WHEREAS, Zenith has acknowledged, and by its consent hereto does hereby acknowledge, that Zenith has imported into the United States, its territories or possessions, a quantity of diazepam in excess of 500 kilograms (more than half a ton); that Zenith has manufactured, from a part thereof, pharmaceutical dosage form units suitable for administration to humans, including some 100,000 tablets each containing two milligrams of diazepam as the active ingredient, some 100,000 tablets each containing five milligrams of diazepam as the active ingredient, and some 100,000 tablets each containing ten milligrams of diazepam as the active ingredient; that Zenith has used several thousand of said tablets for the purpose of obtaining data and information demonstrating the pharmacological efficacy and suitability for administration of such tablets to humans, the portion so used amounting to approximately 0.19 kilogram of diazepam (less than 0.04% of the amount imported); that Zenith's remaining stock of diazepam is sufficient for it to manufacture more than 250,000,000 tablets each containing two milligrams of diazepam as the active ingredient; that Zenith has made application to the United States Food and Drug Administration for approval to market and distribute diazepam in dosage unit form of tablets containing two milligrams, five milligrams, or ten milligrams of diazepam as the active ingredient, and has pursued said application by, inter alia, submitting data and information, including that described above, in support thereof; that Zenith's aforesaid acts have all been without leave or license of Roche; and that Żenith has never received the authorization or consent of the United States Government to use or manufacture diazepam in dosage unit form or otherwise; and WHEREAS, new management has assumed responsibility for the decision making process in Zenith and that management has chosen not to continue with the litigation or contest the validity of Roche patents, the subject of this litigation and desires to settle this litigation; and WHEREAS, Zenith has acknowledged, and by its consent hereto does hereby acknowledge, that the invention disclosed and claimed in said Letters Patent No. 3,371,085 is the invention of Earl Reeder and Dr. Leo Henryk Sternbach, that it was made by them in this country and that said invention is a pioneer invention; and WHEREAS, Zenith desires to continue in its experimentation with diazepam as hereinafter provided, and will retain in its possession for such use only five (5) kilograms of diazepam; and WHEREAS, Zenith has represented, and by its consent hereto does hereby represent, that it will not make, use or sell diazepam, either alone or in conjunction with others, and will not assist, aid or abet others to make, use or sell diazepam, in bulk or dosage unit form, either pure or in admixture with other compounds, including excipients, without leave and license of Roche, on or after the date of this Judgment and until expiration of said Letters Patent on February 27, 1985; and WHEREAS, Zenith has acknowledged, and by its consent hereto does hereby acknowledge, that it consents to entry of this Judgment as its free act and deed, without coercion or duress, and that there are no agreements or understandings between the parties, except as part of this Judgment; IT IS HEREBY ORDERED, ADJUDGED AND DECREED: 1. That this Court has jurisdiction over the parties and the subject matter of this action. 2. That United States Letters Patent No. 3,371,085, issued to Roche on February 27, 1968, are good, valid and enforceable, and that Roche is the owner of &id Letters Patent and solely entitled to recover for any infringement thereof. 3. That Zenith, each and every subsidiary thereof and each and every company under its direct or indirect control, their officers, agents, servants, employees, Successors and assigns, be, and each of them hereby is, enjoined and restrained, for the duration of said Letters Patent No. 3,371,085 through and including February 27, 1985, from (a) infringing United States Letters Patent No. 3,371,085 or aiding, assisting or abetting others to infringe said Letters Patent; (5) inducing or contributing to the infringement by others of United States Letters Patent No. 3,371,085; (c) making, using, selling, offering for sale, delivering, formulating, encap→ sulating, tableting, advertising, importing or otherwise obtaining diazepam, or any other substance covered by any claim or claims of United States Letters Patent No. 3,371,085, without leave and license of Roche; (d) making, using, selling, offering for sale, delivering, formulating, encapsulating, tableting, advertising, importing or otherwise obtaining any product containing diazepam or any other substance covered by any claim or claims of United States Letters Patent No. 3,371,085 as an active ingredient, without leave and license of Roche; and (e) making, using or selling diazepam, or any other substance covered by any claim or claims of said Letters Patent No. 3,371,085, either alone or in conjunction with others, and will not assist, aid or abet others to make arrangements or preparations for, or take steps, to make, use or sell diazepam, or any other substance covered by any claim or claims of said Letters Patent No. 3,371,085, without leave and license of Roche. 4. That nothing herein shall be construed as limiting, expanding or otherwise affecting any applicability of Title 28, United States Code, Section 1498(a), to Zenith's past or future activities. 5. That nothing herein shall be taken as a waiver or limitation of Roche's right to seek remedy for any sales by Zenith to the United States Government, or others; and nothing herein shall be taken as the grant of a license, or as the grant or waiver of any rights by Roche. 6. That the answer, affirmative defenses and counterclaims filed by Zenith be dismissed with prejudice in all respects. awarded. 7. That no costs, disbursements, attorneys' fees or damages be 8. That all terms and conditions of this Judgment shall apply to Zenith and each and every subsidiary thereof and each and every company under its direct or indirect control. 9. Zenith may retain in its possession five (5) kilograms of diazepam for the limited purpose of such experimentation as fairly falls within permissible experimentation under the patent laws of the United States. Nothing herein shall prejudice Zenith from taking advantage of its rights, if any, under Title 28 U.S.C. S 1498(a). Nothing contained herein (and in particular by way of illustration and not limitation, Paragraphs 3(c), 3(d) and 3(e)] shall be construed as limiting, expanding or otherwise affecting the provisions of this Paragraph 9. ENTERED as of this day of , 1979, United States District Judge PLAINTIFF ROCHE'S MEMORANDUM IN SUPPORT OF ITS MOTION UNDER RULE 12 DIRECTED TO ZENITH'S ANSWER AND COUNTERCLAIMS CRUMMY, DEL DEO, DOLAN & PURCELL Newark, New Jersey 07102 (201) 622-2235 Attorneys for Plaintiff On the Brief: Fisher, Christen & Sabol 1000 Connecticut Avenue Washington, D.C. 20035 Watson Leavenworth Kelton & Taggart 100 Park Avenue New York, New York 10017 |