Court sets limits on the scope of protection for biotech patents

Commercial Court no 6 of Madrid has issued the first ever Spanish ruling to resolve a patent infringement action dealing with the interpretation of Directive 98/44/EC on the Legal Protection of Biotechnological Inventions (the Biotech Directive), and applying the legal provisions that implemented the directive in the Spanish legal system.

Monsanto had filed a lawsuit for patent infringement against the Spanish company Sesostris as the legal holder of patent ES 2 089 232 (ES ‘232). The patent protects an isolated DNA sequence, which includes the codification of a specific enzyme belonging to Class II EPSPS enzymes. The technical advantage provided by the invention is revealed in the field of agrobiotechnology; genetically modified plants incorporating Monsanto’s sequence, and thus codifying the relevant enzyme, are glyphosate resistant. This means that crops can be treated with glyphosate herbicides to destroy weeds without being damaged. Monsanto’s patent not only protects the gene sequence, but also claims the cell plants and plants genetically modified in this way.

Sesostris had imported into Spain from Argentina a batch of soy meal that had been obtained from transgenic soy beans incorporating Monsanto’s patented DNA sequence. This was deemed by Monsanto to infringe its patent rights, as the soy meal derived from glyphosate-resistant beans would also fall within the scope of protection of patent ES ‘232, according to Monsanto’s criterion.

Both Article 9 of the Biotech Directive and Article 50.4 of the Patent Act, which implemented the directive in Spain, require three conditions to be fulfilled in order for patent rights over an invention consisting of genetic information to extend to any subsequent material not claimed in the patent. Therefore, Monsanto was bound to give evidence that the patented DNA sequence:

• was incorporated into the soy meal;
• was contained in the soy meal; and
• most importantly, still performed its function in the soy meal.

Monsanto argued that these provisions should be broadly interpreted to enlarge the scope of protection for patents protecting biotechnological inventions, so that patent rights would extend to any material in which the genetic information is incorporated and in which it can perform a function, irrespective of whether the effective and active function of the patented sequence (in this case, the codification of the Class II EPSPS enzyme providing resistance to glyphosate).

This reading was rejected by the court on two grounds. First, the court's interpretation of Section 8 of the directive was that it does not enlarge the scope of protection for patents, but only complements and adapts existing national legal patent systems to confer adequate protection on biotechnological inventions. Therefore, biotechnological patents must be interpreted under the same rules and principles as any other patent in any other technical field. With this in mind, a broad interpretation of patent-related provisions is inadmissible, as patent law is governed in Spain by the principle of restrictive interpretation.

Second, as to the function performed by the gene sequence – if found – in the derived product, the court referred again to the Biotech Directive, and particularly to Section 24, to observe that the specific function performed by the genetic information, which is essential for acknowledging the industrial applicability of the invention and is described in the patent, is one that shall be performed in the new material (ie, the soy meal). Therefore, Monsanto should have proven not only that the patented DNA sequence was incorporated and contained in the soy meal, but also that said sequence still codified the relevant Class II EPSPS enzyme.

In any case, the court finally considered that Monsanto had not provided any evidence showing that the patented DNA sequence was incorporated into or contained in the soy meal, or performed its function (as described above) therein. The only fact deemed as proven was that the soy meal had been obtained from soy beans that included Monsanto’s event in their genome, which was not enough to extend patent protection to the soy meal.

On the contrary, the evidence submitted by Sesostris led the judge to the conviction that soy meal cannot contain any functional genetic information with any ability to perform its function in such a derived product. In other words, he found that any residual DNA persisting in the soy meal could not codify the Class II EPSPS enzyme and provide the soy meal with resistance to glyphosate herbicides (to which, besides, meal is not exposed). Among other reasons, the court observed that the extremely hard conditions applied to soy beans processed to obtain meal must lead to the destruction of plant cells, so any genetic material contained therein, including enzymes, is irreversibly inactivated. Therefore, as long as soy meal is not the material in which the protected genetic information is incorporated, is contained, and where such information performs its function, it cannot be deemed to fall within the scope of protection of Monsanto’s patent ES ‘232.

This ruling represents an important precedent for future Spanish case law in this field, particularly as regards the scope of protection for biotechnological inventions and limitations to this protection.