Disadvantages For Biotechnology Patents in Japan

    By Kevin E. Noonan --

U.S. patent practitioners have long felt that obtaining patent protection in Japan was more difficult than in other countries, particularly for biotechnology inventions.  An article in Nature Biotechnology last month (Aida et al., "Shortened life spans of biotech pioneer patents in Japan: a lesson from the DNA chip") provides solid evidence that this is the case, and illustrates the disadvantages under which biotechnology patents operate in Japan - which are even more pronounced the more fundamental and "pioneering" the claimed invention.

The authors, from the Intellectual Property Division of the Tokyo Medical and Dental University used as illustrative examples two patents directed to DNA array technology:  one to Oxford Gene Technology (OGT) and the other to Affymetrix.  The subject matter of the OGT patent was directed to methods for identifying a polynucleotide sequence using a microarray, while the Affymetrix patent was directed towards methods for preparing the arrays.  The authors, and the Japanese Patent Office (JPO), treated this subject matter as "pioneering," which in this context appears to have caused heightened scrutiny during examination.

The study compared the term and the time and course of the prosecution histories of corresponding patents granted in Japan, Europe, and the U.S. for each of these technologies.  The results were striking:  the Japanese patents had a shorter term (4 years, five months for the Affymetrix patent, 6 years for the OGT patent) in Japan, compared with 12 years for Affymetrix's patent and 15 years for the OGT patent in Europe.  This metric was not as informative for the U.S. patents, which were filed prior to the change in U.S. patent term from 17 years from grant to 20 years from earliest filing date.

The time in prosecution was another measure, used across all three patent offices (U.S., Europe, and Japan).  Here, the OGT patents were in prosecution for almost ten years in Japan, and the Affymetrix patents were prosecuted for 14 years before the JPO.  These results were not the result of inactivity:  the OGT application was rejected during the course of prosecution over five separate Office Actions, and the Affymetrix applicants responded to six separate Actions.  In contrast, the OGT patent was in prosecution for a little less than 5 years (three Actions) in Europe and about 4 years (three Actions) in the U.S., and the Affymetrix application prosecuted for 5 years (two Actions) in Europe and 3 years (two Actions) in the U.S.

Turning to the substance of the examination, for the OGT patent the Japanese Patent Office was concerned with whether the claims would encompass prior art methods for membrane-based nucleic acid transfer and hybridization ("Southern" blotting).  OGT was compelled to limit the claims to an "impermeable support" wherein the oligonucleotides were "covalently linked" in order to overcome these grounds of rejection.  However, the patent was opposed by Canon (Tokyo) after grant, and the JPO required the applicant to further limit the claims to recite a minimum of at least 72 oligonucleotide probes on the array.  The broadest claim issued to OGT was this one:

A method of analyzing a polynucleotide sequence, by the use of an impermeable support to the surface of which is attached an array of a plurality of oligonucleotides of specific lengths, each oligonucleotide of the array being covalently bound to the surface of the support at given intervals, said method comprising labeling the polynucleotide sequence or a fragment thereof, applying the labeled polynucleotide sequence or a fragment thereof under hybridization conditions to the array, and observing the location of the label on the surface associated with particular members of the set of oligonucleotides.

Of these limitations, only those directed to "covalently bonded" oligonucleotides were required in the other patent offices (the U.S.).

The course of the Affymetrix patent prosecution was even more protracted.  In contrast to OGT's patent, the issue raised by the JPO was lack of enablement.  The Affymetrix specification was directed explicitly to oligopeptide arrays and did not contain examples directed to oligonucleotides, although the claims encompassed oligonucleotide arrays.  The JPO steadfastly maintained its rejection on these grounds, and it was only after Affymetrix was able to show that oligonucleotides could be used in the methods set forth for oligopeptides that the Office allowed claims to issue.  Even then, the JPO required that the claims were limited to using visible or ultraviolet light as an energy source for polymerization.  The broadest claim issued to Affymetrix is this one:

A method for simultaneously manufacturing various oligopeptides or oligonucleotides at known positions on the surface of a single substrate comprising the steps of:

(1) (a) exposing a plurality of selected regions on the surface of the substrate to light or ultraviolet light having a wavelength of at least 280 nm to remove protective groups; and
(b) exposing the regions to selected monomers having protective groups removable by irradiation with light or ultraviolet light of at least 280 nm, the selected monomers being bound to the regions at sites from which the protective groups have been removed; and

(2) repeating step (1) using a plurality of selected regions and the selected monomers, wherein the selected regions in each repeated step are identical to, partially overlap with, or are different from the regions selected in step (1), a monomer selected in each repeated step is identical to or different from the monomer used in the preceding step, the region and the monomer employed in each repeated step are selected so as to bind to the support at sites from which the protective groups on the surface of the support or those of monomers used in step (1) have been removed, various types of oligopeptides or oligonucleotides comprising two or more monomers are synthesized on the substrate through the repeated steps, and the monomers are amino acids or nucleotides.

This delay in obtaining patent protection in Japan for these patents was also found for other "pioneering" biotechnology patents.  The authors compared the time of prosecution for Japanese, European, and U.S. patents for recombinant protein production (14 years in Japan, 3 years in Europe, and 5 years in the U.S.), antisense assays (10 years in Japan, 8 years in Europe, and 2 years in the U.S.), polymerase chain reaction (8 years in Japan, 6 years in Europe, and about 1 year in the U.S.), and transgenic animal methods (8 years in Japan, 7 years in Europe, and 4 years in the U.S.).  The term of these patents was concomitantly shorter in Japan than in either Europe or the U.S.

The results of these analyses confirm that it is folly to delay filing a request for examination upon filing in Japan, since not making this request will only increase prosecution times due to purely administrative delays in prosecution.  Also, these authors showed that designating a patent as being "pioneering" was found to increase the time in prosecution, even when compared with applications on related technology not considered (by the JPO) to be pioneering.  Thus, it would be prudent to avoid, either in the specification or in argument, language that would indicate that the technology is "revolutionary" or "groundbreaking" or the like, since that may trigger categorization of the patent as "pioneering" and thus retard the course of prosecution.  This dependence of prosecution times (and successfulness) on how applications are classified is not unique to Japan:  in the early 1990s, it was a common practice to use the title or the wording of the first claim to attempt to direct an application to the chemical art units, rather than the biotechnology art units, in the U.S. Patent and Trademark Office.  The practice tended to increase the likelihood of avoiding the protracted prosecution times associated with examination by biotech patent examiners.  This study by Japanese patent practitioners convincingly demonstrates that related tactics may be advantageous in Japan for efficiently obtaining biotechnology patent protection.

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[geetha]

stupid