Multinational and Polish drug cos. face off in patent-law battle
Conflicting interests have surfaced between multinational pharmaceutical producers of patented drugs and manufacturers of unpatented drugs as an industry property law affecting the two camps is expected to be voted on in Parliament next month.
Multinational producers of "innovative" drugs claim that the law won't provide sufficient protection for products they spent years researching and testing, nor will it conform to European Union (EU) patent protection laws. "Generic" drug manufacturers those that produce drugs which are no longer protected by patents are pleased with the possible changes to the law because it would allow them to enter the market more quickly. The latter companies are largely Polish.
Because the law may lean toward benefiting Polish pharmaceutical companies, some multinationals could be less interested in setting up shop here.
"As long as the legislative situation is uncertain, foreign research-based companies are unwilling to move know-how to Poland," said Katarzyna Piotrowska, a regulatory affairs manager with Berlin-Chemie/Menarini Polska.
Of the three industry property law articles that apply to pharmaceutical companies, one is particularly controversial: the ability to conduct research while a product is still protected by a patent so that production of a drug can be started immediately after the patent has expired. This would benefit manufacturers of generic drugs, since they would then gain a head start on marketing their own cheaper versions of products.
The second article, on compulsory licensing, would in certain cases allow generic producers to begin manufacturing a drug that is currently under patent protection.
The third article refers to parallel import the ability to import and sell a drug without the permission of the patent holder once the drug has already been introduced to the market a practice common in the EU. Introduction of compulsory licensing would also benefit generic drug producers.
Multinational producers of innovative products also bemoan the lack of an industry property law that would protect their products, such as the Supplementary Protection Certificate (SPC) in the EU. Under certain conditions, the SPC allows a pharmaceutical company to extend its patent for up to five years.
"It sounds like we want 25 years (for the protection of our products). But in fact, we need to deduct the whole period prior to the launching of the product," said Aleksander Watin, general manager of Berlin-Chemie/Menarini Polska.
However, Andrzej Mroz, a lawyer at Polfarmed, the chamber of commerce for Polish generic drug producers, had a different view.
"The countries that prior to Jan. 1, 1990 didn't provide for the patent of pharmaceutical products may have the SPC introduced with a five-year delay," he said. Mroz cited Portugal, Greece or Spain as examples of countries that have negotiated transition periods for the SPC.
The lack of an SPC program, though, may worry not only pharmaceutical companies located in Poland.
"The existing Polish law allows for an earlier patent expiration in Poland than in other EU countries and we want to make sure that copies do not flow back to the EU markets, where the original products are still under patent protection," Watin said.
In addition, innovative drug producers, which spend millions on research, want patents on their products so these remain profitable as long as possible.
"For every 3,000 to 10,000 promising substances, only one or two ends up being a drug," said Jolanta Sabbat, director of health care politics at drug producer MSD.
Polish drug producers, though, are financially unable to take the same risks and make the same investments as multinational innovative pharmaceuticals, which is why they manufacture generic drugs.
"Our political system for the last 50 years didn't leave any resources for scientific research. Out of necessity, we have to take advantage of the fact that we can take up production of drugs, which, in the face of the law, have lost protection," Polfarmed's Mroz said.
Research is also cost prohibitive for domestic companies.
"Polish companies, unfortunately, don't have the capital to do thorough, basic research, because the research cost for generating a new drug is estimated at $300 million-$500 million, much more than the turnover of these companies," Watin said.
Producers of innovative drugs think it would be advantageous for Poland to move toward implementing EU standards and introducing stricter patent laws.
"Poland has a chance to establish its presence on EU markets if it will play according to their rules," said MSD's Sabbat.
