- Ukraine’s reformed patent law provides a framework to prevent unlawful patents and monopolies on essential drugs, which have restricted access to life-saving treatment in the country.
- This follows years of advocacy campaigns, and cooperation between government, scientific institutions and international organizations.
The new patent law entered into force earlier this week, on 16 August.
It is a hugely significant achievement for our partner, 100% LIFE, the largest patient-led network in Ukraine. The network has led campaigns on the issue since 2015, and its legal and technical experts developed the amendments and have worked closely with government.
The reformed law can now begin to prevent intellectual property barriers and the abuse of the patent system in Ukraine. It also provides an example which can be followed by other countries.
It has always been immoral for companies to put profit before people, now we have amendments that also make certain practices illegal – Sergii Dmytriiev
“As the largest national network representing patients across Ukraine, the new patent law is a cause for celebration. Getting to this point has taken years of technical expertise and dedication. There is still work to be done, but we expect change to be visible in the short-term.
Intellectual property barriers, such as evergreening patents, are a key reason for gaps in accessing essential treatment in Ukraine. It has always been immoral for companies to put profit before people, now we have amendments that also make certain practices illegal.
The biggest change we’d like to see, and the reason we continue to fight for life every day, is to see people receiving essential medicines and recovering from otherwise life-threatening illnesses,” says Sergii Dmytriiev, 100% LIFE’s Policy and Advocacy Director.
Key changes as a result of the law
- The law defines more stringent patentability requirements for drugs.
This will eliminate the practice of granting patents for minor modifications of drugs with no improved therapeutic efficacy; for new dosages; for methods of application; and new prescriptions of already known drugs.
When evergreening patents such as these are granted it creates an extended barrier to the entrance of generic drugs. With these changes introduced by the new law, the national pharmaceutical market will become more open for generic competition, which will make medicines more affordable. Additionally, it may boost development of local pharmaceutical companies.
- The law rules out the possibility of obtaining utility model patents for pharmaceutical products. In Ukraine utility models are not a subject to substantive examination, making it possible for patents to be granted even for well-known, widely used drugs (such as aspirin, purely for example). According to the new law, utility models can only be granted for processes or devices.
- The process for challenging patents has been simplified.
The new law introduces mechanisms for pre- and post-grant opposition of patents. Previously it was only possible to challenge a patent at court. The introduction of this new legislation will make it easier to revoke any patents that shouldn’t have been granted.
- The patent extension term has been limited, by introducing a supplementary protection certificate (SPC) and a formula to calculate the SPC term.
Prior to patent law reform in Ukraine the patent term was automatically extended by five years, upon receiving request from a patent holder. This was to compensate for the delay caused by market authorisation process – even if the actual delay was much shorter and so was open to abuse.
The law has followed the European approach, introducing a supplementary protection certificate (SPC). From now on, the patent extension term will be calculated strictly in accordance to a formula, this will depend on the duration of delay and not exceed five years.
- Also taking into account the EU Regulation 2019/933, the new law includes waivers, such as the ability to manufacture and export drugs while an SPC is in place.
In practice this means that, by law, there is now the opportunity to manufacture medical products within Ukraine before the expiration of a SPC, for the purpose of exporting to third countries, or to store within the country, ready for use, six months before the expiry of an SPC, so that there is no further delay to generic access when an SPC expires.
The law simplifies the process of obtaining a compulsory license.It eliminates the requirement to obtain an unjustified refusal from the patent owner to grant a voluntary license, prior to making a decision on granting a compulsory license.
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