Japan is known to be one of the world's most expensive countries, with Osaka and Tokyo regularly topping the rankings as the world's priciest cities. This high-cost perception has clouded the surprisingly refreshing truth that Japan is in fact a relatively affordable and reliably expeditious IP dispute resolution venue as explained in this article.

John A. Tessensohn and Shusaku Yamamoto

Two landmark events — the issuance of the world's first patent for induced pluripotent stem cells and, under a pilot system, the issuance of the fastest patent ever granted—signal a watershed in Japanese academia's transition from gown to town. Japanese universities and research institutes hope that these accelerated patent grants will permit easier and faster commercialization of therapies, regenerative medicine and pharmaceuticals for patients and society. These developments will add to the increasing rush to the patent office as companies, universities and even nation-states seek to prosper amid intense global competition in the fast-emerging stem cell field.

John A. Tessensohn and Shusaku Yamamoto

The advent of follow-on biologics (FOB) in Japan, the world's second largest healthcare market, will spur biotechnology stakeholders to procure patents directed to second medical use, combination therapies and dosage related therapies of known or off patent biologics. By complying with Japan's stringent data requirements and strategically utilizing the various Japanese accelerated patent examination and patent term extension procedures, biotechnology applicants can maximize their effective patent term thereby increasing their partnerability and licensability quotient. Regardless of the final form of any future U.S. FOB regulatory pathway, in the long run, America's world beating biotech industry can only prosper through biopharmaceutical innovation.

John A. Tessensohn and Shusaku Yamamoto

Given that follow on biologics is already part of the market reality in Japan, biotech patent applicants should also avail themselves to the various procedures that can procure accelerated patent grants. Japan has several accelerated examination procedures including the Patent Prosecution Highway (PPH), the Super Accelerated Examination. Japan does have patent term extensions for patents that cannot be worked in view of Japanese regulatory delays. However, Japan's patent term extension provisions are only applicable to granted patents, not pending patent applications. A patent should be granted as soon as possible in order to be eligible for such patent term extensions.

John A. Tessensohn and Shusaku Yamamoto

In response to the troubled economic conditions and to assist users of the Japanese patent system, the JPO has introduced a system for deferring the Official Fee payable at the time of filing a Request for Examination. Specifically, for any Request for Examination filed between April 1, 2009 and March 31, 2011 (inclusive), the applicant can elect to defer the payment of the entire Official Fee for 1 year. In these economically turbulent times, this JPO one year examination fee deferral is a welcome short term reprieve. Some believe that it could take until 2011 before the overall economy improves and worldwide consumers begin purchasing Japanese exports of flat-screen televisions and Wall Street and venture capitalists rediscover their appetite for high risk, high reward biotechnology ventures. Until then, stretching or deferring any cost outlay will definitely impact the bottom line and even mean the continued viability for the patent applicant as an ongoing enterprise.

John A. Tessensohn and Shusaku Yamamoto

The healthcare transformational capacity of biotechnology intellectual property makes it fundamental that such biotech patents are issued promptly in order to have clarity and certainty in the research community and the marketplace. In these economically challenging times, accelerated patent grants will make biotech patent owners more attractive to investors and licensors ensuring their survival. Japanese universities have aggressively patented and licensed their biotech research and utilized the accelerated patent system to procure the world's first ever induced pluripotent stem cells (iPS) patent. This article examines the various accelerated examination procedures available at the Japan Patent Office and how biotechnology patent applicants can secure early patent protection in Japan, the world's second largest biopharmaceutical market.

John A. Tessensohn and Shusaku Yamamoto

While much of the world was transfixed by the spectacular theatrics of the opening ceremony of the 2008 Beijing Summer Olympics, the Japanese Patent Office, with far less ceremony, rolled out an ambitious and far-ranging patent policy strategy document, New Intellectual Property Policy for Pro-Innovation – Intellectual Property System as Global Infrastructure on August 8, 2008. In the increasingly competitive, knowledge-intensive global economic environment, responsive, strong and workable innovation laws are needed by IP owners to tackle the ever-aggressive competitors, counterfeiters and infringers and reward innovation-based companies, universities and other IP stakeholders. In response to the newly emerging, global and technology-based economy, Japan is taking steps to reform its innovation system in line with global realities and dynamics.

John A. Tessensohn and Shusaku Yamamoto

On October 1, 2008, the Japanese Patent Office (JPO) launched the keenly anticipated “Super Accelerated Examination” (SAE) system on a pilot basis. The SAE system has been designed to better respond to the needs of applicants, by requiring the applicant to make prior art searches and providing said results and commentary distinguishing the claimed invention from those results. The JPO's examination backlog worsened from 508,000 cases awaiting first office action in 2002 to 838,000 in 2006. According to the latest JPO Annual Report, the 2007 average first action period was 27 months. Under the pilot system, the JPO forecasted that SAE should be completed in approximately two weeks to one month. Under the current accelerated examination standards, the first action issues in roughly 2 to 3 months.

John A. Tessensohn and Shusaku Yamamoto

These new changes including fee reductions, time periods for appeal proceedings and recordation requirements of licenses are part of the incremental steps that the Japanese government has been undertaking to update its intellectual property laws in order to keep pace with the increasingly competitive, knowledge-intensive global economic environment.

John A. Tessensohn and Shusaku Yamamoto

This article discusses the patent, trademark and IP law changes coming into effect in 2008. It also previews the critical issues that Japan's IP policy makers are studying for possible future changes to Japanese IP laws in order to to achieve its goal for Japan become “the world's most advanced IP-based nation.” These issues include improving patent examination quality and speed, scent trademarks and international patent harmonization.

John A. Tessensohn and Shusaku Yamamoto