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医疗方法的专利保护研究

  4.4 测量方法总体上应当被视为具有工业实用性的发明,因此可以专利,如果测量适用于发展或者控制其自身具备工业实用性的产品、器械、方法。特别地,为工业实验目的使用试验动物,例如检测工业产品(例如为了确保没有pyrogenetic或者过敏效果)或者现象(例如决定水或者大气污染)可以获得专利权。
  4.5 应当指出:susceptibility of industrial application不是一个推翻52(2)的限制的要求。例如:按照52(2)(c),管理方法of stock control不是可享专利性的,尽管其可能被应用到工厂the store of spare parts of a factory. 另一方面,尽管一个发明必须具有工业实用性,而且描述必须表明where this is not obvious the way in which the invention is so susceptible (see II, 4.12),但是权利要求不需要限定于这些工业实用性。
  4.6 总体上,如果这不是自言而明的,欧洲专利申请的描述应当表明发明能够在工业中应用的方式。关于基因的序列和部分序列,这个一般要求给定了具体的形式:基因序列或者部分序列的工业实用性必须在专利申请书中公开。仅仅公布一个核苷酸序列而没有表明功能,不是可以专利的发明(EU Dir. 98/44/EC, rec. 23)。在下列案件中,基因序列或者部分序列用来生产蛋白质或者蛋白质片断,需要指出什么蛋白质或者蛋白质片断被生产,而且指出该蛋白质或者蛋白质片断执行的功能。替代地,如果核苷酸序列没有用于生产蛋白质或者蛋白质片断,那么将被指出的功能可以是例如:序列展示了一个特定的transcription promotor activity.
  EPO的化学和生物化学实践——医学的和疗法的治疗(Medical and Therapeutic Treatments)。
  EPO第53条(c)规定:但是问题复杂了,因为EPC第54条 (5)规定:第2款 和第3款 的规定,还不应排除第4款 所述的任何物质或者组合物在第53条(c)项所述的任何方法中的任何特定用途的可享专利性,但以这种用途没有包括在现有技术为限。第54条第5款规定:禁止性规定不排除专利性:用在这种方法中的任何物质或者组合物的用途发明的专利性,即使此前已经知道其他一些用途,只要那些用途不是人体或者动物身体的治疗或者诊断方法。使用化合物限定的用途权利要求或者所谓的瑞士形式的第二医疗用途权利要求,这可以提供一些形式的保护给:已知化合物的新发现医疗用途。 瑞士形式权利要求的确切涵义在侵权案件中还没有完全解决。然而,南非法院面对这样一个权利要求(目前南非法律主要抄袭EPC规定)认为:production of a transdermal nicotine patch was an infringement of a claim of this type. 这种瑞士形式权利要求仅仅适用于新用途的药物。因此,in Second Surgical Use/Codman they were not allowed for other types of medical treatment such as a new use of a known laser surgery system。 技术申诉委员会认为:“一个器械的外科使用不同于治疗性使用,因为前者在使用中没有被消耗,而且能被重复使用在相同或者不同的目的中。药物则不同,其在使用过程中被消耗了,而且在任何用途中只能使用一次。任何新的使用完全对应一个为此目的地整体性生产的扩张。”
  相同地,laser removal of portions of a lenticule that had already been implanted in an eye and attached to the cornea被认为是不可专利的医疗治疗。 此外,the Flow measurement decision noted in footnote 4 was distinguished in Cardiac pacing/Teletronics 其中,结论是:in order to avoid the prohibition on claims to methods of medical treatment it was necessary that if the claim contained a method step (even if the claim was ostensibly directed to an apparatus - in casu a cardiac pacer characterized by certain method steps) it was essential that none of the method steps should be a method for treatment of a human or animal body by way of therapy surgery or diagnosis.
  目前的这个案子中,装置翻译的特定信号控制pacer的输出,pacer应用于人体来获得一个治疗效果。这与the Flow measurement case案件形成了对比,后者中,在测量的值与应用的therapeutic treatment之间没有功能关系。
  然而,在Blood flow/See-shell 中,一个权利要求包含了动物体中流向特定组织的血流的测量。这个权利要求被允许了,因为权利要求包括了后续的sacrificing of the animal。因此,尽管实施了一个外科手术对动物,但是很明显,治疗不是整体目标。
  在Trigonelline/MAI 中,第二医疗用途权利要求被认为适当for the use of an encapsulated extract from fenugreek seed for treatment of hair loss,尽管在先技术表明topical compositions had been used for the same purpose.
  这是一种胶囊产品第一次用于这个目的。因此,是一个发明。
  类似地,在HCG/Serono 中,下列权利要求被认为可以专利:“用HCG生产a non-depot medicament for use in the treatment by subcutaneous administration of infertility or male sexual disorders.”
  This holding was despite the fact that HCG (human chorionic gonadotrophin) had been used previously for some of the stated conditions. However, the prior route for administration had been by intramuscular injection. Subcutaneous injection provided a number of advantages, including the fact that no visit to a physician was required to make the injection but the prior art showed prejudice against subcutaneous injections for products of this type since resorption of the drug is slower since subcutaneous tissue is poorly vascularized and comprised of a lipid layer. 
  Similarly, a second medical use type claim has been held to be the only permissible type of claim for an invention relating to including lanthanum in oral-care preparations for the purpose of removing plaque or staining, the body of the specification making reference to the medical as well as cosmetic advantages of such plaque removal. In this case the prior art had shown the use of lanthanum in toothpaste and similar compositions to inhibit erosion of tooth enamel. Thus, the present invention represented a new medical effect. Since this was of a prophylactic nature, it was inherent in any cosmetic effect achieved, thus precluding the allowability of a claim limited to the cosmetic effects as had been allowed in Appetite Suppressant/DuPont noted in footnote 3 above.
  It has also been held that a therapeutic treatment of animals did not lose its therapeutic character simply because it had the side effect of increasing meat production from the treated animals. Nor should a treatment be considered as being other than therapeutic simply because it was ancillary to a treatment for a different purpose (contraception). 
  A different approach to the question of contraception was followed in Contraceptive method/British Technology Group. In this case the claim was a use claim to the use of a specified compound as a contraceptive by application to the cervix of a female. After agreeing that contraception is not a method of therapy for which patent protection is barred, the Board nevertheless maintained the rejection of the claim on the ground that the acts specified in the claim were of a private nature and so the invention as claimed was incapable of industrial application. The fact that acts of contributory infringement would clearly be of industrial applicability was felt to be irrelevant; some act of direct infringement had to be industrially applicable for patentability.
  
  
  Abstract
  
  1. Chemical compound composed of thenoyl peroxide with the formula see diagramm : EP0004810,P4,F3 for its use in a method of therapeutic treatment for the human or animal body.
  Claims
  Revendications
  1) Application a titre de médicament, notamment de médica
  ment destine au traitement de l''acné, du peroxyde de
  thénoyle de formule
  2) Compositions pharmaceutiques caractérisées en ce qu''elles
  renferment, a titre de principe actif, le peroxyde de
  thénoyle.
  3) Compositions selon la revendication 2, caractérisées en ce qu''elles renferment de 2 à 20 % de principe actif.
  4) Application à titre de produit cosmetique du peroxyde de thénoyle.
  5) Compositions cosmétiques, caractérisées en ce qu''elles renferment le peroxyde de thénoyle.
  6) Compositions selon la revendication 5, caractérisées en ce qu''elles renferment de 0,2 à 20 do de peroxyde de thénoyle.
  此案中, 当产品被表明有多个特征时,保护权利可以给予多个用途。一个产品在人类或者动物身体上的医疗方法中的第一个用途,和它的美容用途可以因此在一个和相同的专利申请中被主张。产品的美容作用如果同时具备医疗作用并不落入EPC第53条(C)的范围,因此可以专利。
  该案件是:欧洲专利申请号 79 400 198.2,在1979年3月28日提起,1979年10月17日公开。优先权日期为法国1978年3月31日。审查部1982年10月15日拒绝。理由是1981年5月6日提交的几个权利要求:1,7,9,10。
  权利要求1是:Medication characterised in that it is composed of thenoyl peroxide with the formula
  SCO-O-O-CO S
  权利要求7是:Pharmaceutical compositions characterised in that they contain thenoyl peroxide as active principle.
  权利要求9是:Use of thenoyl peroxide as a cosmetic product.
  权利要求10是:Cosmetic compositions, characterised in that they contain thenoyl peroxide.
  拒绝理由是:权利要求1、7违反EPC第54(5)。审查部认为:为了满足该条要求,权利要求必须限定于描述的therapeutic indication。申请人反对,认为:EPC54(5)没有明确限定药物(medication)范围。
  IV. In its interlocutory communications the Board of Appeal proposed certain changes in the wording of the medical claims, principally to bring them into line with Article 54(5). The new wording was accepted by the appellants. The Board also raised the question of Claim 8''s admissibility as it was finally worded, it being identical to Claim 9 of the set of claims refused. Claim 9 had not been contested by the first instance, but appeared to the Board to relate to a method of treatment by therapy (Article 52(4) EPC) since it was intended to treat acne, which is a disease.


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