November 16, 2006
Comment of Japan Fair Trade commission (JFTC) for current situation of drug distribution

  Mr. Kazuyuki Katagiri head of investigation division of trade department in General Executive Bureau of JFTC commented that direct price negotiation by drug makers was not against law.  Mr. Toshihiko Takeda economic officer of Health Policy Bureau of Ministry of Health, Labour and Welfare (MHLW) pointed out that they need to prevent a similar problem from occurring again which happened introducing settlement price system.



November 9, 2006
Disclosure of pharmaceutical enterprise number in 2005

Pharmaceutical and Food Safety Bureau of Ministry of Health, Labour and Welfare (MHLW) disclosed the results of survey about number of pharmaceutical enterprise at the end of year 2005.  The number survey was conducted to pharma industry, medical device industry, quasi drug industry, cosmetic industry and toxic or deleterious substance industry.  Total enterprise number in pharma industry was 128,820, consisted of 11,507 of production and distribution companies, 13,117 of production companies, 51,233 of pharmacies, 21,888 of general distribution companies and the others.  Because of enforcement of revised Pharmaceutical Law on April 2005, former production companies are divided to production and distribution companies and production companies.  After the enforcement, pharmaceutical products manufactured by production companies are delivered to production and distribution companies and then distributed by distribution companies.



November 7, 2006
Astellas filed declaratory lawsuits for duration of license of Lipitor^®

Astellas Pharma Inc. announced that they filed lawsuit asking for declaratory judgment that the license agreement of Lipitor^® with Pfizer Inc. will continue in full force until 8 July 2016. According to their announcement, in the license contract, Astellas (then Yamanouchi) and Pfizer (then Warner Lambert) stipulated the duration of the license agreement to remain in force until the day of the patent expiration or the day ten years after release. The former date is in question. Pfizer has multiple patents covering Lipitor^®, such as a substance patent, a formulation patent, a crystal form patent and the like. In these patents, the crystal form patent will expire latest date of 8 July 2016, which Astellas insist the day of ending the agreement. On the other hand, Pfizer argue that the agreement should end on 17 June 2011 when the substance patent will expire.

Lipitor^® (nonproprietary name: atorvastatin calcium hydrate) is one of the leader products of Astellas, which domestic sales amounts was reported 47.5 billion yen (approx. 403 million US $) for the first half of this year (from April to September, 2006).



October 31, 2006
Committee of MHLW approved three unapproved drugs

The Unapproved Drug Committee of Ministry of Health, Labour and Welfare Ministry (MHLW) approve three unapproved drugs Dacogen^®, Sprycel^® and Elaprase^®, which ware brought up to the committee.  Dacogen^® is used to treat myelodysplastic syndromes.  In the U.S., SuperGen, Inc. and MGI PHARMA, INC. have filed NDA for Dacogen^® and FDA has approved the drug on May 2, 2006.  Sprycel^® is an oral inhibitor of multiple tyrosine kinases, for the treatment of adults in all phases of chronic myeloid leukemia (CML) (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy.  In the U.S., Bristol-Myers Squibb has given an approval of the Sprycel^® on June 28, 2006.  Elaprase^® is human enzyme replacement therapy for the treatment of Hunter syndrome, also known as Mucopolysaccharidosis II (MPS II), which is approved July 24, 2006 in the U.S for Shire.

  In Japan, when a medical service includes prescription of unapproved drugs, a patient should pay for all of the medical service at his/her own expense.  This kind of medical care is called "mixed medical care", and has been considered as a problem in medical treatment in Japan.  At the last committee meeting, the above three drugs have been discussed to accelerated approve.  MHLW will ask for related companies to implement clinical trials and to file NDA promptly.



October 25, 2006
Settlement of Patent Infringement Lawsuit

AstraZeneca Japan K.K. and Taiyo-yakuhin Co., Ltd. (the largest generic drug company in Japan) has entered into settlement of patent infringement litigation. AstraZeneca sued Taiyo-yakuhin on January 14, 2004 for an infringement of their drug formulation patent of Omeprazole, which is used for treatment of ulcers, gastroesophageal reflux disease and other conditions involving excessive stomach acid production. In the settlement, Taiyo-yakuhin admitted the validity of AstraZeneca's patent and agreed on the payment of a royalty for sales of generic products of Omeprazole.



October 23, 2006
New Lawsuite of Inventor's compensation

Mr. Yoshihiko Okamoto who is fifty-five years old former employee of Hitachi, Ltd (Japanese electronic company) have filed 200 million yen (about 1.7 million US$) lawsuit at Tokyo District Court against the company and its affiliate company in compensation for assignment of patents about manufacturing technology of semiconductor circuit. According to the court claim, during his service to Hitachi, Mr. Okamoto invented a technology of minute semiconductor circuit, and patents claiming his technology has granted in Japan, US and Korea. Before his retirement of 2002, Mr. Okamoto has already received about 22 million yen (about 0.19million US$) in compensation for assignment of the patents. However, he alleged in the court claim that he has a right for receiving 20% of 8 billion (about 68 million US$) yen of the company's worldwide profit on his invention, that means he should receive 1.6 billion yen (about 14 million US$) in patent compensation.

On October 17, 2006, the Japan's Supreme Court awarded 163 million yen (about 1.4 million US$) in compensation to a former employee of Hitachi who invented technology for CDs and DVDs, and decided that an inventor has a right to receive patent compensation based on "the worldwide profit" brought by the patent.



October 22, 2006
Political measure to Spred Generic Drugs

Japan's Ministry of Health, Labor and Welfare (MHLW) will launch hearing for large dispensing pharmacy companies to investigate what makes behind in spread of generic drugs in Japan. With respect to promotion of generic drugs the Japan Fair Trade Commission (JFTC) has pointed out in "The report about distribution reality of ethical drugs of September 2006" that there could be inappropriate explanations by MR (medical representative) of new drug company to suggest as if some defect is commonly existing in generic drugs. In the report, the JFTC give warning that obstruction of usage of generic drugs by new drug company with explanation based on inappropriate comparative tests would raise antitrust concerns as unfair business practice.