Abstract
In recent years, the relevance of artificial intelligence (AI) and its potential applications in various technical areas of the life sciences and healthcare have increased. The accumulation of big data, the development of algorithms, and improvements in computer processing capacity have made possible the integration of AI in the life sciences and healthcare. Some examples of AI applications in these fields are drug and molecular design, the prediction of disease risk, diagnosis of diseases, detection of cancerous cells and tumors, genomics, the monitoring of therapeutic progress, the adjustment of therapeutic treatment, and improvements in manufacturing processes. Such applications change the mode of work in hospitals and for doctors and give rise to interdisciplinary products for which a company seeks a monopoly under patent law. A patented technical monopoly may facilitate a company a dominant market position and a return on investment. However, a patent monopoly is subject to legal regulations that define the preconditions for a patent grant as well as exclusion criteria. These may vary in the particular country for which a patent is sought. This chapter is based on the European Patent Convention (EPC) and the case law of the Boards of Appeal of the European Patent Office (EPO). The examples of granted or refused patents presented here may be assessed differently by other jurisdictions [e.g., the United States Patent and Trademark Office (USPTO), Japan Patent Office (JPO), China National Intellectual Property Administration (CNIPA)].
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Notes
- 1.
The official English translation of the Paris Convention for the Protection of Industrial Property is available at the URL: https://wipolex.wipo.int/en/text/288514
- 2.
For the EPO, see EPC, Article 58, Entitlement to file a European patent application, https://www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar58.html
- 3.
EPC, Article 60, Right to a European patent, https://www.epo.org/law-practice/legal-texts/html/epc/2020/e/ar60.html
- 4.
EPC, Article 62 and Article 81, Right of the inventor to be mentioned and Designation of the inventor, https://www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar62.html and https://www.epo.org/law-practice/legal-texts/html/epc/2020/e/ar81.html
- 5.
EPC, Article 63, Term of the European patent, https://www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar63.html
- 6.
- 7.
EPC, Article 69, Extent of protection, https://www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar69.html
- 8.
EPC, Article 84, Claims, https://www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar84.html
- 9.
EPC, Article 64, Rights conferred by a European patent, https://www.epo.org/law-practice/legal-texts/html/epc/2020/e/ar64.html; and national patent law.
- 10.
EPC: Article 52 (Patentable inventions, https://www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar52.html), Article 54 (Novelty, https://www.epo.org/law-practice/legal-texts/html/epc/2020/e/ar54.html), Article 56 (Inventive step, https://www.epo.org/law-practice/legal-texts/html/epc/2020/e/ar56.html), and Article 57 (Industrial application, https://www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar57.html)
- 11.
EPC, Article 83, Disclosure of the invention, https://www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar83.html
- 12.
EPC, Article 53, Exceptions to patentability, https://www.epo.org//law-practice/legal-texts/html/epc/2020/e/ar53.html
- 13.
EPC, Article 52, Patentable inventions, https://www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar52.html
- 14.
- 15.
EPO, Guidelines for Examination, Part G, Chap. II, Sect. 3.3.1, Discoveries, https://www.epo.org/law-practice/legal-texts/html/guidelines/e/g_ii_3_1.htm
- 16.
EPO, Guidelines for Examination, Part F, Chap. IV, Sect. 3.9, Claims directed to computer-implemented inventions, https://www.epo.org/law-practice/legal-texts/html/guidelines/e/f_iv_3_9.htm
- 17.
EPO, Guidelines for Examination, Part G, Chap. II, Sect. 3.3.1 (Artificial intelligence and machine learning, https://www.epo.org/law-practice/legal-texts/html/guidelines/e/g_ii_3_3_1.htm) and 3.3.2 (Simulation, design or modeling, https://www.epo.org/law-practice/legal-texts/html/guidelines/e/g_ii_3_3_2.htm)
- 18.
EPO, Guidelines for Examination, Part G, Chap. II, Sect. 3.3, Mathematical models, https://www.epo.org/law-practice/legal-texts/html/guidelines/e/g_ii_3_3.htm
- 19.
EPO, T 1227/05 (Circuit simulation I/Infineon Technologies) of 13.12.2006, https://www.epo.org/law-practice/case-law-appeals/recent/t051227ep1.html
- 20.
EPO, T 1358/09 (Classification/BDGB ENTERPRISE SOFTWARE) of 21.11.2014, https://www.epo.org/law-practice/case-law-appeals/recent/t091358eu1.html
- 21.
- 22.
EPC, Article 84, Claims, https://www.epo.org/law-practice/legal-texts/html/epc/2020/e/ar84.html
- 23.
EPO, T 1285/10 (Genetic analysis computing system/Iris Biotechnologies) of 23.5.2014, https://www.epo.org/law-practice/case-law-appeals/recent/t101285eu1.html
- 24.
Figure 1 on page 22 is available online: https://worldwide.espacenet.com/patent/search/family/022537965/publication/EP1222602B1?q=EP1222602B1
- 25.
EPC, Article 83, Disclosure of the invention, https://www.epo.org/law-practice/legal-texts/html/epc/2020/e/ar83.html
- 26.
B1 represents the granted patent as decided by the examination division and B2 represented the patent maintained as amended during an opposition filed by a third party, The detailed proceedings of T 0466/09 are available under the following URL: https://register.epo.org/application?number=EP97904470
- 27.
A1, A2, or A3 at the end of a patent number represents a published patent application, for detailed explanation see URL: https://www.epo.org/searching-for-patents/helpful-resources/first-time-here/definitions.html
- 28.
https://worldwide.espacenet.com/patent/search/family/038023611/publication/EP1955228A2?q=EP1955228; The original German wording of the patent application has been translated into English.
- 29.
The references refers to the downloaded document which is available under the following URL: https://worldwide.espacenet.com/patent/search/family/038023611/publication/EP1955228A2?q=EP1955228
- 30.
The decision is available only in German under URL: https://www.epo.org/law-practice/case-law-appeals/recent/t180161du1.html, the following references are made based on the available online version.
- 31.
The complete claim URL: https://www.epo.org/law-practice/case-law-appeals/recent/t191191eu1.html
- 32.
Fig. 1, page 13, paras [0055] and [0056] of EP2351523A1, https://worldwide.espacenet.com/patent/search/family/042128288/publication/EP2351523A1?q=EP2351523A1
- 33.
Reason 4.1 of T 161/18 https://www.epo.org/law-practice/case-law-appeals/recent/t191191eu1.html
- 34.
EPC, Article 54, Novelty.
- 35.
EPC, Article 56, Inventive step, https://www.epo.org/law-practice/legal-texts/html/epc/2020/e/ar56.html
- 36.
The wording of the claims is available under the URL and the numbers are explained in the description of the patent application:
https://worldwide.espacenet.com/patent/search/family/022627891/publication/EP1247229B1?q=EP1247229b1
- 37.
EPO, decision T 0927/14, T 0927/14 (Wireless patient monitoring/Philips) of 20.2.2019, https://www.epo.org/law-practice/case-law-appeals/recent/t140927eu1.html
- 38.
See Reason 7.4 and 8. of the decision: https://www.epo.org/law-practice/case-law-appeals/recent/t140927eu1.html
- 39.
All of the EP patents and applications mentioned in this section can be viewed online at Espacenet (https://worldwide.espacenet.com/patent/), as can any patent application from non-European countries. For that purpose, please, just copy in the cited number.
- 40.
Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:31998L0044
- 41.
Article 6 of Directive 98/44/EC.
- 42.
EPC, Rule 28, Exceptions to patentability, https://www.epo.org/law-practice/legal-texts/html/epc/2020/e/r28.html
- 43.
For example, in Germany, paragraph 13 sec. 1 of the German Patent Act stipulates that (English translation) “The patent shall not take effect if the Federal Government orders that the invention be used in the interest of public welfare. Furthermore, it shall not extend to a use of the invention ordered in the interest of federal security by the competent supreme federal authority or by a subordinate agency on its behalf.”
- 44.
Statement by Moderna on Intellectual Property Matters during the COVID-19 Pandemic (10/08/2020); available under the URL: https://investors.modernatx.com/Statements%2D%2DPerspectives/Statements%2D%2DPerspectives-Details/2020/Statement-by-Moderna-on-Intellectual-Property-Matters-during-the-COVID-19-Pandemic/default.aspx
- 45.
- 46.
- 47.
Kluwer Patent Blog “Covid-19 ‘Patent Waiver’: revolution or tempest in a glass of water?”, Matthieu Dhenne, http://patentblog.kluweriplaw.com/2022/06/22/covid-19-patent-waiver-revolution-or-storm-in-a-glass-of-water/
- 48.
- 49.
CAR = chimeric antigen receptor; CAR T-cells = T immune cells expressing a CAR.
- 50.
For more details, see AIDPATH (https://www.sciencrew.com/c/6499?title=AIDPATH)
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Acknowledgments
Many thanks to my colleague and friend, Benjamin Petri, who is a German and European Patent Attorney with profound experiences on computer implemented inventions for discussions on AI definitions. The author declares no potential conflicts of interest. The views expressed in this chapter do not necessarily reflect those of the author’s organization.
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Heide, A.K. (2022). Patents on Inventions Involving AI in the Life Sciences and Healthcare. In: Ehsani, S., Glauner, P., Plugmann, P., Thieringer, F.M. (eds) The Future Circle of Healthcare. Future of Business and Finance. Springer, Cham. https://doi.org/10.1007/978-3-030-99838-7_9
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