Zentiva Head of Legal

Tereza Ber – General Counsel and Head of Legal at Zentiva, lawyer, graduated from Masaryk University in Brno, Czech Republic. She has 17 years of legal experience, including 10 years at Zentiva in various roles across the country, and leads a global team of legal, patent, trademark and compliance specialists. Zentiva relied on the Paris team at Pinsent Masons, known for their work for generic manufacturers such as Teva and Accord Health Care. Young General Counsel Jules Fabre led the case and joined Teva in mid-2019, where he spent two years as counsel in the IP and regulatory litigation department. At Pinsent Masons, the position of General Counsel corresponds to advising in other law firms. Zentiva is a manufacturer of high-quality and affordable medicines for patients in Europe and beyond. With a dedicated team of over 4,500 employees and a network of production sites, including flagship sites in Prague, Bucharest and Ankleshwar. Zentiva is headquartered in the Czech Republic and has 530 roots in Black Eagle Pharmacy, a small company that served the people of Prague. It now produces some of Europe`s best-known generic and over-the-counter medicines. Borowski began his legal career in Warsaw in 2003 as an associate at Wardynski & Partners.

He joined Hogan Lovells as an associate in 2006 and joined Weil Gotshal & Manges as a senior associate in 2007. In 2013, he joined Chalas i Wspolnicy as Head of Litigation and joined Kochanski & Partners in 2014, where he was appointed Partner. Borowski joined the company in 2019 when he joined JUUL Labs as legal counsel Poland. Almost a year later, he joined Takeda in Switzerland and assumed the role of Senior Legal Counsel for Global Manufacturing and Global Quality. For Zentiva Pinsent Masons (Paris): Jules Fabre; Partner: Marina Jonon Inhouse (Prague): Kristin Cooklin (Head of Intellectual Property), Alessandro Pontiroli (Senior Patent Counsel), Cecile Teles (Chief Patent Counsel) In April 2022, Zentiva announced that it would market its generic drug on the French market. For this reason, Novartis filed an infringement action against Zentiva in May, based on the EPO Board of Appeal`s decision that the Office should grant EP 894. Novartis then requested an injunction prohibiting Zentiva from marketing its generic product fingolimod on the French market until June 25, 2027. When Zentiva became independent in October 2018, our company launched an ambitious strategy to double its size in 5 years. We have identified strategic acquisitions as the most efficient and fastest way to expand our geographic horizons, production capabilities and product portfolio. In February 2022, the Technical Boards of Appeal subsequently annulled the initial decision of the Opposition Division.

This paved the way for the EPO to grant the patent on the basis of the main claim. However, as this has not yet been done, the patent has not yet been officially granted. In November 2019, Novartis filed a second patent application for the medical use of the 0.5 mg dose of fingolimod for the treatment of RRMS. However, in 2020, the EPO Examining Division refused to grant the patent for lack of novelty. The researchers referred to a study published in 2006 and a corresponding Novartis press release, which found that healthcare professionals can use fingolimod to treat RRMS at a dose of 1.25 or 0.5 mg. The company appealed this decision. Novartis also suffered a defeat in the Netherlands in the spring. The District Court of The Hague rejected an application for an interim injunction. The Dutch court recently issued a provisional decision declaring the patent invalid. It was clear to us as a management team that with the right acquisitions, we could outperform local market growth in several countries, especially in Central and Eastern Europe. The agreement with Alvogen CEE has strengthened our presence in Poland, Romania and Bulgaria and has given us access to new markets such as Russia, Ukraine, Kazakhstan, Hungary, Croatia and the Western Balkans. It was also a very good fit as our product portfolios complemented each other perfectly.

While the extended commercial exclusivity for Gilenya was announced on the 22nd. March 2022, the dispute is based on the fact that the EPO has not yet formally granted dosage patent EP 894. In parallel, Zentiva received marketing authorization in France in December 2020 for its own product fingolimod 0.5 mg capsules. For example, the country has included the generic drug in the list of drugs for which health insurance companies cover the costs. We`ve worked hard to bring the best of both worlds to the expanded company, and for now, it seems to be paying off. There is every reason to believe that the merger will be a commercial success and we expect a strong financial performance, which will allow us to continue to grow. Being part of Sanofi has been a great experience. But of course, there`s a big difference between a large, publicly traded company and a leaner, independent company like Zentiva today. As a medium-sized independent company, we can of course act faster and the pace of change is completely different. Over the past couple of years, we have sometimes felt like a transactional lawyer as we embarked on this journey of very rapid growth.

It`s exciting to be so closely involved in this transformation and expansion and to have built this momentum. I believe that Zentiva is indeed a unique company where everyone can have a visible impact. Pinsent Masons came to the current business through Fabre`s contacts in Zentiva. Borowski explained to CEE In-House Matters that he would report to Zentiva`s legal officer in his role. First of all, the fact that it showed determination in business so soon after independence. On the other hand, he highlighted our commitment to rapidly grow the company as a regional market leader. We were able to integrate Alvogen CEE, a company comparable in size to Zentiva, in just four months, and this speed was a real game changer and made us one of the fastest growing companies in our industry. I`m really proud of what we`ve accomplished here. This accelerates the changes we had to make! We are lighter and faster when it comes to delivering our products to our patients. We have put a lot of effort into protecting our employees in order to do everything and support people who really need care. It is a very satisfying feeling to be able to make a difference in these difficult times! Of course.

Onboarding 1,000 new colleagues from Alvogen – as well as 600 from Ankleshwar – was a major challenge. Typically, these are one-on-one, face-to-face meetings and group presentations, which just weren`t possible. We`ve all gotten used to virtual work and feel more connected now, but of course we`re looking forward to seeing each other face to face and for some people working as a team for the first time in 2021.