Sunday, January 07, 2007

New Jersey libido-enhancing patent stirs controversy

Maca growers and indigenous organizations were outraged when, in 2001, a New Jersey-based company, PureWorld Botanicals, received a U.S. patent for exclusive commercial distribution of an extract of maca's active libido-enhancing compounds that it branded as MacaPure. Peruvian officials called the patent an "emblematic case" of biopiracy and are preparing to challenge it in U.S. courts.

[from Inside Bay Area]

The patent in question would seem to be US 6,267,995, issued July 31, 2001, and entitled Extract of Lepidium meyenii roots for pharmaceutical applications. The assignee is listed as Pure World Botanicals, Inc. The first claim of the '995 patent states:

An isolated composition obtained by extracting Lepidium meyenii roots, said composition being substantially free of cellulose and comprising:

a) between about 5% and about 9% of benzyl isothiocyanate,

b) between about 1% and about 3% of Lepidium sterol component,

c) between about 20% and about 30% of Lepidium fatty acid component, and

d) about 10% or more of macamide component,

said composition being prepared by a process comprising:

i) contacting Lepidium meyenii roots with a first aqueous solvent comprising about 90% vol-% or more water,

ii) separating residual Lepidium meyenii root material from the first contacted aqueous solvent,

iii) contacting the residual Lepidium meyenii root material with a second aqueous solvent comprising a mixture of an alcohol and water having about 90 vol-% alcohol or more to form a liquor, and

iv) concentrating the liquor to obtain the composition.

This claim appears to be a "product by process" claim. One can look at the patent on Google Patents.

Note also US 6,428,824, and

US 6,552,206.

If one is interested in this area, note

US 6,803,060, titled Composition to boost libido , with the first claim reading:
A composition for boosting libido of an individual, said composition consisting essentially of an effective amount 667 mg Tribulus, 427 mg Muria Puama, 352 mg, Catuba Bark, 127 mg L-Arginine, 60 mg Avena Sativa, and 37 IU Vitamin E. The '060 includes the text "...a compound which promotes healthy sexual functioning and insures vaginal lubrication, such as Peruvian Maca."

US 6,444,237 [issued 3 Sept. 2002], titled Herbal composition for enhancing sexual response, with the first claim reading: An orally administered composition of ingredients for enhancing sexual response comprising at least about 1.5 grams of L-arginine, at least about 0.04 grams of L-theanine, and effective amounts of each of the following: L-glutamic acid, crataegus monogyna berry extract, turnera diffusa extract, pfaffia paniculata extract, ginkgo biloba extract, pygeum africanum extract, and ginsenoside, wherein said extracts include concentrates of water-soluble or alcohol-soluble plant components. The '237 includes the text: In a preferred embodiment of the present invention the composition further includes effective amounts of BEC and Lepidium meyenii ("Maca"), a traditional Peruvian aphrodisiac. Additionally, Maca has been shown to improve sexual response in rats substantiating long held claims to its traditional use. BEC has been found to bind to and inhibit arginase, the enzyme that digests arginine before it can be used to produce nitric oxide. BEC and Maca together provide an effective enhancement to this formula.

Also on product-by-process claims:

Gregory S. Maskel, Product-by-Process Patent Claim Construction: Resolving the
Federal Circuit's Conflicting Precedent, 17 Fordham Intell. Prop. Media & Ent. L.J. 115 (2006).

The law review article mentioned the paroxetine case:

In this recent case, SmithKline Beecham sued Apotex for infringing its
patent for the drug Paxil (whose chemical name is paroxetine). n106 The
district court granted summary judgment for [p. 132] Apotex, holding that the patent at issue was anticipated by a previous patent held by SmithKline. n107 The
patent at issue claimed the compound paroxetine, but did not define it in terms
of its structural characteristics, instead claiming the compound as the end
result of the process required to make the pill. n108 The prior art reference was
an invalid patent n109 obtained by SmithKline that covered paroxetine as a
compound without any reference to process steps. n110
[SmithKline Beecham v. Apotex, 439 F.3d 1312, 1313 (Fed. Cir. 2006).]

The law review did not appear to discuss Exxon v. Lubrizol.


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