Patent Fairness Act of 1999: The Implications of Extending Patents for Pipeline Drugs

Journal of Intellectual Property Law Volume 8 | Issue 1 Article 6 October 2000 Patent Fairness Act of 1999: The Implications of Extending Patents for Pipeline Drugs Shilpa Patel Follow this and additional works at: https://digitalcommons.law.uga.edu/jipl Part of the Intellectual Property Law Commons, and the Legislation Commons Recommended Citation Shilpa Patel, Patent Fairness Act of 1999: The Implications of Extending Patents for Pipeline Drugs, 8 J. Intell. Prop. L. 145 (2000). Available at: https://digitalcommons.law.uga.edu/jipl/vol8/iss1/6 This Notes is brought to you for free and open access by Digital Commons @ Georgia Law. It has been accepted for inclusion in Journal of Intellectual Property Law by an authorized editor of Digital Commons @ Georgia Law. Please share how you have benefited from this access For more information, please contact . Patel: Patent Fairness Act of 1999: The Implications of Extending Patent PATENT FAIRNESS ACT OF 1999: THE IMPLICATIONS OF EXTENDING PATENTS FOR PIPELINE DRUGS I. INTRODUCTION On April 28, 1999, during the 106th session of Congress, House Representative Ed Bryant introduced the Patent Fairness Act of 1999 On May 27, 1999, Senator Robert Torricelli introduced a similar measure, known as the Drug Patent Term Restoration Review Procedure Act of 1999.2 The proposed legislation is an attempt to extend the patent life up to an additional three years for the following pharmaceutical drugs: Claritin, Relafen, Daypro, Dardiogen-82, Dermatop, Nimtop, Eulexin, Penetrex.3 These drugs, referred to as "pipeline" drugs, had received a patent but were pending Federal Food and Drug Administration (hereinafter "FDA") approval in 1984 when the Drug Price Competition and Patent Term Restoration Act of 1984' (hereinafter "Patent Term Restoration Act") was enacted. The Patent Term Restoration Act provides a five-year extension on patent life for pharmaceutical drugs that require FDA approval before hitting the market and whose patent life is reduced in obtaining such approval.' The provision only applies if the drug obtains a patent or enters the FDA approval phase after the statute's enactment." Therefore, a special provision allowed the pipeline drugs to receive a maximum of a two-year extension," based partly on the assumption that these drugs would be approved within ' Patent Fairness Act of 1999, H.R. 1598, 106th Cong. (1999) (introduced in the House of Representatives on April 28, 1999), avadabein WL 1999 CONG US HR 1598. 2 Drug Patent Term Restoration Review Procedure Act of 1999, S. 1172, 106th Cong. (1999) (introduced in the Senate on May 27, 1999), available in WL 1999 CONG US S 1172. 1 James Frederick, GenerialndustryMobilmzestoFightPatent-ExtensionThrea, DRUG STORE NEWS, August 30, 1999, availablein 1999 WL 10882446. ' Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. No. 98-417, 98 Stat. 1585 (1984 & Supp. 1999) (codified as amended in scattered sections including: 35 U.S.C. S 156 (1984), 35 U.S.C. S 271 (1984 & Supp. 1999), and 21 U.S.C. S 355 (1999). The Drug Price Competition Act and the Patent Term Restoration Act were introduced independently but combined when neither act could be enacted separately. 5 35 U.S.C. S 156(g)(6). 6 Id S 156W(6)(A), W(6)(B). ' ,d S 156(,)(6)(C). Published by Digital Commons @ Georgia Law, 2000 1 Journal of Intellectual Property Law, Vol. 8, Iss. 1 [2000], Art. 6 J.INTELL. PROP.L. [Vol. 8:145 that time.! However, some of these pipeline drugs spent between seven and twenty-two years awaiting FDA approval. 9 Supporters of the Patent Fairness Act argue that the legislation is an attempt to compensate the pipeline drug manufacturers for the unforeseen delays in obtaining FDA approval, which diminished the life of their patents. The proponents argue that the legislation establishes a fair and impartial process, and not a guarantee, for pipeline patentees, seeking restoration of lost patent life. Pipeline drugs were given only a two-year extension pursuant to the Patent Term Restoration Act, based on a miscalculation of approval time. At that time, FDA approval time averaged 2.25 years. However, some drugs, including the pipeline drugs, spent at least five years in the approval process. The proponents attribute the delay to the shortage of resources at the FDA, rather than to the medical safety concerns of the products. Since Congress has extended patent life for similar inequities in the past, the proponents argue for the same treatment. Furthermore, the treatment of brand name drugs is quite disparate in comparison with generic drugs, which do not require nearly the same amount of time and money in drug development, and can often bypass most of the lengthy FDA approval process. Finally, other patented inventions, such as computer components, often receive the maximum patent life and require far less capital on development than pharmaceutical drugs. The opponents argue that the proposed legislation gives the manufacturers of the pipeline drugs a windfall at the expense of consumers. The provisions of the legislation practically guarantee an extension, since the terms unfairly favor the patentee. Further, this issue, at least in the case of LegislativeHearingonH.R.1598, "ThePatentFairnessActof 1999," Before the Subcommitteeon the Courts and Intellectual PropertyCommittee on the Judiciary U.S. Home of Representatives, 106th Cong. (1999), available in 1999 WL 461846 (statement of Peter Barton Hutt, partner at the law firm of Covington & Burling). 9 See Marvin J. Powell, Independent Processfor FairPatentReview Will Assure Fairness, Advance Intellectual PropertyRights, METROPOuTAN CoRp. COUNs., June 1999, at 25, available in Westlaw, METCC Database (reporting that "fo]f 123 pipeline drugs, 17 spent more than five years in the NDA [new drug approval] process after the completion of clinical trials. Several other pipeline drugs, Penetrex, Dermatop, Nimotop, Relafen, and Claritin were subjected to extraordinarily long FDA reviews of over seven years. https://digitalcommons.law.uga.edu/jipl/vol8/iss1/6 2 Patel: Patent Fairness Act of 1999: The Implications of Extending Patent 2000] PA TENT FAIRNESS A CT OF 1999 Claritin, 0 has been debated before Congress and the extension has been denied on more than one occasion. The purpose of the Patent Term Restoration Act was to encourage future development, and the pipeline drugs had already been developed at the time of the statute's enactment. The pipeline drug manufacturers, however, received more than they anticipated at the time they developed the drugs: a two-year extension pursuant to the Patent Term Restoration Act for all of the drugs, and additional time pursuant to the Uruguay Round Agreement Act for some. Furthermore, the brand name drug business, despite the cost of research and development, is earning significant profits and is one of the most profitable industries. This note provides a background of the Patent (...truncated)