Innovation & Invention Yearbook - 2021 Building IP value in the 21st century - Life sciences patentability issues in Europe - Weickmann & ...
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Life sciences patentability issues in Europe
Christian Heubeck and Wolfgang Weiss
Weickmann & Weickmann Patent und Rechtsanwälte PartmbB
Innovation
& Invention
Yearbook
2021
Building IP value in the 21st century
Engineering Chemistry Trademarks
Life Sciences Designs
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Weickmann & Weickmann Patent und Rechtsanwälte PartmbB | Europe Life sciences patentability issues in Europe By Christian Heubeck and Wolfgang Weiss, Weickmann & Weickmann Patent und Rechtsanwälte PartmbB Potential conflict: patent protection and a known medical device cannot be patented via the public interest European patent system. In the fields of molecular biology, pharmaceutics, During the coronavirus pandemic, serious diagnostics and medical technology, great efforts concerns have arisen among the public regarding have been made in research and development whether the existing patent system is adequate for strategies to fight covid-19. Many of to meet the needs of providing protection these efforts are focused on new diagnostic against covid-19 for the whole population at methods, medicaments and vaccines, as well as reasonable costs. There are particular concerns that medical devices. medicaments or vaccines against the coronavirus New inventions in these fields may, of course, might be monopolised by patent owners and be protected by patents, thereby providing a limited to those who can afford to pay a very monopoly for the originators and prohibiting high price. competitors from entering the market. Under the While these concerns might not be completely European patent system, most of these innovations unfounded, we believe that they will play no major are subject to patent protection. This applies role, at least in the near future. First, the EU for novel chemical or biological compounds, patent system provides the legal option of suing including polypeptides such as antibodies or viral patent owners to grant a compulsory licence under antigens and nucleic acid molecules, irrespective a patent to third parties if they cannot meet an of whether these agents might be found in nature. urgent need for supplying the protected products, In addition, patent protection may be obtained applications or methods to the public. Second, for novel therapeutic applications of known in recent months, many countries have passed compounds and compositions. According to EPO emergency legislation allowing governments case law, any novel pharmaceutical use must be direct access to patented technologies in case of made plausible in the patent application (eg, by public need. Third, in the age of social media, experimental data). In case such experimental data patent owners are very careful to avoid giving the is unavailable, plausibility might be established by impression that, for financial interests, they will including a detailed study protocol of the claimed block the public’s access to greatly needed patented medical use. technologies. The present European patent system In the diagnostic field, in vitro methods may should be well equipped to handle the coronavirus be patented. For in vivo diagnostic methods, a crisis without the need of major revisions. different claim format directed at the diagnostic agent for an in vivo diagnostic method must be IP protection of AI-based inventions selected. As in most industries, AI is set to play In the field of medical devices, however, there an increasing role in the life sciences and is a protection gap in the European patent system. pharmaceutical industries. Presently, following While a medical device may be patented as such transport and telecoms, life sciences and (ie, as a product), a novel use or method involving IAM Innovation & Invention Yearbook 2021 61 www.IAM-media.com
Europe | Weickmann & Weickmann Patent und Rechtsanwälte PartmbB
“The basic principles for patenting AI-based methods
themselves are still in a discovery phase, but the EPO has
provided guidelines for applications directed at AI-based
methods in its Guidelines for Examination ”
pharmaceutical patent applications represent the According to Articles 52(2) and (3) of the
third largest group of AI-based patent applications. European Patent Convention (EPC), no
In general, the pharmaceutical industry uses European patent will be granted for mathematical
AI in research and development for analysing big methods, mental acts, computer programs or
data. Such AI-derived solutions are becoming presentation of information, among other things,
increasingly important when it comes to as they are not regarded as inventions. However,
significantly reducing time and costs. AI can process if a claim is directed either at a method involving
vast amounts of data, detecting and interpreting the use of technical means (eg, a computer,
patterns that were previously impossible to identify processor or storage media) or at a device, its
or even imagine. There is a wide variety of possible subject matter has a technical character as a whole
uses. For example, AI may be used for drug- and is therefore not excluded from patentability.
target identification and validation, phenotypic Technical character of a feature results either
drug discovery, identification of biomarkers, from the physical features of an entity or (for a
polypharmacology discovery and drug repurposing, method) from the use of technical means. General
among others. Such AI-based approaches are terms such as ‘support vector machine’ or ‘neural
also closely interrelated to another promising and network’ may, depending on the context, merely
highly relevant field of pharmacologic research – refer to abstract models or algorithms devoid of
personalised medicines. Do AI-based methods for technical character and do not, on their own,
analysing patents, patent applications, publications necessarily imply the use of a technical means (G-
and research literature provide for a strong, II, 3.3.1).
promising application? Merely specifying the technical nature of the
Of course, the results of AI-based methods data or parameters of the mathematical method
can often, in themselves, be the subject of patent may not be sufficient to define an invention in the
applications, such as newly identified drugs and sense of Article 52(1) of the EPC, as the resulting
biomarkers. The basic principles for patenting AI- method may still fall under the excluded category
based methods themselves are still in a discovery of methods for performing mental acts as such
phase, but the EPO has provided guidelines for (Articles 52(2)(c) and (3); see G-II, 3.5.1).
applications directed at AI-based methods in its It is legitimate to have a mix of technical and
Guidelines for Examination. non-technical features appearing in a claim, in
which the non-technical features may even form
General principles the predominant part of the claimed subject matter
According to the EPO Guidelines for (T 154/04; T 1784/06). Novelty and inventive
Examination, AI is based on computational step, however, can only be based on technical
models and algorithms for classification, clustering, features, which must be clearly defined in the
regression and dimensionality reduction, such claim. Non-technical features, to the extent that
as neural networks, genetic algorithms, support they do not interact with the technical subject
vector machines, k-means, kernel regression matter of the claim for solving a technical problem
and discriminant analysis. Such computational (ie, non-technical features ‘as such’), do not
models and algorithms are per se of an abstract provide a technical contribution to the prior art
mathematical nature, irrespective of whether they and are therefore ignored in assessing novelty
can be ‘trained’ based on training data (Guidelines and inventive step (T 154/04). If non-technical
G-II, 3.3.1). The general guidance provided for features belong to the general framework in
mathematical methods (G-II, 3.3) also applies to which the invention evolves, they may be used
AI-based methods. in formulating the relevant technical problem
62 IAM Innovation & Invention Yearbook 2021
www.IAM-media.comWeickmann & Weickmann Patent und Rechtsanwälte PartmbB | Europe
Christian Heubeck Wolfgang Weiss
Partner Partner
cheubeck@weickmann.de wweiss@weickmann.de
Christian Heubeck joined Weickmann & Weickmann Wolfgang Weiss has been a partner at the patent
in 2004 and became partner in 2011. He graduated in law firm Weickmann & Weickmann in Munich since
biochemistry from the Julius Maximilian University 1994. He studied chemistry at Ludwig Maximilian
Wuerzburg. Dr Heubeck has extensive experience in University, Munich and graduated in molecular
preparation and advice on IP strategies and patent biology. Dr Weiss’s areas of particular experience
portfolios, particularly the preparation of patent include patent grant and opposition proceedings
applications and patent grant proceedings, as well before the EPO, as well as patent invalidation and
as defending property rights and attacking third infringement proceedings before national German
parties’ rights at the EPO. He focuses on chemistry courts in the fields of chemistry, pharmacy and
and the life sciences fields. life sciences. His practice also includes providing
freedom-to-operate opinions.
(T 641/00; T 77/14) for assessing inventive step application to a field of technology and by being
using the problem-solution approach. Therefore, adapted to a specific technical implementation
in claims comprising technical and non-technical (T 2330/13)). When assessing the contribution
features it must be evaluated for each feature, in made by an AI-based method to the technical
the context of the invention, if it contributes to character of an invention, it must be taken into
the technical character of the invention, since this account whether the method, in the context of the
is relevant for assessing inventive step and novelty invention, serves a technical purpose (T 1227/05,
(G-II, 2). T 1358/09). According to the guidelines, examples
Once it is established that the claimed of technical purposes which may be served by
subject matter as a whole is not excluded from an AI-based method in the life sciences field
patentability under Articles 52(2) and (3) of the are “providing a genotype estimate based on an
EPC (ie, it comprises technical features and is analysis of DNA samples, as well as providing
therefore an invention in the sense of Article a confidence interval for this estimate so as to
52(1)), it is examined in respect of the other quantify its reliability” or “providing a medical
requirements of patentability, in particular, novelty diagnosis by an automated system processing
and inventive step (G‑I, 1). For the assessment of physiological measurements”.
inventive step, all features which contribute to the Generic purposes such as ‘controlling a technical
technical character of the invention must be taken system’ will not be accepted. The mere fact that an
into account (G‑VII, 5.4). AI-based method may serve a technical purpose
Like mathematical methods, AI-based methods is not sufficient either. The technical purpose
may contribute to the technical character of an must be specific. The claim is to be functionally
invention (ie, contribute to producing a technical limited to the technical purpose, either explicitly
effect that serves a technical purpose, by its or implicitly.
IAM Innovation & Invention Yearbook 2021 63
www.IAM-media.comEurope | Weickmann & Weickmann Patent und Rechtsanwälte PartmbB
Further, like a mathematical method, an AI- ‘person skilled in the art’ in the fast-developing
based method may also contribute to the technical AI field and, therefore, its consequences for the
character of the invention independently of any assessment of inventive step, is currently under
technical application when the claim is directed discussion and has not yet been finally clarified.
to a specific technical implementation of the Regarding AI-based property rights, in addition
AI-based method, and the AI-based method to the patenting requirements of novelty and
is particularly adapted for that implementation inventive step, a number of other questions
in that its design is motivated by technical have arisen that have not yet been clarified. For
considerations of the internal functioning of example, with regard to sufficiency of disclosure or
the computer (T 1358/09). If the AI-based enablement it has not been decided whether, and
method does not serve a technical purpose and if, how detailed the source code of an AI-based
the claimed technical implementation does not method must be disclosed in the corresponding
go beyond a generic technical implementation, application to meet the requirements of Article 83
the AI-based method does not contribute to the of the EPC (ie, disclose the invention in a manner
technical character of the invention. In such a case, sufficiently clear and complete for it to be carried
it is not sufficient that the AI-based method is out by a person skilled in the art).
algorithmically more efficient than prior art AI-
based methods to establish a technical effect (see AI as inventor
also G‑II, 3.6). However, if it is established that It was recently decided in EPO proceedings that
the AI-based method produces a technical effect an AI system cannot be an inventor. In January
when it is applied to a field of technology and/or 2020, the EPO published its decisions setting out
adapted to a specific technical implementation, the the reasons for its refusal of the two European
computational efficiency of the steps affecting that patent applications EP 18 275 163 and EP 18
established technical effect should be considered 275 174, in which an AI system was designated
when assessing inventive step. as the inventor (see www.epo.org/newsevents/
AI-based inventions and methods can be news/2020/20200128.html).
considered almost as a subgroup of computer- In both applications a machine called DABUS,
implemented inventions. This leads to the which is described as “a type of connectionist
following considerations when drafting artificial intelligence”, is named as the inventor.
patent applications: The applicant stated that he had acquired the right
• Claims should be formulated in a similar way to the European patent from the inventor by being
as for a computer-implemented invention (in its successor in title, arguing that as the machine’s
this regard, the guidelines contain a number of owner, he was assigned any IP rights created by
detailed examples under F-IV, 3.9). this machine.
• Claims should be functionally limited to specific The EPO considered that the interpretation
technical purposes. of the legal framework of the European patent
• There should be sufficient disclosure in the system leads to the conclusion that the inventor
description as originally filed describing designated in a European patent must be a
technical purposes, technical effects and natural person. The EPO further noted that
technical advantages for the claimed features. the understanding of the term ‘inventor’ as
referring to a natural person appears to be an
In this context, it is highly recommended that internationally applicable standard and that
the description is drawn up with as much detail as various national courts have issued decisions
possible, since, for example, the definition of the to this effect. Moreover, the designation of an
“The EPO noted that the understanding of the term
‘inventor’ as referring to a natural person appears to be
an internationally applicable standard and that various
national courts have issued decisions to this effect”
64 IAM Innovation & Invention Yearbook 2021
www.IAM-media.comWeickmann & Weickmann Patent und Rechtsanwälte PartmbB | Europe inventor is mandatory, as it bears a series of also be considered. Directive 2016/943 of legal consequences, notably to ensure that the the European Parliament harmonised the designated inventor is the legitimate one and protection of undisclosed know-how and business that he or she can benefit from rights linked to information (trade secrets) against their unlawful this status. To exercise these rights, the inventor acquisition, use and disclosure across the must have a legal personality that AI systems or European Union. machines do not enjoy. Both decisions are under appeal. Comment As the above case illustrates, there is still very little case law from the EPO Boards of Appeal regarding the patentability requirements for AI- based inventions. It will probably take several years before an established case law is developed. Weickmann & Weickmann Patent und In the meantime, however, there are a number Rechtsanwälte PartmbB of other protection options for AI-based Richard Strauss Strasse 80 inventions besides patent applications, which Munich 81679 applicants can consider when building an IP Germany portfolio. Apart from copyright protection of, Tel +49 89 455 630 for example, source code or database structures Fax +49 89 455 639 99 written by programmers, trade secrets should Web www.weickmann.de IAM Innovation & Invention Yearbook 2021 65 www.IAM-media.com
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