In the U.S. Court of Appeals for the Federal Circuit case Perricone v. Medicis Pharm. Corp. (case 05-1022, 05-1023), decided December 20, 2005, summary judgment of invalidity and non-infringement on claims in a patent infringement case involving methods of treating sunburns and skin damage was reversed because the district court erred in its anticipation analysis with respect to certain claims noting that sunburn is not a species of the genus of skin disorders. The Federal Circuit held that skin sunburn is not analogous to skin surfaces generally and that there is a distinction between topical application to skin for the purpose of avoiding sunburn, and topical application to skin sunburn.

Earlier, Dr. Nicholas Perricone sued Medicis Pharmaceutical Corp, alleging that Medicis infringed its patents with its prescription skin depigmenters. On summary judgment, the United States District Court for the District of Connecticut determined that all of the asserted claims of Dr. Perricone’s U.S. Patent Nos. 5,409,693 (the ’693 patent) and 5,574,063 (the ’063 patent) were invalid and, as to the ’693 patent, not infringed. Perricone v. Medicis Pharm. Corp., 267 F. Supp. 2d 229 (D. Conn. 2003). The court affirmed the trial court’s decisions of anticipation based on inherency for the remaining claims of the ’693 and ’063 patents and its double-patenting analysis with respect to claims 9, 11-13, 16, 18, and 19 of the ’063 patent.

The district court noted that “sunburn is a species of the genus of skin disorders” covered by the ’063 patent and concluded that the claimed effective amount in the ’063 patent falls within the ranges of effective amounts in the ’693 patent.

Dr. Perricone’s patents claim methods of treating or preventing sunburns (the ’693 patent) and methods of treating skin damage or disorders (the ’063 patent). Both patents disclose essentially the same subject matter, that is, treatment or prevention of various forms of skin damage through the topical application of ascorbic acid (Vitamin C) in a fat soluble form. Specifically, the patents disclose the topical application of ascorbyl fatty acid ester (e.g., ascorbyl palmitate, ascorbyl laurate, ascorbyl myristate, ascorbyl stearate) with a dermatologically acceptable carrier. Because the carrier, as well as the ascorbyl fatty acid ester, is fat soluble, it can “effectively penetrate skin layers and deliver the active ascorbyl fatty acid ester to the lipid-rich layers of the skin.” 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.

The district court determined that U.S. Patent No. 4,981,845 (Pereira) anticipates claims of the ’063 patent because Pereira teaches a cosmetic composition for topical application and discloses various ingredients in that composition, including skin benefit ingredients, emollients, emulsifiers, and thickeners. In addition to listing examples, Pereira discloses eight distinct example compositions with specific concentrations of ingredients. Pereira identifies the disclosed compositions only briefly, identifying them as “suitable for topical application to the skin or hair.” The district court concluded that Pereira’s disclosed use anticipates Dr. Perricone’s claims because Pereira’s disclosed compositions include all the various ingredients in the concentrations claimed by Dr. Perricone. Thus, according to the district court, the topical application of Pereira’s compositions would necessarily yield Dr. Perricone’s claimed skin benefits.

On appeal, Dr. Perricone argued that: (1) Pereira’s disclosed skin benefit ingredients include ascorbyl palmitate among many others, and so Pereira’s disclosure does not anticipate the specific claimed use of ascorbyl palmitate; (2) Pereira’s disclosed range of concentration of its skin benefit ingredient only partially overlaps with Dr. Perricone’s claimed range; and (3) Pereira does not disclose any benefit directed to skin sunburn, or any of the other specific skin disorders, as claimed by Dr. Perricone.

The court held that:

With respect to the particular claimed skin benefits, the district court reasoned that “Pereira will inherently function in [the claimed beneficial manner] when topically applied to the skin.” Perricone, 267 F. Supp. 2d at 248. Thus, the district court ultimately based its anticipation analysis on inherency. “In general, a limitation or the entire invention is inherent and in the public domain if it is the ‘natural result flowing from’ the explicit disclosure of the prior art.” Schering, 339 F.3d at 1379 (citing Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 970 (Fed. Cir. 2001); In re Kratz, 562 F.2d 1169, 1174 (CCPA 1979)). In some cases, the inherent property corresponds to a claimed new benefit or characteristic of an invention otherwise in the prior art. In those cases, the new realization alone does not render the old invention patentable. See Atlas Powder, 190 F.3d at 1347 (“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s function, does not render the old composition patentably new to the discoverer.”); Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) (explaining that newly discovered results of known processes are not patentable because those results are inherent in the known processes). Thus, when considering a prior art method, the anticipation doctrine examines the natural and inherent results in that method without regard to the full recognition of those benefits or characteristics within the art field at the time of the prior art disclosure.

Like the district court, the dissent seems to ignore, or at least dismiss as “not substantial[],” the distinction between Dr. Perricone’s claimed method and Pereira’s disclosed method. Thus, the dissent characterizes both methods the same way: “Pereira describes not only the same product that is claimed in the sunburn patent, but also the same method of using it, i.e., topically applying it to the skin in an amount necessary to have beneficial effects on the skin.” Unfortunately, the dissent can make that statement only by dismissing the explicit language of Dr. Perricone’s claimed method: “applying to the skin sunburn.” ’693 patent, claim 1. Skin sunburn is not analogous to skin surfaces generally. Thus, there is an important distinction between topical application to skin for the purpose of avoiding sunburn, and the much narrower topical application to skin sunburn. That distinction highlights the flaw in the dissent’s knee brace hypothetical, which suggests that a particular prevention method necessarily anticipates a treatment method. To use a more apt analogy, the disclosure that a sunburn can be prevented by wearing a hat clearly does not anticipate a claim to the discovery that one can treat an existing sunburn by putting on a hat. The dissent attempts to bolster its analogy by comparing the mechanism underlying its knee brace analogy to Dr. Perricone’s invention. With that comparison, the dissent drifts even farther from the facts of this case. The alleged anticipating reference here is Pereira, not Dr. Perricone’s own teachings. Pereira is silent about any sunburn prevention or treatment benefits, not to mention the mechanisms underlying such uses. If Pereira did teach sunburn prevention, as well as the mechanism behind that prevention, those teachings might suggest that Dr. Perricone’s sunburn treatment claims would have been obvious. However, those unrealized possibilities do not alter the analysis in this case where Pereira does not disclose topical application to skin sunburn.

Thus, the court reversed the summary judgment of invalidity and non-infringement for the defendant.

See the opinion here.

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