Allergan, Inc. v. Teva Pharmaceuticals USA, Inc. et al
MEMORANDUM OPINION AND ORDER. Signed by Judge William C. Bryson on 1/17/2017. (ch, )
IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF TEXAS
TEVA PHARMACEUTICALS USA, INC.,
Case No. 2:15-cv-1455-WCB
MEMORANDUM OPINION AND ORDER
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
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 No. 205-1 (Draft Guidance on Cyclosporine (Oct.
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
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
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.
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.
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
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
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).
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
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.”
discovery regarding Mylan’s development of its generic and related products. See Dkt. No. 242,
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
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
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
IT IS SO ORDERED.
SIGNED this 12th day of January, 2017.
WILLIAM C. BRYSON
UNITED STATES CIRCUIT JUDGE
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?