September 16, 2025
The new Patent law aligns Albania’s patent system with Directive 98/44/EC on the legal protection of biotechnological inventions, Directive 2004/48/EC on the enforcement of intellectual property rights, and numerous regulations concerning SPCs for medicinal products.
The major changes relate to annuity fees.
Previously, annuity fees could be paid at the end of the month in which the international filing date falls without any surcharge – this is now in line with validity date counted from the patent application date.
The grace periods remain the same – six months with a 50% surcharge and two additional months with a 100% surcharge.
The law updates the system of Supplementary Protection Certificates by introducing a six-month extension for medicines intended for children, following the EU Regulation on SPCs for medicinal products.
Another key change is the regulation of pre-market preparation and export.
The new patent law permits production of patented products, especially in the pharmaceutical and plant protection sectors.
Under these rules, manufacturers can start preparing for market entry as soon as a patent expires. In line with EU Regulation, the law also allows two exceptions during the SPC period: production for export outside Albania is permitted for the whole SPC term, while production for the Albanian market is allowed only.
The aim is to protect patent holders while also supporting public health. in the last six months of SPC validity.
The law also introduces EU-aligned rules on compulsory licensing, allowing licenses in cases of public health emergencies, anti-competitive practices, or lack of use. The law also allows compulsory licensing for the export of medicines to economically underdeveloped countries.
