Pages 186-198

WORKING SESSION

Recent case law on patenting biotechnological inventions

Friedrich FEUERLEIN - Presiding judge at the Federal Patent Court in Munich - Supplementary protection certificates for plant protection products

Cases currently before the Federal Patent Court

1. Background

Regulation (EC) No. 1610/961 states in its recitals that research into innovative plant protection products is often the result of costly development, contributes to the continuing improvement in crop production and thus is a key factor in the production of food of good quality at affordable prices. In order to protect consumer health and the environment, before new plant protection products may be placed on the market they must undergo a time-consuming authorisation procedure by an industrial property office. At present, the length of time between filing a patent application for a new plant protection product and successful completion of the corresponding approval procedure is such that the period of effective protection under the patent is insufficient to recoup the investment made. To ensure that adequate, effective protection is provided for these products at Community level, the above regulation creating a supplementary protection certificate for plant protection products was adopted on 23 July 1996 by the European Parliament and by the Council. Under this regulation, the holder of a national or European patent can be granted a protection certificate, under the same conditions, by each member state for a maximum period of five years. The holder of both patent and certificate should therefore be able to enjoy an overall maximum of 15 years of exclusivity from the time the plant protection product in question first obtains authorisation to be placed on the market in the Community.

A certificate confers the same rights as those conferred by the basic patent. It is granted under Article 3(1) of Regulation (EC) No. 1610/96 if, in the member state in which the application is submitted, at the date of that application

(a) the product is protected by a basic patent in force;

(b) a valid authorisation to place the product on the market as a plant protection product has been granted in accordance with Article 4 of Directive 91/414/EEC or an equivalent provision of national law;

(c) the product has not already been the subject of a certificate;

(d) the authorisation referred to in (b) is the first authorisation to place the product on the market as a plant protection product.

There are also mandatory deadlines that must be met when applying for a protection certificate. Under Article 7 of Regulation (EC) No. 1610/96, the application for a certificate has to be lodged, for instance, within six months of the date on which the authorisation to place the product on the market as a plant protection product is granted if the basic patent was granted before the authorisation procedure was completed.

In cases currently pending before the Federal Patent Court, questions have arisen as to how Article 3(1)(b) of Regulation (EC) No. 1610/96 is to be interpreted, given that both Directive 91/414/EEC2 and the applicable German legislation - the Act for the Protection of Crop Plants (Plant Protection Act - "PflSchG") - provide for various other types of marketing authorisations for plant protection products. It is important to note in this context that Directive 91/414/EEC was repealed by Article 83(1) of Regulation (EC) No. 1107/20093 with effect from 14 June 2011, but that, under Article 83(2) of that regulation, references to the repealed directive are to be construed as references to the new regulation. Furthermore, a new version of the PflSchG4 was adopted in Germany with effect from 14 February 2012. A comparison of the definitions of "product", "active substance" and "combination of active substances", as these terms are used in Regulations (EC) No. 1107/2009 and No. 1610/96 now raises a question as to what constitutes a product for which a supplementary protection certificate may be obtained.

2. The authorisation required under Regulation (EC) No. 1610/96

Holders of a basic patent who wish to extend the term of protection of that patent in Germany by means of a certificate are faced with a decision as to which of the various types of authorisation (marketing authorisations) specified in the PflSchG their request for grant should be based on. Like the other legislation, the PflSchG of 15 September 19865 ("PflSchG 1986"), as amended on 14 May 1998,6 provided for the following types of authorisation:

1. Authorisation under Section 15 PflSchG 1986 (cf. Article 4 of Directive 91/414/EEC; Article 29 of Regulation (EC) No. 1107/2009): requires that the plant protection product's active substances be listed in Annex I to Directive 91/414/EEC. This authorisation ends after ten years at the latest, though it may be renewed.

2. Provisional authorisation under Section 15c PflSchG 1986 (cf. Article 8(1) of Directive 91/414/EEC; Article 30 of Regulation (EC) No. 1107/2009): as a rule, may be granted for a period not exceeding three years.

3. Emergency authorisation under Section 11(2) PflSchG 1986 (cf. Article 8(4) of Directive 91/414/EEC): may be granted for a period not exceeding 120 days in cases of unforeseeable danger. Under the heading "Emergency situations in plant protection", Article 53 of Regulation (EC) No. 1107/2009 likewise stipulates that the period for placing plant protection products on the market should not exceed 120 days.

Until around 2006, the German Patent and Trade Mark Office (DPMA) issued protection certificates on the basis of both provisional authorisations under Section 15c PflSchG 1986 and emergency authorisations under Section 11(2) PflSchG 1986.7 Following an amendment to this practice, the DPMA began granting certificates only if definitive authorisation under Section 15 PflSchG 1986 (Article 4 of Directive 91/414/EEC) existed at the time of filing; applications made on the basis of other authorisations were refused. It had at that time become questionable whether protection certificates granted on the basis of a provisional or emergency authorisation were valid because under Article 15 of Regulation (EC) No. 1610/96, a certificate is invalid if it was granted contrary to the provisions of Article 3. Choosing the right authorisation documents for an application is thus a key factor in successfully extending the term of a basic patent.

2.1 Provisional authorisation under Section 15c PflSchG 1986

The question of whether a protection certificate may be validly granted on the basis of a provisional authorisation was the subject of patent revocation proceedings in Case 3 Ni 16/08. The claimant here had instituted revocation proceedings against protection certificate 100 75 026, arguing that the contested certificate was invalid under Article 15(1)(a) of Regulation (EC) No. 1610/96 because it had been granted in breach of Article 3(1)(b). The authorisation under Section 15c PflSchG on which the certificate was based did not fulfil the condition set out in Article 3(1)(b) of Regulation (EC) No. 1610/96 that marketing authorisation have been granted under Article 4 of Directive 91/414/EEC or an equivalent provision of national law.

It was decided on 28 April 20098 to stay the proceedings and refer the case to the Court of Justice of the European Union ("CJEU") for a preliminary ruling on whether, for the purpose of applying Article 3(1)(b) of Regulation (EC) No. 1610/96, account could only be taken of a marketing authorisation under Article 4 of Directive 91/414/EEC or whether a certificate could also be issued pursuant to a marketing authorisation granted on the basis of Article 8(1) of Directive 91/414/EEC.

In its judgment of 11 November 2010 in Case C-229/09 iodosulfuron, Husar, the CJEU ruled that Article 3(1)(b) of Regulation (EC) No. 1610/96 must be interpreted as not precluding a supplementary protection certificate from being issued for plant protection products if a marketing authorisation has been granted pursuant to Article 8(1) of Directive 91/414 (provisional authorisation), i.e. where the active substances have not yet been listed in Annex I to the directive. The reason given in the judgment was that the provisional authorisations granted by the member states are subject to the same scientific requirements as to reliability and may be reviewed or cancelled under the same conditions as definitive authorisations granted on the basis of Article 4 of Directive 91/414. There exists therefore a link of functional equivalence between the criteria set out in Article 8(1) of Directive 91/414 and those laid down in Article 4 of that directive.

Following the CJEU's ruling in Case C-229/09, the claim in Case 3 Ni 16/08 was dismissed by judgment of 20 March 2012. The ruling also served as the basis for the decision of the 15th Board (Senat) of the Federal Patent Court of 19 January 2012 in Case 15 W (pat) 22/08 to grant the applicant a supplementary protection certificate for a plant protection product containing cyflufenamid. The DPMA had refused the application for a protection certificate in this case, arguing that the provisional authorisation submitted did not comply with the condition set out in Article 3(1)(b) of Regulation (EC) No. 1610/96.

2.2 Emergency authorisation under Section 11(2) PflSchG 1986

Case 15 W (pat) 24/06,9 currently pending before the 15th Board of the Federal Patent Court, concerns whether the DPMA was right to refuse a request for the grant of a certificate filed on 14 May 2004 on the basis of an emergency authorisation for clothianidin under Section 11(2), first sentence, point 2, PflSchG 1986, which served to implement Article 8(4) of Directive 91/414/EEC. A link of "functional equivalence" between examination criteria as assumed by the CJEU in Case C-229/09 for provisional and definitive authorisations cannot be readily established here because emergency authorisation is granted without rigorous examination as soon as there is an unforeseeable danger which cannot be contained by other means.

An emergency authorisation under Article 8(4) of Directive 91/414 however permits the plant protection product to be placed on the market. The overall maximum of 15 years of exclusivity in the Community required in recital 11 of Regulation (EC) No. 1610/96 for the plant protection product in question could start from the time the emergency marketing authorisation is obtained. A 120-day authorisation is generally sufficient to cover the entire period needed for use of the product during seeding or in the growth phase. Thus, where use of the plant protection product is usually of a merely limited seasonal nature, industry has no great economic incentive to apply for an expensive definitive authorisation, because the difference in turnover between that achieved with an emergency marketing authorisation and that achieved with a definitive one is likely to be negligible. Applications for such exceptional authorisations have therefore proliferated in recent years.

Even if it is assumed in Case 15 W (pat) 24/06 that the emergency authorisation under Article 8(4) of Directive 91/414/EEC does not preclude the issue of a supplementary protection certificate for plant protection products, a question mark remains over the admissibility of the request to grant a certificate. While the application for a certificate was lodged within six months of the date on which the emergency marketing authorisation was granted (Article 7(1) of Regulation (EC) No. 1610/96), Article 3(1)(b) of Regulation (EC) No. 1610/96 also stipulates that a valid authorisation to place the product on the market as a plant protection product must have been granted at the date of the application. In this case, however, the 120-day authorisation had expired the day before the application was lodged.

The prevailing view in legal literature10 is that the marketing authorisation must still be in force at the time of application for the certificate. Depending on the circumstances of the individual case, this approach might have the effect of significantly reducing the six-month period referred to in Article 7. The contrary view11 is based on the fact that Article 3, as worded, does not require that the authorisation be in force at the time of the application.

If it is found in Case 15 W (pat) 24/06 that a certificate may not be issued on the basis of the emergency authorisation, the next question is whether it may be issued on the basis of a later (provisional) authorisation (issued on 8 September 2004) under Section 15c PflSchG 1986, which implements Article 8(1) of Directive 91/414/EEC. When the DPMA refused the application, it was aware that a provisional authorisation had already been issued. This raises another question, namely whether the application for a certificate can validly be lodged even before the start of the period under Article 7(1). The documents relating to the provisional or definitive authorisation would then have to be subsequently furnished within the six-month period and the filing date would have to be moved.

This case highlights the difference of legal opinion that exists in relation to the interpretation of Regulation (EC) No. 1610/96 and the diversity of its application within the Community. As one of the primary aims of Article 267 TFEU12 is to ensure uniform interpretation and application of Community law in all member states, a reference for a preliminary ruling is essential to guarantee a uniform EU-wide practice for the grant of protection certificates. The 15th Board of the Federal Patent Court has therefore decided to stay the proceedings in Case 15 W (pat) 24/06 and refer the following questions to the CJEU for a preliminary ruling:

1. Is Article 3(1)(b) of Regulation (EC) No. 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products to be interpreted as not precluding the grant of a supplementary protection certificate for a plant protection product if a valid marketing authorisation was granted in accordance with Article 8(4) of Directive 91/414/EEC?

2. If Question 1 is answered in the affirmative:

Is it necessary under Article 3(1)(b) of Regulation (EC) No. 1610/96 for the marketing authorisation to be still in force at the time of application for the certificate?

3. If the answer to Question 1 is in the negative:

Is Article 7(1) of Regulation (EC) No. 1610/96 to be interpreted as meaning that an application can be lodged even before the period mentioned in that provision starts to run?

The reference is pending before the CJEU as Case C-210/12.

A similar case is also currently pending before the 3rd Nullity Board of the Federal Patent Court (3 Ni 60/06). At issue here is whether a protection certificate for clothianidin issued by the DPMA on the basis of an emergency authorisation pursuant to Section 11(2) PflSchG 1986 (Article 8(4) of Directive 91/414/EEC) ought to be considered invalid under Article 15(1)(a) in conjunction with Article 3(1)(b) of Regulation (EC) No. 1610/96. Following each grant of authorisation under the PflSchG (emergency, provisional and definitive authorisation), the defendant in this case lodged an application for a protection certificate within the appropriate six-month period under Article 7 of Regulation (EC) No. 1610/96. In accordance with its then prevailing practice, the DPMA issued a protection certificate (published on 19 May 2005) on the basis of the emergency authorisation (first application). This is the certificate contested in the revocation proceedings in Case 3 Ni 60/06. The defendant's second application (after the issue of the provisional authorisation pursuant to Section 15c PflSchG 1986) was refused by the DPMA on the grounds that a certificate had already been issued for the product, and an appeal against this refusal is currently pending before the 15th Board of the Federal Patent Court (as Case 15 W (pat) 15/05). The DPMA has not yet issued a decision on the third application, which was based on the definitive authorisation.

3. Product within the meaning of Regulation (EC) No. 1610/96

The new Regulation (EC) No. 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market has raised further issues with regard to interpretation of Regulation (EC) No. 1610/96 which are now being addressed in Case 15 W (pat) 14/07. In this case, there is uncertainty as to whether the product for which a protection certificate is sought (isoxadifen) is in fact an active substance or a combination of active substances within the meaning of Regulation (EC) No. 1610/96.

Under Article 3(1) of Regulation (EC) No. 1610/96, a certificate is issued if the product is protected by a basic patent in force and a valid authorisation to place the product on the market as a plant protection product has been granted. The term "product" is defined in Article 1(8) of Regulation (EC) No. 1610/96 as "the active substance as defined in point 3 or combination of active substances of a plant protection product", while Article 1(3) defines "active substances" as "substances or micro-organisms including viruses, having general or specific action (a) against harmful organisms; or (b) on plants, parts of plants or plant products". In Case 15 W (pat) 14/07, the basic patent in force protects products in which the chemical substance for which a protection certificate is sought is used as a "safener". While the chemical substance in question is listed under the heading "Active substances" in the marketing authorisation submitted by the applicant, it is also classed there as a "safener". Safeners are product components that suppress or reduce the phytotoxic effect of the plant protection product on certain plants.

Under Regulation (EC) No. 1107/2009, plant protection products are only allowed to contain approved active substances. Under Article 25 of this new regulation, approval is also required for safeners and synergists, the latter being components that strengthen the effect of the active substance in a plant protection product. The regulation, however, draws a clear distinction between safeners, synergists, co-formulants and adjuvants on the one hand, and the plant protection product's actual active substances on the other. According to Article 2(2) of Regulation (EC) No. 1107/2009, substances, including micro-organisms having general or specific action against harmful organisms or on plants, parts of plants or plant products, are referred to as "active substances". The definition of an active substance in Regulation (EC) No. 1107/2009 thus corresponds to the definition found in Regulation (EC) No. 1610/96. It is therefore very doubtful whether a safener is a product (i.e. active substance or combination of active substances) eligible for the issue of a protection certificate within the meaning of Regulation (EC) No. 1610/96.

The decision of the 15th Board of the Federal Patent Court in Case 15 W (pat) 14/07 is still pending, and the board may again decide to stay the proceedings and refer the issues raised to the CJEU for a preliminary ruling.

4. Conclusion

Protection certificates can be issued for plant protection products on the basis of definitive authorisations under Section 15 PflSchG 1986 (Article 4 of Directive 91/414/EEC) and provisional authorisations under Section 15c PflSchG 1986 (Article 8(1) of Directive 91/414/EEC).

The 15th Board of the Federal Patent Court has referred to the CJEU for a preliminary ruling the questions whether an emergency authorisation under Section 11(2) PflSchG 1986 (Article 8(4) of Directive 91/414/EEC) can be used as the basis for issuing a protection certificate for plant protection products, whether the authorisation must still be in force at the time of application for the certificate, and whether the application can be validly lodged with an incomplete set of documents even before the period mentioned in Article 7(1) starts to run.

The same board is now considering whether safeners can also be classed as an active substance in a plant protection product and so as a product eligible for a protection certificate within the meaning of Regulation (EC) No. 1610/96.