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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. *
Status granted, unless specified
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. 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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