Perricone v. Medicis Pharmaceutical Corp.
| Decision Date | 20 March 2008 |
| Docket Number | No. 3:99-CV-1820 CFD.,3:99-CV-1820 CFD. |
| Citation | 539 F.Supp.2d 571 |
| Parties | Nicholas V. PERRICONE, M.D., Plaintiff v. MEDICIS PHARMACEUTICAL CORPORATION, Defendant. |
| Court | U.S. District Court — District of Connecticut |
Brian P. Daniels, Carolyn W. Kone, David R. Schaefer, Rowena Amanda Moffett, Brenner, Saltzman & Wallman, New Haven, CT, Brian E. Ferguson, David A. Spenard, Jennifer C. Chen, Laura E. Eversole, Mary C. Chapin, Raphael V. Lupo, Charles R. Work, Evan A. Parke, Natalia Blinkova, McDermott, Will & Emery-DC, Washington, DC, Stephen P. McNamara St. Onge, Steward, Johnston & Reens, Stamford, CT, for Plaintiff.
Andrea Rea, Christopher K. Walters, Ira Lefton, Maryellen Feehery, Tracy Z. Frisch, Reed, Smith, Shaw & McClay, Heather A. Ritch, William J. McNichol, Jr., Reed Smith, LLP, Philadelphia, PA, Calum B. Anderson, Christopher J. Coxon, R. Cornelius Danaher, Jr., Danaher Lagnese & Neal, P.C., Hartford, CT, for Defendant.
RULING ON MOTIONS FOR SUMMARY JUDGMENT
The plaintiff, Nicholas V. Perricone, M.D., filed this action against the defendant, Medicis Pharmaceutical Corp., alleging infringement of U.S. Patent No. 5,409,693 (filed Mar 1, 1993) entitled "Method for Treating and Preventing Sunburn and Sunburn Damage to the Skin" (the "'693 Patent") and U.S. Patent No. 5,574,063 (filed mar. 17, 1995), entitled "Method and Compositions for Topical Application of Ascorbic Acid Fatty Acid Esters for Treatment and/ or Prevention of Skin Damage" (the "'063 Patent").
In December 2005, the United States Court of Appeals for the Federal Circuit affirmed this Court's ruling that claims 1 through 19 of the '063 patent, and claims 8, 9 and 13 of the '693 patent were invalid. Perricone v. Medicis Pharmaceutical, Corp., 432 F.3d 1368 (Fed.Cir.2005). However, the Federal Circuit reversed this Court's ruling that claims 1 through 4 and 7 of the '693 patent were invalid and remanded for further proceedings on these claims.
Dr. Perricone's 693 patent, col.4, ll.4-6. Upon reaching the lipid-rich layers of skin, the ascorbyl fatty acid ester produces a number of beneficial effects ranging from the acceleration of collagen synthesis to the scavenging of oxygen-containing radicals caused by exposure to damaging ultraviolet radiation. See '693 patent, col.5, ll.30-35, col.6, ll.35-50.
A. The Remaining Claims of the '693 Patent
Currently at issue are five of the remaining claims of the '693 patent. Claim One, the only remaining independent claim, reads:
1. A method for treating skin sunburn comprising topically applying to the skin sunburn a fatty acid ester of ascorbic acid effective to solubilize in the lipidrich layers of the skin an amount effective to scavenge therefrom free radicals present as a result of transfer of energy to the skin from the ultraviolet radiation which produced said sunburn.
The other, dependent, claims at issue specify that the ascorbyl fatty acid ester be delivered in a "dermatologically acceptable carrier" (Claim Two), that a specific ascorbyl fatty acid ester be used (Claims 3 and 4) and that Vitamin E be added to the composition (Claim Seven).
As set forth in this Court's previous summary judgment ruling:
"Skin sunburn," as disclosed in claim 1, is a type of skin damage caused by ultraviolet radiation. The cause of sunburn is believed to be the generation of oxygen species resulting from the transfer of energy from ultraviolet radiation to the skin. Those oxygen species are referred to as "free radicals" and can cause damage to the DNA of the cells. Skin sunburn covers a spectrum of clinical symptoms from mild increased sensitivity of the skin to severe pain. In addition, inflammatory redness of the skin, referred to as "erythema," may accompany the Sensitivity of the skin. Sunburn damage, as described in claim 8, includes damage to the skin membranes, skin cells, DNA, erythema, premature aging of the skin, cancerous growths of the skin, and diminished collagen content. Collagen is a protein that serves as the support structure for the skin and other connective tissues.
"Topically applying" refers to applying a substance directly to the surface of the skin, in contrast to oral, intravenous, or other administration.
A "fatty acid ester of ascorbic acid" is a form of Vitamin C that is fat-soluble. "Soluble" means capable of being dissolved. "Fatty acid" refers to any acid derived from fats by a chemical reaction with water. "Ester" refers to an organic compound that is usually formed by the reaction between an acid and an alcohol with elimination of water. A "fatty acid ester of ascorbic acid" is also referred to as an "ascorbyl fatty acid ester." The class of chemical compounds known as ascorbyl fatty acid esters includes ascorbyl palmitate, ascorbyl laurate, ascorbyl myristate and ascorbyl stearate.
"Effective to solubilize" refers to the ability of the ascorbyl fatty acid ester to be, dissolved and readily absorbed through the skin's surface and delivered to its intended target.
"Lipid-rich layers of the skin" are layers of the skin which contain abundant amounts of lipids. "Lipids" are fat-containing organic compounds. The epidermis and dermis layers are lipid-rich layers of the skin. The epidermis is the outermost layer of the skin, functions as a protective barrier, and consists primarily of cells named keratinocytes, which produce the protein known as keratin, and melanocytes, which produce pigment in the skin. The dermis is the middle layer and is a tough, supportive connective tissue matrix connected to the epidermis. The dermis principally consists of collagen, but also contains fibroblasts, a type of cell that synthesizes collagen, among other functions. "Effective to solubilize in the lipid-rich layers of the skin" therefore means that the ascorbyl fatty acid ester is capable of penetrating the skin's surface and is available to the epidermis and dermis layers of the skin.
"Free radicals" are atoms or molecules having at least one unpaired electron. They are created during an energy transfer that takes place when ultraviolet radiation hits the skin. Because free radicals have an unpaired electron, they naturally seek to normalize (or stabilize) themselves by attacking neighboring molecules and capturing their free electrons. When they attack lipid cell membranes in the skin, free radicals produce a host of dangerous chemicals which can injure cell membranes and impair the proper function of cells. Free radicals may be neutralized or "scavenged" by certain substances that capture the free electron to render the free radical harmless. An ascorbyl fatty acid ester is capable of "scavenging" free radicals when it solubilizes in the lipid-rich layers of the skin.
The amount of ascorbyl fatty acid ester "effective" to scavenge free radicals depends upon the particular disorder, its severity and extent, the particular ascorbyl fatty acid ester employed, and its concentration.
A "dermatologically acceptable carrier" means that the carrier should resist washing off and should aid in delivery and penetration of the ingredient ascorbyl fatty acid ester into the lipid-rich layers of the skin.
Perricone v. Medicis Pharmaceutical Corp., 267 F.Supp.2d 229, 235-36 (D.Conn. 2003).
Dr. Perricone alleges that Medicis infringed the '693 patent with its LUSTRA® line of prescription skin depigmenters. LUSTRA® is a cream that, with hydroquinone as its active ingredient, reduces the production of melanin, i.e., the pigment in skin. LUSTRA® also includes ascorbyl palmitate and Vitamin E.
The general standard for summary judgment applies in a patent case. See Brown v. 3M, 265 F.3d 1349, 1350 (Fed. Cir.2001) (); Tech-Search, L.L.C. v. Intel Corp., 286 F.3d 1360, 1369 (Fed.Cir.2002) (). Accordingly, as to each motion for summary judgment, the burden is on the moving party to establish that there are no genuine issues of material fact in dispute and that it is entitled to judgment as a matter of law. See Fed.R.Civ.P. 56(c); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 256, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). A court must grant summary judgment "`if the pleadings, depositions, answers to interrogatories, and admissions on file, together with affidavits, if any, show that there is no genuine issue as to any material fact....'" Miner v. Glens Fails, 999 F.2d 655, 661 (2d Cir.1993) (citation omitted). A dispute regarding a material fact is genuine "`if the evidence is such that a reasonable jury could return a verdict for the nonmoving party.'" Aldrich v. Randolph Cent. Sch. Dist., 963 F.2d 520, 523 (2d Cir.1992) (quoting Anderson, 477 U.S. at 248, 106 S.Ct. 2505, 91 L.Ed.2d 202). After discovery, if the nonmoving party "has failed to make a sufficient showing on an essential element of [its] case with respect to which [it] has the burden of proof," then summary judgment is appropriate. Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).
A patent is presumed to be valid under 35 U.S.C. § 282. Thus, an accused infringer must prove invalidity by clear and...
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