Related defences

13.27 Some jurisdictions, including Australia, recognise other defences that may protect some forms of experimental or research use of patented inventions. These defences are discussed below and relate to the private and non-commercial use of a patented invention; and the use of a patented invention for regulatory review purposes (or ‘springboarding’). There is also an analogous provision with respect to plant breeder’s rights.

Private and non-commercial use

13.28 Article 27(a) of the CPC provides that the rights conferred by a community patent shall not extend to ‘acts done privately and for non-commercial purposes’.[45] As with art 27(b), discussed above, this provision has been incorporated into the national laws of the United Kingdom and other member States of the European Union.[46]

13.29 In Australia, a defence for private and non-commercial use of a patented invention is not expressly included in the Patents Act. However, the Act may imply such a defence on the same basis that the Act may imply an experimental use defence, namely, that the definition of ‘exploit’ imports a degree of commerciality.

13.30 There has been limited consideration of the ambit of the private and non-commercial use defence and exactly how it differs from the experimental use defence.[47] It appears, however, that a private use defence will apply only where activities involving the patented invention have not been carried out in public, are intended for the benefit of the person who has conducted those activities, and do not have a commercial purpose.[48] At least in the United Kingdom, even a possible commercial application of activities involving a patented invention has been held to preclude the application of the defence.[49]

Regulatory review

13.31 The experimental use defence is broad enough in some jurisdictions to cover some activities connected with regulatory review and approval processes, but in others it is not. Some jurisdictions have, therefore, enacted regulatory review or ‘springboarding’ provisions designed expressly to permit activities directed to obtaining regulatory approval.

13.32 In the United States, these provisions are sometimes referred to as the ‘Bolar exemption’, after a law that was enacted to overturn a case bearing that name.[50] In the Bolar case, the United States Court of Appeals for the Federal Circuit held that an experimental use defence did not entitle a generic pharmaceutical manufacturer to conduct experiments with a patented pharmaceutical in order to prepare a regulatory application to the United States Food and Drug Administration (FDA). Shortly after the Bolar decision, the United States Congress passed the Drug Price Competition and Patent Term Restoration Act 1984 (Hatch–Waxman Act) to overrule it. The relevant provision states it is not an infringement 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 or veterinary biological products’.[51]

13.33 Canadian legislation contains a broader regulatory review exception, the application of which is not restricted to approval processes for drugs or veterinary products.[52] New Zealand enacted a similar provision in 2002.[53]

13.34 In Australia, the Patents Act has included a regulatory review exception since 1999.[54] This provision is applicable only to patented pharmaceutical substances and only where an extension of patent term has been granted under the Act.[55] It is not an infringement if a person exploits a patented pharmaceutical substance solely for purposes in connection with obtaining regulatory approval for therapeutic use in Australia or any foreign country.

Plant breeder’s rights

13.35 An existing example of an experimental use defence in Australian intellectual property law can be found in the Plant Breeder’s Rights Act 1994 (Cth) (Plant Breeder’s Rights Act).[56] The High Court has held that plant breeder’s rights are, in effect, a form of patent right.[57] The Plant Breeder’s Rights Act provides in s 16 that any act done in relation to a plant variety covered by plant breeder’s rights does not infringe plant breeder’s rights if done:

(a) privately and for non-commercial purposes; or

(b) for experimental purposes; or

(c) for the purpose of breeding other plant varieties; …

13.36 There is very limited guidance on the scope of this provision, other than that based on patent law cases, referred to above.[58] It has been stated that ‘bona fide’ experiments on a protected plant variety—for example to discover if it resists a particular disease or can be cultured from tissue—are covered by the term ‘experimental purposes’, but that ‘the balance should fall on the side of the holder of the breeder’s right where the experiments are directed at commercial exploitation of the protected variety’.[59]

[45]Council Agreement relating to Community Patents No 89/695/EEC, 15 December 1989, OJ L 401/01.

[46] See, eg, Patents Act 1977 (UK) s 60(5).

[47] Organisation for Economic Co-operation and Development, Genetic Inventions, Intellectual Property Rights and Licensing Practices: Evidence and Policies (2002), 59.

[48] M Fysh, ‘Infringement, Experimental Use and Clinical Trials: The Experience of the United Kingdom and Ireland’ (Paper presented at Legal Issues in Exploiting Drug Patents in Europe, Licensing Executives Society Italy Conference, Milan, 12-13 December 2002).

[49]McDonald v Graham [1994] RPC 407.

[50]Roche Products Inc v Bolar Pharmaceutical Co 733 F 2d 858 (Fed Cir, 1984).

[51] 35 USC s 271(e)(1). Whether an activity is ‘reasonably related’ to seeking FDA approval has been narrowly interpreted in the case law. The legislative history of the Bolar exemption indicates that only a limited amount of testing to establish the bioequivalence of a generic drug substitute is permitted: S Michel, ‘The Experimental Use Exception to Infringement Applied to Federally Funded Inventions’ (1992) 7 Berkeley Technology Law Journal 369, 374.

[52]Patent Act 1985 (Canada) s 55.2(1).

[53]Patents Act 1953 (NZ) s 68B.

[54]Patents Act 1990 (Cth) s 78.

[55] See Ibid ss 70–79A.

[56] In Australia, it is possible to obtain dual protection over a plant variety using both the Patents Act and the Plant Breeder’s Rights Act. Intellectual property protection for new varieties of plants is required by the International Convention for the Protection of New Varieties of Plants, [2000] ATS 6, (entered into force on 1 March 1989).

[57] At least for the purposes of s 51(xviii) of the Constitution, which empowers the Parliament to make laws with respect to ‘patents of inventions’: Grain Pool of Western Australia v Commonwealth of Australia (2000) 202 CLR 479.

[58] For example, Monsanto Co v Stauffer Chemical Co [1985] RPC 515.

[59] J Lahore, Patents, Trade Marks & Related Rights: Looseleaf Service (2001), [29,090].