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 for drug approval constitutes patent infringement. Under the provisions of the draft, Bolar would be substantially reversed. 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 which are eligible for patent, term restoration. Background PATENT TERMS NOT SUBJECT TO RESTORATION The draft 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. It is possible subsequently to obtain a patent for specific claims (species) on a few specific compounds encompassed within the genus. Under the draft, 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. This provision applies even if the earlier issued genus patent belonged to a third party. In addition, under present law, the Patent Office can require that the claims in a patent application be divided and prosecuted in separate patents. Under the draft, the first issued patent of the series would be the only patent term entitled to restoration, and subsequently issued patents of the series would be precluded from restoration. Accordingly, unless an FDA approved product is claimed within the first issued patent of the series, restoration of a patent term covering the product would not be available. During the patent application process, it is impossible to know which drug or drugs will ultimately be successfully tested and marketed. Therefore, a patent holder is being denied the benefit of patent term restoration due to circumstances beyond its control. Another exception to patent term restoration would occur where one patent covers two FDA approved drugs. Any claims in the patent covering the second FDA approved drug could not be restored. Accordingly, only one restoration is available per patent even though a company has expended considerable resources in developing each FDA approved product. The draft also limits availability of patent term restoration for method of manufacturing patents (not using DNA technology), including the limitation that no other type of patent has been "or may be" issued claiming the product or a method of using it. Recommendations Eliminate these exceptions to encourage innovation and further research of new drugs through patent term restoration. DISCLOSURE OF TRADE SECRETS Background The draft would permit FDA to release all safety and effectiveness data and information submitted in an NDA. Those data and information may retain proprietary value in the United States and could be used by competitors to obtain product registration in foreign countries. Also, it is not clear in the draft that the term "information" is limited to safety and effectiveness information, as distinguished from other confidential data in NDAs such as manufacturing methods and processes. Recommendation The draft should require FDA to make available a detailed summary of safety and effectiveness data, but not the complete raw data. Also, it should be clarified that the term "information" relates only to information on safety and effectiveness. INADEQUATE TRANSITION PROVISIONS Background The draft would permit marketing exclusivity for 10 years only for active moieties approved between January 1, 1982 and the date of enactment of the bill. It would also provide 4 year marketing exclusivity for non-patentable active moieties approved after the date of enactment of the bill. The discussion draft discriminates against those companies that invested in research in areas such as new dosage forms, new delivery systems and innovative formulations. The current draft penalizes those companies by excluding those products from the transition provisions. Recommendation The periods of exclusivity provided by the transition provisions should apply to new salts or esters, new dosage forms, new release mechanisms, new dosages, and, importantly, new indications, for which FDA has required a submission of safety and efficacy data. STATEMENT ON BEHALF OF American Home Products Corporation Merck & Co., Inc. Norwich Eaton Pharmaceuticals, Inc. Stuart Pharmaceuticals BEFORE THE SUBCOMMITTEE ON COURTS, CIVIL LIBERTIES, AND THE ADMINISTRATION OF JUSTICE OF THE COMMITTEE ON THE JUDICIARY UNITED STATES HOUSE OF REPRESENTATIVES HEARING ON H.R. 3605 June 27, 1984 |