Nicholas v. Perricone, M.D. v. Medicis Pharmaceutical Corporation, Defendant-Cross

BRYSON, Circuit Judge,

concurring in part and dissenting in part.

I concur in most aspects of the court’s opinion, including the portions upholding the district court’s ruling that claims 1-19 of the “skin disorder” patent, U.S. Patent No. 5,574,063, and claims 8, 9, and 13 of the “sunburn” patent, U.S. Patent No. 5,409,693, are anticipated by U.S. Patent No. 4,981,845 (“the Pereira patent”). I dissent, however, from the portion of the judgment holding that the Pereira patent does not anticipate claims 1-4 and 7 of the sunburn patent. In my view, the differences between the claims that the court invalidates and those that it holds not to be invalid do not justify a difference in outcome. The written description of the sunburn patent is identical to the pertinent portions of the written description of the skin disorder patent in all material respects. The only significant difference between the two patents for present purposes is that the sunburn patent claims methods for treating and preventing sunburn comprising the topical application of the composition described in the specification, while the skin disorder patent claims a method for treating skin disorders comprising the topical application of the same composition. Moreover, the only difference between the claims of the sunburn patent that this court invalidates and those *1382that it upholds is that the former recite methods for preventing sunburn while the latter recite methods for treating sunburn. The differences between the sunburn and the skin disorder patents, and among the claims of the sunburn patent, simply highlight inherent features of the compositions that are disclosed both in the common written description of the two patents in suit and in the Pereira patent. Under our precedents, those differences do not suffice to avoid anticipation.

Claim 1 of the sunburn patent recites:

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 lipid-rich 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.

Dependent claims 2-4 and 7 recite a method for treating skin sunburn in which the fatty acid ester of ascorbic acid is topically applied to the skin in the form of a composition including a dermatologically acceptable carrier (claim 2), in which the fatty acid ester of ascorbic acid is selected from a group including ascorbyl palmitate (claim 3), in which the fatty acid ester of ascorbic acid is ascorbyl palmitate (claim 4), and in which the composition includes Vitamin E (claim 7). Independent claim 8 and dependent claims 9 and 13 are similar to claims 1, 2, and 7, except that they recite a method for preventing sunburn damage to exposed skin.

In explaining the effectiveness of the claimed method, the sunburn patent states:

The effectiveness of the ascorbyl fatty acid esters in the treatment of ... radiation-induced skin damage ... can be postulated as resulting from the antioxidant properties of ascorbic acid per se, which properties are retained to a high degree in the ascorbyl fatty acid ester form, together with the fact that the ascorbyl fatty acid ester form is capable of being delivered in an effective manner.

Sunburn patent, col. 6,11. 35-43. The patent further explains that “when solubilized in the lipid-rich layers of the skin, the fatty acid ester form of ascorbic acid is capable of scavenging free oxygen-containing radicals, neutralizing other reactive oxidants released extraeellularly and intracellularly, and either interfering with or minimizing oxidative generation of metabolites .... ” Id. col. 6, 11. 43-47. The patent describes the invention as one

which involves the topical application of fat-soluble fatty acid esters of ascorbic acid .... By virtue of the fat-solubility of these fatty acid esters and the further enhancement of this solubility via admixture with fat-penetrating carriers, the active ascorbic acid can be effectively percutaneously delivered to lipid layers so as to bring about these effects and actions ....

Id. col. 6,11. 50-63.

The Pereira patent discloses a composition containing each of the components recited in the sunburn patent, and in amounts falling within the same range. In addition, the Pereira patent discloses that the emulsion of the invention comprises “a selected skin benefit ingredient, a special emulsifier and an emollient oil,” which is effective for delivering the skin benefit agent “to subcutaneous regions of the skin.” Pereira patent, col. 1,11. 14-15; id. col. 2, 11. 13-14. Among the skin benefit ingredients listed in the Pereira patent is *1383ascorbyl palmitate. Pereira further discloses a number of substances for use as the emollient ingredient, including lethicin. Id. col. 4,11. 67-68.

The evidence before the district court established that the Pereira patent discloses topical application of the same substance that is claimed in the sunburn patent, with the same results. Thus, the evidence showed that certain of the skin benefit ingredients of Pereira, including ascorbyl palmitate, operate to benefit the skin by scavenging free radicals. In addition, the evidence showed that lecithin is a dermatologically acceptable carrier that is able to “solubilize the lipid-rich layers of the skin,” as required by the sunburn patent. And the concentration levels of the skin benefit ingredients of Pereira encompass the levels that the sunburn patent asserts are effective in treating and preventing sunburn.

To be sure, Pereira does not expressly refer to the use of the disclosed composition to treat or prevent sunburn. As the district court noted, however, those benefits are inherent in the topical application of the composition claimed in Pereira. The fact that Pereira does not assert that the emulsion is effective in preventing or treating sunburned skin does not avoid anticipation of the sunburn patent, as long as those benefits are the natural result of the normal use of the Pereira emulsion. See MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed.Cir.1999) (prior art article anticipates because it describes a process that necessarily performs the claimed process; “where ... the result is a necessary consequence of what was deliberately intended, it is of no consequence that the article’s authors did not appreciate the results”); Atlas Poivder Co. v. Ireco, 190 F.3d 1342, 1347 (Fed.Cir. 1999) (“Under the principles of inherency, if the prior art necessarily functions in accordance with, or includes, the claimed limitations, it anticipates.”); In re King, 801 F.2d 1324, 1326 (Fed.Cir.1986), quoting In re Ackenbach, 18 C.C.P.A. 769, 45 F.2d 437, 439 (1930) (“if a previously patented device, in its normal and usual operation, will perform the function which an appellant claims in a subsequent application for process patent, then such application for process patent will be considered to have been anticipated by the former patented- device”). Although Dr. Perrieone may have discovered that among the skin benefits of the composition disclosed by Pereira are the prevention and treatment of sunburn, the discovery of a new property of the Pereira composition, when used in accordance with its normal application, is not a sufficient basis for avoiding anticipation. See In re Cruciferous Sprout Litig., 301 F.3d 1343, 1350-51 (Fed.Cir.2002) (“Brassica has done nothing more than recognize properties inherent in certain prior art sprouts .... While Brassica may have recognized something quite interesting about those sprouts, it simply has not invented anything new.”); EMI Group, N. Am., Inc. v. Cypress Semiconductor Corp., 268 F.3d 1342, 1349 (Fed.Cir.2001) (“The discovery of a previously unappreciated property of a prior art composition ... does not render the old composition patentably new to the discoverer.”); Atlas Powder, 190 F.3d at 1349 (“discovery of an inherent property of the prior art [does] not [constitute] the addition of a novel element” and therefore does not serve as patentable subject matter).

This is not a case in which the patentee is claiming a method that consists of a new way of using a previously known product in order to achieve a new result. The Supreme Court long ago explained that “if *1384an old device or process be put to a new use which is not analogous to the old one, and the adaptation of such process to the new use is of such a character as to require the exercise of inventive skill to produce it, such new use will not be denied the merit of patentability.” Ansonia Brass & Copper Co. v. Elec. Supply Co., 144 U.S. 11, 18, 12 S.Ct. 601, 36 L.Ed. 327 (1892). Importantly, however, the Court qualified that rule by adding that “the application of an old process or machine to a similar or analogous subject, with no-change in the manner of application and no result substantially distinct in its nature, will not sustain a patent even if the new form of result had not before been contemplated.” Id.; see also Brown v. Piper, 91 U.S. 37, 41, 23 L.Ed. 200 (1875) (prior art patent for a “corpse preserver” anticipated method for preserving fish and meats that used the same steps; Court held that the new method “was simply the application by the patentee of an old process to a new subject .... The thing was within the circle of what was well known before, and belonged to the public. No one could lawfully appropriate it to himself, and exclude others from using it in any usual way for any purpose to which it may be desired to apply it.”).

The majority accurately describes that governing principle of law when it states: “If Pereira discloses the very same methods, then the particular benefits must naturally flow from those methods even if not recognized as benefits at the time of Pereira’s disclosure.” That principle, however, leads me to a conclusion different from the one reached by the majority, at least as to the sunburn treatment claims. In my view, the method of using the composition recited in the sunburn patent is not substantially different from the “skin benefit” use described by Pereira. The prevention and treatment of sunburn therefore do not qualify as “new uses” of the composition so as to avoid anticipation. See Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809-10 (Fed. Cir.2002) (stating, for illustration, that a claimed use of shoe polish to repel water on shoes does not constitute a “new use” of the prior art polish, although a claimed use of the shoe polish to grow hair would so qualify).

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. Dr. Perricone’s contribution is simply to recognize that among those skin benefits is the prevention and treatment of sunburn. That identification of a new subset of a previously known property is not entitled to patent protection.

While the majority applies that principle to the sunburn prevention and skin disorder claims, it does not apply the same principle to the sunburn treatment claims, even though those claims recite the same composition and process as are disclosed in Pereira and recited in Dr. Perricone’s other claims. Yet, to use the majority’s language, the treatment of sunburned skin is every bit as much a “particular benefit[] that must naturally flow from [Pereira’s] methods” as the prevention of sunburn and the treatment of skin disorders. Under the majority’s test, the sunburn treatment claims should therefore be anticipated by Pereira just as much as the sunburn prevention claims and the skin disorder treatment claims.

The majority distinguishes the prevention claims of the sunburn patent from the treatment claims of that patent by stating *1385that because “all skin surfaces are susceptible to sunburn damage, and because one can only realistically apply a composition to a skin surface when that surface is exposed, Pereira’s ‘topical application’ encompasses the application step of claim 8” of the sunburn patent. But precisely the same reasoning applies to the sunburn treatment claims. The majority seems to attach significance to the notion that topical application of Pereira’s emulsion always prevents sunburn, because all skin is subject to sunburn, but that it does not always treat sunburn, because not all skin is sunburned and in need of treatment. That distinction, however, does not stand up: the fact that the sunburn treatment function is pertinent to only a subset of users of the Pereira method (i.e., those already suffering from sunburn) does not mean that Pereira does not anticipate the treatment claims.

Topical application of the Pereira emulsion results in scavenging oxygen-containing free radicals and neutralizing reactive oxidants, whether the skin is sunburned or not. Thus, the effect that underlies both the prevention and treatment of sunburn is present in all cases of topical application of the Pereira composition. For that reason, Pereira anticipates not only the skin disorder and sunburn prevention claims, but also the sunburn treatment claims, which are based on the same underlying chemical processes. To illustrate the point, if it were discovered that using a particular kind of knee brace that was long worn by athletes to provide stability and thus minimize the effect of ligament injuries would also facilitate the treatment of cartilage damage and protect against further cartilage damage, that subsequent discovery would not give rise to a patentable invention. Moreover, it surely would not be the case that the use of the brace to prevent cartilage damage would be anticipated, but the use of the brace to treat cartilage damage would not, on the ground that all knees are subject to cartilage damage, but only some knees already have it.

The majority illustrates its distinction between sunburn treatment and sunburn prevention with its own analogy, arguing that the prior use of a hat to prevent sunburn would not anticipate the use of a hat to treat sunburn. Yet this analogy is inapt because a hat prevents sunburn by a mechanism, i.e., shade, that does not treat sunburn. In contrast, the mechanism by which a knee brace minimizes the effects of ligament injury, i.e., enhanced stability, is the same mechanism that facilitates treatment of cartilage damage and also prevents further cartilage damage. The same is true here, where the same chemical process treats and prevents sunburned skin.

Furthermore, the majority’s distinction between the sunburn prevention claims, which the majority invalidates, and the sunburn treatment claims, which the majority upholds, is inconsistent with its invalidation of all the asserted claims of the skin disorder patent. The majority distinguishes the sunburn treatment claims by focusing on the applicability of the skin damage patent to aging skin, and suggests that “all skin is a victim of [the natural aging process].” The skin damage patent, however, addresses “[a] wide variety of skin diseases and skin conditions in which the skin has undergone some form of accelerated aging.” Skin damage patent, col.l, 11. 26-28. Like sunburn, those diseases and conditions are not found in all persons. The majority’s distinction appears to rest upon its assertion that “[s]kin sunburn is not analogous to skin surfaces generally.” However, there appears to be *1386no greater specificity in topical application to skin that is sunburned than there is in topical application to skin that is diseased or skin that has suffered from accelerated aging. Accordingly, I submit that the majority’s distinction between the treatment claims and the prevention claims is not a satisfactory ground for decision in this case.

This court’s decisions in Rapoport v. Dement, 254 F.3d 1053 (Fed.Cir.2001), and MEHL/Biophile International Corp. v. Milgraum, 192 F.3d 1362 (Fed.Cir.1999), are not at odds with the district court’s conclusion in this case. Each of those cases involved a prior art method that was directed at an objective different from the objective of the claimed invention. In Rapoport, the prior art was a method for treating anxiety by administering a certain dosage of a particular drug three times a day, while the invention was a method for treating sleep apnea by administering a larger dosage of the same drug at the time of sleep. In MEHL/Biophile, the prior art was a method of using a laser to remove tattoos by aligning the laser over the pigmented skin, while the claimed invention was a method of using a laser to remove hair by aligning the laser over hair follicles. Although in each case practicing the prior art method might sometimes have the effect that was the objective of the claimed invention, the court held in each case that practicing the prior art method would not inherently have that effect. Thus, even if the prior art method for tattoo removal were used on skin having hair, it would not anticipate the claimed method in MEHL/Biophile because the prior art method did not dictate that the laser be aligned with hair follicles. And even if the prior art treatment of anxiety were used on patients suffering from sleep apnea, it would not anticipate the claimed method in Rapoport because the timing of drug administration and the dosages employed in the two treatments were different.

In this case, by contrast, topical application of the Pereira composition to normal skin inherently produces the same chemical processes that underlie the sunburn prevention claims, including scavenging free-oxygen-containing radicals and neutralizing other reactive oxidants. Topical application of the Pereira composition to sunburned skin inherently produces the same processes, which also underlie the sunburn treatment claims. Because the chemical processes that have the effect of treating and preventing sunburn are inherent consequences of the normal use of the Pereira composition, Pereira anticipates all the claims of the sunburn patent, just as it anticipates all the claims of the skin disorder patent.

In substance, the sunburn patent simply selects particular ingredients from among the small class of ingredients identified in Pereira and identifies specific benefits falling within the broader characterization of benefits identified in Pereira. To hold that the treatment claims of the sunburn patent are not anticipated by Pereira is to permit an inventor to secure patent rights to an existing invention merely upon identifying an inherent benefit of the prior art that had not previously been specifically identified, but that falls within a broader class of benefits already identified in the prior art. Because that result is contrary to the law of inherent anticipation as I understand it, I respectfully dissent from the portion of the court’s judgment relating to the treatment claims of the sunburn patent.