Implementation of EU Directive 98/44/EC
Italy adopted the EU Directive 98/44/EC on the legal protection of biotechnological inventions in January 2006, incorporating it into the Industrial Property Code (IPC) in 2010. However, Italian law introduces some significant differences from the EU Directive:
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Human Embryos: Italian law excludes all uses of human embryos, including embryonic stem cell lines, from patentability. This is more restrictive than the EU Directive, which only excludes uses of human embryos for industrial or commercial purposes[1].
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Industrial Applicability: For elements isolated from the human body or produced by a technical process, Italian law requires the specific function and industrial applicability to be concretely indicated and described. In contrast, the EU Directive only requires the industrial application to be disclosed for gene sequences or partial sequences[1].
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Gene Sequences: Italian law mandates that the specific function of a gene or its fragments must be indicated, described, and specifically claimed, whereas the EU Directive requires only the disclosure of industrial application in the patent application[1].
Declaration Requirements for Patent Applications
For national Italian patent applications, the IPC stipulates several declarations:
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Origin of Biological Material: A declaration of the origin of the animal or plant biological material, including the state of origin and the biological organism from which it was isolated[1].
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Informed Consent: A declaration of free informed consent from the person donating human biological material[1].
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Genetically Modified Organisms: A declaration ensuring compliance with obligations related to genetically modified microorganisms or organisms contained in the biological material[1].
Failure to provide these declarations does not result in the refusal of the patent application but must be annotated in the Italian Register[1].
Administrative Sanctions
Italian law imposes significant fines for non-compliance:
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Use of Human Biological Material Without Consent: Fines ranging from €100,000 to €1,000,000 for using human biological material without express consent[1].
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False Certification: Fines ranging from €10,000 to €100,000 for falsely certifying the origin of biological material or compliance with legal requirements for genetically modified organisms[1].
Patent Application and Grant Procedure
The process for patent applications in Italy involves:
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Filing and Preliminary Examination: The application must include a description, claims, and any drawings. The Italian Patent and Trademark Office (UIBM) conducts a preliminary examination to ensure completeness and compliance with filing fees and exceptions to patentability[2].
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Prior Art Search: The European Patent Office (EPO) conducts a prior art search and provides a search report and written opinion on novelty, inventive step, and commercial applicability. This report is usually received within six to eight months from the application date[2].
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Duration of Grant Procedure: The entire process typically takes 24-25 months from the filing date, if successful[2].
Enforceability of Patents
In Italy, patents can be enforced during the application period, provided the application has been published or officially served on the defendant:
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Preliminary Injunctions: Available subject to a prima facie case and urgency. Italian courts may appoint a Court Technical Adviser (CTA) to assess technical aspects of the case[4].
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Civil Actions: Patent holders can obtain final injunctions, seizure or recall of infringing goods, and damages. Publication of the judgment completes the range of remedies available[3].
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Translation Requirements: For EPO or international patent applications, an Italian translation of the claim set or patent specification must be filed with the Italian PTO for enforcement[4].
Scope of Claims and Doctrine of Equivalents
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Claim Interpretation: Italian courts interpret claims strictly based on the claim language, but the doctrine of equivalents can be applied to cover trivial departures from the claim language, promoting fair patent coverage[5].
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Infringement Actions: Actions can target the infringing marketing authorization holder, distributors, and other parties involved in the manufacturing and supply chain. However, healthcare providers and hospitals are rarely involved in such proceedings[4].
Supplementary Protection Certificates (SPCs)
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Eligibility: SPCs can be applied for if the patent holder has a basic patent in force that protects an authorized medicinal or plant protection product with a valid marketing authorization[2].
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Duration: The term of an SPC is calculated based on the time between the filing date of the basic patent application and the first marketing authorization, minus five years, but never exceeding five years after the expiry of the basic patent[2].
Invalidity and Revocation Actions
- Grounds: Third parties can file invalidity or revocation actions based on grounds such as lack of novelty, lack of inventive step, or insufficiency of disclosure. These actions can be filed while opposition proceedings are pending, and courts may decide to stay or postpone the case based on the outcome of these proceedings[4].
International and Unitary Patent System
- Unified Patent Court (UPC): Italy is part of the UPC system, with Milan hosting a branch of the central division. This court will handle cases concerning pharma patents without supplementary protection certificates, as well as non-pharmaceutical biotech, agriculture, and other sectors[3].
Key Takeaways
- Strict Patentability Criteria: Italian law has stricter criteria for patentability, especially concerning human embryos and the industrial applicability of biotechnological inventions.
- Comprehensive Declaration Requirements: Specific declarations are required for patent applications, including origin of biological material and informed consent.
- Strong Enforcement Mechanisms: Patents can be enforced during the application period, and preliminary injunctions are available subject to certain conditions.
- Specialized Courts and Advisers: Italian courts often appoint Court Technical Advisers to handle the technical aspects of patent cases.
- Integration with International Systems: Italy is part of the UPC system, which streamlines patent litigation across Europe.
Frequently Asked Questions (FAQs)
Q: What are the key differences between Italian law and EU Directive 98/44/EC regarding biotechnological inventions?
A: Italian law excludes all uses of human embryos from patentability and requires more detailed descriptions of industrial applicability for elements isolated from the human body.
Q: What declarations are required for biopharmaceutical patent applications in Italy?
A: Declarations of origin of biological material, informed consent from donors, and compliance with genetically modified organism regulations are required.
Q: Can patents be enforced during the application period in Italy?
A: Yes, patents can be enforced during the application period if the application has been published or officially served on the defendant.
Q: How does the doctrine of equivalents apply in Italian patent law?
A: The doctrine of equivalents promotes fair patent coverage by allowing for trivial departures from the claim language, but it is applied strictly based on the claim language.
Q: What is the role of the Unified Patent Court (UPC) in Italy?
A: The UPC, with a branch in Milan, handles patent litigation for various sectors, including pharma and biotech, streamlining the process across Europe.
Cited Sources:
- De Simone & Partners, "Italian provisions on biotech patenting: a short overview"[1].
- Chambers and Partners, "Patent Litigation 2024 - Italy | Global Practice Guides"[2].
- Baker McKenzie, "Italy: Disputes in the tech sector – Law and Practice"[3].
- Chambers and Partners, "Life Sciences & Pharma IP Litigation 2024 - Italy"[4].
- Brics and Beyond, "The Doctrine of Equivalents: Examination of the Law in Italy"[5].
