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BIOTECHNOLOGY


Tese amendments have significantly broadened the scope of biotechnology patentability in Japan. Consequently, claims should be draſted according to the newest examination standards in order to provide the broadest possible protection.


Claim scope


Te Japan Patent Act requires that the invention, as set forth in the claims, is clearly defined. Te JPO has established standards for such clarity by outlining the various ways in which genes, vectors, recombinant vectors, transformants, fused cells, recombinant proteins and monoclonal antibodies may be described in a claim. Te claim scope of inventions related to a gene or a protein corresponding to a gene was broadened to allow claims to encompass genes or proteins that share sequence similarity.


Patent rights in the past were rigidly narrow— protecting patents only if DNA or protein sequences matched base by base or unit by unit. However, it is known that sequences do not need to match completely for an equivalent functional effect. Patents now protect protein amino acid sequences and gene nucleic acid sequences to allow for small “substitution, deletion or addition” in the sequence or include sequences that have enough similarity that they anneal or ‘hybridise’ with the original sequence.


In practice, the expression “substitution, deletion or addition” is understood to refer to a modification within a limited range of usually fewer than 10 units. When claiming an invention related to a gene or a protein corresponding to a gene, the “substitution, deletion or addition” language should be used to broaden the scope of protection. If this language was not used in an original patent of a key invention, it may be advisable to file a divisional application to the original patent containing the “substitution, deletion or addition” language. Before this change, patentees had to rely on the doctrine of equivalents to defend their patent rights. Now, patents can be draſted using this language to better protect their inventions.


Enablement requirement


A patent specification must be written so it enables a person of ordinary skill in the art to which the invention pertains to carry out the invention. In order to satisfy this requirement, a person of ordinary skill in the art must be able to reproduce the invention. Regarding biological inventions, the person must be able to reproduce the biological material, such as a protein, gene, recombinant vector, or cell, on the basis of the description in the specification.


If the biological material cannot be produced, the applicant must deposit the biological material to the National Institute of Bioscience and Human


“WHEN CLAIMING AN INVENTION RELATED TO A GENE OR A PROTEIN CORRESPONDING TO A GENE, THE ‘SUBSTITUTION,


DELETION OR ADDITION’ LANGUAGE SHOULD BE USED TO BROADEN THE SCOPE OF PROTECTION.”


Technology (NIBH) before filing the application and submit a deposit certificate issued by the NIBH, or provide a copy of a receipt issued by the international depository authority under the Budapest Treaty. Failing to deposit such biological material will result in the JPO rejecting an application for failing to satisfy the enablement requirement.


Prior art and advantageous effect


Te applicant is required to describe the technical field and prior art to which the invention pertains within the specifications. Tis requirement aims to highlight


the technical significance of the


invention and may clarify a problem that the invention will solve.


Te prior art should be disclosed so that it explains the current state of the art and the problem to be solved. Although it doesn’t have to, the applicant should then describe an advantageous effect, not exhaustive, of the claimed invention over the relevant prior art. Te explanation of such an advantageous effect will be taken into account as support for the existence of an inventive step. Tis is of particular importance where combinations of publicly known processes or materials are used to create a new invention with an advantageous effect that could not have been foreseen.


Public order


Last, when considering patenting biological inventions, applicants should be aware of Article 32 of the Patent Act, which prohibits the patenting of an invention that is likely to harm public policy or public health. In practice, patents for inventions that include the step of destroying a human embryo have been rejected under Article 32. Tis morality provision has not, however, been used to prohibit the patenting of methods of culturing or differentiating already established embryonic stem cell lines.


68 World Intellectual Property Review Annual 2013


Rebecca Chen is a California licensed attorney. She is based in Palo Alto and specialises in comparative IP law. She serves as the liaison between SUGIMURA’s international clients and the firm’s Tokyo office.


Kenji Sugimura is an experienced Japanese patent attorney and litigator specialising in mechanics and building engineering. Sugimura is a member of AIPPI, APPA, FICPI, INTA and the JPAA.


Although patent applicants may easily overcome Article 32, with respect to iPS cells, it is important they are mindful of such mitigating factors when devising a patent strategy.


Capturing the booming market


Given the substantial growth of its biotechnology industry and its expansion of patentable subject matter, Japan holds tremendous opportunities for companies seeking to expand their biotechnology markets. Understanding the patent landscape as it pertains


to biotechnology in Japan will


enable companies to tailor patent applications appropriately to capture this booming industry. 


Kenji Sugimura is the president of SUGIMURA International Patent & Trademark Attorneys. He can be contacted at: k.sugimura@sugi.pat.co.jp


Rebecca Chen is the business development manager of SUGIMURA International Patent & Trademark Attorneys. She can be contacted at: r.chen@sugi.pat.co.jp


www.worldipreview.com


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