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技术申诉委员会的一些判决：关于医疗方法专利性。
T469/94
A European patent application was filed relating to a method of reducing the perception of fatigue for a person who has participated in, or is about to participate in, major sport. The method involved administering choline. Choline was known for the treatment of muscular diseases. The Board considered that muscular fatigue was not a disease, but was a natural state for a healthy person. As such, fatigue was not comparable with the pathological state typical of a disease or injury. Thus, the Board considered that such treatment of fatigue was not a therapeutic method and hence not excluded from patentability. Also, the Board considered whether the therapeutic and non-therapeutic effects were distinguishable from each other. The Board decided that the effects were distinguishable since the methods would be applied to different groups of patients. Therefore, the methods were distinguishable from each other.
Comment:This decision confirms that treatment of healthy humans or animals, for reasons other than prophylactic, are patentable. Also the fact that the treatment can have therapeutic effects is not a bar to patentability where the treatment is not applied to a sick patient.
T655/92：第二医疗用途权利要求。诊断方法。本案关系到This case relates to a contrast medium for use in a method of in vivo nuclear magnetic resonance (NMR) imaging of a patient. The contrast medium was known as such. Also a first medical use of the contrast medium was known. The applicant therefore filed a claim in the “second medical use” format. The EPO allows so-called “first medical use” claims and “second medical use” claims. A first medical use claim (cf. Art. 54(5)) is a claim to ’substance X for use in medical method Z’. Article 54(5) expressly limits “first medical use” claims to substances or compositions for use in a medical method which is excluded from patentability by virtue of Article 52(4). A second medical use claim is used where there is already a known medical use. The claim is set out as ’the use of substance X in the manufacture of substance Y for use in medical method Z’. The Board considered that the same considerations should apply to such “second medical use” claims. The Board then went on to investigate whether the use of a contrast medium in NMR imaging is indeed subject-matter excluded from patentability as a diagnostic method. The Board came to the conclusion that such a method was a diagnostic method excluded from patentability. The Board therefore allowed the inclusion of “second medical use” claims.
评论：First and second medical use claims derive their novelty from the specified intended use. It is however important to first establish that a direct claim to their use would be excluded from patentability as a medical or diagnostic method. If this is the case then claims in the first or second medical use format can be included in an application.
黑白区域少，灰色区域多。
加拿大公司使用创造性的专利战略，允许投资者保护似乎不可专利的发明。它们还可以获得美国专利来利用美国更自由得美国专利法。美国专利法保护更多更宽的保护。一些领域里，发明人京城不知道专利保护的边界。
在加拿大，医疗方法阿不能得到专利。然而，这种发明可以北保护，通过制作通用专利权利要求为了使用一个药物或者装置，而且忽略执行医疗程序或者管理药物的步骤。
这种抓你并不试图包含技术人员的技巧。该技巧是医疗方法的构成部分。一个新药物或者医疗器械的专利也保护它，因为任何医疗使用该药物或者器械将侵犯专利权。在美国，医疗方法专利可以。无论方法是否包含外科，医疗器械，或者管理药物。
A. The Patents
The three patents at issue, all of which are assigned to Institut Pasteur, are directed to structural components of and methods of detecting the presence of two types of Human Immunodeficiency Virus ("HIV"), HIV-1 and the less common HIV-2. Infection with either type of HIV leads to Acquired Immune Deficiency Syndrome ("AIDS"), and thus assays that can detect HIV-1 and HIV-2 are crucial to diagnosing, treating, and arresting the spread of AIDS. The ''861 patent generally pertains to certain HIV-1 peptides (amino acid sequences which comprise part of the structure of the virus) and methods for detecting the presence of HIV-1. The ''391 patent is directed to diagnostic assays for detecting the presence of HIV-2, and the ''496 patent claims a number of structural peptides of HIV-2. The issues central to this appeal focus on the interpretation of licensing agreements that govern these patents, not on the claims or any other aspect of the patents themselves.
5,217,861
Assignee: Institut Pasteur (FR)
1. An in vitro diagnostic method for the detection of the presence or absence of antibodies which bind to antigens of human retrovirus indicative of Acquired Immune Deficiency Syndrome (AIDS) or of Lymphadenopathy Associated Syndrome (LAS), which method comprises
contacting isolated p18 protein of said retrovirus with a biological fluid for a time and under conditions sufficient for the protein and antibodies in the biological fluid to form a complex; and
detecting the formation of the complex.
2. The method as claimed in claim 1, wherein the detecting step further comprises measuring the formation of said complex.
3. The method as claimed in claim 1, wherein the biological fluid is human serum.
4. Structural protein of Human Immunodeficiency Virus (HIV), which is p18 protein of said virus, and said protein is in isolated form.
5. A labeled polypeptide, wherein
the polypeptide is capable of being immunologically recognized by serum of a patient afflicted with Lymphadenopathy Syndrome (LAS) or Acquired Immune Deficiency Syndrome (AIDS);
the polypeptide is p18 protein of Human Immunodeficiency Virus (HIV) in isolated form; and
said label is an immunoassay label selected from the group consisting of a radioactive label, an enzyme label, and a fluorescent label.
6. An in vitro diagnostic method for the detection of the presence or absence of antibodies which bind to antigens of human retrovirus indicative of Acquired Immune Deficiency Syndrome (AIDS) or of Lymphadenopathy Associated Syndrome (pre-AIDS), which method comprises
contacting an isolated antigen mixture comprising
(A) p18 protein of said retrovirus, and
(B) p25 protein of said retrovirus, with a biological fluid, for a time and under conditions sufficient for the antigen and antibody in the biological fluid to form an antigen-antibody complex; and
detecting the formation of the complex.
7. An isolated mixture of structural proteins of Human Immunodeficiency Virus (HIV), wherein the proteins are p18 and p25 proteins.
8. An in vitro diagnostic method for the detection of the presence or absence of antibodies which bind to antigens of human retrovirus indicative of Acquired Immune Deficiency Syndrome (AIDS) or of Lymphadenopathy Associated Syndrome (LAS), which method comprises
contacting p12 protein of said retrovirus with a biological fluid for a time and under conditions sufficient for the protein and antibodies in the biological fluid to form a complex; and
detecting the formation of the complex.
9. Structural protein of Human Immunodeficiency Virus (HIV), which is p12 protein of said virus, and said protein is in isolated form.
10. A labeled polypeptide, wherein
the polypeptide is capable of being immunologically recognized by antibodies in the serum of a patient afflicted with Lymphadenopathy Syndrome (LAS) or Acquired Immune Deficiency Syndrome (AIDS);
the polypeptide is p12 protein of Human Immunodeficiency Virus (HIV) in isolated form; and
said label is an immunoassay label selected from the group consisting of a radioactive label, an enzyme label, and a fluorescent label.
11. A mixture of structural proteins of Human Immunodeficiency Virus (HIV), wherein the proteins are selected from the group consisting of p12, p18, and p25 proteins, and the mixture is in isolated form.
5,055,391
Assignee: Institut Pasteur (Paris, FR)
What is claimed is:
1. An in vitro diagnostic method for the detection of the presence or absence of human antibodies which bind to antigens of a human retrovirus, which is Human Immunodeficiency Virus Type 2 (HIV-2), indicative of Lymphadenopathy, wherein said antigens comprise protein antigen, glycoprotein antigen, peptide antigen, or a mixture thereof of HIV-2, and wherein said method comprises
contacting antigens of HIV-2 with a biological fluid for a time and under conditions sufficient for the antigens and antibodies in the biological fluid to form antigen-antibody complexes, and
detecting the formation of the complexes.
2. The method of claim 1, wherein the biological fluid is human serum.
3. The method of claim 1, wherein the biological fluid is from a patient with pre-AIDS.
4. The method of claim 1, wherein the human retrovirus is a human retroviral variant of LAV-2 which is cytopathic for human lymphocytes.
5. The method of claim 1, wherein the biological fluid is simultaneously contacted with a mixture of antigens comprising protein, glycoprotein, and peptides of Lymphadenopathy Associated Virus Type 1 (LAV-1) capable of binding to human antibodies, in an amount sufficient to detect the presence or absence of human antibodies which bind to antigens of LAV-1.
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