Ukraine medicine IP waiver becomes ‘matter of life or death’

Patent lawyer Olga Gurgula cannot really explain why she had a compulsion to visit her parents in Kyiv the week before Russia’s February 24 attack on Ukraine. All the Brunel University law school senior lecturer can remember is that she had become terrified that an invasion was imminent.

“I just had this terrible feeling that something [was] going to happen,” she recalls. “I was very concerned that if the invasion happened, no one would be able to help them.”

Gurgula assisted her parents in escaping to a relatively safer location. She then returned to England but has since been back and forth, focused on using her expertise as an intellectual property lawyer to help her country.

She recently suggested a draft law that would help Ukrainians gain access to critical medical supplies. As war broke out, pharmacies were completely empty, Gurgula says.

“You couldn’t find antibiotics, painkillers, or even insulin,” she says. “This is a question of life and death for people with chronic diseases or serious life-threatening illnesses.”

As well as the devastating immediate impact of civilian deaths from Russian attacks, Gurgula says, the war has also produced an “enormous” health crisis due to the shortage of medical supplies.

“Humanitarian aid is helping but, considering the vast scale of the tragedy that affects the majority of Ukrainians, it is not enough,” she adds.

Gurgula, whose research focuses on how patent law impacts the availability of pharmaceutical products, saw a possible solution in Ukraine’s generic drug manufacturing industry.

“[Companies] would be able and willing to produce essential medicines, but some of those medicines are protected by intellectual property rights,” Gurgula explains, adding that such protections prohibit local companies from manufacturing generics.

The country is also unable to import some medicines because they are protected by patents that preclude the importation of generics, she points out.

The draft law, crafted by Gurgula and colleagues at the Ukrainian Intellectual Property Institute and a large patient organisation, is, in effect, an IP waiver.

If passed by the Ukrainian parliament, it would allow the country’s generics manufacturers to produce essential medicines legally, and let the country bypass World Trade Organization prohibitions on producing and importing generics.

Gurgula argues that her proposal is lawful under the “security exceptions” provision contained in Article 73 of the WTO’s agreement on Trade-Related Aspects of Intellectual Property Rights (Trips). This provision allows member states to waive IP rights in certain circumstances, such as war.

“It lets you pause your obligations while protecting the essential security interest of the state, such as saving [the] lives and health of people in Ukraine,” she explains.

This draft law is currently awaiting debate in the country’s parliament.

Gurgula has a history of working to improve her country’s IP infrastructure. In 2018, she was a research co-ordinator on a project run by Queen Mary University’s law school and funded by what was then the UK’s Department for International Development, which aimed to establish a specialised IP court in her native Ukraine. That work would have come to fruition if not for the outbreak of war. The new court was expected to be established later this year.

She is not alone in her struggle to help her country. As part of efforts to help Ukrainian colleagues, the international IP academic community has pulled together. The University of Strasbourg in France, the Max Planck Institute in Germany, and other institutions across Europe, have provided visiting fellowships to Ukrainian academics in a bid to bring them to safety and help them continue their work.

In the early days of the war, German-Swedish national Timo Minssen, a biomedical law professor at the University of Copenhagen, drove to the Ukraine-Poland border to fetch one of his former PhD candidates and his family. He was unable to connect with his former student at the time, but he brought another Ukrainian family and their dog to safety in northern Denmark; his former student and their family eventually made it to Copenhagen.

Minssen has also reserved his academic department’s visiting scholars fund for Ukrainian scholars.

“All this help, and what other institutions are doing, including helping IP academics continue their work, is just incredibly important and greatly appreciated by us,” Gurgula says.

Business as usual? Continuing operations as a general counsel

Andrii Humenchuk has remained in Ukraine throughout the war, partly in response to the Ukrainian government’s pleas to help protect the country’s economy by continuing operations.

Humenchuk, general counsel of Ukrainian ecommerce retailer EVO, has dealt with legal issues inconceivable to a GC in peacetime, like helping employees comply with martial law and conscription requirements.

The company is headquartered in Kyiv, but many of its employees have fled to the relatively safer Ukrainian city of Lviv, or to Poland, Italy and other countries.

In the early days of the war, Humenchuk lost one of his colleagues, who was shot in the suburbs of Kyiv while trying to help move elderly residents out of harm’s way.

“The first two or three weeks were the most difficult, including psychologically,” recalls Humenchuk. “You couldn’t get your head around the fact that people were being killed, and at the same time you had to at least try to help your business and respond to the government’s urging that Ukraine businesses open an economic front . . . to help economic recovery and provide people with jobs and ways to make an income.”

EVO has not only been able to continue, it has served the war effort by lending its logistics operations to help supply necessary equipment to civilians and the Ukrainian military, including helmets, protective vests and medical supplies.

As GC at an ecommerce platform that helps Ukrainian businesses market and sell their products, much of Humenchuk’s team’s work involved protecting the IP of sellers on its site, even before the war. But that need increased and became more complex when Russia invaded his country.

“We saw more incidents of IP infringement as hostilities broke out,” he says, adding that opportunistic counterfeiters seemed to be taking advantage of disruptions in the market, “and dealing with them in other jurisdictions became more challenging.”

Communication lines became unreliable. Even corresponding with opposing counsel and meeting filing deadlines became difficult as his staff dealt with the realities of living in a country under siege. Yet he has been heartened by the treatment he has been given by lawyers in other jurisdictions.

“What struck me was that we haven’t received any pity,” he says. “Relations have been very respectful and tolerant. It has all been very professional, both from a legal perspective and a human perspective.”

Bruce Love is a freelance journalist and Washington reporter at the National Law Journal