Government debate since late last year on whether to introduce a patent system for new types of medical practice, including regenerative medicine, has been deadlocked due to ethical questions and possible sharp increases in medical expenses.
“Patents are a weapon for small companies to do research and development. With a license, even a venture enterprise can talk to a major enterprise on an equal footing,” said Ryuichi Morishita, a visiting professor at Osaka University, speaking in May at a specialized committee meeting of the government’s Intellectual Property Strategy Headquarters.
Based on results of university research, committee member Morishita created AnGes MG Inc., a venture to produce genetically engineered medical supplies.
However, in June it was revealed that an Osaka University professor and other researchers who were conducting clinical trials on AnGes MG medicines had obtained unlisted shares in the firm.
The Health, Labor and Welfare Ministry is now probing the validity of the clinical data.
In Japan, patents are granted to drugs and medical equipment, the development of which usually require huge financial investments. Patents for types of medical practice are not given.
But in the United States, patents are available for surgical methods and medical procedures, including ways to administer medicine.
Proponents of the patents say they support venture enterprises, which are bringing significant changes to the medical industry.
Morishita said he is worried that Japanese enterprises could fall behind globally to rivals whose intellectual property is protected.
The corporate world takes a similar stance.
Hiroshi Akimoto, an executive director of Takeda Chemical Industries Ltd., said, “Even if an advanced medical care method has been developed, enterprises that started later can make an easy advance to the field. Nobody wants to do research that involves spending huge amounts of time and money.”
Protection advocates are calling for patent protection for things like fiberscopes, regenerative medicine and techniques in advance fields, including gene diagnosis and treatment.
“By doing this, development of new medical practices will be accelerated for the benefit of patients,” one advocate said.
But the Patent Agency said the United States is the only country that permits this kind of patent, and patent agencies in Europe reject industrial use of patents for medical practice.
In Japan, there is also concern on the part of patients and doctors that monopolized licenses will lead to restrictions on who can receive medical care. There are also worries that medical expenses might skyrocket.
Soichiro Kitamura, head of the National Cardiovascular Center, referred to possible conflicts of interest between patients and surgeons, citing operations in the United States to replace heart valves. “There are problems concerning doctors who use heart valves produced by companies they are directors of,” he said.
Norie Kawahara, a visiting researcher at Japan Medical Association Research Institute, said: “Medical research depends on cooperation from patients. Is it good for researchers, who are required to have high ethics, to monopolize profits?”
The Intellectual Property Strategy Headquarters was to reach a conclusion in June, but the debate will likely drag on.
In a time of both misinformation and too much information, quality journalism is more crucial than ever.
By subscribing, you can help us get the story right.