Defendant, Zenith Laboratories, Inc., with offices at 140 Le Grand Avenue, Northvale, New Jersey, by way of Answer to the Complaint herein, says: AS TO COUNT ONE 1. Defendant denies that this Court has jurisdiction under the Patent Laws of the United States or under 28 U.S.C. Sec. 1338 in that no case or controversy is stated sufficient to invoke the jurisdiction of this Court either under the above-listed sections or under 28 U.S.C. Sec. 2201 (the Declaratory Judgment Act). 2. Defendant admits the allegations of Paragraph 2. 3. Defendant admits the allegations of Paragraph 3. 4. Defendant, Zenith Laboratories, Inc., denies knowledge or information sufficient to form a belief as to the truth of the allegations contained in Paragraph 4. 5. Defendant denies knowledge or information sufficient to form a belief as to the truth of the allegations contained in Paragraph 5. 6. Defendant denies knowledge or information sufficient to form a belief as to the truth of the allegations contained in Paragraph 6. 7. Defendant denies each and every allegation contained in Paragraph 7, except to admit that it has imported into the State of New Jersey approximately 5 kilograms of diazepam in its raw state. 8. Defendant denies each and every allegation contained in Paragraph 8, except to admit that it has undertaken, as part of the experimentation required for a new drug application to the Food and Drug Administration to reduce part of its diazepam supply into tablet form by mixing the active ingredient with the excipients created by the employees of defendant. 9. Defendant denies each and every allegation contained in Paragraph 9, except to admit that it has applied for approval to market the diazepam in tablet form. 10. Defendant denies each and every allegation contained in Paragraph 10. 11. Defendant denies each and every allegation contained in Paragraph 11, except to admit that it does not possess any assignment of or license under plaintiff's patent rights, if any, in diazepam. 12. Defendant denies each and every allegation contained in Paragraph 12. AS TO COUNT TWO 13. Defendant denies each and every allegation contained in Paragraph 13. 14. Defendant repeats and realleges each and every of its answers to Paragraphs 1-9 and 11 of the First Count of this Complaint as if set forth at length herein. 15. Defendant denies each and every allegation contained in Paragraph 15. WHEREFORE, defendant, Zenith Laboratories, Inc. demands Judgment dismissing the within Complaint, with costs. AS AND FOR AFFIRMATIVE DEFENSES TO ALL COUNTS FIRST AFFIRMATIVE DEFENSE The judicial power of the United States District Court is limited to adjudicating actual cases or controversies arising under its laws or constitution and no act or factual instance of present infringement is charged or shown within the Complaint of the plaintiff herein. SECOND AFFIRMATIVE DEFENSE This Court ought not to exercise the discretionary authority vested in it by the Declaratory Judgment Act to adjudicate the validity of plaintiff's patent for the threat of infringement is, at best, speculative and abstract where none of the activities undertaken by defendant, Zenith, with reference to the importation of and experimentation with diazepam constitute infringements in and of themselves but, rather, are susceptible to a multitude of innocent possibilities, most of which would not ever constitute infringement for which a patentee may sue in this Court. THIRD AFFIRMATIVE DEFENSE The filing of a new drug application for approval to market and distribute diazepam is privileged under the statutory scheme creating the Food and Drug Administration and that application may be neither interfered with nor restrained, though that drug be then the subject of a previous patent grant, by or on behalf of the patentee. FOURTH AFFIRMATIVE DEFENSE Plaintiff is barred from obtaining any remedy in this Court for actions taken by defendant, Zenith, in preparation for or anticipation of gaining eligibility to bid for government contracts for the supply of diazepam by reason of 28 U.S.C. Sec. 1498 (a) by which the United States has authorized the manufacture by private companies of products arguably subject to a patent grant that are needed for the government's use. FIFTH AFFIRMATIVE DEFENSE Upon information and belief, plaintiff is precluded from enforcing the patent issued to it because said patent grant is invalid and void for failure to comply with the statutory requirements for issuance thereof, for misuse of the patent by attempting to widen the temporal and physical scope of the patent monopoly granted by statute, and for leveraging the patent monopoly in violation of the Anti-Trust laws in the United States. COUNTERCLAIMS OF DEFENDANT FIRST COUNT 1. This Court has jurisdiction over the within Counterclaim under Sec. 4 of the Clayton Act, 38 Stat. 731, 15 U.S.C. Sec. 15 and by reason of pendant jurisdiction under the common law of the State of New Jersey for damages suffered and to be suffered by defendant as a result of the actions alleged infra. undertaken by the plaintiff. 2. Zenith Laboratories, Inc. is a generic drug house involved in the manufacture, distribution and sale of drugs under their chemical name. 3. Hoffmann-La Roche Inc. is a major name brand drug company which manufactures, distributes and sells, among others, a drug under the trademark name of Valium. Valium is the name for and is chemically identical with diazepam. 4. Within the drug market, and especially the market in minor tranquillizers, plaintiff and defendant operate as competitors and as potential competitors. 5. The filing of the within litigation by plaintiff, Hoffmann-La Roche Inc., is part and parcel of a malicious course of conduct embarked upon by plaintiff to harass defendant, Zenith Laboratories, Inc., at every turn and to thwart defendant from competing fairly with Roche with the effect that restraints of trade have been and will continue to occur in the minor tranquillizer field, specifically diazepam, beyond the bounds of the patent grant heretofore issued to plaintiff under 35 U.S.C. Sec. 154. 6. Plaintiff is aware of, well knows and fully intends that continuous litigation with defendant will have the effect of delaying and frustrating defendant's legitimate plans to gain an F.D.A. approval for the marketing of diazepam thereafter to bid in competition with Roche for the sale of diazepam to federal government agencies. 7. The relatively small size of the assets and income flow of Zenith Laboratories, Inc. in comparison with the assets possessed and income generated by the business activities of Roche, is such that Roche well knows that it can and does seek to wear down and deter by the process of litigative attrition, the attempt of Zenith to engage in activities which Roche knows are ones in which Zenith is entitled to engage under law. 8. The plaintiff is fully aware of, well knows and fully intends by this litigation to create an effective economic barrier (composed of legal fees, Court costs and expenses of litigation) in the path of Zenith's business relationship into which it has or is about to enter with the various governmental agencies before which it would be eligible to bid to be their suppliers of diazepam. 9. Plaintiff's complaint in the instant action is part of a tortious campaign and illegal course of conduct designed to obstruct, by means of vexatious litigation, defendant's right of access to the Food and Drug |