Introduction
El Salvador has recently approved a new Intellectual Property Law, marking a significant shift in how intellectual property, including biopharmaceutical patents, is managed and protected within the country. This article delves into the key insights regarding patentability, enforceability, and the scope of claims for biopharmaceutical patents in the context of El Salvador's new IP regime.
The New Intellectual Property Law
The new Intellectual Property Law, approved by the Legislative Assembly on August 8, introduces several novel changes aimed at protecting and respecting intellectual property rights. This law is set to take effect six months after its publication in the Official Gazette and is expected to foster innovation, generate foreign investment, and promote economic growth[1].
The Salvadoran Institute of Intellectual Property (ISPI)
A central feature of the new law is the establishment of the Salvadoran Institute of Intellectual Property (ISPI). ISPI will be responsible for managing all types of procedures related to intellectual property, including patents, trademarks, trade names, and more. This centralized body will handle applications through an online system, reducing the time and paperwork needed to protect IP rights[5].
Patentability and Registration Process
First-in-Time, First-in-Right Basis
In El Salvador, the registration of patents follows a first-in-time, first-in-right basis. This means that companies should consider applying for patent protection even before entering the Salvadoran market. It is crucial for rights holders to register, protect, and enforce their rights, often with the assistance of local attorneys or IP consultants[2].
Novel Protections
The new law extends protection to various types of intellectual property, including patents, trademarks, trade names, emblems, expressions or signals of commercial advertising, geographical indications, and trade secrets. Notably, it introduces protection for integrated circuits and layout designs (topography), which were not covered under the previous law[1].
Scope of Claims for Biopharmaceutical Patents
Bolar Exception
The new law addresses the Bolar Exception, allowing third parties to use the subject matter of a patent to generate necessary information for sanitary registration of pharmaceutical products. This use is permitted before the patent protection period expires, and exportation for marketing approval requirements is also allowed[1].
Patent Term and Renewal
The new law sets the term for industrial designs at 15 years. Additionally, trade names and commercial advertising signals, previously with unlimited duration, must now be renewed every 10 years, similar to trademark registrations[1].
Enforceability of Biopharmaceutical Patents
Administrative and Judicial Actions
Protection against patent infringement can be implemented through both administrative and judicial actions. Administrative actions allow the patent owner to stop unauthorized use by a third party, covering activities such as manufacturing, sales, imports, storage, and transit. Judicial actions can be taken based on the Intellectual Property Law, the Mercantile Code, or the Criminal Code[4].
Opposition Procedure
The new law includes an opposition procedure where third parties can file observations to the patentability requirements of a new invention within two months after the publication of the patent extract notice in the Official Gazette. The applicant has the right to reply to these observations, and the Patent Examiner resolves whether the patent application proceeds to the examination phase[4].
Specialized Courts
Patent infringement lawsuits can be brought before the Mercantile Courts in the Judicial District of San Salvador or in courts with mercantile jurisdiction in other districts. Criminal actions are filed before the General Attorney's Office and prosecuted before a criminal court[4].
Burden of Proof
For establishing infringement, invalidity, or unenforceability of a patent, the burden of proof lies with the parties involved. The complaint must be filed before the Mercantile Court or a court with mercantile jurisdiction, and the judge may request a judicial bail to cover any damages. Preliminary injunctions can be requested, and both parties are given time to file their evidence before the judge issues a verdict[4].
Digital Environment and Intellectual Property
The new law includes a section on Intellectual Property in Digital Environments, regulating issues such as cybersquatting on domain names, resolution of disputes between domain names regarding distinctive signs, and protection of digital works. This section aligns with the country's efforts to modernize and protect IP rights in the digital age[1].
Exemptions and Fees
The new law exempts certain parties from paying official fees, including institutions at all levels of education, artists, creators, and natural and legal persons who qualify as micro and small enterprises. A filing fee has been introduced, which did not exist under the previous law[1].
Rehabilitation of Patents
An important aspect of the new law is the possibility to rehabilitate patents that expired due to non-payment of the maintenance fee. This provision aligns with practices in many other countries and provides a second chance for patent holders to maintain their rights[1].
Impact on Biopharmaceutical Innovations
While the new law does not specifically address the complexities faced by the biopharmaceutical industry, such as those related to the scope of patent claims and enablement requirements discussed in other jurisdictions[3], it does provide a more streamlined and protective environment. This could encourage more innovation and investment in the biopharmaceutical sector by ensuring clearer and more robust IP protections.
Key Takeaways
- Centralized Management: The Salvadoran Institute of Intellectual Property (ISPI) will manage all IP-related procedures.
- Extended Protections: New protections for integrated circuits, layout designs, and digital environments.
- Bolar Exception: Allows third-party use of patented subject matter for sanitary registration purposes.
- Renewal Requirements: Trade names and commercial advertising signals must be renewed every 10 years.
- Administrative and Judicial Actions: Available for enforcing patent rights against infringers.
- Exemptions and Fees: Certain parties are exempt from official fees, and a filing fee has been introduced.
- Rehabilitation of Patents: Patents expired due to non-payment of maintenance fees can be rehabilitated.
FAQs
What is the role of the Salvadoran Institute of Intellectual Property (ISPI)?
ISPI is a centralized body responsible for managing all aspects of intellectual property in El Salvador, including registrations, renewals, and dispute resolution.
How does the new law affect the registration of biopharmaceutical patents?
The new law introduces a more streamlined process through ISPI, reduces paperwork, and provides clearer guidelines for patent registration and protection.
What is the Bolar Exception in the context of El Salvador's new IP law?
The Bolar Exception allows third parties to use the subject matter of a patent to generate necessary information for sanitary registration of pharmaceutical products before the patent protection period expires.
Can patents that expired due to non-payment of maintenance fees be rehabilitated?
Yes, the new law allows for the rehabilitation of patents that expired due to non-payment of maintenance fees.
Are there any exemptions from official fees under the new law?
Yes, institutions at all levels of education, artists, creators, and micro and small enterprises are exempt from paying official fees.
Sources
- EL SALVADOR APPROVES NEW INTELLECTUAL PROPERTY LAW - eProint
- El Salvador - Protecting Intellectual Property | Privacy Shield
- Eviscerating Patent Scope - DigitalCommons@NYLS
- Overview Of Patents In El Salvador - vLex
- El Salvador's New IP Law: What EU SMEs Need to Know - Intellectual Property Helpdesk
