The act of including a generic product into the official Austrian pharmaceutical product index before expiry of the relevant patent/SPC, is considered an act of “putting into circulation” and therefore a patent infringement. By the same token the act of applying for reimbursement by an application to be included into the “Red Box” pursuant to the Code of Reimbursement of the Association of (Austrian) Social Security Carriers constitutes patent infringement.

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The right to an unpatented invention does not entitle to its exclusive use; it ceases to exist if the invention is made public without patent protection. The right to an unpatented invention encompasses no more than (i) the right to file a patent application and (ii) the right to claim the patent, in case a third party registers the paent in bad faith.

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As already explained in a previous post, the company governed by the laws of Switzerland, Novartis AG, is the holder of patent EP 0 443 983 entitled “Acyl compounds”, whose subject-matter is a group of antihypertensive compounds, including valsartan, pharmaceutical preparations containing them and processes for the preparation of these compounds.

This patent, filed on 12 February 1991, was to have expired on 12 February 2011. However, Novartis AG endeavoured to extend that protection by obtaining the grant of the supplementary protection certificate (SPC) No. 97 C 0050. This SPC should normally expire on 13 May 2011 but its validity was extended until 13 November 2011, through a “pae [...]

A supplementary protection certificate SPC granted for an enantiomer (escitalopram) cannot be declared void because a prior SPC was granted for the racemate (citalopram) when both the racemate and the enantiomer are protected by individual patents and thus are different products. This must be so because otherwise the enantiomer patent would be invalid for lack of novelty. The patent’s expiration and the SPC’s entry into force do not constitute reason to lift a preliminary injunction (PI), if the infringing product also falls within the scope of the SPC.

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The difference between “inventiveness” within the meaning of the Austrian Patent Act and “inventive step” within the meaning of the Austrian Utility Model Act is too small to distinguish between these two criteria. Thus, the inventive step pursuant to § 1(1) Utility Model Act requires the same qualitative criteria as inventiveness pursuant to § 1(1) Patent Act, which is the finding of a non-obvious solution for a problem.

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If a supplementary protection certificate (SPC) should have been denied (or granted with limited scope), because the six month application period following the date of first marketing approval has lapsed, it is entirely or partially void. There is a lack of legal interest for a negative declaratory action directed at declaring the non-existence of claims pursuant to §§ 147ss Patent Act (injunction etc.), if the complaint is solely based on the nullity of the SPC or the respective patent. In such case nullity proceedings before the Patent Office are the appropriate action for the purpose sought.

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