Czech Republic

The Czech Patent Act of 1991 introducing product patent protection was the first of its kind in the CEE countries.

Pipeline Protection

Paragraph 82 of the Patent Act also enabled pipeline protection, however, for a limited time period only. As a consequence the first patent-protected pharmaceutical products will not be available on the Czech market until 2001. Furthermore, pharmaceutical products which were granted product patents in the US and the EU before 1991, and which are enjoying protection there up to 2011 are and will remain unprotected in the Czech Republic for their entire lifetime. Since 1991, 165 submissions have been made for pipeline protection, of which only 16 have been approved by the Patent Office.

While pipeline protection is not part of the GATT/TRIPS provisions, under the EU Association Agreement, the Czech Republic has promised to achieve a level of protection including appropriate means of enforcement.

Patent Law

Czech Parliament is presently dealing with an Amendment to the Patent Law allowing Supplementary Patent Certificates and specifying stricter conditions for granting compulsory licenses. It is also expected that the Patent Law will be adapted so as to explicitly consider the importation of a patented product as "working the product" and to consequently exclude the granting of a compulsory license for it.

Product Patents — Enforcement

The practice of patent rights enforcement in the Czech Republic is sadly lacking. The only mechanism for challenging patent violators is via lengthy and costly court proceedings. There is an urgent need for granting timely temporary injunctions in cases of suspected patent right infringements.

Data Exclusivity

The Czech Republic is the only first-tier accession candidate to have adopted unconditional registration data exclusivity (6 years) in its 1997 Medicines Act. This is the middle of three options foreseen by EU directive 65/65 (the best grants 10 years, the worst grants 6 years, linked to the existence of a valid patent). In the EU, high-tech and centrally approved products enjoy a mandatory EU-wide 10-year exclusivity. Under the EU Agreements, the Czech Republic should have enacted a data exclusivity fully compatible with Directive 65/65 EEC by January 1, 1997. Under GATT/TRIPS, the Czech Republic is required to implement a TRIPS compatible data exclusivity by January 1, 2000. Since January 1, 1998, the Czech Republic has recognized registration of centrally approved medicines, which are granted a 10-year protection for registration data in the whole EU. It would therefore be recommended that the same protection period for centrally registered products be introduced in the Czech Republic as well.

Marketing Authorization

The Medicines Act guarantees 18 months for the registration for product submissions. Since January, 1998 the State Institute for Drug Control (SUKL) began recognizing EU centralized procedures insuring a maximum of 6 months for the approval of marketing authorization. Registration delays for filings made before 1998 are not uncommon, however with "older registrations" often taking 3-5 years.

Market Pricing

Max Pricing
All pharmaceutical products registered for commercial purposes in the Czech Republic are subject to price regulation. Different criteria are applied for maximum pricing for domestic products versus imported R&D products. Moreover, the criteria are not transparent and leave much room for misinterpretation by the Ministry of Finance. Additionally there are no firm rules for an appeal process.

The Czech Healthcare insurance reimbursement system also lacks objective and verifiable criteria for the inclusion and setting of reimbursement limits. The Categorization Committee which reviews pharmaceutical products for reimbursement generally sets price limits at the price of the least expensive drug in a specific ATC category with no consideration of the innovative/differential nature of a given product. Remarkably there are no transparent rules to appeal reimbursement decisions.

Potential Export/Foreign Sales

PhRMA Czech Republic estimates that the removal of the aforementioned trade barriers could conservatively be in the US $25-50 million range.