Hostname: page-component-5c6d5d7d68-txr5j Total loading time: 0 Render date: 2024-08-19T03:19:02.926Z Has data issue: false hasContentIssue false
  • English
  • Français

The Eleventh Circuit Holds that Agreements in which Pharmaceutical Companies Pay Generic Companies Not to Compete May be Valid

Published online by Cambridge University Press:  01 January 2021

Amy Garrigues
Get access Rights & Permissions [Opens in a new window]

Extract

On September 15, 2003, the US. Court of Appeals for the Eleventh Circuit held that agreements between pharmaceutical and generic companies not to compete are not per se unlawful if these agreements do not expand the existing exclusionary right of a patent. The Valley DrugCo.v.Geneva Pharmaceuticals decision emphasizes that the nature of a patent gives the patent holder exclusive rights, and if an agreement merely confirms that exclusivity, then it is not per se unlawful. With this holding, the appeals court reversed the decision of the trial court, which held that agreements under which competitors are paid to stay out of the market are per se violations of the antitrust laws. An examination of the Valley Drugtrial and appeals court decisions sheds light on the two sides of an emerging legal debate concerning the validity of pay-not-to-compete agreements, and more broadly, on the appropriate balance between the seemingly competing interests of patent and antitrust laws.

Type
Recent Developments in Health Law
Information
Journal of Law, Medicine & Ethics , Volume 32 , Issue 1 , Spring 2004 , pp. 181 - 184
Copyright
Copyright © American Society of Law, Medicine and Ethics 2004

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Valley Drug Co. v. Geneva Pharm., Inc., Abbott Lab., 2003 WL 22120130, *15–*16 (11th Cir.).Google Scholar
Id. at *1.Google Scholar
15 U.S.C.A. § 1 (2002).Google Scholar
Valley Drug Co., 2003 WL 22120130, at*7.Google Scholar
In re Cardizem CD Antitrust Litigation, 332 F.3d 896, 906 (6th Cir. 2003).Google Scholar
Eastern R.R. Presidents Conference v. Noerr Motor Freight, Inc., 365 U.S. 127 (1961).Google Scholar
Resek, J.F., “Biovail v. Hoechst Aktiengesellschaf, Inc: An Analysis under the Sherman Act and the Noerr – Pennington doctrine,” Fordham Intellectual Property, Media, and Entertainment Journal 10 (Winter 2000): 571–94, at 586.Google Scholar
Gardner, B.A., ed., Black’s Law Dictionary, 2nd Pocket Edition, (St. Paul, MN: West Group, 2001): at 476.Google Scholar
In re Terazosin Hydrochloride Antitrust Litigation, l64 F.Supp.2d 1340, 1353 (S.D. Fla. 2000).Google Scholar
See Resek, , supra note 4, at 574.Google Scholar
Valley Drug Co., 2003 WL 22120130, at 2.Google Scholar
Id.Google Scholar
In re Cardizem, 332 F.3d at 901.Google Scholar
Valley Drug Co., 2003 WL22120130, at 3.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id. at 4.Google Scholar
In re Cardizem, 332 F.3d at 901.Google Scholar
However, at the time that the agreements were struck, the FDA had a “successful defense” requirement for generic companies. This required that the generic company successfully defend its ANDA paragraph IV certification before it began exclusively marketing the drug. In re Ciprofloxacin Hydrochloride Antitrust Litigation, 261 F.Supp.2d 188, 239 (E.D.N.Y. 2003).Google Scholar
Valley Drug Co., 2003 WL22120130, at 4.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id. at 5.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
In re Terazosin, 164 F. Supp.2d at 1343.Google Scholar
Id.Google Scholar
Id. at 1348–9.Google Scholar
Id. at 1350.Google Scholar
Id.Google Scholar
Id. at 1351.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id. at 1353.Google Scholar
Valley Drug Co., 2003 WL 22120130, at 1.Google Scholar
Id. at 8.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id. at 12.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id. at 13.Google Scholar
Id.Google Scholar
“Emmanuel Seeks to Reduce Prescription Drug Costs Through Market Reforms, Co-Sponsors Bills to Foster Competition and Lower Prices,” June 20, 2003, available at <http://www.house.gov/apps/list/press/il05_emanuel/RxDrugBills.html>..>Google Scholar
In re Ciprofloxacin, 261 F.Supp.2d at 256–58.Google Scholar
Id.Google Scholar
In re Cardizem, 332 F.3d at 900.Google Scholar
Id.Google Scholar
Troy, D., “Promoting Availability of Lower Cost Drugs,” Congressional Testimony by Federal Document Clearing House, August 1, 2003.Google Scholar
Id.Google Scholar
Anderson, D., “New Generic Drug Rules,” The National Law Journal 25 (September 1, 2003), at 24.Google Scholar
McGinley, L., “Generic-Drug Bill Picks Up Backing of 2 Key Senators,” Wall street Journal, June 5, 2003, at A6.Google Scholar
“Generic Drug Access Speeds Up / Senate Voted 94–1 for Changes to Medicare Prescription Bill,” Houston Chronicle, June 20, 2003.Google Scholar
Wise, M. Zhu, J., “Maximizing Effective Patent Life of Innovator Drugs: Extensions Under the Hatch-Waxman Act Are Helpful, But Are They Long Enough?” The National Law Journal 25 (July 7, 2003), at 15.Google Scholar
Id.Google Scholar