Allergan Inc. & Anor -v- Ocean Healthcare Ltd, [2008] IEHC 189 (2008)

Docket Number:2007 4458 P
Party Name:Allergan Inc. & Anor, Ocean Healthcare Ltd
Judge:McGovern J.
 
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THE HIGH COURT2007 4458 PBETWEENALLERGAN INC. AND ALLERGAN PHARMACEUTICALS

(IRELAND) LTD.PLAINTIFFSAND

OCEAN HEALTHCARE LTD.DEFENDANT

JUDGMENT of Mr. Justice Brian J. McGovern delivered on 24th day of June, 2008

  1. In this case, the plaintiffs claim that the defendant has infringed the first named plaintiffs' registered "BOTOX" Trademarks listed in the Schedule to the Plenary Summons, and they also claim that the defendant is guilty of passing off goods as or for the goods of the plaintiffs under or by reference to their name or Mark, BOTOINA.

    The facts

  2. The plaintiffs are members of the Allergan Group of companies which produces, markets, and sells pharmaceutical products throughout the world. This case concerns one of the better known pharmaceutical products produced by the plaintiffs, namely, 'BOTOX'. This product is a preparation containing a purified form of Botulinum Toxin Type A. The product has been a great success for the plaintiffs. The first named plaintiff is a company incorporated under the laws of Delaware in the United States of America and is the owner of various registered Trademarks throughout the world in respect of BOTOX. The second named plaintiff is the holder of a licence from the first named plaintiff to use its Trademarks and to manufacture Botox. The second named plaintiff holds the product authorisation in this jurisdiction from the Irish Medicines Board and this allows it to manufacture the product. The court has been informed that the worldwide supply of Botox. is manufactured in the second named plaintiff's plant in Westport, County Mayo.

    Botox

    Throughout this judgment, when I refer to BOTOX, I mean the off-label use of the product in the treatment of facial lines or winkles except where I state otherwise.

  3. The Botox Trademark is a very important Intellectual Property asset of the plaintiff companies. The plaintiffs claim that it is the best known purified Botulinum Toxin product and that it has become a household consumer name. It is available for both therapeutic and cosmetic uses. The plaintiffs claim that the name 'Botox' is not interchangeable with any other Botulinum Toxin preparation and that it is a brand which has distinguished its product from other preparations of Botulinum Toxin since its launch in Ireland and elsewhere. The plaintiffs claim that if others were entitled to freely refer to other Botulinum Toxin products under the name 'Botox', the plaintiffs would not only lose its valuable exclusivity in the market, but that many Irish medical practitioners who use the product would no longer be certain which preparation they are using and this would have safety implications for patients. If this were to occur, there would be detrimental repercussions for the plaintiffs.

  4. Botox is a prescription only product which has therapeutic and cosmetic applications. It must be prescribed by a registered medical practitioner and can only be provided from a pharmacy. It is administered either by doctors, dentists or other people with medical training. In its cosmetic application, it is administered by means of a micro needle and syringe. Botox contains, as its active ingredient, Botulinum Toxin Type A in a purified form. The defendant's product, which is complained of, namely, Botoina, does not contain Botulinum Toxin Type A or any other type of Botulinum.

  5. Botulinum Toxin is a potent protein that acts specifically on nerve cells. It is produced by the bacterium, Clostridium Botulinum, which is commonly found in soil. Botulinum Toxin was first recognised and isolated in the late 1890s. When it is purified for medical use, Botulinum Toxin does not contain any bacteria but contains a tiny amount of the chemical protein secreted by the bacterium, Clostridium Botulinum. There are seven known stereotypes of Botulinum Toxin which are designated by the letters A, B, C, D, E, F and G. Each stereotype varies in its potency and effects. Between the 1920s and 1940s, Botulinum Toxin Type A was isolated in a purified form. In the 1950s, it was discovered that injecting Botulinum Toxin into a hyperactive muscle, blocked the release of Acetylcholine from motor nerve endings, thereby inducing a temporary relaxation of the targeted muscle. This gave rise to an interest in creating medical therapeutic products derived from Botulinum Toxin.

  6. In the late 1960s, Dr. Alan Scott, a Clinical Researcher and Ophthalmologist, in San Francisco, began to investigate Botulinum Toxin Type A in pre-clinical studies for the treatment of Strabismus, which is a condition producing "crossed eye" or squint. In the course of his research and trials, Dr. Scott found that if Botulinum Toxin Type A was used in a particular formulation and was injected into certain muscles, it would correct the squint. In the 1980s, a Canadian physician observed that patients who had been treated for Blepharaospasm (Involuntary Eyelid Closure), with Dr. Scott's product showed a reduction in the appearance of the Glabellar Furrows, which are the vertical lines between the eyebrows. This was attributed to the relaxation of the brow muscles. It came to be understood that when Botulinum Toxin Type A was administered as an injection into specific muscles, it attached itself to the nerve endings and was internalised into the nerve. This was followed by a blockage of the release of Acetylcholine, the neurotransmitter responsible for triggering muscle contractions. The treatment resulted in a very effective reduction or elimination of dynamic lines and wrinkles in the face. In the course of this case, Professor Mitchell Francis Brin, gave evidence that during the 1980s, he began, with other colleagues at Colombia University, to undertake a number of clinical studies on patients using injections of Dr. Scott's product, for a range of Dystonias and other disorders resulting in abnormal muscle contraction.

  7. Dr. Brin became involved in discussions with Allergan Inc., in relation to the development of Dr. Scott's product for a range of therapeutic uses in the late 1980s. Around this time, Allergan acquired certain rights to Dr. Scott's product and was interested in marketing the product in the future under the name BOTOX.

  8. Dr. Brin gave evidence to the court that he and his Colombia University colleagues coined the name BOTOX in or around 1986 while studying patients using injections of Dr. Scott's product for therapeutic purposes. At that time, there were two Botulinum Toxin Type A products formulated for human use available, namely, the Dr. Scott product and that being developed by Porton Down in the United Kingdom, which became known as DYSPORT. Dr. Brin and his colleagues were looking for a way of presenting the Dr. Scott`s Botulinum Toxin derived product to patients. The product had been called Oculinum. Dr. Brin considered using the letters 'BTX' and this then was changed to 'BOTOX'. 'Oculinum' referred to the ophthalmic use of the Dr. Scott product but Dr. Brin was using it for a broad group of neurological disorders under a research protocol and for that purpose called it Botox. The plaintiffs contend that the word Botox specifically refers to the purified Botulinum Toxin Type A as used in Dr. Scott's product which was subsequently acquired by the plaintiffs and to distinguish it from any other type of Botulinum Toxin Type A. In the late 1980s, Dr. Scott approached Allergan Inc .to distribute his product for commercial purposes. Allergan Inc. acquired the rights to research, develop, market and sell Dr. Scott's Botulinum Toxin product in 1988, and subsequently Allergan purchased the assets of Dr. Scott's company, Oculinum Inc., including the rights in Dr. Scott's Botulinum Toxin product.

  9. The product has become a great success for the plaintiff companies and is now widely sought after by people throughout the world who wish to eliminate facial wrinkles or lines. The product comes in a vial in vacuum dried form and is diluted with sterile, non-preserved saline, for injection. The product is injected directly and very precisely into selected muscles with a micro-needle. It blocks the signals which would normally cause muscle spasms or contractions. In the cosmetic field, Botox can be used to treat horizontal "worry lines" on the forehead and certain other facial lines and wrinkles. Frowning, raising the eyebrows, and other habitual facial contractions cause wrinkling in this area and the repeated exercise of the forehead muscles crumple the skin on the forehead producing lines and wrinkles...

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