Case 2:15-cv-01455-WCB Document 251 Filed 01/12/17 Page 1 of 7 PageID #: 9811
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
`
`§
`§
`§
`§
`§
`§
`§
`§
`§
`§
`
`MEMORANDUM OPINION AND ORDER
`
`
`
`Case No. 2:15-cv-1455-WCB
`
`
`TEVA PHARMACEUTICALS USA, INC.,
`et al.,
`
`
`v.
`
`Defendants.
`
`ALLERGAN, INC.,
`
`
`Plaintiff,
`
`
`
`Before the Court is plaintiff Allergan, Inc.’s Motion to Compel Discovery, Dkt. No.
`
`205, which seeks to compel responses to Interrogatories Nos. 3 and 5 from defendant Mylan
`
`Pharmaceuticals, Inc., and Mylan, Inc., (“Mylan”). The motion has been fully briefed and was
`
`argued during a telephonic hearing conducted on January 11, 2017. The Court GRANTS the
`
`motion.
`
`BACKGROUND
`
`
`
`Along with several other defendant pharmaceutical companies, Mylan is seeking
`
`approval by the Food and Drug Administration (“FDA”) to sell a generic version of Restasis, an
`
`ophthalmic product sold by Allergan that is indicated for the treatment of keratoconjunctivitis
`
`sicca and dry eye disease. To obtain FDA approval of a generic drug through the filing of an
`
`Abbreviated New Drug Application (“ANDA”), it is necessary for the generic manufacturer to
`
`show that the generic drug is bioequivalent to the previously approved drug. The FDA has
`
`issued several guidance documents setting forth what is required to show bioequivalence for
`
`generic versions of Restasis. See, e.g., Dkt. No. 205-1 (Draft Guidance on Cyclosporine (Oct.
`
`
`
`1
`
`

`

`Case 2:15-cv-01455-WCB Document 251 Filed 01/12/17 Page 2 of 7 PageID #: 9812
`
`2016)). Mylan’s ANDA No. 205894 therefore aims to establish that its generic product is
`
`bioequivalent to Restasis.
`
`When Mylan filed its ANDA with the FDA, it submitted a “paragraph IV certification”
`
`that the related patents held by Allergan are “invalid or will not be infringed by the manufacture,
`
`use, or sale” of its generic drug. 21 U.S.C. § 355(j)(2)(A)(vii)(IV). In response, Allergan filed a
`
`complaint pursuant to the Hatch-Waxman Act, Pub. L. No. 98-417 (1984), alleging infringement
`
`of U.S. Patent Nos. 8,629,111; 8,633,162; 8,642,556; 8,648,048; 8,685,930; 9,248,191.
`
`Allergan’s
`
`infringement contentions
`
`rely on,
`
`inter alia, Mylan’s
`
`representations of
`
`bioequivalence, which Mylan submitted to the FDA. See, e.g., Dkt. No. 205-3, at 18, 31.
`
`Allergan contends that evidence of bioequivalence supports Allergan’s claims of infringement
`
`for at least the patent claims that are directed to clinical efficacy. See, e.g., Dkt. No. 96-1
`
`(Claims 11 and 17 of U.S. Patent No. 8,629,111, col. 15, ll. 45-48, and col. 16, ll. 16-18).
`
`Allergan’s first set of interrogatories to Mylan, served in March of 2016, included requests
`
`regarding Mylan’s ANDA and its bioequivalence evidence. Dkt. No. 205, at 2-3. Interrogatory
`
`No. 3 states:
`
`Identify the persons at Mylan most knowledgeable regarding: (a)
`
`medicaments for treating dry eye disease; (b) use of a cyclosporine-A emulsion to
`treat dry eye disease; (c) topical medicaments for treating dry eye disease; (d)
`ANDA No. 205894; (e) your Paragraph IV Notifications; and (f) Restasis®.
`
`Interrogatory No. 5 states:
`
`Describe fully and with particularity the basis for the assertion in ANDA
`No. 205894 that Your Proposed Product is bioequivalent to Restasis®, and
`identify the persons most knowledgeable about the information requested in this
`interrogatory.
`
`Mylan initially refused to answer the two interrogatories, setting forth only boilerplate
`
`objections and a statement that bioequivalence is irrelevant to infringement. In December of
`
`
`
`2
`
`

`

`Case 2:15-cv-01455-WCB Document 251 Filed 01/12/17 Page 3 of 7 PageID #: 9813
`
`2016, however, Mylan supplemented its responses. Dkt. No. 205-5. Mylan identified two
`
`individuals in response to Interrogatory No. 3(d). Id. at 3. For Interrogatory No. 5, Mylan
`
`pointed Allergan to the production of Mylan’s ANDA and its FDA correspondence, “which
`
`contain documents from which information responsive to this interrogatory may be derived.” Id.
`
`at 3-4.
`
`Allergan has moved to compel Mylan to identify individuals for the remaining topics
`
`listed in Interrogatory No. 3. Allergan has also asked for any bioequivalence documentation that
`
`Mylan submitted to the FDA to comply with the FDA’s most recent draft guidance, which was
`
`issued in October 2016, Dkt. No. 205-1. Finally, Allergan wants Mylan to provide
`
`documentation relating to its bioequivalence assertions, beyond what is contained in Mylan’s
`
`submissions to and correspondence with the FDA.
`
`DISCUSSION
`
`
`
`The Court has broad discretion to decide motions to compel discovery of documents.
`
`Imperial Ethiopian Gov’t v. Baruch-Foster Corp., 535 F.2d 334, 337 n.8 (5th Cir. 1976). The
`
`scope of discovery is limited by Fed. R. Civ. P. 26(b)(1), which allows for
`
`discovery regarding any nonprivileged matter that is relevant to any party’s claim
`or defense and proportional to the needs of the case, considering the importance
`of the issues at stake in the action, the amount in controversy, the parties’ relative
`access to relevant information, the parties’ resources, the importance of the
`discovery in resolving the issues, and whether the burden or expense of the
`proposed discovery outweighs its likely benefit. Information within this scope of
`discovery need not be admissible in evidence to be discoverable.
`
`The parties first argue about whether bioequivalence information in general is relevant to
`
`
`
`
`
`Allergan’s infringement case. It clearly is. Courts have found that bioequivalence is relevant in
`
`infringement cases. See, e.g., Adams Respiratory Therapeutics, Inc. v. Perrigo Co., 616 F.3d
`
`1283, 1289 (Fed. Cir. 2010) (noting that fact-finder could determine that patent was infringed
`
`
`
`3
`
`

`

`Case 2:15-cv-01455-WCB Document 251 Filed 01/12/17 Page 4 of 7 PageID #: 9814
`
`based on, in addition to other evidence, bioequivalence data). For example, courts have found
`
`that bioequivalence is relevant to the function prong of the function-way-result test for the
`
`doctrine of equivalents. See Abbott Labs. v. Sandoz, Inc., 566 F.3d 1282, 1298 (Fed. Cir. 2009)
`
`(en banc); see also, e.g., Intendis GMBH v. Glenmark Pharms. Inc., 822 F.3d 1355, 1361-62
`
`(Fed. Cir. 2016) (affirming judgment that Glenmark’s accused drug product infringed under the
`
`doctrine of equivalents based on, inter alia, Glenmark’s ANDA, which was “[f]atal to
`
`Glenmark’s argument” because it “included repeated statements that [its] excipient and the
`
`claimed excipients function as penetration enhancers”).
`
`Bioequivalence can also be directly relevant to claims that contain limitations directed to
`
`biological functionality. Given that Mylan is seeking to obtain FDA approval by showing that its
`
`generic product functions similarly
`
`to Restasis, Mylan’s evidence
`
`that supports
`
`the
`
`bioequivalence of its product with Restasis also supports Allergan’s claim of infringement of
`
`Allergan’s patent claims that contain functional limitations. See, e.g., U.S. Patent No. 8,629,111,
`
`col. 15, ll. 45-48 (Claim 11: “The topical ophthalmic emulsion of claim 1, wherein, when the
`
`topical ophthalmic emulsion is administered to an eye of a human, the blood of the human has
`
`substantially no detectable concentration of cyclosporine A.”).1
`
`Mylan is correct that establishing bioequivalence for purposes of FDA approval is not the
`
`same as establishing equivalence for purposes of proving patent infringement. Abbott, 566 F.3d
`
`at 1298 (noting that, “while potentially relevant, the bioequivalency of an accused product with a
`
`product produced from the patent at issue is not sufficient to establish infringement by
`
`
`1 Evidence of bioequivalence to support infringement under doctrine of equivalents is
`relevant to more than those claim elements that explicitly describe a function. See Intendis, 822
`F.3d at 1362 (function of the claimed element need not be described in the intrinsic evidence, as
`long as the function of the claimed element is understood by one of skill in the art).
`
`
`
`
`4
`
`

`

`Case 2:15-cv-01455-WCB Document 251 Filed 01/12/17 Page 5 of 7 PageID #: 9815
`
`equivalents.”). But Mylan is wrong to say bioequivalence is not relevant when the asserted
`
`claims relate to function, and it cites no support for that proposition.2
`
`Nor is there any force to Mylan’s argument that its ANDA submissions have no
`
`significance because it is the FDA that makes the final determination of bioequivalence. There is
`
`“no reason why a district court acting as a fact finder should ignore a party’s representation to a
`
`federal regulatory body that is directly on point.” Intendis GMBH v. Glenmark Pharms. Inc.,
`
`822 F.3d at 1362.
`
`Interrogatory No. 3
`
`Mylan has answered interrogatory number 3 in part, but it has refused to provide the
`
`names of individuals as requested in subparts (a)-(c) and (e)-(f) of the interrogatory on the
`
`ground that the requests are overbroad or that Allergan already has the information. The grounds
`
`of objection are not persuasive.
`
`First, the requests that ask for Mylan to identify persons knowledgeable about topical and
`
`other medicaments for treating dry eye disease, as well as about the use of cyclosporine-A to
`
`treat dry eye disease, (subparts (a)-(c)) are not overbroad but fall within the broad definition of
`
`relevant information in Fed. R. Civ. P. 26(b)(1). Those requests are not solely directed to expert
`
`testimony, as Mylan argues. Mylan’s contention that it intends to offer only expert testimony on
`
`these points does not respond to Allergan’s need for that information in order to conduct fact
`
`
`2 The decision in Eli Lilly & Co. v. Wockhardt Ltd., No. 1:08-cv-1547, 2010 WL
`2195436, at *2 (S.D. Ind. May 27, 2010), is distinguishable on exactly that ground. In that case
`the court denied a motion to compel the production of bioequivalence studies because “Lilly
`does not dispute Wockhardt’s contention that “[n]one of the asserted claims . . . require
`Wockhardt’s ANDA products to have any particular biological performance of any kind.” Here,
`as noted, various of the asserted claims require just such “particular biological performance.”
`
`
`
`
`5
`
`

`

`Case 2:15-cv-01455-WCB Document 251 Filed 01/12/17 Page 6 of 7 PageID #: 9816
`
`discovery regarding Mylan’s development of its generic and related products. See Dkt. No. 242,
`
`at 5.
`
`Second, Mylan has offered no satisfactory explanation for its refusal to provide the names
`
`of persons knowledgeable about its Paragraph IV certifications and Restasis (subparts (e)-(f)).
`
`Allergan is not asking for production of documents; rather, it is asking for a list of
`
`knowledgeable individuals. Therefore, Mylan’s reference to its offer to provide corporate
`
`testimony related to Restasis is insufficient. And Mylan’s objection on the ground of privilege to
`
`identifying attorneys as the individuals knowledgeable about the Paragraph IV certifications is
`
`baseless: Supplying attorney names does not reveal client confidences. Moreover, Allergan’s
`
`request is not, as Mylan suggests, “simply a matter of identifying the attorneys who signed the
`
`letters” of the notices regarding Paragraph IV certifications.” Dkt. No. 242, at 5. It is possible,
`
`even likely, that more persons worked on the certifications than the few who signed the letters.
`
`And, in any event, Mylan is in the better position to compile that list, as it has direct knowledge
`
`of the individuals who worked on those certifications. See Fed. R. Civ. P. 26(b)(1) (noting “the
`
`parties’ relative access to relevant information” as a consideration in discovery).
`
`Interrogatory No. 5
`
`Even though bioequivalence information is relevant, Mylan contends that Allergan
`
`already has the information it seeks relating to Interrogatory No. 5. Mylan’s argument is that its
`
`ANDA and FDA correspondence, including all representations regarding bioequivalence, has
`
`been produced and contains all the information that Allergan needs with respect to that
`
`interrogatory. Mylan also states that it has produced and will continue to produce, in accordance
`
`with the local rules, all correspondence responding to the FDA’s most recent October 2016
`
`guidance. Dkt. No. 228, at 4-5 & n.1; Dkt. No. 242, at 1. Furthermore, Mylan has agreed to
`
`
`
`6
`
`

`

`Case 2:15-cv-01455-WCB Document 251 Filed 01/12/17 Page 7 of 7 PageID #: 9817
`
`provide corporate testimony on its compliance activities regarding the FDA’s guidance. Dkt.
`
`No. 228, at 5; Dkt. No. 242, at 2.
`
`Allergan stated during the hearing that the material it is interested in is documentation
`
`reflecting internal deliberations and testing directed to the issue of bioequivalence of Mylan’s
`
`product and Restasis. Moreover, Allergan stated that it appears that Mylan’s deadline for
`
`complying with the FDA’s most recent draft guidance on bioequivalence may fall after the trial
`
`in this case. Mylan did not deny that assertion. Mylan’s current and ongoing correspondence
`
`with the FDA, therefore, may not include Mylan’s documentation supporting bioequivalence that
`
`has been generated and continues to be generated, but has not yet been submitted to the FDA and
`
`may not be submitted until after trial. That information, to the extent any exists, is relevant.
`
`Mylan is therefore directed to produce any documentation of internal deliberations and testing
`
`regarding compliance with the FDA’s October 2016 guidance as to bioequivalence.
`
`Finally, for the same reasons discussed above regarding Interrogatory No. 3, Mylan is
`
`directed to identify the persons most knowledgeable about the bioequivalence assertion in its
`
`ANDA.
`
`IT IS SO ORDERED.
`
`SIGNED this 12th day of January, 2017.
`
`_____________________________
`WILLIAM C. BRYSON
`UNITED STATES CIRCUIT JUDGE
`
`7
`
`