Quetiapine and Bulgaria's transitional ruling

From our colleague Dimitar Batakliev comes news of a decision of the Bulgarian Supreme Court which interprets the transitional provisions of the SPC Regulation, in particular Art.19a(k) of Regulation 1768/92. The case is AstraZeneca Pharmaceuticals LP v Bulgarian Patent Office, in an action which followed the refusal of the Office to issue an SPC for Quetiapine. The main question is whether the Supreme Court has correctly applied the principle of supremacy of the EU law in national legislation. Dimitar explains as follows:

"In 1997 a patent, BG 61365 for Thiazepine compounds, was granted to AstraZeneca Pharmaceuticals LP as a pipeline patent on the basis of EP 240228. The national legislation at that time allowed granting of such patents for medicinal and other compounds, applied for or protected by patents abroad before entry into force of the Bulgarian Patent Act. The law required that, at the time of applying for the patent, the product must not have been marketed on the territory of Bulgaria, that no certificate of authorship had been issued for the same subject-matter, and that the applicant or the patentee had a serious commercial enterprise in the country of origin of the invention.

The national legislation further provided that the term of protection of such patents should expire with the expiration of the foreign parent patent. Consequently, due to an SPC issued in UK for Quetiapine based on EP 240228, the protection of BG 61365 was extended beyond the regular 20-year period until 24.03.2012.

In 2007, the accession of Bulgaria to the European Union was also accompanied by a reform in the patent legislation. A new provision stated that the pipeline patents with extended term of protection should be deemed to have expired at the 20th year following the filing date of the parent patent. Instead, the patent holders were entitled to file an SPC application under Regulation 1768/92, which had just entered into force for Bulgaria. The SPC applications had to be filed within a transitional 6-month period from the accession of Bulgaria to the EU.

The patentee applied for an SPC and furnished a marketing authorisation for Quetiapine, issued in 1999 in UK, which was the first marketing authorisation for the product in the Community. The Bulgarian Patent Office rejected the application for failure to comply with the requirements of Art. 19a(k) of Regulation 1768/92. That provision stated that an SPC should be granted only if the first marketing authorisation for the product was issued after 01.01.2000.

On the appeal against the decision of the Patent Office, the Administrative Court revoked it and held that the requirement for the date of issue of the first marketing authorisation did not apply to the case. According to the court, there was not such requirement in the national provisions that entitle the former holders of pipeline patents to apply for SPCs.

The Bulgarian Patent Office appealed the decision before the Supreme Administrative Court. It also requested a reference for preliminary ruling, asking whether Art. 19a(k) of Regulation 1768/92 allowed for derogation in the national legislation from the requirement for the date of issue of the first marketing authorisation after 01.01.2000 in favour of SPC applications, based on the former pipeline patents. The Supreme Court confirmed the decision of the court of first instance and upheld all of that court's arguments. It refused to refer the case for a preliminary ruling, stating that Art. 19a(k) of Regulation 1768/92 did not have any significance for the correct decision of the case".

The full text of the decision in Bulgarian can be read here.

Thank you, Dimitar, for this information.