USE OF DISCLAIMERS IN ARGENTINA
During substantive examination of patent applications in the chemistry, pharmacy and biotechnology fields, Argentine Examiners often require the inclusion of disclaimers as a condition for granting. These disclaimers consist of certain standard expressions, usually suggested by the examiner with purpose, in the view of the Patent Office, to specifically confirm that the patent does not cover any matter excluded from patentability by the Patent Law. The disclaimers are intended to avoid any interpretation that could extend the scope of protection to non-patentable subject matter. Even when a claim defines clearly and accurately its intended scope of protection, the Office may require the inclusion of a disclaimer if only to make it clear that examination is only considered to be complete when all the requirements provided for by the Patent Law have been analyzed, thus preventing third parties from being unduly affected by patent rights having scope that might be interpreted beyond patentable subject matter.
This should not discourage inventors from filing a patent application or continuing with its prosecution, as the inclusion of disclaimers is mainly intended to protect the Office against any allegations of loose interpretation of the law and its Regulations. Furthermore, in the following paragraphs we describe a case that was finally decided in court, in which the ruling disregarded the disclaimer and the decision was based only on the matter that could be protected under law at the time of granting the patent.
The history of this practice began under Argentina’s former Patent Law, No. 111, which excluded from patentability all pharmaceutical or veterinary products used in therapeutic methods for the treatment of humans or animals.
While the old law was in force, in particular in the pharmaceutical and veterinary fields and even in the agrochemical field, there were inventions referring to compounds having dual activities, for example, an invention directed to a compound having activity as a cosmetic agent or as a dermatological agent for specific diseases. A similar example could be found in the agrochemical field where the compound could be applied as an acaricidal agent to the animal’s site or habitat or directly on the body of the animal in order to remove the ectoparasite. In such cases, it was possible to grant a patent covering a compound for a non-excluded use but it was necessary to limit the scope of protection so as to clearly dismiss any interpretation involving excluded subject matter. The Office started then to require the inclusion of disclaimers.
Returning to the latter example, given that an ectoparasite is considered a disease vector, the compound in question may have an indirect effect on the health of an animal and in such event said compounds fall within the category of pharmaceutical or veterinary products. In cases like this, the Office required limiting the scope of protection of the compound to those applications not excluded from patentability by means of a disclaimer of this type: “compound X except for its applications in humans or animals”. This was intended to provide protection for a compound with a use limited to a non-pharmaceutical or veterinary use.
Under the new law these disclaimers applied to products were no longer necessary, since pharmaceuticals or veterinary products became patentable. However, in cases involving other subject matters excluded from patentability, the use of disclaimers is still a tool frequently used by the Argentine examiners, where there are doubts about the real scope of protection of a patent and it is deemed necessary to specifically define it within the framework of the patent law.
Recent examples can be found in the biotechnology field. For example, if the application claims a method for generating a transgenic plant, the Office may require the inclusion of a disclaimer reading “provided that the plants obtained by such method shall not be included”. In this case, although the claim is directed to a method, the examiner requires the inclusion of such disclaimer based on the general principle by which the scope of protection of a process extends to any new products obtained by it. This concept is set forth in the Patent Law as follows: Section 88.
“For the purposes of civil proceedings, where the subject matter of the patent is a process for obtaining a product, judges shall require the defendant to prove that the process used to obtain the product is different from the patented process. However, if the product obtained as a result of the patented process is not new, the court shall be entitled to order the plaintiff to prove that the process which the defendant uses to obtain the product infringes the patented process ( )”
As written, the scope of protection of a process extends to the product obtained by it when the latter is new and this only applies in the context of civil proceedings for patent infringement.
Another example is related to modified plant cells. In this case the Office requests the inclusion of the following disclaimer “excluding cells which are capable of generating a complete individual” in reference to totipotent cells and in order to avoid the protection of plants, which are specifically excluded from patentability.
Notwithstanding the Office’s practice, there have been court decisions challenging the legal effects of such disclaimers.
For example, in the case named “Cease and desist of use plus damages. Admissibility. Undue exploitation of the insecticide/acaricide known as FIPRONIL”, the product marketed by codefendant LABYES S.A. allegedly infringed Patent no. 255,628 owned by the plaintiff, but the judgment was appealed and reversed.
Patent No. 255,628 discloses “an N-Phenylpyrazole derivative excluding its use for the treatment of an animal body carried out by a physician or a veterinarian as a therapeutic method, a process for preparing it, a composition comprising it, a method for controlling arthropod pests, plant nematodes, worms and protozoa, and compounds useful as intermediates.”
FIPRONIL is a drug for veterinary pharmaceutical use described by patent 255,628, which covers the right to work the patent in general, but it has a disclaimer related to the protection of industrial/intellectual rights in such drug, a disclaimer which, in the defendant’s opinion, includes the use made by defendant LABYES S.A. of the drug in question.
However, the ruling reversing the judgment in this case established the following interpretive concepts:
1 – the authority to establish the scope of the patent and the interpretive criterion applicable for its determination is vested in the court, and is not in the hands of chemistry or veterinary experts.
2 – FIPRONIL is an insecticide and never ceases to be an insecticide: “FIPRONIL does not cure organic alterations caused by fleas and/or ticks” … “it is the body that regenerates or heals the alterations caused by the pathology”.
3 – the patented product is a chemical compound intended to remove certain types of parasites that mainly affect the skin of animals, parasites that cause injuries, but once removed by the application of such product, the body is capable of healing any existing after effects.
Therefore, it is not a medicament, but an insecticide, an acaricide insecticide.
One could say it is a “medicine” but only to convey the idea that it is an appropriate means for combatting a temporary condition suffered by an animal.
Any specific product to remove parasites affecting the skin of animals, whatever the mark or trade name, is an insecticide-acaricide, such as that commercialized by the firm LABYES S.A. under the name FIPROLINE, and does not fall within the exclusion included in patent 255,628, and consequently, it infringes the patent rights.
It was based on this concept that the patent owner requested the reversal of the decision ruling that the product marketed by codefendant LABYES S.A. did not infringe the rights arising from patent No 255,628.
Plaintiff added that FIPRONIL is essentially used for cleaning purposes, because when applied on the skin of the animal, the skin surface becomes free of insects and mites. It was also explained that this product cannot be considered at all as a veterinary product or veterinary clinical application, since it is used as an insecticide/acaricide, i.e., the equivalent of an external antiparasitic (as it removes and kills parasitic insects and mites such as fleas, ticks, etc.).
Furthermore, FIPRONIL cannot be considered a pharmaceutical or veterinary product, but rather an external insecticidal/acaricidal or antiparasitic product. This is supported by the fact that the latter are included in a different class or classification of patents (A01N) to that of pharmaceutical, medicinal or veterinary products (A61K, A61D)
From the conclusions of a veterinary expert it appears that the external antiparasitic products FRONTLINE and APTOPRONIL, comprising Fipronil, are indicated as a treatment of external parasitic diseases, as they cause the removal of ectoparasites that cause diseases, such as fleas and ticks.
The veterinary expert added that in spite of the fact that its use or administration is indicated by veterinarians, FIPRONIL is a specific product for parasite removal from the skin of animals and there is no doubt that the insecticide-acaricide which the co-defendants market under the name APTOPRONIL-M does not fall within the disclaimer included in patent 255,628.
As can be seen, in this legal action FIPRONIL was not considered a pharmaceutical or veterinary product but rather an insecticide acting to remove external parasites. The court did not take into account the fact that said insects can act as disease carriers, which was the reason why the office had requested the disclaimer.
Under this interpretation, the disclaimer introduced in the product claim had no effect whatsoever, and the product intended to treat animals marketed by the defendant fell within the scope of the patent claims, which were then awarded full protection against infringement.