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December 20, 2005

Sunburned

Dr. Nicholas V. Perricone was granted 5,409,693 and 5,574,063 for a vitamin C lotion to prevent and treat sunburn. In suing Medicis Pharmaceutical Corporation for infringement, the patents got singed.

The Appeals Court (CAFC 05-1022) first dealt with double patenting.

Double Patenting
The double patenting doctrine generally prevents a patentee from receiving two patents for the same invention. Thus, this doctrine polices the proper application of the patent term for each invention. The proscription against double patenting takes two forms: statutory and non-statutory. Statutory, or “same invention,” double patenting is based on the language in § 101 of the Patent Act mandating “a patent” for any new and useful invention. 35 U.S.C. § 101 (2000); In re Goodman, 11 F.3d 1046, 1052 (Fed. Cir. 1993) (“If the claimed inventions are identical in scope, the proper rejection is under 35 U.S.C. § 101 because an inventor is entitled to a single patent for an invention.”) (citations omitted). Non-statutory, or “obviousness-type,” double patenting is a judicially created doctrine adopted to prevent claims in separate applications or patents that do not recite the “same” invention, but nonetheless claim inventions so alike that granting both exclusive rights would effectively extend the life of patent protection. Gerber Garment Tech., Inc. v. Lectra Sys., Inc., 916 F.2d 683, 686 (Fed. Cir. 1990) (citing In re Thorington, 418 F.2d 528, 534 (CCPA 1969)). This case involves double patenting in this latter category.

The CAFC agreed with the district court that there were only non-obvious differences between claims 9 & 16 of ’063 and claim 1 of ’693, as well that claims 18 and 19 of the ’063 patent, which both depend from claim 16 of that patent, were not patentably distinct from claims 4 and 7 of '693. The words may have been different, but the court ruled the concepts were the same.

This court first examines the contention that the claims of the ’063 patent contain “material differences” from those in the ’693 patent. This “material differences” argument does not show that the district court erred in its double patenting analysis. Rather, the district court’s analysis specifically addresses differences between the claims of the ’693 and ’063 patents. For instance, the district court discussed the difference between the recitation in the ’063 patent’s claim 9 of “a dermatologically acceptable fat-penetrating carrier” and claim 1’s recitation of no carrier at all. Thus, the district court cogently reasoned that, based on the specification, the “effective to solubilize” language in claim 1 of the ’693 patent means the same thing as the “carrier” language in claim 9. Thus, the difference disappears.

Likewise, the district court properly resolved the apparent difference between treatment of various types of skin damage in claims 9 and 16 of the ’063 patent and treatment of sunburn in claim 1. Sunburn is a species of skin damage. As such, this court perceives no error in the district court’s determination that the earlier species renders the later genus claims invalid under non-statutory double patenting. See Eli Lilly & Co. v. Barr Labs., Inc. 251 F.3d 955, 971 (Fed. Cir. 2001) (“[This court’s] case law firmly establishes that a later genus claim limitation is anticipated by, and therefore not patentably distinct from, an earlier species claim.”) (citations omitted).

And now a bit of lovely light-handed sarcasm from the court in dismissing a hypothetical argument, and noting a remedy for double patenting through terminal disclaimer.

The district court also considered and correctly rejected the suggestion that procedures of the United States Patent and Trademark Office (PTO) militate against double patenting. Specifically, if Dr. Perricone had presented all the claims of the ’693 and ’063 patents to the PTO in a single application, the PTO might have made a restriction requirement. In other words, the PTO might have separated the claimed subject matter into different classifications and different inventions. If the PTO had entered a restriction requirement under that hypothetical situation, 35 U.S.C. § 121 would have barred a double patenting rejection. Yes, and if the court had a brother, he might like buttermilk. In other words, this tortured hypothetical does not correspond to the record in this case. The various claims were not filed together nor restricted by the PTO. Thus, in simple terms, 35 U.S.C. § 121 does not rescue Dr. Perricone’s voluntarily filed continuation-in-part application.

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.

The CAFC then considered the application of inherency in anticipation by prior art.

A single prior art reference that discloses, either expressly or inherently, each limitation of a claim invalidates that claim by anticipation. Minn. Mining & Mfg. Co. v. Johnson & Johnson Orthopaedics, Inc., 976 F.2d 1559, 1565 (Fed. Cir. 1992). Thus, a prior art reference without express reference to a claim limitation may nonetheless anticipate by inherency. See In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir. 2002). “Under the principles of inherency, if the prior art necessarily functions in accordance with, or includes, the claims limitations, it anticipates.” Id. (quoting MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999). Moreover, “[i]hherency is not necessarily coterminous with knowledge of those of ordinary skill in the art. Artisans of ordinary skill may not recognize the inherent characteristics or functioning of the prior art.” Id.; see also Schering Corp. v. Geneva Pharms., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition in the prior art) (citing In re Cruciferous Sprout Litig., 301 F.3d at 1351; MEHL/Biophile, 192 F.3d at 1366).

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.

Pereira listed a total of 14 ingredients in his skin creams, leading patentee Perricone to argue that such a gumbo didn't specifically address with proper emphasis his cream. That argument got creamed.

This court rejects the notion that one of these ingredients cannot anticipate because it appears without special emphasis in a longer list. To the contrary, the disclosure is prior art to the extent of its enabling disclosure. See Hewlett-Packard Co. v. Mustek Sys., Inc., 340 F.3d 1314, 1324 n.6 (Fed. Cir. 2003) (“The anticipation analysis asks solely whether the prior art reference discloses and enables the claimed invention, and not how the prior art characterizes that disclosure or whether alternatives are also disclosed.”) (citing Celeritas Techs. v. Rockwell Int’l Corp., 150 F.3d 1354, 1361 (Fed. Cir. 1998)). In re Baird, 16 F.3d 380, 383 (Fed. Cir. 1994), is not inconsistent with this anticipation analysis. In the first place, In re Baird involved obviousness, not anticipation. Baird observes that “disclosure of millions of compounds does not render obvious a claim to three compounds.” 16 F.3d at 383 (emphasis added). Baird’s reasoning, relevant to obviousness, does not apply to Pereira’s disclosure of a handful of different compositions, the use of one of which anticipates Dr. Perricone’s claims.

While other opinions state that disclosure of a broad genus does not necessarily specifically disclose a species within that genus, see, e.g., Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1262 (Fed. Cir. 1989), this axiomatic proposition also does not rescue Dr. Perricone’s claims. In this case, the prior art does not merely disclose a genus of skin benefit ingredients without disclosing the particular claimed ingredient. Rather Pereira specifically discloses ascorbyl palmitate. That specific disclosure, even in a list, makes this case different from cases involving disclosure of a broad genus without reference to the potentially anticipating species. Thus, these cases do not alter the district court’s correct anticipation reasoning.

As the district court correctly noted, Pereira’s range entirely encompasses, and does not significantly deviate from, Dr. Perricone’s claimed ranges. Thus, this court sustains the district court’s reading of Pereira’s effective amount disclosure. See Atlas Powder Co. v. Ireco Inc., 190 F.3d at 1342, 1346 (Fed. Cir. 1999) (“[W]hen a patent claims a chemical composition in terms of ranges of elements, any single prior art reference that falls within each of the ranges anticipates the claim.”) (citing Titanium Metals Corp. v. Banner, 778 F.2d 775, 781 (Fed. Cir. 1985)).

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.

Dr. Perricone’s independent claims recite particular skin benefits together with methods of achieving those benefits (i.e., topically applying a particular compound). 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. Thus, Pereira anticipates if its disclosure of “topical application” satisfies the application step in Dr. Perricone’s various asserted claims.

But then the issue of application provides ground for validity. In other words, according to the majority of the CAFC, if prior art does not anticipate use for a claimed specific condition, then it does not anticipate the claim.

Claim 1 of the ’693 patent, from which claims 2-4 and 7 ultimately depend, specifically recites application of the fatty acid ester to “skin sunburn.” This claim term raises a different problem. 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.

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... [T]he 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.

For those claims relating to sunburn treatment, the CAFC reversed the district court, but otherwise agreed with the lower court's ruling regarding invalidity.

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Judge Bryson dissented, not buying the "lack of anticipation by application" rule of the court majority, mustering a well-reasoned argument as to where to set the bar with regard to prior art anticipation.

[T]he only difference between the claims of the sunburn patent that this court invalidates and those that 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.

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 Powder 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, 45 F.2d 437, 439 (CCPA 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. Perricone 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 an 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 (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 (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.

Posted by Patent Hawk at December 20, 2005 2:59 PM | Litigation