Topical Application Did Not Anticipate Sunburn Treatment

In Perricone, M.D. v. Medicis Pharmaceutical Corp. (Fed. Cir. December 20, 2005) the court agreed that claim 9 of U.S. Patent No. 5,409,693 was invalid for obviousness-type double patenting in view of claim 1 of U.S. Patent No. 5,574,063, but left open the possibility of remedying the problem with a terminal disclaimer two years after the lower courts holding of invalidity.

Claim 1 of the ’693 patent recited:

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
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.

while claim 9 of the ’063 patent recited:

9. A method for the treatment of skin damaged or aged by oxygen-containing free
radicals or oxidative generation of biologically active metabolites which
comprises topically applying to affected skin areas a composition containing an
effective amount of an ascorbyl fatty acid ester in a dermatologically
acceptable, fat-penetrating carrier such that the ester is percutaneously
delivered to lipid-rich layers of the skin.

Circuit Judge Rader opinion agreed with the district court that the "effective to solubilize" language in claim 1 meant the "dermatologically acceptable fat-penetrating carrier" in claim 9. The court also reasoned that since sunburn is a species of skin damage, there was no error in the district court’s determination that the earlier species (sunburn treatment) rendered the later genus (skin damage treatment) claims invalid under non-statutory double patenting.

Finally, and contrary to the suggestion by the district court, the Patent
Act and PTO rules support the filing of a terminal disclaimer even after
issuance of the second patent. See 35 U.S.C. § 253 (2000) ("[A]ny patentee . . .
may disclaim or dedicate to the public the entire term, or any terminal part of
the term, of the patent granted . . . ."); 37 CFR § 1.321(a) (incorporating the
language of § 253). The district court’s focus on In re Goodman, 11 F.3d 1046,
1052 (Fed. Cir. 1993) (explaining that a terminal disclaimer can overcome a
double patenting "rejection") seems to have led to its conclusion that a
terminal disclaimer cannot be filed for an issued patent to overcome invalidity
based on double patenting. The commentary from In re Goodman arose in the
context of ex parte prosecution, a setting not applicable to this case. An
applicant must always overcome every rejection to gain issuance of a patent.
Accordingly, the pre-issuance timing requirement of a terminal disclaimer to
overcome a double patenting rejection does not dictate a prohibition on
post-issuance terminal disclaimers. A terminal disclaimer can indeed supplant a
finding of invalidity for double patenting. See Applied Materials, Inv. v.
Semiconductor Materials Am., Inc., 98 F.3d 1563, 1577 (Fed. Cir. 1996) ("For
obviousness-type double patenting, [the improper extension of the statutory
term] problem can sometimes be avoided for co-owned patents . . . through the
use of a terminal disclaimer."). This record, however, does not include any
evidence of a disclaimer even though the district court invalidated the claims
over two years ago. Thus, while Dr. Perricone might still file a terminal
disclaimer to overcome prospectively the double patenting basis for invalidity,
this court makes no determination about the retrospective effect of such a
terminal disclaimer.

With regard to anticipation, the court also held that the general disclosure of a similar lotion for "topical application" was insufficient to suggest the specific application to "treating skin sunburn."

The issue is not, as the dissent and district court imply, whether Pereira’s lotion if applied to skin sunburn would inherently treat that damage, but whether Pereira discloses the application of its composition to skin sunburn. It does not.

This court explained in Catalina Marketing International, Inc. v. Cool Savings.com, Inc. that a patent to an apparatus does not necessarily prevent a subsequent inventor from obtaining a patent on a new method of using the apparatus. 289 F.3d 801, 809 (Fed. Cir. 2002). New uses of old products or processes are indeed patentable subject matter. See 35 U.S.C. § 101 (2000) (identifying as patentable "any new and useful improvements" of a process, machine, manufacture, etc.); In re King, 801 F.2d 1324, 1326 (Fed. Cir. 1986) (principles of inherency do not prohibit a process patent for a new use of an old structure). That principle governs in this case as well.

Claim 1 of the ’693 patent recites a new use of the composition disclosed by Pereira, i.e., the treatment of skin sunburn. The district court’s inherent anticipation analysis for this claim contains a flaw. The disclosed use of Pereira’s lotion, i.e., topical application, does not suggest application of Pereira’s lotion to skin sunburn. In other words, the district court’s inherency analysis goes astray because it assumes what Pereira neither disclosed nor rendered inherent. Because Pereira does not disclose topical application to skin sunburn, this court reverses the district court’s holding that Pereira anticipates claims 1-4 and 7 of the ’693 patent.

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." 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.