I Court of appeals, Republic of Chile, Rol 3747-2002
475In this case, Pfizer sought an injunction to prevent the ISP in granting the sanitary permits in favour of Laboratorio Recalcine, which would have had allowed them to commercialise the generic version of Pfizer’s product without their consent (original owner). In doing so, the plaintiff also sought to delimit the ISP’s competences and also the National Health Institute sought, at the same time, to clarify its position in terms of marketing approvals.
The Court of Appeals ruled within the Rol. 3747-2002, that the National Health Institute lacks competence to solve any controversy derived from a patent and therefore this institution attribution only allows pharmaceutical product registrations to thereafter grant a sanitary permit. The original motion for an injunction to prevent the granting of a sanitary permit deviated into a conflict of pure intellectual property between the parties in question.
During the proceedings the Court understood the matter as a conflict derived from an intellectual property privilege granted to the owner by the Law Nº 19.039 and therefore this conflict accordingly should have been presented before the INAPI Chief of Department whom would have had to decide. Otherwise, a Civil Court should have solved the case. Moreover, the court stated that this institution has nothing to do with a patent right or the ability to determine the scope of patent protection granted and thereafter if a sanitary permit was requested by a third party the ISP had to limit itself in only verifying exclusively that the requirements were fulfilled. Another relevant argument used by Pfizer, and later on used against the company, was the fact that the company alleges to have accidentally learned about Laboratorio’s Recalcine request before the ISP for the approval of the permits in question. Later on the court, due to the ISP’s allegation, dismissed the previous argument over the matter, which basically suggested their good diligence in making the plaintiff aware of the situation when the institution submitted a letter of notification that was not accepted.476The last
argument draws attention to the duty of the ISP in making available to patent owners the identity of third parties requesting marketing approvals during the term of the patent, as the U.S.-Chile FTA Article 17(10) b suggested a year after this ruling.
General Comptroller Office, Republic of Chile Dict.
051760N02
477Perhaps the previous case was reinforced by the comptroller’s office ruling over the Chilean Pharmaceutical Chamber’s claim to clarify the National Health Institute’s real attributions, as this was granting sanitary permits for copies of pharmaceutical products with a valid patent. In this case the Asociación
475 Quinta Sala, I Corte de Apelaciones de Santiago, Rol No.3747-2002, Pfizer Chile S.A. Vs. Laboratorio Recalcine S.A./ Instituto Nacional de Salud (Ziprasidona case)
476 Id. Ut Supra 38
477 Contraloría General de la República de Chile, Dictamen No. 51760 de fecha 17.12.2002, Cámara de la Industria Farmacéutica Vs. ASILFA/ISP
Industrial de Laboratorios Farmacéuticos Chilenos A.G. (hereinafter ASILFA)478
sought for the Comptroller to clarify the ISP and to acknowledge that its main responsibility did not regard granting the sanitary permits to those products that fulfil the legal requirements, but also to verify the existence of patent rights. After an extensive analysis, the Comptroller’s Office dismissed the Pharmaceutical Chambers petition dictating that the ISP was not legally attributed to deny a sanitary permit neither on the basis of a valid patent nor to analyse the privileges deriving from the Law No. 19.030 (patent law). And therefore the parties shall present in court when fears over the vulnerability of their rights where plausible.
It is important to highlight that Resolution No.14 was still valid and therefore the ISP had the duty to inform patent owners about third parties’ applications to obtain marketing approvals or sanitary permits to commercialise similar products without their consent.
20° Civil Court of Santiago, Rol No. 5.839-2004
479Even when during the two previous cases the National Health Institute had no attributions or competences to validate any right derived from patents, and therefore their only duty was to grant sanitary permits within the present case, this theory seemed to bend as the Court started recognising the practical consequence of such permits.
In this case, Centro Juvenil Ages sought to void the sanitary permit granted by the ISP to Laboratorios Grünenthal Chilena Ltda, to commercialise Postinor-2 (with the same abortive effects as Postinol)480 also known as the ‘after day pill.’
This court ruling in 2004 contradicts a similar case solved by the Court of Appeals and the Supreme Court in 2001. In this respect, the 20th Civil Court
reinforced the Court of Appeals ruling in relation to the “after day pill”481 by
revoking the sanitary permit granted for this pharmaceutical product upon Centro Juvenil Ages’s motion. The Court decided to safeguard the rights of the unborn since the pill had the same abortive effects as the aforementioned Postinol. Despite the fact that neither of these cases alleges a breach in the intellectual property legislation, it is important to draw attention to the fact that the sanitary permits began to be addressed as marketing approvals. The distribution of the Levonorgestrel pill, brought to the spotlight the ‘real’ implications of such a sanitary permit given that it allowed the commercialisation
478 Asociación Industrial de Laboratorios Farmacéuticos (ASILFA – Industrial Assotiacion of Pharmaceutical Laboratories) is an associationdedicated to ensure the maintenance and implementation of conditions that favour the development of the National Pharmaceutical Industry. This Association works with national and foreign laboratories. Original Text in Spanish. Asilfa web, Mission<www.asilfa.cl/mision.asp>
479 20 Juzgado Civil de Santiago, Rol No. 5839-2004, Centro Juvenil Ages Vs. Laboratorios Grünenthal Chilena Ltda./ISP.
480 Article 17.10.2 Free Trade Agreement US-Chile
481 Noriga Alcala, A., ‘Análisis de la Sentencia del Tribunal Constitucional Chileno sobre el Decreto Supremo que Regula la Distribución de la Pildora del Día Después (Levonorgestrel
of a pill that in principle was contrary to the Chilean Constitution, due to its abortive effects.482
On 28 May 2001 the Court of Appeals in Rol No. 850-2001 denied the injunction petitioned by five nongovernmental organisations, among them Centro Juvenil Ages483, against the National Health Institute and Laboratorio Médico Silesia S.A.
for the commercialisation of the pill in question. By this time one of the arguments used against the ISP was the fact that by limiting itself to verify if a pharmaceutical product fulfilled the sanitary legislation, at the same time they granted a sanitary permit to commercialise a product with unconstitutional effects. The argument was dismissed and the petitions did not proceed on the basis that no one was actually threatened since they were intending to protect the right of unborn children. Later on that the same year in August the Supreme Court acknowledged the cause and granted in Rol No. 2.186-2001 an injunction against the Lab and voided the Resolution No. 2.141 from the National Health Institute where the Postinal was authorised.
Even after the ISP had to withdraw the approval granted for the Postinal on 24 August2001, the same institute granted a sanitary permit for a product named
Postinor-2, which is manufactured on the basis of Levonorgestrel and causes the
same abortive effects.
30
thCivil Court, República de Chile, Rol No. C-6613-
2003
484Within the previous cases it seems like the perception over the marketing approvals or sanitary permits started to shift in Chile, as they are now considered to actually have the power to allow the commercialisation of unwanted products such as the Postinal.
This case brings to the spotlight the attributions of the ISP in light of the FTA. In other words, whether or not a linkage existed between the patent office and the ISP. Accordingly, Pfizer obtained a patent for the process to produce Postinal and a patent for the product per se; these were to expire in 2003 and 2016 respectively, and consequently a marketing approval was also granted to commercialise the product in 2003. The conflict began in 2003 after Laboratorios Recalcine requested the marketing approval for “known products” before the ISP to commercialise a similar product to the ones already registered by Pfizer. The Court concluded that by granting a sanitary permit, the validity to commercialise a pharmaceutical product as stated within the Sanitary Code Article number 102485 was also granted. Thereafter the Court reached the
conclusion that a sanitary permit is an authorisation to commercialise, and that is
482 Constitución Política de La República de Chile, Senado de la República de Chile, Available at: <www.senado.cl/prontus_senado/antialone.html?page=http://www.senado.cl/prontus_senado/sit e/artic/20050516/pags/20050516221649.html>
483 Corte Suprema de Chile, Rol No. 2.186-2001, ONGs’ Vs. ISP
484 30º Juzgado Civil de Santiago, Rol No. C-6613-2003, Porzio Bozzolo Vs. M/Instituto de Salud (2006)
very obvious from the fact that no distribution of pharmaceutical products can be carried out without the mentioned permit.
For the first time in 2006 a Chilean Court actually recognised the existence of a linkage between the ISP and the INAPI. Within the present case, Pfizer Chile S.A. introduced before the court a motion to annul the administrative act through which the ISP accepted and began the process to grant a secondary sanitary permit for Laboratorio Recalcine to commercialise Ziprasidona.486
Pfizer is the right holder for the patent for procedures No. 36.533 valid until November 2003 and the patent for products No.41.031 valid until May 2016. Both patents protect the procedure to obtain the Ziprasidone and the product as such and therefore no generics could be commercialised without Pfizer’s consent. In 2003 the ISP granted the sanitary permits to the company, so it seems obvious that the Institution had knowledge about the existence of both valid patents and sanitary permits by the time that Laboratorio Recalcines had requested a secondary sanitary permit for the same product and procedure as Pfizer.
One of the issues to be highlighted about this ruling is the fact that the court never denied which were the National Health Institute’s attributions and competences, but also did not limit those attributions to a simple requirement fulfilment verification as the previous cases did. In this case the court actually gave a proper interpretation about the linkage and the real duties derived from the sanitary regulation. The question of whether or not the acts executed by this Service are excluded from the applicability of other norms related to patents and property right as such can be raised, enabling them to infringe the rights of others when for example they are analysing similar products.
Data protection and the Chilean Government duties and obligations within the U.S.-CHILEFTA context were also taken into consideration for the ruling that voided Laboratorio Recalcine’s sanitary permits request.
3° Court of Criminal Trial, República de Chile, R.U.C
0510012831-6
487Following the trend settled with the previous case, this case was one of the most expected cases among the Chilean legal society due to the fact that it was one of the few times when a pharmaceutical company sought criminal enforcement of intellectual property right in Chile. As with the Ziprasidona case, this case seeks to clarify the duties of ISP in regard to the linkage.488
Laboratorio Sanofi Aventis sought a court patent infringement in the criminal court for the import, commercialisation and distribution of a pharmaceutical
486 I Corte de Apelaciones de Santiago, Rol. 3747-2002, Pfizer Chile S.A. Vs. Laboratorios Recalcine S.A. and the ISP (2002)
487 3° Tribunal de Juicio Oral en lo Penal de Santiago, R.U.C. No. 0510012831-6, Laboratorios Sanofi Aventis Chile Vs. Jaime Kattan (Laboratorios Royal Pharma)
488 Read further in “LABORATORIOS NACIONALES VS. INTERNACIONALES / Presunta copia de medicamento reabre la discusión. Propiedad intelectual: farmacéuticas a la espera de fallo que sentará precedente” press Article in El Mercurio Journal from 3 September 2007.
<diario.elmercurio.cl/detalle/index.asp?id={bc1e145d-5f5d-4d4c-a535-88773b61d14c}>accessed 01 September 2009
product name “ISKIMIL” from Laboratorios Royal Pharma, which is a generic version of the original product manufactured by the plaintiff.
The Chilean court condemns the patent infringement for the production of the generic version without the patent owners consent. This was a challenging case that also caused great expectations as Sanofi Aventis’s legal representatives sued Royal Pharma’s legal representatives and general manager. Petitioning to fine Jaime Ramirez Kattan for a sum of 100 monthly tax units (UTM) which if calculated in Chilean pesos is worth around 33 million pesos or 50,000 Euros. The court reached their decision after finding the defendant guilty of a charge according to the Chilean Penal Code Article 15 and Law No.19.039 Article 52.489
The reason for suing Royal Pharma’s representative was the fact that he was considered to be carrying out the imports and commercialisation in bad faith,490
since Sanofi Aventis is the patent holder for the product PLAVIX491 which is the
original version. Although the court recognised ISP certain liability on the sanitary permit issue it did not go into the matter very deeply, declaring more or less like an issue out of its competences. The trial was full of technicalities regarding the procedure to manufacture the PLAVIX, and several experts within the field were called to the stand to help the court in solving the issue.