Entscheidungen G 2/12 (Tomato II) und G 2/13 (Broccoli II) der Großen Beschwerdekammer zu Aspekten der Patentierbarkeit von Pflanzen

 


OnMarch 25, 2015, the Enlarged Board of Appeal of the European Patent Officeissued two decisions regarding the patent eligibility of plant materials.

Bothcases are related to the question of a possible impact of the process exclusionin Article 53(b) EPC on claims for plants or plant material.

Thequestions of law referred to the Enlarged Board in both cases turn on thecorrect interpretation of Article 53(b) EPC, which provides as follows:

"European patents shall not be granted inrespect of:

(a) …

(b) plant or animal varieties or essentiallybiological processes for the production of plants or animals; this provisionshall not apply to microbiological processes or the products thereof;

(e) ... "

Underlyingall the referred questions is the issue of the legal scope of the process exclusionin Article 53(b) EPC and its impact on the patentability of product claims and product-by-processclaims. The questions referred to the Enlarged Board do not relate to theinterpretation of Article 53(b) EPC in respect of the exclusion from patentabilityof plant or animal varieties. It is this aspect that distinguishes the presentreferrals from the referrals underlying the Enlarged Board's decision G 1/98and its decisions in the two preceding referrals G 2/07 and G 1/08.

 

I. Referral G 2/12 (Tomato II)

1. The referred questions

Byinterlocutory decision T 1242/06 dated May 31, 2012, (OJ EPO 2013, 42) the referringTechnical Board of Appealreferred to the Enlarged Board the following questions:

"1.Can the exclusion of essentially biological processes for the production ofplants in Article 53(b) EPC have a negative effect on the allowability of aproduct claim directed to plants or plant material such as a fruit?

2. Inparticular, is a claim directed to plants or plant material other than a plantvariety allowable even if the only method available at the filing date for generatingthe claimed subject-matter is an essentially biological process for the productionof plants disclosed in the patent application?

3. Is itof relevance in the context of questions 1 and 2 that the protection conferredby the product claim encompasses the generation of the claimed product by meansof an essentially biological process for the production of plants excluded as suchunder Article 53(b) EPC?"

 

2. The patent in suit

Europeanpatent No. 1 211 926 (tomato patent) concerns a method for breeding tomatoeshaving reduced water content and the product of the method.

 

3. The appeal proceedings T 1242/06

Theproceedings T 1242/06 before the referring Technical Board of Appeal (thereferring Board) concern appeals against the decision of the oppositiondivision dated 29 May 2006. In that decision, the opposition division had foundthat the tomato patent, as amended by patent proprietor then on file,comprising two independent product claims, and the invention to which it relatedmet the requirements of the EPC.

Opponentfiled an appeal against this decision seeking revocation of the patent, but thatappeal was withdrawn during the proceedings before the Enlarged Board by letterof 28 June 2012. With its own appeal, patent proprietor first defended thetomato patent in a form containing both independent process and product claims.

Inits (first) interlocutory decision of 4 April 2008, the referring Board referredthree questions of law to the Enlarged Board. All questions related to theinterpretation of the process exclusion contained in Article 53(b) EPC, namely tothe circumstances under which processes for the production of plants have to beregarded as "essentially biological".

Thosequestions were answered by the Enlarged Board in its decision G 1/08.

Inthe light of this decision, patent proprietor deleted the process claims sothat the claim requests now on file are restricted to product claims directedto tomato fruits or tomato fruit products.

Theseamendments then led to the second referral by the Board.

 

4. The referring decision

Inits second interlocutory decision of 31 May 2012, i.e. referral tomato II, theBoard referred the above questions to the Enlarged Board. According to thereferring Board, in the proceedings before it important points of law arosebecause of patent proprietor’s restriction of the claims to mere product claimsthat were not considered in the first interlocutory decision leading todecision G 1/08. The referring Board gave the following reasons for making thesecond referral:

Withrespect to the area of plant breeding, Article 53(b) EPC prohibited thepatenting of, as a first group, plant (or animal) varieties and, as a secondgroup, of essentially biological processes for the production of plants (oranimals). When the referring Board handed down its first interlocutorydecision, referring to the Enlarged Board questions concerning theinterpretation of the process exclusion contained in Article 53(b) EPC in thelight of Rule 26(5) EPC, both patent proprietor's requests then on filecontained process claims directed to methods for breeding tomato plants as wellas product claims directed to tomato fruits and tomato plants.

Inrespect of the first group of exceptions to patentability, the referring Boardheld that the subject matter of the independent claims according to all patentproprietor's then current requests was not directed to whole tomato plants, butto dehydrated tomato fruits.

Thereferring Board concluded further that such plant fruits were to be regarded asplant parts capable of producing entire plants. However, the referring Boardheld that the claimed tomato fruits did not come under the patent exclusion ofplant varieties contained in Article 53(b) EPC.

 

Consideringdecision G 1/98 (OJ EPO 2000, 111), the Board took the view that, if it onlyhad to consider the exclusion of plant varieties in Article 53(b) EPC, thesubject-matter of the claims of auxiliary request I would not be excluded frompatentability.

However,the referring Board saw itself confronted with the issue of whether, irrespectiveof the interpretation of the exclusion of plant varieties, patenting theclaimed subject-matter rendered the exclusion of essentially biologicalprocesses, i.e. the second group of exceptions to patentability pursuant toArticle 53(b) EPC, completely ineffective, thereby frustrating the legislativepurpose behind the process exclusion in Article 53(b) EPC.

Ifthe product claims of auxiliary request I were allowed, any act of making andusing the claimed dehydrated tomato by applying the breeding method as definedin claim 1 of the tomato patent as granted would, in principle, fall under thepatent proprietor's right in respect of the patent.

Thequestion of a possible impact of the process exclusion in Article 53(b) EPC onclaims for plants or plant material was not answered by decision G 1/98 or settledby Rule 27(b) EPC. In the referring Board's view, the conclusions reached in decisionG 1/98 involved only the meaning and the scope of the exclusion of plantvarieties and were to be understood against the factual background of the appealcase leading up to decision G 1/98. It concerned transgenic plants produced bymodern genetic technology, rather than by a breeding method based on crossingand selection. Rule 27(b) EPC was understood by the referring Board as beingaimed at restricting the scope of the product exclusion in Article 53(b) EPC.This rule had no - and could have no - influence on the scope of the process exclusionin Article 53(b) EPC.

However,albeit acknowledging the different legislative purposes of the exceptions to patentabilityunder Article 53(a) and (b) EPC, the referring Board concluded from Article53(a) EPC, Rule 28 (c) EPC and Article 6 (2) (c) Biotech Directive (Directive98/44/EC of the European Parliament and of the Council of 6 July 1998 on thelegal protection of biotechnological inventions (OJ EU L 213 of 30 July 1998, p.13 to 21) that situations existed where an exclusion directed at a specificprocess might negatively affect the allowability of a product claim.

 

II. Referral G 2/13 (Broccoli II)

1. The Referred questions

Byinterlocutory decision T 83/05 dated 8 July 2013 (OJ EPO 2014, A39), thereferring Board referred to the Enlarged Board the following questions:

"1.Can the exclusion of essentially biological processes for the production ofplants in Article 53(b) EPC have a negative effect onthe allowability of a product claim directed to plants or plant material suchas plant parts?

2. Inparticular:

(a) Is aproduct-by-process claim directed to plants or plant material other than aplant variety allowable if its process features define an essentiallybiological process for the production of plants?

(b) Is aclaim directed to plants or plant material other than a plant variety allowableeven if the only method available at the filing date for generating the claimedsubject-matter is an essentially biological process for the production ofplants disclosed in the patent application?

3. Is itof relevance in the context of questions 1 and 2 that the protection conferredby the product claim encompasses the generation of the claimed product by meansof an essentially biological process for the production of plants excluded assuch under Article 53(b) EPC?

4. If aclaim directed to plants or plant material other than a plant variety isconsidered not allowable because the plant product claim encompasses thegeneration of the claimed product by means of a process excluded from patentabilityunder Article 53(b) EPC, is it possible to waive the protection for suchgeneration by "disclaiming" the excluded process?"

 

2. The patent in suit

Europeanpatent No. 1 069 819 (the “broccoli patent”) concerns a method for selectiveincrease of the anticarcinogenic glucosinolates in brassica species as well as brassicaplants, portions or a seed of a broccoli plant produced according to suchmethod.

 

3. The appeal proceedings T 83/05

Theproceedings in T 83/05 before the referringBoard concern appeals against the decision of the opposition division dated 23November 2004. In that decision, the opposition division had found that thebroccoli patent, as amended by the patent proprietor pursuant to its (new) mainrequest then on file, comprising method, product and product-by-process claims,and the invention to which it related met the requirements of the EPC.

Inits (first) interlocutory decision of 22 May 2007, the Board referred twoquestions of law to the Enlarged Board. Both questions related to theinterpretation of the process exclusion contained in Article 53(b) EPC, namelyto the circumstances under which processes for the production of plants have tobe regarded as "essentially biological". The interlocutory decisionfurthermore dealt with all other objections raised by opponents up to then inthe course of the appeal proceedings. The Board concluded that none of these otherobjections precluded maintenance of the patent as amended on the basis of therespondent's main request. The Enlarged Board answered the referred questionsin its decision G 2/07.

Inthe light of this decision, patent proprietor submitted new requests restrictedto product and product-by-process claims. These amendments then led to thesecond referral by the referring Board.

 

4. The referring decision

Inits second interlocutory decision of 8 July 2013, the referring Board admittedpatent proprietor’s requests and the objection of opponents raised underArticles 100(a) and 53(b) EPC against the product claims into the appealproceedings.

Accordingto the referring Board, in the proceedings before it important points of lawarose because of patent proprietor's restriction of the claims to productclaims that were not considered in the first interlocutory decision leading tothe decision G 2/07.

Inthe reasons for the interlocutory decision, the Board referred to therespective reasons for the referral tomato II (see above), because itconsidered an answer to those referred questions essential for deciding theappeal in case T 83/05. In addition, it gives the following reasons for needingto refer modified questions compared to those in referral tomato II:

Thereasons for the referring Board not just to stay the proceedings pendinganswers to the referral in case G 2/12 but to refer additional questions wereto ensure a decision of the Enlarged Board on the merits of the questions oflaw relevant to both referral cases, independent of the procedural fate of theappeal proceedings in case T 1242/06, and to enrich the basis on which theEnlarged Board would take its decision.

Patentproprietor's claims were directed not to fruits but to plants and plant parts(seed, edible portion, inflorescence) and the referring Board considered thesenot to fall under the exclusion of plant varieties as stipulated in Article53(b) EPC and defined by Rule 26(4) EPC.

Furthermore,the point that patent proprietor's claim requests defined the products byprocess features needed to be addressed in the additional referred questions.

Thereferring Board understood the clause in the claims according to patentproprietor's first auxiliary request "wherein the claim does not encompassan essentially biological process for producing" the plant, the portion ofa plant, the seed of the plant or the inflorescence as an attempt to waive someof its rights in respect of a product patent, such that producing the claimedproduct by an essentially biological process could no longer be prohibited. Referringto G 1/93 (OJ EPO 1994, 541), the Board doubted that the EPC allowed such awaiver.

 

III. The submissions of the parties

TheEnlarged Board in both referrals invited the parties to the proceedings andthird parties to file observations on the referred questions. Furthermore, the EnlargedBoard invited the President of the EPO to comment on the points of law referredto it.

ThePresident's comments in case G 2/12: The President concluded that Article 53(b)EPC did not have a negative effect on the allowability of product claims to plants.Any extension of an exclusion from patentability in this respect would be amatter for the legislator to decide. His conclusion is based on the followingline of argument.

(1)The extent of protection was not to be taken into account in examining thepatentability of a claim.

(2)Just as the patentability of a process claim was not affected by the lack ofpatentability of the direct product, a product-by-process claim was to be examinedindependently of the process by which the product is defined.

(3)Interpreting Article 53(b) EPC, unlike Article 53(a) EPC, did not includeaspects of ordre public or morality.Rather, it was guided by Article 31(1) Vienna Convention alone. The InternationalConvention for the Protection of New Varieties of Plants (UPOV Convention) andthe Biotech Directive could be taken into account as supplementary means ofinterpretation.

(4)Neither the wording nor the travaux préparatoires supported the notion that theexclusion of "essentially biological processes for the production ofplants" covered any product of such a process. Its focus lay rather on theexclusion of patent claims the subject-matter of which was directed to such aprocess. The legislative intent to exclude from patentability the kind of plantbreeding processes which were the conventional methods for the breeding ofplant varieties at that time suggested that Article 53(b) EPC was merely aimedat excluding essentially biological breeding processes sensu stricto.

(5)Applying the process exclusion to plant products generated by selection orplant breeding led to an undesirable inconsistency resulting from thepatentability of plant products achieved by genetic modification.

(6)The process exclusion in Article 53(b) EPC was not rendered void by theavailability of product claims for plants in general, because this processexclusion still had a significant effect. In cases where an applicant had madean invention whose essence lay in the (excluded breeding) method itself, butwhere the resulting product was not patentable, e.g. because it was not new, nopatent could be granted.

ThePresident's comments in case G 2/13:

(1)The President came to essentially the same conclusion as in case G 2/12, namelythat Article 53(b) EPC did not have a negative effect on the allowability ofproduct claims to plants. Any extension of an exclusion from patentability in thisrespect was a matter for the legislator to decide. In respectof the fourth question, the President concluded that there was no legal basisfor a "disclaimer" or "waiver" as suggested by patentproprietor.

 

IV. Reasons of theDecisions G 2/12 and G2/13

1. Legal nature of the claimed invention

Theclaim versions of all pending requests of the patent proprietors in connectionwith both the tomato patent and the broccoli patent are directed to a product,i.e. a tomato fruit (dehydrated / raisin-type / harvested) or broccoli(edible Brassica plant / edible portion of a broccoli plant / seed of abroccoli plant / broccoli plant / broccoli inflorescence). Concerning themethod for generating such products, the specification of the tomato patentdiscloses only a biological process and the broccoli patent defines a specificmethod of such kind in the respective claim itself.

Theclaims of the tomato patent according to the patent proprietor's main and firstto fourth auxiliary requests can be categorized as product claims. Thesubject-matter of the broccoli patent according to all requests as well asaccording to the fifth and sixth auxiliary requests of the tomato patent belongsto the product-by-process claim category.

TheEnlarged Board emphasized that a product-by-process claim – like a productclaim – gives protection for the product as such, not for the process for producingit. In contrast, the scope of protection of a process claim covers the processdefined in the patent claim and the product directly obtained by such process(Article 64(2) EPC). A product claim is directed to a physical entity describedas a concrete physical technological embodiment of an inventive idea.

Aproduct-by-process claim defines a product in terms of the method (manipulativesteps) used to manufacture that product.

Fora product-by-process claim to be allowable it needs to be established that (a)it is impossible to define the claimed product other than in terms of a processof manufacture and (b) the claimed product itself meets the patentability requirements of Article 52(1) EPC. Thus, the specific process needed toobtain the claimed product should make it possible to distinguish theinevitable product of the product-by-process claim over the prior art. The useof the method parameter by which to define a particular product cannot in itselfgive the product novelty, nor can it constitute an inventive step over theprior art.

Thus,the subject-matter of both a product claim and a product-by-process claim isthe product as such, in respect of which the legal (formal and substantive)requirements for its patentability need to be fulfilled, independently of the patentabilityof the process by which the product can be generated or is defined. If theproduct in the product-by-process claim is the same as or obvious from aprior-art product, the claimed product is unpatentable even though the prior-artproduct was made by a different process. Conversely, if the product in theproduct-by-process claim is neither the same as nor obvious from a prior-artproduct, it is patentable even though the process applied is the same as orobvious from a prior-art process.

 

2. Interpretation of exclusions frompatentability

TheEnlarged Board found that for the interpretation of the EPC’s provisions, theEPC itself provides relatively little guidance. Thus, one must look outside theterms of the EPC itself for rules of interpretation.

TheEnlarged Board further found that it is established in the jurisprudence thatthe principles of interpretation provided for in Articles 31 and 32 ViennaConvention are to be applied when interpreting the EPC. Decisions and opinionsgiven by national courts in interpreting the law may also be taken into consideration.

Afterhaving analyzed other decisions related to exclusions from patentability, i.e.G 1/04, G 2/06 or G 1/07, the Enlarged Board concluded that whilst there is nogeneral notion of an obligatorily restrictive construction of exceptions to patentability,for example, such as that adopted by the Court of Justice of the European Union(CJEU) when insisting on a narrow interpretation of exceptions to orderogations from fundamental EC Treaty principles embodied in the four freedoms(Judgment of 21 June 1974, C 2-74, Jean Reyners v. Belgian State, ECJ 1974,631), such a narrow interpretation might well result from applying the generalprinciples of interpretation to a specific provision with regard to specificlegal and factual circumstances.

Thus,the term "essentially biological processes for the production ofplants" in Article 53(b) EPC needs to be construed pursuant to the generalrules of interpretation.

Themeaning of "essentially biological processes for the production" hasalready been defined by the Enlarged Board in G 2/07 and G 1/08. The presentcase does not involve any new issue in this respect.

However,what remains to be determined is whether this conclusion is limited to methodor process claims or whether it also encompasses a patent claim for a productthat is directly obtained and/or defined by an "essentially biological process".

 

TheEnlarged Board applied for methodical interpretation of Article 53(b) EPC theestablished rules of interpretation, i.e. grammatical interpretation, systematicinterpretation, teleological interpretation, historical interpretation, andconsidered subsequent agreements between the contracting parties regarding theinterpretation of the treaty or its application and any subsequent practice in theapplication of the treaty.

TheEnlarged Board concluded, that applying the various methodical lines ofinterpretation provided for in Article 31 Vienna Convention does not lead to theconclusion that the term "essentially biological processes for theproduction of plants" extends beyond processes to products defined orobtained by such processes. This result is confirmed when the preparatory workon the EPC is taken into account as a supplementary means of interpretation (Article32 Vienna Convention).

Thus,in view of the absence of any solid basis for a broad reading of"essentially biological processes for the production of plants" inrespect of the separate claim categories of product and product-by-processclaims, a first intermediate conclusion points towards not extending the scopeof application and legal effect of the exception to patentability according toArticle 53(b) EPC in respect of "essentially biological processes for the productionof plants".

Consideringits wording, context, original legislative purpose and legislative history, theprocess exclusion of Article 53(b) EPC does not extend directly to a productclaim or a product-by-process claim directed to plants or plant material suchas a fruit, or to plant parts other than a plant variety.

Althoughnot mentioned by the parties to the proceedings, the Enlarged Board wished totake up an issue raised in various amici curiae briefs. That is whether thelegal impact of the above understanding of Article 53(b) EPC necessitates broadening the scope of application of the process exclusion havingregard to the following questions:

(a)Is there a need for a dynamic interpretation of Article 53(b) EPC due tofactors that have arisen since the Convention was signed and which give groundsfor assuming that a restrictive reading of the wording of Article 53(b) EPCwhen applying the general principles of interpretation conflicts with thelegislator's intention?

(b)Does allowing the patentability of a product claim directed to a fruit and of aproduct-by-process claim directed to a plant or plant material render theexception to patentability of "essentially biological processes for the productionof plants" meaningless or without any substance in its scope of application?

However,the Enlarged Board concluded, that no dynamic interpretation of Article 53(b)EPC is required to the effect that the process exclusion should extend to productsobtained by essentially biological processes for the production of plants. Norcan it see any imminent legal erosion of its scope when limiting its scope toprocess claims as such and leaving product claims and product-by-process claimoutside the scope of the process exclusion. For this reason, there is neither aneed nor a legal justification to alter the understanding of Article 53(b) EPCachieved by applying the traditional means of interpretation.

 

3. Final conclusions

Thescope of application of the term "essentially biological processes for theproduction of plants" in Article 53(b) EPC is interpreted to the effectthat product inventions where the claimed subject-matter is directed to plantsor plant material such as a fruit or plant parts other than a plant variety, assuch, are not excluded from being patented.

Irrespectiveof the exclusion of plant varieties (G 1/98), the exception to patentability inArticle 53(b) EPC in respect of plants is limited to claims directed toprocesses, in particular as defined in the previous two referrals G 2/07 and G1/08.

Subject-matterclaimed as a product or a product-by-process is not the same as one claimed fora process, which, in the case of essentially biological processes for the productionof plants, is excluded from patentability, regardless of the methods by whichthe claimed product is generated or – as in the case of a product-by-processclaim – defined.

Evenif the product, i.e. the plant or plant material such as a fruit or plantparts, can only be obtained by essentially biological processes with no othermethods either disclosed in the patent application or otherwise known, theprocess exclusion in Article 53(b) EPC does not extend to product claims andproduct-by-process claims.

However,whether such product claims or product-by-process claims are allowable and leadto granting of a European patent depends upon the fulfilment of the formal andsubstantive requirements of the Convention concerning these kindsof claim categories independent of the issue of the allowability of a patentclaim directed to an essentially biological process for the production ofplants. In this respect, the allowability of a product-by-process claim issubject to the additional (restrictive) conditions established in the case lawof the boards of appeal.

Therefore,the mere fact that an applicant or patent proprietor chooses a product claim orproduct-by-process claim instead of a method claim directed to an essentially biologicalprocess for the production of a plant is not a matter of some sort of"skilful claim drafting" or circumvention of legal hurdles but alegitimate choice to obtain patent protection for the claimed subject-matter,on condition that the requirements for allowability of such a claim are met.

 

V. Decision G 2/12

Forsaid reasons it was decided that:

Thequestions of law referred to the Enlarged Board of Appeal are answered as follows:

 

1.            The exclusion of essentiallybiological processes for the production of plants in Article 53(b) EPC does nothave a negative effect on the allowability of a product claim directed toplants or plant material such as a fruit.

2.            In particular, the fact that theonly method available at the filing date for gene rating the claimedsubject-matter is an essentially biological process for the production of plantsdisclosed in the patent application does not render a claim directed to plantsor plant material other than a plant variety unallowable.

3.            In the circumstances, it is of norelevance that the protection conferred by the product claim encompasses the generationof the claimed product by means of an essentially biological process for theproduction of plants excluded as such under Article 53(b) EPC.

 

 

VI. Decision G 2/13

Forsaid reasons it was decided that:

Thequestions of law referred to the Enlarged Board of Appeal are answered as follows:

1.            The exclusion of essentiallybiological processes for the production of plants in Article 53(b) EPC does nothave a negative effect on the allowability of a product claim directed toplants or plant material such as plant parts.

2.            (a) The fact that the processfeatures of a product-by-process claim directed to plants or plant materialother than a plant variety define an essentially biological process for theproduction of plants does not render the claim unallowable.

(b) Thefact that the only method available at the filing date for generating theclaimed subject-matter is an essentially biological process for the productionof plants disclosed in the patent application does not render a claim directedto plants or plant material other than a plant variety unallowable.

3.            In the circumstances, it is of norelevance that the protection conferred by the product claim encompasses thegeneration of the claimed product by means of an essentially biological processfor the production of plants excluded as such under Article 53(b) EPC.

 

VII.Summary

Applicantsseeking patent protection in Europe for plants or plant material are nowprovided with further guidance on how the EPO defines eligible subject matterwith respect to the technical field of plant biotechnology. In particular, thetwo current decisions G 2/12 and G 2/13 provide answers to questions of interpretationof the scope of the process exclusion in Article 53(b) EPC and its impact onthe patentability of product claims and product-by-process claims.

Thescope of application of the term "essentially biological processes for theproduction of plants" in Article 53(b) EPC is interpreted to the effectthat product inventions where the claimed subject-matter is directed to plantsor plant material, as such, are not excluded from being patented.

Irrespectiveof the exclusion of plant varieties, the exception to patentability in Article53(b) EPC in respect of plants is limited to claims directed to processes, inparticular as defined in the previous two referrals G 2/07 and G 1/08.

Subject-matterclaimed as a product or a product-by-process is not the same as one claimed fora process, which, in the case of essentially biological processes for theproduction of plants, is excluded from patentability, regardless of the methodsby which the claimed product is generated or – as in the case of aproduct-by-process claim – defined.

Evenif the product, i.e. the plant or plant material such as a fruit or plantparts, can only be obtained by essentially biological processes with no othermethods either disclosed in the patent application or otherwise known, theprocess exclusion in Article 53(b) EPC does not extend to product claims andproduct-by-process claims.

Themere fact that an applicant or patent proprietor chooses a product claim orproduct-by-process claim instead of a method claim directed to an essentiallybiological process for the production of a plant is not a matter of some sortof "skilful claim drafting" or circumvention of legal hurdles but alegitimate choice to obtain patent protection for the claimed subject-matter,on condition that the requirements for allowability of such a claim are met.

Finally,it should be mentioned that, compared to some national legislation, in light ofthese two decisions at hand the EPO applies a less restrictive approachregarding the exclusion from patentability of plant or animal varieties:

ThoseEuropean national legislatures that are of the more restrictive view that plantproducts obtained by essentially biological processes should not be patentable haveamended their legislation in this respect, thereby deviating from the wordingof Article 53(b) EPC. Both in Germany and in the Netherlands legislation existsexcluding product claims from patentability where the claimed products havebeen generated by an essentially biological process for the production ofplants (see § 2a(1) No. 1 German Patent Act as last amended in 2013;Article 3(1) (d) Dutch Patent Act as last amended in 2014). No such amendmentshave been made in, for example, the United Kingdom, France, Austria and Switzerland.These variations in national legislation and the now clarified(less-restrictive) European interpretation of the scope of the processexclusion in Article 53(b) EPC and its impact on the patentability of productclaims and product-by-process claims should by carefully considered by applicantsin the field of respective plant biotechnology when adopting an appropriate IPstrategy for Europe.