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To: axial who wrote (8999)3/10/2002 8:38:08 PM
From: padco  Read Replies (1) | Respond to of 14101
 
Jim, here we go - Beckysboss to the rescue. BTW, he claims you have him on ignore. Oh well, I don't want to get involved in that. This is what he posted on SH. . .

I noted your discussion on the patent for Pennsaid on SI, here is the patent and some summary info. The patent is for the formula, not the ingredients as they are beyond patent life(diclofenac/DMSO). Simply put it is the mixture/formula of DMSO, diclofenac, propylene glycol, water as a solution that is patented.

Propylene glycol is used in many sunscreen and cosmetic products, it assists in reducing the drying by reducing evaporation of moisture from the skin caused by DMSO and as a stabilizer within the liquid mix. Dermatitis is noted as an issue with prolonged use of DMSO.

Patent law (Hatch-Waxman Act and the Uruguay Round Agreements Act of 1994 ) imply a patent life 20 years from application filing (the earliest relevant filing date)which would suggest this patent comes off May 15/2004 based on the filing date. I am no patent expert but given the nature of Pennsaid as a formula it is doubtful it would qualify for an extension to the patent as a 'drug' as defined by the Hatch-Waxman act. I believe DI7026 has also mentioned that this is not a new drug as defined by the FDA. This is part of what motivated me to ask the question is Becky looking for OTC status. Patent lawyers I am sure could raise questions with my opinion.

Clark Pharmaceutical became Dimethaid many years ago.

You can verify all of this at the U.S. Patent website:

uspto.gov

Pharmaceutical solutions comprising dimethyl sulfoxide

United States Patent 4,575,515
Sandborn March 11, 1986

Inventors: Sandborn; Edmund (Burlington, CA)
Assignee: Clark Pharmaceutical Laboratories Ltd. (Weston, CA)
Appl. No.:610590
Filed: May 15, 1984

United States Patent 4,652,557
Sandborn
March 24, 1987

The embodiments of the invention in which an exclusive property or privilege is claimed are as follows:

1. A deep and rapidly penetrating homogeneous solution for topical application causing medicine to penetrate
deeply into affected parts of the body without irritating the skin or leaving a greasy film on the skin when the
solution is applied topically, the solution comprising:

(a) between about 40% and about 85% DMSO by weight of the solution;

(b) a polyalcohol for assisting to retain moisture in the skin and prevent the skin from dehydrating;

(c) a dispersant for assisting to disperse the components in the solution to provide a homogeneous solution
when applied and when penetrating the skin;

(d) triethanolamine salicylate;

(e) water.

SUMMARY OF THE INVENTION

According to one aspect of the invention, a deeply and rapidly penetrating homogeneous solution for topical application causing medicine to penetrate deeply and rapidly into affected parts of the body without irritating the
skin or leaving a greasy film on the skin when the solution is applied topically is provided, the solution comprising:

(a) between about 40% and about 85% DMSO by weight of the solution, more preferably between about 60%
and about 70% DMSO by weight of the solution of most preferably about 65% DMSO by weight of the solution;

(b) a polyalcohol, preferably having 3-5 carbon atoms, for the retention of moisture in the skin, in one
embodiment, glycerol or glycerine;

(c) a dispersant for assisting to disperse the components in solution to provide a homogeneous solution when
applied to the skin and when penetrating the skin, in one embodiment propylene glycol;

(d) a medicine, for example Naproxen and Diclofenac dissolved in the solution;

(e) water.