Ares-Serono, Inc. v. Organon Intern. BV

• Court: U.S. District Court — District of Massachusetts
• Writing for the Court: BOWLER, United States Magistrate
• Citation: Ares-Serono, Inc. v. Organon Intern. BV, 862 F. Supp. 603 (D. Mass. 1994)
• Decision Date: 14 January 1994
• Docket Number: Civ. A. No. 92-11982-NMG.
• Parties: ARES-SERONO, INC., Serono Laboratories Inc., Applied Research Systems ARS Holding N.V., and Genzyme Corporation, Plaintiffs, v. ORGANON INTERNATIONAL B.V. and Organon, Inc., Defendants.

862 F. Supp. 603

ARES-SERONO, INC., Serono Laboratories Inc., Applied Research Systems ARS Holding N.V., and Genzyme Corporation, Plaintiffs, v. ORGANON INTERNATIONAL B.V. and Organon, Inc., Defendants.

Civ. A. No. 92-11982-NMG.

United States District Court, D. Massachusetts.

January 14, 1994.

Dale A. Malone, John P. Iwanicki, Dennis D. Allegretti, Allegretti & Witcoff, Ltd., Boston, MA, Grantland G. Drutchas, Daniel A. Boehnen, Allegretti & Witcoff, Chicago, IL, for plaintiffs.

Berj A. Terzian, Isaac Jarkovsky, Jennifer Gordon, Scott B. Familant, Pennie & Edmonds, New York City, Alexander H. Pratt, Jr., Peabody & Arnold, Boston, MA, for defendants.

REPORT AND RECOMMENDATION RE: DEFENDANTS' MOTION TO DISMISS (DOCKET ENTRY # 7); DEFENDANTS' RENEWED MOTION TO DISMISS (DOCKET ENTRY # 36)

ORDER RE: DEFENDANTS' MOTION TO QUASH DISCOVERY PERTAINING TO RECOMBINANT MUTANTS OF HUMAN FOLLICLE STIMULATING HORMONE (DOCKET ENTRY # 106); DEFENDANTS' MOTION FOR SUPPLEMENTAL PROTECTIVE ORDER (DOCKET ENTRY # 124); DEFENDANTS' FIRST MOTION TO COMPEL DISCOVERY (DOCKET ENTRY # 109)

BOWLER, United States Magistrate Judge.

On August 24, 1993, defendants Organon International B.V. ("OIBV") and Organon, Inc. ("Organon") (collectively: "defendants") filed a motion to compel discovery. (Docket Entry # 109). Plaintiffs Ares-Serono, Inc., Serono Laboratories, Inc., Applied Research Systems ARS Holding N.V., and Genzyme Corporation (collectively: "plaintiffs") oppose the motion. (Docket Entry # 126). Defendants also filed a motion to quash plaintiffs' discovery pertaining to research sponsored by Organon (Docket Entry # 106) which plaintiffs oppose (Docket Entry # 127). Finally, defendants move to supplement the protective order entered in this case. (Docket Entry # 124). Plaintiffs oppose any supplementation. (Ares-Serono's Opposition to Organon's Motion for a Supplemental Protective Order, No Docket Entry No. Assigned).

On November 15, 1993, this court held a hearing and took the discovery motions (Docket Entry ## 106, 109 & 124) under advisement. (Docket Entry # 129). At the request of counsel, this court also took defendants' motion to dismiss (Docket Entry # 7) and their motion to renew their motion to dismiss (Docket Entry # 36) on the papers.¹

BACKGROUND

According to the Second Amended Complaint (Docket Entry # 17), plaintiff Applied Research Systems ARS Holding N.V. is the exclusive licensee of U.S. Patent No. 4,923,805 ("the '805 patent"), issued by the United States Patent and Trademark Office on May 8, 1990. The '805 patent involves biologically active human fertility follicle stimulating hormone ("FSH") which includes alpha and beta subunits. (Docket Entry # 17, Ex. A). In Count I plaintiffs charge defendants with past infringement of the '805 patent by producing a recombinant follicle stimulating hormone ("rFSH")² outside the United States comprising alpha and beta subunits of FSH and then importing the rFSH into the United States for commercial purposes in violation of 35 U.S.C. § 271(g).

Count II alleges that Organon's manufacture, use or sale of rFSH in the United States and/or its importation of rFSH into the United States infringes the '805 patent. Plaintiffs therefore seek a declaration that such acts constitute an infringement of the '805 patent. (Docket Entry # 17).

In Count IV,³ plaintiffs seek a declaration that Organon's manufacture, use or sale of rFSH in the United States and/or its importation of rFSH into the United States infringes U.S. Patent No. 5,156,957 ("the '957 patent"). Entitled "Follicle Stimulating Hormone," the '957 patent claims an alternate method of producing rFSH using expression vectors separately encoding alpha and beta subunits. Count IV seeks declaratory relief with respect to the '957 patent. (Docket Entry # 17 & Ex. B).

The '805 patent uses a single expression vector to encode alpha and beta subunits of FSH ("one vector process"). The '957 patent uses separate expression vectors each encoding the alpha or beta subunit of FSH ("two vector process"). (Docket Entry # 17).

Defendants admit they are engaged in activities in the United States concerning the development of an rFSH product. (Docket Entry # 17, ¶ 29; Docket Entry # 71, ¶ 29). OIBV further admits that it produced an rFSH product outside the United States containing expression vectors encoding alpha and beta subunits. (Docket Entry # 17, ¶ 33; Docket Entry # 71, ¶ 33). Defendants also concede that they undertook preinvestigative new drug animal studies of rFSH in the United States and human studies abroad of rFSH to obtain regulatory approval to manufacture and sell an rFSH product produced from a two vector cell line in the United States. (Docket Entry #9; Docket Entry # 17, ¶¶ 37 & 46; Docket Entry # 39, ¶¶ 37 & 46; Docket Entry # 71, ¶ 46).

Plaintiffs represent that defendants initially produced an rFSH product through a one vector method. After learning of the '805 patent, defendants purportedly began developing a two vector method to produce an rFSH product for the purpose of eventually marketing the product in the United States. As an affirmative defense confirmed in its answers to interrogatories, OI represents that it is preparing an investigational new drug application ("IND") to prepare a new drug application ("NDA") for filing with the Food and Drug Administration ("FDA"). (Docket Entry #39, ¶ 50; Docket Entry # 94, Ex. B, ¶ 18). Organon's President confirms that Organon intends to seek FDA approval for an rFSH product produced by the two vector process. (Docket Entry # 10, ¶ 5).

Defendants generally submit that their research and development activities are protected under 35 U.S.C. § 271(e)(1) ("section 271(e)").⁴ Defendants seek a declaration that their activities of importing, manufacturing, using and/or selling rFSH to develop and to submit information to the FDA for obtaining approval of defendants' rFSH product do not infringe the '805 and '957 patents in light of the safe harbor of section 271(e). Defendants and plaintiff are competitors in the field of developing drugs to treat infertility.

I. DEFENDANTS' FIRST MOTION TO COMPEL DISCOVERY (DOCKET ENTRY # 109)

Defendants seek to compel plaintiffs to supplement their answers to interrogatory numbers 11 and 12 of defendants' first set of interrogatories and to produce certain documents in response to defendants' first set of requests for production of documents. Defendants' motion involves the following categories of material: (1) information developed by plaintiffs after the filing of the '805 patent; (2) plaintiffs' efforts to secure additional patents concerning recombinant dimeric proteins other than rFSH, i.e., human luteinizing hormone ("hLH") and chorionic gonadotropin ("hCG"); and (3) plaintiffs' patent application for U.S. Patent No. 4,840,896 ("the '896 patent") and three abandoned patent applications, i.e., U.S. Application Serial No. 016,673 ("the '673 application"), which is a continuation in part of U.S. Application Serial No. 811,959 ("the '959 application"), which is a continuation in part of U.S. Application Serial No. 548,211 ("the '211 application").

Turning to the first category of information, defendants maintain that plaintiffs should produce information relating to plaintiffs' testing and selecting of host cells and expression vectors to produce rFSH after the filing date of the patents in suit. Defendants contend that plaintiffs' decision to test and select different expression vectors for rFSH production after they filed the '805 patent implicates the issue of whether one skilled in the art could practice the claimed invention. Consequently, defendants reason that such information is relevant to the issue of utility, operability and enablement of the '805 patent. (Docket Entry # 110).

This court disagrees. According to plaintiffs' answer to interrogatory number four, the effective filing date of the patents in suit is January 30, 1985. (Docket Entry # 126, Ex. A). Enablement, i.e., whether the patent "enables one skilled in the art to make and use the claimed invention," is determined at the time "of the filing of the patent application." Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384 (Fed.Cir. 1986), cert. denied, 480 U.S. 947, 107 S.Ct. 1606, 94 L.Ed.2d 792 (1987); Phillips Petroleum Company v. U.S. Steel Corporation, 673 F.Supp. 1278, 1291 (D.Del.1987), affm'd, 865 F.2d 1247, 1251 (Fed.Cir.1989) ("post-filing developments in the art are irrelevant to the enablement inquiry").

Similarly, utility and operability under 35 U.S.C. § 101, which implicate whether the claimed invention is useful and operable, relate to the sufficiency of the patent application at the time of filing. Assessing utility requires interpreting the claim in order to define the invention and then testing the invention for utility. Raytheon Company v. Roper Corporation, 724 F.2d 951, 956 (Fed. Cir.1983), cert. denied, 469 U.S. 835, 105 S.Ct. 127, 83 L.Ed.2d 69 (1984). "Utility must be determined as of the date of the invention." Banning v. Southwestern Bell Telephone Company, 384 F.Supp. 831, 837 (S.D.Tx.1974). Whether a claimed invention is capable of being used to effectuate and accomplish the object proposed or is a useful advance necessarily requires an interpretation and analysis of the claim at the time of filing.

Absent further authority forthcoming from defendants,⁵ discovery of information occurring after the filing date is not relevant to the defenses cited by defendants. See generally Micro Motion, Inc. v. Kane Steel Company, Inc., 894 F.2d 1318, 1325-1328 (Fed. Cir.1990) (discussing relevance and denying speculative inquiry).

Turning to the second and third categories of information, defendants argue that plaintiffs' efforts to secure additional patents for LH and hCG involve a common subject matter in relation to the patents in suit. Defendants further submit that the claims in the '211, '956 and '673...