Depomed, Inc. v. Lupin Pharmaceuticals, Inc. et al

Filing 143

ORDER regarding 141 the parties' joint discovery letter dated January 17, 2012. See order for details. Signed by Judge Laurel Beeler on 01/20/2012. (lblc2, COURT STAFF) (Filed on 1/20/2012)

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UNITED STATES DISTRICT COURT

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Northern District of California

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Oakland Division
DEPOMED, INC.,

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For the Northern District of California

UNITED STATES DISTRICT COURT

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No. C 09-05587 LB
Plaintiff,

ORDER REGARDING THE PARTIES’
JOINT DISCOVERY LETTER DATED
JANUARY 17, 2012

v.
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LUPIN PHARMACEUTICALS, INC., et al.,
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Defendants.
_____________________________________/

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I. INTRODUCTION
This is an action under the Hatch-Waxman Act1 that arises out of Defendants Lupin

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Pharmaceuticals, Inc. and Lupin Limited’s (collectively, “Lupin”) desire to market a generic version

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of Plaintiff Depomed, Inc.’s (“Depomed”) Glumetza® product. A dispute has arisen over whether,

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and/or to what extent, Lupin must respond to certain of Depomed’s document requests and its

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noticed Rule 30(b)(6) deposition topics. Upon review of the parties’ joint discovery letter dated

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January 17, 2012 and relevant legal authority, the court ORDERS Lupin to respond to Depomed’s

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document requests and deposition notice in the manner described below for the products that are the

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subject of ANDA No. 91-664.

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See “Drug Price Competition and Patent Term Restoration Act of 1984,” Pub. L. No.
98-417, 98 Stat. 1585 (codified at 21 U.S.C. § 355(b), (j), (l); 35 U.S.C. §§ 156, 271, 282)
(“Hatch-Waxman Act”).
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II. BACKGROUND2

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Depomed is a specialty pharmaceutical company that designs, develops, and markets

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pharmaceutical products utilizing optimized drug delivery technologies. Its three patents-in-suit

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focus on the development of a gastric-retentive drug delivery system designed as a

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conventionally-sized pill, which swells over time in the stomach, thus providing continuous and

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controlled drug delivery to the patient’s upper gastrointestinal (“GI”) tract.

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U.S. Patent Nos. 6,340,475 (“the ‘475 patent”) and 6,635,280 (“the ‘280 patent”), both entitled

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“Extending the Duration of Drug Release Within the Stomach During the Fed Mode,” were issued to

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Depomed as assignee of the inventors on January 22, 2002, and October 21, 2003, respectively. The

swallowed or ingested – typically, one or more tablets), which benefits from a prolonged period of

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invention of the ‘475 and ‘280 patents relates to an oral drug dosage form (a dosage form that is

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controlled release in the upper GI tract, and from an enhanced opportunity of absorption in the upper

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GI tract rather than in the lower portions of the GI tract. The controlled release oral dosage form

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(described in Claim 1 of the ‘475 and ‘280 patents) comprises a drug dispersed within a polymeric

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matrix. This polymeric matrix has a special property of being able to absorb or imbibe water,

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thereby causing the dosage form to increase in size and, in turn, retard the rate of release of drug

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from the swollen dosage form.

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U.S. Patent No. 6,448,962 (“the ‘962 patent”), entitled “Tablet Shapes To Enhance Gastric

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Retention of Swellable Controlled-Release Oral Dosage Forms,” was issued to Depomed as assignee

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of the inventors on December 3, 2002, and arises out of an application filed in June 2000. The

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invention of the ‘962 patent discloses an improvement over the ‘475 and ‘280 patents by extending

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gastric retention of a dosage form by using particular shapes, sizes, and swelling properties. The

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particular shape of these dosage forms and the minimum dimensions of the dosage form increase

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gastric retention over the dosage forms of the ‘475 and ‘280 patents.

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With these patents, Depomed commercialized Glumetza® – a product used to treat adults

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diagnosed with type-2 diabetes. Glumetza® contains the drug metformin HCL, formulated in

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In drafting this section, the court relied heavily on Judge Hamilton’s factual description in
her Order Construing Claims dated May 17, 2011. See 5/17/2011 Order, ECF No. 107.
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extended controlled-release 500 mg. and 1000 mg. tablets.
In 2009, Lupin, which is in the business of making and selling generic pharmaceutical products,

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submitted Abbreviated New Drug Application (“ANDA”) No. 91-664 to the FDA pursuant to 21

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U.S.C. § 355(j), seeking approval to market generic metformin HCL extended-release tablets in the

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500mg and 1000mg dosage strengths. In November of that year, Lupin sent Depomed written

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notification that Lupin had filed the ANDA. It also asserted that the ‘475, ‘280, and ‘962 patents are

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invalid or will not be infringed by the commercial manufacture, use, or sale of the Lupin products

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covered by the ANDA. Following this notification, Depomed filed the present lawsuit. Original

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Complaint, ECF No. 1.3

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Discovery has been open since March 2010. See 3/18/2010 Minute Order, ECF No. 52. On May
17, 2010, Depomed served contention interrogatories on Lupin. James Declaration, Ex. 2, ECF No.

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131-3. Lupin responded to these interrogatories on July 2, 2010. Id., Ex. 3, ECF No. 131-4. Over a

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year later, on August 26, 2011, Lupin supplemented its original interrogatory responses. Id., Ex. 4,

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ECF No. 131-5. In these supplemental responses, Lupin contended that Lupin’s accused products

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do not infringe Depomed’s patents-in-suit in part because Lupin’s products use a “reservoir system,”

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rather than a polymeric “matrix system” as claimed in the patents-in-suit, to extend the release of the

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drug. See id., Ex. 4, ECF No. 131-5 at 12-17.

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About two months later, on October 17, 2011, Depomed served a Rule 30(b)(6) deposition notice

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on Lupin seeking testimony about, among other topics, Lupin’s products that employ its so-called

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“reservoir system.” Id., Ex. 6, ECD No. 131-7.4 Roughly a month after that, on November 22,

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Citations are to the Electronic Case File (“ECF”) with pin cites to the electronic page
number at the top of the document, not the pages at the bottom.
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Topic No. 17 is “[t]he identity, structure and formulation of each and every
extended-release product, product candidate, and/or formulation that LUPIN employs or has
employed for the delivery of highly soluble drugs that contains hydroxypropylmethyl cellulose as a
polymer matrix with a coating that comprises Eudragit”; Topic No. 19 is “[t]he identity, structure
and formulation of any LUPIN product that employs reservoir system technology, including such
systems that comprise Eudragit as a coating on the tablet”; and Topic No. 20 is “[t]he identity,
structure and formulation of each LUPIN product that employs or has employed for the delivery of a
highly soluble drug a hydroxypropylmethyl cellulose polymer matrix.” James Declaration, Ex. 2,
ECF No. 131-7.
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2011, Depomed served additional requests for production of documents (“RFPs”) seeking similar

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information. Id., Ex. 5, ECF No. 131-6.5

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In December 2011, Lupin objected to both Depomed’s RFPs and Rule 30(b)(6) deposition topics

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as being, among other things, overly broad, irrelevant, and not reasonably calculated to lead to the

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discovery of admissible evidence, because the RFPs and deposition topics are not limited to the

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Lupin product covered by its ANDA. Id., Exs. 7-8, ECF Nos. 131-8, 131-9. Subject to those

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objections, Lupin nevertheless offered to produce responsive, non-privileged documents that relate

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to the products covered by the ANDA and to produce a Rule 30(b)(6) deponent to testify about the

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same. Id., Exs. 7-8, ECF Nos. 131-8, 131-9.

four RFPs (Nos. 72-75) and to produce a deponent for the three deposition topics (Nos. 17, 19-20) at

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On January 6, 2012, Depomed filed a motion for an order compelling Lupin to respond to the

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issue. Motion to Compel, ECF No. 130. On January 9, 2012, Judge Hamilton referred the motion to

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this court for resolution. Order of Referral, ECF No. 136. The court dismissed Depomed’s motion

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without prejudice and instructed the parties to comply with the discovery dispute-related procedures

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set forth in the undersigned’s standing order. Notice of Referral, ECF No. 138. In accordance with

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those procedures, the parties met and conferred about the dispute, during which Lupin reiterated its

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previous offer and also agreed to search its files for documents directly related to a statement found

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in one of its produced documents. Joint Letter, ECF No. 141 at 5. Depomed rejected the offer, and

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the parties filed the instant joint discovery letter on January 17, 2012. Id.
III. LEGAL STANDARD

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Subject to the limitations imposed by subsection (b)(2)(C), under Rule 26, “[p]arties may obtain

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RFP No. 72 seeks “ALL DOCUMENTS RELATING TO ANY LUPIN product that
employs a reservoir system as part of an extended-release or delayed-release drug dosage form”;
RFP No. 73 seeks “DOCUMENTS sufficient to identify ANY LUPIN product that employs a
reservoir system, or that can be characterized as employing a reservoir system, as part of an
extended release or delayed-release drug dosage form”; RFP No. 74 seeks “ALL DOCUMENTS
RELATING TO definitions, characteristics, formulations, methods for producing, and/or methods
for using a reservoir system as part of an extended-release or delayed-release drug dosage form”;
and RFP No. 75 seeks “ALL DOCUMENTS RELATING TO the use of Eudragit and/or other
coatings as part of an extended-release or delayed-release drug dosage form.” James Declaration,
Ex. 2, ECF No. 131-6.
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discovery regarding any nonprivileged matter that is relevant to any party's claim or defense . . . .”

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Fed. R. Civ. P. 26(b)(1). “Relevant information need not be admissible at the trial if the discovery

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appears reasonably calculated to lead to the discovery of admissible evidence.” Id. However, “[o]n

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motion or on its own, the court must limit the frequency or extent of discovery otherwise allowed by

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these rules or by local rule if it determines that: (i) the discovery sought is unreasonably cumulative

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or duplicative, or can be obtained from some other source that is more convenient, less burdensome,

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or less expensive; (ii) the party seeking discovery has had ample opportunity to obtain the

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information by discovery in the action; or (iii) the burden or expense of the proposed discovery

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outweighs its likely benefit, considering the needs of the case, the amount in controversy, the

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parties’ resources, the importance of the issues at stake in the action, and the importance of the

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discovery in resolving the issues.” Fed. R. Civ. P. 26(b)(2)(C).

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IV. DISCUSSION

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In order to resolve this dispute, the court must determine whether, and to what extent, the

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information sought by Depomed is relevant to any party’s claim or defense. In their joint letter,

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Depomed contends that the information is relevant because Lupin’s non-infringement position,

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which Lupin “grounded . . . in three pages of supplemental interrogatory response that broadly

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distinguished between reservoir technology and matrix-based technology,” “is not limited to just the

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two accused products, but represents broad statements on technological approaches for developing

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extended-release tablets upon which its experts will surely rely.” Joint Letter, ECF No. 141 at 5, 6.

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In other words, “Lupin has placed into issue a theory that its two accused products fall within the

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generic family of reservoir system, extended-release tablets as compared to the matrix family.” Id.

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at 6. Thus, because “Lupin came to the development of the accused products with knowledge of the

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use of coatings in extended-release drugs,” “Depomed seeks discovery that would specifically show

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Lupin’s knowledge and experience regarding the reservoir system approach to extended-release

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tablets in comparison to matrix-based systems, and how Lupin has employed that technology for

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extended-release drug products.” Id.

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While Lupin has already offered to produce responsive, non-privileged documents that relate to
the products covered by the ANDA and to produce a Rule 30(b)(6) deponent to testify about the

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same, it disagrees that its non-infringement defense based on its use of a “reservoir system” allows

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Depomed “sweeping discovery on unidentified Lupin products that are not at issue in this case.” Id.

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Indeed, as Lupin points out, Depomed has not identified any products (aside from the two products

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covered by the ANDA) that might be relevant, but instead wants to (in Depomed’s words) “explore

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the scope and content of Lupin’s institutional knowledge.” Id. at 6, 7.

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Upon consideration of the parties’ arguments, the court believes that the requested information is

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relevant but only with respect to the two Lupin products covered by the ANDA. Depomed argues

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that Lupin’s interrogatory responses “are not specifically tied to the two accused extended-release

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pharmaceutical tablets,” but it is wrong. Depomed’s interrogatories sought the bases for Lupin’s

that its two ANDA-covered products do not infringe Depomed’s patents because the two products

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claim that its two ANDA-covered products do not infringe Depomed’s patents, and Lupin responded

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use a “reservoir system” rather than a “matrix system.” After such a response, Depomed surely is

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entitled to its requested information with respect to Lupin’s two ANDA-covered products – the two

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products at issue in this case. But Lupin’s insertion of a description and comparison of a “reservoir

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system” and a “matrix system,” whether three paragraphs or three pages, does not transform its

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interrogatory response into a defense of all of its products, nor does it allow Depomed to mine,

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without restriction, Lupin’s “institutional knowledge” on the subject.

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V. CONCLUSION
Based on the foregoing, the court ORDERS the following:
1. With respect to RFP Nos. 72-75, Lupin shall produce responsive, non-privileged documents

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within its possession, custody, or control that relate to Lupin’s products that are the subject of

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ANDA No. 91-664, to the extent that such documents exist and have not already been produced.

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In so producing, Lupin, per its offer in the parties’ joint letter, shall search its files for documents

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“directly related to the following statement on LUP(GLUM)000257 that from previous

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formulation experience, when Hypromellose was used as [a] control release polymer for

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preparing a matrix, it was unable to control the burst release.”

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2. With respect to Topic Nos. 17, 19, and 20 of Depomed’s Rule 30(b)(6) deposition notice, Lupin
shall designate a witness to testify regarding relevant, non-privileged information concerning the

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identity, structure, and formulation of Lupin’s products that are the subject of ANDA No. 91-

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664. The deposition shall take place during the week of January 22, 2012, with the specific date,

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time and location to be determined by the parties.

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This disposes of ECF No. 141.

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IT IS SO ORDERED.

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Dated: January 20, 2012
_______________________________
LAUREL BEELER
United States Magistrate Judge

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