BIOPATENTS IN CHINA. Christopher Shaowei Heather Lin. April 4, 2014, Budapest, Hungary 2014/4/4 NTD IP ATTORNEYS
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1 BIOPATENTS IN CHINA Christopher Shaowei Heather Lin April 4, 2014, Budapest, Hungary
2 Unpatentable subject matter Art 5, Patent Law: No patent right shall be granted for any invention-creation that is contrary to the laws or social morality or that is detrimental to public interest.
3 Unpatentable Subject Matters Art 25, Patent Law: For any of the following, no patent right shall be granted: (1) scientific discoveries; (2) rules and methods for mental activities; (3) methods for the diagnostic or for the treatment of diseases; (4) animal and plant varieties; For processes used in producing products referred to in items (4) of the preceding paragraph, patent right might be granted in accordance with the provisions of this Law.
4 Stem Cells Embryonic Stem Cells (ESCs) Human ESCs & preparation thereof: unpatentable (contrary to morality, Art 5) Animal ESCs: unpatentable (animal variety, Art 25) Adult Stem Cells patentable if they are not totipotent, and the source of the cells meets the requirement of practical applicability, e.g. stem cells from umbilical cord blood (UCB)
5 Stem Cells Method of preparing/culturing/expanding stem cells including animal ESCs patentable if the acquisition of the cells does not involve killing embryos, e.g. the ESC cultured is an established cell line, and the source of the cells meets the requirement of practical applicability
6 Diagnostic Method , Chapter 1, Part II, Guidelines for Patent Examination: Where a method involving diagnosis of a disease complies with the following two requirements, it is a diagnostic method and cannot be granted a patent right: (1) it is practiced on a living human or animal body; and (2) its immediate purpose is to obtain the diagnostic result of a disease or health condition. If an invention, as viewed from its description, is practiced on samples in vitro, but its immediate purpose is to obtain the diagnostic result of a disease or health condition for the same subject, it shall not be granted a patent right.
7 Diagnostic Method In vitro method also considered as unpatentble diagnostic method, e.g. A method of predicting the risk of suffering cancer in a subject, comprising the steps of detecting the presence of gene X in a sample from the subject A method of detecting a tumor marker X, comprising the steps of extracting RNA from a sample of a subject Swiss-type use claim or kit claim (if novel and inventive) allowable
8 Dosage Regime SIPO and Patent Reexamination Board deny the novelty of Swiss-style use claims with dosage as the distinguishing feature. SIPO s Examination Guidelines: The distinguishing features merely present in the course of administration do not enable the use (in a medical use claim) to possess novelty
9 Dosage Regime In a recent decision (Nov. 2013), the Supreme Court affirmed SIPO s practice on dosage regime. According to the Court: Features such as dosage amount, dosing intervals or the like, if not directly relating to the manufacture of a pharmaceutical, in essence belong to a method of using said pharmaceutical on a human body. Such features merely present in the course of administration are not features of a medical use claim and have no weight in defining such a claim.
10 Animal and Plant Varieties According to the Guidelines for Patent Examination: An ESC of an animal, an animal at various stages of its formation and development, such as a germ cell, an oosperm, an embryo, etc., belong to the category of the animal variety of Art 25 A single plant and its reproductive material (such as seed, etc.) belong to the category of the plant variety of Art 25 Transgenic animal or plant belongs to the category of the animal variety or plant variety of Art 25
11 Process for the Production of Plants or Animals Essentially biological processes for the production of plants or animals are unpatentable. Whether or not a process is an essentially biological process depends on the degree of human technical involvement in the process. If the human technical involvement is the controlling or decisive factor for achieving the result or effect of that process, the process is not essentially biological.
12 Patentable Subject Matters Isolated polynucleotides & genes Vectors & recombinant constructs Polypetides, proteins, antibodies, vaccines Cells & microorganisms Methods of genetic engineering Compositions, Kits Medical uses (in Swiss-style)
13 THANK YOU
6. We believe that the Guidance does not accord with TRIPs. Any administrative or judicial interpretation of the provisions of any statute,
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