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LimeGreenIP News

Generic drugs taking hold in the Asian marketplace: STAT News interview

Aging populations and rising healthcare costs across Asia particularly in Japan have created new market opportunities for generic drug makers operating in the region. For originator drug manufacturers, that means increased competitive pressures, and a new urgency to protect patents. In this interview with STAT News, Tokyo partner Dr. Fred Ch’en explains the political and demographic changes fuelling changes in Japan and throughout Asia, and the practical impact on pharmaceutical companies doing business in the region.

Q: Broadly speaking, why are we seeing a trend towards generic drugs in Asia?

“The Japanese pharmaceutical market is the world’s second-largest (after the United States). Healthcare costs in the region have been spiraling, and the Japanese government has been encouraging the use of generic drugs with increased vigor over the past few years. That has created new incentive for generic companies to invest in Japan. And that creates new commercial problems for our originator clients.”

Q: What specific political pressures have spurred the proliferation of generics in Japan?

“To encourage adoption of more generic products, the government has set a target that by the autumn of 2020, 80 percent of non-patented pharmaceutical products (i.e. the generic share of the market replaceable by generics) should be generic (from around 56 percent currently). That means that regulators may arguably be more lenient with certain types of authorizations… and in the last three or four years we’ve had the impression that they may be becoming a bit more relaxed in granting generic marketing authorizations. It may also be that regulators are increasingly feeling the need to ‘do their part’ to manage costs by increasing access to generic drugs.”

Q: What other challenges are originator companies facing?

“One of the big trends we are seeing is that a lot of Japanese companies and, to a greater extent, international pharmaceutical companies and their Japanese subsidiaries are having their patents challenged. Generally speaking, Japanese companies don’t like contentious litigation and prefer to settle. But we’re still witnessing a huge increase in the number of preliminary injunctions and active litigation, especially in the life sciences sector.”

Q: How is defending a patent in Japan different than in the Western market?

“If you are litigating patents in a Western country, one of the first priorities is to engage an expert. You’ll look for someone in the relevant technical field who can help advise and inform your legal arguments, and also be presentable in court, in the sense of having appropriate gravitas, skill in explaining complex concepts, and the ability to respond effectively to cross-examination and detailed questioning. In Japan, the practices are far more paper-based. One might engage an expert to help with legal arguments for the purpose of a written brief, but his or her role is much less weighted towards performance at the hearing, providing oral explanations or educating the court.”

Q: Big picture, what should originator companies in Japan be thinking about?

“There’s an interesting new tension (in Japan) right now because typically the population prefers branded products. They’ve learned to trust originator products, but now they’re getting more information on the generic side. Indeed, we’re even seeing a surge in TV commercials involving well-known personalities that encourage the use of generic drugs. Originator companies need to be prepared to navigate that shift. I’d encourage them to seek early advice from members of their legal team with expertise in the region. These new challenges require not only sound interpretation of the law and of changing trends, but the ability to interpret unique differences on a cultural level as well.”

Watch the video here to learn more about patent trends in Asia and the legal issues facing the industry.

Advances in Polish IP law, part 1: Patents – Indirect infringement, limitation of scope & state of the art searches

The bill amending the Industrial Property Law, published on 14 November 2017, introduces important changes with respect to patent protection. The bill adapts the Polish provisions to the European Patent Convention, as well as the Patent Cooperation Treaty of 1970. The bill is presently being discussed within the Council of Ministers.

The bill stipulates, among other things, a broader scope of protection for patent owners. It covers the prohibition of supplying or offering to supply the means relating to the essential element of an invention which would make it possible to put the invention into effect. In practice, this opens up more opportunities for the originator pharma companies to enforce their patent protection. These provisions enable the originator companies to prevent third parties from knowingly supplying generic manufacturers with substrates, which in themselves, are not covered by patent protection, but can be used for a synthesis of the active substance which is considered the actual invention. This form of patent infringement (referred to as “indirect infringement”) has not existed in the Polish legal system thus far. Current regulations only enable entitled parties to prohibit third parties from making, using, offering, putting on the market, or importing for these purposes any product or process that enjoys patent protection. This protection also covers products directly obtained from this process.

Thanks to another amendment, entitled parties will now be able to request that the scope of patent protection is limited by way of amending patent claims. Currently, an applicant can only request this change before patent protection is granted. This new regulation partially applies legal instruments introduced by the European patent convention, under which entitled parties can request that the scope of protection is limited by amending the patent claims in the course of patent invalidation or opposition proceedings. This approach often saves a patent by limiting its scope.

However, disappointingly, the proposed changes to the Act are of a more limited nature. According to the bill, entitled parties can file a motion for limiting the patent only if the patent is not the subject of invalidation or opposition proceedings. In practice, this solution seems quite useless for a patent owner and does not respond to their needs, aimed at preserving their right to a patent in connection with precisely these proceedings.

The bill also stipulates the international-type search carried out by the International Searching Authority, a measure which can enable an applicant pursuing patent protection to obtain more detailed information on the state of the art, as compared to the results of a search conducted only by the national authority. The results of this search enable an applicant to determine any potential territorial scope of the patent protection within countries which are party to the Patent Cooperation Treaty.

We expect that, the bill will be passed before the end of 2018 but will report on further developments here.

The China Food and Drug Administration pushes forward on conditional approval and compassionate use of new drugs

On December 20, 2017, the China Food and Drug Administration (“CFDA“) released two draft documents for public comment:

(1) Conditional Approval for Urgently Needed Drugs Technical Guidance  (the “Draft Conditional Approval Guidance“); and

(2) Compassionate Use of Clinical Trial Drugs Administrative Measures (the “Draft Compassionate Use Measures” and, together with the Draft Conditional Approval Guidance, the “Draft CFDA Documents“).

The Draft Conditional Approval Guidance provides rules on the early use of new drugs where there is a pressing clinical need in China to treat patients in a critical clinical condition. As the name of the document suggests, the marketing of these drugs on the Chinese market is permitted on the basis of a conditional approval.

The Draft Compassionate Use Measures regulate the administration of clinical trial drugs to patients who are not enrolled in clinical trials in China, but who have an urgent need.

Please click here for the full article.

Hogan Lovells appoints IP partner Leopold von Gerlach as Chair

We are delighted to report that Hamburg-based Intellectual Property partner Leopold von Gerlach has been appointed as Chair of Hogan Lovells’ Board from 1 May 2018. Leo will serve in the post for three years. He takes over from London real estate partner Nicholas Cheffings who will have served two full terms as Chair, starting in May 2012. Nicholas will continue with his market-leading real estate practice.

Commenting on the appointment of Leo, Hogan Lovells’ current Chair Nicholas Cheffings said:

“Leo taking on the role of Chair is a natural step for him and for Hogan Lovells. Leo has been an excellent contributor to the Board as the elected representative for Continental Europe and he has a very deep sense of the culture, ethos and heritage of our firm.”

Says Leo von Gerlach:

“Hogan Lovells is uniquely positioned in the market – it has unrivalled strengths on both sides of the Atlantic and a strong shared single sense of identity based on common values which transcend national boundaries. As the elected Board member for Continental Europe it has been very impressive to see just how cohesive we are as a firm and how well we collaborate and innovate for the benefit of our clients – something which they see as truly distinctive for us.”

Leo first joined the Board in May 2014 as the representative for Continental Europe. As an accomplished IP litigator with extensive trial experience, Leo mainly acts against counterfeit and grey market goods, look-alikes, and other types of IP infringements. Leo is also a staunch contributor to LimeGreen IP News and continues to drive our IP Enforcement Focus series as well as giving many short video summaries of European cases before the courts.

His clients from various industries include The LEGO Group, Citi, eBay, PayPal, Estee Lauder and Gibson Brands. He has been named as ‘one of the leading names in trademark law’ by the World Trademark Review 1000 report and has also been commended by Chambers for his strategic approach to IP litigation. He and Washington, DC partner Cate Stetson led the 2015-2016 project to produce the consolidated history of the firm.

As a member of the Board Leo has served on the Partner Advancement Committee, working with other members of the Board and members of the firm’s International Management Committee on the promotion of associates and counsel to the partnership.

Heavy jail sentence handed down on illegal set-top boxes sellers in Hong Kong

On 28 December 2017, the District Court of Hong Kong handed down sentences varying from 21 to 27 months’ imprisonment against 3 individuals who took part in a scheme that enabled users of the “Maige Set Top Box” (the “Maige Box“) to view pay TV channels for free.  This case sets one of the heaviest custodial penalties imposed in Hong Kong for Internet piracy to date.

Copyright Infringement – sharing of decrypted signals

During the 2014 FIFA World Cup, the Hong Kong Customs & Excise Department (“HKCED“) located suspicious webpages promoting the “Maige Box” which claim to enable users to view paid TV channels without having to pay monthly subscription fees.  These illegal Maige Boxes were sold in a stall in Sham Shui Po at HKD2,500 (about USD320) each.  Once connected to the Internet, the Maige Box streams over 190 channels to users for viewing, among which 11 were paid TV channels. Essentially, these Maige Boxes circumvented the encryption protection that was applied to protect the copyright of the programmes of those paid TV channels.

Three individuals, were arrested and charged with 6 offences including providing a circumvention device or service, conspiracy to defraud and other violations against the Copyright Ordinance (Cap. 528).

One of the defendants was found to have acted upon the request of a Mainland Chinese individual to set up a signal transmission system in Hong Kong by subscribing for 7 paid TV accounts and installing 7 decoders at home. The transmission system then captured and sent decrypted TV channel signals to a server located in Mainland China, which were then streamed to individual Maige Boxes.

Considering the potential substantial loss caused to the paid TV operator (and after factoring in the defendants’ guilty pleas and assistance provided to the prosecution), the Court sentenced the three individuals to 21-27 months’ imprisonment.

Significance of the Case

Charges of “providing a circumvention device or service” and “conspiracy to defraud” are, for the very first time, successfully applied in the criminal prosecution of an online piracy case in Hong Kong. Hopefully, this decision sets the scene for more vigorous enforcement actions against illegal set-top boxes which have been troubling pay TV operators and content owners. It is also worth noting that in addition to or in lieu of criminal charges brought by the HKCED, it is also open for the aggrieved parties to take civil actions to claim and recover losses arising out of the infringement.

DSM Watch: Leaked JRC Study calls into question neighbouring right for press publishers

The evolution of a new neighbouring right for press publishers is currently the subject of wide and heated debate. The European Commission proposed such a right in Article 11 of its proposal for a new directive on copyright in the Digital Single Market (Draft Copyright DirectiveCOM(2016) 593 final). The European Parliament’s first approach to this proposed right has been rather skeptical. The Legal Affairs (JURI) committee’s initial report merely proposed a statutory presumption of representation of authors of literary works contained in press publications and the publishers’ legal capacity to sue in their own name when defending the rights of such authors. JURI’s position however changed somewhat when Axel Voss took over the role as rapporteur from Therese Comodini Cachia.

Most recently, we have now seen a leaked draft of a paper analysing the effect such a neighbouring right is likely to have if enacted. The Joint Research Centre (JRC) of the European Commission is authoring a paper headed “Online News Aggregation and Neighbouring Rights for News Publishers”. Although currently only a draft the message is however quite clear. JRC reaches the conclusion that “law can create a right but market forces have valued this right at a zero price”.

Background

Whether press publishers require their own rights in articles they publish, separate from the copyright of authors, is a question that has been in debate for quite some time. Germany as well as Spain have already passed legislation introducing such a neighbouring right for press publishers on a national level. Even though the provisions differ in the detail, the underlying thought is the same: press publishers have rights allowing them to participate in secondary use being made of their online publications, e.g. by news aggregators. Whoever goes beyond referencing so-called “snippets” (very short parts of the actual article) must obtain a license and pay a fee.

So far, neither in Germany nor in Spain has the concept worked out in practice. In other words, the press publishers have not been able to negotiate licenses that have generated any significant revenue. News aggregators and search engine providers have refused to pay for the content they are gathering. The core argument is that they are the ones generating traffic on the publisher’s websites and thereby making those sites more attractive for advertisements.

It is noteworthy that under German law, there is also a case pending before the European Court of Justice. A key question is whether the respective domestic provisions lack the necessary notification to the EU. Thus, the dispute is about the formal conformity of the law (see blog post).

The draft paper Continue Reading

.NL leads the way in the fight against malicious online activity

Malicious activities are an ongoing problem across the Internet and growth is increasing as a result of ever more sophisticated phishing attacks.  One ccTLD Registry that has demonstrated it is taking these issues very seriously is SIDN, the Registry for the .NL extension (Netherlands).

The Anti-Phishing Working Group (APWG) regularly publishes a Phishing Activity Trends Report which analyses phishing attacks reported to them by its member companies and its Global Research Partners, through the organisation’s website.

In the last quarter of 2017 the APWG released its Phishing Trends Report for H1 2017 and indicated some key findings:

  • Hundreds of companies are being targeted regularly, at least every few weeks, while a smaller number of companies are attacked intermittently.
  • Phishing attacks occurred most frequently in the payment, financial and webmail sectors.
  • There has been an increase in the number of phishing attacks using free hosting providers or website builders.
  • In the new generic Top Level Domains (gTLDs) and country code Top Level Domains (ccTLDs), much of the phishing activity was concentrated in a small number of domains.

The .NL registry operator SIDN also recently published an article on the subject called “A fight on three fronts”.  Abuse is a growing problem, according to Lilian van Mierlo, the Registration & Service Manager at SIDN, who states:

“There are some types of abuse that we used to get reports about maybe ten times a year, and now we’re getting a thousand reports about. Or more! It’s not just that there’s more abuse going on. The abuse is also becoming more sophisticated. Most phishing sites used to stand out a mile, with clumsy layouts and machine-translated text. Whereas a lot of them nowadays are hard to tell apart from the real thing”.

The article talks about the three measures that SIDN have implemented to fight abuse: Continue Reading

China: Annual online piracy crackdown campaign 2017: Results announced

The results of the 2017 edition of China’s annual online piracy crackdown campaign, called the “Sword Net Action” (剑网行动), were recently published. As we announced earlier, the 2017 crackdown campaign promised to take a heavy hand against the unauthorized online distribution of films, games, TV programs and other online copyrighted content.

The crackdown campaign was a joint effort of four ministerial bodies and resulted in the following measures: 1,655 infringing websites were taken down, 274,800 infringing links were deleted, 1.51 million of infringing works were confiscated, and 37 cases were transferred for criminal investigation.

We highlight some of the most interesting enforcement cases of the crackdown campaign below: Continue Reading

Welcoming new IPMT partners and counsel in 2018

We are delighted to announce our new Intellectual Property, Media & Technology (IPMT) partners and counsel. The promoted members of the IPMT practice span patents, trademarks, unfair competition, domain names, copyright, designs, trade secrets, and IPMT Transactions, and include representatives from the Americas, Asia and Europe. Their promotions are very much deserved and we wish them success in their new roles.

Firm wide, they form part of the 31 new partners and 38 new appointments to the role of counsel in offices across a network spanning Africa, the Americas, Asia, Australia, Europe and the Middle East. Hogan Lovells CEO Steve Immelt said:

“We are seeing real momentum with these promotions – in terms of diversity of our practices, our offices, by gender, and by ethnicity.   They represent the globally diverse nature of our business. I congratulate all those who were promoted and wish them every success as they continue their career with us.”

Meet our new IPMT partners

Meryl Rosen Bernstein – Meryl is based in the Washington DC metro area and helps internet, fashion, software, and pharmaceutical companies with a range of intellectual property and technology transactional matters. She co-heads the firm’s Global Retail, Consumer Products, and Fashion group and has expertise in sourcing, supply, distribution, sales and marketing arrangements. She also has significant experience handling life sciences acquisitions and transactions, including commercialization, collaboration and licensing relationships.  Having served as Assistant General Counsel at Gilt Groupe, the e-commerce company, Meryl also helps her clients with cutting-edge issues relating to their online marketing and sales initiatives, social media presence, and technology and distribution platforms.  She serves as President of the Board of Ellevate’s (global professional women’s network) Washington, DC Chapter.

Henrik Lehment – Henrik is based in Dusseldorf and advises on all aspects of intellectual property rights with a particular focus on patent law. Over recent years, Henrik has been heavily involved in the “smartphone wars” and helped his industry clients in litigation both against competitors and non-practicing entities. In the automotive sector, Henrik represents his clients both in cases concerning traditional automobile technologies as well as emerging technologies related to connected cars and automated driving.

Benjamin Schröer -Benjamin is a patent litigator who advises and represents clients from the telecommunications, automotive and mechanical engineering industries in patent infringement and validity cases. In addition, he advises clients in licensing negotiations relating to the case law on Standard Essential Patent (SEP) and Fair, Reasonable and Non Discriminatory (FRAND) patent licensing terms.

 

Helen Xia – Helen is based in Beijing and focuses her practice on contentious and non-contentious IP matters involving trademarks, copyright, patents, unfair competition and IP licensing. She has strong experience in IP litigation and has advised clients on administrative, civil, and criminal litigation involving IP infringement in China. Helen represents clients from a wide range of industries, including construction, mining, fashion, food, multimedia, telecommunications, computer and entertainment and is director of Hogan Lovells (Shanghai) Intellectual Property Agency Service Co., Ltd., an IP service affiliate established under Hogan Lovells International LLP.

Meet our new IPMT counsel

Yu-An Chang – Yu-An is based in Shanghai and has broad experience in advising on all aspects of brand and copyright protection and litigation, as well as IP and technology-related transactions.  He acts for a diverse range of IP owners in the region including consumer brands, and technology, healthcare, education and toy companies.  Yu-An regularly handles multi-jurisdictional IP enforcement actions and assists IP owners in negotiating and drafting IP licenses and commercial agreements.

 

Thorsten Klinger – Thorsten is based in Hamburg where he advises national and international companies on all matters of trademark and unfair competition law. He has particular experience in the strategic management of mid-size and large trademark portfolios, including the legal support of national and international product roll-outs and name clearances. Thorsten also focuses on online and domain name law, advising clients on their domain name portfolio and representing them in UDRP proceedings before WIPO. Thorsten has mainly helped companies from the telecommunications and IT sector, as well as from other innovation-driven technology branches.

Serena Lim – Serena is based in Hong Kong and her practice focuses on brand protection and enforcement. She acts predominantly for consumer brands including those in the food and beverage, fashion and retail industries, as well as pharmaceutical and technology companies. Serena helps brand owners with securing trademarks protection, either through negotiating co-existence agreements, reaching amicable settlements in the course of contentious proceedings, or simply dealing with difficult Registry objections. Serena acts before the Courts or Registry in infringement or passing off actions and other inter-parte proceedings. She also has extensive experience in dealing with issues posed by trademark hijackers, cyber squatters, shadow companies and counterfeiters. Serena is currently the Vice President of The Hong Kong Institute of Trade Marks Practitioners.

Fabian Pfuhl – Fabian is based in Frankfurt. He is well-known for his anti-illicit trade work, particularly in the pharmaceutical and consumer goods sector. Fabian’s enforcement practice focuses on defending his clients rights against any forms of black and grey market trades. His advice covers civil actions as well as criminal law aspects and customs measures. Based on his extensive experience in his field of expertise, Fabian maintains excellent relations with the criminal investigation and prosecution authorities. Since 2012, Fabian has been a lecturer at the Hochschule Darmstadt where he teaches License Law and Contract Design.

Vironika Pilyugina – Vironika is based in Moscow where she focuses on regional and global IP portfolio management and dispute resolution in sectors including consumer, life sciences and healthcare and automotive. She helps various Russian and international clients in trademark and patent litigation and advises on brand protection and enforcement strategies in Russia. Vironika represents clients before the Russian PTO and Chamber for Patent and Trademark Disputes under the Russian PTO as well as before the Russian courts and competition authorities.

Marcus Schönknecht – Marcus is an experienced IP litigator and advisor based in Dusseldorf. He specializes in patent law, including employee inventions law, as well as trade secrets, unfair competition, trademark, and design law. Marcus’ experience comprises a wide range of industry sectors including engineering, telecommunications, chemicals, and medical devices.

Stella Wong – Stella is based in London and is dual qualified as a medical physician and a solicitor. She predominantly advises pharmaceutical and medical device companies on complex multi-jurisdictional patent litigation, and she has also advised on some of the largest European technology patent disputes. Stella has developed a specialist knowledge in the field of 3D Printing. Stella has qualified as a Member of the Royal College of General Practitioners and still works as a general practitioner on Saturdays. She has been named a “rising star to watch” 2016 & 2017 in IP Stars directory of Managing Intellectual Property.

Ernest Yakob – Ernest is based in New York and with years of experience in both the lab and the law, he has unique insight into the complex patent issues facing his life sciences clients. He focuses on life sciences patent litigation in federal court and the U.S. Patent Trademark Office. He also routinely advises clients on a wide range of IP matters, including patent prosecution and opinions, and IP licensing and due diligence. In addition to being a registered patent attorney, Ernest holds a doctorate degree in microbiology and immunology from Albert Einstein College of Medicine, as well as academic degrees in molecular biology and chemical engineering.

Sites get ICEd in transatlantic assault on cyber crooks

As part of a sustained and coordinated effort, law enforcement agencies on both sides of the Atlantic have rounded off their on-going fight against cybercrime known as “Operation In Our Sites” with the traditional annual flourish on “Cyber Monday”.  In the U.S., and increasingly elsewhere, the Monday following “Black Friday” (the first Friday after Thanksgiving), which sees an avalanche of discounted consumer goods unleashed onto the public via the Internet, is known as Cyber Monday.  Hence, the day’s special resonance with the fight against cybercrime and counterfeiting.

Operation In Our Sites is a continuing effort to detect and combat intellectual property violations on the Internet – notably counterfeiting – commenced in 2014 by the U.S. government’s National Intellectual Property Rights Coordination Center (NIPRCC), a body managed by the U.S. Immigration and Customs Enforcement’s (ICE) Homeland Security Investigations (HSI) unit.  This year, in a joint initiative between (ICE), Europol, Interpol and industry members called “In Our Sites / Project Transatlantic VIII”, around 50,385 illegal domain names were seized and 320,701 e-commerce / social media links removed across the globe.

In the U.S., once seized, domain names associated with counterfeiting and fraudulent websites are redirected to the NIPRCC’s seizure banner which, the organisation asserts, “serves as a tool in educating the public about the perils of counterfeit items available on the Internet.”

Speaking about the importance of the operation, acting NIPRCC Director Nick Annan stated that: “Targeting copyright-infringing websites that market dangerous counterfeit goods to consumers and engage in other forms of intellectual property theft will continue to be a priority for law enforcement” going on to add that: “Strengthening our collaboration with police authorities around the world and leaders of industry will reinforce the crackdown on IP crimes, and demonstrate that there is no safe haven for criminals committing these illicit activities.”

On this side of the Atlantic, as part of the joint effort, the European Union Agency for Law Enforcement Cooperation’s (Europol) Intellectual Property Crime Coordinated Coalition (IPC³) seized more than 20,520 domain names that were selling counterfeit goods, a substantial increase on the 7,776 domain names seized over the first three years of the operation.  Europol put this down to “a global operation that saw a big range of anti-counterfeiting associations and brand owner representatives joining law enforcement authorities, facilitating international cooperation.Continue Reading