Purdue Pharma L.P. v. Boehringer Ingelheim Gmbh
| Decision Date | 16 May 2000 |
| Docket Number | No. 99 Civ. 3658 (SHS).,99 Civ. 3658 (SHS). |
| Citation | 98 F.Supp.2d 362 |
| Parties | PURDUE PHARMA L.P., The Purdue Frederick Company, The P.F. Laboratories, Inc., The Purdue Pharma Company, Plaintiffs, v. BOEHRINGER INGELHEIM GMBH, Roxane Laboratories, Inc., Boehringer Ingelheim Corporation, Defendants. |
| Court | U.S. District Court — Southern District of New York |
This case arises out of a patent dispute between pharmaceutical companies seeking to develop and market drugs designed to treat moderate to severe pain, including chronic cancer pain. On September 28, 1999, plaintiffs Purdue Pharma L.P., the Purdue Frederick Company, the P.F. Laboratories, Inc., and the Purdue Pharma Company (collectively, "Purdue") filed an amended complaint in this Court asserting one count of patent infringement against defendants Boehringer Ingelheim GmbH, Roxane Laboratories, Inc., and Boehringer Ingelheim Corporation (collectively, "Roxane"). Specifically, the amended complaint seeks declaratory and injunctive relief and damages, based on allegations that defendants' research of, development of, and plans to market the pharmaceutical product "Roxicodone SR" infringe upon Purdue's patents protecting its product "OxyContin," in violation of 35 U.S.C. §§ 284 and 285. See Amended Compl. ¶¶ 14-17, A-H.
One week later, defendants Boehringer Ingelheim GmbH and Roxane Laboratories, Inc. submitted a joint answer asserting a counterclaim seeking a declaration that the patents in question are invalid and unenforceable and that the Roxicodone product does not infringe upon those patents.1 See Answer ¶¶ 14-62, a-d.
Contemporaneously with the commencement of this action, Purdue moved for a preliminary injunction pursuant to 35 U.S.C. § 283 and Fed.R.Civ.P. 65 barring defendants from making, using, or offering to sell Roxicodone SR pending a final resolution of this action. Roxane has opposed the injunction essentially on the grounds asserted its counterclaim. A factual hearing was held from November 15 through November 18, 1999. For the reasons stated below, Purdue's motion for a preliminary injunction is granted.
Drugs known as opioid analgesics, which are designed to treat moderate to severe pain, have been available for several decades. Until the early 1980s, however, they were limited to immediate-release dosage forms, such as Percocet, where pain relief is given at once. Immediate-release forms had the distinct disadvantage that they controlled pain for only 4-6 hours, thereby requiring frequent repeat administration for patients experiencing chronic pain. Such frequent dosing did not permit patients to sleep through the night, and patients often failed or forgot to take their medication when required. See Paul D. Goldenheim Decl. ¶¶ 10-17.
In the early 1980s, a Purdue-associated company, Napp Laboratories Limited, developed a controlled release form of morphine, marketed in the United States under the name MS Contin. Although MS Contin overcame many of the difficulties associated with immediate release analgesics, it presented two disadvantages of its own: First, morphine carried the stigma of being perceived by the public as an addictive narcotic to be used only as a last resort for the terminally ill. Second, the dosage level of MS Contin required to eliminate pain effectively varied greatly from patient to patient. Consequently, the titration process — i.e., the process of repeatedly adjusting the dosage level until a steady state of pain relief is achieved — took too long. See id. ¶¶ 18-24.
Purdue therefore looked to other opioid substances as means of narrowing the dosage range and shortening the titration process. Purdue's research indicated that oxycodone would fulfill this purpose because of its ready absorption into the bloodstream (that is, its "high oral bioavailability") coupled with its prompt elimination from the bloodstream. In December 1995, after spending several years and more than $40 million in research, development, and testing, Purdue obtained approval of its product from the Food and Drug Administration ("FDA") and began marketing its controlled release oxycodone analgesic under the name OxyContin. See id. ¶¶ 25-31. Through the end of 1998, Purdue has spent over $207 million marketing OxyContin in the United States. See Michael Friedman Decl. ¶ 33.
OxyContin, which has approximately half the dosage range of MS Contin, see Goldenheim Decl. ¶ 29, has proved enormously successful. Sales of OxyContin from January through August 1999 were $330 million, with total 1999 sales forecast at over $600 million. See Friedman Decl. ¶ 20. Sales for 2000 are presently forecast at between $925 million and $1.2 billion. See Transcript at 138 (testimony of Michael Friedman). As such, OxyContin represented approximately 67% of Purdue's 1999 sales, and is forecast to constitute 79% or more of Purdue's sales in 2000. See Friedman Decl. ¶ 83.
Roxane's research and development of Roxicodone SR has followed a similar trajectory. Prior to its research on oxycodone, Roxane had developed a controlled-release morphine product, marketed under the name Oramorph SR, that competed directly with Purdue's MS Contin. Roxane then turned to oxycodone as means of slowing absorption of the pain killer into the blood stream, in order to extend the length of time pain was relieved. Roxane filed its initial paperwork with the FDA on July 7, 1992, and thereafter began clinical studies whose results Roxane included when it filed its New Drug Application ("NDA") with the FDA on December 29, 1997. On October 26, 1998, the FDA approved the NDA for Roxicodone SR. See Second Decl. of Michael J. Schobelock ¶¶ 3-9.
Through September 30, 1999, Roxane has spent approximately [REDACTED] on research and development of Roxicodone SR. See id. ¶ 6. In addition, Roxane has spent approximately [REDACTED] during 1999 in preparation for marketing the Roxicodone product in the United States. At the time of the preliminary injunction hearing in this action, Roxane estimated that Roxicodone SR would generate approximately [REDACTED] in United States sales in the year 2000. Based on this projection, the product would constitute about [REDACTED] of total United States sales for Roxane Laboratories, Inc., which is a wholly owned subsidiary of defendant Boehringer Ingelheim Corporation. See John T. Swartz Decl. ¶¶ 4, 10-12.
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