Case 1:17-cv-00401-LPS Document 11 Filed 07/07/17 Page 1 of 15 PageID #: 99
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. 17-401-LPS
`
`)))))))))))
`
`BRISTOL-MYERS SQUIBB COMPANY
`and PFIZER INC.,
`
`Plaintiff,
`
`v.
`
`DR. REDDY’S LABORATORIES, LTD.
`and DR. REDDY’S LABORATORIES, INC.,
`
`Defendants.
`
`DR. REDDY’S LABORATORIES, LTD. AND DR. REDDY’S LABORATORIES, INC.’S
`ANSWER, DEFENSES, AND COUNTERCLAIMS
`
`Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, “DRL”
`
`or “Defendants”), by their attorneys, for their Answer, Defenses, and Counterclaims to the
`
`Complaint filed by Bristol-Myers Squibb Company (“BMS”) and Pfizer Inc. (“Pfizer”)
`
`(collectively, “Plaintiffs”) state as follows:
`
`GENERAL DENIAL
`
`Pursuant to Fed. R. Civ. P. 8(b)(3), DRL denies all allegations in Plaintiffs’ Complaint
`
`except those specifically admitted below.
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement arising under the patent laws of the United
`States, Title 35, United States Code, against Defendants Dr. Reddy’s Laboratories, Ltd.
`(“Dr. Reddy’s Ltd.”) and Dr. Reddy’s Laboratories, Inc. (“Dr. Reddy’s Inc.,” and
`together with Dr. Reddy’s Ltd., “DRL”). This action relates to Abbreviated New Drug
`Application (“ANDA”) No. 210082 filed by DRL with the U.S. Food and Drug
`Administration (“FDA”).
`
`ANSWER: DRL admits that Plaintiffs purport to bring this action for patent
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`infringement under the patent laws of the United States. DRL further admits that this action
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`

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`Case 1:17-cv-00401-LPS Document 11 Filed 07/07/17 Page 2 of 15 PageID #: 100
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`purports to relate to ANDA No. 210082, filed by DRL with the FDA. DRL denies any
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`remaining allegations of paragraph 1.
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`2.
`
`In ANDA No. 210082, DRL seeks approval to market 2.5 mg and 5 mg tablets of
`apixaban, generic versions of Plaintiffs’ Eliquis® drug product (the “DRL ANDA
`product”), prior to expiration of U.S. Patent No. 9,326,945 (the “’945 patent” or “patent-
`in-suit”).
`
`ANSWER: DRL admits that it filed ANDA No. 210082, which seeks FDA approval
`
`to market 2.5 mg and 5 mg tablets of apixaban prior to the expiration date of U.S. Patent No.
`
`9,326,945 (“the ’945 patent”). DRL further admits that ANDA No. 210082 identifies Eliquis®
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`(apixaban) oral tablets, 2.5 mg and 5 mg, as the Reference Listed Drug. DRL denies any
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`remaining allegations of paragraph 2.
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`PARTIES
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`3.
`
`BMS is a corporation organized and existing under the laws of Delaware, having a place
`of business at Route 206 and Province Line Road, Princeton, New Jersey 08540.
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`ANSWER: DRL lacks sufficient information to form a belief as to the truth of the
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`allegations in paragraph 3 and therefore denies them.
`
`4.
`
`Pfizer is a corporation organized and existing under the laws of Delaware, having its
`principal place of business at 235 East 42nd Street, New York, New York 10017.
`
`ANSWER: DRL lacks sufficient information to form a belief as to the truth of the
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`allegations in paragraph 4 and therefore denies them.
`
`5.
`
`Plaintiffs are engaged in the business of creating, developing, and bringing to market
`revolutionary pharmaceutical products to help patients prevail against serious diseases,
`including treatments for thromboembolic disorders. Plaintiffs sell Eliquis® in this
`judicial district and throughout the United States.
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`ANSWER: DRL lacks sufficient information to form a belief as to the truth of the
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`allegations in paragraph 5 and therefore denies them.
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`6.
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`Upon information and belief, Dr. Reddy’s Ltd. is a corporation organized and existing
`under the laws of India, having its principal place of business at Door No. 8-2-337, Road
`No. 3, Banjara Hills, Hyderabad, Telangana, 500034, Andhra Pradesh, India.
`
`ANSWER: DRL Ltd. is an Indian corporation with a principal place of business at 8-
`
`2-337 Road No. 3, Banjara Hills, Hyderabad, 500034, India. DRL denies any remaining
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`allegations of paragraph 6.
`
`7.
`
`8.
`
`Upon information and belief, Dr. Reddy’s Inc. is a corporation organized and existing
`under the laws of the State of New Jersey, having its principal place of business at 107
`College Road East, Princeton, New Jersey 08540.
`
`ANSWER: DRL admits the allegations of paragraph 7.
`
`JURISDICTION AND VENUE
`
`This action arises under the patent laws of the United States, 35 U.S.C. §§ 100, et seq.,
`and this Court has jurisdiction over the subject matter of this action under 28 U.S.C.
`§§ 1331, 1338(a), 2201, and 2202.
`
`ANSWER: The allegations set forth in paragraph 8 are legal conclusions to which no
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`answer is required. To the extent any response is required, DRL admits for purposes of this case
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`only that this Court has subject matter jurisdiction over the claims alleged by Plaintiffs. DRL
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`denies any remaining allegations of paragraph 8.
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`9.
`
`Venue is proper in this Court under 28 U.S.C. §§ 1391 and/or 1400(b), and this Court has
`personal jurisdiction over DRL. DRL, through its counsel, by e-mail dated March 27,
`2017, agreed that it does not contest jurisdiction or venue in this Court in this matter.
`
`ANSWER: The allegations set forth in paragraph 9 are legal conclusions to which no
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`answer is required. To the extent any response is required, DRL does not contest personal
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`jurisdiction or venue in this judicial district solely for purposes of Plaintiffs’ claims against DRL
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`in this case and solely as they apply to the proposed product described in ANDA No. 210082.
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`DRL denies any remaining allegations of paragraph 9.
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`3
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`PATENT-IN-SUIT
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`10. On May 3, 2016, the U.S. Patent and Trademark Office duly and legally issued the ’945
`patent, titled “Apixaban Formulations.” A true and correct copy of the ’945 patent is
`attached hereto as Exhibit A. The claims of the ’945 patent are valid, enforceable, and
`not expired. Plaintiffs are the joint owners of the ’945 patent and have the right to
`enforce it.
`
`ANSWER: DRL denies every allegation set forth in this paragraph, except admits that
`
`the ’945 patent is entitled “Apixaban Formulations,” the face of the ’945 patent indicates that it
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`issued on May 3, 2016 and lists Bristol-Myers Squibb Company and Pfizer Inc. as its Assignees,
`
`that what appears to be a copy of the ’945 patent is attached to the Complaint as Exhibit A, and
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`on information and belief that FDA’s Approved Drug Products with Therapeutic Equivalence
`
`Evaluations (the “Orange Book”) lists the expiration date of the ’945 patent as February 24,
`
`2031.
`
`11. BMS is the holder of New Drug Application (“NDA”) No. 202155, by which the FDA
`granted approval for the marketing and sale of 2.5 mg and 5 mg strength apixaban
`tablets. Plaintiffs market apixaban tablets in the United States, under the trade name
`“Eliquis®.” The FDA’s official publication of approved drugs (the “Orange Book”)
`includes Eliquis® together with the patent-in-suit. Eliquis® is a factor Xa inhibitor
`indicated: (1) to reduce the risk of stroke and systemic embolism in patients with
`nonvalvular atrial fibrillation; (2) for the prophylaxis of deep vein thrombosis (“DVT”),
`which may lead to pulmonary embolism (“PE”), in patients who have undergone hip or
`knee replacement surgery; and (3) for the treatment of DVT and PE, and for the reduction
`in the risk of recurrent DVT and PE following initial therapy. A copy of the complete
`prescribing information for Eliquis® approved in NDA No. 202155 is attached as Exhibit
`B.
`
`ANSWER: DRL admits that the Orange Book lists Bristol Myers Squibb Co
`
`Pharmaceutical Research Institute as the holder of NDA No. 202155, which is directed to 2.5 mg
`
`and 5 mg apixaban tablets that are marketed under the trade name Eliquis®. DRL further admits
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`that the Orange Book lists the ’945 patent in relation to Eliquis®. DRL further admits that what
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`appears to be a copy of the prescribing information for Eliquis® is attached to the Complaint as
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`Exhibit B. DRL admits that the prescribing information for Eliquis® recites, in part:
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`Case 1:17-cv-00401-LPS Document 11 Filed 07/07/17 Page 5 of 15 PageID #: 103
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`DRL denies any remaining allegations of paragraph 11.
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`INFRINGEMENT BY DRL
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`12. By letter sent by UPS Next Day Air on March 9, 2017, DRL notified Plaintiffs that DRL
`had submitted ANDA No. 210082 to the FDA under Section 505(j) of the Federal Food,
`Drug, and Cosmetic Act (21 U.S.C. § 355(j)) (“the Eliquis Notice Letter”). Plaintiffs
`received the Eliquis Notice Letter no earlier than March 10, 2017.
`
`ANSWER: DRL admits the allegations of paragraph 12.
`
`13. The Eliquis Notice Letter states that DRL seeks approval from the FDA to engage in the
`commercial manufacture, use, and sale of the DRL ANDA product before the expiration
`of the patent-in-suit. Upon information and belief, DRL intends to – directly or indirectly
`– engage in the commercial manufacture, use, and sale of the DRL ANDA product
`promptly upon receiving FDA approval to do so.
`
`ANSWER: DRL admits that its Notice Letter states that DRL seeks approval from the
`
`FDA to engage in the commercial manufacture, use, and/or sale of DRL’s proposed ANDA
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`products in ANDA No. 210082 before the expiration of the ’945 patent. DRL denies any
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`remaining allegations of paragraph 13.
`
`14. By filing ANDA No. 210082, DRL has necessarily represented to the FDA that the DRL
`ANDA product has the same active ingredient as Eliquis®, has the same dosage form and
`strength as Eliquis®, and is bioequivalent to Eliquis®.
`
`ANSWER: DRL admits that ANDA No. 210082 identifies ELIQUIS® (apixaban) oral
`
`tablets, 2.5 mg and 5 mg, as the Reference Listed Drug and that ANDA No. 210082 contains
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`Case 1:17-cv-00401-LPS Document 11 Filed 07/07/17 Page 6 of 15 PageID #: 104
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`information intended to establish bioequivalence with the Reference Listed Drug. DRL denies
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`any remaining allegations of paragraph 14.
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`15. Upon information and belief, DRL is seeking approval to market the DRL ANDA
`product for the same approved indications as Eliquis®.
`
`ANSWER: DRL admits that the product labeling for the proposed apixaban oral
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`tablets, 2.5 mg and 5 mg, that are the subject of ANDA No. 210082 will comply with applicable
`
`law. DRL denies any remaining allegations of paragraph 15.
`
`16.
`
`17.
`
`In the Eliquis Notice Letter, DRL states that its ANDA contains a certification pursuant
`to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) asserting that the patent-in-suit is invalid,
`unenforceable, and/or will not be infringed by the commercial manufacture, use, and sale
`of the DRL ANDA product.
`
`ANSWER: DRL admits the allegations in paragraph 16.
`
`In the Eliquis Notice Letter, DRL offered confidential access to portions of its ANDA
`No. 210082 on terms and conditions set forth in the Eliquis Notice Letter (“the DRL
`Offer”). DRL requested that Plaintiffs accept the DRL Offer before receiving access to
`DRL’s ANDA No. 210082. The DRL Offer contained unreasonable restrictions well
`beyond those that would apply under a protective order on who could view the ANDA.
`For example, the DRL Offer contained a broad patent prosecution bar, which, among
`other things, does not have a carve-out for inter-partes reviews or other adversarial
`proceedings, and a broad restriction barring access by outside counsel who engage in any
`FDA counseling, litigation, or other work before or involving the FDA. The DRL Offer
`unreasonably restricted the ability of counsel to seek the opinions of outside experts
`without written permission from DRL’s designated counsel, and DRL had broad
`authority to reject any request by Plaintiffs to seek outside expert access to the DRL
`ANDA. The restrictions DRL has placed on access to ANDA No. 210082 contravene
`21 U.S.C. § 355(j)(5)(C)(i)(III), which states that an offer of confidential access “shall
`contain such restrictions as to persons entitled to access, and on the use and disposition of
`any information accessed, as would apply had a protective order been entered for the
`purpose of protecting trade secrets and other confidential business information”
`(emphasis added).
`
`ANSWER: DRL admits that its Notice Letter contained an offer of confidential access
`
`in compliance with 21 U.S.C. § 355(j)(5)(C)(i)(III), which required that the recipients accept the
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`offer of confidential access before receiving a copy of ANDA No. 210082, consistent with the
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`statute. The other allegations set forth in paragraph 17 are legal conclusions to which no answer
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`Case 1:17-cv-00401-LPS Document 11 Filed 07/07/17 Page 7 of 15 PageID #: 105
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`is required. To the extent an answer is required, DRL denies any remaining allegations of
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`paragraph 17.
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`18. This Complaint is being filed before the expiration of forty-five days from the date
`Plaintiffs received the Eliquis Notice Letter.
`
`ANSWER: DRL admits the allegations in paragraph 18.
`
`COUNT I
`(INFRINGEMENT OF THE ’945 PATENT)
`
`19. Each of the preceding paragraphs 1 to 18 is incorporated as if fully set forth herein.
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`ANSWER: DRL incorporates its responses to paragraphs 1–18 as if fully set forth
`
`herein.
`
`20. DRL’s submission of ANDA No. 210082 to obtain approval to engage in the commercial
`manufacture, use, offer to sell, or sale of the DRL ANDA product prior to the expiration
`of the ’945 patent constituted a technical act of infringement of at least one of the claims
`of the ’945 patent, either literally or under the doctrine of equivalents, including but not
`limited to claims 1, 9-12, 20-23, 25, 27, 29, 31, 33, 35, and 37, under 35 U.S.C. §
`271(e)(2)(A).
`
`ANSWER: DRL denies the allegations in paragraph 20.
`
`21. DRL’s commercial manufacture, use, offer to sell, sale, or importation of the DRL
`ANDA product prior to the expiration of the ’945 patent, and its inducement of and/or
`contribution to such conduct, would further infringe at least one of the claims of the ’945
`patent, either literally or under the doctrine of equivalents, including but not limited to
`claims 1, 9-12, 20-23, 25, 27, 29, 31, 33, 35, and 37, under 35 U.S.C. §§ 271(a), (b)
`and/or (c).
`
`ANSWER: DRL denies the allegations in paragraph 21.
`
`22. Upon FDA approval of DRL ANDA No. 210082, DRL will infringe one or more claims
`of the ’945 patent, either literally or under the doctrine of equivalents, including but not
`limited to claims 1, 9-12, 20-23, 25, 27, 29, 31, 33, 35, and 37, by making, using, offering
`to sell, and selling the DRL ANDA product in the United States and/or importing said
`product into the United States, or by actively inducing and contributing to infringement
`of the ’945 patent by others, under 35 U.S.C. § 271(a)-(c), unless enjoined by the Court.
`
`ANSWER: DRL denies the allegations in paragraph 22.
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`23.
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`If DRL’s marketing and sale of the DRL ANDA product prior to expiration of the ’945
`patent and all other relevant exclusivities are not enjoined, Plaintiffs will suffer
`substantial and irreparable harm for which there is no remedy at law.
`
`ANSWER: DRL denies the allegations in paragraph 23.
`
`RESPONSE TO PLAINTIFFS’ PRAYER FOR RELIEF
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`The remainder of Plaintiffs’ Complaint is a prayer for relief and does not require a
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`response. To the extent a response is required, DRL denies any allegations in Plaintiffs’ “Prayer
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`for Relief” and denies that Plaintiffs are entitled to any relief whatsoever against DRL in this
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`action, either as set forth in their Prayer for Relief or otherwise.
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`DEFENSES
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`DRL asserts the following defenses without prejudice to the denials in this Answer,
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`without admitting any allegations of the Complaint not otherwise admitted. DRL reserves the
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`right to assert additional defenses, at law or in equity, as they become known through further
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`investigation and discovery. DRL does not intend to hereby assume the burden of proof with
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`respect to those matters as to which, pursuant to law, Plaintiffs bear the burden of proof.
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`FIRST DEFENSE
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`Plaintiffs’ Complaint fails to state a claim upon which relief may be granted. The claims
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`in Plaintiffs’ Complaint are not pleaded with sufficient particularity to give DRL a full and fair
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`opportunity to defend itself. Plaintiffs’ Complaint does not explain why any accused product
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`allegedly infringes any claim of the ’945 patent.
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`SECOND DEFENSE
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`DRL does not infringe, has not infringed, and will not infringe, directly or indirectly, any
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`valid and enforceable claim of the ’945 patent, either literally or under the doctrine of
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`equivalents.
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`8
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`THIRD DEFENSE
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`The claims of the ’945 patent are invalid and/or unenforceable for failure to comply with
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`one or more of the requirements of Title 35, United States Code, including without limitation
`
`§§ 101, 102, 103, and/or 112.
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`FOURTH DEFENSE
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`Plaintiffs’ claims for relief are barred, in whole or in part, by one or more of the equitable
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`doctrines of laches, waiver, estoppel, prosecution history estoppel, unclean hands, and/or
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`inequitable conduct.
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`FIFTH DEFENSE
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`Any additional defenses that discovery may reveal.
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`COUNTERCLAIMS
`
`Pursuant to Rule 13 of the Federal Rules of Civil Procedure, Dr. Reddy’s Laboratories,
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`Ltd. (“DRL Ltd.”) and Dr. Reddy’s Laboratories, Inc. (“DRL Inc.”) (collectively, “DRL” or
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`“Defendants” or “Counter-Claimants”), by their attorneys, hereby state for their Counterclaims
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`against Bristol-Myers Squibb Company (“BMS”) and Pfizer Inc. (“Pfizer”) (collectively,
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`“Plaintiffs” or “Counter-Defendants”), the following, without prejudice to the denials in this
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`Answer, without admitting any allegations of the Complaint not otherwise admitted, and without
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`assuming the burden of proof when such burden would otherwise be on Plaintiffs/Counter-
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`Defendants:
`
`1.
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`DRL repeats and incorporates by reference each of the foregoing paragraphs of
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`DRL’s Answer and Defenses to the Complaint as if fully set forth herein.
`
`2.
`
`This is an action for a declaratory judgment of non-infringement and invalidity, of
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`one or more claims of U.S. Patent No. 9,326,945 (“the ’945 patent”) under 28 U.S.C. §§ 2201
`
`9
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`Case 1:17-cv-00401-LPS Document 11 Filed 07/07/17 Page 10 of 15 PageID #: 108
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`and 2202. Upon information and belief, a true and correct copy of the ’945 patent was attached
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`to the Complaint as Exhibit A.
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`THE PARTIES
`
`3.
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`DRL Ltd. is an Indian corporation with a principal place of business at 8-2-337
`
`Road No. 3, Banjara Hills, Hyderabad, 500034, India.
`
`4.
`
`DRL Inc. is a corporation organized and existing under the laws of New Jersey
`
`with a principal place of business at 107 College Road East, Princeton, New Jersey 08540.
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`5.
`
`Upon information and belief, BMS is a corporation organized and existing under
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`the laws of the State of Delaware, having its principal place of business at Route 206 and
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`Province Line Road, Princeton, New Jersey 08540.
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`6.
`
`Upon information and belief, Pfizer is a corporation organized and existing under
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`the laws of the State of Delaware, having its principal place of business at 235 East 42nd Street,
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`New York, New York 10017.
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`JURISDICTION AND VENUE
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`7.
`
`These counterclaims arise under the Patent Laws of the United States, 35 U.S.C.
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`§ 1 et seq., and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
`
`8.
`
`This Court has subject matter jurisdiction to hear these Counterclaims under
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`28 U.S.C. §§ 1331 and 1338(a), and under the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and
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`2202, based on an actual controversy between Plaintiffs and DRL created by the claims asserted
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`in Plaintiffs’ Complaint.
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`9.
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`This Court has personal jurisdiction over Plaintiffs by virtue of Plaintiffs’
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`commencement of this action for patent infringement involving the ’945 patent against DRL in
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`this jurisdiction.
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`10
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`10.
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`Venue is proper in this judicial district under 28 U.S.C. §§ 1391 and/or 1400(b),
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`and because Plaintiffs commenced this action in this venue.
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`BACKGROUND
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`11.
`
`Plaintiffs allege that they are the joint owners of the ’945 patent, which is entitled
`
`“Apixaban Formulations.”
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`12.
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`On April 10, 2017, Plaintiffs filed a Complaint against DRL alleging infringement
`
`of the ’945 patent based on the submission of ANDA No. 210082, seeking approval to engage in
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`the commercial manufacture, use, sale and/or importation of DRL’s proposed ANDA products
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`prior to the expiration of the ’945 patent.
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`13.
`
`Based on Plaintiffs’ allegations in the Complaint, there is now an actual and
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`justiciable controversy between Plaintiffs and DRL regarding, inter alia, the infringement and
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`validity of the ’945 patent that is of sufficient immediacy and reality to warrant the issuance of a
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`declaratory judgment.
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`COUNT I
`(Declaratory Judgment of Non-Infringement of the ’945 patent)
`
`14.
`
`DRL repeats and re-alleges each of the foregoing paragraphs of its Answer,
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`Defenses, and Counterclaims as if fully set forth herein.
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`15.
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`DRL does not, has not, and will not directly or indirectly infringe, either literally
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`or under the doctrine of equivalents, any valid and enforceable claim of the ’945 patent.
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`16.
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`DRL’s manufacture, use, offer for sale, sale in the United States, and/or
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`importation into the United States of the products proposed in ANDA No. 210082 will not
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`infringe, directly or indirectly, either literally or under the doctrine of equivalents, any valid and
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`enforceable claim of the ’945 patent.
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`11
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`17.
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`To the extent one or more of Plaintiffs’ claims of infringement are based on the
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`doctrine of equivalents, they are barred, in whole or in part, by the doctrine of prosecution
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`history estoppel.
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`18.
`
`DRL is entitled to a declaratory judgment of non-infringement.
`
`COUNT II
`(Declaratory Judgment of Invalidity of the ’945 patent)
`
`19.
`
`DRL repeats and re-alleges each of the foregoing paragraphs of its Answer,
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`Defenses, and Counterclaims as if fully set forth herein.
`
`20.
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`The claims of the ’945 patent are invalid for failure to comply with one or more of
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`the requirements of Title 35, United States Code, including without limitation, §§ 101, 102, 103,
`
`and/or 112.
`
`21.
`
`By way of example only, the claims of the ’945 patent are invalid under 35 U.S.C.
`
`§ 103, at least in view of one or more of the following references: Garcia, D. et al., “The new
`
`oral anticoagulants,” Blood 7 January 2010, Vol. 115, No. 1, 15–20; Raghavan, N. et al.,
`
`“Apixaban Metabolism and Pharmacokinetics after Oral Administration to Humans,” Drug
`
`Metabolism & Disposition 2009, Vol. 37, No. 1, 74–81; Lassen, M.R. et al., “The efficacy and
`
`safety of apixaban, an oral, direct factor Xa inhibitor, as thromboprophylaxis in patients
`
`following total knee replacement,” 5 J. Thromb. Haemost. 2368–75 (2007); U.S. Patent
`
`Publication No. 2006/0160841; PCT Publication No. WO 2010/003811; U.S. Patent Publication
`
`No. 2007/0203178; U.S. Patent Publication No. 2012/0087978; PCT Publication No. WO
`
`2010/147978; Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems, 9th ed., edited
`
`by Loyd V. Allen, Nicholas G. Popovich, and Howard C. Ansel, Lippincott Williams & Wilkins
`
`2000; U.S. Patent Application Publication 2009/0291913; U.S. Patent No. 5,145,684; and U.S.
`
`12
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`Case 1:17-cv-00401-LPS Document 11 Filed 07/07/17 Page 13 of 15 PageID #: 111
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`Patent Application Publication No. 2009/0285887. DRL reserves the right to provide additional
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`bases for invalidity as this action proceeds.
`
`22.
`
`The claims of the ‘945 patent are invalid under 35 U.S.C. § 112 for (1) failure to
`
`comply with the definiteness requirement, (2) failure to comply with the enablement
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`requirement, and (3) failure to comply with the written description requirement. The claims of
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`the ‘945 patent do not satisfy the definiteness requirement at least because the claims, read in
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`light of the specification and the prosecution history, fail to inform, with reasonable certainty, a
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`person of ordinary skill in the art about the scope of the claimed invention. The claims do not,
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`for example, point out anything more than what is obvious over the prior art or was known to a
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`person of skill in the art at the time that the application for the ‘945 patent was filed. Thus, the
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`claims, specification, and prosecution history of the ‘945 patent do not inform with reasonable
`
`certainty, a person of skill in the art about the scope of the alleged invention of the ‘945 patent.
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`The claims of the ‘945 patent do not satisfy the enablement requirement at least because the
`
`specification would not have enabled a person of ordinary skill in the art to make and use the
`
`claimed invention to its full scope without undue experimentation. The specification does not,
`
`for example, enable anything more than what is obvious over the prior art or was known to a
`
`person of skill in the art at the time that the application for the ‘945 patent was filed. Thus, the
`
`specification of the ‘945 patent does not include a sufficient disclosure to enable a person of skill
`
`in the art to make and use the alleged invention of the ‘945 patent to the full scope of the claims.
`
`The claims of the ‘945 patent do not satisfy the written description requirement at least because
`
`the specification fails to describe what is claimed in sufficient detail such that a person of
`
`ordinary skill in the art could have concluded that the inventors were in possession of the
`
`claimed subject matter as of the filing date. The specification does not, for example, describe
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`Case 1:17-cv-00401-LPS Document 11 Filed 07/07/17 Page 14 of 15 PageID #: 112
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`anything more than what is obvious over the prior art or was known to a person of skill in the art
`
`at the time that the application for the ‘945 patent was filed. Thus, the specification of the ‘945
`
`patent does not include an adequate written description for the full scope of the claims of the
`
`‘945 patent.
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`23.
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`DRL is entitled to a declaratory judgment that the claims of the ’945 patent are
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`invalid.
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`DRL’S PRAYER FOR RELIEF
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`WHEREFORE, DRL respectfully requests that the Court enter judgment in its favor and
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`grant the following relief:
`
`A.
`
`Dismissing Plaintiffs’ Complaint and denying each and every prayer for relief
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`contained therein, with prejudice;
`
`B.
`
`C.
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`Declaring that DRL has not infringed any claim of the ’945 patent;
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`Declaring that DRL’s proposed ANDA products and the submission of ANDA
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`No. 210082 to obtain approval to engage in the commercial manufacture, use, offer for sale,
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`sale and/or importation of DRL’s proposed ANDA products prior to the expiration of the ’945
`
`patent do not infringe, directly or indirectly, literally or under the doctrine of equivalents, any
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`claim of the ’945 patent;
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`D.
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`E.
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`Declaring that the claims of the ’945 patent are invalid;
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`Declaring this case exceptional and awarding DRL its reasonable attorneys’ fees
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`under 35 U.S.C. § 285, with pre- and post-judgment interest thereon;
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`F.
`
`G.
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`Awarding DRL its costs and expenses; and
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`Awarding DRL such other and further relief as the Court deems just and proper.
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`Case 1:17-cv-00401-LPS Document 11 Filed 07/07/17 Page 15 of 15 PageID #: 113
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`OF COUNSEL:
`
`Keith D. Parr
`Michael J. Gaertner
`David B. Abramowitz
`Carolyn A. Blessing
`Nina Vachhani
`LOCKE LORD LLP
`111 South Wacker Drive
`Chicago, IL 60606
`Tel: (312) 443-0700
`
`Dated: July 7, 2017
`5290659 / 44017
`
`Respectfully submitted,
`
`POTTER ANDERSON & CORROON LLP
`
`By: /s/ David E. Moore
`David E. Moore (#3983)
`Bindu A. Palapura (#5370)
`Stephanie E. O’Byrne (#4446)
`Hercules Plaza, 6th Floor
`1313 N. Market Street
`Wilmington, DE 19801
`Tel: (302) 984-6000
`dmoore@potteranderson.com
`bpalapura@potteranderson.com
`sobyrne@potteranderson.com
`
`Attorneys for Defendants Dr. Reddy’s
`Laboratories, Ltd. and Dr. Reddy’s
`Laboratories, Inc.
`
`15
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`