Malta: Patent Law – An Update On Manufacturing / Research Opportunities In Malta For The International Generics Drugs Industry

Last Updated: 7 March 2017
Article by Antoine Camilleri

Most Popular Article in Malta, March 2017

Without doubt Malta offers significant opportunities for the generics drugs Industry and the evidence for this lies in the pharmaceutical patenting history of the country and in its legislative framework.

The following events have played a major role in the history of patenting in Malta, and have actually shaped the present scenario regarding generic drugs in the country.

1899 – The Industrial Property (Protection) Ordinance (Chapter 29 of the Laws of Malta) was enacted and this was the first piece of legislation that recognized the registration of inventions as patents in Malta. The effect of the law was territorial and the recognition, registration and protection of patents was dealt with by the law in just a few legislative provisions (the law in question catered also for trademarks and industrial designs).

1 June 2002 – The above-cited Ordinance was repealed and the Patents and Designs Act (Chapter 417 of the Laws of Malta) was brought into effect, as amended to date, and it is still the law in force in Malta which deals with patents. This Act is very detailed in nature and it provides for adequate measures which concern patentable and non-patentable inventions, the examination and grant process, the rights afforded to the owner of a patent (effects of patents), exploitation of patents, enforcement provisions concerning patents, and other provisions concerning the application and the registration process. It is to be noted here that Malta has always followed a patent registration system, rather than a patent examination system. To this end, the abovementioned Act is supplemented by the Patent Regulations (Subsidiary legislation No. 417.01) that were adopted also on 1st June 2002 and which mostly concern rules of procedure that are to be followed in the filing of patent applications and with other formalities which could be observed during and after the patent registration process.

1 January 2003 – the Patents (Plant Protection Products) Regulations (Subsidiary Legislation No. 417.02) and the Patents (Medicinal Products) Regulations (Subsidiary Legislation No. 417.03) came into force and provided legal recognition for supplementary protection certificates (SPCs) for plant protection products and for pharmaceuticals.

1 May 2004 – Malta joins the European Union

1 March 2007 – Malta joins the European Patent Convention (EPC) and the Patent Cooperation Treaty (PCT). On this date the Patent Cooperation Treaty Regulations (Subsidiary Legislation No. 417.04) and the European Patent Convention Regulations (Subsidiary Legislation No. 417.05) came into force. Both measures mainly regulate issues of procedure such as the validation of European Patents (EP) in Malta.

The above dates are important since, to a large extent, up till 1 May 2004 when Malta joined the EU and became part of a larger and more unified economic market, Malta was never chosen by the large foreign pharmaceutical companies as a country in which to register one's own pharmaceutical patents. Until this mentioned date of 1 May 2004, the Maltese Patents Register contained only around 2,500 patents, a sizeable number of which had already expired by the said date. Between the period 1 May 2004 and 1 March 2007, Malta experienced an increase in national patent filings, the filings generally covering all the sectors of industry (engineering, manufacturing and pharmaceutical sector patents) whereby the Patents Register increased by around an additional 2,000 patents (in the region of around 3 years).

Following Malta's accession to the EPC and the PCT, national patent applications virtually came to a standstill with only a few direct national filings observed every year. However, since 1 March 2007 up to the present date (beginning of the year 2017, i.e. a period of approximately 10 years in total), the Industrial Property Registrations Directorate (IPRD) of Malta received around 4,500 applications for EP validations and for the renewal of the national counterpart of those EPs granted at European Patent Office level and which designated Malta. The outlook for these latter type of applications is that they will continue to increase over time. As far as SPCs are concerned, the information which we have from the IPRD is that there were around 70 SPC requests since the year 2003.

The above-mentioned figures lead one to understand that a substantial amount of pharmaceutical compounds were never registered in Malta, in particular those that had to be filed by the year 2003.

One may state that, to a large extent, in particular up till 2004, Malta was "forgotten" by most of the major pharmaceutical companies, probably due to its small size and population. It is true that the amount of applications increased in the period 2004 up till 2007 (i.e. the interim period between Malta's accession to the EU and Malta's accession to the EPC and PCT), however, Malta never saw substantial filings of patent applications similar to the amounts which are ordinarily seen in other larger countries.

It is also important to note that the Patents and Designs Act, as referred to above, includes certain exceptions to the patent owner's exclusive rights which are highly relevant. The said exclusive rights and exceptions are found in Section 27 of the said Act and the relevant provisions are the ones as follows below:

"(1) Where the patent concerns a product, the proprietor of the patent shall have the right to prevent third parties from performing, without his authorisation, the following acts:

  1. the making of a product incorporating the subject matter of the patent;
  2. the offering or the putting on the market of a product incorporating the subject-matter of the patent, the use of such product, or the importation or stocking of such product for such offering or putting on the market or for such use;
  3. the inducing of third parties to perform any of the above acts.

(2) Where the patent concerns a process, the proprietor of the patent shall have the right to prevent third parties from performing without his authorisation, the following acts:

  1. the use of a process which is the subject matter of the patent;
  2. in respect of any product directly obtained by the use of the process, any of the acts referred to in subarticle (1)(b), even where a patent cannot be obtained for the said product;
  3. the inducing of third parties to perform any of the above acts."

The above-mentioned exclusive rights are subject to the following exceptions which include the 'experimental' and 'scientific research' exception, together with a 'Roche Bolar' exception:

"(6) Notwithstanding subarticles (1) and (2), the proprietor of a patent shall have no right to prevent third parties from performing the acts referred to in subarticles (1) and (2)(b) in the following circumstances:

  1. where the act consists of making or using such product for purely experimental purposes or for scientific research; ...
  1. when an act is done for purposes which can reasonably be related to the development and presentation of information required by the law of Malta or any other country that regulates the production, use or sale of medicinal or phytopharmaceutical products;"

The above patenting history and legislative framework therefore have placed the country in an advantageous position in the generics field, especially when compared with other countries, since most of the international pharmaceutical inventions in the period 1990 up to 2007 were never registered in Malta.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.