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Europe to Join Japan and the US -- a Bolar Exemption in Europe?

The Problem of Further Innovation and Development During a Patent's Term

Around the world national patent systems are designed to protect innovation and reward innovators. Among many other challenges patent systems raise, one problem they face is reaching a resolution of the inherent conflict between their avowed intent of promoting innovation and the patent monopoly granted to inventors. In other words, what happens to innovations and developments based on the patented invention during the term of the patent monopoly?

Clinical Trials and Generic Drugs -- Japanese and US Resolutions

Developing pharmaceuticals for commercial exploitation is an expensive, time consuming and highly risky business. The pharmaceutical arena in particular brings the problem of further innovation and development into sharp focus in connection with development of generic drugs before patent expiry. Patent systems often allow scientific experiments as an exception to patent infringement but only some allow clinical trials to provide the basis for a generic drug's regulatory approval to escape infringement of an existing patent. Patent infringement caused by clinical trials can thus be one component risk of implementing a generic drug development program.

The Japanese Supreme Court resolved the problem by including such clinical trials for regulatory approval within the legislative experimental use exception[fn1] on the basis that to find infringement in such cases would ".. effectively extend the life span of a patent, a benefit that cannot be said to be intended by the Patent Act" [fn2].

The United States resolved this problem by introducing ‘Bolar provisions' into law[fn3] to ensure that such drug testing for regulatory approval would not be a patent infringement, reversing the decision in the case of Roche Products v. Bolar Pharmaceutical [fn4].

Clinical Trials in Europe

In order to highlight the similarities and differences in national European patent laws, we briefly compare the current law on clinical trials in two European countries, namely, Germany and the UK, before turning to the proposed developments at the European Union (EU) level.

Germany -- Clinical Trials for New Uses May Not Infringe

As in the patent law of most EU member states, in Germany acts done for experimental purposes which are related to the subject matter of the patented invention do not constitute infringement[fn5]. In Clinical Trials II [fn6] the German Federal Supreme Court held that, since the experimental use exception "restricts the experimental acts neither qualitatively nor quantitatively this means that studies and trials may represent purely scientific experiments or commercially oriented tests….It is not evident from the wording of the provision that it would exclude an economical orientation or commercial objective of the experimental acts." The court's decision reviewed the origins of the legislation in the Community Patent Convention and held that research with a patented pharmaceutical compound that was aimed at the identification of a new medical use was permitted, as was the use of the regulatory data obtained from such research[fn7]. The court noted that the scope of such research should not disadvantage the patentee because any inventions made would only result in a dependent patent which could only be used with license from the dominating patentee.

UK -- Clinical Trials for Generics Do Infringe

As in Germany, UK law also provides for a statutory experimental use exception to patent infringement for acts done "for experimental purposes relating to the subject matter of the invention"[fn8]. However, the UK courts have determined that this experimental use exception is not applicable to clinical trials conducted to provide data for regulatory approval. The leading case is Monsanto Co. v. Stauffer Chemical Co. [fn9] in which the Court of Appeal held that clinical trials were not exempt from patent infringement since they were not regarded as acts done for "experimental purposes." In this case the Court of Appeal dismissed an appeal against an interlocutory injunction granted to the plaintiff, Monsanto. The injunction restrained the conduct of field trials by the defendant, Stauffer, of a variant of Monsanto's patented weed killer. Stauffer was carrying out the field trials "in order to demonstrate to a third party (such as a regulatory body) that a product works as its makers claim" and these trials were thus not within the experimental use exception.

The Proposed Relaxation of EU Laws Relating to Clinical Trials -- a European Bolar Exemption

The European Commission's Draft Directive in relation to medicinal products[fn10] includes the proposed introduction of a "Bolar provision" into the laws of the EU Member States which would eliminate the risk that clinical trials to test a generic drug would infringe a patent. The current form of the relevant part of the Draft Directive is as follows:

"Conducting the necessary tests and trials with a view to application of [this Article] to a generic medicinal product shall not be regarded as contrary to patent rights or to supplementary protection certificates for those medicinal products."

The European Council's common position on the Draft Directive is expected later this year. It is too early to determine when the Draft Directive might be transposed into the EU Member States' national laws.

Unsurprisingly the proposed Bolar exemption has been generally criticised by research pharmaceutical companies and broadly welcomed by generics companies. However, it now seems a Bolar provision will be introduced in the EU, although the precise form it will take cannot be predicted. However it is worded, such an important change in the law applicable to generic drug development will very significantly alter the landscape for European generic drug development. Among the anticipated profound effects that such a Bolar provision would have, it is likely to result in earlier and more widespread post patent expiry generic exploitation across Europe.



1: § 69(1) Patent Law "... the effects of the patent right shall not extend to the working of the patent right for the purposes of experiment or research."

2: Japanese Supreme Court April 16, 1999, Ono Pharmaceuticals Co. Ltd. v Kyoto Pharmaceutical Industries, Ltd. Clinical Trials III noted in (1999) 30 IIC 448, 449.

3: The Bolar provisions were introduced in 1984 in 35 U.S.C. § 271(e)(1) which states that "[i]t 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."

4: 733 F. 2d 858, 221 U.S.P.Q. 937.

5: Based on Article 27(b) of the Community Patents Convention and enacted in Germany as section 11 No, 2 of the Patent Act.

6: Klinische Versuche (Clinical Trials) II. (BGH CASE XZR 68/94)

7: For assistance with interpretation on the relevant legislation, the German Federal Supreme Court considered the Community Patent Convention and concluded that:

  • research must aim to bring about new knowledge about the subject matter of the invention, including research about aspects of the invention that are uncertain;
  • the borderline is that the research must relate to the subject matter of the invention;
  • the research must not use the invention merely as a tool;
  • the research may not exceed the normal scope of research and may not aim at unreasonably interfering with the use of the invention by the patentee.

8: Again the law is based on Article 27(b) of the Community Patents Convention, enacted in the UK as section 60(5)(b) of the Patents Act 1977.

9: [1984] FSR 574 (CA).

10: The Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, 2002/C 75 E/216 Submitted by the European Commission on 26 November 2001, with European Commission reference COM(2001) 404 final - 2001/0253(COD).




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