On 25 October 2018 the CJEU handed down its highly awaited ruling concerning the possibility of extending the European patent term extension provisions (briefly denoted "SPC") to drug-containing medical devices.
Background of this case was a referral of the German Bundespatentgericht (Federal Patent Court) facing the inconsistent SPC-granting practice of Member States in the interpretation of Article 2 of Regulation (EC) No 469/2009 (the so-called "SPC Regulation"): this Art. 2 defines the scope of the SPC Regulation and provides that any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as medicinal product, to an administrative authorisation procedure as laid down in the Medicinal Product Directive 2001/83/EC, may be the subject of a patent-extending certificate.
The referral concerned a German SPC application relating to a patent claiming a stent having incorporated the anti-proliferative drug paclitaxel (PTX) as an integral part. Since the stent is a medical device its EU market authorisation had to be made under a legal regime different from the Directive 2001/83/EC referred to in the SPC Regulation, namely by way of Directive 93/42/EEC concerning medical devices (and which ultimately lead to CE mark registrations). Accordingly, in the present case the SPC request was based on a CE-mark as a marketing authorisation. The decisive question was whether such CE mark registration of a medical device, with a drug incorporated into the device, is in conformity with Art. 2 of the SPC Regulation.
The Court of Justice of the EU (CJEU) now answered this question to the negative. It ruled that a CE-mark approval for a medical device comprising an active ingredient as an integral part can not be considered as an approval in accordance with the Medicinal Products Directive 2001/83/EC, even if the ingredient was assessed (in terms of safety and efficacy) during the consultation process. The CJEU reasoned that the terms ‘medicinal product’ and ‘medical device’ are mutually exclusive. According to the CJEU, the principle mode of action of the product should be taken in to account. A product is regarded as a ‘medical device’ if it does not achieve its principal mode of action by pharmacological, immunological or metabolic means. Accordingly, merely performing an ancillary function by carrying an active ingredient is not enough. Conversely, only a product which achieves its principal intended action in the human body by any such pharmacologically, immunologically or metabolically active means may be classified as a medicinal product within the meaning of Directive 2001/83 and thus amenable to SPC protection (provided that the other conditions for the grant of an SPC are met, including the requirement of a "first" marketing authorisation – which however would have failed in the present case since the drug paclitaxel was already subject to an earlier marketing authorisation).
As a result, under the current legal regime medical devices having obtained CE-mark approval, even if combined with an active drug substance, will under normal circumstances not be amenable to patent term extension by SPC protection.
While this is a message from the highest EU court disappointing for medical device developers who undertake much effort to obtain market approval, this ruling at least provides legal certainty under the present legal status. If the situation shall be improved for medical device owners the law makers are asked to amend the SPC Regulation to make clear and determine the requirements that medical devices shall be also covered, if so desired.
If you have further questions regarding this topic, we will be glad to assist you.
Jürgen Feldmeier, Managing Director of Prüfer & Partner, will attend the 18th General Assembly and the 68th & 69th Council Meetings of the Asian Patent Attorneys Association (APAA) from November 17 to 21, 2018 in New Delhi, India.
In addition to enriching committee meetings and workshops, patent and trademark attorneys from all around the globe having strong ties to Asian countries will have the opportunity to discuss upcoming IP issues in Asia with experts and help shape a strong IP for a better future.
Prüfer & Partner will take this opportunity to renew its collegial ties with IP professionals in Asia and around the world and to further extend its business network worldwide.
Upon invitation by the Tokyo-based Foundation for Intellectual Property, the Managing Partner Dr. Dorothea Hofer at Prüfer & Partner accompanied by associated Partner Dr. Christian Einsel had been given an opportunity to present lectures on September 28, 2018 at the premises of the Kanazawa Institute of Technology (K.I.T.) Graduate School Toranomon Campus in Tokyo.
Topics of the lectures had been "strategies of patent prosecution between the European and national routes particularly in terms of costs" (Dr. Einsel) and "the Unitary Patent System and the Unitary Patent Court" (Dr. Hofer). About 30 participants from various industry companies, patent firms and scientific or administrative organizations attended the seminar and experienced a lively discussion of the topics. Following the presentations, the plenum had been divided into subgroups to foster discussion on specific topics of interest and to allow networking and linkage between the participants. Finally, each of the subgroups presented their results and Dr. Hofer and Dr. Einsel addressed open questions in a panel discussion.
The lecturers were further accompanied by associated Partner Dr. Peter Klein, who supported the discussion, and Ms. Naoko Ritter, who furnished an excellent translation of the lectures into Japanese. The organizer of the seminar, Mr. Ginichi Yamaji, concluded that profound insights have been given by the lecturers and that both the filing strategy in Europe as well as the future outlook regarding the UPC emerge to be very important issues for Japanese companies for the time being. Given the innovative schedule of the seminar and the awesome commitment of the facilitator team, the feedback by the participants had been overwhelming.
Prüfer & Partner will attend the 3rd China Pharma IP Summit (CPIPS) from October 24 to 26, 2018 in Beijing, China. As one of the keynote speakers of the Summit, Dr. Andreas Oser, Managing Partner at Prüfer & Partner, will hold a lecture entitled "The Supplementary Protection Certificates in Europe and Potential Modification (Manufacturing Waiver) on October 25, 2018. In addition, Dr. Oser will chair a panel discussion in the afternoon on the same day about the topic "Patent protection and enforcement of first, second or further medical uses of known compounds and pharmaceutical products in Europe".
As a comprehensive and strategic event for the pharmaceutical and biotechnological industry in China, CPIPS provides the participants with a chance to follow the latest development of patent linkage, patent term extension as well as regulatory data protection in various jurisdictions. Further, differences and updated requirements of patent examination, invalidation, and litigation in China, EU, US, Japan and other regions will be discussed. Around 500 participants from pharmaceutical and biotechnological companies, Chinese government, law firms and IP agencies are expected to attend this year's event.
During CPIPS, Prüfer & Partner will host a booth (No. 6) to meet its partners and associates and to further extend its network in Asia and China.
After CPIPS, Dr. Andreas Oser will head for the Osaka Symposium of International Federation of Intellectual Property Attorneys (FICPI), the only international NGO whose membership consists exclusively of IP attorneys in private practice, from November 1 to 3, 2018 in Osaka, Japan.
普律丰专利律师事务所的高级合伙人Jürgen Feldmeier先生及Andreas Oser博士带领事务所的专利律师们一起热烈地欢迎了代表团的成员们。与会成员积极地探讨了中德两国专利律师职业的发展与进程，并就专利侵权及专利无效案例进行了仔细的探讨。宋健法官提到，中国在2017年里大约有3000件专利侵权纠纷案例，其中将近1000件专利被宣告无效。
Jürgen Feldmeier先生还给了代表团成员介绍了筹备中的欧洲统一专利法庭的最新进度。欧洲统一专利法庭是一个由25个欧盟国家一起联合推进的创建中的跨国法庭。法庭的核心法律即为成员国联合签署的《统一专利法院协议》。Jürgen Feldmeier先生还提到英国脱欧给创建中的欧洲统一专利法庭可能带来的影响。
Managing partner Dr. Dorothea Hofer and partner Mr. Alexander Lehmann attended this year's INTA Annual Meeting that took place May 19 – 23, 2018 in Seattle, WA.
It was a great opportunity for them to further strengthen our important and long-standing business relationships with associated law firms from all over the world and to meet professionals from various countries.
Dr. Hofer and Mr. Lehmann also attended several lecture events and workshops on current topics in order to provide best and newest advice to our clients. Particular attention was paid to the further development of patent and trademark protection in China, current developments in EU trademark law as well as Brexit and its effects on EU trademarks and EU designs.
Overall, it was a successful conference participation for Prüfer & Partner and we look forward to the 2019 INTA Annual Meeting in Boston, MA.
1. Third annuity fee can be paid earlier in the future
From April 1st, it will be possible to pay the third annuity fee six months before it will become due, instead of three months before as it has been possible up to now.
2. Abrogation of the reduced search fee for the supplementary European Search
The reduction of the search fee for the supplementary European Search where the International Search Report was drawn up by the United States Patent and Trademark Office (USPTO), the Japanese Patent Office (JPO), the Korean Intellectual Property Office (KIPO), the Chinese Intellectual Property Office (SIPO), the Federal Service for Intellectual Property (Russian Federation) or the Australian Patent Office will be abrogated.
3. Amendments of the Rules relating to Fees
* Under the condition, that the appellants expressly declare that they are a natural person or an entity covered by Rule 6(4) EPC.
On March 6, 2018, Prüfer & Partner held a seminar for IP professionals from Japan as part of the seminar series of "Munich IP Study Group" at the new branch office in the Ottostrasse in Munich, directly opposite the Munich District Court. The "Munich IP Study Group" consists of more than 50 members from Japan, who are predominantly working as IP professionals in Munich.
Our Partner and Patent Attorney, Dr. Christian Einsel, accompanied by Managing Partner and Patent Attorney Dr. Hofer and Patent Professional Ms. Naoko Ritter, gave a lecture about "Artificial Intelligence (AI): Impacts on Patent Law in Europe".
Thanks to the timeliness of this topic, the number of participants was above average and in addition, numerous guest listeners attended the seminar, who were not members of the group.
The lecture dealt in detail with concrete questions such as "What is an AI invention?", "How to assess the patentability of an AI invention?", "Who can be the inventor if an invention is created by an AI system?" and "What impact could AI have on the patent law in the future?"
The participants of the seminar gained extensive information and knowledge about the very latest topic and provided a positive feedback to our team, not only with regard to the topic but also with regard to the support and the pleasant atmosphere in our new premises.
We are looking forward to many more events in this context in our premises of our new office in the Ottostrasse in Lenbachpalais.
From January 26 – 28, 2018, the 8th China IP international Annual Forum & Annual Conference of In-house IP Managers in China was held in the JW Marriott Hotel, Beijing on the theme of "Transformation - Reinstalling the IP Value of Enterprises". More than 1000 IP professionals attended the conference, mainly from China but also from abroad.
Managing Partner, Mr. Jürgen Feldmeier, accompanied by Patent Professional Ms. Maggie Huang, has been invited as a guest speaker and gave a lecture about "Possibilities of IP Protection in Germany and Europe". Participants of the Forum provided a positive feedback to our Prüfer & Partner team because of the valuable information and insights given.