10 April

Conference Availability of medicines and industrial property rights

We would like to invite you to free of charge conference "Availability of medicines and industrial property rights", which will take place on April 10, 2024, from 9:00 to 13:30 at our University in the senate chamber D/202. It will be held in Polish language.

Industrial property rights are intended to encourage the search for innovative therapies by guaranteeing the introducers of new drugs a temporary monopoly. However, it must not be abused to delay competition in the market, which guarantees price reductions and wide availability of therapies. During the conference, experts in law and the pharmaceutical market will discuss the impact of regulations related to the operation of industrial property rights on the availability of medicines. The speakers will also present the most important current regulations on industrial property rights and drug market management in Poland. They will also discuss planned changes to pharmaceutical law in the EU. 

The conference is addressed to lawyers, representatives of pharmaceutical companies and students.

 

Schedule:

9:00 - 9:10 Welcome guests and introduction - Ewa Skrzydło-Tefelska, Ph.D., professor at L. Kozminski, SK&S partner

9:10 - 10:10 Importance of availability of medicines for the realization of health care tasks (from the perspective of the EU and Poland) - legal and economic aspect - Grzegorz Rychwalski, Vice President of the Polish Union of Pharmaceutical Industry Employees

Panel moderator: Jacek Myszko, SK&S partner

10:10 - 10:40 Impact of prepared amendments to the Reimbursement Act (patent linkage) on the availability of medicines in Poland - Krzysztof Kopeć, President of PZPPF.

10:40 - 11:00 Discussion

11:00 - 11:20 Break 

11:20 - 11:50 Bolar exception and drug availability - Justyna Ożegalska-Trybalska, PhD, Professor, Jagiellonian University

11:50 - 12:20 Supplementary protection certificate and drug availability - Ewa Skrzydło-Tefelska, PhD.

12:20 - 12:50 Impact of the new system of the Unitary Patent and the Unified Patent Court on the availability of medicines in Poland - Marek Oleksyn, SK&S partner

12:50 - 13:15 Discussion

13:15 - 13:30 Closing of the conference

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Prof. Ewa Skrzydło-Tefelska

Partner at the law firm Soltysinski Kawecki& Szlęzak. In 2015-2016 President of the European, African and Middle East Section of the Global Advertising Lawyers Alliance. 

Lecturer in training courses organized by the UPRP, as well as the International Trademark Association. Long-time lecturer at the European Center at the University of Lorraine. 

Research interests: intellectual property law, advertising law, EU institutional and substantive law. 

At ALK, he teaches in the Department of International Law and the European Union.

Grzegorz Rychwalski

Lawyer. Pharma & Life Sciences Expertise. Government Affairs, Public Affairs, Policy, and Legislation Expert. Former civil servant, diplomat. Top 3 global pharma business experience. Lecturer and panelist. For many years (15+) actively involved in the co-creation of UN & EU & PL law regulations and ecosystems with a proven track record of achievements in Geneva, Brussels, and Warsaw.

Expert in the field of the law-business environment having an impact on the creation and operation of the pharmaceutical industry in Poland and EU. Polish and European legislation expert.

Vice-President of the Medicines for Poland, Vice-President of the Health Cluster of National Smart Specializations (thematic areas with the highest scientific and economic potential on a national scale) at the Ministry of Development and Technology, Member of the Business Council at the Medical Research Agency, expert of the Commission for Cooperation with the Business Community of the Therapy and Medicine Science Committee at the Polish Academy of Sciences. Member of the Polish Legislation Society.

Vice-Chair of Business at OECD (BIAC) Health Committee. Advisor to European Economic and Social Committee.

Pharma & Life Sciences expert at the Association of Entrepreneurs and Employers, Business Centre Club and the Lewiatan Confederation. 

Leader of the IP Council of the Lewiatan Confederation. Member of the Working Groups of Medicines for Europe, an organisation which associates the largest producers of generic and biological equivalent medicines in Europe. Member of the BusinessEurope Working Groups. 

Formerly, Head of the Legal Department in the Department of Drug Policy and Pharmacy of the Ministry of Health, the Attaché for Medicinal Products and Medical Devices at the Permanent Representation of the Republic of Poland to the EU in Brussels and the Deputy Chairman of the Group for Pharmaceuticals and Medical Devices of the Council of the European Union. Former delegate of the Government of the Republic of Poland to the working groups of the European Council, the European Commission and the World Health Organization. Corporate experience gained as the Head of Strategy at INFARMA, as well as as a Governmental Affairs & Policy Manager at Janssen Polska.

Awards and distinctions:
•    a congratulatory letter from the Prime Minister of Poland
•    presence on the List of the 100 most influential people in the Polish healthcare system in 2018, 2019, 2021, 2022.
•    the Golden OTIS Trust Award in 2023.

Krzysztof Kopeć

Lawyer and economist, expert on issues pertaining to the medical market also in particular the production and reimbursement of medicines, law and administrative proceedings.President of the Polish Union of  Employers in Pharmaceutical Industry – Medicines for Poland, vice-president of the LEWIATAN Confederation, member of the Management Board of Medicines for Europe associating the largest producers of generic and biosimilars medicies in Europe, member of the Council and co-founder of the KOWAL Foundation (National Medicines Verification System), health expert of the BCC (Business Centre Club) and Association of Entrepreneurs and Employers, member of the Mazowiecki Council Provincial Branch of the National Health Fund. Member of the Commission for Cooperation with the Business Community of the THERAPY AND MEDICINE SCIENCE COMMITTEE at the Polish Academy of Sciences.

Former member and secretary of the Economic Commission at the Minister of Health. He was also the head of the Department of Reimbursement and Prices in the Department of Drug Policy and Pharmacy of the Ministry of Health. He worked at the Chief Sanitary Inspectorate. As a national expert, he participated in the work of the European Union working groups on medicines and WHO working groups, he was also a delegate within the cooperation of EU countries in the Competent Authorities on Pricing and Reimbursement (CAPR) working group. He dealt with the issues of the medical market in the Warsaw office of the international law firm Linklaters. 

Awards and distinctions:
•a congratulatory letter from the Prime Minister of Poland 
•2015 included and recommended (associates to watch) in the Life Sciences in the Chambers & Partners legal ranking.
•presence on the List of the 100 most influential people in the Polish healthcare system in 2018, 2019, 2021, 2022.
•the Golden OTIS Trust Award in 2023.
 

Jacek Myszko

Jacek Myszko has been a member of the SK&S team since 2003, and is currently the supervising partner of the firm's Life Science practice. He specializes in intellectual property and pharmaceutical law. He has advised on a number of regulatory projects, including the acquisition of pharmacy chains, restructuring processes of pharmaceutical companies, product launches and various aspects of wholesale operations in the medicinal products’ market in Poland.
 
For years he has been advising Polish and foreign clients on all aspects of patent and know-how licensing and also on intellectual property protection matters (including precedent-setting cases before the Polish Supreme Court).
 
Jacek Myszko is the author of national and international publications in the field of intellectual property law, pharmaceutical and food law. He appears as a speaker at national and international conferences. He is recommended by international rankings in the field of intellectual property law and Life Science.
 

Marek Oleksyn

Marek is attorney-at-law-law and Partner at SK&S law firm. He represents national and international clients in matters related to the protection of intellectual property, including patents, know-how, trademarks, designs, copyrights, databases and Internet domain names. He appears before the Court of Justice of the European Union, common and arbitration courts, administrative courts, the Polish Patent Office and the EUIPO.

Marek advises clients on the development of intellectual property protection strategies. He supports entrepreneurs in aspects related to counteracting unfair competition. Marek prepares and negotiates agreements concerning the acquisition and licensing of intellectual property and research and development agreements. He advises on technology transfer projects and issues related to employee creativity. 

Marek is the author of numerous publications in this area. He lectures at MBA and postgraduate courses in topics related to intellectual property protection.

dr hab. Justyna Ożegalska-Trybalska

Justyna Ożegalska-Trybalska, PhD (Doctor Habilitatus), is a university professor in the Department of Intellectual Property Law at Jagiellonian University. She is also a lecturer in patent law, copyright law, and Internet law at Jagiellonian University, Tongji University in Shanghai, and Technische Universität Dresden. In addition, she is a trainer at the WIPO-Harvard School of Law PatentX Course on Patents and Global Public Health. Furthermore, Justyna Ożegalska-Trybalska coordinates the international Joint Mater’s "Intellectual Property Law and New Technologies” program with WIPO Academy and the Polish Patent Office. She is also an expert in national and EU research projects, including IPR-Helpdesk, NetFinTex, IP-Unlink, HEIP-Link, PILA, and CIPNet. 

Justyna Ożegalska-Trybalska has authored over 90 Polish and foreign publications in the field of intellectual property law, including the monograph "Limitations of Patent Protection and Patent Infringement" (Wolters Kluwer, 2019) and articles and conference presentations focused on patent protection and access to pharmaceuticals.

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