Giovedì 8 novembre 2012, la Corte Suprema canadese ha deciso che il brevetto per il farmaco Viagra, della compagnia farmaceutica Pfizer Inc., non è più valido, aprendo così le porte alla concorrenza dei farmaci generici. La causa, iniziata da un'altra industria farmaceutica, la Teva Pharmaceutical Industries Ltd., è fondata sull'insufficiente indicazione delle componenti del principio attivo nel brevetto del farmaco.
Canada - Supreme Court - Teva Canada Ltd. v. Pfizer Canada Inc. : brevetti e concorrenza di farmaci generici
8 novembre 2012
Numero
SCC 60
Anno
2012
Riportiamo i passaggi principali della sentenza (.pdf completo nel box download).
«[65]As required by s. 2 of the Act, an invention must be novel. In the instant case, the invention is not sildenafil, per se, because this compound was already known. In fact, Pfizer had been investigating sildenafil as a cardiovascular drug when it first suspected that the compound would be useful in treating ED (R.F., at para. 13). The invention is therefore not sildenafil, but the use of sildenafil to treat ED».
«[76]Pfizer had the information needed to disclose the useful compound and chose not to release it. Even though Pfizer knew that the effective compound was sildenafil at the time it filed the application, it limited its description to the following statement:
In man, certain especially preferred compounds have been tested orally in both single dose and multiple dose volunteer studies. Moreover, patient studies conducted thus far have confirmed that one of the especially preferred compounds induces penile erection in impotent males. [Emphasis added; A.R., vol. X, at p. 173.]
It chose a method of drafting that failed to clearly set out what the invention was. Even now, in its factum to this Court, Pfizer offers no explanation as to why — knowing that Claim 7 contained the tested and thus, the useful, compound — it elected to withhold that information».
«The disclosure failed to state in clear terms what the invention was. Pfizer gained a benefit from the Act — exclusive monopoly rights — while withholding disclosure in spite of its disclosure obligations under the Act. As a matter of policy and sound statutory interpretation, patentees cannot be allowed to “game” the system in this way. This, in my view, is the key issue in this appeal. It must be resolved against Pfizer».
Pubblicato il: Giovedì, 08 Novembre 2012 - Ultima modifica: Martedì, 11 Giugno 2019
