A Bulgarian milestone as Supreme Court rules on Atripla application

From our friend Dimitar Batakliev (IP Attorney, Bulgaria) comes the following news:

"I would like to report a recent case before the Supreme Administrative Court of Bulgaria regarding an SPC application for Atripla, a drug for treatment of HIV infection.

In a decision of 8 June 2014 the Court held that the claimed product, consisting of efavirenz, emtricitabine and tenofovir disoproxil fumarate, was not protected by the basic patent BG 62612 and therefore did not meet the requirements of Article 3 of the SPC Regulation. According to the court, this combination was outside the scope of claim 8 which protected 

“a combination of a compound of Formula I or Formula II according to claim 2 with a nucleoside analog having biological activity against HIV reverse transcriptase”. 

Although efavirenz was found to be a compound of Formula I and emtizitabine -- a nucleoside analogue -- the court held that the claim envisaged only combinations of two active ingredients, while the applied product consisted of three. Further, the court confirmed that the third ingredient, tenofovir disoproxil fumarate, was also outside the scope of the claim as it was a nucleotide rather than a nucleoside analogue. Although after its intake it was transformed in the human body into a nucleoside, at the time of composing the claimed product it lacked such characteristics. As a result the Supreme Court reversed the decision of the court of first instance and instead upheld the decision of the Patent Office to reject the application of Merck Sharp & Dohme Inc.

In its detailed analysis the Supreme Court touched on a number of important topics of the SPC domain. It provided guidance on the methods of interpretation of patent claims, on the applicability of the infringement test and the significance of the Medeva and Eli Lilly decisions. It also commented on decisions of other jurisdictions which had been put forward by the parties in support of their arguments. Therefore, in my opinion the Atripla case resulted in a milestone decision of the Bulgarian case law with respect to the application of the SPC Regulation.

If you can cope with the original Bulgarian text of the judgment, Dimitar has kindly provided a link to it here.

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.

Tour of Patent Offices: Bulgaria

This week, it's off to Bulgaria, thanks to the kind information from Ventsi Stoilov, a Bulgarian IP specialist.

The Bulgarian Patent Office (BPO) website can be accessed here and searches on their database can be done on the BPO On-line website here. However, the database appears to be limited to trademarks, industrial design and case law - unfortunately not much help to those interested in patents. While researching this I noticed I was visitor no. 201,070 to the site. By the time I had done 3 searches, I was visitor no. 201,073...