Malta's Bolar Exemption:

Pharmaceutical Companies setting up in Malta

Dr. Maria Chetcuti Cauchi co-authored with Silvana Zammit | 09 Mar 2020

Chetcuti Cauchi Advocates CCMalta default banner

The Origins of the Bolar Provision 

The Bolar Provision defines the circumstances in which the proprietors of a patent are precluded from preventing third parties from performing acts which are otherwise protected by patent law. 

The Bolar provision originated within the United States, by virtue of the judgment Roche Products v Bolar Pharmaceutical. This judgement limited the scope of the ‘experimental use exemption’ to the experimental use of a patented article for the sole purpose of ‘philosophical experiments', curiosity, or for mere amusement.

In response to this judgement,the US Congress introduced the Hatch-Waxman Act, which allowed the use of patented material for uses reasonably related to the development and submission of information pursuant to the regulatory laws concerning the use or sale of drugs. 

The Bolar Provision within Malta

The present position within Europe is that the nature of what constitutes experimental use is left to the discretion of each EU Member States.

Malta has fully embraced the extensive reach of the so-called Bolar Provision. Malta has been very pro-active in this regard; the Bolar Provision was implemented into Maltese law during 2003, prior to its accession in the European Union.

The Maltese Patent and Designs Act extends the exemption to purely experimental purposes and scientific research, acts done privately and for non-commercial purposes as well as to acts done for the development and presentation of information as required under Maltese or foreign legislation regulating the production, use or sale of medicinal or phytopharmaceutical products.

A brief comparative analysis of various EU member states serves to show that, whilst a few countries such as Poland have interpreted the Bolar provision in a wide manner similar to Malta, others have adopted a restrictive interpretation of the provision. For instance, the UK Patents Act 1977 qualifies ‘experimental purposes’ as being those’ relating to the subject-matter of the invention’.

In Monsanto v Stauffer, the Court held that tests conducted in order to demonstrate that a product or process works as claimed were held not to qualify as experiments under the exemption because they do not relate to ‘the subject matter of the patented invention’.

Under Maltese law experiments and scientific research per se are permitted; generic companies may carry out experiments and clinical trials for the purposes of obtaining regulatory approval prior to the expiration of the lifetime of the patent concerned.

Upon the expiration of the patent of a competitor’s product and the obtainment of the regulatory approval, a generic manufacturer may market his products without undue delay. In the light of the highly competitive nature of the pharmaceutical industry where time is of the essence, Malta’s positive approach towards this exemption the Bolar exemption has proved to be a significantly competitive edge over other countries which opted for a more restrictive approach.

The Impact of the Bolar Provision 

Considering the number of pharmaceutical companies which re-locate to Malta on an annual basis, it is clear that the Maltese interpretation of the Bolar provision has, and remains to be, a great advantage. Permitting generic companies to perform research tests and experiments without falling in the realm of patent infringement, has attracted key players.

The adoption of a broad interpretation of the Bolar exemption and having a strong Patent Legislation proves to be a prime source of attraction for Foreign Direct Investment and a positive incentive for innovation, whilst at the same time protecting brand owners against abuse.


Request More Information

Please send me legal and other updates

Key Contacts
Related Industry Groups
Related Services
Related Opportunities