Globalising Intellectual Property Rights: The Trips Agreement by Duncan Matthews

Author:Duncan Matthews [Matthews, Duncan]
Language: eng
Format: epub
Tags: Political Science, General
ISBN: 9781134594962
Google: 65OzgDg9RDoC
Goodreads: 17494250
Publisher: Routledge
Published: 2002-05-23T00:00:00+00:00

Bolar exemptions and stockpiling

There are instances in which it is expedient for the United States to allow the European Communities to take the lead in WTO Dispute Settlement Proceedings for political and diplomatic reasons. The Canada–EC dispute is a case in point. On 19 December 1997 the European Communities and its Member States initiated a complaint against Canada concerning its obligations under Articles 27.1, 28 and 33 of the TRIPs Agreement45 and the incompatibility of Sections 55.2(1) and 55.2(3) of the Canadian Patent Act with the TRIPs Agreement. The lead taken by the European Communities, in preference to a complaint by the US, can be accounted for by the existence of the so-called ‘Bolar exemption’. This provision of US law made it politically unacceptable in domestic terms for the US pharmaceutical industry to make a formal complaint about the stockpiling of pharmaceutical products in Canada and expect that complaint to be taken up by the USTR. The disputed provisions of Canadian patent law in turn owed much of their origins to pressure from a new set of corporate actors. Canadian generic drug manufacturers such as Novafarm, which had been largely absent from the debate about the content of the TRIPs Agreement during its formative stages, now saw the potential of direct benefits from replicating and expanding upon the US Bolar provisions.

The Bolar provision is derived from the case of Roche v. Bolar,46 in which Bolar Pharmaceuticals Co. Inc. had been intending to introduce a generic version of a Roche pharmaceutical product into the United States as soon as the patent held on this product expired.47 Bolar carried out clinical testing of its version of the product while the patent held by Roche was still in force. The US Federal Circuit Court held that the exception to patent infringement for experimental use that had been allowed in earlier case law did not cover experiments where there was a clear commercial goal, as opposed to purely speculative research which was patent protected. The US Congress later overruled the decision in Roche v. Bolar in the Drug Price Competition and Patent Term Restoration Act of 1984 (the so-called Hatch–Waxman Act), which specified that it was not an infringement of a patent to make, use or sell 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 (see also Evans 1994: 148; Grubb 1999: 162). In the light the Hatch–Waxman Act, the Abbreviated New Drug Approval (ANDA) procedure allows generic companies to carry out testing at any time, regardless of patent protection on the original product, with regulatory approval being granted for the generic version of the drug on the expiration of the patent.

Following the Hatch–Waxman Act, generic drug manufacturers worldwide began to lobby other countries to introduce equivalent measures, with the implication that they would locate manufacturing facilities in countries with regulatory arrangements that were sympathetic to the idea of ‘Bolar exemptions’.48 It was against this background that the US approach has been taken a step further by Canada.

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