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                    [post_content] => Recently, the Rotterdam District Court addressed the question whether an advertisement (“ad”) text on Bol.com (a Dutch variant of Amazon) is protected by copyright. The court mentioned a number of elements in which creative choices can be made in a text with objective content[1].

The dispute

Plaintiff sells BBQ gloves on Bol.com, and had an ad text written by a third party for its ad on the platform. Plaintiff also obtained the copyrights to the text. Defendant in this matter copied the ad text almost one-to-one in its ad for BBQ gloves. Even mistakes in the text were copied. The plaintiff summoned the defendant to stop infringing its copyright, after which the defendant partly changed the ad text. Defendant disputed that ad text can be protected by copyright. According to the defendant, the ad text is very general and basic, which means that it cannot have its own and original character.[2] And even if this should be the case, these rights do not – according to the defendant - accrue to the plaintiff. The plaintiff, on the other hand, believes that the creative choices made are in the length of the sentences, used word choices, sentence construction as well as the explicitly chosen information and bold text, how the information is represented and in the layout of the text.

Courts judgement

Copyright The court held that “a collection or certain selection of elements not protected in themselves, may be an (original) work, provided it bears the personal stamp of the creator.” The ad text contains factual information, but because it was incorporated into the text in a free and creative manner, the ad text enjoys copyright protection. The court also points out that the plaintiff was not asking for protection for some (enumerated) words, but for the text as a whole. Copyright holder The court does not go along with defendant’s defence that it does not appear that the third party has drafted the ad text for the BBQ gloves. However, the order confirmation clearly states that it concerns “Product description BBQ gloves Xamax”. The court concluded that the plaintiff must be regarded as the owner of the copyrights on the ad text. Is there infringement? Situation before the summons The defendant argued that his ad text was based on the ad text of the plaintiff on Bol.com, that he copied the text and adjusted it on some points. However, it appears that the defendant copied the text one-to-one, including the language errors in the text. The plaintiff made two adjustment, changing the trademark and the heat resistance from 500 °C to 800 °C. Thus almost a complete reproduction of the ad text. According to the court, it is established that the defendant has infringed the copyright of the plaintiff. Situation after the summons De court’s view is that after the adjustments in the ad text, the defendant has sufficiently deviated from the plaintiff’s text. Therefore, there is no infringement on the plaintiff’s copyright from that point onwards. Damages If the defendant had asked permission to use the ad text, the plaintiff would have charged a licence fee of € 140. This amounts to the price paid by the plaintiff for the ad text. Since it has been established that infringement has taken place, the court awards the damages determined at € 140. As the infringement was of a very short duration in combination with the ranking of the plaintiff’s ad against the defendant’s ranking, the court rejected damages for reduction of the exclusivity value of the ad. The plaintiff was in fact at the top of page 1 (of the 17 pages) with comparable gloves on Bol.com. In order to get to the defendant’s ad, one had to scroll far down. Profit remittance The plaintiff claims that the defendant has made a profit by using its ad text. According to the defendant, the consumer’s choice will be influenced by the ranking, brand and price of a product on Bol.com and not so much by the ad text. The court follows the defendant’s defence and rejects the profit remittance. In doing so, the court distinguishes the subjective and objective content of a text. The copyright protection is only applicable to the subjective form of the text, which in this case is characterized by the length of the sentences, used word choices, sentence construction as well as the explicitly chosen information and boldfaced text, how the information is represented and the layout of the text, according to the court.

The practical implications

An ad text consist of subjective and objective content. Only the subjective content of the ad text is eligible for copyright protection. Thus, if the factual information about a product is processed in the ad text by creative choices in, for example, the length of sentences, choice of words, sentence construction as well as the explicitly chosen information is displayed and in the layout of the text, the ad text can be protected by copyright. Do you have questions about copyright, want to have your ad text checked or want to take action against the use of your ad by someone else? Please do not hesitate to contact any of our specialists. [1] In this case, factual information regarding the offered product. [2] For a work to be protected under copyright, it is required for the work to have an own and original character and needs to bear the personal stamp of the creator, according to Dutch Copyright law. Mustafa Kahya nieuw 1 [post_title] => Copyright on advertisement text [post_excerpt] => [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => copyright-on-advertisement-text [to_ping] => [pinged] => [post_modified] => 2022-09-27 15:25:08 [post_modified_gmt] => 2022-09-27 13:25:08 [post_content_filtered] => [post_parent] => 0 [guid] => https://bg.legal/?p=32215 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [1] => WP_Post Object ( [ID] => 32207 [post_author] => 65 [post_date] => 2022-09-26 13:39:14 [post_date_gmt] => 2022-09-26 11:39:14 [post_content] => Hollanda’da şirket kurmak aslında kolay bir işlemdir. Avrupaya açilmak için Hollanda’da şirket kurmak son derece mantıklı bir ikamet ülkesidir. Uygun bir vergi ortamına sahip olmanın yanı sıra, lojistik altyapı da bir avantajdır. Rotterdam'daki Avrupa'nın en büyük limanı ve Schiphol'deki büyük havaalanı ile Hollanda aynı zamanda (Avrupa’da) elverişli bir coğrafi konuma sahiptir. Yurtdışına açılmak büyük bir adım. Bu durumda, hukuki konular dahil olmak üzere birçok konu dikkate alınmalıdır. Aşağıda Hollanda’da şirket kurmak için bazı önemli hukuki hususlardan bahsedeceğiz.

Hollanda’da şirket kurmak

Aralarından seçim yapabileceğiniz çeşitli şirket formları vardır. Startuplar ve scale-uplar tarafından en çok tercih edilen form limited şirkettir (Besloten Vennootschap). Anonim şirket (Naamloze Vennootschap) ise daha fazla yükümlülük gerektirir. Limited şirketinin kuruluşu noter tasdikli olur. Noter, yeni kuruluş sözleşmesi ile birlikte Ticaret Odası'na kaydeder. Bu nedenle kuruluş sözleşmesi hazırlanmalıdır. Ayrıca, noter vergi makamlarında kayıt işlemlerini de halledecektir. Limited şirketin anonim şirkete kıyasla avantajı, € 0,01 başlangıç sermayesi ile kurulabilmesidir. Dikkat, limited şirket hayata geçene kadar, ‘oluşum halinde limited şirket’ olarak hayatta olduğunu unutmayın. Bu, kuruluş aşamasında yapılan sözleşmelerden müştereken ve müteselsilen sorumlu olduğunuz anlamına gelir. Bazı durumlarda, risk ve sorumluluğu dağıtmak veya vergi nedenleriyle bir holding şeklinde birkaç limited şirket kurmak akıllıca olabilir. Ayrıca şirketiniz için doğru sigorta poliçesini yaptırıp yaptırmadığınızı da dikkatlice kontrol etmelisiniz. Birden fazla hissedar/yönetici ile birlikteyseniz, daha sonra sorun yaşamamak için birbirinizle iyi anlaşmalar yapmanız ve bu anlaşmaları kağıda dökmenizi tavsiye ediyoruz.

Vergi hususları

Hollanda'daki şirketler için geçerli olan vergi düzenlemelerine aşina olmamanız elbette mümkündür. Bir örnek, şirket rakamlarını 7 yıl boyunca saklamanız mecburiyetdir. Vergiyle ilgili konularda da size yardımcı olabiliriz.

Çalışanlar

Büyümek için daha fazla ele ihtiyacınız olacaktır. Yani yeni çalışan işe almak zorunda kalacaksınız. Bunlar Hollanda'da yerleşik çalışanlar veya yurtdışından Hollanda'ya getirdiğiniz çalışanlar, expat olabilir. Expatleri işe alırken yerine getirmeniz gereken çeşitli koşullar vardır. İş sözleşmenizin Hollanda kanunlarına uygun olup olmadığını ve iş sözleşmesinin belirli pozisyona uygun olup olmadığını kontrol ettirmenizi tavsiye ediyoruz.

Yeni konum

Ayrıca Hollanda'da bir şubenizin olması da gerekebilir. Bu, bir ofis alanı veya depolama veya üretim için bir alan olabilir. Alanın satın alınması veya kiralanması arasında bir seçim yapmanız gerekecektir. Kendi çalışanlarınızı yerleştirmek için bir ev satın almak veya kiralamak istemeniz de söz konusu olabilir. Evin çalışanlarınızı barındırmak için uygun olup olmadığını önceden kontrol etmek veya kontrol ettirmenizi tavsiye ediyoruz.

Fikri Mülkiyet ve Gizlilik (kişisel veriler)

Elbette ticari unvanınız altında faaliyet göstereceksiniz. Ancak, ticari adınız halihazırda kullanılmakta olup olmadığını veya marka olarak tescil edilip edilmediğini hiç araştırdınız mı? Böyle bir durumda ticari unvanınızı özgürce kullanmanız zorlaşabilir. Ayrıca gizlilik kanunları da (KVKK) dikkate almanız gerekecektir. Daha önce de belirtildiği gibi, çalışanları işe almak isteyeceksiniz. Başvuru prosedürlerinden geçeceksiniz. Örneğin, başvuru sahibi buna izin verirse, başvuru sahibinin özgeçmişini 1 yıldan fazla tutamayacağınızı lütfen unutmayın.

Faaliyet göstermek

Yeni bir yer ve çalışanların işe alınmasından sonra asıl iş başlayacaktır. Hukuki sorunlar bununla da bitmiyor. Tedarikçiler ve müşterilerle sözleşmeler yapılması gerekecektir. Bu anlaşmalar yasal olarak değerlendirildi mi? Doğru bir şekilde uygulanabilir olduğu beyan edilen genel şartlar ve koşullar hazırlandı mı? Ya işyerinde bir kaza olursa veya bir çalışan uygunsuz davranırsa? Bu tür yasal sorunlar da ortaya çıkabilir. BG.legal'in avukatları ve ortakları yukarıdakilerin tamamında size yardımcı olabilir. Hollanda'da şirket mi kurmak istiyorsunuz? Çalışanları işe almak ve iş sözleşmesinin düzenlenmesini veya kontrol edilmesini mi istiyorsunuz? Yoksa genel şartlar ve koşulların veya sözleşmelerin düzenlenmesini veya kontrol edilmesini mi istiyorsunuz? Bu konuda yardim edebiliriz. BG.legal, şirketler hukuku, gayrimenkul, iş hukuku, fikri mülkiyet hukuku ve ihale hukuku alanında tam hizmet veren bir ofistir. Ayrıca, vergi alanında da size yardımcı olmak için vergi uzmanlarıyla yakın bir şekilde çalışıyoruz.

Daha fazla bilgi?

Bizimle veya hizmetlerimiz hakkında daha fazla bilgi almak isterseniz, lütfen bizimle Felemenkçe, İngilizce veya Türkçe olarak iletişime geçmekten çekinmeyin. Mustafa Kahya nieuw 1 [post_title] => Hollanda’da şirket kurmak [post_excerpt] => [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => hollandada-sirket-kurmak [to_ping] => [pinged] => [post_modified] => 2022-09-26 16:41:01 [post_modified_gmt] => 2022-09-26 14:41:01 [post_content_filtered] => [post_parent] => 0 [guid] => https://bg.legal/?p=32207 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [2] => WP_Post Object ( [ID] => 31893 [post_author] => 65 [post_date] => 2022-08-31 16:33:00 [post_date_gmt] => 2022-08-31 14:33:00 [post_content] => The organization that evaluates the trademark application checks whether a word or logo meets the basic requirements. Otherwise, an application will be rejected. The main reasons for rejections are:
  • The word is self-explanatory: This is the most common reason for rejection. The word requested is descriptive when it describes the product or service for which it is requested, or their features.
For example, 'biomild' for mild flavoured organic yogurt or 'babydry' for diapers.
  • The word has no distinguishing feature: For example, if a word or words cannot distinguish the product or service, it cannot be registered as a trademark.
For example, the word LIMO for lemonade syrup.
  • If the word/logo is misleading: For example, if protection is requested for a logo containing images that may mislead consumers about the products/services to be offered under the trademark, the trademark applied for is misleading.
In case of rejection of the application, the costs and taxes paid are not refundable.

Extensive trademark research

In order to avoid rejection, we recommend that you do a preliminary research on the mark you want to register as a trademark. In a comprehensive trademark research, we do not merely search for the previous use of the mark (or a similar mark) in the trademark register. For example, we also check Google and the Chamber of Commerce registry. As a result of our research, we produce a report in which we explain our research and give clear advice on our view, feasibility and risks we see.

Why BG.legal?

We specialize in advising and litigation in intellectual property law, including trademark law. We are doing research on the usability of trademarks. We also register, manage and track trademarks. We also assist clients in objection and infringement lawsuits and draft contracts for the transfer of trademarks.

Costs

The cost of the extensive trademark research depends on the number of countries and the number of classes to which the mark will be applied for.

More information?

For more information, please contact one of our IP specialists. Click here for the Turkish version. Mustafa Kahya nieuw 1 [post_title] => What are the trademark registration requirements? [post_excerpt] => [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => what-are-the-trademark-registration-requirements [to_ping] => [pinged] => [post_modified] => 2022-08-31 16:33:00 [post_modified_gmt] => 2022-08-31 14:33:00 [post_content_filtered] => [post_parent] => 0 [guid] => https://bg.legal/?p=31893 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [3] => WP_Post Object ( [ID] => 31894 [post_author] => 65 [post_date] => 2022-08-31 16:32:37 [post_date_gmt] => 2022-08-31 14:32:37 [post_content] =>

Marka tescil şartlar nelerdir?

Marka tescil başvurusunu değerlendiren kuruluş, bir kelime veya logonun temel kriterleri karşılayıp karşılamadığını kontrol etmektedir. Aksi takdirde, bir başvuru reddedilecektir. Reddedilmenin ana nedenleri şunlardır:
  • Kelime açıklayıcıdır: Bu reddetmenin en yaygın nedenidir. Talep edilen kelime, talep edildiği ürün veya hizmeti veya bunların özelliklerini tanımladığında açıklayıcıdır. Örneğin, hafif bir tada sahip organik yoğurt için 'biomild' veya bebek bezleri için 'babydry'.
  • Kelimenin ayırt edici özelliği yoktur: Örneğin bir kelime veya kelimeler ürünü veya hizmeti ayırt edemiyorsa marka olarak tescil edilemez. Örneğin, limonata şurubu için LIMO kelimesi.
  • Kelime/logo yanıltıcı olursa: Örneğin marka altında sunulacak ürünler/hizmetler hakkında tüketicileri yanıltabilecek görsel içeren bir logo için koruma talep ediliyorsa, başvuru yapılan marka yanıltıcıdır.
Başvurunun reddedilmesi durumunda, ödenmiş olan masraflar ve vergiler iade edilmiyodur.

Kapsamlı araştırma

Reddedilmeyi önlemek için, marka olarak başvurmak istediğiniz işaret hakkında ön araştırma yapmanızi tavsiye ederiz. Kapsamlı bir marka araştırmasında, sadece markanın (veya benzer bir markanın) marka sicilinde önceki kullanımını araştırmakla kalmıyoruz. Örneğin, Google'ı ve Ticaret Odası sicilini de kontrol ediyoruz. Araştırmamız sonucunda, araştırmamızı açıkladığımız ve görüşümüz, fizibilite ve gördüğümüz riskler hakkında net tavsiyeler verdiğimiz bir rapor hazırlıyoruz.

Maliyet

Soruşturmanın maliyeti, markanın uygulanacağı ülke sayısına ve sınıf sayısına bağlıdır.

Neden BG.legal?

Marka hukuku da dahil olmak üzere fikri mülkiyet hukuku konusunda danışmanlık ve dava açma konusunda uzmanız. Markaların kullanılabilirliği konusunda araştırma yapıyoruz. Ayrıca markaları tesciol ederiz, yönetir ve izleriz. Ayrıca, itiraz ve ihlal davalarında müvekkillere yardımcı oluyoruz ve markaların devri için sözleşmeler hazırlıyoruz.

Daha fazla bilgi?

Kapsamlı araştırma hakkında fazla bilgi veya başka sorularınız için benimle iletişime geçebilirsiniz. Mustafa Kahya nieuw 1 [post_title] => Marka tescil şartlar nelerdir? [post_excerpt] => [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => marka-tescil-sartlar-nelerdir [to_ping] => [pinged] => [post_modified] => 2022-08-31 16:34:06 [post_modified_gmt] => 2022-08-31 14:34:06 [post_content_filtered] => [post_parent] => 0 [guid] => https://bg.legal/?p=31894 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [4] => WP_Post Object ( [ID] => 31892 [post_author] => 65 [post_date] => 2022-08-31 16:23:51 [post_date_gmt] => 2022-08-31 14:23:51 [post_content] =>

Neden bir kelimeyi veya logoyu marka olarak tescil ettirmelisiniz?

Bir marka tescili ile, bir marka sahibi, belirli ürünler veya hizmetler için bir marka [kelime ve/veya logo] kullanma münhasır hakkını elde eder. Marka sahibi, marka hakkını veya markaya çok benzeyen bir işareti kullanan herkese karşı marka hakkını ileri sürebilir. Daha sonra, markanın tescilli olduğu ürün veya hizmetlerin kullanımına ilişkin olmalıdır. Bu nedenle pek çok şey, bir markanın tescil edildiği ürün ve/veya hizmetlerin iyi bir şekilde tanımlanmasına bağlıdır. İşte bu noktada bilgimiz ve tecrübemiz devreye giriyor. Marka ihlali durumunda da dava açtığımız için yasal bir anlaşmazlıkta neyin önemli olduğunu biliyoruz. Ve bu bilgi ve deneyim, markaların tescili sırasında da işe yarar.

Nerde koruma istiyorsunuz?

Yalnızca markayı tescil ettirdiğiniz yerde korumanız olur. Benelüks Benelüks'te tek bir marka tescil sistemimiz var. Bir tescil ile, bir marka sahibi, Benelüks'ün tüm ülkelerinde korumaya sahiptir. Yani Belçika, Lüksemburg ve Hollanda’da. Avrupa Birliği Avrupa Birliği içinde bir Topluluk markamız var. Alicante'deki [İspanya] EUIPO, Topluluk markası için başvuruları ele almaktadır. Bir tescil ile marka sahibi, Avrupa Birliği'nin tüm ülkelerinde korumaya sahiptir. Bu, bir kelime veya logonun Avrupa Birliği ülkelerinden birinde geçerli bir marka olmaması durumunda, başvurunun tüm Avrupa Birliği için reddedileceği anlamına gelir. Örneğin, Avrupa Birliği ülkelerinden birindeki bir kelime, tescili talep edilen ürünleri/hizmetleri tarif ettiği için. Bu, kapsamlı bir marka araştırması yapmayı önemli kılar. Uluslararası Farklı ülkeler için marka tescili tek bir acente [WIPO] aracılığıyla yapılabilir. ABD, Çin ve AB gibi ülkeler üyedir. Başvuru WIPO'ya yapılır ve ardından başvuruda seçilen ülkeler için marka başvurularına bölünür. Bu nedenle koruma talep edilen ülkelerin seçimi, markanın kullanılacağı ülkelere bağlıdır.

Marka sahibinin yükümlülükleri

Bir marka, tescilden sonraki beş yıl içinde ticarette normal olarak kullanılmalıdır. Dolayısıyla bir marka, gelecekte kullanılabileceği bir ülke için de tescil edilebilir. Bir Topluluk markası için, beş yıl içinde Avrupa Birliği'nin en az üç ülkesinde kullanılmalıdır. Marka sahibi de tescil için markanın kayıtlı olduğu ofise [BOIP, EUIPO, vb.] ödeme yapmakla yükümlüdür. Bu masrafların önceden ödenmesi gerekmektedir. Marka tescili belirli bir süre [10 yıl] için geçerlidir. Bundan sonra, tescil her seferinde 10 yıl uzatılabilir.

Maliyet

Maliyetleri olabildiğince net tutmak için sabit oranlarla çalışıyoruz. Maliyetler, bir marka için başvurulan alan ve sınıf sayısına bağlıdır.

Neden BG.legal?

Marka hukuku da dahil olmak üzere fikri mülkiyet hukuku konusunda danışmanlık ve dava açma konusunda uzmanız. Markaların kullanılabilirliği konusunda araştırma yapıyoruz. Ayrıca markaları kaydeder, yönetir ve izleriz. Ayrıca, itiraz ve ihlal davalarında müvekkillere yardımcı oluyoruz ve markaların devri için sözleşmeler hazırlıyoruz. Marka başvurusu yaparken başvuruyu hazırlayacağız, aynı kelime işaretini araştıracağız ve size markanın sertifikasını göndereceğiz.

Daha fazla bilgi?

Marka başvuruları ve maliyetleri hakkında daha fazla bilgi veya diğer sorularınız için benimle iletişime geçebilirsiniz, kahya@bg.legal veya +31 (0) 88 141 08 74. Mustafa Kahya nieuw 1 [post_title] => Neden bir kelimeyi veya logoyu marka olarak tescil ettirmelisiniz? [post_excerpt] => [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => neden-bir-kelimeyi-veya-logoyu-marka-olarak-tescil-ettirmelisiniz [to_ping] => [pinged] => [post_modified] => 2022-08-31 16:33:31 [post_modified_gmt] => 2022-08-31 14:33:31 [post_content_filtered] => [post_parent] => 0 [guid] => https://bg.legal/?p=31892 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [5] => WP_Post Object ( [ID] => 31891 [post_author] => 65 [post_date] => 2022-08-31 16:21:54 [post_date_gmt] => 2022-08-31 14:21:54 [post_content] => With a trademark registration, a trademark owner acquires the exclusive right to use a trademark [word and/or logo] for certain products or services. The trademark owner can assert the trademark right against anyone who uses the trademark or a sign very similar to the trademark. It should relate to the use of products or services for which the mark is registered. Therefore, much depends on a good description of the products and/or services for which a trademark is registered. This is where our knowledge and experience come into play. We know what's important in a legal dispute, as we also sue for trademark infringement. And this knowledge and experience is also useful during the registration of trademarks.

Where do you want protection?

You only have protection where you register the trademark. Benelux We have a single trademark registration system in the Benelux. With a registration, a trademark owner has protection in all countries of the Benelux. That is in Belgium, Luxembourg and the Netherlands. European Union We have a Community trademark within the European Union. EUIPO in Alicante [Spain] handles applications for the Community trademark. With a registration, the trademark owner has protection in all countries of the European Union. This means that if a word or logo is not a valid trademark in one of the European Union countries, the application will be rejected for the entire European Union. For example, if a word in one of the European Union countries describes the products/services. This makes it important to do an extensive trademark research. International Trademark registration for different countries can be done through a single agency [WIPO]. Countries such as the USA, China and the EU are members. The application is made to WIPO and then split into trademark applications for the countries selected in the application. For this reason, the choice of countries for which protection is requested depends on the countries where the trademark will be used.

Obligations of the trademark owner

A trademark must be normal used in commerce within five years of the registration. Therefore, a trademark can also be registered for a country where it can be used in the future. For a Community trademark, it must be used in at least three countries of the European Union within five years.

Why BG.legal?

We specialize in advising and litigation in intellectual property law, including trademark law. We are doing research on the usability of trademarks. We also register, manage and track trademarks. We also assist clients in objection and infringement lawsuits and draft contracts for the transfer of trademarks. When applying for a trademark, we will prepare the application, search for the same word mark and send you the certificate of the trademark.

Costs

We work with fixed rates to keep costs as clear as possible. The costs depend on the number of fields and classes applied for in a trademark application.

More information?

For more information, please contact one of our IP specialists. Click here for the Turkish version. Mustafa Kahya nieuw 1 [post_title] => Why should you register a word or logo as a trademark? [post_excerpt] => [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => why-should-you-register-a-word-or-logo-as-a-trademark [to_ping] => [pinged] => [post_modified] => 2022-08-31 16:24:17 [post_modified_gmt] => 2022-08-31 14:24:17 [post_content_filtered] => [post_parent] => 0 [guid] => https://bg.legal/?p=31891 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [6] => WP_Post Object ( [ID] => 31579 [post_author] => 6 [post_date] => 2022-08-08 16:34:37 [post_date_gmt] => 2022-08-08 14:34:37 [post_content] => Deadly diseases still exist to this day and they need to be addressed. Thus, we have to predict, prevent and respond to the outbreak of deadly viruses like COVID-19. Artificial Intelligence (‘AI’) technology may be of help here, as it combines the computational capacity of a computer with the reasoning ability of humans. AI technologies (e.g. Machine Learning, Natural Language Processing, Deep Learning) are applied in all stages of drug discovery, for example: target validation, identification of biomarkers, lead optimization, annotation and analysis of clinical data in trails, pharmacovigilance and clinical use optimization. Nonetheless, these AI applications create both regulatory and legal challenges. The AI Act, an initiative of the European Commission, will also have its effect on the application of AI in the pharmaceutical industry. This legal framework addresses, inter alia, the risks specifically created by AI applications. Particularly when AI systems are applied in a pharmaceutical setting (e.g. health apps), or when software is classified as a medical device on the basis of the Medical Device Regulation, the integrated AI system will fall within the high risk category. Consequently, AI systems in the field of pharmaceutics have to comply with the strict requirements set in place for a high risk AI system. Additionally, the AI Act introduces the AI regulatory Sandbox. This is an instrument where innovators and regulators may connect with one another. Subsequently, it provides a controlled environment for them to cooperate. It should facilitate the development, testing and validation of innovative AI systems, but simultaneously ensuring compliance with the AI Act. Therefore, this instrument offers interesting possibilities for AI systems used in pharma. See this blog for more information on the AI Act.

Regulatory challenges

The International Coalition of Medicines Regulatory Authorities (ICMRA) has made a report of a horizontal scanning exercise in AI.[1] In order to examine the challenges the use of AI poses to global medicine regulation, two hypothetical case studies were developed. a. AI in clinical medicine development and use: A Central Nervous System App
  • Regulators need to take into consideration the context of use of the AI system and its software and algorithm(s);
  • Validation may require access to the underlying algorithm and datasets by regulators;
  • Updates to the AI software or hardware would need re-testing or bridging studies to ensure reproducibility/validation.
b. Hypothetical case study: AI in pharmacovigilance
  • The challenge lies in creating the right balance between AI and human oversight of signal detection and management;
  • AI use may discover safety signals that are more difficult to detect with current methods;
  • Software updates that affect the data will need to be communicated to regulators.

Recommendations:

  • The validation will require access to the employed algorithms and underlying datasets. Legal and regulatory frameworks may need to be adapted to ensure such access options.
  • Consider the concept of a Qualified Person responsible for AI/algorithm(s) oversight compliance.

Legal challenges

  • Regulatory status of AI/ML software
  • Black box: explainable AI
  • Securing data against cyber attacks

1. Algorithm

In most cases the algorithm (software) will be developed by a data science company (and not by the pharmaceutical company). Therefore, parties need to address issues like liability, a license for the use of the software service/updates of the software by way of an agreement. Furthermore, the data science company needs to develop the software in such a way that the pharmaceutical company can meet the regulatory requirements (transparency, explainability and a possible regulatory access to the employed algorithms and underlying datasets). The pharmaceutical company will also need a license to use the software. This license agreement needs to address issues regarding ownership and usage rights. One of the reasons for this is that, from a legal perspective, ‘ownership’ (in Dutch: ‘eigendom’) of data is not possible. On the other hand, the data science company may want to use the algorithm or knowhow related to developing the algorithm, for other customers. This therefore needs to be addressed in the agreement.

Legal issues:

  • IP related to the software/data sets used to develop and train the algorithm.
  • IP related to AI and the outcome of the AI system (who has rights to the newly structured data, the correlations derived from the data, the compounds discovered).
  • Exit rights: can the pharmaceutical company transfer the algorithm/data to another data science company.
  • If the data science company may use the knowhow for other customers.
  • Liability for the outcome of the AI system.
  • Non-performance of the AI system.
  • Explainable XAI: black box prediction model.

2. Dataset

There is a rapid growth in all kind of datasets that are useful in the process of drug discovery. In each phase of drug discovery different sources are used. The legal challenges that will arise in a certain case will depend on the nature of the dataset. In most cases the dataset will contain non-personal (health) data. When AI is used for target identification or lead optimization, the data set will not contain personal data. However, if AI is used for disease identification of in a diagnostic contact or in clinical trials, the data will contain personal (health) data. This will also be the case in the phase of monitoring the medicines or the medical treatment. This is especially true for rare diseases during this phase, as the number of patients will be small. For this reason, it will become increasingly difficult to anonymize the data in a way that the data cannot be linked to a specific person. When the dataset does contain personal (health) data, ethical aspects need to be taken into consideration: transparency and explainability (problem of opacity); equality, fairness and non-discrimination (problem of bias) and data quality and data sharing (problem of privacy).

Legal issues:

  • Privacy: does the dataset contain personal (health) data
  • Quality of the dataset used is bias
  • Data sharing: conditions for data sharing
  • IP related to the data set
  • IP related to the AI system
  • Liability for the outcome of the AI system

Contact

For more information in relation to AI in pharma, contact Jos van der Wijst. [1] ICMRA, Informal Innovation Network, Horizon Scanning Assessment Report – Artificial Intelligence, 6 August 2021   [post_title] => AI in Pharma [post_excerpt] => [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => ai-in-pharma [to_ping] => [pinged] => [post_modified] => 2022-08-08 16:44:40 [post_modified_gmt] => 2022-08-08 14:44:40 [post_content_filtered] => [post_parent] => 0 [guid] => https://bg.legal/?p=31579 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [7] => WP_Post Object ( [ID] => 31582 [post_author] => 6 [post_date] => 2022-08-08 16:31:46 [post_date_gmt] => 2022-08-08 14:31:46 [post_content] => The European Commission has proposed a legal framework on Artificial Intelligence (‘AI’). This AI Act proposes a risk based approach with clear requirements and obligations regarding specific uses of AI. More specifically, the AI Act defines 4 levels of risk in AI: (i) Unacceptable risk, (ii) High risk, (iii) Limited risk and (iv) Minimal / No risk. All AI systems need to be categorized, based on a self-assessment, in one of these levels. Most of the AI systems used in Pharma will probably either fall within level III or IV. If the AI system forms a component of a product (e.g. the Central Nervous System App in the ICMRA report[1]) it will probably be considered a high risk level AI System. As a result, these AI systems will be subject to strict obligations. For example:
  • Adequate risk assessment and mitigation systems;
  • High quality of the datasets feeding the system to minimize risks and discriminatory outcomes;
  • Logging of activity to ensure traceability of results;
  • Detailed documentation providing all information necessary to the system and its purpose for authorities to assess its compliance;
  • Clear and adequate information to the user;
  • Appropriate human oversight measures to minimize risk;
  • High level of robustness, security and accuracy.
Moreover, as key risks for AI related to health are mentioned[2]:
    • Bias in training data may lead to discrimination and individual injury/death (i.e., racial bias may lead to incorrect diagnoses) and deepen existing socio-economic inequalities;
    • Technical system errors in AI could lead to mass patient injuries because of widespread use; Increased use and sharing of health data threatens privacy and data protection rights of patients;
    • Lack of transparency and explainability threatens patients’ rights to information and to informed consent to medical treatment;
    • Issues with cybersecurity threaten patients’ health in the case of cyberattacks on for example insulin pumps and pacemakers.
     
It is therefore suggested to classify all health-related AI systems as ‘high risk’ as referred to in Annex III of the AI Act (i.e. public health, pharmaceuticals and wellbeing).

AI regulatory sandbox

The proposal for the AI Act also introduces the instrument of the AI Regulatory Sandbox. This is “a controlled environment that facilitates the development, testing and validation of innovative AI systems for a limited time before their placement on the market or putting into service”. The benefits of a regulatory sandbox in pharma are:
  • Early involvement of the regulator (aim of mutual learning and adaptation)
  • Faster adaptation of current regulations to suit the new product or service.

Contact

For more information in relation to (legal aspects of) AI, please contact Jos van der Wijst. [1] ICMRA, Informal Innovation Network, Horizon Scanning Assessment Report – Artificial Intelligence, 6 August 2021 [2] https://haiweb.org/prioritise-health-in-the-artificial-intelligence-act     [post_title] => AI Act and Pharma / Health [post_excerpt] => [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => ai-act-and-pharma-health [to_ping] => [pinged] => [post_modified] => 2022-08-08 16:37:32 [post_modified_gmt] => 2022-08-08 14:37:32 [post_content_filtered] => [post_parent] => 0 [guid] => https://bg.legal/?p=31582 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [8] => WP_Post Object ( [ID] => 31410 [post_author] => 68 [post_date] => 2022-07-27 11:09:03 [post_date_gmt] => 2022-07-27 09:09:03 [post_content] => It has become lucrative for businesses to generate revenue through sourcing and purchasing goods elsewhere. However, these businesses must also be aware of the accompanying risks in doing so. If the purchased goods constitute an infringement of intellectual property rights of a third party, the purchaser could be held liable for the damages resulting from this infringement. In a recent case, this issue is addressed by the court of appeal (hereinafter: the Court) in the Hague. This blog post discusses this particular case and more specifically what a purchasing company could do in order to guard itself against liability in case an IP infringement occurs.

Case facts

Van Caem Sports (hereinafter: VCS) is a store specializing in sports goods. In 2013 VCS purchased Converse shoes from EN-S Sports (hereinafter: EN-S) twice. Subsequently, Converse sued VCS for trademark infringement and ordered VCS to pay the damages for the sale of the infringing shoes. The issue in the present case was whether the infringing shoes were supplied by EN-S and whether EN-S is obligated to indemnify VCS for the damages it must pay as a result of the trademark infringement. In the ruling at first instance, VCS's claims were rejected as VCS was unable to provide sufficient evidence. VCS only submitted unverifiable statements from its Business Controller and CFO, but no verifiable data from its records showing the path taken by the two batches of shoes supplied by EN-S. After that, VCS lodged an appeal.

The Court’s decision

This time around, the Court held that VCS had succeeded in proving that the shoes originated from EN-S. The trademark infringement in the main case was not based on the fact that the shoes were counterfeit, but on the fact that the shoes had not been marketed by Converse in the EEA. As a result, the question of whether the shoes were counterfeit was not of relevance. Since the Court was of the opinion that no exhaustion of trademark rights had taken place, the shoes were not freely marketable in the EEA. Moreover, the Court ruled that EN-S is obliged to indemnify VCS on the basis of the indemnification statement and a closed chain of administration. As EN-S could not further invoke VCS's own fault or estoppel, the Court was of the opinion that the claims of VCS are admissible if EN-S does not succeed in providing evidence to the contrary.

Conclusion

This case clearly shows that it is of utmost importance that a purchasing party is able to provide evidence that the infringing goods seized are the same goods sold and delivered by the contracting party. In the present case, the Court ought the indemnification statement including a lawyer’s letter and a closed chain administration to be sufficient as evidence. At BG.legal we can help you gather this evidence by, inter alia, drafting an indemnification statement including a lawyer's letter as well as assisting in the establishment of a closed chain of administration. If you have any questions regarding IP infringements and damages for purchasing parties, please do not hesitate to contact us. Britt van den Branden nieuw 1 [post_title] => Indemnification and IP infringement: a matter regarding shoes [post_excerpt] => [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => indemnification-and-ip-infringement-a-matter-regarding-shoes [to_ping] => [pinged] => [post_modified] => 2022-07-27 11:10:14 [post_modified_gmt] => 2022-07-27 09:10:14 [post_content_filtered] => [post_parent] => 0 [guid] => https://bg.legal/?p=31410 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [9] => WP_Post Object ( [ID] => 30442 [post_author] => 61 [post_date] => 2022-06-01 09:31:11 [post_date_gmt] => 2022-06-01 07:31:11 [post_content] =>

When processing personal data, the controller must adhere at all times to the principle of transparency. In practice, this means that data subjects should be adequately informed about the different processing activities that might take place using their personal data. More often than not, this information is provided by means of a privacy policy. In this blog by Stan Elsendoorn, we shall take a closer look at the specific information that needs to be provided, as well as the core values that need to be taken into account when drawing up a privacy policy.

General requirements

Article 12 of the GDPR lists several requirements that should be kept in mind when writing a privacy policy. Each of these requirements shall be further explained below. I. Concise, transparent, intelligible and in an easily accessible format The information needs to be presented/communicated efficiently in order to avoid information fatigue, whilst also being intelligible, meaning that the information is comprehensible by the average member of the intended audience. II. Written in clear and plain language The information should be provided in as simple a manner as possible, avoiding complex sentences and language structures. Abstract or ambivalent terms which could leave room for different interpretations should be avoided. When targeting children, the controller should also ensure that the vocabulary, tone and style of the language used to communicate the information is appropriate to and resonates with children.[1] III. Delivered in a timely manner The information must be provided in a timely manner. The specific time frame depends on the manner in which the personal data are obtained: when the personal data are directly obtained or collected from the data subject, the information should be provided directly after obtaining the personal data. When the personal data are obtained from third parties or other sources, the general rule is that the information should be provided within a reasonable time period and no later than one month after obtaining the personal data. This one-month time limit can be curtailed in the following situations: (i) when the first communication with the data subject takes place prior to the one month time frame, or (ii) when the personal data are disclosed to another recipient. In those situations, the information should (at the very latest) be provided at the time of the disclosure and/or first communication with the data subject.[2] IV. Provided free of charge Finally, it is not allowed to restrict access to a privacy policy through the use of a paywall or any other technical/financial means.

Necessary information

In addition to the aforementioned requirements, the following information – depending on the manner in which the personal data were obtained – should also be included when drawing up a privacy policy Necessary information when the personal data is directly provided by the data subject (article 13 GDPR) I. The identity and contact details of the controller; II. (Where applicable) the contact details of the data protection officer; III. The purpose and legal basis for the processing; IV. (Where applicable) if the legal basis for the processing is a legitimate interest of the Controller, a description of said interests; V. (Where applicable) the (categories of the) recipients of the personal data; VI. (Where applicable) if the controller intends to transfer the personal data to a recipient in a third country for which the EU has not (yet) adopted an adequacy decision, the appropriate and/or suitable safeguards taken; VII. The (criteria to determine the) period for which the personal data will be stored; VIII. Information on the existence of data subject’s rights, including the right to request access, rectification or erasure of the personal data, the right to restrict or object to the processing of personal data as well ass the right to data portability; IX. (Where applicable) if the legal basis for the processing activities is the consent of the data subject, the existence of the right to withdraw said consent at any given time; X. The right to lodge a complaint with the supervisory authority; XI. Whether the provision of personal data is part of a statutory or contractual requirement or obligation and the possible consequences of failing to provide the personal data; XII. (Where applicable) Information on the existence of an automated decision-making system, including profiling, including meaningful information about the logic involved, the significance as well as the consequences that the system’s automated decision-making might entail for (the rights of) the data subject. Obtained from third parties or other sources (article 14 GDPR) When the personal data are obtained from third parties or different sources, the privacy notice must contain the same information as mentioned above, with the exception of: XI. Whether the provision of personal data is part of a statutory or contractual requirement or obligation and the possible consequences of failing to provide the personal data  Which must be replaced by: XI. The source from which the personal data originate.

Conclusion

There are a lot of things to keep in mind when drawing up a privacy policy. One should not only take into account the aforementioned prerequisites, but also the way in which this information is conveyed to the data subject. In need of a privacy policy or other GDPR-documentation? BG.Legal offers a GDPR-starterkit that is specifically tailored to entrepreneurs. For more information, please check the following link. [1] WP29, Guidelines on transparency under Regulation 2016/679 (WP260 rev.01), 11th of April 2018, rec. 12 to 16. [2] Article 13.1 jo. 14.3 (a) to (c) WP29, Guidelines on transparency under Regulation 2016/679 (WP260 rev.01), 11th of April 2018, rec. 26 to 28. [caption id="attachment_29432" align="alignleft" width="240"] Stan Elsendoorn,[/caption] [post_title] => What information needs to be included in a privacy policy? [post_excerpt] => [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => what-information-needs-to-be-included-in-a-privacy-policy [to_ping] => [pinged] => [post_modified] => 2022-06-01 09:33:19 [post_modified_gmt] => 2022-06-01 07:33:19 [post_content_filtered] => [post_parent] => 0 [guid] => https://bg.legal/?p=30442 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) ) [post_count] => 10 [current_post] => -1 [in_the_loop] => [post] => WP_Post Object ( [ID] => 32215 [post_author] => 65 [post_date] => 2022-09-27 15:25:08 [post_date_gmt] => 2022-09-27 13:25:08 [post_content] => Recently, the Rotterdam District Court addressed the question whether an advertisement (“ad”) text on Bol.com (a Dutch variant of Amazon) is protected by copyright. The court mentioned a number of elements in which creative choices can be made in a text with objective content[1].

The dispute

Plaintiff sells BBQ gloves on Bol.com, and had an ad text written by a third party for its ad on the platform. Plaintiff also obtained the copyrights to the text. Defendant in this matter copied the ad text almost one-to-one in its ad for BBQ gloves. Even mistakes in the text were copied. The plaintiff summoned the defendant to stop infringing its copyright, after which the defendant partly changed the ad text. Defendant disputed that ad text can be protected by copyright. According to the defendant, the ad text is very general and basic, which means that it cannot have its own and original character.[2] And even if this should be the case, these rights do not – according to the defendant - accrue to the plaintiff. The plaintiff, on the other hand, believes that the creative choices made are in the length of the sentences, used word choices, sentence construction as well as the explicitly chosen information and bold text, how the information is represented and in the layout of the text.

Courts judgement

Copyright The court held that “a collection or certain selection of elements not protected in themselves, may be an (original) work, provided it bears the personal stamp of the creator.” The ad text contains factual information, but because it was incorporated into the text in a free and creative manner, the ad text enjoys copyright protection. The court also points out that the plaintiff was not asking for protection for some (enumerated) words, but for the text as a whole. Copyright holder The court does not go along with defendant’s defence that it does not appear that the third party has drafted the ad text for the BBQ gloves. However, the order confirmation clearly states that it concerns “Product description BBQ gloves Xamax”. The court concluded that the plaintiff must be regarded as the owner of the copyrights on the ad text. Is there infringement? Situation before the summons The defendant argued that his ad text was based on the ad text of the plaintiff on Bol.com, that he copied the text and adjusted it on some points. However, it appears that the defendant copied the text one-to-one, including the language errors in the text. The plaintiff made two adjustment, changing the trademark and the heat resistance from 500 °C to 800 °C. Thus almost a complete reproduction of the ad text. According to the court, it is established that the defendant has infringed the copyright of the plaintiff. Situation after the summons De court’s view is that after the adjustments in the ad text, the defendant has sufficiently deviated from the plaintiff’s text. Therefore, there is no infringement on the plaintiff’s copyright from that point onwards. Damages If the defendant had asked permission to use the ad text, the plaintiff would have charged a licence fee of € 140. This amounts to the price paid by the plaintiff for the ad text. Since it has been established that infringement has taken place, the court awards the damages determined at € 140. As the infringement was of a very short duration in combination with the ranking of the plaintiff’s ad against the defendant’s ranking, the court rejected damages for reduction of the exclusivity value of the ad. The plaintiff was in fact at the top of page 1 (of the 17 pages) with comparable gloves on Bol.com. In order to get to the defendant’s ad, one had to scroll far down. Profit remittance The plaintiff claims that the defendant has made a profit by using its ad text. According to the defendant, the consumer’s choice will be influenced by the ranking, brand and price of a product on Bol.com and not so much by the ad text. The court follows the defendant’s defence and rejects the profit remittance. In doing so, the court distinguishes the subjective and objective content of a text. The copyright protection is only applicable to the subjective form of the text, which in this case is characterized by the length of the sentences, used word choices, sentence construction as well as the explicitly chosen information and boldfaced text, how the information is represented and the layout of the text, according to the court.

The practical implications

An ad text consist of subjective and objective content. Only the subjective content of the ad text is eligible for copyright protection. Thus, if the factual information about a product is processed in the ad text by creative choices in, for example, the length of sentences, choice of words, sentence construction as well as the explicitly chosen information is displayed and in the layout of the text, the ad text can be protected by copyright. Do you have questions about copyright, want to have your ad text checked or want to take action against the use of your ad by someone else? Please do not hesitate to contact any of our specialists. [1] In this case, factual information regarding the offered product. [2] For a work to be protected under copyright, it is required for the work to have an own and original character and needs to bear the personal stamp of the creator, according to Dutch Copyright law. Mustafa Kahya nieuw 1 [post_title] => Copyright on advertisement text [post_excerpt] => [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => copyright-on-advertisement-text [to_ping] => [pinged] => [post_modified] => 2022-09-27 15:25:08 [post_modified_gmt] => 2022-09-27 13:25:08 [post_content_filtered] => [post_parent] => 0 [guid] => https://bg.legal/?p=32215 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [comment_count] => 0 [current_comment] => -1 [found_posts] => 57 [max_num_pages] => 6 [max_num_comment_pages] => 0 [is_single] => [is_preview] => [is_page] => [is_archive] => 1 [is_date] => [is_year] => [is_month] => [is_day] => [is_time] => [is_author] => [is_category] => [is_tag] => [is_tax] => 1 [is_search] => [is_feed] => [is_comment_feed] => [is_trackback] => [is_home] => [is_privacy_policy] => [is_404] => [is_embed] => [is_paged] => [is_admin] => [is_attachment] => [is_singular] => [is_robots] => [is_favicon] => [is_posts_page] => [is_post_type_archive] => [query_vars_hash:WP_Query:private] => 67d48224e84c62fb276234f54eeafc96 [query_vars_changed:WP_Query:private] => 1 [thumbnails_cached] => [stopwords:WP_Query:private] => [compat_fields:WP_Query:private] => Array ( [0] => query_vars_hash [1] => query_vars_changed ) [compat_methods:WP_Query:private] => Array ( [0] => init_query_flags [1] => parse_tax_query ) [tribe_controller] => Tribe\Events\Views\V2\Query\Event_Query_Controller Object ( [filtering_query:Tribe\Events\Views\V2\Query\Event_Query_Controller:private] => WP_Query Object *RECURSION* ) )
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