Seirogan

Seirogan (正露丸 formerly 征露丸) is a pharmaceutical drug marketed in Japan, sold as a treatment of the digestive tract (especially as an antidiarrhoeal), whose main active ingredient is "wood creosote" (also wood-tar creosote, or beechwood creosote[1]).

Seirogan
Seirogan
Clinical data
Trade namesSeirogan
Identifiers
CAS Number

The name is nominally a registered trademark of Taiko Pharmaceutical (大幸薬品, Taikō Yakuhin) based in Suita, Osaka which is still the major market-share holder, but the enforceability of the tradename has been voided by the Supreme Court of Japan, which ruled seirogan to be a common generic name. The ruling only recognizes proprietary use of the bugle logo by Taiko,[2] but not protection of its characteristic packaging. As a result, dozens of extremely similar packaged drugs are being manufactured and sold in the market.[2]

Overview

Seirogan is a general-use medicine, mainly to treat the gastro-intestinal system. It contains wood-tar creosote (木クレオソート) as its main active ingredient.[3] That ingredient in the West may otherwise go by such names as "wood creosote", "beechwood creosote", or "liquid pitch oil", and should be distinguished from industrial "coal-tar creosote". To emphasize the distinction, wood creosote in Japan is sometimes called by such names as Nikkyokuhō kureosōto (日局方クレオソート, "Japanese Pharmacopoeia creosote") and minor variants thereof.

The wood creosote is blended with two or more crude medicines (生薬, shōyaku) recognized in Chinese materia medica (漢方薬, kanpōyaku) for their antiseptic and other effects, but the additional ingredients used are different among manufacturers (See under § Chemical composition for a sampling of formulas). Some quarters (perhaps kanpō medicine practitioners and others) insist however that "Seirogan is not strictly speaking kanpō medicine", and this point was emphatically printed in a retraction by a certain consumer-watch type book that criticized seirogan but had confused wood creosote with the industrial type[4] (See § Accusation controversy).

In the classic form, it is a dark brown round pill, but in order to mask its distinctive medicinal odor and bitterness, sugar-coated tablet forms have become available as well.

Trademark

The Seirogan (正露丸) name was filed for trademark registration by Taiko Pharmaceutical in 1954,[5] but approximately thirty competitors[5] such as Izumi Yakuhin Kogyou Co., Ltd. objected, leading to a lengthy battle, petitioning the Patent Office, then later litigating in court. The Tokyo District Court rejected Taiko's claim to proprietary use of the Seirogan name, and the Supreme Court of Japan upheld that decision[2] in 1974. The Supreme Court delivered the opinion that the name seirogan had passed into a common noun, so that use of the Seirogan (正露丸) name by any company was valid, not answerable to the claims of this trademark, and did not constitute an infringement of any intellectually property rights thereof. The court also did not recognize Taiko Pharmaceutical's exclusive right to use the distinctive color scheme and graphic design on the packaged box (and sticker label on the pill bottle), with the exception of the product logo depicting a bugle (cf. §Taiko's trademark registration and Izumi's lawsuit to revoke trademark).[2]

As a consequence, there are currently numerous Seirogan products in the market that feature logos other than the bugle but otherwise look remarkably similar:[2] Izumi Yakuhin Kogyou (calabash logo), Kyokuto Co., Ltd. (triangle and bear logo, nicknamed Yūtan[6]). The retailer/drug store chain Fujiyakuhin Co., Ltd. and wholesaler Fujiyakuhin Co., Ltd. also market their own brands.

In 2005, Taiko filed a lawsuit against a competitor, demanding suppression of what it considered copycat merchandise, but again lost the case in court, and the Supreme Court rejected the appeal in 2008 (cf. §Taiko's petition for an injunction against unfair competitive practices).

The bugle tune being played in Taiko's commercials for the product is the ex-Japanese Imperial Army bugle call to announce mealtime, colloquially known as the Shokuji rappa (食事ラッパ, "Chowtime bugle"). The tune used currently by the Self Defense Force is of a different melody.

Medical aspects

Uses and effects

Seirogan is touted to be effective in the following:

  1. Treating and allaying stomach aches, diarrhea, diarrhea due to digestive disorders, food poisoning, vomiting, water contamination (Montezuma's revenge), runny bowels warning of diarrhea, soft stool.
  2. Regulating stomach and intestines condition.
  3. Pulpitis-caused tooth cavity aches.[7]

In pre-World War II Japan, Seirogan was believed to combat tuberculosis or aid someone with a weak constitution, and employed as a panacea (cure-all) of sorts.[8]

Chemical composition

(1 day dose for adults)

Taiko Pharmaceutical's Seirogan
(main ingredients)
  • pharmacopoeial wood-tar creosote: 400 mg
  • pharmacopoeial gambir leaves and young sprig (asenyaku (阿仙薬)) powder: 200 mg
  • pharmacopoeial Amur corktree bark (ōbaku (黄檗)) powder: 300 mg
  • pharmacopoeial Chinese liquorice root (kanzō (甘草)) powder: 150 mg
  • (chenpi (陳皮, chimpi)) powder: 100 mg
(additives)

Izumi Yakuhin Kogyou's Izumi Seirogan
(main ingredients)
  • pharmacopoeial wood-tar creosote: 275 mg
  • pharmacopoeial Japanese belladonna (rōto (ロート)) extract: 19.8 mg
  • pharmacopoeial cinnamon powder: 49.5 mg
  • pharmacopoeial Amur corktree bark (ōbaku) powder: 99 mg
  • pharmacopoeial Chinese liquorice root (kanzō) powder: 165 mg
  • chenpi powder: 105 mg
(additives)

Matsumoto Pharmaceutical Manufacture Co., Ltd.'s Matsuba Seirogan
(main ingredients)
  • pharmacopoeial wood-tar creosote: 400 mg
  • pharmacopoeial Amur corktree bark (ōbaku): 150 mg
  • pharmacopoeial Chinese liquorice root (kanzō) powder: 250 mg
  • cinnamon: 100mg
  • pharmacopoeial gentian (genchiana (ゲンチアナ)) root powder: 100 mg
  • pharmacopoeial chenpi powder: 100 mg
(additives)
  • glycerine
  • rice starch

History
Advertisement for Seirogan, 1930s

There are several contending theories regarding the origins of the drug, and several names crop up as its inventor.

The Japanese Imperial Army, which experienced considerable setbacks due to unclean water sources during the Sino-Japanese War at the end of the 19th century, was working on solutions to combat infectious diseases. Surgeon-major Michitomo Tozuka (戸塚機知), an instructor at the Military Medical College, discovered in 1903 that creosote agent was an effective suppressant for the typhoid fever pathogen. Taiko Pharmaceutical claims the Osaka-based medicine merchant Saichi Nakajima (中島佐一) developed the Chūyū Seirogan (忠勇征露丸) a year earlier in 1902 and initiated sales, which business was eventually handed over to Taiko.

The higher echelons of the Army Medical Corps, including writer Mori Ōgai, favored the German view that beriberi, a disease that caused an even heavier death toll than typhoid, was caused by an undiscovered transmittable pathogens (in contrast, British-trained doctors in the navy correctly saw it as a nutritional disorder). Prompted by their misguided view, the army distributed vast quantities of Seirogan (with their proven antiseptic properties) among the troops to be administered daily throughout the Russo-Japanese War of 1904-5. In an army medical journal of 1901 there is mention of the pill as Kureosōto gan (クレオソート丸), but in the journals of 1904-5 appears the name Seirogan (征露丸 "Conquer Russia pills").[9] The name Seirogan was widely used as the academic term by army doctors for about a 4-year span.

But this was in the days when drug use as preventive medicine was not a widely embraced concept, and soldiers resisted swallowing this weird-smelling and unfamiliar pill, even when so instructed. The top brass decided to invoke the name of Emperor Meiji, telling the men that taking the pill was "according to the wishes of His Imperial Majesty".[9] This subterfuge reportedly greatly improved the soldiers' compliance towards taking the pill, making them less prone to be forced out of action due to stomach aches or diarrhea. The army doctors were however disappointed to find that the pill did not show any of the desired combative effect towards the (non-existent) beriberi microbe. The army insisted on feeding their men pure white rice to boost morale, but that led to vitamin-deficient diet, so that one in three men serving the Russo-Japanese War were afflicted by beriberi, and 27,800 succumbed to it. Meanwhile, the Japanese navy deduced early on that beriberi was a nutritional disorder, and added breads and mugimeshi (麦飯) (wheat or wheat-rice mixture steam-cooked like rice) to their rations, so that none of their servicemen fell ill with beriberi.

While Seirogan proved powerless against beriberi, the antidiarrheal and toothache-soothing properties of the pill were passed on, in somewhat exaggerated fashion, by repatriated war veterans. Amid the mood of victory in war, Seirogan's name became "the cure-all that defeated Russia" and many drug-makers rushed to manufacture the pill, which became a national medicine unique to Japan.

The reputation for the pill's effectiveness also spread within areas under Japanese control before the end of World War II, and Seirogan is said to be one of the popular items purchased by travelers from Taiwan, Hong Kong, the People's Republic of China, and other Asian countries.

The pill ceased to be part of regular military issue supplies in 1906, but the military continued to keep itself constantly supplied for use. In 2007, it was part of the supply kit issued to the SDF during the UN Mission in Nepal.

After the war with Russia, and again after World War II, administrative guidance was issued against the use of the kanji character 征 (Sei, "conquer") as being undesirable from the standpoint of international relations. So in most cases, the written name of the pill was changed to 正露丸 ("right dew pill"). Taiko Pharmaceutical made the change in 1949.[10] But one manufacturer Nihon Iyakuhin Seizō (日本医薬品製造) still uses the old written form that reads "conquer".

Intellectual property rights dispute

Taiko's trademark registration and Izumi's lawsuit to revoke trademark

In 1946,[10] Taiko Pharmaceutical the leading manufacturer of the pill, had obtained through formal negotiation with Saichi Nakajima the right to continue selling his "Chūyū Seirogan" pill. Accordingly, in 1954, Taiko made a claim for the exclusive use of the "Seirogan" name, and filed for trademark registration.

Other manufacturers of the seirogan-type pill objected to this move, led by Izumi Yakuhin Kogyou Co., Ltd., which had developed its own creosote formula, and had supplied the military with its seirogan throughout World War II despite supply shortages. The group petitioned the Patent Office in April 1955 to revoke the trademark. It was not until April 1960, that the Patent Office handed down its decision to maintain the registered trademark. So the group filed a suit in the Tokyo High Court, which in September 1971, ruled that "The seirongan is recognized by the nation's populace as a common name for bowels-regulating agents that use creosote as main ingredient, and [the court hereby] rules to void the Patent Office's decision to make it a proprietary trademark". This ruling was upheld by the Supreme Court of Japan, thus finalizing the decision in March 1974.

However, the Seirogan registered trademark is still retained by Taiko Pharmaceutical (Trademark Registration No. 545984). It is not clear why the registered trademark remains unexpunged despite the supreme court ruling, but a trademark registration does not vanish automatically, and needs to go through a Patent Office review process. The Patent Office may have surmised that the Court's ruling effectively accomplished the purpose or remedy sought by the petitioners, obviating the need for another review. The Court's opinion made it expressly clear that the name Seirogan had passed into a common noun, which meant that the trademark privileges (proprietary rights) upon it was not protected or enforceable pursuant to Japan's Trademark Act, Article 26, Paragraph 2.

Thus companies other than Taiko are allowed to sell the drug under the "Seirogan" name, without this constituting an infringement of trademark. Taiko's attempted litigation in 2005-8 (described) also failed to establish its proprietary rights. But the Court's opinion curiously left open a leeway, allowing for possible future reversal depending on the shift in popular convention. Seirogan is one of few pharmaceutical drugs names thus given public domain status, aspirin being another immediately called to mind.

Taiko's petition for an injunction against unfair competitive practices

On November 24, 2005,[11] Taiko Pharmaceutical filed a suit against Izumi Yakuhin Kogyou in the Osaka District Court, claiming the sales of merchandise with similar packaging constituted an act of unfair competitive practice under Unfair Competition Prevention Act (Japan) 2.1.1 or 2.1.2, and was an infringement of its trademark rights (docket number: Heisei 17 (wa）No. 11663).[12] On July 27, 2006,[13] The Osaka District Court ruled against the plaintiff saying a distinction can be made between the bugle and calabash logos.[12][14][15] Taiko then appealed on August 7, but the Osaka High Court upheld the decision, and the Supreme Court's second Petty bench (Japan)[15] rejected against hearing the case on July 4, 2008,[15] which finalized Taiko's loss in this lawsuit.

But in the opinion read by the court contained this passage: "Whether a certain label is a common name or not is an issue pertaining to perception by users (commercial dealers and consumers at large), so even if a label has been regarded as a common name within a certain period, it may later come to be perceived as denoting a specific product as a matter of the ongoing real situation of its commerce, and it is not impossible for it to regain its source designator (出所表示機, shussho hyōji kinō) (i.e., manufacturer specifying) purpose".

Misinformed drug risk accusation controversy

The primary active ingredient used in seirogan is wood-tar creosote. This was listed merely as "creosote" in the first edition of the Japanese Pharmacopoeia (日本薬局方, Nihon yakkyokuhō), a Ministry of Health issued guidebook, and remained so for a time, until it was listed more specifically as moku-kureosōto (木クレオソート, "wood creosote") in the fifteenth revised first supplement dated 2007,[16] making this the official name. In addition, "a long-term safety study in rats documented a lack of oncogenicity for wood creosote"[17] The second supplement then defined the coal-derivative kureosōto-yu (クレオソート油, "creosote oil") as a separate commodity (containing carcinogenic substances such as Benzo(a)pyrene, a Polycyclic aromatic hydrocarbon[18]). The wood-tar creosote is commonly called "Nikkyoku creosote" (i.e. Japanese pharmacopoeial creosote) as a means to distinguish from potentially harmful industrial creosote.

These recent naming conventions were prompted by a controversy set off by a consumer alert booklet, Katte wa ikenai (買ってはいけない, "Should not buy") (pub. 1999) that anthologized a series run in the magazine Shūkan kin'yōbi. The booklet accused seirogan of its dangers, based on the mistaken notion that the wood-tar creosote and the industrial creosote oil were identical commodities.

Notes
  1. Ahmad I, Aqil F, Owais M (2007). Modern Phytomedicine: Turning Medicinal Plants Into Drugs. John Wiley & Sons. p. 265. ISBN 9783527609536.
  2. Nishioka 2010, pp. 131-; discusses bugle as only recognized trademark; mentions a site that collected 26 different similar looking seirogan brand boxes; on p. 134 is a gallery of 20 different such boxes.
  3. Matsumoto (松本有右); 渡辺謹三,三溝和男 (2011). 正露丸に次ぐ成長の柱「クレベリン」で世界を目指す大幸薬品の勝算. Inside Enterprise; Shukan Diamond (online). 秀和システム. p. 166. ISBN 9784798030708... 整腸薬・下痢止めの成分比較表
  4. "Re: 週刊金曜日『買ってはいけない』特集より（８月２０日号）【正露丸、ラウンドアップ、マクドナルドハンバーガー】その３". ★阿修羅♪ Ψ空耳の丘Ψ３. 19 September 1999. Archived from the original on 2004-03-19. Retrieved 23 April 2014.. The retraction was in the magazine Shūkan Kin'yōbi issue 8/20/1999, special on Katte wa ikenai; excerpt:"正露丸を「漢方薬」としましたが、漢方薬の成分である生薬は使われているものの、厳密には「漢方薬」ではありません。... 正露丸に使われているクレオソートはコールタールを原料とする日本工業規格クレオソート油ではなく、プナの木などから得られる乾留物を精製・蒸留して作る日本薬局方クレオソートでした。...(「回答企業にお応えします」より)
  5. Suehiro I, Kenkyūjo S (1974). "Hōritsu jihō" (snippet). Hōritsu jihō. Nihon Hyōronsha. Retrieved 23 April 2014. 判決によると「正露丸」の名で丸薬を指定商品として商品登録していたのは大阪府吹田市内本町、大幸薬品。二十九年に特許庁で認められたため「正露丸」を製造していた約三十社は「正露丸」の名前を使えなくなった。これに対し大阪府和泉市芦部町、和泉薬品工業..
  6. Kyokuto (2006). "ゆうたんマークのご紹介". Kyokuto website. Archived from the original on 2008-04-25. Retrieved 23 April 2014., says the mascot name Yūtan is a pun on yūtan (熊胆, "bear's gall bladder")
  7. 虫歯の齲窩に直接詰めて使用するが、歯髄が壊死することによって痛みが治まるだけであり、根本的な治療にはならない。また、そのまま放置すると感染が根尖部に広がり、悪化してしまう。(Used by directly stuffing in cavity, but only mitigates pain by causing necrosis of the pulp, and is not treatment that effects fundamental cure. If left otherwise untreated, infection can spread to the roots and worsen the condition)
  8. Machida, Shinobu (町田忍), MacArthur and Seirogan (「マッカーサーと正露丸」)
  9. Gold H (2004). Unit 731: Testimony. Tuttle Publishing. ISBN 9780804835657., p.21-22
  10. Nagai S, Izumi T (2009). 生きつづけるということ: 文学にみる病いと老い (snippet). Vol. 2. メディカルレビュー社. ISBN 9784779203824., quote:"「正露丸」は当初、一九〇二年、中島住一によつて「任露丸(露西亜を任伐するの意)」の商品名によつて製造発売されたが、一九四六年大幸薬品が製造発売するようになり、一九四九年「正露丸」と名称変更"
  11. braina (2005-11-26). "大幸薬品、ひょうたんマーク「正露丸」販売の和泉薬品を提訴". 知財情報局(Braina). Retrieved 23 April 2014.
  12. Wada N (2006). "判例13 「正露丸」事件（有名商標の普通名称化）". Kizuna International Patent Office. Retrieved 23 April 2014.
  13. braina (2006-07-28). "ラッパとひょうたんで識別可能、正露丸訴訟で大幸薬品の請求棄却". 知財情報局(Braina). Retrieved 23 April 2014.
  14. 平成１８年７月２７日判決言渡 平成１７年(ワ)第１１６６３号不正競争行為差止等請求事件 (text of the Osaka Court's opinion)
  15. Kyodo News (共同通信) (2008-07-04). "大幸薬品の敗訴確定 「正露丸」混同せず". 47 News. Retrieved 23 April 2014.
  16. Japanese Ministry of Health Bulletin No. 316, dated 9/28/2007
  17. Kuge T, Shibata T, Willett MS, Turck P, Traul KA (2001). "Lack of oncogenicity of wood creosote, the principal active ingredient of Seirogan, an herbal antidiarrheal medication, in Sprague-Dawley rats". International Journal of Toxicology. 20 (5): 297–305. doi:10.1080/109158101753253036. PMID 11766127. S2CID 26988810.
  18. US Dept. of Health and Human Services 1996 notes a study by Weiner that found incidence of cancer highest in Toyama prefecture where a manufacturer of Seirogan was located, but cautions this cannot be ascertained to be a correlating factor. Besides, Toyama is not the prefecture where the major manufacturer is headquartered.

References
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