'No Patent on Life' – Unitary Patent to circumvent Austrian’s latest amendment to Patent Act?

With the announcement “No patents on life”, the Austrian federal government has presented the latest initiative to amend the Patent Act. It makes clear that in the future no form of conventional breeding shall be patented in Austria. However, a deviation to the unitary patent could arise. 

Austria's Patent Law Amendment 2023 (RV 1955 XXVII GP) contains national provisions for the introduction of the unitary patent. Thus, rules are introduced in the national patent law to ensure that the unitary patent may become effective on 1 June 2023. The amendment also contains clarifications on provisions on exceptions to patentability under Sec 2 para. 2 Patent Act, which the Austrian government summarised as “No patent on life”. 

Exception of patentability for animal and plant breeding 

Under the current law, exceptions to patentability covers “essentially biological processes for the production of plants or animals” (Sec. 2 (2) Patent Act). This provision is based on Art 4(1)(b) of the Biotech Directive (Directive 98/44/EC) and is also found in Art 53(b) EPC, which provides exceptions to the European patent. 

Despite the exceptions to patentability for biological processes, the EPO has in the past affirmed the patentability of products of breeding. According to the EPO, the exception is only applicable if biological processes are based entirely on natural phenomena, such as crossbreeding or selection. If a technological measure or step is involved in a certain way, then patent protection shall be granted. This may be the case, for example, with genetic modifications and chemical or physical measures (EPO (EBoA) 9.12.2010, G 2/07-Broccoli).

Similarly, the Enlarged Board of Appeal has taken the view that patentability cannot be excluded under Art 53(b) EPC if the subject matter of the invention relates to plants or plant material as such, for instance fruits or plant parts. Thus, product claims or product-by-process claims are not covered by Art 53(b) EPC (EPO (EBoA) 25.03.2015, G 2/12 and 2/13). 

For this reason, the European Commission published a statement stating that Art 4(1)(b) of the Biotech Directive is to be understood that the exceptions of patentability also applies to animals or plants obtained essentially by biological processes, so the product as such (EC 08.11.2016, C-411/7). However, since the European Patent Convention (EPC) is not an instrument of the EU but an independent international agreement, the European Commission statement is not binding for the EPO. Also, the Enlarged Board of Appeal may not refer questions to the CJEU for a preliminary ruling. Therefore, pursuant to Art 112(1)(b) EPC, the President of the EPO referred the relevant questions to the Enlarged Board of Appeal. In its opinion of 14 May 2020 G 3/19, the Enlarged Board of Appeal aligned its interpretation of Art 53(b) EPC with the European Commission's interpretation of Art 4(1)(b) Biotech Directive. However, the Enlarged Board of Appeal made clear that the interpretation does not apply to European patents with a filing date or priority date prior to 1 July 2017. 

Broadening exceptions of patentability by the Austrian Patent Law Amendment 2023

The Austrian Patent Law Amendment 2023 intends to avoid circumventions of the exception of patentability regarding biological breeding processes. Thus, non-targeted mutagenesis shall also be included in the exception of patentability. In this case, for instance , a plant is exposed to a certain stress, such as intensive UV irradiation. This may result in random mutations that can be further bred by means of crossbreeding and selection. The patent law amendment 2023 states that a process remains essentially biological even if it contains a technological step in a process that enables or supports the execution of the steps of crossbreeding or subsequent selection. Explicit reference is made to the EPO (EBoA) Decision 9.12.2010, G 2/07-Broccoli. 

However, such a broad interpretation of the exceptions of patentability may not concluded  from the Decision G 2/07-Broccoli. In that case, the Enlarged Board of Appeal held that Art 53(b) EPC applies if the introduction or modification of a trait is achieved by mixing the genes of plants selected for crossbreeding. Therefore, if a breeding process contains an additional technological step/measure, the process may not be excluded from patentability under Art 53(b) EPC. 
    
Therefore, it might be possible that the Austrian interpretation of Art 4(1)(b) of the Biotech Directive differs from the EPO’s interpretation of Art 53(b) EPC, although both provisions should be identical in content.

Nullity for European patents already granted in Austria? 

The planned patent law amendment 2023 is only applicable for Austrian national patents. However, since there is no central European nullity procedure, national nullity proceedings can be initiated in any jurisdiction where a European patent is valid. Thus, according to Sec 10 PatV-EG, Austrian parts of European patents can be declared invalid on grounds of Art 138 (1)(a)-(d) EPC. A ground for nullity therefore exists if the subject matter of the patent would not be patentable under Art 53(b) EPC. The question how the Austrian Patent Office will deal with the patentability of biological breeding methods in nullity proceedings after the Patent Law Amendment 2023 has become effective remains unclear. This question is viable because the Austrian Patent Office could base the nullity proceedings on the Austrian interpretation of Art 53(b) EPC or Art 4(1)(b) of the Biotech Directive and thus declare the Austrian part of the European patent null and void in the sense of a broader exception of patentability. 

There are, however, constitution law objections. For example, the Austrian Constitutional Court has in the past confirmed that cancellation of a right, which is retrospectively effective from the beginning of the term of protection, is to be assessed according to the legal framework applicable at the time of registration of such right (Austrian Constitutional Court 30.11.1999, B 889/97). 

Remedy via unitary patent 

The unitary patent, which will be available from 1 June 2023, may provide a remedy for the potentially inconsistent application of the law. This is because the unitary patent will be granted by the EPO exclusively according to the rules and procedures of the EPC. Patentability will therefore be examined exclusively according to the substantive requirements of Art 53(b) EPC. According to Art 3 of Regulation (EU) No 1257/2012, the unitary patent enjoys uniform protection in all participating member states. 

The unitary patent is not accessible to national nullity proceedings. This is because it can only be declared null for all participating member states. In this aspect, the Unified Patent Court has exclusive jurisdiction. By obtaining a unitary patent, right holders may thus circumvent the Austrian Patent Amendment 2023. 

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