Introduction to Malta's Pharmaceutical and Biotech Sector
Malta has emerged as a significant hub for pharmaceutical and biotech companies, largely due to its robust patent protection regime and favorable legal framework. Here, we delve into the key insights regarding patentability, enforceability, and the scope of claims for biopharmaceutical patents in Malta.
Patent Protection Regime in Malta
Malta's patent law system offers strong protection to patent holders, granting 20 years of exclusive protection from the date of the patent application filing[1][2][3].
Novelty, Inventive Step, and Industrial Applicability
For a patent to be granted in Malta, the invention must meet the criteria of novelty, involve an inventive step, and have industrial applicability. This is in line with international standards and ensures that only innovative and practically applicable inventions are protected[5].
Biological Inventions
Maltese law also allows for the patenting of biological inventions, subject to certain ethical and moral considerations. This is crucial for biopharmaceutical companies that often deal with complex biological materials and processes[5].
The Bolar Provision: A Competitive Edge
Implementation and Scope
Malta has proactively implemented the Bolar Provision, even before its accession to the EU. This provision, originating from the US case of Roche Products vs. Bolar Pharmaceuticals, allows generic companies to conduct clinical trials and commercial testing for regulatory approval before the expiration of the original patent[1][2][3].
Permitted Activities
Under the Bolar Provision in Malta, generic companies can perform acts that would otherwise be protected by patent law, including:
- Clinical trials
- Commercial testing
- Acts done privately and for non-commercial purposes
- Acts for the development and presentation of information required under Maltese or foreign legislation regulating medicinal or phytopharmaceutical products[1][2][3].
Competitive Advantage
This broad interpretation of the Bolar Provision gives Malta a significant competitive edge over other EU countries with more restrictive approaches. It allows generic companies to prepare and launch their products immediately after the patent expiration, reducing time-to-market and enhancing competitiveness[1][2][3].
Enforceability of Patents
Legal Framework
Malta's legal framework is designed to protect patent holders effectively against third parties. The Maltese Patent and Designs Act ensures that patents are enforced rigorously, providing a secure environment for innovation and investment[1][2][3].
Retroactive Patent Registration
Maltese law does not allow for retroactive patent registration, which benefits pharmaceutical and biotech companies by enabling them to be among the first to register their patents in a highly competitive industry[1][3].
Scope of Claims
First or Further Medical Use
Malta follows the European Patent Convention (EPC) guidelines regarding the patentability of known substances for new medical uses. A known substance can be patented for a new medical use if the new use is novel and involves an inventive step[4].
Claim Formulations
- Use of a Known Substance: Claims for the use of a known substance in a new medical application are acceptable if the use is novel and inventive.
- Swiss-Type Claims: For applications filed after 29 January 2011, Swiss-type claims are no longer allowed; instead, claims must be formulated as "Substance X for use in the treatment of disease Y"[4].
Unity of Invention
Multiple independent claims can be allowed for different therapeutic uses of a known substance, provided each claim involves an inventive step over prior art[4].
Validation of European Patents
Process and Requirements
Malta allows the validation of European patents granted by the European Patent Office (EPO). For patents drawn up in French or German, an English translation must be filed. Patents in English are automatically valid, but require the payment of renewal fees to be registered in the Maltese Patent Registry[5].
Benefits for Biopharmaceutical Companies
Early Market Entry
The Bolar Provision and the efficient validation process for European patents enable biopharmaceutical companies to prepare for market entry well in advance, reducing the time gap between patent expiration and product launch[1][2][3].
Strong Patent Protection
Malta's robust patent protection regime ensures that innovators can safeguard their inventions, encouraging investment and innovation in the biopharmaceutical sector[1][2][3].
Compliance with International Standards
Malta's adherence to international patent conventions, such as the Patent Cooperation Treaty (PCT) and the European Patent Convention, ensures that industrial property rights are protected not only within Malta but also in other member or signatory countries[3].
Key Takeaways
- Strong Patent Protection: Malta offers 20 years of exclusive patent protection from the date of application filing.
- Bolar Provision: Allows generic companies to conduct clinical trials and commercial testing before patent expiration, giving Malta a competitive edge.
- Scope of Claims: Known substances can be patented for new medical uses if novel and inventive.
- Validation of European Patents: Efficient process for validating European patents, facilitating broader protection.
- Compliance with International Standards: Adherence to PCT and EPC ensures global protection of industrial property rights.
FAQs
What is the duration of patent protection in Malta?
Patent protection in Malta lasts for 20 years from the date of the patent application filing[1][2][3].
How does the Bolar Provision benefit generic pharmaceutical companies in Malta?
The Bolar Provision allows generic companies to conduct clinical trials and commercial testing before the expiration of the original patent, enabling them to launch their products immediately after the patent expires[1][2][3].
Can known substances be patented for new medical uses in Malta?
Yes, known substances can be patented for new medical uses if the new use is novel and involves an inventive step[4].
How can European patents be validated in Malta?
European patents can be validated in Malta by filing a validation application and providing an English translation of the patent documents if necessary. Patents in English are automatically valid but require the payment of renewal fees[5].
What are the benefits of Malta's patent regime for biopharmaceutical companies?
Malta's patent regime offers strong protection, allows for early market entry through the Bolar Provision, and ensures compliance with international standards, making it an attractive location for biopharmaceutical companies[1][2][3].
Sources
- Chetcuti Cauchi Advocates: Malta Pharmaceutical & Biotech Sector.
- Legal Malta: Pharmaceutical Companies in Malta.
- CCLEX Investment Migration: Bio-Tech & Pharma.
- European Patent Office: Guidelines for Examination - First or further medical use of known products.
- CSB Group: Patent Protection in Malta.
