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Phase III clinical trials for the use of Zimycan in the treatment of infants with proven Candida - associated diaper dermatitis were purported to have been underway since the first quarter of 2003. In addition to the significant length of time that had passed during these trials, investors also paid particular attention to defendant's statements about the Zimycan Phase III trials. This was true because, previously, the Company had received a Not Approvable Letter from the FDA in connection with Barrier's 1998 New Drug Application "NDA" ; for marketing approval of Zimycan for the broad indication of diaper dermatitis, without the complications of Candida. 28. Accordingly, at the time of the IPO, defendants represented that Zimycan.
SKF No. 2 spawned numerous cases involving applications for registration of trade marks said to consist of a specific color or colors, as applied to a tablet or capsule of a specific shape. The shape is typically shown in the drawing in dotted outline. A typical description of the trade mark is as follows: "The tablet shown in dotted outline does not form part of the mark. Color is claimed as a feature of the trade mark. The trade mark is illustrated by the specimen tablets filed with the application and consists of the color identify color ; applied to substantially the entire surface of a describe shape ; pharmaceutical tablet of the illustrated shape and size." The wares typically are also described narrowly, such as "pharmaceutical tablets containing name of drug ; for use in the treatment of name of disease or diseases ; ." The foregoing description clearly identifies the color, the shape of the color, and identifies the pharmaceutical in specific terms. To avoid the objection that the color or shape is not clear, a specimen may be filed, although the Trade-mark Rules do not specifically require this to be done. The reason for stating that the shape does not form part of the mark is that product shapes as such are registrable only a s distinguishing guises, which require proof of secondary meaning as of the filing date. Color of a particular shape, however, does not require proof of secondary meaning and therefore applications for registration of color of a particular shape can in theory be filed on the basis of proposed use. In view of SKF No. 2, an application conforming to the foregoing conditions would likely be accepted for advertisement. With the exception of a few that seem to have escaped the scrutiny of the Apotex or Novopharm, all have been opposed, and each reported case has ultimately resulted in a decision refusing registration. This is s o despite the strong pronouncement of the Supreme Court of Canada in Ciba-Geigy.44 The reasons are as follows. First, it has been held that the burden of establishing distinctiveness of a mark rests on the applicant, both in the opposition proceeding and on appeal to the Federal Court from a decision of the Registrar in the opposition proceeding.45 The correctness of this view is open to doubt. A trade mark is distinctive if it actually distinguishes the goods of the owner of the mark from those of others, or is adapted to do so.46 Distinctiveness is determined at the date when distinctiveness is called by the Opponent showed that the mark as used was associated with the word ZOVIRAX, i.e. the design mark was not used simpliciter. 44. supra note 1.
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