IRACM Institut International
de Recherche
Anti Contrefacon
de Medicaments
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Intellectual Property

A patent is granted to products that deliver innovation. It can be obtained for a drug as it can be obtained for any other kind of invention. A drug patent gives its owner a commercial exclusivity for a period of 20 years from the day of the application’s filing. In fact, the actual period of protection for the drug itself will be much shorter, since after the filing of the patent, the drug will still undergo almost 10 years of further research and testing before a Marketing Authorization Application (MAA) can be commercially exploited.

Yet, an intellectual property approach to drug counterfeiting is justifiable for three major reasons: - – Sometimes the only illegal thing about a fake drug seized in a batch during a customs control for example is that it violates an industrial property right. Thus, in many cases, only the legal approach on the grounds of a breach of an industrial property right can start a judicial proceeding.

However, among the limits to the rights for brands, it may be noted:

ACTA members include the following countries: Australia, Canada, South Korea, the United Arab Emirates, the United States, Japan, Jordan, Morocco, Mexico, New Zealand, Singapore, Switzerland and the European Union.

the INTELLECTUAL PROPERTY

Intellectual property refers to creations of the mind: inventions, literary and artistic works, but also to symbols, names, images, designs and models used in commercial trade.

There are two branches to Intellectual property:

– Literary and artistic property, which applies to creations of the mind. On the one hand it covers copyright and concerns literary and artistic works such as novels, poems, films, musical works and works of art such as drawings, paintings, photographs, and sculpture; and on the other hand it covers other rights, that are similar to copyright, held by performing artists over their performances, by producers of sound recordings over their recordings, and broadcasters over their radio or television programs.

– Industrial property which protects technical discoveries (patents), ornamental creations (drawings and models) and distinctive signs (commercial trademarks, corporate signs, domain names, other names). With regard to drugs, it concerns above all the question of industrial property rights on trade marks and patents.

How is a drug protected by an industrial property right?

The drug is protected by industrial property law if a patent has been filed to protect it and if it possesses a distinguishing trade mark or a protected design and model.

To compensate for this, it is possible to obtain a “supplementary protection certificate” which extends the protection of the drug for up to 5 additional years.

The brand is defined as any sign (word, letter, logo, shape, colour, sounds, etc.) capable of distinguishing goods or services of a natural or legal person that can be protected by a trademark. In the pharmaceutical field, laboratory and drug names are protected by the law of trademarks. This law gives the holder an exclusive right to these names. These designations also allow the patient to recognize the product and thereby provide a guarantee of quality and safety. The brand differs from the international Non-proprietary name (INN), which is the chemical name of the substance. A list of INNs is provided by the World Health Organization. Therefore, a drug is identified by a unique INN, but may be sold under different brand names.

The design and model are defined as any object whose shape, configuration or an external effect gives it a new and specific physiognomy which distinguishes it from other objects. This characteristic allows the object to be protected over a specified period. In practice, the term design refers to a two-dimensional design and model a three-dimensional creation. Designs and models refer to graphics and shapes that are not directly linked to the manufacturing process.

These industrial property rights are recognized internationally and have been discussed under the TRIPS agreements (“Trade-related aspects of intellectual property rights”).

Various Intellectual Property offices register and ensure the protection of these rights at national, European Community (OHIM – Office of Harmonization for the Internal Market) or global level (WIPO – World Intellectual Property Organization).

How is industrial property a means of effectively combating the traffic of fake medicines?

“Drug counterfeiting is not a problem of intellectual property. It is first and foremost a problem of public health. This is the fundamental point. The problems of intellectual property may exist, but they are secondary to the problems of public health. » This sentence of Prof. Amor Toumi, Advisor to the WHO, recalls how intellectual property rights, alone, cannot apprehend the magnitude and the specificities of the issues raised by fake medicine trafficking which has become a global health scourge causing the death of millions of people. This is all the more true that the drug counterfeiters copy both brand name and generic products.

  • – Sometimes the only illegal thing about a fake drug seized in a batch during a customs control for example is that it violates an industrial property right. Thus, in many cases, only the legal approach on the grounds of a breach of an industrial property right can start a judicial proceeding.
  • – A fake drug without an active principle is a snare: it is only dangerous for health in that it deprives the patient of a real treatment or protection against a disease. Therefore as the manufacture and marketing of this kind of fake medicine is not specifically and legally recognised as punishable crime, the infringement of intellectual property remains one of the most reliable legal levers to stop the traffic
  • – The mechanism of suspension of release by customs authorities, as provided by articles 51 and seq. of the TRIPS Agreement is only possible in the case of suspected violations of intellectual property rights. As this mechanism has not been extended to false drugs, the Intellectual property approach is effective. It allowed customs to intercept more than 7 million fake medicines in Europe in 2009.

Let it be noted that the intellectual property rights defining the act of infringement do not make special provisions for drugs.

This means that violations of the right to intellectual property are independent of the issues related to the quality or safety of the product concerned.

However, some countries, such as France for example, apply heavier criminal punishments in cases where the infringement of patents, trademarks, designs or models endangers “human or animal health or security.”

In the combat against fake drug trafficking, intellectual property rights should be considered as one of several effective legal means available (alongside prosecution for crimes of deception and forgery, the illegal practice of pharmacy, misleading information and advertising, etc.) to help save lives, and not, of course, as an end in and of itself.

How are industrial property rights violated in the case of medicines?

Any infringement of an industrial property right is considered as counterfeiting. The manufacturing, marketing, detention, sale, offer for sale, import, export, use, production, reproduction, imitation, affixing, usage of an industrial property… without the consent of the owner of the copyright are considered prohibited by the law.

In the case of drugs, counterfeiting most often takes the form of brand reproduction, i.e. an identical reproduction of a branded product.

Sometimes, slight modifications or partial reproductions occur: the counterfeit is then an imitation leading to the likelihood of confusion in the mind of the public.

An infringement can also be the copy of a patent, which grants to its holder the monopoly to commercialise a product in compensation for the long years of research and the costs induced by its development. At the end of the period of protection, the patent falls into the public domain and becomes free of copyright.

What are the limits of industrial property rights with regard to medicines?

These limits may differ depending on the country and applicable regulations.

  • Comparative advertising and reference made to the brand. This refers to the objective comparison between goods or services of the same kind where either a trademark for goods, for a trade, for services, is quoted or represented or where a company name, business name or sign is quoted or represented. The compared goods or services must be of the same nature or meet the same needs or have the same objectives and the comparer must be identified.
  • The right of substitution and prescription under INN (International Non-proprietary Name which is the name of the molecule). Under this principle, the pharmacist may offer the client a generic drug in replacement of the medicine prescribed by the doctor. This right of substitution aims to reduce the cost of the prescription.

The limits for patents, include:

  • Acts for non-commercial and private ends;
  • Acts on an experimental basis;
  • The exceptions related to inventions concerning plants or animals;
  • Pharmaceutical preparations made using patent-protected drugs: preparations of medicinal compounds made by pharmacists on medical prescription, which are not made in advance and are for single use escape infringement laws. This exception allows pharmacists to continue to achieve their extemporaneous preparations and thus to freely practice their art;
  • The mechanism of the compulsory license: this device is provided for in the TRIPS Agreement. Despite the existence of a patent, which gives its holder a monopoly, the public authorities may permit third parties to manufacture the patented product or use the patented process without the consent of the proprietor of the patent. This concerns either compulsory licenses to supply the domestic market or, since 2003 and the Doha Declaration, compulsory licenses authorizing the manufacture for export (to countries with no production capacity).

In addition, some countries allow manufacturers of generic drugs to use the patented invention to obtain their marketing approval without the permission of the owner of the patent and before the patent’s protection has expired. Generic producers can thus market their products as soon as the patent expires. This provision is sometimes called the regulatory exception or the Bolar provision.

To conclude, nations that are behind schedule have until July 1, 2013 to put themselves into conformity with the TRIPS Agreement. However, under the Doha Declaration on the TRIPS Agreement and public health, this deadline is extended until 2016 for pharmaceutical patents.

Anti-Counterfeiting Trade Agreement (ACTA): a treaty to respond to global counterfeiting issues?

Initiated in 2008, ACTA or the Anti-Counterfeiting Trade Agreement is an ambitious project to obtain the signing of an international treaty to strengthen intellectual property rights and gain in efficiency in the fight against counterfeiting in all its forms.

According to the European Commission, these meetings aim to improve international standards to effectively combat large scale infringements of intellectual property law.

ACTA particularly aims to obtain the accountability of internet access providers, the creation of a new legal framework and a governing body which would be independent from the already existing international institutions (WIPO, ONU, etc.).

It was signed on January 26, 2012 in Tokyo by 22 Member States of the European Union.