Presentation by Philipp Marchand and Birgitte Bieler, Vossius & Partner at the DayOne Expert Event Legal challenges and opportunities for digital health innovation Philipp Marchand from Vossius & Partner and co-host of the event said: “Technological developments, especially in the digital space, brought up completely new issues which lack clear definition. So, as lawyers and regulatory advisers, we have to be innovative and also come up with new solutions. This is a learning curve we have to go through together with entrepreneurs, industry and regulatory bodies“. In other words, instead of being a French garden à la Versaille, the legal landscape has become a rather rough terrain to navigate. The uncertainty can be seen as a threat and show killer. A more entrepreneurial attitude, however, would be to see it as an opportunity, if not an invitation, to pursue more of a greenfield approach. But in order to make this happen, it is essential to address the legal aspects early on and make them part of the solution. Protection Accustomaed as it is to a science and engineering-driven approach, the healthcare industry has to change its mindset when it comes to protecting its business. As it is reasonable to patent a digital solution and to protect medical devices as well as mobile app interfaces by means of design and trademark rights, the legal framework is becoming more important. So, developing a great technological solution and then having it beautified later on will not suffice. Those capabilities have to be built in from day one to ensure freedom to operate and to generate added value from the digital solutions.

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Legal Framework for Digital
Health Innovation
Protection through patents,
designs and trademarks

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Patent protection

3. Patentability requirements are always the same
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Patentable subject matter
Industrial applicability
Novelty
Inventive step
Enablement

4. Patentable subject-matter
Article 52 EPC
(1) European patents shall be granted for any inventions, in all fields of technology, provided
that they are new, involve an inventive step and are susceptible of industrial application.
(2) The following in particular shall not be regarded as inventions within the meaning of
paragraph 1:
(a) discoveries, scientific theories and mathematical methods;
(b) aesthetic creations;
(c) schemes, rules and methods for performing mental acts, playing games or doing
business, and programs for computers;
(d) presentations of information.
(3) Paragraph 2 shall exclude the patentability of the subject-matter or activities referred to
therein only to the extent to which a European patent application or European patent relates
to such subject-matter or activities as such.
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5. Software?
- Computer programs are excluded from patentability under Art. 52(2)(c) and (3) if claimed as
such
- The exclusion does not apply to computer programs having a technical character.
 Software patenting is possible if it has a technical character!
 Processsing physical data parameters
 Processing which affects the way a computer operates (saving memory, increasing speed etc.)
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6. Novelty
Article 54 EPC
(1) An invention shall be considered to be new if it does not form part of the state of the art.
(2) The state of the art shall be held to comprise everything made available to the public by
means of a written or oral description, by use, or in any other way, before the date of filing
of the European patent application.
[…]
(3) to (5)
 Trade secrets are usually not a good idea!
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7. Inventive step
Article 56 EPC
An invention shall be considered as involving an inventive step if, having
regard to the state of the art, it is not obvious to a person skilled in the art.
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8. How to become inventive
- There is a particular technical effect;
- No hints exist leading the skilled person to the invention
For inventive step, it has to be considered whether the skilled person
would have had an inventive to try with a reasonable expectation of
success to solve the underlying technical problem with the means
provided in the claims and resulting in the achieved technical effect.
 AI and unexpected effect?
The unexpected technical effect must apply to the entire range as
claimed. If it occurs in only part of the claimed range, the claimed
subject-matter does not solve the specific problem to which the effect
relates, but only the more general problem of obtaining, for example,
"a further product X" or "a further process Y" (see T 939/92).
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9. Methods comprising AI
• Generalize technology to formulate a generic claim comprising the use of
AI techniques
• How to demonstrate inventive step?
– Known problem
– AI is a commonly used tool
– No results – no surprising effect
 Result cannot be claimed!
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Design protection

11. Design rights: Design rights – what is it all about?
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Design protection
for a dental implant

12. Requirements for design protection
The shape, i.e. the external appearance, of an object is
protectable as a design if it is:
1. Novel
2. Overall impression has to differ substantially from existing
designs
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13. Requirements for design protection
3. No violation of applicable law and morals
 No protection of sole technical function, idea, concept
 The creation of official emblems, symbols is not protectable
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14. Graphical user interfaces
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Inflation device display screen

15. Graphical user interfaces
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Layout of a screen of a medical device

16. Graphical user interfaces
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Layout of a screen of
a medical device

17. Display screen with graphical user interface
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Course of a screen design in the use
of the application

18. Design rights for icon of a mobile app
IMAIOS e-Anatomy
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Das Arzneimittelkompendium Ada

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Trademark protection

20. Figurative TM
Trademarks: some examples first
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21. Trademark owner
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Combined word / figurative TM

22. Requirements for trademark protection
A sign is protectable as a trademark if it is:
• distinctive
• non-descriptive for goods/services in question
• no infringement of earlier third-party rights
• no violation of applicable law and morals
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23. Requirements for trademark protection
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Figurative TM with descriptive words
In general: distinctive elements have to influence the overal
impression essentially
Weaker word element needs stronger figurative element
The Federal Supreme Court (FSC) required „originality of the
grafic design“

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Breakout session

25. Digital Health Methods
• Generalize technology to formulate a generic claim comprising the use of
software techniques
• How to be enabled?
– one way to put the invention into practice
• How to demonstrate inventive step?
– Known problem
– Software/AI is a commonly used tool
– No results – no surprising effect
 Result cannot be claimed!
 Dilemma between enablement and inventive step
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26. Use of software tool (AI) in a method
“ incentive to try with a reasonable expectation of success“ – T60/89
• Applying software solution to a known problem is not inventive
 Obvious to use software to solve a known problem
• No data to demonstrate surprising effect
 No effect going beyond the expectation of the skilled person in the application
as filed
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27. Ways to establish inventive step
1. Post-published data
I. “ Plausibility“ is sufficient in the application as filed
II. Post-published data can be used to demonstrate technical effect
2. Unconventional use of software tool / AI
I. Input data
II. Alternative “goal“ of AI optimization
3. Technical effect in the claim!
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28. Examples
Further technical effect
• control of a brake in a car
• faster communication between mobile
• phones
• secure data transmission (encryption
• of data)
• resource allocation in an operating
• system
No further technical effect
• aesthetical effects of
• music or a video
• new rules for
• an auction scheme
• selling and booking sailing cruise
• packages
• calculation of a pension contributions
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29. Examples
Method for determining the propensity of cells to interact in a population of cells comprising at
least two distinguishable subpopulations of cells, wherein the method comprises the following
steps:
(a) determination of the number of interactions between cells of a first distinguishable
subpopulation and cells of a second distinguishable subpopulation;
(b) determination of the number of interactions in the population of cells by randomly assigning
cells comprised in the population of cells to first and second distinguishable subpopulation of
cells, wherein the absolute number of cells in the first and second distinguishable
subpopulation of cells, respectively, are identical to the number of cells in the first and
second distinguishable subpopulation of cells in (a); and
(c) determination of the propensity of cells to interact by dividing (a) through (b), wherein
propensity increases with the resulting number.
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30. Examples
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31. How to protect an app?
• Patent?
Under certain circumstances software can be patented.
• Copyright?
Software may be protected by copyright law.
In Switzerland no register law, therefore in case of conflicts /
infringements difficulties in proof.
• Design right?
Design protection of icon advisable.
• Trademark?
Advisable for the name and icon of the app.
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