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Dr. Ute Kilger writes about the “Digitalisation of Medicine” in the trade magazine Plattform Life Sciences
The digitalisation of medicine – a challenge also for patenting
Artificial intelligence, augmented reality, robotics, machine learning and big data are the trends and challenges of our time and will also revolutionise our healthcare system.
But how can innovations in these technical fields be protected? What needs to be considered when patenting software-based processes? After all, therapeutic and diagnostic procedures on the human body as well as software are generally excluded from patentability in Europe.
BOEHMERT & BOEHMERT partner and patent attorney Dr. Ute Kilger deals with these questions in her article “Digitalisation of Medicine” in the March 2022 issue of the trade journal Plattform Life Sciences.
In this article, Dr. Kilger appeals to take these new challenges into consideration when drafting a patent application and summarises that corresponding technical expertise with regard to software, medical devices and life sciences will be indispensable in the future.
The article by Dr. Ute Kilger on page 44 of the journal is available online in German here.
Dr. Dennis Kretschmann and Dr. Michael Rüberg on the European Unitary Patent in legaleraonline.com
After almost 50 years of preparation, the European Unitary Patent could come into force in the close future. Optimistic voices assume an implementation in 2023 or already at the end of 2022.
But what do patent owners and managers of patent portfolios need to consider in advance? Will the future European Unitary Patent System only affect newly granted patents or also existing European (bundle) patents? Can patents invalidated in some European countries be maintained in other European countries? And are opt-out options available?
Patent attorney Dr. Dennis Kretschmann and attorney at law Dr. Michael Rüberg answer these and other questions in their article on the website of the Indian trade magazine Legal Era. In addition, they recommend that all patent owners and managers carefully review the patent portfolios of their companies in Europe and advise prompt strategic consideration of how best to benefit from the new system and which patents should be submitted for registration and which should not.
A short description of the historical development of the European Unitary Patent and the challenges on the way to its realization complete this informative article.
The article “The European Unitary Patent System is finally back on track and is now scheduled to arrive mid/end 2022 already” appeared on https://www.legaleraonline.com on December 20, 2021.
Recent German Court Decisions and Legislation shape the future of European Patent Litigation
The German Federal Constitutional Court has recently rejected two urgent applications directed against the creation of the European Unified Patent Court. If political support for the project continues and no further unexpected hurdles arise, the unitary patent could thus be – finally! – on the home straight and, according to optimistic estimates, could enter into force within the next 9 to 12 months. At the same time, legislation is overhauling the rules of national German patent litigation. The revised German Patent Act provides for a new and controversially discussed proportionality exception for injunctive relief as well as measures to accelerate patent nullity proceedings and to better align them with patent infringement proceedings.
The unitary patent on the home straight?
The European patent system so far only provides for a centralized grant procedure, resulting in a bundle of national patents. This may be about to change, and in the future the European Patent Office might also grant a genuine European patent with unitary effect in all participating member states (currently all EU members with the exception of Spain, Poland and Croatia). These patents shall in future be enforceable against patent infringers before a Unified Patent Court (UPC) with effect for all participating member states.
The first ideas for such a unitary patent already existed when the European Patent Office was established in the 1970s. Efforts have intensified over the past fifteen years, and since 2013 the relevant agreements to implement this idea have been in place and have already been ratified by numerous EU member states. However, the German ratification of the agreement on the UPC, which is essential for its entry into force, was held up twice by constitutional complaints, first in 2017 and then again in 2020. These complaints allege violations of the rule of law, of the fundamental right to effective judicial protection, as well as violations of EU law. The plaintiffs complained, in particular, that the judges at the Unified Patent Court are only appointed for a limited time period, so that judicial independence is not sufficiently guaranteed.
The Constitutional Court dismissed these complaints in June 2021. In the opinion of the Court, the plaintiffs were not able to prove that the organizational structure of the Unified Patent Court violated the rule of law, and to what extent this impaired the principle of democracy. After a four-year interval, the unitary patent has thus cleared a decisive hurdle. In August 2021, the German President already signed the German ratification bill into law.
However, some further obstacles on the way to realization remain. As a consequence of Brexit, the United Kingdom already withdrew from the UPC project last year. This poses organizational and legal challenges, because London is explicitly designated in the agreements as one of the three seats of the Unified Patent Court (alongside Paris and Munich). Germany has proposed a division of jurisdiction between Paris and Munich. In the Explanatory Memorandum, the German Federal Government argued that the withdrawal of the United Kingdom would not prevent the implementation of the Unitary Patent. The provisions of the agreements were to be interpreted in such a way that the withdrawal of a member state, which could not be foreseen by anyone, did not prevent the entry into force for the remaining participants. In addition, the agreements were to be interpreted in such a way that, in the event of the London seat ceasing to exist, its responsibilities could be taken over by Paris and Munich, at least on a transitional basis. France, on the other hand, would prefer to consolidate in Paris. Several other countries have also signaled their interest in taking over the London seat. Italy, for example, has brought Milan into play and has pushed for a corresponding revision of the agreements. Even though the political will to move ahead apparently remains strong, we might still see some heated discussions on the details of the implementation.
Moreover, preparations for the establishment of the Unified Patent Court and the selection of judges have come to a standstill due to Brexit and the German constitutional complaints. This work now needs to resume as soon as possible, but might still take several months, according to estimates published by the Preparatory Committee.
Germany has deliberately postponed the deposition of the ratification bill with the Council of the European Union, to delay the start of the UPC system until the preparations are complete. Despite the remaining obstacles, optimistic voices believe that the unitary patent could become a reality within the next 9 to 12 months – a manageable timeframe given the 50 years of preparations.
If the unitary patent system finally comes into existence sometime in 2022 or 2023, patent owners will face tough decisions if and how to use it.
After the system will have started to operate, unitary protection can be requested within one month after grant of a European patent, without an extra fee. But you should be aware that the UPC system not only affects newly granted European patents, but all existing European (bundle) patents in countries that have ratified the UPC Agreement. By default, they will all be subject to the jurisdiction of the UPC. There will be a transitional period of at least seven years (possibly extended by another seven years) during which patent owners can opt out of the new system, but this requires an active filing of an opt-out request. Patent owners will be able to file their opt-out requests in a “sunrise period” even before the UPC Agreement comes into force, to avoid being trapped in the new system by commencing litigation.
Should you request unitary protection? Should you opt out your existing patents? It’s a tough decision that depends on many factors, including the costs of validating and maintaining the unitary patent (moderate) and the costs of litigating patents before the UPC (probably also moderate), but also your faith in a completely new court system without any case law to rely on. Many big filers have vowed to make use of the new system, but may decide to opt out their crown jewel patents, at least for the start.
Hardship exceptions for injunctive relief and faster nullity proceedings – the reform of the German Patent Act enters into force
While Europe is preparing for the unitary patent, Germany is currently overhauling its national patent litigation system, in an attempt to cure some perceived imbalances.
Injunctive relief is the sharpest sword in German patent infringement proceedings. If an infringement court has found a patent infringement, it not only orders the patent infringer to pay damages for past infringing acts, but also rules that the infringing product must be removed from the market and that the infringing process may no longer be carried out.
This mandatory or quasi-automatic injunctive relief has come under increased criticism by parts of the industry. In particular, the telecommunications industry and the automotive industry with their suppliers see a risk of abuse when the patent-infringing product is only a small and subordinate component of a complex overall product, for example a mobile phone chip installed in a car, but the injunctive relief ultimately affects the overall product. In these constellations, the threat of injunctive relief means that the patent infinger often has to grudgingly accept excessively high license fees in order to avoid a production stoppage and the associated enormous costs.
The revised Patent Act now explicitly provides for a proportionality test for injunctive relief in Sec. 139 (1):
“The claim for injunctive relief is excluded to the extent that the claim would lead to disproportionate hardship for the infringer or third parties not justified by the exclusive right, due to the special circumstances of the individual case and in accordance with the principle of good faith. In this case, the infringed party shall be granted appropriate compensation in money. The claim for damages pursuant to paragraph 2 shall remain unaffected. “
The Utility Model Act was amended correspondingly. For the first time, the amendment expressly provides for the possibility of an exclusion of the injunctive relief if this would lead to unjustified hardship for the infringer himself, or for third parties. In such a case, the infringer could, for example, be granted a conversion period or sell-off period by the court, which would allow him to continue to market the patent-infringing product, at least temporarily. In extreme cases, the injunctive relief could even be permanently excluded.
Most commentators, however, expect the infringement courts to use the new rule with extreme restraint and to limit it to special cases of hardship. Voices from the judiciary also point out that the new rule merely explicitly codifies in the Patent Act what they were already able to rule anyway by applying the case law of the Federal Court of Justice. In its “Wärmetauscher” (“heat exchanger”) decision (case ref BGH X ZR 114/13), the Federal Court of Justice already held in May 2016 that the patent infringer may be granted a grace period in exceptional cases. The Federal Government’s explanatory memorandum also emphasizes the exceptional nature of the hardship provision. In this respect, the decision-making practice of the infringement courts may not change much at all. However, the exception will presumably be invoked by the defendants more frequently in the future than in the past.
How the additional monetary compensation provided for in the amendment to Sec. 139 (1) will be structured remains to be seen in practice. In particular, it is still unclear, and a topic of heated debate, whether this compensation is higher than the claim for damages to which the patent proprietor is entitled anyway.
Another significant and much less controversial reform concerns the streamlining of the patent nullity proceedings in order to better align them with the patent infringement proceedings.
In German patent infringement proceedings, the alleged infringer can only defend himself by claiming that he does not infringe the patent, for example, because his product differs from the patented solution or because he is entitled to use the invention. However, if he wants to claim that the patent was wrongly granted, for example that it is not novel or obvious in view of the prior art, he must attack the patent in separate nullity proceedings before the Federal Patent Court. This is usually called bifurcation or separation.
Due to the role of the nullity proceedings, they usually already start with a considerable time delay compared to the infringement proceedings, and then even progress much more slowly. As a result, the alleged infringer often faces the unfortunate situation that the infringement court has already found a patent infringement before the Federal Patent Court decides on the validity of the patent many months later. Even the preliminary opinion of the Federal Patent Court, which the legislator had introduced with a previous reform in 2009, often comes too late to have an impact on the infringement proceedings. In the meantime, under the pressure of the threatened injunctive relief, the patent infringer may already have felt compelled to agree with the patent proprietor on a high royalty payment, even though the patent would ultimately have turned out to be invalid.
In order to remedy this deficiency (sometimes known as the “injunction gap”), in the future the patent proprietor must submit his defense arguments against the nullity action already within two, in exceptional cases at the latest three months after service of the nullity action, and the Federal Patent Court should prepare its preliminary opinion at the latest six months after service of the nullity action. In typical case constellations, these deadlines should result in the infringement court having the preliminary opinion of the Federal Patent Court at hand before its decision on the patent infringement. The infringement court could then suspend its proceedings on the basis of the preliminary opinion, until the final decision in the nullity proceedings.
This approach is promising and could synchronize the patent nullity proceedings with the patent infringement proceedings much better than before. However, its success essentially presupposes that the Federal Patent Court will be in a position to issue its preliminary opinions quickly and in a reliable quality, and that the speed-up at the initial phase of the nullity proceedings will also translate into a shorter time to final judgement. This might become the acid test for the new system.
G 4/19 – Confirmation of the prohibition of double patenting before the EPO
In its most recent decision G 4/19, the Enlarged Board of Appeal of the European Patent Office deals with the so-called prohibition of double patenting. The Board confirms therein that a European patent application may be refused if it claims the same subject-matter as a European patent, granted to the same applicant, which is not part of the state of the art. This applies irrespective of whether the application to be refused was filed on the same day as the European patent already granted, is a parent or divisional application thereof or claims the same priority as the European patent already granted.
Previous practice
The prohibition of double patenting is based on the assumption that the applicant has no legitimate interest in granting of a second patent for the same subject-matter for which he already owns a patent.
The European Patent Convention (EPC) does not contain any explicit provisions on the prohibition of double patenting. However, such a prohibition was derived from general principles of law (“Ne bis in idem”), for example in an “obiter dictum” in decisions G 1/05 and G 1/06. Under Art. 125 EPC, principles of procedural law generally recognized in the contracting states may be used in EPO decision-making practice, provided that corresponding provisions are not provided by the EPC.
The problem of a possible double patenting may arise for the following three situations:
- (1) Two applications containing at least one identical claim are filed on the same date.
- (2) At least one claim of a parent application and a divisional application derived therefrom are identical.
- (3) At least one claim of a first application and a subsequent application claiming the priority of the first application are identical.
A practical interest of the applicant in double patent protection exists in particular in the third of the mentioned situations. The term of a patent is 20 years. The relevant date for calculating the term is the filing date of the application, but not its priority date. This means that the maximum term of protection of a subsequent application filed one year after a first application and claiming its priority ends 21 years after the filing date of the first application. In other words, an effective extension of the term of protection by one year can be achieved for the subject-matter claimed in the subsequent application.
G 4/19
The question brought before the Enlarged Board of Appeal was whether a European patent application can actually be refused with reference to double patenting and, if so, whether a distinction must then be made between the above three possible situations. In particular, the question was raised whether in the practically very relevant third case (application and its priority application) a legitimate interest of the applicant in double patenting would result from the fact that the filing date and not the priority date is decisive for calculating the term of the patent.
The Enlarged Board of Appeal initially affirms that a European patent application can be refused with reference to double patenting. A prohibition of double patenting could indeed be derived from the legislative history of the EPC and can be applied under Art. 125 EPC.
Nor was it necessary to distinguish between the three situations outlined above. From the “travaux préparatoires”, i.e. the official records of the history of the proceedings of the EPC, it would be clear that the legislator did not want to distinguish between these cases. Therefore, the question of a legitimate interest of the applicant in double patenting could also remain unanswered in the case of an application and its priority application.
Conclusion
The decision follows the established practice of the EPO on the prohibition of double patenting, in particular the decisions G 1/05 and G 1/06. It makes explicitly clear that the prohibition of double patenting can indeed be applied under the EPC and also applies to an application and its priority application. The fact that the Enlarged Board of Appeal leaves the question of a legitimate interest of the applicant in a second patent in such a case unanswered is to a certain extent unsatisfactory. Such an interest would probably not have been easily to deny in the light of the effective extension of the term of the patent.
The decision also leaves open when two claims relate to “the same subject-matter” and therefore fall under the prohibition of double patenting. According to established practice, an application is refused with reference to the prohibition of double patenting only if the scope of protection of the claims is identical. Overlapping scopes of protection of non-identical claims, on the other hand, are generally regarded as uncritical.
Even if this question remains unanswered in the decision, it can probably be assumed, in accordance with established practice, that the prohibition of double patenting is still to be interpreted narrowly and thus remains limited to identical claims. This is also supported by the fact that the reasoning of the decision distinguishes between “double protection” (overlapping claims) and “double patenting”.
Dr. Dennis Kretschmann on the European unitary patent and the reform of the German patent law in the magazine “The Patent Lawyer” and on the website of the “4iP Council”
After decades of effort, the European unitary patent seems to be on the home straight. The purpose of the project, which was already envisaged in the 1970s, is to be able to enforce patents before a Unified Patent Court (UPC) with effect for all participating EU member states. After significant delays due to Brexit and constitutional complaints filed against the German ratification, the preparations have recently resumed, and the unitary patent system is currently expect to swing into action in late 2022 or early 2023. In parallel, Germany is currently revising its national patent litigation system and provides for a proportionality test for injunctive relief and an improved interplay between the infringement proceedings and the nullity proceedings.
BOEHMERT & BOEHMERT partner and patent attorney Dr. Dennis Kretschmann devotes his detailed article “Recent German Court Decisions and Legislation shape the future of Patent Litigation” to these two trend-setting topics in the current issue of the professional journal “The Patent Lawyer” as well as on the website of the European Research Council “4iP Council”.
The article is published in English on page 71 of the September / October 2021 issue of the journal The Patent Lawyer and is available as a PDF here. Visitors to the 4iP Council website can download the article here.
“Patents in Engine Development” – Contribution by Dr. Giulio Schober at the 3rd Freiberg Colloquium on “Electric Drive Technology”
What industrial property rights are there? How do you apply for a patent and what protection does it provide? BOEHMERT & BOEHMERT patent engineer Dr. Giulio Schober answers these questions in his contribution “Patents in Engine Development” to the 3rd Freiberg Colloquium “Electric Drive Technology”.
The article begins with a brief overview of the patent as a technical property right and its differentiation from other industrial property rights such as utility models, trademarks and designs. It further outlines some strategies for filing and utilizing patents, especially for start-ups. Finally, the basic structure of a patent application is explained on the basis of the historically important patent “Anker für Wechselstrommotoren” (armature for alternating current motors), which deals with the three-phase asynchronous motor with squirrel-cage rotor.
Dr. Schober’s article was published in the conference proceedings of the 3rd Freiberg Colloquium on “Electric Drive Technology” at the Technical University Bergakademie Freiberg and is available online in German here.
New Article by Prof. Dr. Heinz Goddar on “Dependent Patents in SE Asia” in Les Nouvelles
In his article “The Fate Of Dependent Patents In Cambodia, Laos, Myanmar, Thailand, And Vietnam – A Comparison With The Situation In Germany And India”, BOEHMERT & BOEHMERT partner and patent attorney Prof. Dr. Goddar and co-author Chandavya Ing. look at the legislation and practice regarding dependent patents in the countries of Cambodia, Laos, Myanmar and Vietnam, including a comparative view of the situation in Germany and India.
According to the authors, a compulsory licensing system exists in most Southeast Asian countries, but compulsory licences are rarely issued there, and when they are, it is in connection with the patenting of pharmaceuticals.
As a result of this practice, Prof. Dr. Goddar and Chandavya Ing. see a hindrance in the development of new innovative technologies. With a view to preserving the balance between the rights of the right holder of the earlier patent and the rights of subsequent users, the authors recommend an increased use of compulsory licensing to encourage inventions as well as to enable technology transfer for the economic benefit of all.
The article by Prof. Dr. Goddar and Chandavya Ing. appeared in the September 2021 issue of Les Nouvelles on pages 250 to 254 and is available to registered users here.
Dr. Jan B. Krauß as co-author of scientific article on therapy of skin disease Epidermolysis bullosa junctionalis
In the context of his work at the University of Salzburg, BOEHMERT & BOEHMERT patent attorney Dr. Jan B. Krauß has published an article as co-author on the topic “Drug Development for Target Ribosomal Protein rpL35/uL29 for Repair of LAMB3R635X in Rare Skin Disease Epidermolysis Bullosa”.
In the scientific paper, atazanavir and artesunate are identified as candidate compounds that bind to the ribosomal protein rpL35. The compounds are currently being tested for their potential to trigger a rpL35 ribosomal switch to increase the production of full-length Lamb3 protein from a LAMB3PTC mRNA. This serves as a targeted systemic therapy in treating the rare genetic blistering skin disorder severe junctional epidermolysis bullosa.
Dr. Krauß published the article together with A. Rathner, P. Rathner, A. Friedrich, M. Wießner, CM. Kitzler, J. Schernthaner, T. Karl, F. Lottspeich, W. Mewes, H. Hintner, JW. Bauer, M. Breitenbach, N. Müller, H. Breitenbach-Koller and J. von Hagen.
It may be read in the July 2021 issue, Vol. 34, No. 4, of the scientific journal “Skin Pharmacology and Physiology” published by S. Karger AG and can be purchased here.
