JUrISdIctIOn repOrt: rOmAnIA
SUppLementArY prOtectIOn certIFIcAteS
margareta Oproiu and raluca Vasilescu (pictured)
Cabinet M. Oproiu
Since January 1, 2007, the date of Romania’s accession to the European
“ ALL tHeSe AppLIcAtIOnS Were denIed
Union, all the Council Regulations issued by the European Parliament
bY tHe exAmInInG depArtment OF
and the Council have been directly applicable within Romania, including
Regulation (EC) No. 1768/92, concerning Supplementary Protection
tHe rOmAnIAn pAtent OFFIce On tHe
Certificates (SPCs) for medicinal products—currently, Regulation (EC)
GrOUndS tHAt tHe FIrSt mA WAS ISSUed
No. 469/2009 of May 6, 2009 (the Regulation).
prIOr tO 2000 And tHIS WAS cOntrArY
This article deals with the particular difficulties encountered in Romania in
tO tHe trAnSItIOnAL prOVISIOnS.”
cases where the request for an SPC was submitted to the Patent and Trademark
Office during the grace period from January 1, 2007 to June 30, 2007.
Council Regulation (EC) No. 1768/92 sets out the requirements and the
procedure for the granting of SPCs, which add additional protection
of up to five years beyond the expiration of a patent for a medicinal
product. The procedural provisions applicable are those of the national
Essentially, in all cases, the defence is based on the fact that the Certificate
law corresponding to the basic patent, unless the national law lays down
of Registration issued prior to 2000 is not a valid MA, because it was not
special provisions for certificates, with the exception of the opposition
issued pursuant to the criteria of safety and efficacy laid down by the
(Article 19).
Directive. The line of reasoning is that these certificates issued pursuant to
The standard provisions require that an application for an SPC is lodged
a law of 1979 do not constitute an “authorisation to place the product on
within six months of the date of valid authorisation to place the product
the market” in the EU and that authorisations lodged pursuant to the law of
on the market. This so-called Marketing Authorization (MA) is granted to
2002 should be the ‘first’ authorisation according to the legal provisions.
a medicinal product that has met the requirement for safety and efficacy
During the debates before the Board of Appeal in public hearings, counsel
tests for medicinal products.
have equally invoked European case law, including Merck v. Almirall,
The transitional provisions for Romania as set out by the Regulation refer
Neuraxpharm Arzneimittels v. Merz and Generics UK v. Synaptech.
to a period of six months from January 1, 2007 to June 30, 2007. During
So far, it appears that the Board of Appeal of the Patent Office is inclined
this period, patent owners could file a request for an SPC for patents for
to deny protection for all the applications for SPCs that fall within this
medicinal products that received their first MA after January 1, 2000.
category, reasoning that the interpretation of the validity of the Certification
Approximately, 100 applications for SPCs were filed with the Romanian
of Registration as a true MA is a matter of purely legal interpretation and,
Patent and Trademark Office between January 1, 2007 and June 30, 2007.
as such, should be decided by the courts.
Among the applications—filed during the grace period of six months—
At time of writing, it appears that these proceedings will continue at the
were cases in which the first MA submitted in the file was issued pursuant
Municipal Court of Bucharest, which has jurisdiction over the decisions
to a law dated 2002. The medicinal product in question, however, had
rendered by the Romanian Patent Office.
already been placed on the market based on a so-called Certificate of
It will be interesting to see how the court will interpret the legal
Registration issued by the relevant health authority under the provisions
provisions regarding the requirements for granting Supplementary
of a law dating back to 1979.
Protection Certificates.
All these applications were denied by the Examining Department of the
Romanian Patent Office on the grounds that the first MA was issued prior
to 2000 and this was contrary to the transitional provisions. Margareta Oproiu is a senior patent attorney and general partner at
Cabinet M. Oproiu.
To date, all such cases have been rejected by or are pending before the
Board of Appeal of the Romanian Patent and Trademark Office, the first Raluca Vasilescu is a patent and trademark attorney and partner at Cabinet
tier of justice. M. Oproiu. She can be contacted at: raluca@oproiu.ro
70 World Intellectual property review September/October 2009 www.worldipreview.com
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