As we discussed earlier today, we are working An example of the variety of patent law issues A This is only one of many issues that require For these reasons, we think it would be appropriate for the Judiciary Committee to ask for a period through the end of July in which to study the bill and, once received, to ask Chairman Kastenmeier's Subcommittee to promptly commence an appropriate set of hearings. I am sure that all the parties concerned with these issues will be prepared to present witnesses at the hearings. In this regard, it is significant, as you know, that no hearings at all have been held before the Judiciary Committee on these important issues. Indeed, representatives of the Pharmaceutical Manufacturers Association and the Generic Pharmaceutical Industry Association were scheduled to testify last week on these very issues before Chairman Kastenmeier's Subcommittee, but at the last moment declined to testify. We think it is imperative that a record be made on these important Judiciary Committee issues and, as I said, that your Committee make an independent call on these troubling provisions of the proposed legislation. I hope Thanks so much for your consideration. you will share these concerns with Chairman Rodino. POSITION PAPER The companies, which are among the nation's leading research-based pharmaceutical companies, favor a patent term restoration abbreviated new drug application bill which: (1) Restores patent life lost to regulatory review for innovative drug products; and (2) Accelerates the availability of safe and effective generic drug products. The companies are prepared to support a bill that addresses the following issues: LIMITS ON FDA AUTHORITY TO ASSURE SAFETY AND EFFICACY Background Unlike current ANDA regulations for drugs approved before 1962, the June 2 discussion draft precludes FDA from requesting information from an ANDA applicant concerning its drug product beyond the limited information specifically set forth in the draft. This does not permit FDA to request safety and effectiveness data other than bioequivalence data. In addition, the draft does not authorize rejection of an ANDA for most drugs on grounds of lack of safety or effectiveness. Recommendations Congress should maintain FDA's explicit discretionary authority: (1) to require safety and effectiveness information from an ANDA applicant when needed to protect the public health; and (2) in such instances, to disapprove any ANDA if the applicant is unable to demonstrate that its drug product is safe and effective. We believe that failure to include simple clear authority in the bill will: (1) raise questions about the scope of FDA's authority; (2) probably result in litigation; and (3) perhaps create a separate class of products subject to premarket approval requirements 1 - post-1962 ANDAS - for which FDA will be unable to obtain adequate safety and efficacy data. ENCOURAGEMENT OF PATENT LITIGATION Background Under the discussion draft, an ANDA applicant can force the patent holder to litigate the validity of the patent well before the ANDA filing date and at a time when the applicant has incurred only minimal investment. The bill permits the ANDA applicant, in effect, to compel the patent owner to commence litigation on the validity of a patent within 45 days of receiving notice of formulation of dosage form or initiation of bioequivalence studies. Recommendations The bill should provide that the trigger mechanism can occur only upon the "filing" of a complete ANDA. As used in the context of the current Federal Food, Drug, and Cosmetic Act, this means acceptance for "filing" by FDA of a complete application. ENCOURAGEMENT OF PATENT INFRINGEMENT Background Under present law, a patent has a statutory presumption of validity. Under the draft, an ANDA applicant will be allowed to market a drug after the expiration of a two year period following notice to the patent holder. This is unfair because final adjudication of the validity of a patent normally will not be reached within the two year time period. Since a patent is presumed valid, an ANDA applicant should not be allowed to market the drug until adjudication of the patent by the trial court. Recommendation An ANDA applicant should not be allowed to market a drug until a trial court has ruled that a patent is not valid or has not been infringed. However, if the pioneer fails to exercise due diligence in prosecuting an infringement action, the court should have discretion to make effective the second-comer's ANDA, if FDA has approved the ANDA. Should that occur, and be reversed on appeal, an injunction against marketing of the infringing product should be mandatory. REVERSAL OF THE BOLAR DECISION Background In the Bolar case, the United States Court of Appeals for the Federal Circuit reaffirmed the rights of the pharmaceutical |