Andreia Liana CONSTANDA

Judge, High Court of Cassation and Justice, Civil Section

Recent developments in the Romanian patent law and case law

I would like to present a short overview of a number of patent-law issues, based on decisions given by Romanian courts in recent years, especially 2012 and 2013. In fact, I only feature one pre-2012 decision, which is included because it is of particular interest in the case law.

I. Provisional patent protection

This decision (High Court of Cassation and Justice (HCCJ) decision No. 1302 of 26 February 2010) concerns revocation of a provisional protection certificate. In it, the court laid down the legal requirements for the grant of provisional protection, and the effects on that protection if the underlying ("reference") patent is revoked.

Under Article 1 of Law No. 93/1998, Romania grants provisional protection for patents claiming a priority date before 21 January 1991 from a Paris Convention or WTO member state and relating inter alia to nuclear and chemical substances and medicaments.

In this case, the Romanian patent office granted provisional protection under Law No. 93/1998 to Merck Sharp & Dohme Corporation. EP 0 402 152 B1 was the reference patent, granted for 14 EPO member states including Great Britain.

The petitioner (the firm Gedeon Richter România) sought revocation of the provisional protection certificate on the grounds that (a) the invention in the reference patent was not patentable under Romanian law because it lacked novelty and inventive step, and (b) the underlying reference patent had been revoked by UK High Court decision HC 02C00845 of 10 February 2003.

On ground (a), the HCCJ held that provisional protection was not conditional on compliance with the patentability requirements laid down in framework Law No. 64/1991 on patents, but on the special, different conditions laid down in Law No. 93/1998.

Thus, provisional protection is granted for valid patents, with a priority date before 21 January 1991, in a Paris Convention or WTO member state, which are directed to products or methods falling within the categories explicitly and exhaustively laid down in Article 1 of the latter law.

On ground (b), the HCCJ ruled that here Article 2 of Law No. 93/1998 applied, and thus that provisional protection ended inter alia on the date of revocation of the reference patent. It therefore examined the petitioner's assertions that the reference patent had been revoked by the UK court

It held that the reference patent was not EP 0 402 152 B1 but the European patent granted for the UK as reference country, chosen by the proprietor and duly indicated as such in the provisional protection certificate.

This interpretation is based on the special characteristics of European as compared to national patents. It is widely accepted in legal doctrine and the case law that a European patent is like a "bundle" of patents, each of which has the effect of national patent in the designated EPC contracting state concerned.

Under Articles 64, 65, 138 and 139 EPC, a European patent granted for several designated states may be validated in all of those countries or only some of them. Similarly, the protection it confers may be limited or set aside in all or only some of the designated states.

To ascertain the scope and duration of the protection conferred, the request for provisional protection had to indicate which of the 14 patents in the European "bundle" was the reference one.

Looking at the reference patent's status in the light of the UK High Court decision, the HCCJ found that it had been revoked in part in the UK: admitting the request had led to deletion of the first four claims. Although Merck as proprietor had acknowledged during the litigation that novelty-destroying prior art existed, that did not mean it had partly disclaimed the protection conferred by the patent. The proprietor was free to make such a disclaimer, but it had ex nunc effect, i.e. protection was lost only for the future.

In the UK litigation, the actual validity of the patent had been challenged, leading to an amendment in the form of the deletion of the four claims.

In other words, the scope of protection had been limited, because the grounds for revocation affected only the patent only in part – a possibility expressly laid down in Article 138(2) EPC and referred to as "amendment" in the literature and judicial practice.

Nullity and revocation are sanctions which are applied not only in patent law but also in civil law generally. The have ex tunc effect, i.e. as far as the amended part is concerned the patent is regarded as having never existed.

As regards the effect of the reference patent's revocation on the provisional protection certificate, the HCCJ found that the certificate had to be revoked too, because it followed on from the reference patent. Article 2 of Law No. 93/1998 ("provisional protection ends … on the date of revocation of the reference patent") is an acknowledgement of the legal principle that revoking the main document leads to revocation of the subsequent one.

II. Novelty of the invention

Two of the cases settled by the Romanian courts concerned whether the patentability requirement of novelty was fulfilled. In both, it was found that employees of a company that used the invention before the patent application was filed were not part of the "public" with access to pre-existing information, as long as they were under confidentiality obligations towards their employer. This approach is similar to the way the EPO boards of appeal apply Article 54 EPC.

In the first case (settled by Bucharest court of appeal decision No. 1701 of 5 July 2012) it was acknowledged that, before the patent application was filed, the inventor had allowed a company to use the invention. It was used for company-specific activity by a limited number of staff whose tasks involved the operation of the technical installation concerned.

These staff had a confidentiality clause in their contracts of employment. That meant they were not part of the "public", and their use of the invention prior to the filing of the application did not mean that it had become publicly available prior art.

In the second case (settled by HCCJ decision No. 921 of 22 February 2013), it was acknowledged that the equipment had been used in a uranium processing plant for 13 years before the patent application was filed, and all the documentation about this plant was confidential or indeed a state secret. Thus, special legislation prohibited the staff directly involved in operating the equipment from disclosing any information, data and documents about it, even after leaving this employment.

In this case, however, the HCCJ court found that the novelty criterion was not fulfilled, given the prior-art information available. The inventors were themselves plant employees who used the invention, and as such had full access to prior art relating to similar equipment which they implemented in their invention.

The HCCJ concluded that the prior art on the filing date also included knowledge available to the general public when the invention was made. If such public information existed when the invention was made, it was even more part of the prior art by the time the application was filed.

III. Effect of non-payment of patent renewal fees

Under Romanian patent law No. 64/1991, if the renewal fees payable throughout the patent term are not paid, then the proprietor’s patent rights lapse. Such lapse is recorded in the national patent register and published in the Official Bulletin of Industrial Property.

Romanian law (unlike say France's or Belgium's) does not expressly regulate the date on which lapse takes effect.

The HCCJ has repeatedly ruled in recent years that lapse takes effect on expiry of the time limit for paying the renewal fees, and not on the date when lapse is established by the Romanian patent office or a court, or published in the Bulletin. How much time has passed between the last fee payment and the date on which notice of lapse is published (which can be 7, 8 or even 10 years) is irrelevant.

The HCCJ took the view that keeping the patent in force until publication of lapse, even though no fees had been paid during that period, would vitiate what is supposed to be the sanction imposed on the non-diligent or uninterested proprietor for failing to maintain it.

The date on which lapse becomes effective is the same for the proprietor and the inventor, if the latter is not also the former (e.g. because the inventor has assigned the property rights under the patent to his employer). The inventor then no longer enjoys any financial rights under the patented invention (this is consistent HCCJ case law; see e.g. decision No. 4080 of 5 June 2012).

If a patent lapses, the proprietor can re-establish his rights, for justified reasons, within six months of the date of publication of lapse. However, re-establishment does not mean that the proprietor fully regains his earlier status. Romanian patent law is quite clear about that. Third parties are free to exploit the invention (HCCJ decision No. 6109 of 9 October 2012).

They can even use the invention after re-establishment, subject to the conditions laid down in Article 34(1)(f) of the patent law. Thus, they do not infringe the proprietor's rights of exclusive use if they in good faith use or make effective and serious preparations for using the invention in the period between lapse of the patent and re-establishment of the proprietor's rights. They can then continue to use the invention to the extent they were using it on the date of publication of re-establishment, although they can only transmit that right of use together with their property or the relevant part of it.

A third party is acting in good faith if he is convinced that using the invention is not detrimental to the property rights conferred by the patent. The lawmaker acknowledges third parties' rights to continue using the invention after re-establishment, for their business purposes and without payment. However, good faith ends with the publication of re-establishment, i.e. once third parties know – or could have known – the patent's legal status (see e.g. decisions No. 5431 and 5432 of 22 November 2013, and No. 881 of 17 March 2014, all from the HCCJ).

Romanian law recognises third parties' rights of use "to the extent existing on the date of publication of re-establishment" (although Article 122(5) EPC, which also governs third-party rights, does not include any such wording). In practice, third parties can continue to use the invention as long as they obtain the same quantitative results as before. This is not limited to the quantities of products, corresponding to the invention, that the third parties have in stock on the date of re-establishment. The patent was for a "multiangular excavator bucket", and a third party was using the invention in ten excavators on the date of re-establishment. This decision (No. 95 of 12 December 2012 from the Craiova court of appeal) has yet to be interpreted in Supreme Court case law.

IV. Supplementary protection certificate (SPC)

Two cases settled concerned the grant of an SPC to extend patent protection under Article 3(a) of Regulation (EC) No. 469/2009 concerning the SPC for medicinal products, which requires that the product be protected by a basic patent in force. Both cases predate the CJEU's decision in C-493/12 (Eli Lilly), which found that an SPC may be granted for an active ingredient covered by a functional formula in the patent claims, "on condition that it is possible to reach the conclusion on the basis of those claims, interpreted inter alia in the light of the description of the invention, as required by Article 69 EPC and the Protocol on the interpretation of that provision, that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question, which is a matter to be determined by the referring court."

In these cases, the proprietors of two different patents applied separately for an SPC for Atripla, a product which comprised a combination of three active substances (A, B and C) and was used under marketing authorisation EU/1/07/430/001 to treat HIV infection.

Both applications were rejected by the Romanian patent office in administrative proceedings. These decisions were appealed to Bucharest's first-instance court and then to its court of appeal.

In the first case, settled in 2012 (Bucharest court of appeal decision No. 2608 of 4 December 2012), the Romanian patent was for a product and a process and had been granted on the basis of an international PCT application (US basic patent).

The court found that for determining the scope of protection conferred by the basic patent, the infringement test – pace the patent proprietor – was not relevant; what mattered were the criteria laid down by national law on the basic patent, in the absence of a definition of patent protection in the Regulation and in line with its Article 4 referring to "the limits of the protection conferred by the basic patent".

Thus, the scope of protection is determined by the claims, which are to be interpreted (under Article 32(3) of Romanian patent law No. 64/1991, which is worded similarly to Article 69 EPC) in the light of the description and drawings.

The court acknowledged that the claims and description of the basic patent specified the structural formula of active ingredient B of Atripla, but not the product for which an SPC had been requested (which was a combination of three active ingredients, including B). Thus the protection conferred by the patent was limited to the product described in the claims; it could not be extended to combinations of active ingredients not mentioned in the patent.

The court noted that this interpretation of Article 3(a) of Regulation (EC) No. 469/2009 was in line with CJEU case law in C-322/10 (Medeva) and C-518/10 (Yeda), which expressly stated that, if an SPC is to be granted, the active ingredient covered by the SPC must be mentioned in the claims of the basic patent.

In the second case, settled by Bucharest court of appeal decision No. 982 of 23 April 2013, the Romanian patent was for a process for preparing pharmaceutical substances, compositions and combinations and for a method of HIV inhibition. For the same product (Atripla), the proprietor obtained SPCs in six EU states in which the basic national patent, like the Romanian one, had also been obtained on the basis of an international PCT (US) patent application.

The Romanian patent office refused the application for an SPC on the grounds that the condition laid down in Article 3(a) of Regulation (EC) No. 469/2009 – that the product be protected by a basic patent in force – was not fulfilled. Although the basic patent also protected a combination of three active substances, it did not protect the combination A + B + C of Atripla, because this was not specified in either the claims or the description. Whilst claim 7 did indicate that a combination of the first two substances with a third – an HIV inhibitor – was possible, the description specified that the third substance had to belong to specific groups which did not include substance C.

The court ruled that an SPC could be granted. Although the patent did not expressly mention the three active substances, in view of its claim 7 and the description (which was used to interpret the claims) this combination could be protected.

Claim 7 of the basic patent refers to a "synergetic combination of the antiviral AIDS compounds, characterised by the fact that it contains a compound with the formula (...) [substance A] and, potentially, one or more HIV inhibitors".

Given the basic patent's description, a combination of three or more active substances always including active ingredient A (specifically mentioned in claims 1 and 2) was protected. The combination could be with one or more HIV inhibitors, with one or more agents used in treating AIDS, but in particular with any pharmaceutical composition used in AIDS treatment.

The technical pharmacological analysis conducted for the court proceedings showed that B and C were both separate antiviral AIDS agents and HIV inhibitor compounds, used in combination in a pharmaceutical composition to treat AIDS. At the date of filing of the basic patent application, they were already part of the state of the art.

In this decision too, the Bucharest court of appeal cited the CJEU's decision in C-322/10 (Medeva).

Another 2013 case was about the scope of Regulation (EEC) No. 1768/1992 concerning the creation of an SPC for medicinal products. In its decision No. 1583 of 26 March 2013, the Bucharest court of appeal upheld the Romanian patent office's refusal to grant an SPC.

The issue was whether an SPC could be granted for the product Sildenafil, given the conditions laid down in Article 3 of Regulation (EEC) No. 1768/1992. The application for an SPC was filed on 26 June 2007, when this regulation was still in force (it was repealed by Regulation (EC) No. 469/2009).

The court based its ruling on CJEU case law on Article 2 of the regulation, namely the decisions of 28 July 2011 in cases C-195/09 (Synthon BV) and C-427/09 (Generics UK Ltd).

In those decisions, the CJEU held that a medicinal product for human use was not covered by the regulation – and therefore could not have an SPC – if it had been placed on the market in the EU without prior authorisation under Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (as amended by Council Directive 89/341/EEC of 3 May 1989), and in particular without any prior assessment of its safety and effectiveness.

In this context, the Bucharest court of appeal found that Sildenafil had been marketed before the first authorisation under Directive 65/65 was issued (which occurred on 10 May 2006), and therefore no SPC could be granted for it. The fact that the product had been marketed under registration certificates issued by the Romanian medicines agency in 1998 was not relevant, because these were not "first authorisations to place the product on the market" within the meaning of Regulation No. 1768/1992, having not been issued in accordance with Directive 65/65/EEC.

Looking at the facts, the court noted that not only the Romanian certificates but also the first marketing authorisation (granted in 2006) under the EU regulation had been issued before 1 January 2007, when Romania joined the European Union. So the first point to resolve was the point in time at which Regulation No. 1768/1992 became applicable.

The court ruled that the regulation was applicable, under its Article 19a(l) – now Article 20(j) of Regulation (EC) No. 469/2009) – even though the first marketing authorisation had been issued prior to 1 January 2007.

Indeed, the regulation laid down the conditions under which it applied to countries, including Romania, that joined the EU after 1 January 2004. Thus, under its Article 19a(l), "any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Romania. In cases where the period provided for in Article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting no later than 1 January 2007".

Given that the regulation contains special provisions for Romania, does its Article 2 ("Scope") apply? Is it necessary that the first marketing authorisation was issued under Directive 65/65/EEC (but after 1 January 2000, in accordance with Article 19a(l) as just quoted) and that the product for which an SPC is sought was placed on the market before that first authorisation was obtained?

The heading of Article 19a(l) is "Additional provisions relating to the enlargement of the Community", which is followed by the proviso that Article 19's provisions apply if not overridden by ("without prejudice to") the other provisions of the regulation.

Can the directive apply even before the date on which Romania joined the EU? The national laws of countries joining after 2004 were harmonised with EU legislation beforehand, so it is not impossible to fulfil the Article 2's requirement regarding Directive 65/65/EEC. In the case in point, the court noted that the 2006 authorisation was obtained in Romania under a procedure adapted to the relevant EU rules, namely Directive 2001/83/EC which superseded Directive 65/65/EEC).

The requirement of "placing on the market" the product for which an SPC is sought is explained as regards EU territory in the CJEU's Synthon BV and Generics UK Ltd decisions.

Does it apply in the context of Article 19a(l), which concerns marketing authorisations obtained after 1 January 2000, i.e. for products marketed only in a country that was not yet an EU member? How should it be interpreted for countries that joined after 2004? Is it relevant that a product was marketed before 1 January 2000 in such a country, in accordance with the relevant national regulations? (Bear in mind that the two CJEU decisions posit an evaluation of the product's "safety and effectiveness".)

Another decision to be mentioned here is No. 84 of 1 March 2011 taken earlier by the Bucharest court of appeal. This allowed an SPC to be granted, because the first marketing authorisation had been issued in Romania in 2001, thus complying with Article 19a(l) of Regulation No. 1768/1992, although the product had already been marketed on the basis of certificates issued under national law. However, this decision was taken before the CJEU's rulings in Synthon BV and Generics UK Ltd, cases, and future case law may clarify the above issues.