As reviewed in Part 1 of this post, inventors should be aware of similarities and differences in what constitutes patentable biotech subject matter in the U.S. and Europe. This post discusses the nuances of patenting biotech inventions in Europe and identifies biotech products that are patentable.
Part 2. Europe
In Europe, patentability is governed by Article 52 EPC. Under this Article, European patents are granted for inventions if they are new, involve an inventive step and are susceptible of industrial application. Article 52 also expressly states what constitutes non-patentable subject matter in Europe. Somewhat similar to U.S. law, discoveries, scientific theories and mathematical methods are excluded from being patentable.
In the area of biotechnology, the EPO lists the following products as patentable:
- Genes and nucleic molecules (e.g. disease-related genes for diagnosis and antisense, siRNA molecules for therapy),
- Proteins (e.g. insulin, erythropoietin for therapy, cellular receptors for drug screening),
- Enzymes (e.g., proteases for washing powder, cellulose-degrading enzymes for the production of bio-fuels),
- Antibodies (e.g., for cancer treatment, pregnancy tests, or diagnostics),
- Viruses and virus sequences (e.g. hepatitis C virus and HIV for blood testing and the development of vaccines and therapies),
- Cells (e.g., hemapoiteic stem cells for treatment of leukemia), micro-organisms (e.g., bacteria for bioremediation, yeast for food production),
- Plants (e.g. herbicide resistant soybean, golden rice which accumulates pro-vitamin A, drought resistant plant, algae and genetically modified yeast for capturing CO2 from the atmosphere), and
- Animals (e.g. disease models for research such as “oncomouse,” donor animals for xenotransplantation, dairy animals which produce medicament in milk). (See Patents on Life? European law and practices for patenting biotechnological inventions).
Although the above list of patentable products includes genes and nucleic acids, the sequences of a gene or genes without a description of the technical problem they are intended to solve and a technical teaching are considered non-patentable discoveries.
Further, plant or animal varieties, or essentially biological processes for production of plants or animals, are excluded from patentability.
A recent decision of the EPO Enlarged Board of Appeal excluded plant breeding methods involving steps of classical crossing and selection using DNA markers from being patentable. (See “Broccoli” and “Tomato” cases, G2/07 and G1/08). As of now, however, it appears that patent protection extends to seeds produced by transgenic plants.
Beyond any doubt, biotech inventions are patentable in Europe. Biotech companies seeking global protection for their inventions should stay up-to-date regarding strategies for obtaining and enforcing patent rights in different jurisdictions.
Post by: Marina Sigareva