Shire LLC, Supernus Pharmaceuticals, Incl et al v. IMPAX Laboratories, Inc. et al

Filing 231

DISCOVERY ORDER re 223 Letter, filed by Shire LLC, Supernus Pharmaceuticals, Inc, IMPAX Laboratories, Inc.. Signed by Judge Maria-Elena James on 11/26/2012. (cdnS, COURT STAFF) (Filed on 11/26/2012)

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1 2 3 4 UNITED STATES DISTRICT COURT 5 Northern District of California 6 7 SHIRE LLC, and SUPERNUS PHARMACEUTICALS, INC., No. C 10-05467 RS (MEJ) DISCOVERY ORDER 8 Plaintiffs, 9 10 Re: Dkt. No. 223 IMPAX LABORATORIES, INC., WATSON PHARMACEUTICALS, INC., WATSON LABORATORIES, INC.–FLORIDA, WATSON PHARMA, INC., and ANDA, INC., 12 For the Northern District of California UNITED STATES DISTRICT COURT 11 v. 13 Defendants. _____________________________________ 14 15 16 INTRODUCTION This is a patent infringement action under the Hatch-Waxman Act, 35 U.S.C. 271(e). Plaintiff 17 Shire LLC (“Shire”) is an exclusive licensee of United States Patent Numbers 6,287,599 and 18 6,811,794. Both patents pertain to the manufacture and sale of guanfacine hydrochloride extended 19 release tablets called Intuniv. Defendant Impax Labratories (“Impax”) submitted Abbreviated New 20 Drug Application number 202238 (“Impax ANDA”), seeking approval to engage in the commercial 21 manufacture and sale of generic guanfacine hydrochloride extended release tablets. Shire claims that 22 Impax infringed on their patents when Impax submitted the Impax ANDA. 23 24 DISCOVERY MOTIONS On November 5, 2012, the parties filed a joint letter regarding certain discovery disputes. Jt. 25 Ltr., Dkt. No. 223. In that letter, Shire contends that Impax’s production has been “only partially 26 responsive or entirely non-responsive to about 95% of Shire’s [Request For Production of 27 Documents]” and that Impax gives no “credible or sustainable reason why it has not or should not 28 produce.” Id. at 2. Specifically, Shire has two claims: (1) that Impax has not produced any 1 electronically stored information related to employee-to-employee communication within Impax, or 2 communication between Impax and third parties, and (2) that Impax has not produced physical 3 samples of the raw materials used in Impax’s generic version of Intuniv. 4 Impax contends that Shire is withholding and refuses to produce relevant documents related to 5 other current guanfacine hydrochloride cases in which Shire is involved. 6 A. Shire’s Motion to Compel 7 Shire moves for an order compelling additional responses from Impax to the following 8 discovery requests: 9 1. Electronically Stored Information Related to Shire’s Second Set of Requests for Production of Documents.1 10 On October 19, 2012, following a meet and confer between the parties, Impax produced 5,535 11 For the Northern District of California UNITED STATES DISTRICT COURT pages of documents. Jt. Ltr. at 2. Shire contends that this production was “virtually devoid of 12 electronically stored information (“ESI”),” – specifically, information related to “why Impax is 13 proposing to market a copy cat product, the market research Impax did, the research and development 14 of its proposed infringing products, and more.” Id. Shire alleges that Impax has not fulfilled its 15 promise to produce additional discovery after implementing new software to adequately retrieve the 16 requested information. Id. at 3. In response, Impax claims that this is a non-issue and that any delay 17 was due to Shire originally providing overbroad search terms. Id. at 4. However, Impax contends 18 that Shire has since narrowed its search terms and that the requested information will be produced in 19 two to three weeks. Id. 20 Given that Impax does not object to producing such documents, and that it has stated that it 21 intends to produce the material Shire requests, the Court orders that Impax produce these documents 22 23 24 25 26 27 28 Shire does not contend that Impax has failed to respond or produce documents and things particular to one request for production; rather, it argues that Impax has failed generally to respond to its second set of RFPs. However, an example of what Shire is requesting from its second set of RFPs is “Request for Production No. 71: ALL DOCUMENTS RELATING TO ANY agreements between DEFENDANT AND third parties concerning the IMPAX ANDA PRODUCTS AND/OR IMPAX ANDA, including those agreements relating to this action, expenses for this action, or the distribution, marketing, sales, or promotion of the IMPAX ANDA PRODCUTS in the attention deficit hyperactivity disorder market.” Ex. B. at 11, Dkt. No. 223. 1 2 1 within 14 days of the date of this Order. 2 3 2. Request For Production No. 93: Sufficient Quantities of Each Component of Each Strength of IMPAX’s Guanfacine Hydrochloride Extended Release Tablets to Make Two Hundred (200) Tablets of Every Dosage Strength of IMPAX’S Guanfacine Hydrochloride Extended Release Tablets. 4 5 Shire contends that Impax has not produced any samples of the components of Impax’s ANDA 6 products and that these products are “necessary for Shire to study in light of the functions that various 7 individual components are alleged to perform or not to perform in Impax’s product.” Jt. Ltr. at 3. In 8 response, Impax states that it will not produce these samples due to the public availability of each of 9 the raw materials that make up its product. Id. at 5. 10 Given that Shire does not dispute that the raw materials of Impax’s products are publically 12 for Impax to produce them for Shire. Therefore, the Court denies Shire’s motion to compel Impax to For the Northern District of California UNITED STATES DISTRICT COURT 11 available, the Court finds Shire can obtain these products from the open market and there is no need 13 produce such samples. 14 B. Impax’s Motion to Compel 15 Impax moves for an order compelling additional responses from Shire to Requests for 16 Production Nos. 4–8: Documents and things related to other Guanfacine Hydrochloride cases. Jt. Ltr. 17 at 6. Impax’s requests are focused on a case that Shire litigated in Delaware last September. Id. at 5. 18 On October 19, 2012, following a meet and confer between the parties, Shire produced 1,318 pages 19 of documents related to other guanfacine hydrochloride cases. Id. at 1. Impax contends that Shire 20 has refused to produce necessary documents, and that any documents that were produced were overly 21 redacted. Impax alleges that Shire’s claim of third-party confidentiality is overbroad given that 22 public disclosures were made during the Delaware trial and the “Delaware defendants’ indication that 23 they would review and approve Shire’s proposed redactions.” Id. at 5. In response, Shire claims that 24 another court’s protective order precludes Shire’s counsel from seeing much of the information 25 requested. Id. at 3. 26 Since the Delaware defendants agreed to review any proposed redactions, the Court finds that 27 Shire can ensure that Shire will not violate any third party confidentiality or the Delaware court’s 28 3 1 protective order by providing such documents to the Delaware defendants for their review and 2 approval. Accordingly, the Court orders Shire to produce documents to Impax after it has provided 3 the Delaware defendants with the proposed redactions. Shire shall also produce a privilege log 4 detailing its claimed privileges relating to Impax’s requests for production. 5 IT IS SO ORDERED. 6 Dated: November 26, 2012 7 _______________________________ Maria-Elena James Chief United States Magistrate Judge 8 9 10 12 For the Northern District of California UNITED STATES DISTRICT COURT 11 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 4

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