Health Care and IP: Patents and Medical Research (including "Bolar" exemptions).

• Legal Documents
  • The US "Bolar" amendment is 35 USC 271(e)(1), which reads in part:

    It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

  • List of existing and proposed Bolar Provisions.
  • March 17, 2000, WTO Panel Report, WT/DS114/R-Canada-Patent Protection of Pharmaceutical Products Complaint by the European Communities and their Member States
  • June 18, 1990, US Supreme Court Opinion, Lilly & Co. v. Medtronic, Inc.

• Academic papers
  • May 1, 1998, Michael A. Heller and Rebecca S. Eisenberg in Science, Can Patents Deter Innovation? The Anticommons in Biomedical Research.

• Country Disputes
  • USA
    • March 9, 1998, Brian Coggio and Francis D. Cerrito, Immunity for Drug-Approval Process: No Patent Infringement Under Certain Circumstances, published in New York Law Journal.
    • March/April 1998, James J. Elacqua and Karen Y. Spencer, US Narrows Patent Rights in Medical Devices .
    • Based upon a May 20-21, 1997 presentation. Brian D. Coggio and Francis D. Cerrito, The Application of the Patent Laws to the Drug Approval Process.
  • Europe
    • February 1997, Trevor Cook, Pharmaceutical Patents and the Generics Sector in Europe . This article focuses on Experimental use as an exception to patent rights.
    • May 1996, Trevor Cook, Compulsory Licenses, first published in Biosciences Update. Examines use of compulsory licenses for medical research, with examination of German Federal Supreme Court case regarding Bioferon.
    • September 1995, Trevor Cook, Experimental Use, first published in Biosciences Update. Covers European laws.
  • Japan
    • From the Japanese Patent Office english version of Japan Patent laws, the reasearch exception in patent rights..

      (1) The effects of the patent right shall not extend to the working of the patent right for the purposes of experiment or research.

    • November/December 1998, John A. Tessensoh, Japanese Courts Clash Over Pharmaceutical Patents: Courts give diametrically opposed readings to the experimental use exception. From Intellectual Property Worldwide.
  • Canada
    • November 12, 1998, DGI press release, European Union launches WTO panel against Canada protection. This and the following items concern the Canadian practice of permiting companies to manufacture and store or export pharmaceuticals prior to expiration of patent in Canada. Canada does not permit a generic drug to be sold in Canada until after the patent expires.
    • November 12, 1998, the Canadian Drug Manufacturers Association (CDMA), press release, Generic Drug Industry confident European Union's attempt to delay entry of generic drugs to market will fail .
    • December 2, 1998. A WTO Dispute:

      European Communities - Patent Protection for Pharmaceutical and Agricultural Products, complaint by Canada (WT/DS153/1). This dispute, dated 2 December 1998, is in respect of the protection of inventions in the area of pharmaceutical and agricultural chemical products under the relevant provisions of EC legislation, particularly Council Regulation (EEC) No. 1768/92 and European Parliament and Council Regulation (EC) No. 1610/96, in relation to EC obligations under the TRIPS Agreement. Canada contends that under the above Regulations, a patent term extension scheme, which is limited to pharmaceutical and agricultural chemical products, has been implemented. Canada alleges that Regulations (EEC) No. 1768/92 and (EC) No. 1610/96 are inconsistent with the EC's obligations not to discriminate on the basis of field of technology, as provided by Article 27.1 of the TRIPS Agreement, because these Regulations only apply to pharmaceutical and agricultural products.

    • December 19, 1997, at the WTO:

      Canada - Patent Protection of Pharmaceutical Products, complaint by the European Communities (WT/DS114/1). This request, dated 19 December 1997, is in respect of the alleged lack of protection of inventions by Canada in the area of pharmaceuticals under the relevant provisions of the Canadian implementing legislation (in particular the Patent Act). The EC contends that Canada's legislation is not compatible with its obligations under the TRIPS Agreement, because it does not provide for the full protection of patented pharmaceutical inventions for the entire duration of the term of protection envisaged by Articles 27.1, 28 and 33 of the TRIPS Agreement. On 11 November 1998 the EC requested the establishment of a panel.

  • Israel
    • February 1998. Israel amends law to permit non-patent holders to manufacture and export patented pharmaceutical products prior to the expiration of the patent to seek foreign and Israeli marketing approval when the patent expires. This is similiar to Canadian legislation that it is a focus of a EU dispute before the WTO.
    • 1998. Israel Schacter. Amendment of the Israel Patent Law In Order To Provide for Non-Infringing Pre-expiry Exploitation of Patents and for Their Extension of Term.
    • May 1, 1998, USTR ISRAEL "SPECIAL 301" DECISION.

• March 10, 2003. Peg Brickley for the Scientist Magazine., Patent Rights Wrangle Puts Law In Question: Duke physicist fights to exercise rights to technology he designed.