[Pharm-policy] Patent news for Japan

[James Love]

http://www.okuyama.com/news.html#apr299

Supreme Court Decides for Generic Drug Makers 
 
       On April 16, 1999, the Supreme Court handed down an awaited
decision concerning the question of experimental use exemption in favor
of generic drug manufacturers. The Court found that tests carried out
during the patent term in an attempt to obtain governmental approvals
for manufacture and sales after the expiration of patents do not
constitute patent infringement under Section 69(1) of the Patent Law.
English translation of the decision in HTML format (8 kb). 

        
        New Guidelines for Licensing Patents Owned by the Government 

        On June 29, 1998, the Japanese Patent Office disclosed new
guidelines for determining royalty rates for licensing patents owned by
the Japanese Government. The new guidelines do not set specific figures
for standard royalty rates and allow flexibility to set higher or lower
rates depending on the value of a patent. Under the old guidelines, such
rates were set to be 2 to 4% of sales with the possibility of minor
variations. This revision of guidelines is for the first time in fifty
years. These guidelines are used as a de-facto standard by some in
Japan. It is aimed that patentees in general as well as the Japanese
government will be able to collect  more money in return for a license
and that patent protection should become stronger with possible higher
damage awards calculated according to the new liberalized guidelines. 



Amendment to Patent and Design Laws Passes the Diet on April 24 

        The bill for the amendment to the Patent and Design Laws passed
the Diet on April 24, 1998 and became law. Under the amended Patent Law,
the court is freed from the constraint of an "average" royalty. The term
"reasonable" which is found in the provisions setting the minimum level
of damage awards for patent infringement (Section 102 of the Patent Law)
and which reads more like "normal" or "averaged" in Japanese has been
one of reasons for conservative damage awards found by Japanese courts.
Also, patent annuities for the 13th year and beyond have been reduced
starting June 1, 1998. Criminal sanctions are to become harsher under
the amendment. The design protection will also be overhauled. 





-- 
James Love, Consumer Project on Technology
v. 1.202.387.8030, fax 1.202.234.5176
love@cptech.org, http://www.cptech.org