Le secteur des Sciences du vivant est en pleine expansion en Wallonie, en particulier dans les domaines du diagnostic et du développement de thérapies. Si une position forte en matière de brevets est essentielle dans ces domaines d’activité, notamment pour assurer un retour sur investissement et pour convaincre les investisseurs, certaines complications peuvent être rencontrées en termes de brevetabilité. Lors de cette rencontre-conférence, des mandataires en brevets du cabinet GEVERS et une entreprise du secteur discuteront des aspects fondamentaux tels que le degré de preuve nécessaire et les différences observées entre les procédures en Europe et aux Etats-Unis, ceci avec pour objectif de construire un portefeuille de brevets solide.

1. Mardi, 7 novembre 2023
La brevetabilité dans le cas des méthodes thérapeutiques
et de diagnostics
Elodie Naveau, Mandataire en Brevets Européens et Gestionnaire PI
(RISE, ULiège)
Pascal Leroy & Stijn Lagaert, Mandataires en Brevets Belges et
Européens (Cabinet GEVERS)
Benoît Granier, Directeur Général (Unisensor)

2. LIEGE CREATIVE, en partenariat avec :

3. La brevetabilité dans le cas
des méthodes thérapeutiques et de
diagnostics
Introduction
Elodie Naveau – IP Manager

4. 13/11/23 2
La science évolue…
Ø Nouvelles connaissances
Ø Interdisciplinarité
Ø Diffusion
• Facteur d’impact
• Peer reviewing
• Preprints

5. 13/11/23 3
Le monde des brevets aussi.
Ø Témoin des nouvelles frontières de la science
• Convention du brevet européen
• Directives relatives à l’examen
• Jurisprudence
• Thérapeutique
• Diagnostic
• Utilisation médicale et non médicale

6. epo.org – Compendium
2023/A/FR/8
13/11/23 4
Exemple de revendication
Dispositif permettant l’application d’un champ électrique (E) sur la peau
Ø Protéger le produit et ses utilisations
Ø Distinguer 2 types : guérir des lésions et lisser la peau
a') Utilisation à des fins cosmétiques
b') du dispositif conformément à l'une des
revendications précédentes
c') pour le lissage des rides de la peau,
d') où le dispositif est porté sur une peau ridée
intacte.
Formulation de sorte à éviter une guérison implicite !

7. Campus de Gembloux
Passage des Déportés, 2 •
5030 Gembloux
+32 81 62 21 04
Campus du Centre-ville
Place du XX Août, 7 •
4000 Liège
+32 4 349 85 11
www.recherche.uliege.be
Campus du Sart-Tilman
Espace Eurêka – LIEGE science park
Avenue Pré-Aily, 4 •
4031 Liège
+32 4 349 85 10
13/11/23 5

8. Patents, Trademarks,
Designs & More

9. Patentability of
Therapeutic and
Diagnostic methods
Stijn Lagaert – European and Belgian Patent Attorney, Partner
Pascal Leroy – European and Belgian Patent Attorney
7 November 2023

10. Methods for treatment in Europe

11. General principle
In Europe, patents shall not be granted in respect of methods for treatment of the human or animal body
by surgery or therapy* and in respect of diagnostic methods practiced on the human or animal body; this
provision shall not apply to products, in particular substances or compositions, for use in any of these methods
(Article 53 c) EPC).
! Therapeutic and non-therapeutic effects applying simultaneously
First medical use
A known substance or composition may be patented for use in a method for treatment of the human or animal
body by therapy if the known substance or composition has not previously been disclosed for use for such
method.
Examples
Substance or composition X for use as a medicament.
Substance or composition X for use in therapy.
Substance or composition X for use in a method of treatment by therapy.
*recovery from illness or organic dysfunction, including prophylactic treatments

12. Second and further medical use (Europe)
If the known substance or composition was previously disclosed for use in a method for treatment by therapy
practised on the human or animal body, a patent may still be obtained for any second or further use of the substance in
such a method provided that said use is novel and inventive.
Examples
a) use of the same product in the treatment of a different disease:
Even if substance or composition X is known for its use in the treatment of the disease A, it can be patented for its use
in the treatment of another disease Y
Substance or composition X for use in the treatment of the disease Y
Substance or composition X for use in a method for the treatment of the disease Y
Substance or composition X for use in the therapy of the disease Y
b) use of the same product in a different treatment of the same disease:
Even if substance or composition X is known for its use in the treatment of the disease Y, it can be patented for its use
in a different treatment of the same disease Y
Substance or composition X for use in a method for the treatment of the disease Y, wherein the substance is
administrated topically / 3 times a day / …

13. Methods for treatment in the US

14. General principle
In the US, if a method of medical treatment satisfies the novelty and non-obviousness criteria, then it will be
eligible for patent protection.
Examples
A method of treating disease X, comprising :
- administering to a subject the compound Y,
[- obtaining the effect of …]
USPTO allows method of treatment claims but the US Patents Code exempts from patent infringement a
medical practitioner’s performance of a medical activity.
The terms "medical activity" mean the performance of a medical or surgical procedure on a body, but shall not
include (i) the use of a patented machine, manufacture, or composition of matter in violation of such patent and
(ii) the practice of a patented use of a composition of matter in violation of such patent.

15. Methods of treatment (US)
No ‘first medical use’ equivalent possible
A method of treatment of a patient, comprising :
- administering to a subject the compound Y.
Mitigations possible
A pharmaceutical composition comprising compound Y and one or more pharmaceutically acceptable
carriers.
Sometimes possible to claim mechanism of action (in most cases not possible in Europe)

16. Diagnostic methods in Europe

17. General principle
In Europe, patents shall not be granted in respect of methods for treatment of the human or animal body by surgery
or therapy* and in respect of diagnostic methods practiced on the human or animal body; this provision
shall not apply to products, in particular substances or compositions, for use in any of these methods (Article 53 c)
EPC).
Diagnostic methods as such
Only if the diagnostic method can be carried out separately from the body (in vitro, ex vivo)
Diagnostic method comprising acquiring data from a biological sample previously collected on a human,
analyzing the acquired data, …
First diagnostic use
Substance or composition X for use in diagnostics in vivo*.
Second or further diagnostic use
Substance or composition X for use in a method of diagnosis in vivo* of disease Y.
* The wording "in vivo“ is required and limits the scope of the claim to diagnostic methods which are excluded from patentability

18. Diagnostic methods in EP
Example
1. A method of detecting PSMA in a patient, comprising drawing blood and isolating a plasma sample, and detecting
PSMA presence by contacting the sample with an anti-PSMA antibody.
2. A method of detecting PSMA in a patient, comprising obtaining a plasma sample and detecting PSMA presence by
contacting the sample with an anti-PSMA antibody.
3. Use of an anti-PSMA antibody in the in vitro diagnosis of prostate cancer.
4. An anti-PSMA antibody for use in the in vivo diagnosis of prostate cancer.

19. Diagnostic methods in the US

20. General principle
In the US, there is no exclusion for the patentability of diagnostic methods.
However, possible issues are mostly related to the exclusion of patentability of “laws of nature and natural
phenomena”
Eligibility test

21. Diagnostic methods in the US
Natural products and phenomena (Step 2A)
Natural products: nature-based product that is not “markedly different” examples:
• isolated DNA,
• primer sequences,
• a cloned farm animal,…
Natural phenomena examples:
• a correlation between the presence of a biomarker and cancer,
• detection of cell-free fetal DNA,…
Integration into a practical application can overcome the issue, examples:
• particular treatment or prophylaxis
• meaningful limit on the judicial exception

22. Diagnostic methods in the US
“Something more” (Step 2B)
Inventive concept based on additional elements that amount to significantly more than the judicial exception
Not well-understood, routine, conventional activity
Not only adding “apply it” to the exception
Not adding insignificant extra-solution activity

23. Diagnostic methods in the US
Example
1. A method of detecting PSMA in a patient, comprising obtaining a plasma sample and detecting PSMA presence
by contacting the sample with an anti-PSMA antibody.
2. A method of diagnosing prostate cancer, comprising obtaining a plasma sample and detecting PSMA presence by
contacting the sample with an anti-PSMA antibody, diagnosing the patient with prostate cancer if PSMA presence
is detected.
3. A method of diagnosing prostate cancer in a patient, comprising obtaining a plasma sample and detecting PSMA
presence by contacting the sample with a porcine anti-PSMA antibody, diagnosing the patient with prostate cancer
if PSMA presence is detected.
4. A method of diagnosing prostate cancer in a patient, comprising obtaining a plasma sample and detecting PSMA
presence by contacting the sample with antibody mAb-D33, diagnosing the patient with prostate cancer if PSMA
presence is detected.
5. A method of diagnosing and treating prostate cancer in a patient, comprising obtaining a plasma sample and
detecting PSMA presence in the sample, diagnosing the patient with prostate cancer if PSMA presence is
detected, and administering an anti-neoplastic agent.

24. Experimental evidence required for
enablement / inventive step

25. General principles - Europe
The European patent application shall disclose the invention in a manner sufficiently clear and
complete for it to be carried out by a person skilled in the art. (Article 83 EPC)
§ A detailed description of at least one way of carrying out the invention must be
given.
§ The description must disclose any feature essential for carrying out the invention
in sufficient detail to render it apparent to the skilled person how to put the invention into
practice.
§ A single example may suffice.
§ Where the claims cover a broad field, the application is not usually regarded as satisfying the
requirements of Art. 83 unless the description gives a number of examples or describes
alternative embodiments or variations extending over the area protected by the claims.
§ Sufficiency of disclosure cannot be acknowledged if the skilled person has to carry out a
research program based on trial and error to reproduce the results of the invention, with
limited chances of success.
§ Inventions relating to biological material: Public availability of biological material / Deposit of
biological material.

26. Experimental evidence (Europe)
Therapeutic claims
Medical use claims: enablement requires demonstration that substance/composition is suitable for treatment
Must be credible for skilled person working in the field on the effective date (priority/filing date):
• No human data required
• In vitro or animal model data normally sufficient
• Demonstration of in vitro inhibition of molecule may be sufficient, if molecule is known to be causative for disease
• Standard is lower than e.g. data required for strong conclusion in scientific paper and/or regulatory approval
Possibility to submit post-filing data:
• If credibility threshold met on priority/filing data to further support suitability
• To defend novelty/inventive step with comparative data versus prior art

27. Experimental evidence (US)
Therapeutic claims
Method of treatment claims: enablement requires demonstration that substance/composition is suitable for
treatment of all claimed diseases.
Must be credible for skilled person working in the field:
• No human data required
• In vitro or animal model data normally sufficient
• Demonstration of in vitro inhibition of molecule may be sufficient, if molecule is known to be causative for disease
• Standard is lower than e.g. data required for strong conclusion in scientific paper and/or regulatory approval
Possibility to submit post-filing data:
• More flexibility to demonstrate suitability during prosecution
• To defend novelty/non-obviousness with comparative data versus prior art
• To demonstrate prior art link of e.g. target inhibition with claimed disease

28. In practice
- In-vitro tests and/or tests on animals / cells are sufficient for filing a patent application;
- Additional results / tests can be added during prosecution:
q during the priority year (within 12 months from the first filing date)
q before the national patents offices even after the priority year (as post-filing data) with certain
restrictions
- Aggressive filing strategies are possible (and sometimes advisable) because lower threshold in
US vs Europe, for example:
• File priority application with few or no data;
• File intermediate application with preliminary results;
• Within 12m file final application with all available data

29. Conclusion

30. Conclusions
Therapeutic inventions:
• Inventive products (new API, medical device, administration patch,…): no issue at all
• Therapeutic claims: generally no problem, but requires proper drafting of claims
• For second medical use claims, demonstrating infringement is sometimes complicated and the importance of a
correctly drafted application by experienced attorney cannot be underestimated
Diagnostic inventions:
• Inventive products (array with probes, microfluidic device with components, antibody): no issue at all
• Diagnostic claims:
q Generally no problem, but requires proper drafting
q Restrictions may be required to overcome exclusions, consider and discuss least restrictive possibilities
q Application should be drafted with all relevant fall-back positions/restrictions and ready for all different
jurisdictions

31. Conclusions
Experimental evidence:
• Sometimes no need for (substantial) data for priority filing,
• Priority year is important to provide sufficient data for most countries (but not all),
• In vitro or animal model data normally sufficient
• Comparative data vs prior art may be useful (e.g. to demonstrate benefit or unexpected effects)

32. www.gevers.eu
Pascal Leroy
European and Belgian
Patent Attorney
pascal.leroy@gevers.eu
Stijn Lagaert
European and Belgian
Patent Attorney
European Patent Litigator
Partner
stijn.lagaert@gevers.eu

33. 1
© Unisensor - 2022 - All rights reserved.
© Unisensor - 2022 - All rights reserved.
Liège Créative
« Brevetabilité »
Benoît Granier
07/11/2023

34. 2
© Unisensor - 2022 - All rights reserved.
Peace of mind in food
and Animal Health
Vision & Mission
Bringing Smart Diagnostic Solutions
to Point of Need

35. 3
© Unisensor - 2022 - All rights reserved.
We are Unisensor
1997
75
€15M
5
Patent families Network of local distributors in over 60 countries

36. 4
© Unisensor - 2022 - All rights reserved.
Innovation
By Differentiation
Meet the needs of the field with new technologies that are
unmatched in the market.
Through innovation, we don’t just optimise our products within
our business, we aim to reshape and redefine our industry.
Make the competition irrelevant.

37. At the Farm
MastiSensor DipSensor - aurox
Milk Transport
Milk Processing
SENSOR - LITE - Extenso
Third-party Laboratories
BeadYplex
Fermentation Control
Milk Model

38. 7
© Unisensor - 2022 - All rights reserved.
o CONTRATS DE DISTRIBUTION
o PATENTS
o 2001 – Tetrasensor - Transcriptional Receptors.
o 2005 – Twinsensor – Multianalyte.
o 2017 – Extenso – Pluralité d’analytes.
o 2021 – Aurox – Dispositif microfluidique.
o 2023 – Mastisensor – Detection of bacteria.
o UTILITY MODEL
o 2021 – Tube DipSensor
o TRADEMARKS
o 2016 - UNISENSOR
o 2016 - TWINSENSOR
o 2016 - EXTENSO
o 2017 - 4SENSOR
o 2017 - READIP
o 2019 - 3LITE
o 2020 - MilkSensor
o 2020 - MeatSensor
o 2021 - PIECE OF MIND IN FOOD
o 2021 - DipSensor
o 2021 - Aurox
o 2022 - MastiSensor
IP Protection Strategy

39. 8
© Unisensor - 2022 - All rights reserved.
Patent Strategy
o Our Rules
1. Do not seek to extend the scope beyond our business.
2. Defend what you are going to sell, not what you have developed.
3. Helps strengthen our marketing position.
4. We must be able to defend it (Product ≠ Patent).
5. Defend it if the opportunity arises.
6. Respect annual dedicated budget.
o Mandatory condition
1. Must be new
2. Must be susceptible to Industrial Application.
3. Must be non-obvious (Inventive step).
Highly Subjective

40. 9
© Unisensor - 2022 - All rights reserved.
Patent Strategy
Support
Belgique 5709 5705 5706 5707 5708
PCT 5709 5705 5707
Nat
5709 +
5707
Optical Device
EU ≠ USA ≠ CHINA ≠ RUSSIA ≠ JAPAN

41. 10
© Unisensor - 2022 - All rights reserved.
Patentability in diagnostics
o Legal ? Yes for food and animal health diagnostics (?)
o Subjective with regards to Inventive Step.
o Complex and requires the help of skilled people.
o Time consumer.
o Risky to get granted (be public).
o Costly (excluding Tax deduction).
o Secondary interests.
Thank you
I look forward to answering your questions