BIOTECHNOLOGY Japanese biotechnology companies have seen
their values triple since the start of 2013. T is growth in the biotechnology fi eld represents a high-value market for foreign companies.
Patenting biological inventions
Under the umbrella of biotechnology, biological inventions, like iPS cell technology, are examined according to general examination guidelines for patents. In response to requests for additional clarity,
the Japan Patent Offi ce (JPO) set
forth specifi c guidelines for biological-related inventions. T rough the years, the JPO has continued to amend these guidelines to bring greater clarity to new technologies. T e result of these amendments has been a broadening of the scope of patentability within the biotechnology industry.
Understanding how the JPO interprets specifi c patent
requirements is the key to capitalising on this expansion of biological invention patentability and securing a market within this booming economy. T is article will highlight key issues to note when patenting biological inventions in Japan.
Requirement for industrial applicability
T e Japanese Patent Act requires that all patentable inventions be “industrially applicable”. Essentially, inventions must have market or commercial potential to be patentable. T e JPO explicitly lists “medical activities” among inventions that fall outside the scope of industrially applicable inventions, meaning that methods of surgery, therapy and the diagnosis of human diseases cannot be patented.
Some people have incorrectly assumed that this designation means all medical technology cannot be patented in Japan. T is is a misunderstanding, as most inventions in the fi eld of medical technology can be characterised as devices, substances and other products that patentable subject matter.
constitute
T e JPO continues to revise patent examination guidelines regarding industrial applicability, further clarifying the scope of patentability as it includes or excludes specifi c emerging technologies.
Methods for manufacturing medical
materials from raw material collected from a human body were added to the realm of patentable subject matter in 2003. In 2009, the JPO added illustrative examples of patentable “methods for manufacturing medical material” to include methods of inducing diff erentiation and induction of human iPS cells.
Methods for controlling the operation of a medical
device were also added to the scope of patentable subject matter in 2003 and further expanded in 2005. With regard to these types of method patents, it is important to note that the claim language must be draſt ed in a way to claim the function of the medical device as a method of controlling the device, not as a method for the function of the device. T e claim language should also avoid any step with an action taken by medical personnel or the infl uence on a human body by the device.
Methods for gathering various kinds of information from the human body were included in the examination guideline as patentable subject matter in 2009. Care must be given while draſt ing these claims to avoid including any step that involves the judging of the physical or mental condition of the subject human body or the prescription, treatment or surgery plan of the subject human body.
www.worldipreview.com World Intellectual Property Review Annual 2013 67
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