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Last Updated: April 19, 2025

Malta Drug Patents


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Drug Patents in Malta and US Equivalents

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.
Patent Number Estimated Expiration Equivalent US Patent US Expiry Date Generic Name US Applicant US Tradename
P1012 ⤷  Try for Free 4963590 2007-11-27 carbidopa; entacapone; levodopa Orion Pharma STALEVO 100
P1012 ⤷  Try for Free 4963590 2007-11-27 carbidopa; entacapone; levodopa Orion Pharma STALEVO 125
P1012 ⤷  Try for Free 4963590 2007-11-27 carbidopa; entacapone; levodopa Orion Pharma STALEVO 150
P1012 ⤷  Try for Free 4963590 2007-11-27 carbidopa; entacapone; levodopa Orion Pharma STALEVO 200
P1012 ⤷  Try for Free 4963590 2007-11-27 carbidopa; entacapone; levodopa Orion Pharma STALEVO 50
P1012 ⤷  Try for Free 4963590 2007-11-27 carbidopa; entacapone; levodopa Orion Pharma STALEVO 75
P1012 ⤷  Try for Free 5112861 2009-05-12 carbidopa; entacapone; levodopa Orion Pharma STALEVO 100
>Patent Number >Estimated Expiration >Equivalent US Patent >US Expiry Date >Generic Name >US Applicant >US Tradename

Patentability, Enforceability, and Scope of Claims for Biopharmaceutical Patents in Malta

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

  1. Chetcuti Cauchi Advocates: Malta Pharmaceutical & Biotech Sector.
  2. Legal Malta: Pharmaceutical Companies in Malta.
  3. CCLEX Investment Migration: Bio-Tech & Pharma.
  4. European Patent Office: Guidelines for Examination - First or further medical use of known products.
  5. CSB Group: Patent Protection in Malta.

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