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Creatine Patents |
Howard Foundation and its Creatine Patents
Background
and Introduction
Professor Roger Harris (biochemist) and Professor Eric Hultman (doctor of medicine), who
had worked together in the Department of Metabolic Research at St Eriks
Hospital, Stockholm (1968-76) and subsequently at the Huddinge University
Hospital, Stockholm (1981-92), were interested to see if the muscle
performance of mammals could be enhanced by supplementation with
creatine. A research team led by
Harris and Hultman investigated creatine as a supplement for use in humans,
and concluded that it was possible to increase the muscle
creatine-phosphorylcreatine pool which in turn increased the capacity of
the individual to perform sustained or intermittent strenuous
exercise. In addition the period for
the restitution of phosphorylcreatine levels after work was shortened. They also ascertained that such
supplements could increase body mass in humans. Harris and Hultman filed international
patent applications in July 1993, entitled Method of Inceasing Creatine Supply Depot, in collaboration with Pharmacia. Despite the subsequent widespread use of
creatine by athletes and other sportsmen, largely in the form of capsules
or free powder, they did not maintain the patents in countries other than the US, Canada, Australia and
New Zealand. The Howard Foundation
purchased these patents in 2001, and have maintained them since. The Howard Foundation then engaged the US
law firm, Patton Boggs LLC of Washington, D.C. to act for its commercial
affiliate, Original Creatine Patent Company Limited and now owner of its US
creatine patents to license and enforce them against companies
commercialising products within the claims of the patents within the
US. This has led to eight cases
where such companies settled out of court by accepting a licence for
consideration under the terms of one or more of the patents, additionally
acknowledging their validity. In some cases, the settlements included additional creatine patents developed by the Howard Foundation and Professor Harris from 1996 onwards, which are also detailed in the schedules below. Whilst loading doses as high as 20g per day can be used to elevate muscle creatine content, it was believed that a wider range of the public would benefit from smaller doses of 2 to 5 g per day given over a longer period. New patents filed from 1997 onwards contain claims claims covering a wide range beverages and foodstuffs containing creatine. In addition to benefitting athletes and others involved in power, intermittent-sprint and endurance-type sports or events, research has pointed to an improvement in mental accuity in the elderly, as well as younger persons under stress, such as those working long or untimely hours, from students to nightworkers, forces under active service and even sole-transoceanic sailors. Such is the range of research work currently being undertaken that Howard Foundation is organising a major Conference on recent developments to be held at Cambridge University in July 2010: see www.creatineconference2010.org. Commercial affiliates of Howard Foundation working through Quantum Nutritionals LLC of Michigan from 2001 onwards, established a product development project that led to commercially available gels and drinks that fall within the claims of some of the patents. A number of voluntary licences and agreements under the patents were signed in North America, and the UK. However, due to commercial and technical factors none of these formulations are currently in production. Realising the need to collaborate with a larger entity with worldwide marketing ability, in 2006 Howard Foundation approached Degussa AG, a large German-based chemical manufacturer, which already manufactured creatine at its plant in Bavaria. This led in 2007 to an exclusive licence granted to its affiliate AlzChem Trostberg GmbH in respect of all Howard Foundation’s creatine patents outside North America, and in 2008 to a separate licence to its North American patents. AlzChem is thus able to supply licensed creatine of a high standard under its Creapure brand worldwide: see www.creapure.com.
Schedule 1: Creatine patents outside North America
All are
owned by Howard Foundation and licensed exclusively to AlzChem Trostberg
GmbH Where possible
the respective patents are available to view in Adobe pdf format. Please
click on the relevant number to view.
Schedule 2: Creatine
Patents in North America and Loading Dose Patents Worldwide All are owned by
Howard Foundation, and those in United States by its affiliate, Original
Creatine Patent Company Limited, a UK registered company. All are licensed
non-exlusively to AlzChem GmbH, with the exception of the Loading Dose
patents for Australia and New Zealand.
Schedule 3:
Claims of Patents and Examples of Products The descriptions
below are summaries taken from published patents as a guide to their
scope. The claims and other details
within any given patent should be referred to for any authoritative
reference or guide, and it should be further noted that modifications have
been imposed in some cases by national examiners as a condition of
acceptance and grant of them. Increasing
Creatine Supply Depot These patents claim comprise the method of making and supply of
Creatine, when supplied for human consumption when used in connection with
intensive activity. Thus, where
Creatine is supplied, preferably in
several separate doses, in an amount
of 15 to 30 grammes per day, or 0.2 – 0.4g/kg body weight, it
prevents the effects of depletion of the muscle phosphoryl-creatine store
during intensive activity, and thereby improves the capacity of the
muscles, and shortens the recovery phase. Creatine may be supplied in a pure form, as salts or following
other chemical modifications, or in combination with conventional nutrients
such as lipids, carbohydrates, amino acids, electrolytes, trace elements,
and vitamins. Creatine
Drink Compositions These patents comprise the method of making and supply of creatine
in dry powder, liquid or semi liquid
such that when incorporated into a substance with acidic pH: i) conversion of creatine to creatinine is
lower, thus extending the shelf life of the product; ii) further shelf life
is obtained by storage in a commercial chiller cabinet e.g. 4 to 8 degreees
C.; iii) as a dry powder which when mixed or dissolved in liquid has
substantially undiminished creatine content, with a range per drink of 0.5g
to 30g. Thus physiologically effective quantities of creatine can be
provided as a powder to make up into an isotonic drink, or a prepared
foodstuffs such as flavoured drinks, or semi-solid foodstuffs such as
yoghurt, with the possibility of enhancement by the addition of
electrolytes, lipids, sweeteners, colouring, clouding agents and minerals. Creatine in Suspension These patents comprise the method of making and supply of creatine
suspended in an edible viscous liquid or semi-liquid supporting matrix, The composition may be provided in solid, liquid or semi-liquid
form, such as a gel, drink, soup or yoghurt, through any active form of creatine,
within the range 5 to 300g of prepared composition. Creatine and
Creatinine These patents comprise the method of making and supply of
compositions comprising creatine and creatinine and to a method of
providing stable creatine-containing compositions, through the addition of
creatinine (used hitherto as a meat or savory flavoring agent) to
compositions intended to have a flavor (especially a fruit flavor) other
than meaty or savory. Creatine becomes suspended in the foodstuff in a composition provided
as a liquid, semi-liquid, edible matrix or solid for subsequent solution in
water. Practical examples would be
spreadable solids such as dairy or cheese spreads, margarines and other
such spreads, fish and meat spreads; or by using sugar or carbohydrate
bases, such as honey, molasses, syrup, treacle, glycerol or energy gels. The claims incorporate drinks suitable for refrigeration containing
up to 1.2g creatine/100 ml or for storage at ambient temeratures of 18 to
25 degrees C up to 1.5g cratine/100ml. Creatine,
Creatinine and Methyl Xanthine This is a US
Continuation in Part patent to the Creatine and Creatinine patent (above)
and comprises the method of making and addition of methyl xanthine (for
example, caffeine), especially in aqueous solutions for drinks, using
methyl xanthine for stablility.
Included are further treatments to prepare the beverage commercially
through heating and adjustment of parameters such as pH/water levels. Examples would
be caffeine-containing (in a dose 10 to 1000 mg) beverages to be used by
sportsmen and others wishing to enhance physical activity or recovery after
exercise. Creatine Bar
with Low Glycemic Index This patent comprises a method of making and supply of food
compositions in an edible supporting matrix, preferably in the form of a
solid or semi-solid snack bar, to deliver creatine, and provides the
additional properties that the creatine is stable. The snack bar envisaged ranges from 15 to
250g and containing 2 to 5g creatine. Schedule IV:
Licenses Completed Subsequent to Litigation Howard Foundation previously, and now in
conjunction with its licensee AlzChem, has defended and will defend the
creatine patents, through litigation or other legal means. The following licences were concluded after
litigation by Original Creatine Patent Company Limited (affiliate to the
Howard Foundation) in various US courts commenced from 2002 onwards, all
under the US Patent 5767159 and 5968544 in respect of US territory, unless
further noted: Date of Agreement Defendant
1 June 2003 Twin
Laboratories Inc, Utah
1 July 2003 Optimum
Nutrition Inc, Florida. 29 October 2003
Kaizen Inc, California 13 September 2004
Muscletech Research & Development Inc, Ontario (Included 6274161, 6524611
and foreign equivalents; license extended to Iovate Sciences Group Inc.) 8 July 2005 Extreme
Labs-Muscle Energy, Nevada. 2 March 2006
Universal Nutrition Inc, New Jersey 27 March 2006
AST Sports Science Inc, Colorado 24
August 2007
Dymatize Enterprises Inc, Texas |
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