We handled serious compliance cases for major phamarceutical manufacturers. Remediation plans were prepared within 2 months of the engagement.
We were tasked by a leading medical device manufacturer for their issues in QMS and GVP efforts. As we provided full support in problem identification, remediation and governmental contact, the issues were resolved
successfully, without any regulatory penalty.
A foreign start-up medical device company with virtually no experience in Japan has successfully obtained product approval with our support. We provided full support in respect of pre-approval marketing, distributor's compliance failure, partner disputes,
always devising and implementing practical solutions both for the market and the authorities.
We are continuously engaged by major drug/medical device manufacturers for a comprehensive review of their compliance efforts. We provide unique and efficient remedies upon completion of the review.
We successfully handled several major compliance-related matters for drugs and other consumer products, preventing them from escalating into a material dispute.
The International Who's Who Legal continued to recognize Kitamura as a leading life science lawyer, even though we never pay these British evaluation/promotion services.
Kitamura successfully defended a blockbuster drug product against product liability claims in Tokyo. He also led a
defendant Japanese company to a successful resolution of a joint venture dispute in mediation at San Francisco.
Kitamura successfully handled an amicable resolution of an international drug development program and fended off reduction of reimbursement rates of best-selling drug products under the National
Health Insurance, each resulting in benefits of tens of millions of dollars for the clients.
|Kitamura's advice on merger of two major pharmaceutical multinational companies enabled the parties to achieve expeditious product integration
Kitamura's expert testimony in Japanese law led to an over 90 million dollar award to a pharmaceutical client in commercial
arbitration in the United States.
|Food and Drug Law Institute published "Global Pharmacovigilance Laws and Regulations." to which Kitamura contributed
the Japan chapter.|
Kitamura has been recognized as a leading expert in life sciences law in Japan by the International Who's Who.
Kitamura has been appointed an examiner of the Japanese national bar examination for 2008, on the subject of international
Kitamura obtained agreement from the health authorities that a client's food product is importable, without registration as a new food additive.
Kitamura helped the pharmaceutical industry lobbying for longer data protection of new drugs. As a result, the government Council for Intellectual Property Strategy decided to extend the exclusivity period from 6 years to 8.
Representing the ICT coalition (Apple Computer, Dell, Intel and others),
Kitamura successfully lobbied the Japanese government not to impose a
surcharge on iPod, a popular digital player. The government further agreed
that it would set up a working group toward possible elimination of all
copyright levies on ICT products by 2007.
Representing a worldwide Web-based retailer, Kitamura organized a last-minute lobbying drive to successfully refine the House of Representatives resolution accompanying the latest amendment to the Copyright Law. The amendment was designed to block reverse importation of inexpensive CDs.
||Kitamura represented SES Americom for its type 1 telecommunications license. The license was granted within 2
months of the engagement.|
Kitamura served as special counsel for Ministry of Agriculture in a
Kitamura's expert testimony on Japan's drug reimbursement policy helped an
American law firm win against a 80 million dollar damage claim for a lost
patent, where negligence was admitted.
Representing a major creditor, Kitamura
successfully thwarted bankruptcy petition of a foreign-owned
The Ministry of Health and Welfare granted safety confirmation for a
genetically modified food additive to a Palo Alto biotechnology firm
represented by Kitamura.
Kitamura represented a Hollywood channel provider and PCCW successfully for
TV channels on board a new digital broadcast satellite.
Kitamura worked as member of a special defense team which successfully defended
a major foreign corporation against publicized criminal investigation.
successfully defended the Japan Fair Trade Commission in a Fuji/Kodak trade
dispute before the World Trade Organization at Geneva.|
In Japan's first multi-channel DTH satellite services, Kitamura helped an
American platform provider to obtain TV licenses for over 60 channels.
delivered the first type 1 telecommunications license ever to a 100% foreign
carrier to Pacific Century (currently PCCW, Hong Kong).|