Genes and Compound Protection – Disharmonisation in Europe?
(IPRinfo 2/2009)
Ralf Uhrich
LLM (London), PhD candidate, DFG Graduate School ”Intellectual Property and the Public Domain” at the University of Bayreuth, Germany
The Directive on the legal protection of biotechnological invention allows EC Member States to decide freely on the question of compound protection for gene patents.
The advent of modern biotechnological inventions in the 1980s sparked a vast controversy in academia and public about the patentability of such inventions.
In particular, the patentability of human genes was fiercely disputed which eventually led to the Relaxin decision by the European Patent Office (EPO) and the explicit acknowledgement of gene patents.
In the meantime, at least the academic debate has shifted from the radical opposition of gene patenting to a discussion about the scope of such patents. One fundamental question insofar is how the protection for product patents for DNA sequences has to be organised.
A Wee Bit of Molecular Biology
Genes are naturally occurring chemical compounds with the feature to code for RNA and/or proteins.
Due to a process called alternative splicing and other biological mechanisms, many genes are believed to be multifunctional, i.e. may code for more than one protein. It is also important to point out that human genes are operating just the same way as animal or plant genes do.
The Concept of Compound Protection in Europe
It is a well-established principle in the European case law that product or compound protection is absolute. This means that the protection conferred by a product patent is not limited to any use or any way of obtaining the patented invention.
”It is generally accepted as a principle underlying the EPC [European Patent Convention] that a patent which claims a physical entity per se, confers absolute protection upon such physical entity; that is, wherever it exists and whatever its context (and therefore for all uses of such physical entity, whether known or unknown).”
– EPO, Enlarged Board of Appeal
– MOBIL/Friction reducing additive
This probably holds true for ”ordinary” chemical inventions like dyestuffs or fertiliser. However, it remains an open question whether the concept of absolute compound protection should also apply to DNA sequences. Since many genes may turn out to be multifunctional, absolute protection could lead to ”overrewarding” patents; at least, this seems to be a common fear.
Directive 98/44/EC and Its Implications on Gene Patents
In 1998, after nearly a decade of controversy, Directive 98/44/EC on the legal protection of biotechnological invention was finally adopted. The Directive, inter alia, acknowledges the patentability of (human) genes (cf. Art 3 (2) and 5 (2)) and imposes certain requirements concerning such patent applications.
One of those requirements is contemplated in Art 5 (3), which reads in its English version (other language versions, e.g. the German translation, differ considerably):
The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application.
Mainly based on Art 5 (3) and its corresponding recitals, several commentators have contested the concept of absolute compound protection by proposing a regime of purpose-bound protection for gene patents. In contrast, there is also a faction arguing for absolute product protection.
Nevertheless, the Directive does not require any particular organisation of compound protection for gene patents. In fact, it allows EC Member States to decide freely on this question. Following this point of view, the success of harmonising the national patent laws of the Member States is yet rather doubtful.
Implementation of the Directive: EPOrg, Finland and Germany
The Directive’s silence with regard to the organisation of compound protection for gene patents constitutes a breeding ground for disharmonisation in Europe.
EPOrg
Even though not legally required to implement EC directives, there is a factual necessity for the EPOrg to consider EC patent law legislation. Thus, the relevant parts of Directive 98/44/EC were transposed verbatim with Decision of the Administrative Council of 16 June 1999, which came into force on 1 September 1999. However, the chosen road might turn out to be quite bumpy.
Since the Directive was transposed by amending the Implementing Regulations instead of the EPC itself, the latter prevails in case of conflicts, Art 164 (2) EPC. With this in mind, one might ask whether any substantial change of patent law was achieved by this transposition at all. In any case, it seems highly probable that the EPO will be applying its long-standing MOBIL doctrine to gene patents.
Finland
Directive 98/44/EC was implemented with Act no 650/00 of 30 June 2000, which entered into force on 15 July 2000. The first two subsections of Art 5 were transposed in Sec 1a FPA without major changes. Interestingly, Art 5 (3) was not specifically transposed.
This implies that the Finnish legislator like the Administrative Council did not deem it necessary to change the existing concept of product protection for gene patents on grounds of the Directive.
Germany
Transposing the Directive in Germany was a particularly hard nut to crack. It was only implemented with the Biopatent Act of 21 January 2005, which came into force on 28 February 2005. Art 5 was transposed in § 1a GPA, whereas the wording of § 1a (3) significantly differs from the Directive’s language.
Additionally, a special provision for human genes was introduced which intends to limit the protection for such patents. § 1a (4) GPA reads loosely translated:
If the subject matter of the invention is a sequence or partial sequence of a gene the structure of which is concordant to the structure of a natural sequence or partial sequence of a human gene, then its use, for which the industrial application is concretely described in accordance with subsection 3, has to be included into the patent claim.
By limiting human gene patents to purpose-bound protection and thereby, allegedly, considering ”the particularities with regard to human beings”, the German legislator created a myriad of issues. Just to name one, § 1a (4) GPA cannot be taken into account in revocation proceedings of a European patent (cf. Art 138 (1) EPC).
By applying for a European patent for Germany, patent applicants could easily circumvent the aforementioned requirement. However, it is unclear whether this also holds true for infringement proceedings. Overall, narrowing the scope of § 1a (4) GPA to human gene patents seems arbitrary and merely motivated by ethical concerns. However, the circumstances constituting these concerns remain misty.
Additionally, an issue of ”over rewarding” patents exists, if at all, independently in all fields of gene patenting and is not exclusive to human genes. Insofar, the German implementation is a failure.
Conclusion
Absolute product protection for chemical compounds is a well-established principle in European patent law. However, it is ambiguous whether this concept also applies to DNA sequences. Since Directive 98/44/EC is not governing this aspect, several national implementations vary considerably in this regard.
The EPOrg and Finland opted to verbally transpose (most of) the relevant provisions, thus maintaining the existing regime of product protection. Germany, however, chose a different path. By introducing purpose-bound protection for human gene patents, German patent law now differs significantly from other major jurisdictions in Europe.
In the end, Directive 98/44/EC is not harmonising but rather disharmonising the respective patent laws of the Member States. It, indeed, seems to be ”legislation for disharmony”.
Abbreviations
FPA the Finnish Patent Act
EPOrg European Patent Organisation
GPA the German Patent Act
Legislation
Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological invention [1998] OJ L 213/13
Decision of the Administrative Council of 16 June 1999 amending the Implementing Regulations to the European Patent Convention
[1999] OJ EPO 437
Cases
HOWARD FLOREY/Relaxin [1995] E.P.O.R. 541
MOBIL/Friction reducing additive [1990] E.P.O.R. 73
[EPOR = European Patent Office Reports (ISSN: 0269-0802). Sweet & Maxwell, available in Westlaw databank].
