Bolar Provision: A Global History and The Future For Europe
The availability of pre-patent expiry provisions for working patents for the purposes of obtaining regulatory approval or other commercial purpose, generally in regard to pharmaceutical products, (sometimes referred to as Bolar provisions), varies throughout the world.
The situation was initially unclear in the USA, and the subject of litigation in the Roche-Bolar case decided in 1984 (Roche Products Inc v. Bolar Pharmaceutical Co. Inc. 221 USPQ 937 (Fed. Cir. 1984)). The Court held that exception for experimental use must be construed narrowly, and that experimentation for pure speculative research was not infringement, but that as soon as the experiments were directed to a clear commercial goal, then infringement occurred.
An ensuing compromise between R&D based and generic companies culminated in the Drug Price Competition and Patent Term Restoration Act of 1984 (known more familiarly as the Hatch/Waxman Act) in which Congress overruled the decision in Roche-Bolar, specifying that it was not an infringement to make, use, or sell a patented invention “solely for purposes reasonably related to the development and submission of information under a Federal law which regulated the manufacture, use, or sale of drugs.” Clearly pharmaceutical research is included in this definition. However it does not extend, for example, to agrochemical products.
However, for Europe the situation, until the emergence last year of Directive 2004/27/EC was less clear cut. The present position is that an experimental use provision does exist in most national laws, but the nature of what is experimental is left to the discretion of individual EU member states. Case law at present disallows the provision of samples in the UK and Netherlands during the patent period. Germany allows the working of patented pr ucts only if it is part of a general research investigation. In the UK and Germany, in litigation between Monsanto and Stauffer in 1985, Stauffer made extensive trials of a herbicide very similar to Monsanto’s patented Roundup. Although not literally falling within Monsanto’s claims the product was arguably close enough to be an infringement if sold commercially. The cou rts held consistently that the field trials were as much an infringement as commercial sales would have been.
“…trials carried out in order to demonstrate to a third party that a product works or, in order to amass information to satisfy a third party, whether a customer or a [regulatory body] that a product works as its maker claims are not, in my judgement, to be regarded as acts done ‘for experimental purposes’.”
Subsequent litigation introduced doubt into this narrow interpretation, especially as the judgement did not address the situation where experiments or trials may have a dual purpose, that of true experimentation and also that of submission to the authorities. A decision of the German Federal Supreme Court in Clinical Trials I, in 1995, resulted in the summary which essentially provided that a collateral non-experimental purpose does not prevent true experimentation from being non-infringing experimentation. However, this case did arise under special circumstances.
A subsequent decision, in 1997, in the German Federal Supreme Court concerned the protein erythropoietin in Clinical Trials II [1998]RPC 423. The court held,“the intention that is associated with an activity begun and carried out for research purposes cannot render such an activity infringing merely because the results of the research will not solely serve research purposes but above all will serve commercial purposes as well.” While the situation is not entirely clear it does appear that submitting the results of trials to the regulatory authorities does not render those trials unable to be the subject of the experimental use defence, provided that those trials really are experimental.
Italy allows testing during extended patent term (SPC). In Portugal the Ministry of Industry has indicated developmental work may be possible. Hungary has a Bolar provision in its patent law, and Poland and Slovenia have provisions in their draft laws.
Outside Europe the position is clearer. Canada, Japan, Israel, Australia and New Zealand all have some provision for pre-patent expiry activity. In Japan the Tokyo District Court, in Otsuka/Procaterol Hydrochloride 7430/1966 refused to consider testing as infringement, based on public policy considerations. In Australia the patent law was amended in 1998 to allow extension of term of pharmaceutical patents, but it was also enacted that not only in the extended period, but also in the main term of the patent from the day that the application for extension is granted, testing for commercial purposes will not be considered as infringement. In New Zealand, in December 2002, the Patents Act was amended by the insertion of new Section 68B, stating;
“It is not an infringement of a patent for a person to make, use, exercise, or vend the invention concerned solely for uses reasonably related to the development and submission of information required under New Zealand law or the law of any other country that regulates the manufacture, construction, use or sale of any product”.
Interestingly, this provision is not limited to pharmaceutical products. The existing law in Canada extends the provision to allow manufacture and stockpiling of a patented product prior to patent expiry.
The position in Europe has clarified considerably with the EU Directive 2004/27/EC which must be implemented in all member states by 30 October 2005. Article 10(6) of the Directive states,
“Conducting the necessary studies and trials with a view to applications of paragraphs 1, 2, 3 and 4 and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for those medicinal products.”
Paragraphs 1, 2, 3 and 4 define the regulatory requirements for obtaining regulatory approval for medicinal products.
What is not yet clear is what text will be used in each of the member states in implementing the Directive, how and when each member state will implement it, and how it will be interpreted. For example, there is some concern in the generic industry that the proposed implementation text in Germany omits the exemption for “consequential practical requirements”. In addition, while the type of studies and trials which would not be contrary to patent rights have been discussed, no list has been agreed at an EU level. What is certain is that the precise scope of Bolar in Europe will be a matter for some debate and no doubt litigation in the future
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