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PATENT PROTECTION IN FIELD OF ADVANCED MEDICAL TECHNOLOGIES

June 4, 2009
HARAKENZO WORLD PATENT & TRADEMARK
Patent Attorney: Toshiro Kuroda

1. Introduction
The Secretariat of the Intellectual Property Strategy Headquarters of the Cabinet Secretariat announced “Patent Protection in Field of Advanced Medical Technologies (Draft)” (hereinafter, referred to as draft) on April 28, 2009, and invited public comments on the draft (closed on May 17, 2009).
The draft was compiled as a result of study and discussion conducted on the patent protection in the field of advanced medical technologies, through seven gatherings of the Advanced Medical Patent Exploratory Committee set up in November 2008 under the Expert Study Group on Enhancement of Competitiveness through Intellectual Property, the Intellectual Property Strategy Headquarters. In reference to the public comments on the draft, the draft will be ultimately complied into an official report “Patent Protection in Field of Advanced Medical Technologies.” Then, related office, ministries, and agencies will take necessary measures including the revision of the examination standards, on the basis of the proposal of the official report.
According to the draft, subjects of patent protection will be expanded in the field of advanced medical technologies. The following introduces the outline of the draft. It is hoped that the outline will serve as a reference of trends of the patent protection in the field of advanced medical technologies.

2. Outline of “Patent Protection in Advanced Medical Technologies (Draft)”
The following focuses the following two topics of the draft which are useful information for the patent practice: “clarification of the examination standards as to subjects of patent” and “review on subjects of patent.”

2-1. Clarification of Examination Standards as to Subjects of Patent
The draft proposes that subjects of patent should be clarified in the examination standards, as to the following inventions: (1) inventions characterized by the novel combinations of existing things, (2) inventions characterized by methods for treating cells etc. outside an organism, (3) inventions characterized by uses of organism-derived materials such as cells, (4) inventions with difficulty in identifying a cell, and (5) inventions related to techniques for assist devices. The following illustrates the inventions (1) through (5).

(1) Inventions Characterized by Novel Combinations of Existing Things
The draft proposes that the examination standards should clearly show, giving patentable examples, that the following inventions of combinations can also be subjects of patent as inventions of “products”: (i) the combinations of physical means (a magnetism generating device, an infrared irradiating device, an ultrasonic device, etc.) and biochemical means (an agent and a cell) and systems made up of the combinations, (ii) the combinations of organism-derived materials such as cells and scaffold materials, and (iii) the combinations of organism-derived materials such as cells and agents such as growth factors.

(2) Inventions Characterized by Methods for Treating Cells Etc. outside Organism
Inventions such as the following methods (i) through (iii) are said to be key techniques in regenerative medicine, and are subjects of patent also in the current practice because they apply to methods for producing medicines or medical materials: (i) methods for the inducing the differentiation of a human iPS cell into tissue cells such as neurocytes, (ii) methods for separating and purifying harvested stem cells or differentiated tissue cells, and (iii) methods for confirming the safety of treated cells etc. and examining them. Unfortunately, whether those inventions can be subjects of patent or not is unclear to researchers. Therefore, the draft proposes that the criteria for determining inventions which can be subjects of patent should be further clarified in the examination standards while the collection of both cases which can be subjects of patent and cases which cannot should be expanded.

(3) Inventions Characterized by Use of Organism-Derived Materials Such as Cells
The creation of human iPS cells has activated research and development in the field of regenerative medicine. It is accordingly expected that various cells will be artificially created, and this will lead to many related use inventions. Unfortunately, researchers do not understand sufficiently that such use inventions related to organism-derived materials such as cells can be subjects of patent. Therefore, the draft proposes that the examinations standards should clearly show, while showing plenty of patentable examples, that new uses of organism-derived materials such as cells and cell-derived products can also be subjects of patent as long as the new uses are expressed as use inventions.

(4) Inventions with Difficulty in Identifying Cell
In a case where an invention is characterized in that a cell composition is used in the treatment of a new indication, the invention can be a subject of patent as long as the invention is expressed as a use invention of a “product” such as a therapeutic agent. In contrast, the invention cannot be a subject of patent as a use invention of a “product” such as a therapeutic agent in a case where it is difficult to identify a cell in cell compositions which is effective in actual medical treatment and to distinguish the cell from known cells. However, the draft proposes that the examination standards should clearly show that an invention in which material, a processing method (producing method), and a use are established can be a subject of patent, as an “invention of a method for producing a product whose use is limited” (e.g., a method for producing a therapeutic agent for a disease Z which agent contains, as an active ingredient, a resultant cell composition obtained in such a manner that a cell composition X harvested from a human body is processed by a processing method A; so-called “Swiss-type” claim) in a case where the use is novel even if the material and the processing method (producing method) are publicly known.

(5) Inventions Related to Techniques for Assist Devices
As for so-called assist-device-related techniques such as those for assisting and aiding human bodily movement, which are, for example, robots for assisting caretakers and walking aid devices, a process claim (claim expressed by process) that enables comprehensive protection includes a step of affecting a human body or a step of determining a human body status, by its nature. Therefore, such a process claim can be rejected for the reason that it applies to an invention of a method of medical treatment because it notionally encompasses a method of medical treatment. This can lead to hesitation in applying for a patent of a developed technique.
For the sake of avoiding such a problem and smoothing the acquisition of patents related to the assist-device-related techniques, the draft proposes that the examination standards should clearly show, while showing plenty of patentable examples and claim examples, that the following inventions can be subjects of patent since it is obvious that the following inventions do not apply to “methods for medical operation, treatment, or diagnosis of a human body”: (i) inventions of determination methods except diagnosis, (ii) inventions of methods for devices except medical devices to operate which methods include steps of affecting a human body, and (iii) inventions of methods for reducing workload of workers.

2-2. Review on Subjects of Patent
With regard to the following two types of inventions, the draft proposes that they should be added into subjects of patent in the field of advanced medical technologies.

(1) Inventions Characterized by Uses or Dosages of Cell or Medical Agent
As for inventions characterized by uses or dosages of a cell or a medical agent, in Japan, they are currently deemed to have novelty as use inventions, and, therefore, can be subjects of patent, only if they are expressed as inventions of “products” such as “medicines with specific uses and specific dosages” and they can be deemed to be different from others in medical uses, e.g., different in patient groups clearly or in application sites. Except for this, “inventions characterized by uses or dosages of a medical agent or a cell such as time periods, procedures, applied doses, transplantation sites, etc.” cannot be subjects of patent for the reason that they lack novelty no matter how inventive steps can be seen in their uses and dosages.
However, it is expected that research and development of new uses and dosages will be active also outside Japan with increasing difficulty in developing new substances. Under the situation, lack of patent protection for medicines characterized only by their new uses and/or dosages which medicines show effects beyond the expectations of experts may be a disincentive that hinders the introduction of the medicines into the Japanese market.
In view of this, the draft proposes that the examination standards should be revised so that inventions of medicines with new uses and/or dosages which medicines show effects beyond experts’ expectations can be protected as inventions of “products,” for the sake of promoting research and development of medicines which are drastically reduced in side effects by the renovation of their uses and/or dosage, and medicines which greatly improve the quality of life (QOL) of patients, and increasing the availability of such medicines.

(2) Inventions of Methods for Collecting Data of Human Body for Assisting Final Diagnosis
In Japan, currently, it is difficult to specify inventions of measurement methods such as novel mechanisms and principles of tomographic imaging with X-ray CT scanners, MRI devices, or the like, as methods for devices to operate which methods do not affect a human body. This is because the inventions are to affect a human body with electromagnetic waves or the like and, then, measure the answer signals. If such inventions are specified as those of methods except methods for devices to operate, they are excluded from subjects of patent for the reason that the inventions are methods for diagnosis of a human body. Therefore, even if an innovative invention is made in future in the technical field of measurement devices, the invention cannot receive comprehensive patent protection, as an invention of a measurement method which plainly specifies the measurement mechanism. As a countermeasure to this, inventions of “products” such as measurement devices which inventions specify device features such as physical structures etc. are currently specified in a multiplexed manner, assuming various modifications. There is concern here that they can be taken as circumvention inventions and, therefore, protection is insufficient.
In view of this, the draft proposes that the examination standards should be revised so that “inventions of methods for collecting data of a human body for assisting final diagnosis (i.e., methods for measuring a human body in which methods medical operation, treatment, and diagnosis are not included)” (e.g., mechanisms and principles of tomographic imaging by MRI, X-ray CT, or the like) can be newly added into subjects of patent, in order that comprehensive protection for inventions of future measurement devices with innovative mechanisms and/or principles can be enabled for proper protection of new technologies, in harmony with the patent systems of advanced foreign countries.

3. Final Remarks
Advanced medical technologies are critical technologies in that they directly improve health and life of people through the realization of health and longevity of the people and the fight against various diseases. It is considered that technical innovation in the field of advanced medical technologies is advancing at an unexpectedly rapid speed while the development of laws for patent protection etc. falls behind it. It is known that some insist that protection should be deliberately given from viewpoints such as the aspect of medical care in which safety is particularly regarded as important, “free access to medical care,” and suppression of medical cost inflation. On the other hand, it is hoped that the patent system is reformed so that superior advanced medical technologies can be properly protected also from a viewpoint of the acceleration of development of advanced medical technologies. If patent protection falls behind in Japan in a situation where the other countries are expanding subjects of patent protection, the Japanese citizens may not be able to receive the benefits of superior advanced medical technologies. In order to avoid such disadvantage, it is strongly hoped that proper measures are immediately taken on the basis of the proposal of the draft.

References
[1] Medical Patent Also to Diagnosis and Treatment, Nikkei, March 17, 2009.
[2] Invitation of public comments on Patent Protection in Field of Advanced Medical Technologies (Draft), Secretariat of Intellectual Property Strategy Headquarters, April 28, 2009.



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