It is a good time for the CEE region, and for Poland. In September 2018 Poland became the first country in CEE to be ranked as a “developed market” in the FTSE Russell index. And the Polish Life Sciences market, which had previously been driven by a transition economy dogma, has made a leap from a purely generic market to a more innovative one. A few recent developments may allow Poland to become a leader in the CEE Life Sciences industry.
Economic Trends
Traditionally the Life Sciences market in Poland (as elsewhere in CEE) has consisted of generic and branded generic manufacturers. Poland has the biggest share of the primary pharmaceutical market in CEE, with a steadily-growing number of pharmaceutical and medical device companies. Health-related industries are among the most rapidly-expanding innovation sectors in Poland. R&D provides for the largest share of innovation expenditure, followed by investment in capital goods with embedded technology. The Polish Life Sciences industry is supported by state funding, in particular by the European Commission and Poland’s National Center for Research and Development. According to a recent report by the Polish Patent Office, the Polish Life Sciences industry (in particular health tech) has grown steadily since Poland’s accession to the EU and now includes around 100 large and small business entities. Since 2010 companies in Poland have accounted for 2.7% of all new healthcare technology in the EU.
Patent Trends
Recently, EU investment in Poland has contributed to greater domestic innovation and has strengthened EU ties to the domestic R&D scene. Furthermore, the growing awareness of IP issues is increasing the number of inventions registered at the Patent Office.
According to the Patent Office’s report on the scale and intensity of patenting activity, Polish health sector entities filed 34,639 applications for worldwide IP rights (patent and utility model applications) between 2006 and 2015, including 3,193 patent applications and 270 utility model applications, of which 1,656 (48%) were in pharma and 1,807 (52%) were in med-tech. The share of healthcare applications in Poland increased by 6% to 8% yearly since 2010. The top 14 most valuable applications were filed in the health sector (both pharma and med-tech). Most Polish Life Sciences companies file their patent applications in Poland (76%). Nearly half of all patent applications were filed jointly with other applicants. Also, most patent applications were filed for non-biological preparations (42%) and new chemical compounds (31%). The key specializations in the field of med-tech were in the fields of diagnosis & surgery (34%) as well as stents, orthopaedic, nursing or contraceptive devices, treatment or protection of eyes or ears, bandages, dressings, or absorbent pads (18%). There were 534 patent applications filed with the European Patent Office by Polish entitles last year alone, and this trend is increasing.
Finally, it is worth noting that top foreign Life Sciences giants patent in Poland as well. More than 50% of foreign patents originated from Germany, followed by the US, France, Switzerland, Italy, the Netherlands, and Japan.
Legal Trends
A trickle of patent and regulatory clashes has been flowing through Poland’s courts, with a rising number of confrontations between foreign pharmaceutical titans and local rising stars. With a total of 13,432 healthcare-related national and PCT applications and validations of European patents, Poland is the leader in the CEE region.
The hot news is that the Polish Ministry of Justice has initiated public discussions about specialized IP courts in Poland (primarily for trademarks and patents), which may facilitate dispute resolution in the Life Sciences sector and thereby increase the effectiveness of IP protection for Life Sciences companies. Furthermore, in mid-May of this year the Polish Ministry of Entrepreneurship and Technology launched another public debate on the Unified Patent Court system. The Polish decision to opt out of the Unified Patent Court means self-preservation for the country’s patent scene. Moreover, Poland will keep its hands on the local patent policy and no Life Sciences company can omit Poland from its strategy when launching a new patent-related product into the market. Further developments in this area are eagerly awaited!
By Przemyslaw Walasek, Partner, and Agnieszka Sztoldman, Head of Life Sciences and Pharma, Taylor Wessing Poland
This Article was originally published in Issue 6.6 of the CEE Legal Matters Magazine. If you would like to receive a hard copy of the magazine, you can subscribe here.
