MEMORANDUM AND ORDER
For the reasons described more fully in court on August 16,2004, the court is allowing the plaintiffs' Motion for LimitedDiscovery Relevant to the Issue of Non-Statutory Double Patenting(the "Motion"). With the agreement of the plaintiffs, which aredrug companies, the court is entering a protective orderconcerning the information produced as a result of the Motionbeing allowed.
The Motion seeks discovery of the prosecution history of apending patent application, Application No. 08/477,159 (the "'159application"). The defendant in these case, the Trustees ofColumbia University in the City of New York ("Columbia") opposesthe Motion. Normally, a pending patent application and itsprosecution history are confidential. See35 U.S.C. § 122.1 Therefore, in deciding the Motion, the court has used thebalancing test adopted by many other district courts asarticulated in Fischer Imaging Corp. v. Lorad Corp.,148 F.R.D. 273 (Colo. 1993).
Information contained in a patent application may have some relevance in a patent infringement action [or declaratory judgment action], and, thus, a request for such information may meet the liberal standard of relevancy under Fed.R. Civ. P. 26. However, it is also well established that materials relating to a patent application are confidential, and, therefore, enjoy a degree of protection against disclosure. For example, 35 U.S.C. § 122 expressly provides that patent applications shall be kept confidential unless disclosure is authorized by the applicant. This statutory prohibition is not binding on the courts. Paper Converting Machine Co. v. Magna-Graphics Corp., 207 U.S.P.Q. 1136 (E.D. Wisc. 1980); Ideal Toy Corp. v. Tyco Industries, Inc., 478 F. Supp. 1191, 1192 (D. Del. 1979). Nevertheless, the courts have uniformly recognized that a heightened relevancy standard must be applied to patent applications and materials related thereto. Generally, the courts have employed a balancing test in determining whether or not to permit discovery of a patent application, weighing the requesting party's interest in the materials against the objector's legitimate interest in the secrecy. Davco Manufacturing Corp. v. Peninsular Diesel, Inc., 128 F.R.D. 91, 93 (N.D. Ohio 1989); Ideal Toy Corp. v. Tyco Industries, Inc., 478 F. Supp. at 1192 & 93; Cleo Wrap Corp. v. Elsner Engineering Works, Inc., 59 F.R.D. 386, 388 (M.D. Pa. 1972). A demonstration of direct relevancy will tip the scale in favor of disclosure. Paper Converting Machine Co. v. Magna-Graphics Corp., 207 U.S.P.Q. 1136 (E.D. Wis. 1980). On the other hand, the fact that the parties are competitors is a matter which weighs against disclosure. Wolowitz v. United States, 185 U.S.P.Q. 155 (Ct.Cl. 1975); Struthers Scientific & Int'l Corp. v. General Foods Corp., 45 F.R.D. 375, 381 (S.D. Tex. 1968). Likewise, if the plaintiff can obtain sufficient information regarding the allegedly infringing product from other sources, discovery of the defendant's patent application generally will be denied. Ideal Toy Corp. v. Tyco Industries, Inc., 478 F. Supp. at 1193; Wolowitz v. United States, 185 U.S.P.Q. 155 (Ct.Cl. 1975); Cleo Wrap Corp. v. Elsner Engineering Works, Inc., 59 F.R.D. at 388.Id. at 274.
As indicated earlier, the '159 application as filed is publiclyavailable because it is listed as a publication in thepatent-in-suit, the '275 patent. The Motion seeks discovery ofonly the '159 application's prosecution history. Since the '159application is part of the same family of patents as the '275patent and contains some identical claim language, statementsthat Columbia has made and will make during the prosecution ofthe '159 application are directly relevant to the claimconstruction of the '275 patent. See Microsoft Corp. v.Multi-Tech Sys., Inc., 357 F.3d 1340, 1350 (Fed. Cir. 2004);Laitram Corp. v. Morehouse Indus., Inc., 143 F.3d 1456, 1460 n.2 (Fed. Cir. 1998).
The harm to Columbia that will result from disclosure is notsufficient in the facts and circumstances of these cases to outweigh the showing of direct relevance that the plaintiffs havemade. Columbia does not use the '275 patent or any other patentinvolved in this case for commercial purposes. Rather, it hashistorically licensed the patents to plaintiffs and other drugcompanies. Therefore, Columbia and the plaintiffs are notcompetitors.
Since the '159 application as filed is publicly available andthe written description has been publicly available since 1983,the plaintiffs will not learn about an invention that is not yetthe subject of an issued patent. Thus, a primary reason formaintaining the confidentiality of patent prosecution does notexist in this case. See, e.g., Lee Pharms. v. Kreps,577 F.2d 610, 616 (9th Cir. 1978). Although the plaintiffs will learnabout the scope of the claims of any patent that issues from the'159 application earlier than the general public, the protectiveorder being issued will prevent the plaintiffs from using thatinformation to begin designing around any of Columbia's claimsbefore the '159 application issues as a patent. It will alsogenerally prevent the public from receiving the prosecutionhistory as, unlike the plaintiffs, the public lacks aparticularized need that outweighs Columbia's interest in keepingthe prosecution history confidential.2 In addition, the disclosure of the prosecution history of the'159 patent should facilitate the full, fair, and efficientpreparation of the parties' motions for summary judgment and, ifnecessary, trial concerning the plaintiffs' contention that the'275 patent is invalid under the doctrine of non-statutory doublepatenting. In June 2004, the court identified this as an issuethat could be prepared for presentation and resolution promptly,either on cross-motions for summary judgment or at a trial to beconducted in December, 2004. See June 23, 2004 Order (DocketNo. 32). Resolution of this issue may, as a practical matter, endthis litigation, which otherwise promises to be complex andprotracted, and necessarily create uncertainty about plaintiffs'rights to produce drugs that are important to human health. Thus,it is particularly in the interests of justice in thisMultidistrict Litigation that plaintiffs receive promptly anyinformation that is directly relevant to the non-statutory doublepatenting issue, including any such information that may beincluded in the prosecution history of the '159 application.
Accordingly, it is hereby ORDERED that:
1. The Motion (Docket No. 60) is ALLOWED. 2. The June 23, 2004 Protective Order, which was entered withthe agreement of the plaintiffs, is VACATED.
3. Columbia shall, by August 20, 2004, produce to theplaintiffs the entire prosecution history of the '159application.
4. Columbia shall, within five days of any addition to theprosecution history of the '159 application, supplement theproduction ordered in paragraph 3.
5. With the agreement of the plaintiffs and their attorneys,the documents, records, and information they contain that theplaintiffs receive pursuant to paragraphs 3 and 4 of this Order,as well as the prosecution history of the '159 applicationreceived from any other source, shall only be disclosed toplaintiffs' inside and outside counsel and the individualsnecessary to assist them in this case, including but not limitedto testifying and non-testifying experts, litigation supportvendors, and support staff. Each of the foregoing will be deemedan "Authorized Individual" for the purposes of this Order.
6. The documents, records, and information they contain shallbe used by each Authorized Individual solely for the purpose oflitigating matters in this case.
7. Each Authorized Individual shall not divulge the documents,records, and information they contain to anyone who is not anAuthorized Individual.
8. Submissions to the court referring to documents, records orinformation that is subject to this Order shall be filed under seal with redacted versions to be made part of the public record.
9. Each Authorized Individual except for secretarial-typesupport staff shall promptly file a statement under oathrepresenting that he or she has read this Order, recognizes thathe or she is subject to it, and that any violation of it may bedeemed a civil and/or criminal contempt.
10. Any violation of this Order may be deemed a civil and/orcriminal contempt.
1. Despite the requirement of confidentiality imposed by35 U.S.C. § 122, the United States Patent and Trademark Office has,on multiple occasions, inadvertently released to third parties,including the plaintiffs and their attorneys, confidentialportions of the '159 application prosecution history in responseto requests for the application as filed, to which the public isentitled because it is referenced by the patent-in-suit, U.S.Patent No. 6,455,275 (the "'275 patent"). The protective orderthe court is entering restricts disclosure of the entireprosecution history of the '159 application regardless of how theplaintiffs and their attorneys obtained it. The court hasexpressed serious doubts as to whether it would ordinarily bepermissible or appropriate to restrict distribution ofinformation obtained independently of discovery in this case inview of the heavy presumption against prior restraints on speech.See June 23, 2004 Order (Docket No. 33) (questioning reasoningof Public Citizen Health Research Group v. FDA,953 F. Supp. 400, 404-05 (D.D.C. 1996) (rejecting First Amendment arguments)in view of Seattle Times Co. v. Rhinehart, 467 U.S. 20, 22, 26,32, 33-34 (1984) (distinguishing between information obtainedonly through discovery and information obtained independently)).However, at the August 16, 2004 hearing, in an effort to persuadethe court to allow the Motion, the plaintiffs and their attorneysoffered to waive any First Amendment right they may have todiscuss information they obtained independently of thislitigation and, instead, to subject that information to theprotective order proposed for any parts of the '159 prosecutionhistory obtained in discovery. Therefore, the court did not needto resolve the First Amendment issue.
2. The court recognizes that parts of the '159 prosecutionhistory may become public if the court relies on it in decidingthe foreseeable motions for summary judgment or if they are madepart of the public record at any trial. See FTC v. Std. Fin.Mgmt. Corp., 830 F.2d 404 (1st Cir. 1987); Anderson v.Cryovac, Inc., 805 F.2d 1 (1st Cir. 1986) (discussing publicright of access to materials on which a court relies indetermining the substantive rights of litigants); Std. & Poor'sCorp. v. Commodity Exchange, Inc., 541 F. Supp. 1273 (S.D.N.Y.1982) (discussing public right of access to civil trial andcourt's authority to close portions of trial to protect tradesecrets). This does not, however, alter the outcome of thebalancing analysis.