The opinion of the court was delivered by: Judge: Honorable John A. Mendez
JENNIFER RANDLETT MADDEN (Bar No. 184905) MEGHAN M. BAKER (Bar No. 243765) DOWNEY BRAND LLP 621 Capitol Mall, 18th Floor Sacramento, CA 95814 Telephone: (916) 444-1000 Facsimile: (916) 444-2100 firstname.lastname@example.org email@example.com Admitted Pro Hac Vice: CLEM C. TRISCHLER (Pa. Bar No.: 52957) JASON M. REEFER (Pa. Bar No.: 208514) PIETRAGALLO GORDON ALFANO BOSICK & RASPANTI, LLP One Oxford Centre, 38th Floor Pittsburgh, PA 15219 Telephone: (412) 263-2000 Facsimile: (412) 263-2001 firstname.lastname@example.org email@example.com Attorneys for Defendants Mylan Inc.; Mylan Pharmaceuticals Inc; Mylan Technologies Inc.
STIPULATED PROTECTIVE ORDER
WHEREAS, Plaintiffs and/or any other party may seek the production of documents and information from Defendants, Mylan Inc., Mylan Pharmaceuticals Inc., and Mylan Technologies Inc., (collectively, "Mylan"), and Janssen Pharmaceuticals, Inc. (formerly known as Ortho-McNeil-Janssen Pharmaceuticals, Inc. and improperly sued as Janssen Pharmaceuticals) ("Janssen") (Mylan and Janssen collectively referred to herein as "Product Defendants");
WHEREAS, Product Defendants allege such documents contain competitive sales, marketing, or product information including, but not limited to: (1) descriptions, identifications, changes, and modifications of any sort made to equipment used in the manufacturing process; (2) operations involved in the entire manufacturing process; (3) manufacturing practices and procedures and specific records illustrating same; (4) formulations and specifications relating to the product at issue; (5) practices, procedures and protocols relating to quality control and quality assurance; (6) other scientific marketing and/or research and development information; and/or (7) corporate financial Janssen-specific information and/or Mylan-specific information which Product Defendants deem confidential.
WHEREAS, Product Defendants deem that knowledge of any of the foregoing categories of information to the public and specifically to any competitor would cause a severe competitive injury to Product Defendants in that many years have been invested in researching, developing, manufacturing, and marketing the products at issue, and Product Defendants currently rely on such expertise;
WHEREAS, it has been agreed by and among the parties in the above-styled action, through their counsel, that such documents may include trade secrets that are protected under applicable state and federal law;
WHEREAS, it has been agreed by and among the parties in the above-styled action, through their counsel, that a Protective Order preserving the confidentiality of certain documents and information should be entered by the Court; and
WHEREAS, the Court has reviewed the terms and conditions of this Protective Order submitted and stipulated to by the parties, and has found that the confidentiality provisions of this Protective Order are proper.
IT IS HEREBY ORDERED THAT:
1. Non-Disclosure of Documents. Documents produced by Product Defendants may be stamped "CONFIDENTIAL -- SUBJECT TO PROTECTIVE ORDER" and/or "Protected Document. Document Subject to Protective Order" (hereinafter "Protected Documents") to signify that the documents are subject to protection by this Order. Interrogatory answers, responses to Requests for Admission, deposition transcripts and exhibits, pleadings, motions, affidavits, briefs, summaries, notes, computer-generated material, computer discs or retrievable data, other means of storage or duplication, and oral statements or communications that quote, summarize, or contain information from the Protected Documents are also subject to protection by this Order. No Protected Document or any portion of any Protected Document produced by Product Defendants may be disclosed to any person, except as permitted in paragraphs 2, 3 and 4 below.
2. Protected Documents and/or any portion thereof deemed confidential may be disclosed to (a) counsel of record who are actively engaged in the conduct of this litigation; (b) the partners, associates, secretaries, paralegals, and employees of such counsel to the extent reasonably necessary to render professional services in the above-styled action; and (c) any party to this litigation, including current employees or representatives of Product Defendants, subject to the restrictions set forth in paragraphs 3 and 4.
3. In addition, Protected Documents and/or any portion thereof deemed confidential may be disclosed to (a) employees of the producing party noticed for depositions or designated as trial witnesses; and (b) outside consultants or experts retained by any party or their counsel for the purpose of assisting counsel in the litigation or to testify at trial, provided, however, that such experts or consultants are not presently employed by, nor have any present intention to be employed by, any party or a competitor of any party. Before any Protected Document may be disclosed to any person described in (a) and/or (b) of this paragraph, however, the person so described must sign the attached Confidentiality Agreement. The Confidentiality Agreement reflects that the signatory has read this Protective Order, understands that anything other than the inadvertent disclosure of Protected Documents constitutes contempt of court, and consents to the exercise of personal jurisdiction by this Court. The original of each signed Confidentiality Agreement shall be retained by counsel and a copy thereof served upon Product Defendants' counsel, except that a copy of the Confidentiality Agreement signed by a person described in subsection (b) need not be served upon Product Defendants' counsel until such person is disclosed as a witness.
4. Protected Documents subject to this Protective Order shall not be disclosed to any Competitor of Product Defendants. For purposes of this Order, "Competitor" shall be defined as any entity or person currently engaged in the commercial discovery and/or commercial development and/or commercialization of transdermal or patch technology designed to deliver pharmaceuticals through the skin, and shall include any agent, employee, consultant, or other person currently similarly affiliated with such entity or person. For purposes of this Order, Mylan and Janssen and their agents, employees, consultants or other persons similarly affiliated with Mylan and Janssen respectively, are deemed to be Competitors. For purposes of the captioned matter, Competitor shall not refer to those individuals identified in paragraph 2(a) & (b). Before disclosing any Protected Document to any person listed in paragraph 2(c), 3(a) or 3(b), who may also be a Competitor of Product Defendants, the procedures in this paragraph shall be followed to assure that no confidential information is disclosed to any Competitor.
Entry of this Protective Order by the Court imposes a duty upon any person who may be a Competitor of Product Defendants to whom any Protected Documents are to be disclosed to make a good faith determination as to whether he or she is a Competitor. a. If the person determines himself or herself to be a Competitor, neither the Protected Documents nor the contents thereof shall be discussed with or disclosed to such person. b. If the person determines himself or herself not to be a Competitor, that person and counsel who intends to disclose Protected Documents to that person shall execute Affidavit "A" and Affidavit "B" respectively in addition to the Confidentiality Agreement attached hereto. Except as otherwise provided in paragraph 3, the original Affidavits and Confidentiality Agreement shall be retained by counsel and a copy thereof served upon Product Defendants' counsel seven (7) business days prior to the disclosure of any Protected Documents and/or the contents thereof.
c. If the person is unable to determine whether he or she is a Competitor, counsel for the disclosing party shall prepare a written statement identifying the potential Competitor, including the name and current residence of the potential Competitor, his or her job title and employer's name and address for the previous five (5) years. The original of such statement shall be retained by counsel and a copy thereof served in accordance with applicable rules of Civil Procedure upon Product Defendants' counsel. Product Defendants' counsel shall have seven (7) business days to object to the disclosure of Protected Documents to the potential Competitor. If no objection is made, the Affidavits and Confidentiality Agreement shall be executed and served as described in subsection (b).
If there is an uncertainty or a dispute as to whether the person is a Competitor, any party may seek a ruling from this Court regarding the same. Pending a ruling by the Court on that dispute, no Protected Documents shall be disclosed to the potential Competitor. Nothing herein shall prevent Plaintiffs from seeking leave of court upon good cause shown to disclose Protected Documents to a Competitor of Product Defendants. 5. Certain documents prepared in compliance with the regulations of the United States Food and Drug Administration contain material that is privileged and confidential under the patientphysician privilege or specific federal regulations governing clinical trials and adverse drug experience reporting. To protect these privileges, all such documents produced by Product Defendants in response to a discovery request shall have the name and address of the patient and physician redacted as well as all identifying information regarding the reporter, but such redaction shall not be done in such a manner as to redact material data in such reports.
6. Documents at Depositions. a. A deponent who is not a current employee of Product Defendants may, during the deposition, be shown and examined about the Protected Documents as long as disclosure comports with the provisions of the preceding paragraphs, although the deponent can comply with the requirements of the preceding paragraphs via oral testimony on the record under oath during the deposition instead of actually signing the affidavits. Notwithstanding such, a former employee of Product Defendants may be shown a Protected Document if such former employee authored or has previously seen such document. A deponent shall not retain or copy portions of the transcript of his or her deposition containing confidential information not provided by the deponent or the entities whom he or she represents unless he or she signs the Confidentiality Agreement as well as the applicable Affidavit described above. b. Any party and any deponent may, within thirty (30) days after receiving a deposition transcript, designate the transcript as protected pursuant to this Protective Order by written notice to all counsel of the designation and by having the cover page of the transcript marked as follows: "PROTECTED DOCUMENT -- SUBJECT TO PROTECTIVE ORDER," "CONFIDENTIAL -- SUBJECT TO PROTECTIVE ORDER," and/or "Protected Document. Document Subject to Protective Order." During the initial thirty (30) day period, the entire deposition will be treated as subject to protection against disclosure under this Protective Order, but if no party or deponent timely designates the transcript as protected, then the transcript shall not thereafter be subject to this Protective Order. However, deposition exhibits that are protected documents pursuant to this Protective Order will continue to be protected without further designation being required. The continued protection of such documents will not be dependent upon ...