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Judgment and Decision in Relation to Biotechnology

Contents

Judgment on "Obvious to Try" -Comparison between Japan and US-

March 15, 2010
HARAKENZO WORLD PATENT&TRADEMARK
T. KURODA, Patent Attorney

1. Introduction
While some experts viewed that the KSR US supreme court judgment rendered by the US supreme court on April 30, 2007 would have effects only on "predictable art", such as fields of mechanics or electronics etc., and few effects on "unpredictable art", such as fields of biology or chemistry etc., the CAFC judgment according to KSR judgment was rendered in connection with the biological inventions. This would become a new standard for non-obviousness, "Obvious to try" in the biological inventions. Let me explain this judgment together with a similar judicial precedent in Japan.

2. In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009)

Applicants (Marek Z. Kubin et al.)filed a patent application " NK cell Activation inducing Ligand (NAIL) DNA and Polypeptides, and Use thereof" on September 20, 2000. NH cells remove tumor or virus-infected cells etc., and play one of the main roles in the immune system that controls immune response via the emission of cytokine. As described in the background of this invention, it is known that human NK cells have a particular surface protein called "p38" or "NAIL", and exerts cytopathy or cytokine emission ability by activating this surface protein. However, its amino-acid sequence or nucleotide sequence of gene coding for such protein was not identified.
In the above application, Kubin et al. presented a possibility of new medicinal application of human p38 (NAIL) protein by demonstrating that cDNA encoding for human p38 (NAIL) protein was cloned, the nucleotide sequence was identified and NAIL protein was linked to CD48 which is a marker cell in the immune system. The invention filed by Kubin et al. encompasses the nucleotide sequence encoding for CD48 connective protein, that is 80% homologous with the amino acid sequence of NAIL protein, and its use.
The examiner of USPTO denied unobviousness of the subject invention over the cited reference disclosing (i) the presence of p38 (NAIL) protein related to signaling and cellular cytotoxicity of NK cell; (ii) monoclonal antibody bound specifically to p38 (NAIL) protein. The examiner stated that although the reference did not disclose the amino acid sequence or nucleotide sequence of p38 (NAIL) protein, it was possible to identify the nucleotide sequence of p38 (NAIL) cDNA and amino acid sequence of p38 (NAIL) protein using the known art. Although the applicant filed an appeal to BPAI, the obviousness rejection was maintained, and thus the applicant filed a petition of objection to CAFC.
CAFC maintained the judgment of BPAI, stating "the applicant merely isolated cDNA in NAIL using the known art. At the time of filing the subject application, the importance of the isolation of cDNA in NAIL had been fully recognized by the person skilled in the art, and thus it is fully motivated to isolate cDNA in NAIL using the known art." As such, CAFC did not apply In re Deuel standard which had been applied in biological invention, and made a judgment that the invention did not have unobviousness, supporting the judgment of USPTO.
Firstly, it should be noted that CAFC followed KSR US supreme court judgment, and thereby denied the CAFC judgment of In re Deuel in which "obvious to try" is inappropriate as a test for obviousness. The outline of CAFC judgment of In re Deuel is that although partial amino acid sequence of protein is publicly known, a number of nucleic acid molecules encoding for such protein are present, and thus even if the general method for the gene cloning is publicly known, it is not obvious to obtain the nucleic acid molecule encoding for such protein. The judgment has had considerable effects on the judgment of unobviousness of biological inventions.
Secondly, referring to KSR US supreme court judgment, CAFC stated that the claim considered to be "obvious to try" was not necessarily and automatically deemed to be obvious based on the article 103, and that unobviousness can be claimed based on In re O’Farrell if:
(1) trial-and-error approach was carried out, e.g. by changing all parameters or attempting a number of choices, until a successful result was obtained, where the prior arts had not suggested or indicated which parameter is important, or which choice is likely to be successful among many choices;
(2) experiments were carried out for exploring a new technology or a general approach that seemed to be a promising field of experimentation, where the prior art only gave only general guidance as to the particular form of the claimed invention or how to achieve it.
In particular, it is considered that the second point in re Kubin is a useful suggestion for claiming unobviousness and can be applied not only to the biological invention but to all technical fields.


3. Judicial Precedent in Japan based on Similar Judgment
Japan also has a judicial precedent in which the similar judgment as in re Kubin was made. Let me explain the outline of such case.
The subject invention relates to immunoreactive polypeptide composition including epitope which exists in the variable domain of envelop polypeptide of HCV (hepatitis C virus), and is applicable to vaccine etc. The court pointed out that the cited reference 1 suggested the possibility of the presence of immunoreactive polypeptide in the hypervariable domain of HCV, and the cited reference 3 suggested epitope and a section inducing neutralizing immune response are present in the variable domains of different viruses. Given these facts, the court upholded the trial decision wherein the inventive step is denied, stating that "in conjunction with the suggestion of the cited reference 1 and the description of the cited reference 3, a person skilled in the art expects the presence of immunoreactive section including epitope in the hypervariable domain of HCV envelope polypeptide as in HIV-1 and is strongly motivated to confirm it. Even if immunoreactiveness within the hypervariable domain of HCV envelope polypeptide is confirmed as a result thereof, this merely means the result as expected by the person skilled in the art is obtained…"
The above judicial precedent is introduced as "the claimed invention related to a certain protein with a newly found function lacks an inventive step, as the protein function must be foreseen, and there could have been strong motivation to confirm the existence of the protein function before the filing date (priority date)" in Major Judicial Precedents of Biological Invention by Appeals Department, JPO. The examination standard of in re Kubin adopts the similar approach. Both in US and in Japan, the inventive step (or unobviousness) is denied if the person skilled in the art has a strong motivation and it is obvious for him/her to attempt the invention with reasonable expectation of success, and significance of the effect is not recognized.

(Cited references)
[1] In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009)
[2] In re Deuel, 51 F.3d 1552, 1558-59, 34 USPQ2d 1210, 1215 (Fed. Cir. 1995)
[3] KSR v. Teleflex, 550 U.S. 398 (2007)
[4] In re O’Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988)
[5] Heisei 17 (Gyo-ke) 10073 (Judicinal Date: May 17, 2005)
[6] Case 7 "Immunoreactive Polypeptide Composition of Hepatitis C virus" Major Judicial Precedents of Biological Invention, Japan Patent Office


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Toshiro KURODA
DEPUTY DIRECTOR GENERAL Toshiro KURODA Mr. Kuroda specialized in Biotechnology and Molecular and Cellular Biology at university and graduate school, where he carried out research into improving the function of proteins and the protein localization.

After graduate school, he worked for a cosmetics company at R&D division carrying out fundamental research and developing new products. Following this, he joined HARAKENZO WORLD PATENT & TRADEMARK, and became involved in patent prosecution for domestic and international cases in the fields of biotechnology and chemistry. After qualifying as a patent attorney and a specially qualified attorney for infringement litigation, he also gained experience in license agreements, expert opinions, consulting, litigation and so on. Currently, he not only carries out patent-related work, but handles cases from all areas of intellectual property, including design and trademark cases.

"In recent years, as the globalization of business has continued, competition has become much fiercer. In this fiercely competitive environment, outstanding technology is of course important, but it is not enough on its own. With only technical superiority, it is increasingly difficult to maintain a distinctive value.

"Therefore, to differentiate oneself from others and to increase one's competitiveness, in addition to technology, it is vital to incorporate design and brand into a multi-layered IP strategy. In order to increase the value of our clients' businesses, I aim to help provide a service that fully satisfies the demands of our clients in all fields of intellectual property."
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Kazuya HASEGAWA
Kazuya HASEGAWA Kazuya HASEGAWA,born in 1969, obtained an MS in industrial chemistry from Hiroshima University. The targets of his research include analysis of Immunology, Fermentation Technology, Enzymatic Technology and Saccharide Chemistry. His specialty covers Allergy, Food, Microorganism, Cosmetics, Enzyme and Saccharide. He is presently a member of JPAA. Certified in 2005 as Litigation Certified Intellectual Property Attorney.

More than anything else, I love to try something new. I will keep trying, so that I can provide satisfactory services to out client, making good use of my know-how obtained through research experience at a business enterprise.
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Kenjiro FUJITA
Kenjiro FUJITA Specialized in agricultural chemistry and human enviromentology

Based on my experiences of not only patent applications and prosecutions but also contracting work such as licensing in all areas of intellectual property, I aim to keep honing my skills and provide services relating to intellectual property including design and trademark, etc.

Patent Department Senior Manager <in the field of Chemistry and Biology>
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Morio NAKAO
Morio NAKAO Morio NAKAO, born in 1978, obtained a Master of Environmental Engineering from Osaka University. His specialty covers Biotechnology, high polymer chemistry and Environmental Sanitary Engineering.

I will make the most of my variety of experiences so as to contribute to our clients’ benefit.
Please feel free to contact us if you have any questions or problems concerning intellectual property such as patent, design, and trademark.
Patent Department manager
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Naoki AONO
Naoki AONO Naoki AONO was born in 1974.
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A research field: Chemical biology, molecular biology and vegetable evolution embryology

The combination of my doctorate level education, ability to ascertain the facts cultivated from my post-doctoral research experience, and expert knowledge of intellectual property rights, I will respond to the expectations and demands of our clients.
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