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Recently, the U.S. Food and Drug Administration (“FDA”) released two sets of guidance surrounding how pharmaceutical, medical devices and prescription drug companies should utilize social media platforms, particularly those like Twitter with limited character space, in order to effectively provide information on products to consumers.  Specifically, the FDA is concerned with accurately regulating communications of medical devices and prescription drug products in terms of the benefits and risks associated with their usage.  However, a #FDAMedia post on Twitter dated June 27^th, approving a new product to treat diabetes, “a rapid-acting inhaled insulin”, appears to follow none of the newly conceived guidance.

The new set of media guidance, which goes as far as to provide “Twitter Rules”, reminds the Regulated Entities that “beneficial claims in product promotion should be balanced with risk information (U.S. Department of Health and Human Services Food and Drug Administration, Guidance for Industry Internet/ Social Media Platforms with Character Space Limitations- Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (June 2014).”  A thorough examination of the guidance reveals that Regulated Entity’s should qualify with the following criteria (Id., page 5 and 6):

• Be relevant and responsive to the misinformation;
• Be limited and tailed to the misinformation ;
• Be non-promotional in nature, tone and presentation;
• Be accurate;
• Be consistent with the FDA-required labeling for the product;
• Be supported by sufficient evidence, including substantial evidence, when appropriate, for prescription drugs;
• Either be posted in conjunction with the misinformation in the same area of forum (if posted directly to the forum by the firm), or should reference the misinformation and be intended to be posted in conjunction with the misinformation (if provided to the forum operator or author); and
• Disclose that the person providing the corrective information is affiliated with the firm that manufactures, packs, or distributes the product.

The #FDAMedia tweet, which reads “FDA approves Afrezza, a rapid-acting inhaled insult to treat diabetes go.usa.gov/97P9” does not hold any risk information and the generic and chemical name is also not noted.  Mark Senak of Fleishman-Hillard’s Washington, D.C. office, who is the blog author of Eye on FDA commented that the, “FDA is not so contrained when it sends out news of its own,” which appears to be an accurate statement concerning this case (“To Tweet or Not to Tweet? Or Even Retweet? FDA, Tweeting and Twitter”).

In the future, it should be expected that the FDA will uphold and abide by its own guidance when posting on social media platforms, or else the expectation that companies will follow suit, is not a realistic one.

The Hamon law of March 17, 2014 on consumption came into effect on June 13 of this year. This law has been transposed from a European Directive of 2011 that aims to enhance consumer protection.

A summary of the changes brought about by this law:

According to the Hamon law, a consumer should be provided with a number of information about his order on a «durable medium» after executing the contract. In practice, this concerns the general terms and conditions that contain the complete clause on the right of withdrawal and the standard withdrawal form, as well as a summary of the order (product or service ordered, price, delivery time). In practice, there are 3 options:

• Send the general terms and conditions and the form in PDF format as an attachment to the confirmation email
• Insert the text of the general terms and conditions and the form in the body of the confirmation email
• Print the general terms and conditions and the form, and attach them to the parcel containing the goods ordered

These do not apply to B2B websites:

• “Order with obligation to pay” feature
• Right of withdrawal
• Automatic responsibility for transportation risks
• Penalty scheme andwithdrawal from the contract in case of late delivery

The following continues to apply to B2B websites:

• Obligations relating to the protection of personal data (CNIL notices, privacy policy, cooky rules)
• Complete legal notice
• Permanent feature allowing for an order to be confirmed at the check-out stage

These are not new additions brought forth by the Hamon law.

This article contains general recommendations but does not, in any case, constitute a legal opinion for which Dreyfus can be held liable in case of inaccuracy. Do not hesitate to contact us for advice regarding your specific situation.

French Food Blogger Caroline Doudet was ordered to amend her blog review of II Giardino, a restaurant in the Aquitaine region of the South of France and pay thousands of Euros in damages to cover harm to the business and the complainant’s costs.  The owner of the restaurant, who has been working on building and maintaining its reputation seven days a week for a total of fifteen years , took issue with the entire article, however, the decision was limited to the blog posts title, “the place to avoid in Cap-Ferret: II Giardino”.  Nevertheless, according to Doudet in a BBC interview, the “decision creates a new crime of ‘being too highly ranked [on a search engine], or of having too great an influence.’

Ms. Doudet’s fashion and literature blog, “Cultur’elle” has roughly 3000 followers.  These followers, as well as the general public with access to the site could have discovered from her post that she received poor serviceduring her visit in August of 2013 with particular regard to the owner, who was described as having a poor attitude.  The restaurateur commented on the website Arrêt sur Images that, “maybe there were some errors in the service, which happens sometimes in the middle of August.” Moreover, the restaurateur was extremely troubled by the fact that the article showed in Google search results and that the criticism was not appropriately done.

So, what are the effects of this decision, if any? 

Despite the fact that Ms. Doudet has brought forward the idea that she is being penalized for having too great of an influence as a blogger, currently, under French law, this type of decision does not create legal precedent.  An emergency order can be issued by a judge to force a person to cease any activity they find to be harming the other party in the dispute.  This is done to protect a person who is deemed to be a victim in a given situation.  To issue such an order under French law requires a judge to identify a wrong on the defendant’s part, a negative effect on that of the appellant and a causal relationship between the two.

In terms of an appeal, Ms. Doudet, who pleaded her own case in court, has stated she will not appeal further.  Although French law remains relatively unchanged, this decision surely acts as a warning sign to bloggers to mind what they say, and where they eat!

The French data protection authority (CNIL) published its annual report for the year 2013. For 2014, the Commission will focus on the “construction of well-being” and assess the impact of new health-related digital trends on privacy.

Ranging from connected bracelets and watches to connected scales, connected health has recently invaded the stalls of specialized stores. These items make it possible to gather a vast amount of data on their users. For instance, it is easy to collect data pertaining to the heart rate, the number of steps made per day, sleep quality and blood pressure. And this, according to the CNIL’s report, is only the beginning. It is expected that by 2017, half of the population of smartphone users will have at least one well-being or health related application installed.  Apple Inc., to mention but one example, is expected to launch the so-called Healthbook application later this year, which will be installed as a default application on all its handsets.

This digital well-being phenomenon, also called “quantified self”, is interesting in several respects. It should be noted that the data are generated by the users. Nevertheless, even though these data are of a private nature, users very often share them.

Yet the CNIL is concerned by the fine line between well-being and health. Indeed, health data are treated as sensitive and are more strictly regulated. Section 8 of the Data Protection Act (loi Informatique et Libertés) of July 6, 1978 provides that the collection and processing of such data are prohibited as a matter of principle. However, the many exceptions linked to this rule have allowed the aforementioned trend to emerge.

Furthermore, the Commission is concerned about the security of such data and its use by the companies which collect them. The report states that users feel that they are directly connected to these data “for they come from them”, although companies could sell them or use them for purposes unknown to the users.

Finally, the report points to the fact that so-called “quantified self” practices could become the norm. Some American insurers reportedly treat clients who do not self-measure their medical data as suspicious and refuse to compensate them in the event of damage. According to the CNIL, the challenges of connected health are only just beginning and risks abound. However, with the support of the G29 and European Commissioner Viviane Reding, the Commission will undoubtedly be committed to protecting those very private data.

Dreyfus can assist you in better protecting your data and in managing your online presence. Please contact us for further details.

The once unmarked territory of designs, which has been in need of a good sprucing from both the IP community and the Luxembourg Courts, has finally received the attention that it requires from the Court of Justice of the European Union (CJEU).  The recent Irish Supreme Court decision,Karen Millen Fashions Ltd v Dunnes Stores (Limerick) Ltd [2013]has begun to shape the United Kingdom’s case law surrounding designs by smoothing out some ambiguities pertaining to the area of unregistered designs.

Starting with a striped shirt and a black knit top, made and sold originally by Karen Millen, this case was spun into motion when Dunnes admittedly copied and sold these women’s luxury clothing items.  In 2007, Karen Millen responded to these actions in a proceeding against Dunnes in the Irish High Courts where the company claimed infringement of an unregistered Community design under the Community Design Regulation 6/2002 (CDR).

In their defense, Dunnes claimed that their clothing items were new and furthermore challenged the validity of Karen Millen’s unregistered Community design on the grounds that it lacked “individual character”.  Evidently, Dunnes assumed that Millen’s designs were simply a combination of features drawn from earlier designs, such as a grey Dolce & Gabana knit top and a Paul Smith Blue striped shirt.  Lastly, Dunnes alleged that Karen Millen also had to prove that their respective design was individual in character.

Dunnes’ assessment of the Karen Millen design, taken with uncertainty, formed the basis of the questions posed to the CJEU.  After Millen’s claims were initially granted in the Irish High Courts, Dunnes appealed to the Supreme Court, which decided to pass the decision over to the CJEU.

The outcome of this decision on designs begins to define the lines that shape the way in which courts can assess individual character, the overall impression and the issue of the burden of proof pertaining to designs; the quintessential accessories of any valid unregistered design.  In effect, the concision of this decision has equally provided designer brands with statutory tools of protection against knock-off and look-alike designs that seek to emulate their brand’s appeal at a lower price.  Therefore, this decision will certainly be welcomed by high end designers and retailers.  At the same time, designers working in the lower end of the market, so to speak, “fast fashion” retailers must now take further precautions when seeking to replicate higher end looks for a lower price given the higher threshold introduced in this case for challenging the validity of an unregistered design.

The CJEU had to design on the following matters: within the purpose of the Community Design Regulation No 6/2002, should the overall impression of a design produced on an informed user be considered in whether it differs from the overall impression produced on such a user by any individual design made public, or any combination of known designs and/or their features, drawn from more than one such earlier designs? Furthermore, within the purpose of Article 85(2) of Regulation No 6/2002, is a Community design court bound to uphold the validity of an unregistered Community design where the right holder merely indicates what constitutes the individual character of the design or is the right holder bound to prove that the design has individual character in order to assert its validity?

As it was decided, Article 6 is to be interpreted as meaning that the overall impression that is produced on an informed user must differ from individual designs made public, not from a combination of different designs and/or their features. Next, Article 85(2) of Regulation No 6/2002 is to be interpreted as meaning that the right holder must merely indicate what constitutes the individual character of the design, and therefore is not bound to prove that the design has individual character in order to assert the validity of the design.  In practice this means that designers can explain the individual character of their design by drawing attention to certain elements that they feel give it individuality as opposed to proving that the design itself is has individual character.

Within the design and fashion community, as it has been noted, the effects of this decision will depend on where a brand is situated in the market.  Whether or not this decision will be act as a powerful precedent for those to come is still unknown, but future case law will indicate as so.  Unregistered designs are, especially within the workings of the fashion industry, an important Intellectual Property right, given the short lives of designs that may not justify the cost of design registrations.

This decision will now travel back to the Irish Supreme Court where the final decision awaits.  It seems likely that the decision will follow the guidance and advice of the CJEU.

On April 15 2014, the European Parliament adopted a proposal reinforcing consumer product safety. The new regulation creates a mandatory “made in” label for all non-food products.

Manufacturers, importers and distributors will be obligated to state the country of origin of the product, whether it was made in the EU or not. If the good was produced in the EU, the maker can choose to label either the country of fabrication or the EU in general. To prevent abuse and wrongdoing regarding this label, proportionate and dissuasive penalties will be set up.

The aim of the regulation is to improve the monitoring of the market. It represents a major progress for the transparency of the supply chain.

Today, countries which rely on the luxury industry such as France are favorable to the proposal in hopes of promoting its goods.

However several countries, including Germany and the UK, are opposed to the new rule. Indeed, their products are well known for their quality but they are now manufactured mostly outside of the EU. Therefore, the “made in” label might negatively impact those products’ reputation. This new rule would therefore be anti-free-trade and protectionist.

The proposal is now pending validation by the Council before it can become enforceable.

To be continued…

January 14th, 2014− A recent Russian Court decision, Eldorado v Ulmart, found that the use of a trademark’s keywords in advertising can constitute intellectual property infringement and specifically, trademark infringement. This marks a departure to the current global consensus on this issue, as most jurisdictions have refrained from providing any clear legal insight.

The facts of the Eldorado case are as follows: Eldorado sued its competitor Ulmart for trademark infringement. Eldorado is a major Russian electronics retailer and an exclusive licensee of a number of Russian trademarks, including “Eldorado” and “Territory of low prices”. The suit concerned Ulmart’s purchasing and utilization of these keywords from third party search engine, Yandex: “Eldorado of low prices. Here!” “Ulmart: territory of service. Shops, delivery, fair prices, bonuses! Ulmart.ru.”

Evidence presented in the Commercial (Arbitrazh) court of Saint Petersburg and Lennigrand region, suggested that when users typed “Eldorado” into Yandex, that potentially the first three sponsored links were affliated to Ulmart. That being said, the first link contained the keywords, “Eldorado of low prices. Here!” Upon activating the link, users would be transferred to www.ulmart.ru, the defendant’s website.

In agreement with the plaintiff, the court decided that the use of “Eldorado” with “low prices” increased a brand association between the plaintiff and defendant and that such use on the part of Ulmart risked confusion within the public. Additionally, the court noted that the words “Eldorado” and “low prices” appeared in a bigger font than the other textual elements of the advertisement. In drawing attention to these words through an increased font size, trademark affiliation and ultimately confusion with Eldorado seemed even more probable. This also contributed in favor of the plaintiff’s case.

Conversely, Ulmart argued that there could be no confusion between the two websites and that there was no visible link to the name “Eldorado”. Ulmart also put forth the argument that Eldorado was a generic word, which did not deserve protection. The court was not persuaded by either argument and ultimately dismissed both.

The Commercial (Arbitrazh) court of Saint Petersburg and Lenningrand region’s first decision was subsequently supported by the 13th court of appeal, on May 8th, 2014. Although Ulmart claimed that the use of the word “Eldorado” was purely descriptive and too broad of a term, meaning “land rich with gold and other resources” in Russian, the court could not separate the use of the term from the trademark itself and therefore rejected the defendant’s appeal. Ulmart also expressed disagreement to the amount of damages claimed but again, the 13th court of appeal reiterated the court’s decision at first instance. Finally, the appeal court confirmed that so long as a trademark is protected, the owner or exclusive licensee can enforce its rights against third parties.

Here are some preliminary observations that can be noted. Reflected within the decisions of both courts, the use of a protected trademark as a keyword and in the text of a sponsored search result equates to trademark use. Eldorado did not sue Yandex, the third party search engine. The use of a mark or confusingly similar sign in advertising in respect of similar goods is also recognized by Russian law as trademark use. Russian law accounts for “internet use” so the use of a mark in a keyword could fall within “internet use”. The way in which the trademark is used in an advertisement plays a crucial role to the ultimate judicial outcome. The court noted that had the trademarks “Eldorado” and “lower prices” not been placed in the text, the outcome of the case could have been different.

The Eldorado case marks the first of what will predictably be many cases to follow in Russian law that deals with keywords and trademark. In the future, it is still unclear as to whether or not claims will be brought onto advertisers alone, or to advertisers and search engines alike. Similarly, the court did not condemn the keyword practice per se, but only that the use of a trademark as a keyword constituted trademark infringement.

In its IP notebook of May 2014, the CNIL took interest in the human body as a new connected object, notably with regard to digital respect of the individual through data and more particularly, in terms of the respect of the body by connected objects. While the Magna Carta provides for Habeas Corpus, the CNIL proposes the idea of a Habeas data to protect health data.
With the proliferation of connected objects related to quantified self, the health data of individuals has increased tenfold. Unlike conventional personal data, health data is of a sensitive nature. Indeed, this data not only affect the individual but also his family due to genetic connections. These data may thus be the source of discrimination based on the health status of the individual.
The CNIL highlights the fact that despite being highly regulated in France and Europe, health data is not clearly defined. While some would prefer a broad definition, leaving room for the courts’ interpretation, others wish to promote a clearer definition for the sake of legal certainty. The draft European regulation on personal data, which is currently under discussion, provides the following definition: “any information relating to the physical or mental health of a person, or the provision of health services to that person.” Another recommended option is gradation of data according to sensitivity so as to treat the data in a less simplistic way than ‘sensitive’ or not.
A paradox can be discerned between the commercial value of the data related to Big Data and the principle of inalienability of the human body. It seems that restrictions of use should be imposed, particularly to prohibit the marketing of health data. Ethical and fundamental principles must be established to curb infringements.
Finally, the CNIL suggests distinguishing apps for medical purposes (providing a diagnosis, treatment or prevention means) from non-medical apps. This would afford more security to the individual from a physical and digital point of view. This highlights the complexity of managing health data which affects not only personal data but also the privacy and dignity of the individual and the dignity that he is legally entitled to.
Owing to their special nature, the European Commission has, on 12 May 2009, recommended the use of Privacy Impact Assessments for quantified self apps. These could provide for more stringent requirements as regards safeguarding the data and information of individuals.

Dreyfus can assists you in auditing your data collection and can help you develop privacy policies consistent with French and European regulations.

Since the beginning of the year, new domain name extensions (new gTLDs) have been hitting the market. More than 1000 new gTLDs will eventually exist alongside the traditional .com and .fr. Yet in 2012, ICANN, through its President and CEO, Fadi Chéhadé, had already committed to open up once more the root of the Internet by offering a new application round for new domain name extensions. While no date has yet been fixed, rumor has it that the opening date of the procedure should be in early 2016.

Since then, Internet stakeholders have been suggesting solutions to overcome the shortcomings and defects of the first wave of new gTLDs. Indeed, over time, a number of criticisms were raised such as high application fees and inadequate rights protection mechanisms.

Amongst the suggestions made by the community, that of application files tailored to the needs of the different types of TLDs is recurrent since the uniformity of the files, which were not suited to all applications, were widely criticized. To streamline the application process, other observers suggest a system of prioritizing files in a random manner, the pre-evaluation of technical service providers for registries and even a dedicated “customer” service. According to IP Constituency, which is part of the Generic Names Supporting Organization (GNSO), ICANN will have to stick to a defined and predictable process, while simultaneously being able to address unexpected issues.

The first phase of the launch of the new gTLDs could be assimilated to a test, especially for “dot brands” (such as .kpmg or .chanel). The second application round should therefore be even more successful. The community also requests ICANN to set a detailed, realistic and public timetable in the interest of applicants. In case of delay in the procedure, ICANN should commit to take corrective measures. In addition, the community requests that application fees be reduced, and be made to correspond to the actual costs incurred by ICANN.

However, the most important improvements in the eyes of stakeholders relate to the protection of rights. Thus, the Domains Protected Trademark List (DPML), which allows the registration of a trademark to be blocked, could be extended to all new gTLDs to compensate for an inadequate Trademark Clearinghouse (TMCH). The procedures for dispute resolution should also be updated so as to be more accessible to trademark owners. The URS (Uniform Rapid Suspension) procedure could thus be revamped to allow for lower standards, since currently, domain squatting can only be halted in cases of flagrant trademark infringements.

Several other issues are also being debated, such as the lists of premium names containing trademarks, objection mechanisms to applications, the protection of geographical indications or the auction system contemplated by ICANN.

All these issues should be clarified before the launch of the second application round for the new extensions. While time is of the essence, all actors, starting with the applicants, intends to defend their interests. The next ICANN meeting scheduled for October in Los Angeles should shed light on many concerns raised by the community.

Owing to its cutting edge expertise on new gTLDs, Dreyfus can assist you in preparing for the second round of applications. Please do not hesitate to contact us for more information.

The French Supreme Court confirmed a lack of distinctiveness in the term “argane,” which constitutes the necessary and generic designation for hygiene and skincare products covered by the trademark. (CCass, Com., SAS Pierre Fabre dermo-cosmétique c/ Sté Clairjoie, 6 May 2014, No.13-16470)
In 2010, Pierre Fabre, owner of the “Argane” trademark since 1983, accused the company Clairjoie of counterfeiting the trademark “Karité-Argane” through commercial usage. In its defense, Clairjoie requested for the trademark “Argane” to be cancelled due to fraudulent filing and a lack of distinctiveness.
The Court of Appeals maintained the judgment of the Court of first instance and upheld the cancelation of the trademark. The Court affirmed that “Argane” is not a neologism which gives the term “argan oil” a feminized dimension, but rather a word of Arabic origin.
The defendant company argued that the judges were confused in differentiating between the evocative and the distinctive characters of the trademark, that no reference was made to consumer perception of the trademark and that the generic and necessary character of the trademark had not been established.
However, the French Supreme Court rejected the arguments of Pierre Fabre, stating that the Court of Appeals rightly decided the issue in referring to the clientele of the products of the brand. The Court also reiterated that the chosen term, also spelt as “argan” and designating a tree or shrub as well as its fruit, used in the manufacturing of soap, “constituted the necessary and generic designation of a plant substance used for hygiene and skin care which should have remained freely available to actors of the industry wishing to include it in their products.” Accordingly, it asserted that “the term was merely descriptive of the constituents of the product covered by the trademark”, thence justifying the cancellation of the latter.
This judgment puts an end to 30 years of use of the mark “Argane” but most importantly, emphasizes a heightening of the judges’ rigid approach with regards to the descriptive character of a trademark, by underscoring its lack of distinctiveness which was not obvious due to the divergence in pronunciation. Furthermore, the term “argane” is seldomly used. This decision also raises the delicate question of the difference between the evocative nature of a trademark and its lack of distinctiveness. Finally, this decision casts a doubt on the requirements for acquiring distinctiveness through the use of the trademark. Indeed, if such a lifespan and such frequent and intensive exploitation of a trademark do not suffice to grant distinctiveness to “Argane”, then what conditions must be satisfied?