Important decision on patent infringement relating to genetic material
Summary
The Court of Justice of the European Union (CJ), which is Europe’s top court when it comes to harmonizing law across Europe, recently delivered its first judgement concerning patent infringement relating to genetic material. According to the decision, a product comprising patented genetic material does not infringe the patent if the genetic material does not perform the function for which it was patented. The judgement raises questions on what protection a patent drawn to genetic or biological material actually confers, and applicants are well advised to have this in mind already at the stage of drafting the application.
The law
The European Union’s so-called Biotech Directive (98/44/EC) was issued in 1998 to force the EU member states to harmonize their patent laws with regard to biotechnological inventions. The directive comprises provisions on what the national patent laws of the member states should attain with regard to patentability of biotech inventions and how infringement should be considered. It also comprises 56 recitals in the preamble that further discuss the reasons and thinking behind the legislation. The recitals are thus helpful in interpreting the articles of the directive. If a court in a member state finds that the national or European law is unclear, it may ask the CJ for a preliminary ruling on the question at hand. That is what the Dutch court did in the present case.
Article 9 of 98/44/EC, the essence of which has been incorporated into national Dutch law, states
The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material, save as provided in Article 5(1), in which the product is incorporated and in which the genetic information is contained and performs its function.
Although the directive was enacted in 1998, it applies retroactively to all patents filed or granted before 1998.
The case
Claim 6 of a European patent (EP 546 090) owned by Monsanto Technology LLC, covers two specific DNA sequences (genes) encoding a Class II EPSPS enzyme. When this enzyme is expressed in a plant it confers resistance to the herbicide glyphosate, which is sold by Monsanto’s under the trademark Roundup®. Plants, such as soy, that contain the gene covered by the patent express classII EPSPS enzyme and are thereby resistant to glyphosate. These transgenic plants are marketed as Roundup Ready®.
Roundup Ready® soy is grown in large scale in Argentina where the Monsanto does not have any patent protection for the DNA sequences. Monsanto sued two importers of Argentinean soybean meal in the Netherlands and it was uncontested that DNA covered by claim 6 was present in the soybean meal.
Claim 6 is drafted as a product claim, no different from any claim drawn to a chemical compound or any other product, e.g. a car engine. The claim does not specify any function or purpose of the DNA sequence. In most other areas of technology, such a claim would confer absolute patent protection for the DNA sequence. Of course, the protection would extend also to any product containing the protected product. A plant containing the patented DNA would thus be protected, just as a car containing a patented engine would be covered by a patent for a car engine.
However, soybean meal is a dead material and the enzyme encoded by the protected DNA is not, and never will be, produced in the soybean meal. Furthermore, the enzyme would not confer glyphosate resistance in the soybean meal for two reasons. Firstly, resistance is the effect of not being killed by the herbicide. Since the soybean material is already dead it cannot be killed again, and there is in effect no resistance. Secondly, there is no commercial or industrial need to apply herbicides to soybean meal. In the absence of herbicide, there can be no resistance effect.
The question in the case is thus whether the patent extends to protect a product (soybean meal) comprising the patented product (the DNA) if the patented product is non-functional.
The decision
As mentioned above, the protective scope of a patent extends to complex products comprising the patented product. This is valid in all areas of technology, e.g. a patent for a battery extend to a mobile phone comprising the battery. For biological inventions article 9 of 98/44/EC however limits this extension so that the patent for the genetic material will only extend to protect the complex product as long as the genetic material performs its function in the complex product. The court consequently found that in the present case, the protection for the DNA could not extend to protect the soybean meal since the DNA did not perform its function.
That was hardly surprising. Monsanto however argued that the patent covers the DNA as such and that no protection under Article 9 was claimed. Although the soybean meal itself could not give rise to new soybean plants, the DNA could be extracted and inserted into new plants and thereby perform its function and confer herbicide resistance to such new plants. The interesting question then arises if the protection conferred by the claim language, which contains no requirement for a function, is void if no function is performed.
The court came to the conclusion that a claim drawn to a DNA sequence does not cover that DNA sequence if it appears in a context where it does not perform its function. Consequently, the absolute protection defined by the claim language does not confer an absolute protection when it comes to infringement.
In coming to this conclusion, the court relies heavily on recitals 23 and 24 and Article 5(3) of the directive. These passages read
(23) Whereas a mere DNA sequence without indication of a function does not contain any technical information and is therefore not a patentable invention;
(24) Whereas, in order to comply with the industrial application criterion it is necessary in cases where a sequence or partial sequence of a gene is used to produce a protein or part of a protein, to specify which protein or part of a protein is produced or what function it performs;
amendments, it will not be possible to introduce claims to products that are not clearly and unambiguously described as being part of the invention at the time of filing the European or PCT application. It is therefore advisable to consult European counsel such as Brann AB already at the stage of drafting your international applications or, preferably, the priority founding application. It will also be necessary to file new patent applications for any new use of a previously patented genetic material as the product patent not necessarily will protect the patented product if it is used in a new way or for a different purpose.
Hampus Rystedt
Director, Patent Department BRANN AB
European Patent Attorney
BRANN AB is a full-service IP Law Firm based in Sweden. With 70 patent attorneys, lawyers and paralegals in four offices, Brann provides clients from all over the world with advice on all aspects of Swedish and European intellectual property protection.