Both Tokyo and Osaka District Court denied indirect infringement of a patent provided under Japanese Patent Act by pharmaceutical companies who manufactured and sold compound A where a patent at issue claimed the combination of compounds A and B.
Patents at issue here are JP 3148973 and 3973280 (“Subject Patents”). Representative claim is Claim 1 of JP 3148973 which reads as follows;
Defendants in this case started selling pioglitazone hydrochloride salt pills (“Subject Products”) after obtaining approval for manufacture and sale thereof from the Ministry of Health, Labor and Welfare under the Japanese Pharmaceutical Affairs Act.
Doctors administered or prescribed said pioglitazone hydrochloride salt pills manufactured and sold by defendants to patients in combination with Subject Companion Drugs, such as α-Glucosidase inhibitor, biguanide and sulfonylurea agent, considering the physical conditions of the patients.
Plaintiff, Takeda Pharmaceutical Company, filed a lawsuit against other drug companies alleging that the defendants’ acts of producing and selling pioglitazone pills constitute direct or indirect infringement of the Subject Patents.
The most important issue here is whether acts of manufacture and sale of the Subject Products by the defendants constitute indirect infringement of the Subject Patent provided under Article 101(ii) of Patent Act, which provides:
Osaka District Court
On September 27, 2012, the Osaka District Court held that the nature of the invention at issue here is an invention of a product, not an invention of a method, and the claim “medicine…comprising of …” shall be interpreted as a newly produced medicine manufactured by associating two or more active ingredients into one. On the other hand, the court held that co-administration of drugs does not by itself produce a new block of an article and thus does not fall under the scope of the claim at issue here.
The Court further held that “producing….product” under Article 101(ii) requires that an alleged infringer manufactures “a product fulfilling all elements of an invention” using “things which do not by themselves fulfill all the elements of the invention” as materials. That is, according to the Court, the wording “producing…product” provided in Article 101(ii) requires that a material at issue should be manipulated and it does not include the act of merely using a material in accordance with its intended purpose of use.
Therefore, Subject Products, which are by themselves finished products and thus are not to be manipulated and are to be administered as they are, cannot be used for “producing…product” under Article 101(ii).
Tokyo District Court
On February 28, 2013, the Tokyo District Court took a different approach but reached the same conclusion as the Osaka District Court.
The Tokyo District Court held that while “any product… indispensable for the resolution of the problem by the said invention” can include tools used for manufacture of products or materials, an element of an invention which has been needed independent of problems to be resolved by the invention does not fall under this definition. The Court further held that things which can settle such problems for the first time by their use, that is, what directly brings about composition or components which characterize technical means not shown in prior arts and newly described in the invention at issue, shall fall into the scope of this article.
Such being the case, even a member or component, etc., disclosed in a claim does not fall into ” product… indispensable for the resolution of the problem by the said invention ” so long as it does not directly bring about characteristic technical means described by the invention for the first time.
The Court found that what is newly described in the invention at issue is the specific combination of pioglitazone and Subject Companion Drug. Therefore, the defendants’ Subject Products do not fall under “product … indispensable for the resolution of the problem by the said invention”.
The Tokyo District Court and Osaka District Court used different analyses and reasons in denying indirect infringement of the Subject Patent. It remains to be seen whether this difference in analysis will have any impact on subsequent infringement cases.