K&P's Intellectual Property High Court Decision Report in December, 2012

Sandoz K.K. v. Werner-Lambert Company LLC, Case No. 2011 (Gyo-Ke) 10445 (Decision rendered on December 5, 2012)

The Patentee, Werner-Lambert Company LLC, obtained a patent relating to a crystal polymorph of atorvastatin in 2002, against which Sandoz K.K. filed an invalidation trial before the JPO in 2010. The JPO dismissed Sandoz's demand in 2011, followed by Sandoz's appeal against the JPO's decision to the IPHC in 2011.

Claim 1 of the patent at issue claims as follows:

"Crystalline Form I atorvastatin hydrate characterized by the following X-ray powder diffraction pattern expressed in terms of the 2θ, d-spacings, and relative intensities with a relative intensity of > 20% measured after 2 minutes of grinding using CuKα radiation: ... ".
(The claimed X-ray powder diffraction pattern is omitted).

The issues in this case were (1) what degree of description was required for satisfying the enablement requirement, and (2) how the wording "recrystallization" in the prior art reference 1 should have been interpreted in examining the inventive step, in the case of a so-called crystal polymorph claim. The IPHC answered to the issues as follows.

Regarding the enablement requirement, the IPHC found that the specification of the patent at issue disclosed a general crystallization method and a specific co-solvent used therein for preparing the claimed crystalline compound, but did not disclose other various factors which could generally produce an effect on the crystallization, for example, a pH value, slurry concentration, temperature and other additives.
On the basis of the above findings, the IPHC decided that there might be some cases depending on these factors where the claimed crystalline compound could not be obtained even by a method included in the methods disclosed in the specification, and thus that those skilled in the art could not prepare the claimed crystalline compound without excessive burden even by taking into consideration the common technical knowledge.

Regarding the inventive step, the JPO had decided earlier that Example 10 of the prior art reference (p.a.r.) 1 had not demonstrated a formation of crystal of atorvastatin since the wording "recrystallization" used in Example 10 should have been interpreted as a misused term instead of "reprecipitation" on the basis of the fact that no specific support data had been shown therein.
On the other hand, the IPHC found that Example 10 demonstrated a formation of crystal of atorvastatin since no specific reason was found to suggest that the wording "recrystallization" was misused in p.a.r. 1 and it was not required to make a reproduction test showing that the crystal was produced.
On the basis of the above findings, the IPHC decided that a strong motivation for crystallizing an amorphous compound was found in p.a.r. 1, and it was a routine work for those skilled in the art to research the crystallization conditions and the crystal polymorph, and that no remarkable effect was found on the claimed crystalline compound.

Conclusively, the IPHC upheld Sandoz's appeal and cancelled the JPO's decision.

An appeal to the Supreme Court was filed against this decision, and thus the decision is not final and binding.

This decision teaches that it is very important to disclose the preparation method for the claimed crystal compound in detail in the specification, which should include various factors which could produce an effect on the crystallization, and to show a remarkable effect on the claimed crystal compound over an amorphous compound, for obtaining a patent relating to crystal polymorphs.

X (an Individual) v. Kao Corporation, Case No. 2011 (Gyo-Ke) 10339 (Decision rendered on December 13, 2012)

The Patentee, Kao, obtained a patent relating to a low-salt soy sauce in 2009, against which X filed an invalidation trial before the JPO in 2010. The JPO accepted X's demand and made a decision of invalidation in 2011, followed by Kao's appeal against the JPO's decision to the IPHC along with a trial for correction before the JPO in 2011. The IPHC remanded the case to the JPO and the JPO accepted the correction and dismissed X's demand in 2011, followed by X's appeal against the JPO's decision to the IPHC in 2011.

The corrected Claim 1 of the patent at issue claims as follows:

"A low-salt soy sauce containing the following components (A) to (C):
(A) 7 to 9% by mass of salt,
(B) 1 to 4.2% by mass of potassium, and
(C) 0.05 to 1% by mass in terms of free succinic acid of disodium succinate".

One of the main issues in this case was whether the additional data could be accepted for the support requirement. The IPHC answered to the issue as follows.

First, the IPHC found (i) that the problem to be solved by the invention of the patent at issue was to provide a low-salt soy sauce having a salty taste similar to that of an ordinary soy sauce with decreasing foul taste caused by the addition of potassium, (ii) that the working examples in the specification of the patent at issue demonstrated (a) that a low-salt soy sauce having 8.11% of salt, 0.05% of disodium succinate and 0.78-3.91% of potassium solved the problem, (b) that a low-salt soy sauce having 7.04% of salt, 0.10% of disodium succinate and 1.01-4.16% of potassium solved the problem, and (c) that a low-salt soy sauce having 7.78-7.63% of salt, 0.005-0.2% of disodium succinate and 2.34% of potassium solved the problem, and (iii) that the specification had the disclosure from which those skilled in the art could recognize that the problem could be solved at near the lower limit of salt. Further, the IPHC found that two additional data A and B which Kao submitted after the filing of the patent at issue were intended to supplement what might result near the upper limit of disodium succinate (data A) and that of near the lower limit of salt (data B).
On the basis of the above findings, the IPHC decided that by taking into consideration the working examples and the detailed explanation in the specification and the common technical knowledge, those skilled in the art could recognize that the problem could be solved in the claimed whole range, and that the additional data A and B only confirmed the content of the disclosure of the specification or the effect that those skilled in the art could expect, and were not intended to supplement the content beyond the extent of the specification after the filing.

Conclusively, the IPHC dismissed X's appeal and upheld the JPO's decision.

An appeal to the Supreme Court was not filed against this decision, and thus the decision is now final and binding.

Under the Japanese practice, supplemental data is not generally acceptable for compensating the deficiency in the support requirement. Nevertheless, as seen from this decision, additional data would be acceptable if it is intended to only confirm the content of the disclosure of the specification or the effect that those skilled in the art can expect.

In December 2012, the IPHC handed down 36 decisions including the above 2 cases on patents, and overturned the previous decisions in 6 cases.

Gotham, Inc. v. Comite Interprofessionelle des Vins du Champagne, Case No. 2012 (Gyo-Ke) 10267 (Decision rendered on December 19, 2012)

Plaintiff, Gotham Inc., an event planner and trader of liquor and foods filed a trademark application for “CHAMPAGNE TOWER in Japanese Katakana” designating “Providing foods and beverages” in International Class 43 and the mark was registered in 2010.
Defendant, Comite Interprofessionelle des Vins du Champagne, a French organization founded for the protection of producers of sparkling wine produced in Champagne region in France, filed a trial for invalidation against the registration of “CHAMPAGNE TOWER in Japanese Katakana” asserting that said registration was in contravention of the public order or morality (Art. 4, para. 1, No. 7 of the Trademark Law). The board of appeals of the JPO rendered a decision in 2012 that the registration should be invalidated, against which Plaintiff filed a cancellation action before the IPHC in 2012.

The main issue in this case was whether granting a trademark registration for a mark containing the word “CHAMPAGNE” to a private corporation would contravene the public order or morality.

Plaintiff alleged that Art.4, para. 1, No.7 of the Trademark Law was inherently stipulated to reject the marks which by itself would contravene the public order or morality and should not be applied unless there have been very specific circumstances. Actually, there were no specific circumstances to reject �CHAMPAGNE TOWER in Japanese Katakana� with respect to the service �providing foods and beverages�, and therefore the registration for said mark was not in contravention of the public order or morality.

Defendant alleged that Art.4, para. 1, No.7 of the Trademark Law could be applied not only to a mark which itself contravenes the public order or morality, but also to the marks whose registration may insult any specific country and its people or harm the international faithfulness.
Actually, the word or indication �CHAMPAGNE� had been strictly protected by the Defendant and INAO (National Institute of Appellation of Origin) and internationally recognized as a French cultural property. Therefore, granting a registration for a mark containing �CHAMPAGNE� to a private corporation may destroy business order in control of indication of place of origin, spoil French Champagne producers� efforts in building trust in Champagne wine and finally dilute the trust and reputation accumulated in the indication of �CHAMPAGNE�. Therefore, the registration for �CHAMPAGNE TOWER in Japanese Katakana� could not be admitted in consideration of the international faithfulness.

IPHC sustained the decision to invalidate the registration of “CHAMPAGNE TOWER” for the following grounds.
IPHC first acknowledged the facts that the indication of “CHAMPAGNE” had been strictly controlled under the French law, that INAO and the Defendant had made tremendous efforts to prevent marks containing “CHAMPAGNE” from being registered in Japan, and that the indication of “CHAMPAGNE” has been well-known in Japan. Further, considering the significance and importance of the indication of “CHAMPAGNE” in France and its well-known status in Japan, using a mark in connection with the services related to providing beverage including sparkling wines may injure not only the Defendant but also the French people, impair the relationship between France and Japan, and therefore is against the international faithfulness.

In this decision, the IPHC cited many cases and controversies the Defendant and INAO filed to prevent the registration of marks containing �CHAMPAGNE� with the JPO, and valued their longtime efforts to protect �CHAMPAGNE� as an indication of place of origin. To perfect protection of indication of place of origin, such thorough efforts may be required, though protection is guaranteed by TRIPs agreement.

In December 2012, the IPHC handed down 9 decisions including the above 1 case on trademarks, and overturned the previous decisions in 3 cases.