The Court of Appeal issued an interesting judgement on March 23rd, 2017, on the requirements for the granting of a supplementary protection certificate (SPC). The decision was published in the Industrial Property Bulletin on 19 June.
Alcon Laboratories Inc. had applied for SPC No. 576 for “nepafenac”, a non-steroidal anti-inflammatory drug contained in the medicinal product NEVANAC (a collyrium), invoking the European Patent No. 999825, regarding “ophthalmic compositions containing galactomannan polymers and borate” as the basic patent.
The Portuguese Patent Office (INPI) refused the SPC on the grounds that it did not meet all the requirements of Regulation (EC) 469/2009, namely that the product for which the applicant sought protection was not covered by a basic patent in force. In fact, from the INPI’s perspective, the core of the invention protected by the patent consisted of a composition comprising only the adjuvants - which cannot be protected by means of SPC -, being the addition of active principle(s) only an embodiment of the invention. The INPI further noted that neither in the description nor in the claims (interpreted inter alia in the light of the description of the invention, as required by Article 69 of the Convention and the Protocol) there was any reference to “nepafenac”.
Against that latter argument, the claimant invoked the guidance given by decision of the Court of Justice of the European Union in case C-493/12 (Eli-Lilly vs. HGS). The Office however, considered that contrary to what happened with the product that based the decision invoked (of the biotechnological type), nepafenac could be perfectly defined in a structural way. Furthermore, the Office added that even if the active principle were to be defined by a functional formula, it would always had to be concluded, in the light of the Eli Lily case, that the claims relate, implicitly but necessarily and specifically , to the active ingredient in question, which was not the case.
On appeal, the first instance court – the Intellectual Property Court – upheld the INPI's decision, basically reaffirming the examiner’s argumentation. The Court of Appeal would also do so with a more detailed reasoning.
The ensemble of the three decisions form an interesting reading for legal experts and are important for those who deal with SPCs, mainly because it involves a fundamental SPC topic and the application of the jurisprudence of the European Court of Justice. The core question is about whether a product is contained in the basic patent or not and more specifically when it is considered that the product’s definition (be it structural or functional) made in the claims specifically addresses, in an implicit but necessary way, the active principle to be protected. In this case the Courts made clear that the definition cannot be too generic, for example, made by reference to a too broad category (such as that of “anti-inflammatories”). The IP Court and Court of Appeal decisions follow another judgment of the IP Court published on November 2016, on a SPC for agalsidase beta where the Eli Lilly case was also relevant for the IP Court’s findings. Again, the IP Court confirmed refusal of protection to the SPC because it was considered that the active principle was not covered by the basic patent invoked.
According to the Ministry Decree No. 39/2017 new official fees are applicable in the Industrial Property Office of Mozambique as from 15 July 2017.
The last amendment of the official fees in Mozambique had been made in 2006. Therefore the new decree updates and increases the fees for the several registration actions regarding trademarks, patents, utility models, designs and the remaining industrial property rights.
Furthermore the new table of fees published by the Ministry Decree No. 39/2017 appears to simplify the calculation of the relevant items e.g. the application fee for trademarks is a single fee instead of a group of fees (request fee, publication fee, examination fee, etc.).
Some new specific fees are adopted for instances regarding the recordal of a change of representative (1500 MZN), requesting urgent certificates (4000 MZN whereas the normal certificate fee will be 1275 MZN), requesting patent substantive examination (10000 MZN) and requesting the conversion of patent into utility model (3000 MZN).
Portugal has stepped forward to house the European Medicines Agency (EMA) currently located in London, once Brexit becomes a reality. “Portugal has technical, scientific and regulatory conditions to receive the Agency" said recently the Portuguese Health Minister Adalberto Campos Fernandes during a visit to the EMA’s headquarters in London.
The Minister highlighted the merits of Lisbon promising the national commitment to a rapid transition that would minimize the impact on the regular activities of the EMA. “This is a logistics operation of many thousands of people. What the Agency wants is a good building, with good conditions and space to work. This is the easiest to do. But in 30 days people have to be accommodated, the kids ' school must be set and the employability for spouses/partners. There has to be a package of integration, to make life easier.”
The Minister considered that “the climate, the cost of accommodation, the existence of international schools and infrastructures in Portugal are strong arguments”, believing that it will not be easy to find equivalent conditions in other cities, namely the combination of life quality and cost of living itself, such as Lisbon provides. Other strong advantages of Lisbon are its hotel capacity, cosmopolitan culture and overall safety.
The importance of being EMA
The EMA acts as the regulatory agency deciding if pharmaceutical products are safe for the European single market as well as in the countries of the European Economic Area. Set up in 1995, EMA employs about 900 highly skilled staff, making it one of the biggest EU agencies. With its annual budget of €300 million and some 65,000 visitors to more than 500 international meetings every year it is expected that the relocation of EMA brings a positive effect for any country’s medical and pharmaceutical industry. The decision on where to move EMA is a political one and will be made by the European Council, presumably until 2019.
A very lively competition for the EMA relocation after Brexit is already in place. Other countries such as the Netherlands, Germany, Ireland, Sweden, Austria, Denmark and Spain are preparing to make formal bids for the EMA. In addition to Portugal, according to the information known, for over 13 countries that have also publicly expressed their interest in hosting the headquarters of the EMA. The Portuguese Minister, however, is optimistic: “Portugal and the Portuguese have come to give evidence of their resistance, resilience and competence”.
IP STARS 2017 has listed Simões, Garcia, Corte-Real & Associated as a notable firm in "patent prosecution", "trademark" and "contentious trademark prosecution" and distinguished João Luís Garcia on an individual level.
IP STARS 2017 is an international ranking of intellectual property professionals annually organized by the well-known Intellectual Property magazine Managing Intellectual Property.
On 15 March 2017 the Industrial Property Office of Mozambique has issued a notice which confirms applicability of the 11th Edition of the Nice Classification in said country. The Nice Classification is an international classification of goods and services applied for the registration of marks which was established by the Nice Agreement (1957).
The 11th edition of the Nice Classification came into force on January 1, 2017 and is applied in Mozambique as from 1 April 2017.
A new Industrial Property Code is in force in São Tomé and Príncipe since 9 February 2017 (Decree-Law No. 23/2016, dated February 9, 2017).
The new law makes an extensive revision of the IP law that existed for more than twelve years in Sao Tome e Principe (Law No. 4/2001, of 31 December and Decree 6/2004 of 30 June) and adopts many concepts and solutions that are enshrined in the current Portuguese law and in European law. Among the changes introduced by the new law we point out the following:
In the area of patents
In the area of trademarks
Louis Azzaro BV prevailed in a cancellation case against Nature Up, EURL holder of an international trademark AZZARO for tobacco, ie cigarettes, cigars and pipes, smokers articles, ie matches, lighters, boxes for cigarettes and cigars, cigars and cigarettes cases, in class 34. AZZARO was registered for class 34 goods in Portugal since 2004.
On 19-Nov-2014 the owner of the well-known perfumery and couture brand AZZARO requested cancellation of the identical mark in class 34 on grounds of non-use. The IP Office rejected the cancellation because the holder of the challenged mark submitted evidence that the mark had been used through a licensee who had paid royalties at least until 31-Dec-2009. On appeal to the Intellectual Property Court the Office decision was confirmed.
The problem was that although there was evidence that the mark had been used through a licensee the license agreement was not recorded at the IP Office. The Court of Appeal, in its judgement published on 20 February 2017, found that the entry of the license in the Register was essential since the law recognizes only the use made through a licensee with a "duly recorded" license. Furthermore the court noted that the law establishes that a license may only have effect vis-à-vis third parties after the date of recordal. With no further queries, the court reversed the Office decision and ordered cancellation of the international mark on grounds of non-use.
Unfortunately the court gave limited explanations for its findings. A relevant point which appears to have remained unexamined by the court was that Nature Up, EURL alleged “proper reasons for non-use” since 2010 in view of the fact that the licensee had been judicially notified to cease and desist the use of the mark AZZARO under penalty of a fine. The Court of Appeal deemed that this was not relevant although the IP Office and 1st instance court had considered that such circumstance qualified as a “proper reason” to non-use.
On 14 February 2017 our Lisbon office welcomed 24 graduate students in Law and ICT (information and communication technologies) at the University of Groningen in the Netherlands for a one day workshop organized by SGCR.
The topics focused by various SGCR speakers were intellectual property in Portugal, the IP national and international legal framework, with a particular focus on patents, utility models, trademarks, appellations of origin and means of enforcement.
The work was followed by an interesting presentation and tasting of Portuguese wines and cheeses with appellation of origin.
The international specialized magazine World Trademark Review has again given its maximum classification ranking – gold – to Simões, Garcia, Corte-Real & Associados in 2017. Individually, João Luís Garcia and António Corte-Real were distinguished as 2017 recommended trademark experts.
The WTR 1000 research directory, which focuses exclusively on trademark practices and practitioners, has established itself as a definitive resource for those seeking legal trademark expertise.
The WTR 1000 identifies the trademark industry's leading lights in 72 jurisdictions around the world.
The Decree Law 5/2017, of 6 January, approves the general principles of advertising for medicinal products and medical devices based on the European Commission guidelines established on the List of Guiding Principles Promoting Good Governance in the Pharmaceutical Sector. The principles are core ethical values for all stakeholders which aim at contributing to ensure good governance in the Health System.
According to the Decree Law 5/2017, companies that produce, distribute or sell medicinal products or medical devices should observe the principles of integrity, respect, responsiveness, accountability, moderation, transparency and collaboration.
This new law also provides for specific rules for entities of the National Health Service (NHS) and the Ministry of Health (MS), concerning the promotion, fund raising and receiving of benefits from suppliers of goods and services in the areas of drugs, medical devices and health technologies, equipment and services in the area of IT or other related matters. Exceptionally NHS and MS bodies may receive benefits from suppliers provided that such benefits are proven to not compromise their impartiality and exemption or have been duly authorised by the MS.
The new law comes into force on 5 February 2017.
On 15 December 2016 the TM Office of Mozambique has issued an official notice providing clarifications on the requirement to file declarations of intention to use a mark (DIU) and the relevant deadlines.
1- The requirement to file the DIU applies to both national and international registrations designating Mozambique. For such purpose the holder must submit an appropriate form in Portuguese directly to the TM Office of Mozambique and pay the prescribed fees.
2- Concerning national trademark registrations the initial DIU should be filed 5 years after the application date. The subsequent DIU shall be filed 5 years after the renewal date. No DIU is required on the renewal date.
3- Concerning international trademark registrations the following rules apply:
(a) The initial DIU must be presented 5 years from the date the TM Office of Mozambique is notified of the international registration or the subsequent designation.
(b) Where the TMO of Mozambique is notified of a subsequent designation less than 5 years before the due date for renewal, the DIU must be submitted within 5 years from the date of renewal.
(c) The subsequent DIU shall be filed 5 years after the renewal date. No DIU is required on the renewal date.
(d) In the instance of international registrations covering several classes the official fee will apply per class.
4- The DIU may be filed 6 months before the above-mentioned 5 year anniversaries, but at the latest of 6 months after the said anniversaries.
The notice brings no new developments regarding national registrations however as to the international trademark registrations this new official interpretation of the Office involves some important changes:
- According to the Office of Mozambique the relevant date for counting the 5 year period is from the date when WIPO notifies the TMO and not from the date of the international registration.
- In the instance of a DIU for international registrations protected in several classes of goods or services the official fee will be charged per each class. Until now only one fee per registration was applied. This is a change of practice that appears to have the purpose of harmonization with national trademark registrations which allow only a single class.
The Macao Economic Services and Macao Chain Stores and Franchise Association signed an agreement to support the setting up of a service platform to assist local small and medium-sized enterprises in registering their trademarks in the Mainland.
The platform provides free information and consultancy services concerning trademarks in China, application procedures, agent referrals and assistance in preliminary contacts. The “Chinese Trademark Registration Information Centre” of Macao Chain Stores and Franchise Association was officially opened on 22 August 2016.
On 28 November 2016 the UK government announced that it will ratify the Unified Patent Court Agreement and will work with the Preparatory Committee to bring the Unified Patent Court (UPC) into operation as soon as possible. The information was given by the UK’s Intellectual Property Minister Lady Neville-Rolfe at a meeting of the EU’s Competitiveness Council.
This announcement follows after months of uncertainty since the United Kingdom voted in favour of Brexit last June. It was thought that the Brexit vote would significantly delay the implementation of the UPC and the unitary patent effect because the UK’s ratification of the UPC is an imperative step in bringing the system into force. This due to the UK being one of the three Member States that will have the highest number of European patents on the relevant date – the other two States being France (ratified) and Germany (yet to ratify).
In fact, with the UPC comes the recognition of a supranational court with the power to refer questions of law to the Court of Justice of the European Union. Therefore, and after “Brexit is Brexit”, it seems somewhat politically unjustifiable for the UK to ratify the Agreement even though the ratification is most welcome from a business perspective. As Lady Neville-Rolfe has reminded, with the new regime, British businesses “will be able to protect and enforce their patent rights across Europe in a more streamlined way”. Furthermore, it is not irrelevant that the UPC’s Central Division branch devoted to chemistry and life sciences will be located in London and is worth as much as £200m namely for the legal and IP professionals.
Waiting for Germany
As the UK ratification formalities appear to be relatively easy to conclude in the near future, Germany will in fact be the country with the power to decide if and when the UPC becomes a reality as a total of 11 countries, including France, have now ratified the Agreement and at least 13 States are necessary.
The ratification by Germany is not expected to be difficult or delayed. However the political context is evolving constantly. It is expected that the UK will trigger article 50 of the Treaty of the European Union in March 2017. Besides, Lady Neville-Rolfe has warned that “the decision to proceed with ratification should not be seen as pre-empting the UK's objectives or position in the forthcoming negotiations with the EU”. It is virtually impossible to anticipate how Brexit would be reflected in a running and stable UPC system as a lot will depend on the UK’s objectives in their negotiations with the EU, which have yet to start. Consequently the next move could very well be Germany delaying ratification until the Brexit negotiation process is unveiled. In any case 2017 will undoubtedly be a very interesting year for the future of patent law in Europe.
The Portuguese Government has amended the tax rules applicable to corporate income deriving from patents and other industrial property rights. The new law – Decree Law 47/2016, of 22 August – is expected to meet the requirements agreed upon in the European Union (EU) and the Organization for Economic Cooperation and Development (OECD) for combating “erosion of the tax base and the transfer of profits” (tax avoidance strategies, in other words) usually known by BEPS project (Base Erosion and Profit Shifting).
Many countries have established special tax regime for intellectual property revenues (known as “patent box”, “IP box” or “innovation box”), for example, a reduced rate of tax on revenue from IP licensing or the transfer of qualified IP. The Patent Box regime was first introduced in Ireland, in 2000, and has since been introduced in many EU Member States, including the United Kingdom, France, Belgium, Hungary, Luxembourg, Netherlands, Spain, and Italy. While a patent box is considered positive as it may help to incentivize and increase innovation and growth strategies the regime should not encourage companies to shift profits from the location in which the value was actually created to another location where they may be taxed at a lower rate.
BEPS requires that these regimes only grant preferential treatment to income derived from substantial activities effectively carried out by the taxpayer obtaining the benefit. This has been achieved through the adoption of the “nexus” approach which is used to assess whether or not there is substantial activity in IP regimes. Such discussion at international level has resulted in the “Modified Nexus Approach” which requires a nexus element to be incorporated into all IP tax regimes. Under this methodology on a basic level, a direct connection between the patent box benefit and the R&D spending is required.
The new law establishes a transitional regime applicable to patents and companies already benefiting from the old incentive regime, which is repealed from 1 July 2016, safeguarding the application of the same until 30 June 2021.
All patents filed by June 30 will be eligible for the regime under the existing rules whereby companies can enjoy reduced taxation of income deriving from patent transfer or licensing contracts. We note that the existing rules as well the new law apply only to “patents” (utility models are not mentioned although foreseen in Portuguese IP law) or “industrial designs or models” (currently named designs or models).
All patents filed after June 30 will be subject to the new rules.
As from 5 August 2016, the search reports prepared by the Patent Office (INPI) in the scope of provisional patent applications (PPA) are to contain only the results of the state of the art search carried out, with the identification of the documents found which are considered most relevant, eliminating the “comments made by the examiner”.
This amendment is intended to “minimize the impact” of the backlog in the area of inventions and reduce delays caused by a shortage of examiners.
The national law does not specifically provide which elements a search report must contain. However, recently the INPI had been following the format of the European Patent Office search reports, in which the examiner prepares a Written Opinion that provides a detailed explanation of the reasons that led to the identification of the documents referred to in the report. In practice, the Written Opinion is a detailed analysis of the potential patentability of the invention, and is therefore an important element of assessment of the applicant.
The elimination of the examiner’s comments – which currently affects only the search reports of the PPP and not the search reports under the normal application procedure – reduces the information and explanations provided to the PPP’s applicant, making it more difficult to assess feasibility of the conversion into a normal patent application and ultimately the likelihood of final grant of a patent.
In addition to this change, state-of-the-art search services will be suspended by INPI, apparently for the same reasons, as from August 30 2016. This concerns assisted search services, with the support of an examiner and not based on an application for a patent or utility model. INPI says it intends to resume this service as soon as possible. Alternatively inventors may of course use private search services.
The Industrial Property Office of Portugal (INPI) and the Office of Quality Management and Intellectual Property of Cape Verde (IGQPI), have signed a Memorandum of Understanding which entered into force on 18 March 2016.
The Memorandum reinforces the bilateral cooperation between Portugal and Cabo Verde in the field of Industrial Property and shall be implemented in the following technical areas: (a) Training of human resources; (b) Cooperation on the study of cases of major complexity on the granting, renewal and revocation of IP rights; (c) Cooperation on examining applications for the protection of patents and utility models, supplementary protection certificates and topographies of semiconductor products; and (d) Exchange of information and documentation.
On June 24, 2016 the referendum results in the UK were in favor of leaving the EU. It is an unprecedented situation that potentially affects all fields governed by European Union law. At this point there is still a great uncertainty on what are the following steps.
1. The decision to leave the European Union is not an automatic consequence.
For any such decision materializes, the specific procedure laid down in Article 50 of the EU Treaty will have to be observed. First, in accordance with Article 50, the Member State which decides to withdraw from the Union must formally notify its intention to the European Council. Secondly, the EU and that Member State will have to negotiate and conclude the withdrawal agreement, which will establish the framework for its future relations with the EU. To this end, the Council shall take a decision to authorize the opening of negotiations, nominating the Union’s negotiator or the leader of the negotiating team. The final text of the withdrawal agreement must be approved not only by the Council (by a qualified majority) but also by the European Parliament.
2. Leaving the European Union is a lengthy process.
According to the abovementioned Article 50, the Treaties only cease to apply to the State in question from the date that the withdrawal agreement enters into force or, failing that, two years after notification of the intention to leave. Considering the fact that the situation is unparalleled and involves complex negotiations, the whole process could take more than two years. The European Council, with the agreement of the Member State concerned, could decide unanimously to extend this period. This means that the practical implementation of an EU exit may take more than two years, either because all of the parties have agreed as such and/or the deadline is extended by the Council. Until the actual date of departure of the EU, all EU law, including primary and secondary legislation, will continue to apply as normal in the UK.
3. Consequences in the area of intellectual property.
This is a first analysis of the consequences of a possible exit from the UK in the intellectual property field, where inevitably there will be profound changes due to the existence of unitary rights regulated uniformly throughout the EU.
Trademarks can be protected in the UK by a national or international registration (Madrid system), or through the European trademark registration (EUTM) and there will be no immediate change in relation to the registration of EUTMs or the legal enforcement of European trademark rights in the UK. However, the EUTMs depend on European regulations that will no longer apply as from the UK’s departure date. One obvious consequence will be that the registrations of EUTMs applied for after the departure date may not take effect in the UK. As to the registrations of EUTMs that are granted or applied for before the date of UK’s departure their future is still uncertain. It is likely that there will be a legal mechanism to allow the conversion of EUTM to national trademarks, keeping the original priority date of EUTM. In this case, the converted marks would be subject to the national law of the United Kingdom, implying in particular that the genuine use of the mark in another EU country will not be enough to maintain the trademark right in the UK. The transition of existing or pending EUTMs will certainly be one of the topics to deal with in the withdrawal agreement.
The protection of registered and unregistered Community designs will also cease to apply in the UK on the departure date. It is uncertain what will be the status of existing Community design rights on the departure date. It is likely that there will be a transitional solution similar to the one which will apply to EUTMs.
Until the transition rules are defined and in order to avoid legal uncertainty, it is appropriate to consider the protection of trademarks or designs in the UK at a national level, namely using the WIPO international registration systems.
Brexit will have no impact on European patents since the European Patent Convention is a separate international treaty and not EU law. As usual, the European Patent Office will continue to grant European patents that can be validated and enforced in legal proceedings before the UK courts.
The Unified Patent Court and the Unitary Effect
The legislative package which forms the basis for the unitary effect of European patents in the EU and the establishment of the Unified Patent Court (UPC), and was estimated to enter into operation in 2017 is now affected by major uncertainties. The process to ratify the UPC Agreement was underway in the UK but now appears unlikely to occur due to political constraints arising from Brexit. It is more likely that Brexit would, at the very least, involve amending the UPC agreement and postponing the whole project for several years.
If it is confirmed that European patents may not have unitary effect in the UK and that the UPC’s jurisdiction does not extend to the UK, it will strongly affect the interests and feasibility of the Patent Package, since the UK is a substantial part of the protection strategy of European patent owners (with approximately 50% of European patents being validated only in the UK, Germany and France).
Brexit will not immediately affect the area of copyright since there are no uniform EU rules for copyright. Nevertheless the UK’s copyright law is in many aspects harmonized by European directives and case law of the European Court of Justice. Harmonization with the current EU legislation will remain as long as the British legislature does not introduce any changes. However, the UK will not be able to refer questions of interpretation to the European Court of Justice and of course where the EU adopts new directives the UK will no longer be obliged to implement them.
We are very pleased that our partner João Luís Garcia was listed as an IP STAR, by the magazine Managing IP. The list mentions highly recommended trade mark practitioners based on market feedback and other independent information obtained by a team of researchers.
Furthermore we are also glad to report that our partner António Corte-Real was listed by IAM Patent 1000 as a world leading patent professional. The IAM Patent 1000 is a directory exclusively dedicated to identifying the world’s leading patent services providers. The extensive research process for the guide was conducted over several months by a team of full-time analysts, and involved more than 1,500 interviews with patent specialists across the globe.
In April 2016 INFARMED started publishing a set of Therapeutic Recommendations (TR) seeking to contribute to rationalize and increase the quality of medical prescription. The TRs will be published on a regular basis and shall focus on particular areas such as those where new scientific evidence arise or specific treatment trends that could be improved. The first TR covers the prescription of statins.
Statins are indicated for the treatment of hypercholesterolemia (high cholesterol), for the prevention of cardiovascular diseases associated to atherosclerosis. The ability to reduce total cholesterol and LDL-c differs between the various statins and depends on the dose administered. According to the TR issued by Infarmed:
- multiple studies have made it possible to establish the equivalence of LDL-c reduction of statins;
- the option of prescribers for statins that have generics reduces costs for the patient and for the Health System maintaining the same therapeutic efficacy. In particular, if half the patients currently treated with rosuvastatin and pitavastatin are treated with other generic drugs statins it would be possible to obtain savings of about 25ME in a total of 119ME spent in 2015 (over 13ME for patients and the remainder to the Health System).
In its judgment of 4 May 2016 (case C-547/14), the European Union Court of Justice (EUCJ) has clarified several questions concerning the Directive 2014/40/EU on the manufacture, presentation and sale of tobacco and related products. That directive provides in particular for the prohibition from 20 May 2020 of the placing on the market of tobacco products with a characterising flavour (namely menthol cigarettes) and for the standardisation of the labelling and packaging of tobacco products. In addition, it introduces special rules for electronic cigarettes. Poland, supported by Romania, challenges before the Court of Justice the prohibition of menthol cigarettes (Case C-358/14). In this case (C‑547/14) the questions were submitted by the High Court of Justice of England and Wales, Queen’s Bench Division (Administrative Court), in the context of a preliminary ruling concerning the interpretation and validity of a number of provisions of Directive 2014/40/EU. The ECJ examined several questions which raised doubts on the validity of new rules adopted in this Directive.
General prohibition of flavored tobacco products
The EUCJ confirmed the validity of Article 7 of Directive 2014/40, which prohibits the placing on the market of tobacco products with a characterising flavour, namely menthol cigarettes. The EUCJ found there were no grounds for invalidation since the Directive takes the view that those products could facilitate initiation of tobacco consumption or affect consumption patterns, which is also the view of the guidelines of the World Health Organisation Framework Convention on Tobacco Control (FTCT). Furthermore, according to the EUCJ, the EU-wide prohibition is an adequate way of “removing divergences” between the national rules concerning the composition of tobacco products (eg, different lists of permitted or prohibited flavourings), or preventing those rules from developing in divergent ways. The Court found also that the prohibition does not violate the proportionality principle. The prohibition does not go beyond what is necessary since the alternatives do not seem to achieve the objective sought.
Restrictions to product labelling
Another relevant question is Article 13(1) of Directive 2014/40 which prohibits, in essence, the inclusion on the labelling of unit packets and on the outside packaging, as well on the tobacco product itself, of any element or feature that is such as to promote a tobacco product or encourage its consumption. The elements and features that are prohibited may include texts, symbols, names, trademarks, figurative or other signs. The Court found, that the prohibition laid down in Article 13(1) is such as to protect consumers against the risks associated with tobacco use, and that prohibition does not go beyond what is necessary in order to achieve the objective pursued, even when elements and features forbidden include factually accurate information. According to the Directive’s recital 25 the mere indication of the emission levels for tar, nicotine and carbon monoxide on unit packets of cigarettes could be misleading, even when accurate, since “it leads consumers to believe that certain cigarettes are less harmful than others”. Consequently for example labelling elements which refer to taste, smell, any flavourings or other additives, or which resembles a food or a cosmetic product, or suggests that a certain tobacco product has improved biodegradability or other environmental advantages, are not allowed even when factually accurate and true.
Labelling and packaging standartisation
The Directive includes various rules concerning the labelling and packaging of tobacco products which relate, in essence, to the integrity of health warnings after the packet has been opened (Article 8(3) of Directive 2014/40), to the position and minimum dimensions of the general health warning and the information message (Article 9(3) of the directive), to the minimum dimensions of combined health warnings (Article 10(1)(g) of the directive) and to the shape of unit packets of cigarettes and the minimum number of cigarettes per unit packet (Article 14 of the directive). The EUCJ also confirmed validity of said provisions noting that although those requirements may, by their very nature, to some extent increase the similarity between tobacco products, the fact remains that they concern only certain aspects of the labelling and packaging of those products and therefore still allow for adequate opportunities for product differentiation.
As to the requirement of health warnings in the form of messages and a corresponding colour photograph covering 65% of the external front and back surface of each unit packet the EUCJ ruled that that the EU legislature was based on criteria deriving from the FCTC (requiring health warnings to cover ‘50% or more’) and acted within the bounds of its broad discretion and also in view of an high level of human health protection.
Implementation of Directive 2014/40 in Portugal
The Directive 2014/40 on the manufacture, presentation and sale of tobacco and related products was implemented by Law 109/2015 dated 26 August 2015 which amended the Tobacco Prevention Law (Law 37/2007, of 14 August 2007). Law 109/2015 is generally applicable as from 1 January 2016.
The primary tobacco prevention and control law for Macau is Law 5/2011 which governs, among other things, smoking free environments, tobacco advertising, promotion and sponsorship, and tobacco packaging and labeling. Macau, as Special Administrative Region of China, is bound by China’s ratification of the WHO Framework Convention on Tobacco Control China became a Party to said treaty on January 9, 2006.
Between January 1 and March 31 2016, according to the Health Service authorities, 89249 tobacco control inspections were carried out in establishments making up an average of 981 inspections per day. During this period, authorities found 1965 cases of illegal smoking and 4 cases of illegal sale of tobacco products which did not meet labeling standards. The majority of illegal smoking cases (58% of which involved Macao residents and 37% tourists) resulted in the application of a fine.