from an ANDA applicant concerning its drug product beyond the limited information specifically set forth in the bill. For most drugs, this does not permit FDA to request safety and effectiveness data other than bioequivalence data. In addition, the bill does not authorize rejection of an ANDA for most drugs on grounds of lack of safety or effectiveness. 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 post-1962 ANDAS-- for which FDA will be unable to obtain adequate safety and efficacy data. - Recommendations The FDA, which is charged by statute with protecting public health, should have the same authority for all products it approves to properly protect consumers. Simply stated: 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. Background ENCOURAGEMENT OF PATENT LITIGATION A prior concern of the research-based pharmaceutical companies was that the notice provisions allowed an ANDA applicant to force the patent holder to litigate the validity of a patent well before ANDA filing at a time when the applicant had incurred only minimal expense. It allowed the ANDA applicant easily to challenge patent validity beyond those circumstances permitted under current law. The provisions for providing notice to the patent holder have now been changed to require notice on the ANDA submission date. While this is an improvement, it is only partial. In order to trigger the notice provision, the ANDA "submission" need not be complete or acceptable for filing. This would permit sham ANDA applications to be submitted solely for the purpose of precipitating litigation. 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. Background ENCOURAGEMENT OF PATENT INFRINGEMENT Under present law, a patent has a statutory presumption of validity. Under the bill, an ANDA applicant automatically will be allowed to market a drug after the expiration of an eighteen month 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 eighteen month time period. Additionally, in some jurisdictions there may be a judicial backlog which could result in many years of delay. 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. Recommendations 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 This has been reduced from two years in the June 2, 1984 draft. 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 a district court's ruling in favor of a patent challenger be reversed on appeal, an injunction against marketing of the infringing product should be mandatory. Background REVERSAL OF THE BOLAR DECISION In the Bolar case, the United States Court of Appeals for the Federal Circuit reaffirmed the rights of the pharmaceutical innovator to prevent others from using its patented products during the patent term. The Court ruled that the use of a patented pharmaceutical compound for the purpose of testing or investigating it in order to obtain FDA approval constitutes patent infringement. Under the provisions of the bill, Bolar is now completely reversed so that infringement may not be alleged prior to ANDA filing. This portion of the bill raises serious constitutional questions as it relates to the elimination of rights on patents that have already issued. In particular, it abridges the patentees' rights by permitting the manufacture, use or sale of the patented product during the patent term. Recommendations Bolar should be reversed only for drugs covered by patents issued after enactment of the bill and which are eligible for patent term restoration. Background PATENT TERMS NOT SUBJECT TO RESTORATION It is The bill contains limitations on the patent terms which can be restored. Under present law, a patent can be obtained containing a broad claim (genus) covering many compounds. possible subsequently to obtain a patent for specific claims (species) on a few specific compounds encompassed within the genus. Under the bill, should a patent holder obtain a patent with species claims covered by a previously issued genus patent, the patent holder could not obtain restoration of the term of the species patent. The bill, differing from an earlier draft, only partially addressed this issue by providing for patent restoration if the earlier issued genus patent belonged to a third party and there was no exclusive license between the parties. |