Sunday, April 3, 2016

Generic Drug Manufactures on the Backfoot

Japans courts recently give decisions in favor of original drug manufactures one after another, while the government is seeking to promote generic drugs in order to reduce total medical expenses.

In June last year,the Supreme Court gave a ruling regarding product-by-process claims that a product having the same structure or feature infringes the patent, even if its production process is different (TEVA v. Kyowa Hakko Kirin). In November, the Supreme Court made a decision that Patent Term Extension should be approved for a drug patent when the drug is granted marketing authorization for different dosage and administration even if the drug has the same ingredients (Genentech Inc. v. JPO), as reported in this blog.

Then, in March 25 this year, IP High Court upheld the decision of Tokyo district court in favor of Chugai Pharmaceutical that generic drug manufactures infringe the Chugais patent for manufacturing process of maxacalcitol which is the active ingredient of antipsoriatic agent, under the doctrine of equivalents. In this case, Chugais corresponding substance patent was already expired but the process patent was alive when generic drug manufactures sold their drugs. 

In view of the above, it seems there is a trend of original drug manufacture’s patent being protected for a longer time and interpreted more broadly.

[Updated]
Regarding the Chugai's case, the drug manufactures made a final appeal to the Supreme Court on April 7.

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