Shigeru ITOH Itoh & Associates

Transcription

1 Conference 2 on November 14, 2008 Shigeru ITOH November 14, 2008 The Indiana Life Sciences Collaboration Conference Series, Conference 2 1

2 1. INRODUCTION "Super-Aged Society" (The number of Japanese of age 65 and older exceeded 21% of the total population of Japan) Government budget for medical and nursing costs as of 2035 estimated 90 trillion yen November 14, 2008 The Indiana Life Sciences Collaboration Conference Series, Conference 2 2

3 2. JAPANESE PRACTICE IN GENERAL A. Patent Application Trends About 30,000 out of a total of 400,000 patent applications in Japan (2007) were filed in the life science field. November 14, 2008 The Indiana Life Sciences Collaboration Conference Series, Conference 2 3

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6 B. Obtaining Patent Rights -- Time-saving Compared to the U.S. Super Expedited Examination (SEE) (Oct. 1, 2008) e.g., Patent granted only 17 days after filing a request for SEE Requirements for requesting SEE: (1) A corresponding application in a foreign country (2) Actual practice of the subject invention in JAPAN American can obtain Japanese Patent prior to its U.S. counterpart. Exam. of U.S. Application can be expedited. November 14, 2008 The Indiana Life Sciences Collaboration Conference Series, Conference 2 6

7 C. Patentability in Medical Field The patentability of different medical areas in Japan, the U.S., and the EPC. November 14, 2008 The Indiana Life Sciences Collaboration Conference Series, Conference 2 7

8 C-1. Invention of Medical Practices/Procedures Medical diagnosis, treatment, and operation method are not patentable in Japan. The Tokyo High Court determined that a method to use an ion toothbrush is unpatentable. Criterion: presence of a human body November 14, 2008 The Indiana Life Sciences Collaboration Conference Series, Conference 2 8

9 European Patent A method of obtaining a sectional image of an examinee based on projection data relating to X-ray absorption in sectional planes of the examinee, which data are collected radially of the sectional planes by causing X-ray emitting means and X-ray detecting means opposed to each other across the examinee to scan the sectional planes of the examinee lying still, said method comprising the steps of: (a) scanning a predetermined number of sectional planes starting with a sectional plane in an initial position by successively shifting a direction of X-ray emission from said X-ray emitting means along a body axis of said examinee; (b) effecting a reset operation, after scanning the predetermined number of sectional planes, to switch the direction of X-ray emission to scan a sectional plane in said initial position, and moving said examinee synchronously with said reset operation to set a new sectional plane adjacent said predetermined number of sectional planes to said initial position; and (c) repeating the steps (a) and (b) above until all sectional planes are scanned. November 14, 2008 The Indiana Life Sciences Collaboration Conference Series, Conference 2 9

10 European Patent A method of conducting a non-invasive female breast cancer test comprising the steps of: (a) forming a magnetic field between the poles of a magnet wherein the magnetic field defines a sensitive volume between the poles and the sensitive volume has the requisite magnetic field intensity for NMR testing; (b) moving incrementally from a beginning point toward an ending point the sensitive volume to scan a female breast; (c) periodically interrogating by a transmitted pulse from a coil and the breast portion located in the sensitive volume for NMR response; (d) wherein the magnetic field intensity in the sensitive volume and the pulse from the coil cause an NMR response from the breast portion; and (e) determining anomalies arising from abnormal growths as indicated by variations in NMR responses from different pulse interroqations. November 14, 2008 The Indiana Life Sciences Collaboration Conference Series, Conference 2 10

11 The followings are patentable: (i) Examination method of human-derived tissue such as blood and hair (ii) Medical treatment of animal November 14, 2008 The Indiana Life Sciences Collaboration Conference Series, Conference 2 11

12 C-2. Medicinal Invention is patentable. 1st discovery and second medical indication of a compound or a substance are patentable as medicinal inventions. Typical types of claim are: (i) A medicine for disease Z containing an effective component A; (ii) A medical composition for disease Y containing an effective component B. November 14, 2008 The Indiana Life Sciences Collaboration Conference Series, Conference 2 12

13 C-3. Pharmacological Data At least one pharmacological data must be incorporated in the specification. Pharmacological data corresponding to all embodiments covered by the claimed invention should be included. November 14, 2008 The Indiana Life Sciences Collaboration Conference Series, Conference 2 13

14 3. PATENT INFRINGEMENT A. Three-Tiered Judicial System The patent owner first files a lawsuit with the district court in either Tokyo or Osaka. Appeals from these courts are brought to the Intellectual Property High Court (Court of Appeal). Appeals against High court decisions are brought to the Supreme Court. November 14, 2008 The Indiana Life Sciences Collaboration Conference Series, Conference 2 14

15 B. Claims Injunction to stop the infringement Preliminary injunction Award of damages against the infringer November 14, 2008 The Indiana Life Sciences Collaboration Conference Series, Conference 2 15

16 C. Court Procedures (Details in handout) No discovery and jury Five or six hearings before closing the proceedings Damages: two or three additional hearings November 14, 2008 The Indiana Life Sciences Collaboration Conference Series, Conference 2 16

17 D. Judicial Cost Approximately, less than ten million yen November 14, 2008 The Indiana Life Sciences Collaboration Conference Series, Conference 2 17

18 Thank You November 14, 2008 The Indiana Life Sciences Collaboration Conference Series, Conference 2 18