Israel is an innovation hub and a pioneer in many technological fields, especially in the medical arena. The following article outlines and highlights general guidelines related to Pharmaceutical and Biotechnology patent applications in Israel.
Patentable subject matter
In Israel, patentable inventions are broadly defined under Section 2 of the Israel (IL) patents law as follows: “An invention, be it a product or a process in any field of technology, which is new and useful, has industrial application and involves an inventive step, is a patentable invention.”
Exclusions from patentability
Specific types of subject matter are excluded from patentability under Section 7 of the IL patents law, as follows:
“No patent shall be granted for (1) a method of therapeutic treatment on the human body; (2) new varieties of plants or animals, except microbiological organisms not derived from nature.”
Pharmaceutical compositions of matter
Pharmaceutical compounds are patentable and can be regarded as novel chemical entities. Acceptable subject matter includes inter alia novel compounds, novel derivatives of known compounds, novel salts, and novel individual forms of a compound including, for example, specific isomers, or identifiable polymorphs. Novel pharmaceutical compositions of active pharmaceutical ingredient(s) are patentable. Further, inventive chemical processes for synthesizing or purifying active pharmaceutical ingredient(s) are patentable.
Biotechnological compositions of matter
Patentable biotechnology related subject matter includes inter alia isolated polynucleotides of known function, constructs containing these sequences, vectors containing such constructs, host cells comprising the vectors or constructs, and the polypeptides encoded by isolated polynucleotide sequences. Animals or plants per se, other than microorganisms not derived from nature, are not patentable types of subject matter, as specified under Section 7(2) of the law, as noted above. New plant varieties can be protected in Israel under the “Plant Breeders’ Act” which is generally synchronized with the principals of the Union for Protection of new Varieties of Plants (“UPOV”) in which Israel has been a member since December 12, 1979.
Therapeutic methods
As mentioned above, methods of therapeutic treatment on the human body are excluded from patentability according to section 7(1) of the IL patents law. Methods of therapeutic treatment include surgical and therapeutic procedures, regenerating, alleviating, and preventing symptoms or diseases. Such method claims may be patented according to the IL practice provided the claims are formulated in an acceptable claim language.
The following claim language is required for medical use type claims to conform with guidelines issued by the IL Registrar of Patents:
“A product X for use in the treatment of Y.”
“Product X for use as a medicament.”
“Use” type claim formats are considered improper and are referred to as process claims or claims that define a method of treatment. Such claims do not conform with guidelines issued by the IL Registrar of Patents. Examples include:
“Use of a compound/product X in the treatment of disease/disorder Y”.
Similarly, the so-called “Swiss” type claim format is also unacceptable. Hence, the following claim language is also not allowed:
“Use of substance X in the manufacture of a medicament to treat Y, the treatment comprising.”
Second medical use claims
Second medical use type claims formulated in an acceptable claim language, as described above, are acceptable under the Israeli practice. Thus, a claim to a second medical use of a compound/composition already known to have a first medical use is permitted provided such use is novel and non-obvious. The application should adequately describe the new medical use of a known pharmaceutical product and indicate the non-obvious reasoning.
Selection invention
A selection of a limited class or an individual species from a broader family or group may be patentable, if the selection is novel and non-obvious. The selection must be shown to have unexpected and superior properties from other members of the generic family in order to be considered non-obvious. This is particularly significant to the pharmaceutical industry where a compound previously disclosed only generically may be subsequently disclosed and claimed by means of a patent of selection if shown to have superior or unexpected properties compared to other compounds of the same generic structure.
Diagnostic and cosmetic methods
Diagnostic, cosmetic and detection methods are patentable and not considered as methods of treatment of the human body. Nevertheless, invasive cosmetic procedures associated with pathological or traumatized conditions are considered as methods of treatment of the human body, hence are not considered patentable in Israel.
Surgical/operative methods
Any method that requires an operative or an invasive stage in the human body is considered as a method of treatment and is therefore excluded from patentability. Claims that involve medical procedures with steps outside the human body are acceptable and comply with section 7(1) of the IL patents law.
Plant varieties, animals and microorganisms
As mentioned above, according to section 7(2) of the IL patents law, new varieties of plants or animals, except microbiological organisms not derived from nature are excluded from patentability. The phrase “not derived from nature” refers to a human creation, either directly or indirectly. Bacteria, fungus (or mold), or viruses not derived from nature are therefore patentable. Claims for products (e.g., a transgenic plant/animal, a transgenic seed) may comply with section 7(2) of the IL patents as long as the claims do not recite the plant or animal variety or strain per se. Specific advice should be sought on a case-by-case basis.
Biological sequences
Claims referring to biological sequences of interest by means of corresponding SEQ ID. No. of a DNA or RNA or amino acid should be defined by the sequences in order to clearly identify the claimed subject matter. An appropriate sequence listing should therefore be filed along with the filing of the application.
Other patentable subject matter
- Known products when produced by a novel process (i.e., a product-by-process invention);
- Novel processes for producing known compounds;
- Known processes used to produce novel products; and
- Naturally occurring biological material, when purified or isolated from its natural environment or when produced by a non-natural process such as recombinant DNA technology.
Keren Miller IP is an Israeli IP firm that specializes in advising clients on intellectual property matters in various technological fields, including life science, chemistry, mechanical devices, food-tech and agri-tech. The firm provides services in patents, industrial designs, and trademark matters to a wide range of clients, including many of Israel’s leading high-tech companies, as well as Israeli venture capital and other investment companies.
Dr. Keren Miller, the founder of Keren Miller IP, is a registered Patent Attorney in Israel. She counsels clients on protecting innovations, portfolio development, and patent filing strategies. Her practice encompasses various aspects of patent law, including patent preparation and prosecution, infringement and validity analysis, due diligence, clearance, and landscape analysis.
For more information and consultation on any Israeli patent issues, please contact our office at office@miller-patents.com.