Speech is Silver, Silence is Golden: The Cultural Importance of ...

Speech is Silver, Silence is Golden: The Cultural Importance of ...

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  • cours - matière potentielle : classroom
17 Speech is Silver, Silence is Golden: The Cultural Importance of Silence in Japan Sally Jones Abstract In Japan, there exists a strange dichotomy. On the one hand, it is a noisy place: the constant announcements in the train stations and shopping centres, the loud cries of shopkeepers greeting customers to their stores, the hustle and bustle of the busy streets. On the other hand, the Japanese value silence. It might seem odd that silence is valued in a place where such a cacophony exists, but silence in everyday interaction is a vital form of non-verbal communication for the Japanese.
  • truthfulness
  • cultural significance
  • context cultures
  • individual values
  • use of the spoken word
  • silence
  • verbal communication
  • americans
  • goals
  • communication

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EPLAW Patent Blog 22 December 2011 ES  Cinfa et al. v. WarnerLambert Company et al. / Atorvastatin / Cassation Appeal Laboratorios Cinfa, S.A., Kern Pharma, S.L., Laboratorios Alter, S.A. & Laboratorios Belmac, S.A. v. WarnerLambertCompany LLC, Pfizer, S.A. & Parke st Davis, S.A., Supreme Court (Civil Chamber, 1Section), Spain, 11 November 2011, Docket No. 1174/2008. The Spanish Supreme Court has recently put a term to the longlasting litigation between a pool of manufacturers and marketers of generic drugs (Cinfa, Alter, Kern, Belmac), on one side, and WarnerLambert Company, Pfizer and ParkeDavis on the other side, in relation to these latters’ patent on the atorvastatin hemicalcium salt and the authorization and marketing in Spain of generic drugs thereof. The background of the case dates of 2004. With an eye on the forthcoming authorization of atorvastatin generic drugs, the aforesaid generics companies brought then legal actions seeking the invalidation of claims 1, 2 and 3 of WarnerLambert’s patent EP 409281, validated in Spain with number ES 2167306, alleging on one side its lack of novelty and on the other that since the patent was applied for in 1990 the challenged claims were affected by the reservation entered by Spain to the European Patent Convention (EPC), under its Article 167(2)(a), pursuant to which chemical and pharmaceutical products were excluded from being patentable in Spain until 7 October 1992 (in such a way that any patent registered in Spain, or designating Spain, prior to that date containing claims for chemical/pharmaceutical products was ineffective). The plaintiffs alleged that the aforesaid patent claims fell within such prohibition as they did protect the atorvastatin hemicalcium salt (claim 1), a pharmaceutical composition thereof (claim 2) and the use of atorvastatin hemicalcium salt to prepare a pharmaceutical composition suitable for the treatment of hypercholesterolemia and hyperlipidemia (claim 3). While rejecting the invalidity arguments, the defendants also filed a counterclaim for patent infringement against the plaintiff generics companies in the light that, further to the statements in the complaint, they were taking the necessary steps to market in Spain hemicalcium atorvastatin generic drugs. One of such necessary steps being the obtaining of authorization from the Spanish Medicines Act, and such authorization process requiring providing said Agency with samples of the medicinal product for which authorization is sought, the counterclaiming defendants argued that providing samples of calcium atorvastatin drugs to that end represented a nonauthorized use of the patented product. The first instance judgment, of 26 September 2006, had established as to the possible patent invalidity arising from the application of the Spanish reservation to patentability of pharmaceuticals, that said reservation accepting the patentee’s arguments had been partially abolished by a later rule such as the TRIPS Agreement to the extent that its provisions are incompatible with the provisions of the latter. As Articles 27 and 70 of said Agreement protect the obtaining of product claims in chemical and pharmaceutical patents, the relevant claims in the atorvastatin patent, though applied for while the reservation was in force, should be deemed
EPLAW Patent Blog 22 December 2011 validated pursuant to such provisions and no longer ineffective since the entry into force of the TRIPS Agreement in Spain. This interpretation, according to which pharmaceutical product claims initially affected by the reservation to the EPC are deemed automatically valid due to the subsequent application of the of TRIPS Agreement in Spain, is representative of the wellsettled position adopted by Spanish Courts in the many patent invalidity proceedings introducing this debate, brought especially between 2004 and 2006, with occasion of the expiration of the data exclusivity periods for many drugs that were protected in Spain by process patents. In fact it has already been confirmed twice this year by the Supreme Court, by means of its Judgment of 10 May 2011 (in Eli Lilly’s olanzapinerelated proceedings), and its recent Judgment of 11 November in the commented atorvastatin case subject of this review. Despite the above, claims 1, 2 and 3 of the atorvastatin patent were declared invalid in that first instance judgment of 2006 because of lack of novelty, which led WarnerLambert Company, Pfizer and ParkeDavis to lodge an appeal against that decision. The Court of Appeals of Barcelona revoked then, on a Judgment dated 17 March 2008, that previous first instance decision and affirmed the validity of the EP 409281 patent. However, it denied at the same time the existence of the patent infringement raised via counterclaim, stating that the preparatory activities of the plaintiff generics companies to obtain authorization for their atorvastatin generics would fall within the experimental use exemption of the Spanish Patents Act [Article 52(1)(b)] taking advantage of the ‘Bolartype provision’ introduced therein in 2006, even if the patent infringement action was filed before such provision was implemented into the Spanish legal system. In this regard, as many other Courts have been interpreting in the past years, the Court of Appeals of Barcelona understood that the ‘Bolartype provision’ introduced in the Patents Act in 2006 did not add anything to but merely clarified the scope of the previously existing experimental use exemption, specifying that it also comprised any acts aimed at obtaining a drug marketing authorization, which should therefore not be deemed infringing acts. The rejection of both the invalidity and the infringement actions led both parties to appeal the decision of the Court of Appeals before the Supreme Court, giving rise to the referred recent Judgment of 11 November. Regarding the plaintiff generics companies’ appeal, the Supreme Court reaffirms the assessment of novelty made by the Court of Appeals and rejects the plaintiffs’ challenge of claims 1, 2 and 3 on the grounds of its own previous Judgment of 27 April 2011, rendered in relation to a parallel invalidity action on the same EP 409281 patent filed by Lek Pharmaceuticals. Indeed, the plaintiffs had defended all through the proceedings –similar to Lek’s arguments that the atorvastatin hemicalcium salt and its use for the treatment of hypercholesterolemia and hyperlipidemia had been disclosed in WarnerLambert’s prior European patent application no. 89103078.5 (EP 330172) alleging, in summary, that said prior art document (“Improved process for trans6[2(substitutedpyrol1yl)alkyl]pyran2one inhibitors of cholesterol synthesis”) discloses the atorvastatin and the possibility to obtain its pharmaceutically acceptable salts, one of them being its calcium salt. The Supreme Court, accepting Court of Appeals’ assessment, and referring to its own previous Judgment of 27 April, denies that the cited prior art unambiguously discloses said teachings in such a way that the skilled person would have inevitably deduced the atorvastatin hemicalcium
EPLAW Patent Blog 22 December 2011 salt therefrom. Quite the opposite, the Supreme Court maintains that WarnerLambert’s patent application invoked as prior art protects a doublelist selection invention whicha)does not disclose atorvastatin as the sole starting compound,b)provides a list of salts that requires previously discarding amine salts to select metal salts one of them being calcium salt, andc)does not explicitly disclose not only atorvastatin calcium salt but any salt thereof. Hence, according to the Supreme Court such doublelist system imposes to the skilled person multiple complex choices that exclude considering that he would have inevitably and indefectibly obtained atorvastatin hemicalcium salt from the implicit teachings of the prior art document, not being said compound clearly and unambiguously disclosed therein so as to consider that its selection is not novel. These considerations about the novelty of the patent, together with the rejection of other arguments raised by the plaintiffs, relating to the wrong interpretation of claim 3 in the appealed judgment and the invalidity of the challenged claims under the reservation entered by Spain to the EPC –to which reference has already been made, are the basis of the Supreme Court’s decision to completely dismiss the generics companies’ appeal and confirm the judgment of the Court of Appeals in respect of the validity of the EP 409281 patent claims. The same cannot be said of the Court of Appeals’ rejection of the patent infringement raised by the patentee on the grounds of the application of the experimental use exemption. Contrary to the statements of the Court of Appeals, the Supreme Court, accepting the defendants’ arguments, establishes that the amendment of Article 52(1)(b) of the Patents Act, so as to implement the ‘Bolartype provision’ in the Spanish patent legal system, did only enter into force in 2006 (particularly on 28 July). The Supreme Court, confirming the line of reasoning expressed in its earlier Judgment of 30 June 2010 (rendered in amlodipine besylaterelated proceedings), maintains that the previous wording of such Article 52(1)(b) –in force when the proceedings was initiated only covered experimentation with scientific purposes, not activities aimed at obtaining marketing authorizations for generic drugs. In the opinion of the Supreme Court, opposite to the Court of Appeals’ view, the purpose of such modification was actually introducing in the Spanish patent system the ‘Bolartype provision’ as a consequence of the mandate contained in the Directive 2004/27/EC of 31 March 2004, and it actually meant adding the aforesaid acts involving generics to the scope of the exemption. Accordingly, the wording of Article 52(1)(b) further to the modification of such exemption cannot be retroactively applied to the plaintiff generic companies’ activities at the time when the infringement counterclaim was filed, which were therefore infringing activities at that moment. Notwithstanding the admission of the counterclaiming defendants’ stance on the patent infringement, the Supreme Court finally rejects their appeal as the claims raised in the writ of counterclaim had either been abandoned by such defendants, or were not connected to Article 52(1)(b) of the Patents Act while involved sentencing acts yet to come, or were incidental petitions subject to the main claims that should therefore be dismissed as well.