Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News
Amendments in Japan take effect in April, and approval of the Australian bill is expected mid-year.
The U.S. is not the only nation dealing with an overhaul of its patent law. Australian lawmakers are expected later this year to approve the most substantive changes to their nation’s patent law since it was last rewritten in 1990, while amendments to Japan’s system take effect in April.
The Intellectual Property Laws Amendment Bill, better known as “Raising the Bar,” sits in Australia’s Senate. The bill is expected to be approved by the middle of the year. If and when it is green-lighted, the measure will likely take full effect after early 2013.
“When you step back and you look at this bill, I think that what it’s actually doing is just trying to remove uncertainty in the Australian system,” Tom Gumley, Ph.D., a partner in Freehills Patent & Trade Mark Attorneys in Sydney, told GEN.
Among significant changes in Raising the Bar impacting biopharma patent holders is an exemption that would allow researchers to carry out experiments without fear of possible patent infringement.
Another key part of the measure redefines the standards for common knowledge and information used to prove an invention has the “inventive step” required to obtain patents. Current Australian law bars applicants from citing prior art documents unless they could have been “ascertained, understood, and regarded as relevant” to a person skilled in the art in Australia.
The new law measures the inventive step against all information available to the public anywhere in the world at the patent’s priority date, while redefining common general knowledge to include anything known anywhere in the world. The changes recognize the 21st century reality that global knowledge is as convenient as surfing the internet, setting a new standard that aligns Australia with the U.S. and Canada.
Also aligning Australia with the U.S. and Canada is the bill’s revised definition of “useful” to require that applicants reveal a “specific, substantial, and credible” use for their claimed inventions.
Raising the Bar tightens the standards for invention disclosure by requiring that even a provisional specification disclose an invention completely and clearly enough for it to be performed by a person skilled in the relevant art. Current law allows a more general description. The new provision also aligns Australia with U.K. and European patent laws.
The tighter standards and new definitions will have the effect of narrowing the scope of claims in new patents.
As for Japan, its patent law is being amended with the goals of strengthening IP, enhancing fairness, and speeding up resolution of disputes. One amendment, for example, abolishes the prohibition of double jeopardy on third parties in a patent invalidation trial. This allows third parties who have not been involved in earlier trials to file a request for another trial based on the same facts and evidence as the previous trials.
Unlike the U.S., Japan has no post-grant opposition review system, relying instead on its court system and the Japan Patent Office (JPO) for resolving disputes. Perhaps the most important provision of the amended Japanese patent act will end the current practice of allowing a defendant or plaintiff to perpetuate already lengthy litigation by requesting a retrial of an infringement case that was lost several years before.
“Ratio legis of this amendment is that if the patentee or defendant may correct or invalidate the patent now, they should have so argued in the infringement law suit years before,” Nobuhiro Takahashi, Ph.D., an attorney with the Moegi Patent Office in Tokyo, told GEN.
Dr. Takahashi cited a typical scenario the new law is intended to deter: When a patentee believes that a patent is being infringed, he/she can initiate a lawsuit at the Tokyo or Osaka District Court, while the potential infringer would file an invalidation trial at the Japan Patent Office. The JPO trial board and the Court reach their decisions independently, and “it is not rare that the JPO and the Court reach different conclusions,” noted Dr. Takahashi.
In a scenario where the patentee wins the JPO trial while the defendant wins its infringement law suit, he said, both parties will appeal to the Intellectual Property High Court, and the losing party can subsequently file an appeal with the Supreme Court. “However, the Supreme Court will dismiss the case unless it involves a very important matter of law,” Dr. Takahashi said. In one such matter, the Supreme Court ruled in 1999 that the patent held by the developer of a method of assaying inhibitory action of a kallikrein formation inhibitor was not infringed by a drug developer that used the assay during the manufacture of a product outside Japan territory.
More often, he said, patent disputes are typically remanded to the JPO, where an appeal board bound by the court decision will decide that the claims are invalid. In this case the patentee now may request a correction trial to remove the defects of the patent, usually by narrowing its patent claims. That provision will change under the new law, which will bar patentees from making correction trial requests once they ask the IP High Court to rescind the decision of the patent invalidation trial.
“Under the new system, the panel that will decide to invalidate the patent in question must disclose to the parties its determination in advance when the time is ripe for a trial decision, and then the patentee is given an opportunity to correct the patent in response to the advance notice,” according to a summary of the amendments by the JPAA.
The court scenario in Japan highlights the consequences of a lack of a streamlined postgrant review system, which was fine-tuned in the America Invents Act, the U.S.’ latest revisions to its patent system. Officials and industry in Japan might consider amending this system the next time the country’s patent law is rewritten.
Alex Philippidis is senior news editor at Genetic Engineering & Biotechnology News.