Opinion ID: 788070
Heading Depth: 4
Heading Rank: 1

Heading: Plaintiff's Dealings Before 1996 with Defendant ACIC/Brantford

Text: 19 Geneva's attempt to obtain a source of clathrate encountered nearly insurmountable obstacles. Between 1993 and 1996 it sought to obtain a clathrate supply from numerous chemical companies, including Hoechst Celanese, Chemoswede, Banyan Chemicals, and others. A critical issue in the present dispute is whether any of these potential suppliers was in fact a viable commercial source of clathrate because nearly all of plaintiff's accusations depend on its theory that ACIC/Brantford's monopoly on clathrate created a bottleneck for others attempting entry into the generic warfarin market. At the relevant time, Geneva concluded that ACIC/Brantford was its only viable supplier. But, the district court found several other sources were available to plaintiffs. 20 Geneva had purchased a variety of products from ACIC/Brantford during the 1980's and 90's. Dr. Panjak Dave, Geneva's regulatory manager, had represented Geneva in most of the prior dealings with ACIC/Brantford. Sergio Getrajdman was ACIC/Brantford's sales representative responsible for sales to Geneva. On September 20, 1994 when Dr. Dave contacted Getrajdman to discuss the availability of clathrate, Getrajdman told him that ACIC/Brantford had no exclusive arrangement with respect to clathrate and that it could supply clathrate to Geneva. The next day, Dr. Dave telephoned ACIC/Brantford for a price quote on a small purchase and was quoted approximately $2,500 per kg. 21 From late 1994 through early 1995, ACIC/Brantford sent Geneva several samples and R & D quantities of clathrate. At one point, Geneva purchased 15 kg. In March 1995 ACIC/Brantford sent three additional samples along with technical information that Geneva had requested. In April 1995 ACIC/Brantford sent the FDA a Master File reference letter on behalf of Geneva (then known as Invamed). The letter provided: 22 Dear Sir, Re: WARFARIN SODIUM DMF # 11387 23 Authorization is hereby given to the Food and Drug Administration to refer to our Master File for WARFARIN SODIUM on behalf of: 24 INVAMED, INC. 2400 Route 130 North 25 Dayton, NJ 08810 — U.S.A. 26 In support of any new drug application they may file on pharmaceutical preparation containing the drug manufactured by us. 27 ACIC (CANADA) INC. herewith commits itself to manufacture all of their pharmaceutical products in accordance with the current good manufacturing practices and by the methods described in this specific Drug Master File, and to issue a new DMF reference letter after each amendment on the above Drug Master File. 28 In July 1995 Geneva ordered 5 more kg of clathrate at $2,500 per kg and requested ACIC/Brantford's safety and handling procedures. ACIC/Brantford shipped the product along with information about its procedures.