The article deals with plant patents and examines the interplay between technology, patents and markets from a twofold perspective, a legal–technical and a conceptual one. On the legal–technical level, it raises the question whether the Commission’s Notice of 8 November 2016 on the EPO Broccoli/Tomatoes constellation and the novel Rule 28 EPC-IR (2017) have an impact on the patentability of modern genome editing techniques. It argues that these affect patentability and limit the available protection scope to bare process claims. On the conceptual level, the article is interested in the role of patent law in structuring primary and secondary markets. It submits that in the face of modern biotechnology’s challenges, patent law cannot restrict itself to the classical principles of patentability, dependency and exhaustion, which disconnect patentability requirements and scope. It argues that the EU Biotech Directive is to be interpreted as a relinking of patentability and scope in order to also serve the freedom to operate on secondary markets.
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Andolfo et al. (2016). The various techniques encompass zinc finger nucleases, CRISPR (clustered regularly interspaced short palindromic repeats), TALEN (transcription activator-like effector nucleases), ODM (oligonucleotide-directed mutagenesis), and the like.
A publicly discussed example is the suppression of three genes in wheat resulting in a resistance to blight, Sentker, (2017), p. 31. “Unser bedrohtes Gold”, Die Zeit, 20 July 2017
Controversially discussed by academic institutions, see ALLEA (2016).
EPO-EBA G1/08 (Tomatoes I) and G2/07 (Broccoli I), 9 December 2010, OJ EPO 2012, 130.
G 2/13 (Broccoli II) and G2/12 (Tomatoes II), both 25 March 2015, OJ EPO 2016, 17, download: http://www.epo.org/law-practice/legal-texts/official-journal/2016/03/2016-03.pdf.
Pbp-claims aim at a product protection via a process description since the product cannot be described otherwise. While the EPO accepts these claims, under the two conditions that the product cannot be described otherwise and that the product itself meets the patentability requirements (see § 4.12 EPO Guidelines for Examination, http://www.epo.org/law-practice/legal-texts/html/guidelines/e/f_iv_4_12.htm), their exact scope is contested and varies between EPO member states; Krasser and Ann (2016), § 14, para. 110.
European Commission (2016b). It was adopted by EU Member States in February 2017. The Commissions Notice, as a matter of law, has no legal effect on the EPO. However, if the same EU Member States agree with others in the EPO Administrative Council on changing the EPC Implementing Regulations, it would be a surprise if the EBA-EPO did not respect the organization’s vote for change, especially after a decision which requires a three-fourths majority and which was carried with 35 votes for, 1 against and 1 abstention.
Decision of 29 June 2017, revised rule in force since 1 July 2017; see https://www.epo.org/law-practice/legal-texts/html/epc/2016/e/r28.html.
It must be acknowledged that the term can have a number of meanings. Cf. Metzger (2017), p. 214 “new properties resulting from classical breeding methods of crossing and selecting”; cf. Lawson (2015), p. 99: “Limited nature of genetic traits and their limited substitutability”; and cf. Kock (2017), p. 132 “plants exclusively consisting of naturally occurring plant genetics, which is combined in the plant by sexual crossing. The genetics can include natural mutants such as somaclonal variations. One example is the trait in the ‘Broccoli patent’”.
Heidenreich and Mattes (2018, forthcoming).
For biotechnological inventions, the exhaustion principle is concretized by Art. 10 Directive 98/44/EC – and its respective national transpositions, e.g. Secs. 9b and 9c of the German Patent Code.
The hottest current issue is access to standard essential patents based on misuse of a dominant market position under competition law (Art. 102 TFEU), see C-170/13, CJEU of 16 July 2015, ECLI:EU:C:2015:477.
Most noteworthy stipulated by the EU Block Exemption on Research and Development Reg. 1217/2010), Off. J. EU 2010 L 335, 36, and Block Exemption Technology Transfer Reg. 316/2014, Off. J. 2014 L 93, 17.
C-428/08, Monsanto Technology LLC v. Cefetra BV  ECR I-6761. Technically, the case revolves around determining the meaning of Art. 9 Directive 98/44/EC (“contained and performs its function”) vis-à-vis the principle of absolute product protection.
C-34/10, Brüstle  ECR I-9821.
Directive 98/44/EC of the European Parliament and of the Council on the legal protection of biotechnological inventions 98/44/EC, OJ L 213, 30.7.1998, p. 13–21: Art. 8(1) Biotech Directive 98/44/EC: “extend[s] to any biological material derived from that biological material through propagation or multiplication in an identical or divergent form and possessing those same characteristics”, and Art. 9 Biotech Directive 98/44/EC “performs its function”.
Hubicki (2015), pp. 27–80.
Example given by Christopher Heath, cited by Hubicki (2015), p. 78.
On the relationship between economics and law in IP, and the tasks of law, see Van Overwalle (2013), p. 361.
A body of rules determines the interpretation of “the” claim. Claims, for example, may not be interpreted in such a way as to subvert the original meanings of the terms used. Claims are divided into “types” which imply the specific scope, for example there is a basic differentiation between “product claims” and “process claims”. The scope of the latter process type, for example, is restricted to the use of the process itself but extends to the products directly obtained by such a process (Art. 64(2) EPC); first judicial decision of 14 March 1888 by the Supreme Court of the German Empire (Reichsgericht) of 14 March 1888, RGZ 22, 8 – Methylenblau.
As a principle, “absolute product protection” secures two extensions: (1) the patent scope will not be limited to the disclosed industrial applications (provided that the national law does not stipulate otherwise, as does § 1a Secs. 3 and 4 German Patent Code – for human genomic inventions); (2) any other mode of production beyond the disclosed production process is also protected.
For various restrictions to the “freedom to operate” in modern plant breeding see Parisi (2013).
For emblematic examples (although ineffective in practice due to the EPC system), see § 1a(4) German Patent Law; Art. L613-2-1 French Patent Code.
Mayo (decided 20 March 2012), and Myriad (decided 13 June 2013). These decisions have been implemented by the USPTO “Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena and Natural Products”, USPTO of 4 March 2014, download https://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf.
Brüstle, supra note 18.
Supra note 17.
Particularly instructive are the diverging answers from jurisdictions at that time on case scenarios concerning the distinction between production and sale, and between primary and secondary markets. This variation prompted the WIPO position of harmonizing protection and extending it from primary products (“consisting/containing”) to secondary products (“containing”); Hubicki (2015), at p. 44.
Complementing “contained” by “and performs its function”.
On the complex relationship between the EU and the EPO system after the transposition of the EC Biotech Directive 98/44/EC into the EPC system in 1999, see Schneider (2010), p. 394.
E.g. “plant varieties” in Art. 53b EPC, G 1/98, EPO Enlarged Board of Appeal (EPO-EBA), 20 December 1999, Off.J. EPA 2000, 545 – Novartis.
Applied, e.g. in EPO-EBA G1/08 (Tomatoes I) and G2/07 (Broccoli I), 9 December 2010 (supra note 6). Even more articulated in G 2/13 (Broccoli II) and G2/12 (Tomatoes II), both 25 March 2015 (supra note 7); for a critical discussion see Dolder (2017).
Parisi (2013), p. 130, p. 134.
EPSPS (5-enolpyruvylshikimate-3-phosphate) synthase is an enzyme produced by plants and microorganisms. It catalyzes a central chemical reaction which is the biological target for the herbicide glyphosate.
Adding to the persistent resistance to judicial patent oversight on the part of the CJEU, see Godt (2018, forthcoming). Yet, the Monsanto decision is not far stretched: It only reiterates the three cumulative conditions as required by Straus (2008), p. 649 (“the patented genetic information must be incorporated in that [sic. the infringing] material, must still be in that material, and must perform its ‘inventive’ function”.
“Using biology to improve IP”, see Hubicki and Sherman (2005), p. 740.
Also acknowledged by Dreier (2001), pp. 60 and 70.
A noteworthy exception is Hubicki (2015). An emblematic example is the narrowing of the competition law-rooted exhaustion principle by the CJEU decision in Greenstar v. Kanzi (C-140/10, decision of 20 October 2010). The decision rejects a market-based, objective standard of exhaustion, but overly respects the contractual duties, which the CJEU extends (against the basic principle of contract law) against third parties.
A presumption strengthened by the wording of Art. 8 Directive 98/44/EC.
Thus formulated by Krauss (2011), p. 283.
The most recent decision of the CJEU, C-170/13, Huawei, ECLI:EU:C:2015:477 of 16 July 2015, digital publication only.
EP 1211926, claiming a tomato plant with a low water content which ripens at the shrub.
EP 1 069 819, for a broccoli plant with a higher than usual glucosinolate level which is supposed to be beneficial in inhibiting cancer cells.
Whereas the patentability of transgene plants (genetically modified [GMO] plants) has not been in question since 1995 (EPO – Boards of Appeal of 21 December 1995, T-0356/93 – 3.3.4), and since 1999 has not been excluded by the breeders’ rights exemption (EPO – Enlarged Board of Appeal of 20 December 1999, G 1/98), research has shifted towards other improvement techniques as in Europe, GMO food and feed are not marketable.
A minor technical a process “technical”, EPO-EBA of 9 December 2010, G 2/07 – Broccoli I/Tomatoes I (supra note 6).
Defined as “sexually crossing the whole genomes of plants”, cf. Art. 53 lit b EPÜ, Art. 2 II, Art. 4, recital 32 Biotech Directive, § 2a German Patent Act.
Considering the closeness of the process in this description to the production of hybrid seeds, one may wonder if the EPO decision on hybrid seeds of 2010 needs to be reconsidered. In its Lubrizol decision of 10 November 1988, the Technical Board of Appeal argued that the definition of “essentially biological” has to be judged on the totality of human intervention (mirroring the “surprising effect” jurisdiction, Melullis, in: Benkard (2015), § 2a, para. 49). This reasoning reappears in the EPO-EBA decision in Broccoli/Tomatoes I (2010). The hybrid-seed decision of the TBA in T 2362/10- Monsanto of 21 January 2014 rejected pbp-claims on transgenic corn plants.
The standard example, which the EPO accepts for patentability, is mutagenesis as a process distinct from crossing and selection. Krasser and Ann (2016), § 14 para. 9 clarify that it is the quality of the process not the result which matters (regardless of whether the quality of a mutation is spontaneous or a point mutation).
Thus rejecting the considerations of the submitting judge, see Sterckx and Cockbain (2015), p. 195. The opinion was also in opposition to several Member States which had, in the meantime, included these products into the process exclusion, such as Austria, Germany, the Netherlands, and France. The German patent law was revised in 2013, introducing § 2a(1) No. 1, last part of the sentence.
G2/12 and G2/13. EPO-EBA of 25 March 2015 (supra note 7).
G2/12 (supra note 7), p. 36.
G2/12 under VIII. 2. (6) (b) (supra note 7), p. 55: “Whether a product claim or a product-by-process claim is patentable is to be examined irrespective of the extent of protection that is conferred by it after grant”.
Technically, the EPO-EBA refers in G2/12 to the statement in G 1/98 (“plant varieties”) that Art. 64 II EPC “is not to be taken into consideration”. In both cases, this argument serves the same strategic function: Any patentability exclusion for processes does neither block patents on products nor claims which create product protection (pbp). This argumentative structure preserves the (presumed) rationale of Art. 64 II EPC as a general rule that process patents deserve derived product protection.
Walter (2010), p. 329.
Submitted that all other patentability requirements were met.
European Commission (2016b).
Therefore, transposing the reading of Art. 6 para. 2 lit (c) Directive 98/44/EC by the CJEU in Brüstle (C-364/13, dec. of 18 December 2014, supra note 18) to Art. 4 Directive 98/44/EC.
EPO decision of 24 November 2016 (https://www.epo.org/news-issues/news/2016/20161212.html).
A problem discussed in EPO Dok. CA/PL 4/17 of 23 March 2017, p. 36; here a possible alternative is suggested, that of defining excluded plants and animals not by reference to the process that has been applied but rather to the resulting genetic composition. Since “it is unclear, though, how the skilled person could ascertain this feature in the final product without having to resort to the process used”, this alternative was rejected.
Directive 2001/18/EC Annex I B No. 1, OJ EC L 106 of 17 April 2001, 1–39; a concern that has long been the subject of discussion in the breeding sector, see Parisi (2013), p. 216.
This decision could overturn the position of the German government [and may have an effect on US practices as well]. The German “Bundesamt für Verbraucherschutz und Lebensmittelsicherheit” stated on 31 October 2016: “… Plants with punctual mutations induced by […] CRISPR/Cas9 techniques are not ‘genetically modified organisms’ in the sense of Directive 2001/18/EC”; the US Department of Agriculture’s agency “Animal and Plant Health Inspection Service (APHIS)” decided on CRISPR/Cas9-engineered mushrooms on 13 April 2016, Waltz (2016) p. 293, based on the argument that they do not contain foreign DNA. This was the first CRISPR/Cas9 decision. Another 30 altered organisms were previously exempted from administrative oversight for other reasons (ibid). A US patent for the said mushroom was filed in September 2015 (ibid).
President of the EPO, “Exclusion from Patentability under Art. 5(b) EPC of Plants and Animals Produced by essentially biological processes – amendment of Rules 27(b) and 28 EPC”, Doc. No. CA/56/17 of 6 June 2017, p. 14: “Some forms of mutagenesis occur in nature (usually called spontaneous mutagenesis). However, whether a specific mutation indeed would occur as the result of spontaneous mutagenesis is entirely speculative. […]”.
Issued by the German Patent Office in 1956. Its reasoning and the diverging decisions in the UK and the Netherlands (both of which denied protection) are discussed by Schippel (1958), p. 333.
EP 0799 564 B1, filed 1996, published 2000. As a consequence, product claims, such as petunia patent EP0719080, which claims the mutant allele induced by mutagenesis, would then be invalid.
EP2374349, a patent filed in 2011 on Osteospermum was put on hold until the EPO’s EBA decision in Broccoli/Tomatoes II, since it contains product claims, pbp-claims and process claims on (induced) mutagenesis. It is still in the process of negotiation and has not been issued.
And the method claim does not simply refer to identifying mutants: the US Supreme Court decided in Myriad that this was ineligible patent matter as it refers to an abstract mental process only, 133 S.Ct. 2107, 2111 (at 2116) (2013) – Association for Molecular Pathology v. Myriad Genetics.
Association for Molecular Pathology v. Myriad Genetics, 133 S.Ct. 2107, 2116.
US PTO Guidance Document (supra note 28).
Genomic DNO (g-DNA) is chromosomal DNA in the cell.
Complementary DNA (c-DNA) is synthesized DNA (almost identical to g-DNA) which is produced from RNA by using the Enzyme Reverse Transcriptase.
The term is used for oligonucleotide-directed mutagenesis (ODM), zinc finger nuclease (TFN), meganuclease (MGN), Transcription Activator-Like Effector Nuclease (TALEN) (C. Parisi 2013, pp. 123–132), and recently CRISPR-Cas.
An overview and some interesting case studies are provided in Parisi (2013).
Evidenced by the contributions to the “Second Symposium Zierpflanzenzüchtung” organized by the Julius-Kühn-Institut, Quedlinburg 2017, published in “Julius Kühn Archiv” 2017 (download via: https://ojs.openagrar.de/index.php/JKA).
Inter alia Melullis, in: Benkard (2015), § 2a.
In this, the author disagrees with Sterckx 2010, “Amicus Curiae Brief to G2/07 and G-1/08” (“Addendum” 24 June 2010). She states that the German word Züchtung “also means growing and cultivating, or with bees, keeping”. Retrieve via: http://www.epo.org/law-practice/case-law-appeals/eba/pending/g2-07_de.html (accessed 8 November 2017).
Not in all, but in many, such as potatoes and wheat.
G 1/08, p. 53.
Faithfully to the German-language version, German commentaries focus on “crossing and selection”, cf. Melullis, in: Benkard (2015), Art. 53b, para. 89.
Only transposing national legal acts may diverge where directives allow leeway, Art. 288 para. 3 TFEU.
For a parallel reading of Art. 4 Biotech Directive with regard to plant varieties see Krasser and Ann (2016), para. 231 who argue that (in principle patentable) processes become excluded from patentability when falling under Art. 4 Biotech Directive.
Prior to the Commission’s Notice, Krasser and Ann (2016), § 14, para. 112.
The facts of the case are highly contested, see Hubicki (2015), pp. 70–71. In Germany, the contamination constellation is exempt from patent protection under § 9c(3) of the German Patent Act.
This argument was already forwarded by Sterckx (2008), pp. 15 et seq. as a critique of the “reach-through-claims” of the tomato patent in G1/08.
In Germany, absolute product protection is also granted to pbp-claims: German Federal Supreme Court (BGH), decision of 30 March 1993, 1993 GRUR p. 651 – Tetraploide Chamomille.
EPO Doc. CA/PL 4/17 of 23 March 2017, p. 36.
What happens, however, when only a product claim is filed? The submitted solution then amounts to a “no” patent result. This suggestion might appear hypothetical considering how modern patents are drafted. However, EPC-IR should give guidance for patent claims language in this regard.
Where pbp-claims were (or have already been) granted, the scope of the patent is to be judicially restricted to the scope of the process only, by Member States’ courts.
This fine-tuning is to be executed cooperatively by the administrative and judicial institutions managing the patent system (the EPA as granting institution and the national [and future EU] judiciaries as institutions responsible for horizontal dispute settlement). If these institutions are not able to install the proposed restrictions, it is time to finally submit the Biotech Directive to a legislative review process.
Mayo Collaborative Services v. Prometheus Labs. Inc, 132 S.Ct. 1289, 1296–1298 (2012).
If, indeed, it ever existed. However, in patent adjudication it was often invoked, see EPO-EBA statement in G2/12 under VIII. 2. (6) b) (OJEPA 2015-A27, p. 55): “Whether a product claim or a product-by-process claim is patentable is to be examined irrespective of the extent of protection that is conferred by it after grant”.
Supreme Court of the German Empire (Reichsgericht) of 14 March 1888 – Methylenblau (supra note 24).
Ziff. 5.3 of the EPO-EBA decision G 1/98 of 22 December 1999.
Parties to the International Treaty of the International Union for the Protection of New Varieties of Plants, (French: “Union internationale pour la protection des obtentions végétales”, UPOV).
I owe this third lacuna to a note of an anonymous peer-review.
A scientific-technological bias based on the idea of authoritative knowledge, as Habermas coined it, see Girard (2015).
Schneider (2010), describing an institutional enclosure of the patent system based on an epistemic community.
The breeders’ privileges in the biopatents’ schemes are usually very limited and do not function. While § 11 No. 2 German Patent Act allows research on and research with patented material (allowing the breeder to actually integrate patented material into new lines); however, the breeding material is only freely marketable after expiration of the patent term; see § 9a(3) German Patent Act. Cross-licensing schemes are too rigid to be operable.
Yet, national policies remain possible. This is documented by the case of Argentina which is at the bottom of the CJEU Monsanto case: Argentina had denied patent protection to Monsanto’s glyphosate resistant soy. Therefore, the production of soy from seeds patent protected in the US/EU was legal in Argentina. Attorney General Mengozzi based his opinion on the argument that it is not the patent law’s function to remedy protection lacunae in other countries (Opinion of 9 March 2010, para. 35, ECLI:EU:C:2010:128), discussed by Hubicki (2015), pp. 78–79.
Schneider (2010), p. 226, p. 236.
Schneider (2010), p. 225, e.g., describes the former rules for process protection and how these developed.
The long list of cases starts with C-15/74, CJEU of 31 October 1974, ECR 1974, 1147 – Centrafram establishing the principle of Community exhaustion. Yet, the principles applys equally to immobile property, see C-69/88, CJEU of 7 March 1990, ECR 1990, I-583 – Krantz, C-515/99, C-519/99 to C-524/99, C-526/99 to C-540/99, CJEU of 5 March 2002, ECR 2002, I-2157 – Reisch.
Notwithstanding how equivocal the concepts are, see Godt (2007), p. 112 et seq.
Supreme Court of the German Empire (Reichsgericht) of 14 March 1888 – Methylenblau; for more detail Uhrich (2015), p. 174 et seq.
German Patent Office practice since 1934; see Schippel (1958), p. 336 (fn. 21).
In Germany since 1971, BGHZ 57, 1 – Trioxan, confirmed by the German Federal Supreme Court, 1993 GRUR p. 651 – Tetraploid Chamomile.
Two decisions account for it: German Federal Supreme Court of 28 July 1977, 1978 GRUR p. 238 – Naturstoffe; German Federal Supreme Court of 14 March 1972, BGHZ 58, 280 = 1972 GRUR p. 541 – Imidazoline.
German Patent Act of 28 July 1977, 1978 GRUR p. 238 – Antanamid.
Schneider (2010), focuses on three principles, pp. 232, 233, 237.
The most evident one is self-reproduction. This issue was first discussed with regard to microorganisms (cf. Budapest Convention 1981). Later, this reasoning was transposed to genetic engineering (discussed by EPO-EBA in G 1/98, para. 5.2, at p. 34).
Schatz, Art. 53, in: Singer and Stauder (2003), para. 28.1.
Schneider (2010), p. 238.
On the discussion of how the Directive 98/44/EC implemented/changed the doctrine of product protection see Uhrich (2010). He describes the attempts to restrict the doctrine of product protection as having “miscarried” (German “missglückt”, p. 299) because it was dogmatically implemented as part of “commercial usefulness” – which he qualifies as “carelessness” (German “Nachlässigkeit”, p. 300); also Godt (2007), p. 114 (“contradicts the spirit of the Directive”). Both see the concrete transposition of the restriction delegated to Member States [Uhrich (2010), p. 300; Godt (2007), p. 114]. For a recent dispute on the meaning of patent protection under the Directive, see the Expert Report on Biopatents of May 2016 (commented on by Godt 2016b).
Adapted from the quote attributed to Georg Büchner, Dantons Tod, orig. 1853, Insel Verlag; Frankfurt, 1963.
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I am indebted to several peer reviewers (two of them anonymous) for their critical and thoughtful comments on previous drafts. Yet, the usual disclaimer applies: All errors are mine.
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Godt, C. Technology, Patents and Markets: The Implied Lessons of the EU Commission’s Intervention in the Broccoli/Tomatoes Case of 2016 for Modern (Plant) Genome Editing. IIC 49, 512–535 (2018). https://doi.org/10.1007/s40319-018-0710-6
- Product protection
- Plant patents
- Native traits
- Process claim