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U.S. – What does the Impression Products v. Lexmark decision mean for drug companies? 5 takeaways

Last May, the U.S. Supreme Court issued a highly-anticipated decision in Impression Products, Inc. v. Lexmark Int’l, Inc., reversing the Federal Circuit and holding that, when a patent holder sells a product, it exhausts all of its patent rights in the product, regardless of certain restrictions that the patent holder sought to impose on further resale. The Court held that exhaustion applies whether the product was sold internationally or within the United States, such that the patent holder may not bring an infringement claim for otherwise-infringing activities once the product has already been sold by the patent holder or its licensee authorized to do so.

On its face, the decision presents a number of challenges for drug companies, who, on the one hand, frequently commercialize their products through complex networks with multiple tiers of licensees and distributors, and on the other hand, seek to impose limitations on the jurisdictions and fields in which their licensees and distributors may sell their products. Here are five takeaways for drug companies in light of the Lexmark decision:

Your patents don’t provide quite the protection they used to. The Supreme Court’s decision takes from patent holders a right that they enjoyed under the Federal Circuit’s original holding, namely, the right to bring certain patent infringement lawsuits against a purchaser outside the U.S. that carries out post-sale infringing activities inside the U.S.. In light of the Lexmark decision, the patent holder might have a breach of contract claim against certain purchasers, but not an infringement claim.

You can still enforce your patent against your licensee. The Lexmark decision goes to some lengths to clarify that a licensee (who is not itself a purchaser) may still be subject to restrictions such as a specific territory or a particular field, and that only an authorized sale by the licensee (or patent holder) exhausts the patent holder’s IP rights. The patent holder can still assert infringement against a licensee who engages in activities outside the scope of its license, and can still enforce its patent against persons buying through the licensee where the patent holder has not given authority to the licensee to make the sale. The latter point raises the question of what constitutes an authorized sale. For example, what if the downstream customer believed in good faith that the sale was authorized? And can a subsidiary selling under a foreign patent extinguish domestic patent rights by authorizing a foreign sale? The Court did not explore these questions, aside from reaffirming that a sale by a licensee in accordance with the terms of a license is effectively authorized by the patent holder. Continue Reading

SSAC gives the thumbs down to the use of emoji in domain names

Emoji, the pictorial symbols typically presented in a colourful cartoon form, are nowadays being widely used on smartphones, in chat, in email applications and in social media.  Their increasing popularity has prompted the question of whether they could be used in domain names, just like other non-American Standard Code for Information Interchange (ASCII) letters (e.g. Han, Cyrillic and Arabic) used in internationalized domain names (IDNs).  This regulatory ambiguity may be ended, however, by a recent advisory issued by the Internet Corporation for Assigned Names and Numbers (ICANN) Security and Stability Advisory Committee (SSAC) strongly discouraging the idea.

While it is already possible to register domain names with emoji at the second level under the country code Top Level Domain (ccTLD) .WS (Samoa), ICANN has not yet expressed its formal position on this issue.

In its advisory of 25 May 2017 to the ICANN Board on the use of emoji in domain names, the SSAC recommends that the ICANN Board reject any TLD (root zone label) containing emoji and, more generally, strongly discourages the registration of any domain name that includes emoji in any of its labels. The SSAC also advises registrants of domain names with emoji that such domains may not function consistently or may not be universally accessible as expected. Continue Reading

Pharma advertising in Italy – Online publication of OTC medicinal products list, prices and reimbursability

The Court of Milan held in a Judgment recently handed down in the proceedings brought by Bayer S.p.a. against the generic manufacturer DOC Generici S.r.l. that online publication of over-the-counter (OTC) medicinal products in the manner specified in the proceedings is in breach of Italian law on advertising of medicinal products and amounts to an act of unfair competition.

Case details

DOC Generici S.r.l. (“DOC“) is an Italian manufacturer of generic medicinal products. DOC decided to give visibility to its portfolio of OTC generic medicinal products on the company website, listing information on its products such as the name of its generic medicinal products, the names of the corresponding reference medicinal products, their classification, price and reimbursability in Italy. Similar information was also published as an advertisement in an Italian magazine. Bayer contested that making available such information to the public, which included a reference to some of its products as reference medicinal products, was in breach of the law on the advertising of medicinal products. As a consequence, this behaviour also amounted to an act of unfair competition. DOC responded that the publication was exclusively intended to inform the public on essential data concerning the reimbursability of the products that corresponded to the regulatory information made available by the Italian medicines agency (AIFA) in the transparency list. Such list is compiled by AIFA in order to allow pharmacists to inform the consumers on the availability of a generic medicinal product having the same composition, dosage, pharmaceutical form and route of administration of a reference medicinal product. In that case, the reimbursability by the National Health System is limited to the lower price of the generic medicinal product.  DOC further argued that, according to Italian and EU law, trade catalogues and price lists cannot be regarded as advertising. By way of background, it is worth noting that advertising of OTC medicinal products in Italy is allowed only upon previous authorisation of the advertising message by the Ministry of Health. In the present case, such authorisation was not requested by DOC on the assumption that the information could not be deemed to be advertising.

The finding of the Court Continue Reading

Mexico: Cost-benefit analysis in trademark protection – Interview

International clients in Mexico should be considering solid strategies to protect their trademarks in this jurisdiction. Finding a good adviser is essential, not just from the legal side but also from an industry sector perspective, with local experience.

When taking the first step to secure protection in Mexico a frequent question is “how much is it going to cost me?”. On this point, the reality is that the cost-benefit of investing in trademark protection often far outweighs the alternatives, such as lawsuits.

In addition to trademark protection, clients should put in place training for their people in Mexico on trademark strategy and what they can and can´t do, always bearing in mind that the IP needs to be respected and protected.

Watch this interview with Bernardo F. Herrerias on Iberian Lawyer here

Visit our free LimeGreen IP know-how platform for more information on IP in Mexico

DSM Watch: Compliance deadlines for EU online Portability Regulation pushed back

In our 18 July blog we reported the then recently published key dates for compliance with the EU online Portability Regulation.   Following a correction published in the EU Official journal on 28 July 2017, those deadlines have been pushed back by just under two weeks.   A revised version of our blog post is below, with the new deadlines added.

In our 21 June blog we reported that the text of this, the first legislative proposal published by the Commission under the Digital Single Market strategy banner, had been finalised by the European Parliament and Council.  The Regulation on ensuring the cross-border portability of online content services in the internal market ((EU) 2017/1128), to give it its formal title, has now been published in the Official Journal of the European Union (on 30 June 2017).  That means the key dates for businesses providing portable online content services are now known.

These are:-

1 April 2018 (previously 20 March 2018): Regulation becomes applicable, with direct legal effect in all EU Member States.

Continue Reading on our GMCWatch bog

To learn more about the EU Digital Single Market (DSM), please visit our microsite dsmwatch.com

U.S. International Trade Commission Judge Theodore R. Essex Joins IP Litigation Practice at Hogan Lovells

We are delighted to welcome former U.S. International Trade Commission (ITC) Administrative Law Judge Theodore R. Essex to the Intellectual Property Litigation practice in Washington, D.C.

Appointed to the ITC bench in October 2007, Judge Essex has been at the forefront of intellectual property law issues for ten years, handling scores of Sec. 337 proceedings involving the world’s most valuable and renowned companies. He is the only person to have served as the President of both the Pauline Newman and Giles S. Rich American Inns of Court, which focus on the Court of Appeals for the Federal Circuit and the most significant intellectual property issues. Judge Essex also teaches and speaks extensively on intellectual property issues across the globe for such organizations as the American Intellectual Property Law Association, the Intellectual Property Owners Association, the Association of Corporate Patent Counsel, ChIPs (dedicated to the advancing of women in technology law and policy), the Korean Judicial Conference, the Beijing Taipei Conference, the International Judges Conference in Brussels, and the National Taiwan University, among many others. Judge Essex is a professorial lecturer in law at George Washington University Law School, and a co-author of a chapter on ITC Mediation in one of the ABA’s foremost books on alternative dispute resolution.

“Judge Essex has been one of the most well-known and respected judges at the ITC, not only for his judicial work, but also for regularly sharing his intellectual property insights with lawyers, judges, and scholars around the world,” said Celine Crowson, head of Hogan Lovells’ Intellectual Property, Media, and Technology practice in the Americas.

Read our full press release here.

First Cyberspace Court set up in China: the Chinese judiciary enters the digital age

China’s first Cyberspace Court was inaugurated on Friday 18 August in Hangzhou, Zhejiang Province. Going forward, this new court will handle all internet-related disputes in all districts of Hangzhou through a fully digitalized, online procedure. The establishment of a specialized cyberspace court in China’s internet capital Hangzhou is an encouraging step for the Chinese internet sector as well as for IP owners: it promises a more flexible procedure and higher quality judgments, handed down by specialist judges.

The new cyberspace court will draw on the existing experience of the Hangzhou courts, including the Court’s predecessor; the pilot e-commerce online tribunal. The courts and tribunal have collectively dealt with the largest – and still growing – number of internet-related cases in China: from 600 cases in 2013 to more than 10,000 in 2016. This large number of internet-related cases is mainly due to the fact that some of China’s largest internet companies are established in Hangzhou: companies such as Alibaba and NetEase have got their corporate headquarters in this metropolis.

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Digital Single Market: Draft Copyright Directive – What is the current state of the European ancillary copyright for publishers?

The ever-lasting discussion regarding the implementation of a European ancillary copyright for press publishers has now entered the next round. In March 2017, MEP Therese Comodini Cachia, who then was the rapporteur of the European Parliament’s committee on legal affairs (JURI), spoke out against such a right (report), after the Commission had envisaged such a right in the proposal for a new Copyright Directive (COM (2016) 593 final).

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UK Supreme Court case: criminal sanctions for trade mark infringement

R v M; R v C and R v T

The Supreme Court has held that the criminal sanctions under section 92(1) of the Trade Marks Act 1994 (“the Act”) will apply to the sale or so called “grey” market goods as well as counterfeit goods.

The Supreme Court’s judgment, handed down last week, is good news for trade mark owners who may be considering seeking criminal sanctions against unauthorised dealers in grey and counterfeit goods, in addition to any civil remedies, even if trading standards or the police are reluctant to take action. This could prove a useful weapon in a trade mark owner’s enforcement strategy, particularly where an importer of grey goods, weighing up the financial sanctions or risk of an injunction being imposed upon them under the civil system, has decided that the rewards outweigh the risks. The possible criminal sanctions include a fine or imprisonment for up to 10 years.

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