In a pro-patentee decision, the Intellectual Property High Court of Japan enforced a Japanese pharmaceutical patentee’s crystal form patent against the generic drug maker, even though the basic substance patent on its blockbuster antibiotic compound had expired some 5 years earlier, Taiyo Yakuhin Co. Ltd, v Astellas Pharma. Inc. Heisei 19 (ne) 10034, 10 September 2007. This decision is a vivid example of how Japanese innovator drug patentees are not raising the white flag to generic makers but actually taking the battle to them in the world’s second largest national pharmaceutical market. However, outright victory is difficult as the road for crystal form patent enforcement against generic makers has been rocky with the outcomes being decidedly mixed in the various jurisdictions. Nevertheless, the billion or hundred million dollar pharmaceutical stakes are more than sufficient for innovator drug companies to continue beefing up their comprehensive patent coverage, with a generous helping of crystal form patents, on promising or proven drugs.

John A. Tessensohn and Shusaku Yamamoto

In a landmark decision Recycle Assist Co. Ltd. v. Canon Co. Ltd., Case No. Heisei 18 (ju) 826 dated November 8, 2007, the First Petty Bench of the Supreme Court of Japan conclusively ruled that the refurbishment, importation and sale of recycled ink cartridges for ink-jet printers infringe a patented product claim covering the ink cartridge. According to the ruling, a recycled product infringes the patent right of the original product if the recycled product can be recognized as a “new manufacture” of the patented product. A recycled product is recognized as a “new manufacture” of the patented product based on the characteristics of the recycled product and how the original product is processed, among other points.

John A. Tessensohn and Shusaku Yamamoto

The article discusses how to maximize the benefits of the current practice & procedure of the Patent Prosecution Highway (PPH), the joint accelerated examination project of the Japanese Patent Office (JPO) and United States Patent & Trademark Office (USPTO) that was fully implemented in January 2008 after a successful two year pilot project.

John A. Tessensohn and Shusaku Yamamoto

Several important changes to Japan's Patent, Trademark and Design laws will come into effect from April 1, 2007. Users of the Japanese IP system will have greater flexibility and scope of protection under these new legal changes.

John A. Tessensohn and Shusaku Yamamoto

In Japan, the applicant does not have an onerous burden to continuously and affirmatively provide any prior art references to the patent office, and examination at the patent office is not delayed as the patent examiner does not have to negotiate a swamp full with numerous prior art references that are just submitted because it has to be submitted. The Japanese duty of disclosure provision strikes a balanced and fair approach, a goal that the United States is apparently trying to emulate as well.

John A. Tessensohn and Shusaku Yamamoto

As Japanese science becomes more internationalized in terms of authorship and collaborations, US, European and international scientists are likely to conduct more research in cooperation with Japanese academia in the near future. They and their respective university employers should embrace and use Japan's six-month novelty grace period as a critical rescue tool to salvage potentially lucrative university-based inventions that may have otherwise perished if they were published before patent filings, thereby successfully overcoming the dilemma of rushing to publish and perishing one's patent rights.

John A. Tessensohn and Shusaku Yamamoto

In its second inventor compensation ruling in three years, Japan's Supreme Court ruled in favor of the ex-employee/inventor by expanding the scope of calculating the inventor's reasonable remuneration by including the employer/company's profits derived from foreign patents, and not only Japanese patents obtained by the employer/company, Hitachi v. Seji Yonezawa, Case No. H16 (ju) 781 dated October 17, 2006.

John A. Tessensohn and Shusaku Yamamoto

Under the Patent Prosecution Highway pilot program starting July 3, 2006, an applicant receiving a ruling from either the Japanese Patent Office or the USPTO office of first filing that at least one claim in an application is patentable may request that the other office expedited the examination of corresponding claims in corresponding application. This program is just to speed up examination on the merits at the JPO, it does not seek to eliminate or replace the JPO's examination of the application on the merits.

John A. Tessensohn and Shusaku Yamamoto

The finalized 2002 Biotechnology Strategy Guidelines issued by the Biotechnology Strategy Council called for "unified planning, drafting and comprehensive coordination of budgetary allocation policies and their execution, for all budgets biotechrelated science and technology budgets (amongst the Council for Science and Technology Policy, related ministries and agencies)" and to "build up and improve the funding functions of budget-allocating institutions" with competitive research funds and transparent evaluation criteria.

In the past, this biotechnology funding was jealously controlled by the differing government Ministries and agencies e.g., METI, MEXT, Ministry of Labor, Health and Welfare with their respective broad portfolios, and there were concerns that "eventually the bureaucrats walk off and follow the particular interest of their ministry", with the result that "the Japanese scientific community does not have very much influence on research funding". It remains to be seen whether the "unified planning, drafting and comprehensive coordination" will improve the implementation of the 2002 Biotechnology Strategy Guidelines discussed earlier.

John A. Tessensohn and Shusaku Yamamoto

This article will discuss the recent landmark policy reforms to Japan's university, intellectual property, science & technology, and biotechnology policy environments which seek to jump-start Japan's underperforming biotechnology sector by encouraging Japanese universities to patent and transfer the fruits of their research to industry or venture startups. If academic researchers at Japanese universities publish their research prior to filing patent applications, in view of their unfamiliarity with patent law, such publications will not destroy all Japanese patent rights in view of Japan's novelty grace period and the designation of several universities to enjoy such grace period benefits. The article concludes that these landmark changes could serve to positively transform Japan's biotechnology sector.

John A. Tessensohn and Shusaku Yamamoto