA®.”
`
`22.
`
`The ORACEA® label also lists pseudomembranous colitis in the “Warnings and
`
`Precautions” section as a potential issue for a patient or doctor to monitor.
`
`
`
`14
`
`Galderma Laboratories, Inc. Ex 2006
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01777
`
`

`
`Case 1:15-cv-00670-LPS Document 13 Filed 09/22/15 Page 15 of 27 PageID #: 236
`
`23.
`
`The ORACEA® label states in section 6, “Adverse Reactions,” that certain side
`
`effects including diarrhea, headaches, and nausea are possible. Such side effects are well known
`
`to be common when taking antibiotics.
`
`24.
`
`DRL Ltd. is the owner of NDA No. 208286, filed by DRL Inc. on behalf of DRL
`
`Ltd. under 21 U.S.C. § 355(b)(2), which seeks approval of the FDA to market a doxycycline
`
`capsule, 40mg (“DRL’s NDA Product”). DRL’s NDA Product is also referred to as
`
`ZENAVOD™ or DFD-09.
`
`25.
`
`ZENAVOD™ is a tetracycline-class drug indicated for the treatment of only
`
`inflammatory lesions (papules and pustules) of rosacea in adult patients.
`
`26.
`
`ZENAVOD™ capsules, 40mg, include modified release beads containing
`
`doxycycline hyclate equivalent to 40 mg of doxycycline.
`
`27.
`
`DRL’s NDA No. 208286 included a certification by DRL Ltd. with respect to
`
`each of
`
`the patents-in-suit under 21 U.S.C. § 355(b)(2)(A)(IV) and 21 C.F.R.
`
`§ 314.50(i)(1)(i)(A)(4), certifying that the patents-in-suit 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 DRL’s NDA Product.
`
`28.
`
`DRL sent a letter to Galderma dated June 22, 2015, advising that DRL Ltd. had
`
`filed patent certifications with NDA No. 208286 as to the ‘267, ‘572, and ‘506 Patents
`
`(collectively “the Ashley Patents”) that, inter alia, 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 DRL’s NDA Product.
`
`29.
`
`As of June 22, 2015, Galderma, as Galderma Laboratories, Inc., was the recorded
`
`owner of the Ashley Patents in the United States Patent & Trademark Office (USPTO)
`
`
`
`15
`
`Galderma Laboratories, Inc. Ex 2006
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01777
`
`

`
`Case 1:15-cv-00670-LPS Document 13 Filed 09/22/15 Page 16 of 27 PageID #: 237
`
`assignment database. Upon information and belief, Galderma Laboratories, Inc. was a
`
`predecessor to Galderma.
`
`30.
`
`Upon information and belief, Nestlë is now the owner of the Ashley Patents,
`
`though Nestlë’s ownership has not been recorded in the USPTO assignment database.
`
`31.
`
`DRL sent a letter to Galderma, TCD, and Supernus Pharmaceuticals, Inc. dated
`
`June 22, 2015, advising that DRL Ltd. had filed patent certifications with NDA No. 208286 as to
`
`the ‘532, ‘740, ‘405, ’406, ‘364, and ‘478 Patents (collectively “the Chang Patents”) that,
`
`inter alia, the Chang 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
`
`DRL’s NDA Product.
`
`32.
`
`As of June 22, 2015, TCD, via a recent transfer from Supernus Pharmaceuticals,
`
`Inc., was the recorded owner of the Chang Patents in the USPTO assignment database.
`
`33.
`
`Upon information and belief, Galderma received and reviewed DRL’s June 22,
`
`2015 letter, which included the notice of patent certification under 21 U.S.C. § 355(b)(2)(A)(IV)
`
`and 21 C.F.R. § 314.50(i)(1)(i)(A)(4), certifying 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 DRL’s NDA Product.
`
`34.
`
`Upon information and belief, Galderma, TCD, and Supernus Pharmaceuticals,
`
`Inc. received and reviewed DRL’s June 22, 2015 letter, which included the notice of patent
`
`certification under 21 U.S.C. § 355(b)(2)(A)(IV) and 21 C.F.R. § 314.50(i)(1)(i)(A)(4),
`
`certifying that the Chang 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
`
`DRL’s NDA Product.
`
`
`
`16
`
`Galderma Laboratories, Inc. Ex 2006
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01777
`
`

`
`Case 1:15-cv-00670-LPS Document 13 Filed 09/22/15 Page 17 of 27 PageID #: 238
`
`35.
`
`DRL’s June 22, 2015 letter concerning the Ashley Patents included an Offer of
`
`Confidential Access (“OCA”).
`
`36.
`
`37.
`
`DRL’s June 22, 2015 letter concerning the Chang Patents included an OCA.
`
`DRL is not licensed to practice medicine in any state of the United States; does
`
`not practice medicine anywhere in the United States; and does not treat patients of any kind in
`
`the United States.
`
`BACKGROUND OF SKIN CONDITIONS AND
`
`TREATMENT USING TETRACYCLINES
`
`38.
`
`DRL incorporates by reference each of the preceding allegations as if fully set
`
`forth herein.
`
`39.
`
`Rosacea is a common skin condition that includes various symptoms, including
`
`papules and pustules.
`
`40.
`
`Prior to the earliest priority date of the patents-in-suit, papules and pustules of
`
`rosacea were known to be inflammatory in nature.
`
`41.
`
`Prior to the earliest priority date of the patents-in-suit, tetracyclines, including
`
`doxycycline, were well known antibiotics, and were well known to be effective as
`
`anti-inflammatory agents.
`
`42.
`
`Prior to the earliest priority date of the patents-in-suit, tetracyclines, including
`
`doxycycline, had long been used to treat rosacea and specifically the papules and pustules of
`
`rosacea.
`
`43.
`
`Prior to the earliest priority date of the patents-in-suit, tetracyclines, including
`
`doxycycline, were well known to be effective as anti-inflammatory agents at doses lower than
`
`those that were allegedly used for antibiotic therapy.
`
`
`
`17
`
`Galderma Laboratories, Inc. Ex 2006
`Dr. Reddy's Labs v. Galderma Labs., Inc.
`IPR2015-01777
`
`

`
`Case 1:15-cv-00670-LPS Document 13 Filed 09/22/15 Page 18 of 27 PageID #: 239
`
`44.
`
`Prior to the earliest priority date of the patents-in-suit, no medical necessity was
`
`known to exist for giving antibiotic doses of doxycycline to treat papules and pustules of rosacea.
`
`Indeed, just the opposite was true. Advantages of lower doses, such as cost and pill size, in
`
`addition to possibly avoiding the known antibiotic-level side effects of that drug and reducing the
`
`prospect of creating drug resistant bacteria, were well known, and would provide particular
`
`benefit for the long-term treatment of the papules and pustules of rosacea.
`
`45.
`
`Prior to the earliest priority date of the patents-in-suit, dermatologists would have
`
`been motivated to use, or at least try, lower doses of doxycycline to treat inflammatory
`
`conditions like rosacea and its symptoms because they knew doxycycline was effective in
`
`treating rosacea, and that doxycycline was active as an anti-inflammatory at almost any level.
`
`46.
`
`Prior
`
`to
`
`the earliest priority date of
`
`the patents-in-suit, Col