TESTIMONY OF U.S. REPRESENTATIVE LAWRENCE COUGHLIN SUBMITTED TO THE SUBCOMMITTEE ON COURTS, CIVIL LIBERTIES, June 26, 1984 Mr. Chairman, as a lawyer and former member of the Judiciary Committee as well as a sponsor of a patent term restoration bill (H.R. 3502) providing for up to a seven year patent extension for products subject to regulatory review, I wish to address one provision of H.R. 3605, the Drug Price Competition Act, which causes me particular concern. H.R. 3605 would allow generic drug manufacturers submitting Abbreviated New Drug Applications to market a drug automatically eighteen months after notifying the patent holder of his intention to do so. The present statutory presumption of a patent's validity would be undermined by such a provision. A patent should continue to be presumed valid unless it is successfully challenged in court. Since final adjudication of the validity of a patent is a lengthy process usually lasting more than eighteen months, this provision of the bill would allow applicants to begin marketing a drug before a court has ruled on the patent validity issue. While the generic manufacture of drugs should be allowed and encouraged once a valid patent has expired or been found invalid by a court, the fundamental principle of a patent's validity should not be violated. By allowing a reasonable period of marketing exclusivity for pioneer drug manufacturers to recover their new drug research and development costs, the basic patent system provides an important incentive for drug companies to invest in new life-saving and health care-improving drugs. Although the patent laws need to be improved and updated in some respects such as the patent term extension for regulatory reviews, it is important that the basic incentives and protections afforded by patent statutes not be weakened. The proposal to permit Abbreviated New Drug Applicants to market a drug automatically eighteen months after giving notice to a patent holder represents a major weakening of the patent law and should not be approved by your committee. I would urge that this section of H.R. 3605 be amended to provide that a manufacturer submitting an Abbreviated New Drug Application to market a drug still under a patent be barred from doing so until a trial court has ruled that the patent is not valid or that it has not been infringed. At the same time, the court should have discretion to allow a manufacturer's Abbreviated New Drug Application (if approved by FDA) in cases where the patent holder is not diligent in prosecuting an infringement action. Thank you for this opportunity to present my views to the subcommittee. TESTIMONY OF U.S. REPRESENTATIVE LAWRENCE COUGHLIN PATENT LAW REFORM SUBMITTED TO THE SUBCOMMITTEE ON COURTS, CIVIL LIBERTIES, June 26, 1984 Mr. Chairman, as a lawyer and former member of the Judiciary Committee as well as a sponsor of a patent term restoration bill (H.R. 3502) providing for up to a seven year patent extension for products subject to regulatory review, I wish to address one provision of H.R. 3605, the Drug Price Competition Act, which causes me particular concern. H.R. 3605 would allow generic drug manufacturers submitting Abbreviated New Drug Applications to market a drug automatically eighteen months after notifying the patent holder of his intention to do so. The present statutory presumption of a patent's validity would be undermined by such a provision. A patent should continue to be presumed valid unless it is successfully challenged in court. Since final adjudication of the validity of a patent is a lengthy process usually lasting more than eighteen months, this provision of the bill would allow applicants to begin marketing a drug before a court has ruled on the patent validity issue. While the generic manufacture of drugs should be allowed and encouraged once a valid patent has expired or been found invalid by a court, the fundamental principle of a patent's validity should not be violated. By allowing a reasonable period of marketing exclusivity for pioneer drug manufacturers to recover their new drug research and development costs, the basic patent system provides an important incentive for drug companies to invest in new life-saving and health care-improving drugs. Although the patent laws need to be improved and updated in some respects such as the patent term extension for regulatory reviews, it is important that the basic incentives and protections afforded by patent statutes not be weakened. The proposal to permit Abbreviated New Drug Applicants to market a drug automatically eighteen months after giving notice to a patent holder represents a major weakening of the patent law and should not be approved by your committee. I would urge that this section of H.R. 3605 be amended to provide that a manufacturer submitting an Abbreviated New Drug Application to market a drug still under a patent be barred from doing so until a trial court has ruled that the patent is not valid or that it has not been infringed. At the same time, the court should have discretion to allow a manufacturer's Abbreviated New Drug Application (if approved by FDA) in cases where the patent holder is not diligent in prosecuting an infringement action. Thank you for this opportunity to present my views to the subcommittee. TESTIMONY OF U.S. REPRESENTATIVE LAWRENCE COUGHLIN PATENT LAW REFORM SUBMITTED TO THE SUBCOMMITTEE ON COURTS, CIVIL LIBERTIES, June 26, 1984 Mr. Chairman, as a lawyer and former member of the Judiciary Committee as well as a sponsor of a patent term restoration bill (H.R. 3502) providing for up to a seven year patent extension for products subject to regulatory review, I wish to address one provision of H.R. 3605, the Drug Price Competition Act, which causes me particular concern. H.R. 3605 would allow generic drug manufacturers submitting Abbreviated New Drug Applications to market a drug automatically eighteen months after notifying the patent holder of his intention to do so. The present statutory presumption of a patent's validity would be undermined by such a provision. A patent should continue to be presumed valid unless it is successfully challenged in court. Since final adjudication of the validity of a patent is a lengthy process usually lasting more than eighteen months, this provision of the bill would allow applicants to begin marketing a drug before a court has ruled on the patent validity issue. While the generic manufacture of drugs should be allowed and encouraged once a valid patent has expired or been found invalid by a court, the fundamental principle of a patent's validity should not be violated. By allowing a reasonable period of marketing exclusivity for pioneer drug manufacturers to recover their new drug research and development costs, the basic patent system provides an important incentive for drug companies to invest in new life-saving and health care-improving drugs. |