Intellectual propertyPatentability and inventorship
What are the most noteworthy rules and considerations relating to the patentability and inventorship of digital health-related inventions?
Section 3 of the Patents Law 1967 requires that a patentable invention be industrially applicable. Where an invention pertains to use on a singular person, the Israel Patent Office practice follows that of the European Patent Office in such regard.
Section 7(1) of the Patents Law 1967 excludes the grant of a patent to methods for treating the human body. This exclusion does not apply to devices.
With regard to the ownership of the actual artificial intelligence (AI) system that performs the manipulation and use of collected data (regardless of it being subject to proprietary rights or privacy limitations), currently the practice in Israel overlooks the many doctrinal issues that arise in connection with AI. With regards to patenting AI systems and inventions involving the use of AI as an element of the invention, the Israel Patent Office has expressed a position similar to that of the European Patent Office and the United States Patents and Trademarks Office, that the AI system will be regarded as an element similar to a software element implemented in an invention. Thus, for the sake of patentable subject matter, the examination will be concerned with identifying a technical effect brought about by the implementation of the invention as a whole. This ‘black-box’ approach disregards the special features of an AI element in an invention – its cause and effect in the invention are not analysed. This workaround has postponed the discussion of enablement. Current industry standard is that most AI components are not explainable, and their workings are not transparent. Thus, it is yet to be determined how the enablement standard set forth in section 12 of the Israel Patents Law 1967 is to be construed with regard to such technology.
Another issue the local patent practice has worked around is whether a patent should be granted for an invention made by a machine. The language of the US Constitution determines that inventorship requires real personhood – in other words, the first applicant for a patent in the US would be the inventor. This is not necessarily the case in Israel, where the applicant is considered to be the first owner of the invention (unless contested).
Upon making the application, the applicant is to state how ownership was obtained.
Indeed, the inventor may be the first applicant, but then also any person who obtained the rights in the invention (such as by force of transfer of title or by service invention rights) may be the first filer and thereby the first sole applicant. In effect, the examination will not raise issues against the presumption of title. A large number of patent applications first filed in Israel are made by and on behalf of corporations without noting the name of the inventor. In the short term, this situation may be amenable for obtaining patent protection for machine-made inventions, while for the time being leaving the declaration of ownership to be construed by the actual applicant. This would also apply to data-driven inventions in the digital health space.Patent prosecution
What is the patent application and registration procedure for digital health technologies in your jurisdiction?
There are no specific requirements or limitations pertaining to a specific field of technology with regard to application and registration. However, patent term extension is uniquely available for pharmaceutical products and medical equipment (some medical devices may qualify as medical equipment under the definition in the Medical Equipment Law 2012, though this has yet to happen).
Where an invention pertains to biological matter (such as gene sequence data) or its use, a patent application may make reference to a deposit made in an institution recognised under the Budapest Treaty.Other IP rights
Are any other IP rights relevant in the context of digital health offerings? How are these rights secured?
Registered and unregistered design rights are provided under the Designs Law 2017. Registered design rights are obtainable by filing an application with the Israel Patent Office. Unregistered design rights are enforced in a court of law.
Confidentiality of data as a trade secret is provided under the Commercial Torts Law 1999 and enforced in courts of law. Confidentiality of exclusive data – such as in vitro or in vivo experiment results – filed for obtaining marketing licences is protected under the Pharmacists Ordinance (New Version) 1981.
The Copyright Law 2007 provides, inter alia, for protection of the manner of expression of ideas. This protection, such as for instructions for the use of a medical device kit, may be invoked in a court of law.Licensing
What practical considerations are relevant when licensing IP rights in digital health technologies?
Issues of joint ownership should be taken into account on several levels.
Unless agreed otherwise, the employer is the proprietor of an invention made during and as a consequence of an employment relationship (service invention). Where medical staff invent in the scope of their employment at a hospital or in collaboration with an academic institution, they may obtain rights that should be regarded upon licensing and technology transfer.
Where IP involves the use of patient data, the ownership of the data should be cleared either by waiver or by another function of law.Enforcement
What procedures govern the enforcement of IP rights in digital health technologies? Have there been any notable enforcement actions involving digital health technologies in your jurisdiction?
Like any other IP right, IP rights in the digital health space enforcement of rights is carried out in a court of law as a civil matter. Interim reliefs may be available. As a rule, seizure of evidence may be available. Where digital assets are concerned, regulations provide for specific process.