CREATIVE PATENT CLAIMING - texasbarcle.com Inc. v. Upjohn Co., 122 F.3d 1476, 44 USPQ2d 1181 ... CREATIVE PATENT CLAIMING Eugenia S. Hansen A. Traditional Claiming to ChemicalPer Se

CREATIVE PATENT CLAIMING

EUGENIA S. HANSEN717 North Harwood

Suite 3400Dallas, Texas 75201

(214) 981-3315Facsimile: (214) 981-3400

[email protected]

16TH ANNUAL INTELLECTUAL PROPERTY LAW COURSEState Bar of TexasMarch 6-7, 2003

Austin, Texas

CHAPTER 3.1

The views expressed in this paper, and observations made, are made by the author solely for the purposes of scholarly discussion and debate. Further, theviews and observations should not be attributed to the firm of Sidley Austin Brown & Wood LLP or any of its clients.

© 2003 Eugenia S. Hansen

EUGENIA S. HANSEN

Biographical

GENIE HANSEN is a partner based in Sidley Austin Brown & Wood's Dallas office. She has focusedher patent practice on litigation of patents from various disciplines and prosecution and licensing ofbiochemical, chemical, microbiological, plant and medical device patents. She was a co-author of thebrief in the successful appeal for the leading patent decision concerning inequitable conduct law,Kingsdown Medical Consultants, Ltd. and E. R. Squibb & Sons, Inc. v. Hollister, Inc., 863 F.2d 867(Fed. Cir. 1988). Trademarks comprise a substantial portion of her practice as well, includingproviding for trademark searches and opinions on the availability of marks, registration,opposition/cancellation practice, and litigation. Ms. Hansen has handled a number of cyberlaw mattersdealing with trademark, copyright and domain name issues.

At Texas A&M University, her B.S. and M.S. studies in Biochemistry included a curriculum of chemistry,immunology and microbiology. She was selected for the University Undergraduate Fellows HonorsProgram and was inducted into the Phi Lambda Upsilon chemistry honor society and Alpha Zeta. Atthe University of Houston Law Center, she was Articles Editor for the Houston Journal of InternationalLaw, and was named to the Order of the Barons for academic merit.

She currently serves on the Board of Directors of the American Intellectual Property Law Association(AIPLA), an association of attorneys in private, corporate, and government practice currentlycomprising over 13,000 members. She has actively served on the AIPLA Chemical Practice Committeeand is past Chair of the AIPLA Women in Intellectual Property Law. She is an officer in the State Barof Texas Intellectual Property Section Council. She has served the Brand Name Education Foundationof the International Trademark Association and the inauguration of the Pattishall Medal for TeachingExcellence. Ms. Hansen is also a member of the Licensing Executives Society and the Dallas/FortWorth Patent Law Association. She is a member of the American Chemical Society and currently asponsor of The Southwest Retort, a publication of the local chapter. Ms. Hansen also serves on theBoard of Trustees of a private school.

Recent speaking engagements, papers and presentations include: AIPLA: "Creative PharmaceuticalPatent Claims" (Spring, 2002); Biotechnology/ Chemical Practice Seminar Three City Series (1994,1996, 1998, 2000); Panelist, "Effective Patent Practice in the Post-GATT Era" (Spring, 1996). TheSouthwestern Legal Foundation Annual Institute on Patent Law: "Process Patents: Friend or Foe?"(1999); "The Provisional Patent Application: Strategies" (1995); "Rule 30(b)(6) Deposition: Noticing,Defending, and Avoiding Sanctions" (1992); and "Trade Dress Protection for Pharmaceuticals-PublicPolicy Arguments" (1986); ABA: 1998 Summer IP Institute in Williamsburg, VA. "Recent Developmentsin Section 112" (1998), University of Houston Law Foundation: "Unfair Competition, Trade Dress &Interface of Trademark Law With Patent Law" (2000 and 2001). Others: "Practical Considerations forMedical and Biotech Companies in Intellectual Property Management" (1994); "Getting a Handle onGATT" (1995); Intellectual Property Issues in Product Marketing" (1996); "Ethics for PTO Practitioners"(1998 and 1999) "Basic Trademark Law" (1999); "Pharmaceutical Patents" (1999); "The WrittenDescription Requirement" (State Bar of Texas Annual Meeting, Austin 2001) and "Trademark andCopyright Issues Arising from Internet Commerce" (Defense Research Institute, Chicago 2000)

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Creative Patent Claiming Chapter 3.1

i

TABLE OF CONTENTS

I. INTRODUCTION .................................................................................................................................................................... 1

II. TRADITIONAL AND CREATIVE CLAIMING.................................................................................................................. 1A. Traditional Claiming to Chemical Per Se or Apparatus by Structure ....................................................................... 1B. Creative Claiming.............................................................................................................................................................. 1

1. Physical Form............................................................................................................................................................ 12. Fingerprint Claim...................................................................................................................................................... 33. Product-By-Process Claims .................................................................................................................................... 54. Prodrugs .................................................................................................................................................................... 95. Dosage Form and Pharmaceutical Compositions.............................................................................................. 106. Methods .................................................................................................................................................................. 12

a. Introduction and Statutory Authority for And History of The Process Claim.............................. 12b. New Use for Old Composition of Matter.............................................................................................. 12c. Mechanism of Action.............................................................................................................................. 15d. Plasma Concentration and Methods..................................................................................................... 15e. Process of Administration...................................................................................................................... 16f. Step-Plus Function .................................................................................................................................. 17g. Method of Making vs. Recipe Claims ................................................................................................... 18

III. CONCLUSION....................................................................................................................................................................... 18

TABLE OF AUTHORITIES

CASES

American Home Products Corp. v. Johnson & Johnson, 25 USPQ2d 1954 (Fed. Cir. 1992)................................................ 9Amgen Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200,18 USPQ2d 1016 (Fed. Cir.), cert. denied, 502 U.S. 856

(1991)............................................................................................................................................................................................. 4Atlantic Thermoplastics Co. Inc. v. Faytex Corp., 970 F.2d 834, 23 USPQ2d 1481 (Fed. Cir. 1992)................................ 6, 8Atlantic Thermoplastics Co. Inc. v. Faytex Corp., 974 F.2d 1279, 23 USPQ2d 1801 (Fed. Cir. 1992).................................. 6Atlantic Thermoplastics Co. Inc. v. Faytex Corp., 974 F.2d 1299, 24 USPQ2d 1138 (Fed. Cir. 1992).................................. 6Augustine Medical Inc. v. Gaymar Industries Inc., 181 F.3d 1291, 50 USPQ2d 1900 (Fed. Cir.1999)................................. 1Bayer AG v. Biovail Corporation, 279 F.3d 1340 (Fed. Cir. 2002)............................................................................................ 2Bayer AG v. Elan Pharmaceutical Research Corp ., 212 F.3d 1241, 54 USPQ2d 1710 (Fed. Cir.), cert. denied, 531 U.S.

993 (2000).................................................................................................................................................................................. 1, 3Bird Provision Co. v. Owens Country Sausage, Inc., 568 F.2d 369, 375, 197 USPQ 134, 139 (5th Cir. 1978)................... 13Bristol-Myers Squibb Co. v. Ben Venue Laboratories Inc., 246 F.3d 1368 (Fed. Cir. 2001)............................................... 16Burroughs Wellcome Co. v. Barr Laboratories Inc., 40 F.3d 1223, 32 USPQ2d 1915, 1917 n.3 (Fed. Cir. 1994), cert.

denied, 516 U.S. 1070 (1996).................................................................................................................................................... 10Chiuminatta Concrete Concepts Inc. v. Cardinal Industries Inc., 145 F.3d 1303, 46 USPQ2d 1752 (Fed. Cir. 1998)...... 4Dekalb Genetics Corp. v. Northrup King Co., No. 96 C 50169, 1997 WL 587492 (N.D.III. Aug. 14, 1997)........................ 7Eli Lilly & Co. v. Barr Laboratories, Inc., 251 F.3d 955, 58 USPQ2d 1869, 1879 (Fed. Cir. 2001), amended, 58 USPQ2d

1865, cert. denied, __U.S.__, 122 S.Ct. 913 (2002) ............................................................................................................... 15Epcon Gas Systems Inc. v. Bauer Compressors Inc., 279 F.3d 1022, 61 USPQ2d 1470 (Fed. Cir. 2002) .............................. 3Ex parte Logan, 38 USPQ2d 1852 ( Bd. Pat. App. & Interferences 1994)................................................................................ 8Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Int. 1990)..................................................................................................... 5Exxon Chemical Patents Inc. v. Lubrizol Corp., 64 F.3d 1553, 35 USPQ2d 1767 (Fed. Cir. 1996), cert. denied, 518 U.S.

1020 (1996).................................................................................................................................................................................. 18Generations II Orthotic Inc. v. Medical Technology, Inc., 263 F.3d 1356, 59 USPQ2d 1919 (Fed. Cir. 2001).................. 18Glaxo Inc. v. Novopharm Ltd. 110 F.3d 1562, 1565-66 (Fed. Cir. 1997) .................................................................................... 3Hazani v. U.S. International Trade Comm’n , 126 F.3d 1473, 44 USPQ2d 1358 (Fed. Cir. 1997) .......................................... 7Hoechst-Roussel Pharmaceuticals Inc. v. Lehman, 109 F.3d 756, 42 USPQ2d 1220 (Fed. Cir. 1997)................................ 10In re Benner, 174 F.2d 938, 942, 82 USPQ 49, 53 (CCPA 1949) .......................................................................................... 13, 14In re Freeman, 30 F.2d 1459, 31 USPQ2d 1444, 1447 (Fed. Cir. 1994) ....................................................................................... 8


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In re Fuetterer , 319 F.2d 259, 264, 138 USPQ 217, 222 (CCPA 1963) ..................................................................................... 17In re Garnero , 412 F.2d 276, 278-79, 162 USPQ 221, 223 (CCPA 1969)..................................................................................... 7In re Hack , 245 F.2d 246, 248, 114 USPQ 161, 162 (CCPA 1957)........................................................................................ 13, 14In re Marshall, 578 F.2d 301, 198 USPQ 344 (CCPA 1978)...................................................................................................... 13In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607(CCPA 1978) ............................................................................................ 16In re Moore, 439 F.2d 1232, 1236, 169 USPQ 236, 239 (CCPA 1971) ......................................................................................... 7In re Pearson, 494 F.2d 1399, 1403, 181 USPQ 641, 644 (CCPA 1974) .............................................................................. 13, 14In re Schreiber, 128 F.3d 1473, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997)............................................................................ 12, 13In re Shetty, 566 F.2d 81, 195 USPQ 753 (CCPA 1977).............................................................................................................. 13In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) ....................................................................................... 13, 14In re Spada, 911 F.2d 705, 708, 15 USPQ2d 1655, 1657 (Fed. Cir. 1990)............................................................................ 13, 14In re Tarczy-Hornoch, 397 F.2d 856, 158 USPQ 141, 142.......................................................................................................... 12In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985)......................................................................................................... 5In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934, 1937 (Fed. Cir. 1990)................................................................................... 13In re Zierden, 411 F.2d 1325, 162 USPQ 102, 104 (CCPA 1969) ................................................................................... 12, 13, 14Kimberly-Clark Corp. v. Johnson & Johnson, 745 F.2d 1437, 223 USPQ 603 (Fed. Cir. 1984)............................................ 8Loctite Corporation v. Ultraseal, Ltd., 781 F.2d 861, 228 USPQ 90, 99 (Fed. Cir. 1985) ..................................................... 12Marion Merrell Dow Inc. v. Geneva Pharmaceuticals, Inc., 877 F.Supp 531, 33 USPQ2d 1673, 1674 (D. Colo 1994)... 10McNeil-PPC Inc. v. L. Perrigo Co., 200 F.Supp2d 356, 63 USPQ2d 1493, (E.D. Pa. 2002).................................................. 11Mehl/Biophile Int'l Corp. v. Milgraum, 192 F.3d 1362, 1366, 52 USPQ2d 1303, 1306-1307 (Fed. Cir. 1999) .................... 17Mentor Corp. v. Coloplast Inc., 998 F.2d 992, 27 USPQ2d 1521 (Fed. Cir. 1993) ................................................................... 8Micro Chemical, Inc. v. Great Plains Chemical Co., 194 F.3d 1258, 52 USPQ2d 1258 (Fed. Cir. 1999)........................... 17Newell Companies, Inc. v. Kenney Mfg. Co., 864 F.2d 757, 765 (Fed. Cir. 1988).................................................................... 7Novartis Corp. v. Ben Venue Laboratories, Inc., 271 F.3d 1043, 60 USPQ2d 1836 (Fed. Cir. 2001).................................... 3O.I. Corp. v. Tekmar Co., 115 F.3d 1576, 42 USPQ2d 1777 (Fed. Cir. 1997)........................................................................... 17O'Reilly v. Morse, 56 U.S. (15 How.) 62 (1853)........................................................................................................................... 12Ortho Pharmaceutical Corp. v. Smith, 959 F.2d 936, 22 USPQ 2d 1119, 1122 n.4 (Fed. Cir. 1992)...................................... 9Phillips Petroleum Co. v. U.S. Steel Corp ., 673 F.Supp 1278, 6 USPQ2d 1065 (D.Del. 1987), aff’d, 865 F.2d 1247 (Fed.

Cir. 1989)....................................................................................................................................................................................... 1Process Resources Corp. v. Delta Air Lines Inc., 53 USPQ2d 1995 (S.D.N.Y. 2000) .......................................................... 15Purdue Pharma L.P. v. Faulding Inc. 230 F.3d 1320, 56 USPQ2d 1481, 1483, 1485-1486 (Fed. Cir. 2000)........................ 16Purdue Pharma LP v. Boehringer Ingelheim GmbH, 237 F.3d 1359, 57 USPQ2d 1647 (Fed. Cir. 2001)........................... 16Research Corporation Technologies, Inc. et. al v. Gensia Laboratories, Inc., 2001 U.S. App. LEXIS 4444, 10 Fed.

Appx. 856 (Fed. Cir. 2001) ........................................................................................................................................................ 11Richardson-Vicks Inc. v. Upjohn Co., 122 F.3d 1476, 44 USPQ2d 1181(Fed. Cir. 1997)...................................................... 11Scripps Clinic & Research Foundation v. Genentech Inc., 927 F.2d 1565,18 USPQ2d 1001 (Fed. Cir. 1991)........... 5, 6, 8See Trustees of Columbia University v. Roche Diagnostics GmbH, 126 F.Supp.2d 16, 57 USPQ2d 1825 (D. Mass.

2000).............................................................................................................................................................................................. 6Senmed, Inc. v. Richard-Allan Medical Indus ., 888 F.2d 815, 818 n.7, 12 USPQ2d 1508, 1511 n.7 (Fed. Cir. 1989) ......... 8Standard Oil Co. v. American Cyanamid Co., 774 F.2d 448, 453, 227 USPQ 293, 297 (Fed. Cir. 1985)............................... 5Talbert Fuel Systems Patents Co. v. Unocal Corp., 275 F.3d 1371, 61 USPQ2d 1363 (Fed. Cir. 2002) ............................... 5Tanabe Seiyaku Co. v. U.S. International Trade Commission, 109 F.3d 726 41 USPQ2d 1976, (Fed. Cir 1997), cert.

denied, 522 U.S. 1027 (1997).................................................................................................................................................... 18Texas Instruments v. Cypress Semiconductor Corp ., 90 F.3d 1558 (Fed. Cir. 1996) .............................................................. 7Titanium Metals Corp. of Am. v. Banner, 778 F.2d 775, 782, 227 USPQ 773, 778 (Fed. Cir. 1985)................................ 13, 14Tropix Inc. v. Lumigen Inc., 825 F.Supp. 7, 27 USPQ2d 1475 (D. Mass. 1993) ....................................................................... 6Ultradent Products Inc. v. Life-Like Cosmetics Inc., 127 F.3d 1065, 44 USPQ2d 1336 (Fed. Cir. 1997).............................. 4Verdegaal Bros., Inc. v. Union Oil Co. of Calif., 814 F.2d 628, 632-33, 2 USPQ2d 1051, 1054 (Fed. Cir.), cert. denied,

484 U.S. 827 (1987) .............................................................................................................................................................. 13, 16Zenith Laboratories Inc. v. Bristol-Myers Squibb Co., 19 F.3d 1418, 30 USPQ2d 1285, 1286 (Fed. Cir. 1994), cert.

denied, 513 U.S. 995 (1994)............................................................................................................................................ 1, 2, 3, 9Zenith Laboratories Inc. v. Bristol-Myers Squibb Co., 24 USPQ2d 1652, 1655-66 (D. N.J. 1992), rev’d, 19 F.3d 1418

(Fed. Cir. 1994)........................................................................................................................................................................... 10


















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OTHER AUTHORITIES

21 U.S.C. Section 505(j)(2)(B)(ii)..................................................................................................................................................... 235 U.S.C. § 271(a).............................................................................................................................................................................. 135 U.S.C. §112 ................................................................................................................................................................... 3, 4, 16, 17Landis on Mechanics of Patent Claim Drafting 159 (3d ed. 1974).......................................................................................... 3


1

CREATIVE PATENT CLAIMINGEugenia S. Hansen1

I. INTRODUCTIONThe art and strategy of patents is in the patent

claims. Will the claim be allowed by the U.S.P.T.O.? Will it be allowed in foreign countries? Will it hold upin litigation?

In the chemical arts, broadly includingbiotechnology and pharmaceuticals as well, there is anadded component to the claim strategy made possiblebecause chemicals can undergo reactions,pharmaceuticals can be metabolized in the body, andbiological molecules have inactive and active sites. Inthe mechanical arts, the ability to claim using methodclaims is a strategy sometimes overlooked.

This paper will discuss various patent claims andtheir fate in the courts, providing for thoughtfulconsideration of mining the specification for patentclaims beyond the ordinary.

II. TRADITIONAL AND CREATIVE CLAIMINGA. Traditional Claiming to Chemical Per Se or

Apparatus by StructureWhen a patent claims a compound by reciting its

chemical structure, the patent claim is fairly easy fora court to construe. The claim is considered a claimto the chemical per se, and is generally believed to bethe most desirable type of claim because such a claimcan be literally infringed by any physical form of thechemical. See Zenith Laboratories Inc. v. Bristol-Myers Squibb Co., 19 F.3d 1418, 30 USPQ2d 1285,1286 (Fed. Cir. 1994) (discussing expired cefadroxilpatent to chemical per se which covered "any and allforms of cefadroxil"), cert. denied, 513 U.S. 995(1994). Such a claim also covers any use of thepatented invention, i.e. the chemical per se, even ifdifferent from the use described in the specification ofthe patent. See 35 U.S.C. § 271(a) (defininginfringement to include use of a patented invention).

The analogous type of claim in the mechanicalarts is the apparatus claim. See Augustine MedicalInc. v. Gaymar Industries Inc., 181 F.3d 1291, 50

1 Partner, SIDLEY AUSTIN BROWN & WOOD LLP, 717

North Harwood – Suite 3400, Dallas, Texas 75201B.S. & M.S. (Biochemistry) Texas A&M University;J.D. University of HoustonThe views expressed in this paper are the presentviews of the author and should not be attributed tothe firm of Sidley Austin Brown & Wood LLP orany of its clients© 2003 Eugenia S. Hansen

USPQ2d 1900 (Fed. Cir.1999) (apparatus claims givepatent protection covering "all uses" for the claimedapparatus, but not methods using non-infringingapparatus).

B. Creative Claiming1. Physical Form

At times the precise chemical formula of asubstance may not be known and a different way todefine it may be necessary. A classic example can befound in polymer chemistry. The claim "Normallysolid polypropylene consisting essentially of recurringpropylene units, having a substantial crystallinepolypropylene content. . . ." was discussed in PhillipsPetroleum Co. v. U.S. Steel Corp., 673 F.Supp 1278,6 USPQ2d 1065 (D.Del. 1987), aff’d , 865 F.2d 1247(Fed. Cir. 1989). It was noted in that case that thephysical characteristics of the polymer were affectedby the crystal lattice. For example, the strongattractive forces in the lattice rendered the polymerinsoluble in solvents which would otherwise dissolvethe polymer if it were not crystalline, the materialexhibited a melting point (the temperature at which thepolymer changes from the solid, crystalline state to amolten state), the density of crystalline polypropylenewas higher than that of the amorphous ornoncrystalline form because of the close packing ofthe polymer molecules in the crystal lattice. It wasalso noted that crystallinity imparted several importantmechanical properties to polypropylene.

In the pharmaceutical art, the physical form of acompound may also be important to the properties ofa given chemical composition. For example, in BayerAG v. Elan Pharmaceutical Research Corp., 212 F.3d1241, 54 USPQ2d 1710 (Fed. Cir.), cert. denied, 531U.S. 993 (2000), a patent claimed a solidpharmaceutical composition containing crystals of agiven specific surface area or SSA (defined as the totalsurface area divided by the particle’s weight) and asolid diluent. The SSA of the active ingredient waspertinent to providing a sustained presence in the body. The patent claims each recited a specific SSA rangefor the active ingredient crystal used. The broadestSSA range was recited in Claim 1:

1. A solid pharmaceutical compositioncomprising as the active ingredient an effectiveamount of nifedipine crystals with a specificsurface area of 1.0 to 4m2/g, in admixture with asolid diluent, to result in a sustained release ofnifedipine.










2

Even though the patent claim reciting the SSAwas appropriate, the claim was not necessarilyinfringed. In this case, the defendant’s ANDA, asamended, specified that defendant’s product wouldcontain crystals having an SSA of 5 m 2/g or greater. The required notice under 21 U.S.C. Section505(j)(2)(B)(ii) (notice of defendant’s ANDA and itsParagraph IV certification) stated that that the SSA ofthe active ingredient in defendant’s proposed productwas outside any of the patent's claimed SSA ranges. The defendant won summary judgement of non-infringement, upheld by the Federal Circuit on appeal.

In a later proceeding, Bayer AG v. BiovailCorporation, 279 F.3d 1340 (Fed. Cir. 2002),evidence of actual infringement of the patent by acommercial tablet was provided. Nifedipine crystalshaving SSA’s in the claimed range were found by anexpert who so stated in an affidavit. The FederalCircuit stated that infringement under §271(e)(2)(A)was not synonymous with infringement under §271(a)by a commercial product. The patentee did not havea full and fair opportunity to litigate the issue ofinfringement by the commercial tablets, and the ANDAcase did not support collateral estoppel on the case. Further, the district court needed to fully construe themeaning of the claims, which it had not done.

A particular crystalline form of cefadroxil, knownas a “Bouzard monohydrate” was the subject ofanother litigated patent. As discussed above, an earlierpatent, expired at the time of the litigation, had claimedcefadroxil per se by chemical formula. See Zenith, 30USPQ2d at 1286. The Bouzard form was claimed asfollows:

Crystalline 7- [D-a-amino-a-(p-hydroxyphenyl-)acetamido]-3-methyl-3-cephem-4-carboxylic acidmonohydrate exhibiting essentially the followingx-ray diffraction properties: [a 37-line table ofrelative intensities exhibited by Bouzardmonohydrate at various scan angles].

The product that the alleged infringer planned tomarket was cefadroxil DC, a hemihydrate form ofcefadroxil that differed structurally from Bouzardmonohydrate. The dispute began as a challenge to thefiling of an ANDA, in which it was claimed thatcefadroxil DC was bioequivalent to a form ofcefadroxil monohydrate (other than Bouzardmonohydrate) which had already been approved by theFDA for commercial sale. When the manufacturer ofcefadroxil DC dropped its plans to manufacture, thatlitigation was dropped upon stipulation of the parties. A declaratory judgement action ensued.

There was a concession that cefadroxil DC didnot literally infringe the patent, but it was alleged thatit converted on ingestion to the patented compound inthe stomach. and the trial court so found. The courtreasoned that an act of literal infringement occurs inthe patient's stomach as a result of ingestion ofcefadroxil DC, and that therefore the sale of cefadroxilDC would induce infringement of the '657 patent.

The Federal Circuit reversed the judgement of thetrial court. First, on the question of literal infringementit stated that the evidence compared the accusedinfringing product with a commercial embodiment ofthe patent, not with the claims, and this was error:

Since the finding of infringement was based ontestimony which incorporated an impropercomparison, and since that comparison was anessential element in the conclusion thatinfringement occurred, the conclusion that Zenithby selling cefadroxil DC would engage ininducement of infringement is insupportable.Zenith is correct that there was a failure of proofas to whether any crystals, assumed to form inthe stomach from ingested cefadroxil DC, literallyinfringe the '657 claim. In the absence ofevidence comparing the '657 claim with thecefadroxil DC after ingestion Bristol has failed toestablish any infringing use and therefore wemust reverse the district court's conclusion thatZenith's sale of cefadroxil DC inducesinfringement of the '657 patent.

The court also found no infringement under thedoctrine of equivalents due to a failure of proof of“function” in the traditional “function/way/result” test:

[There were] numerous statements in theprosecution history regarding the superiormanufacturing-related benefits of the Bouzardcrystal in relation to the prior forms of cefadroxil,it is clear that the primary, if not the only,function of the Bouzard crystal form of the drugas compared to other forms is to facilitate pre-ingestion manufacturing. No other intendedfunction is described or suggested. Since anyunanticipated production of the Bouzard crystalin the patient's stomach as a result of ingestingcefadroxil DC does not even remotely performthat function, the "function" part of thefunction/way/result test of equivalency is notmet. As a matter of law, there can be noinfringement under the doctrine of equivalents.



3

See id. at 1291.In Novartis Corp. v. Ben Venue Laboratories,

Inc., 271 F.3d 1043, 60 USPQ2d 1836 (Fed. Cir.2001), the court affirmed the district court’s grant ofsummary judgment of non-infringement. The patentcovered crystalline formulations of a drug. Thedefendant filed a paper NDA for its own formulation,a liquid, of the drug. It certified that neither itsformulation nor its manufacturing process involved thecrystalline form of the drug claimed by the patent. The allegation of infringement was premised on thelimitations of the claim being met some time during themanufacturing process. Id. at n.5. However, thecourt held that the patentee failed to created a genuineissue of material fact as to this issue.

Physical combination rather than merecombination was discussed in the case of Epcon GasSystems Inc. v. Bauer Compressors Inc., 279 F.3d1022, 61 USPQ2d 1470 (Fed. Cir. 2002). In EpconGas, the court considered the construction of theword “integral.” The court concluded:

Integral is defined to mean “[c]omponents thatform a complete unit.” The Contractors'Dictionary of Equipment, Tools and Techniques315 (1st ed. 1995). Integrated is defined to mean“[a] type of design in which two or more basiccomponents or functions are physically, as wellas electrically, combined - usually on one chassis,such as an integrated amplifier.” ModernDictionary of Electronics 381 (7th ed. 1999). “Integral”connotes that the stored gas supply isa component part of the claimed invention, asopposed to “integrated,” which connotes physicalcombination. Thus, an infringingapparatus/method must have a stored gas supplyas a component part, but it is not required thatthe gas supply be physically combined on onechassis with all other parts.

2. Fingerprint ClaimA fingerprint claim defines a chemical in terms of

properties rather than in terms of its chemical orphysical structure. Such a claim is proper if itdistinctly claims the invention under 35 U.S.C. §112. See Landis on Mechanics of Patent Claim Drafting159 (3d ed. 1974). The Landis book discusses afamous example of a fingerprint claim in thepharmaceutical art. Aureomycin was claimed via afingerprint claim in U.S. Patent 2,482,055. See id. Afingerprint claim may recite such characteristics as X-ray diffraction patterns, solubility, melting points,solubility in various solvents, absorption

characteristics, melting point, and perhaps others. Seeid.

One of the issues that arises in the case offingerprint claims is whether a different value for aparticular characteristic will be obtained if the test isrun under different conditions, or if a different test isused to measure the same property. For example inthe Aureomycin patent discussed above, one of thefingerprint recitations referred to the characteristicabsorption bands in the infra red region. The claimrecited that the values recited were obtained “whensuspended in a hydrocarbon oil in solid form.” Specifying conditions needed for the recited fingerprintto be valid is appropriate. Even a property such asmolecular weight, especially that of a biologicalsubstance, may vary depending on the technique used. In the Bayer v. Elan case discussed above, one of theissues was the time at which the SSA measurementwas to be taken. In that case, since defendant was anANDA defendant, no infringing product was yet on themarket. However, a biobatch had been made andmeasured. Plaintiff asserted on appeal that there wasa genuine issue of material fact regarding infringement,since the ANDA defendant had not specified avalidated test protocol or test equipment to measurethe SSA of its proposed product.

The defendant was successful in its argumentthat its ANDA specification stated that the SSA of itsactive ingredient had to be at least 5 m 2/g within fivedays prior to the manufacturing of tablets and that itcould not lawfully produce a drug that did not meet theANDA specification. Even though the Plaintiffproduced some evidence that the SSA would decreaseover time, it was insufficient to indicate that the SSAcould decrease sufficiently so that the defendant’sproduct would be covered by the patent claims. “Therefore,” said the Federal Circuit, “under theANDA specification, Elan cannot literally infringe the'446 patent.” See 54 USPQ 2d at 1716.

In another case, the compound at issue existed inmultiple crystalline forms and mixtures, possiblycontaining either Form 1 or Form 2 of the activeingredient. The asserted patent covered mixtures thatcontained Form 2. Glaxo Inc. v. Novopharm Ltd. 110F.3d 1562, 1565-66 (Fed. Cir. 1997). The ANDA wasfiled to market Form 1, but permitted the marketedproduct to have a Form 1 purity as low as 90%. See110 F.3d at 1564, 42 USPQ2d at 1260. The issue ofinfringement was whether a drug produced under theANDA would contain Form 2 of the active ingredient. The test to determine which form was present was ininfra red spectrum in which Form 2 exhibited 29peaks. See id. Evidence of only one peak was







4

submitted, and this was insufficient. Therefore, wherethere are recitations of identification in a patent claim,the proof at trial must be sufficient to complete therequired analysis.

In another case, a dental bleaching compositionwas defined in terms of the composition's viscosityand stickiness. Ultradent Products Inc. v. Life-LikeCosmetics Inc., 127 F.3d 1065, 44 USPQ2d 1336(Fed. Cir. 1997). The claim contained the followinglanguage:

(a) said matrix material has sufficiently highviscosity and low solubility in saliva that thematrix material provides for the dental bleachingagent to be in contact with the tooth surfacesover a period of time greater than about 2 hours,thereby providing bleaching of the tooth surfaces,and such that (b) the matrix material issufficiently sticky to retain and hold said dentaltray in place over said teeth for a period of timegreater than about 2 hours without any significantmechanical pressure from the dental tray.

The court noted that the parties did not disputethe district court’s claim interpretation, nor did thedefendant take issue with "the patent's purelyfunctional method of claiming the bleachingcomposition." Prior art was asserted to anticipate theclaim, even though it did not contain information aboutthe viscosity and stickiness of the materials. Thecourt held that the art did not “explicitly disclose adental bleaching composition with viscosity andstickiness levels that satisfy the claims of the '006patent.” The asserted art disclosed multiplecompositions, and the defendant had alleged that if onemade some of the compositions, and tested them, thatsuch compositions would have the level of viscosityand stickiness required by the claims of the patent insuit. The court rejected the contention that such testevidence constituted anticipation:

There were many possible compositionsthat could be made within the range ofcarboxypolymethylene concentration (0.05% to5%) that the art disclosed. The challenger'sburden at trial was to show that the prior artwould describe to one of skill in the art the testedcombinations, or other combinations meeting thelimitations of the claims, from among the manypossible candidates.

44 USPQ2d at 1341-42.

The court noted that the district court hadentered summary judgment against Life-Like on itsclaim of anticipation with respect to the patents, and itremanded that issue to the district court for furtherproceedings. It upheld the jury's determination ofinfringement, noting however that the issue ofinfringement become moot if the district court onremand found the asserted claims of the patentsinvalid.

A recitation of a test to define a claim limitationwas also approved by the Federal Circuit in the case ofChiuminatta Concrete Concepts Inc. v. CardinalIndustries Inc., 145 F.3d 1303, 46 USPQ2d 1752(Fed. Cir. 1998).

In Chiuminatta, the patent contained methodclaims which provided recitations of a hardnessproperty of the concrete involved in the method, andthe claim recited a test in order to define the hardnessproperty:

The asserted claims of the '675 patent aredirected to a method for cutting concrete at atime "before the concrete has hardenedsufficiently to allow cutting by a conventionalabrasive concrete saw, while still producing anacceptable surface finish adjacent to the cutgroove." The claims further elaborate on thetiming of the cutting. Claim 3, for example, statesthat it occurs when the concrete has a hardnesssuch that a 1.125 inch diameter steel rod with aflat end, and weighing about 5.75 pounds, wouldcause an indentation in the surface of theconcrete of about 1/32 to 1/2 of an inch whenthe rod is dropped from a height of about 24inches above the surface of the concrete.

46 USPQ2d at 1758-59.When defining limitations by a property

discernable by a test or method, one must take carethat the claim meets the standards of 35 U.S.C. § 112. In the case of Amgen Inc. v. Chugai PharmaceuticalCo., 927 F.2d 1200,18 USPQ2d 1016 (Fed. Cir.), cert.denied, 502 U.S. 856 (1991), a specific activitylimitation of "at least about 160,000" was heldindefinite, in part because of the range of errorinherent in measuring that limitation:

The district court found that "bioassays providean imprecise form of measurement with a rangeof error" and that use of the term "about"160,000 IU/AU, coupled with the range of erroralready inherent in the specific activity limitation,served neither to distinguish the invention over






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the close prior art (which described preparationsof 120,000 IU/AU), nor to permit one to knowwhat specific activity values below 160,000, ifany, might constitute infringement.

13 USPQ2d at 1787.Because the meaning of claims was in doubt and

because there was close prior art, the court reasonedthat it was proper to declare the claims invalid. See id.(citing Standard Oil Co. v. American Cyanamid Co.,774 F.2d 448, 453, 227 USPQ 293, 297 (Fed. Cir.1985)). It affirmed the district court's determinationon this issue.

In Talbert Fuel Systems Patents Co. v. UnocalCorp., 275 F.3d 1371, 61 USPQ2d 1363 (Fed. Cir.2002), the Federal Circuit construed the followingclaim:

1. A low Reid Vapor Pressure liquid gasoline foruse in a standard carbureted internal combustionengine; said gasoline comprising a priming agentand a hydrocarbon mixture having anintermediate carbon range relative to C4-C12 fuel;said intermediate carbon range consistingessentially of C6-C10 hydrocarbons with C9 andC10 paraffinic hydrocarbons being present in themixture; said gasoline having a boiling point rangeof 121°F-345°F at 1 atmosphere pressure; andsaid priming agent consisting of a hydrocarbonselected from the group consisting of C4 and C5hydrocarbons and mixtures thereof and saidpriming agent being present in a minimumeffective amount for raising the front endvolatility of the gasoline to a minimum level forcold engine starting with said minimum effectiveamount being less than that required for C4-C12gasoline.

The district court had ruled, and the FederalCircuit agreed, that claim 1 is limited to gasolineswhose final boiling point is 345°F. The patentee hadargued that the consisting essentially of languageallowed it some leeway, especially since the finalboiling point would be inoperable if small amounts ofcarbons above C10 were present. However, thislanguage was held to apply only to the C6-C10 range.

One type of claim that has been considered in thepast to be a type of fingerprint claim is the product-by-process claim. Because the Federal Circuit has issuedtwo opinions that some believe are directlycontradictory to one another on the subject ofproduct-by-process claim construction, such a claim

should be used with caution. Product-by-processclaims are discussed in the next section.

3. Product-By-Process ClaimsProduct-by-process claims initially were a

subcategory of fingerprint product claims in which theprocess defined the limitations of the product. As thecourt indicated in In re Thorpe, 777 F.2d 695, 227USPQ 964 (Fed. Cir. 1985):

Product-by-process claims are not specificallydiscussed in the patent statute. The practice andgoverning law have developed in response to theneed to enable an applicant to claim an otherwisepatentable product that resists definition by otherthan the process by which it is made. For thisreason, even though product-by-process claimsare limited by and defined by the process,determination of patentability is based on theproduct itself. (citations omitted)

It was observed in Ex parte Lyell, 17 USPQ2d1548 (Bd. Pat. App. & Int. 1990) that patentability ofa product does not depend on its method ofproduction. If the product in a product-by-processclaim is the same as or obvious from a product of theprior art, the claim is unpatentable even though theprior product was made by a different process.

The Federal Circuit in the case of Scripps Clinic& Research Foundation v. Genentech Inc., 927 F.2d1565,18 USPQ2d 1001 (Fed. Cir. 1991) adhered to theview that a product-by-process claim was indeed aproduct claim. In Scripps product-by process claim13 was at issue:

13. Highly purified and concentrated human orporcine VIII:C prepared in accordance with themethod of claim 1.

Claim 1 read as follows:

1. An improved method of preparing FactorVIII procoagulant activity protein comprising thesteps of

(a) adsorbing a VIII:C/VIII:RP complex from aplasma or commercial concentrate source ontoparticles bound to a monoclonal antibody specificto VIII:RP,

(b) eluting the VIII:C,

DA1 254321v1







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(c) adsorbing the VIII:C obtained in step (b) inanother adsorption to concentrate and furtherpurify same,

(d) eluting the adsorbed VIII:C, and

(e) recovering highly purified and concentratedVIII:C.

Scripps contended that recombinant FactorVIII:C produced by the defendant infringed Claim 13. The district court had ruled that only Factor VIII:Cproduced according to the process of Claim 1 couldinfringe Claim 13. The Federal Circuit, in remandingfor trial stated:

In determining patentability we construe theproduct as not limited by the process stated in theclaims. Since claims must be construed the sameway for validity and for infringement, the correctreading of product-by-process claims is that theyare not limited to product prepared by the processset forth in the claims.

18 USPQ2d at 1016. (emphasis added)However, the Federal Circuit later decided the

case of Atlantic Thermoplastics Co. Inc. v. FaytexCorp., 970 F.2d 834, 23 USPQ2d 1481 (Fed. Cir.1992) in which the technology concerned shoe insoles. The Atlantic Thermoplastic court held that a product-by-process claim will be construed in litigation toencompass only products made by the recited process. The Atlantic Thermoplastics case is one of theinteresting historical “happenings” at the FederalCircuit during the ‘90’s . Not only did the court issuethe opinion cited above, but a “rehearing denied”opinion containing lengthy separate dissents authoredby Judge Rich and Judge Newman, AtlanticThermoplastics Co. Inc. v. Faytex Corp., 974 F.2d1279, 23 USPQ2d 1801 (Fed. Cir. 1992) and another“concurring” opinion concerning the denial ofrehearing authored by Judge Rader, AtlanticThermoplastics Co. Inc. v. Faytex Corp., 974 F.2d1299, 24 USPQ2d 1138 (Fed. Cir. 1992). In thedissent by Judge Rich, for example, it is written thatthe majority’s failure to rehear the case in banc in viewof the earlier decision in Scripps was“insulting...mutiny...heresy and illegal.”

Despite the controversy at the time about the lawon this issue, the Atlantic Thermoplastics majorityview has not been further clarified by the FederalCircuit. The District of Massachusetts has been facedwith construing product-by-process claims after

Atlantic Thermoplastics on at least two occasions,however. In the first reported case, despite confusionby the court as to whether the law was settled (in viewof the apparent controversy among the Federal Circuitjudges), it followed Atlantic Thermoplastics. SeeTropix Inc. v. Lumigen Inc., 825 F.Supp. 7, 27USPQ2d 1475 (D. Mass. 1993). In contrast, anotherdistrict court in Massachusetts refused to followAtlantic Thermoplastics. See Trustees of ColumbiaUniversity v. Roche Diagnostics GmbH, 126F.Supp.2d 16, 57 USPQ2d 1825 (D. Mass. 2000).

The Columbia University court observed:

As I discussed earlier, whether a product byprocess claim is limited to covering only productsmade with the identical process described in theclaim is a question of law. The Federal Circuithas been less than helpful in providing guidanceon the issue. In a 1991 case involvingbiotechnology dealing with the ultrapurification ofblood clotting factor using monoclonal antibodies,a three judge panel held that the “correct readingof such product-by-process claims is that theyare not limited to product prepared by theprocess set forth in the claims.” Scripps Clinic &Research Foundation, v. Genentech, Inc., 927F.2d 1565, 1583 (Fed. Cir. 1991). One year later,involving patents dealing with shoe innersoles, adifferent three judge panel held the opposite, thatthe process described is essentially a limitation onthe product claimed. Atlantic Thermoplastics Co.,Inc. v Faytex Corp., 970 F.2d 834 (Fed. Cir.1992) reh'g en banc denied, 974 F.2d 1299(concurring opinion), 974 F.2d 1279 (dissentingopinion) (Fed. Cir. 1992). In other words, theAtlantic Thermoplastics panel held that therecould be no infringement unless the same processwas used.

The Columbia University court decided the caseper Scripps, after discussing the lack of guidance bythe Federal Circuit:

Plainly, the law on this issue is in a state ofuncertainty. By denying the rehearing en banc,not only are lower courts left with little guidance,but so are the inventors and investors of thebiotechnology and pharmaceutical industries whomust make research and development decisionsnot knowing how much protection is available toa claim for a novel biological or chemicalproduct. On both sides of the debate, there are






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policy arguments as to which rule will promotemore innovation and progress.

Although acknowledging the Tropix case inwhich a court in its own district relied on the premisethat a majority of the judges of the Federal Circuitwould rule that Atlantic Thermoplastics states thecontrolling law, the Columbia University courtdisagreed:

I do not share the Tropix Court's confidence thatthe votes of the Federal Circuit can be so easilypredicted. Two panel opinions are in directconflict. It is impossible to divine the reasonswhy the various judges voted for a denial of arehearing en banc.

While this leaves the Court in an unenviableposition with respect to the appropriate ruling onthe merits, there is Federal Circuit case lawwhich offers clear guidance to escape thedilemma. When confronted with two panelopinions in direct conflict, the earlier decision iscontrolling. See Texas Instruments v. CypressSemiconductor Corp., 90 F.3d 1558 (Fed. Cir.1996); Newell Companies, Inc. v. Kenney Mfg.Co., 864 F.2d 757, 765 (Fed. Cir. 1988). Untilthe Scripps decision is rejected by a hearing enbanc, it is the precedential decision. Id. ThisCourt is not alone in adopting this approach withrespect to this very conflict regarding product byprocess claims. See Dekalb Genetics Corp. v.Northrup King Co., No. 96 C 50169, 1997 WL587492 (N.D.III. Aug. 14, 1997).

Accordingly, the product by process claims shallbe interpreted so that “they are not limited toproduct prepared by the process set forth in theclaims.” Scripps, 927 F.2d at 1583.

Arguments were made in two other cases beforethe Federal Circuit that claims at issue were product-by-process claims, but the court found otherwise andthus did not comment further on the AtlanticThermoplastics holding. In Hazani v. U.S.International Trade Comm’n, 126 F.3d 1473, 44USPQ2d 1358 (Fed. Cir. 1997), Hazani argued that:

the "chemically engraved" claims are product-by-process claims. We agree with the respondents,however, that those claims are best characterizedas pure product claims, since the "chemicallyengraved" limitation, read in context, describes

the product more by its structure than by theprocess used to obtain it. See In re Moore, 439F.2d 1232, 1236, 169 USPQ 236, 239 (CCPA1971); In re Garnero, 412 F.2d 276, 278-79, 162USPQ 221, 223 (CCPA 1969). As such, theclaims are anticipated, because the claimedproducts are found in the prior art.

In Hazani, the claim at issue read as follows:

18. An electrically readable and electricallywritable semiconductor memory cell including acapacitor that is coupled to a field effecttransistor (FET), said memory cell and saidcapacitor and said transistor are formed on asemiconductor substrate and wherein saidcapacitor is insulated from the control gate ofsaid transistor, and said capacitor comprising:

a first plate of an electrically conductivematerial having a chemically engraved surfaceof a predetermined pattern, said first plateforming storage node for said memory cell;

a first insulator constituting an oxidedielectric layer being disposed along and incontact with said engraved surface of saidconductive first plate;

a second insulator having at least onedielectric layer with a higher dielectric constantthan the dielectric constant of said first insulator,and said second insulator being disposed alongand in contact with said first insulator so that saidfirst insulator is disposed between said engravedsurface of the first plate and said secondinsulator; and

a second plate of an electrically conductivematerial being disposed along and in contact withsaid second insulator to form a sandwich whereinsaid dielectric layers are disposed between saidplates, thereby said capacitor exhibiting increasedcapacitance and said capacitor exhibiting reducedcharge transport capability between said plates sothat it is lower than the charge transportcapability characteristically exhibited by said firstinsulator alone in all modes of operation of saidmemory cell.

U.S. Patent 5,166,904 (emphasis added)Interestingly enough, the argument was also

made by a party in another case subsequent to AtlanticThermoplastics, but prior to Hazani that product-by-process claims were involved. In this case, thepatentee argued that “claims 1-4 are product-by-process claims and that, under Scripps Clinic &








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Research Foundation v. Genentech, Inc., 927 F.2d1565, 18 USPQ2d 1001 (Fed. Cir. 1991), the processlimitations do not prevent the claims fromencompassing an identical product made by a differentprocess.” The court avoided the issue by stating: “Mentor's argument, however, is inapplicable to thepresent case. The claims in issue here are not in factproduct-by-process claims; product-by-process claimsrecite how a product is made, not how it is used. Theonly process aspect of the present claims relates tohow the product is used, and that is an essential aspectof the claims.” See Mentor Corp. v. Coloplast Inc.,998 F.2d 992, 27 USPQ2d 1521 (Fed. Cir. 1993). The language at issue in Mentor, in claims addressedto a device for male incontinence, was “so that”language:

with the inner surface of an adjacent roll so thatas the sheath member is unrolled the adhesive onthe outer surface is transferred to the portion ofthe inner surface in engagement with the outersurface, without rolling the catheter inside out, tocause the inner surface to adhere ...

If a product-by-process claim cannot beinfringed unless the accused product is made by thesame process recited in the claim, drafting claims witha view toward litigation may change the philosophy ofthe drafter. Under the Scripps philosophy, if thedrafter uses the process steps like a chemicalpractitioner might use spectroscopy, molecular weight,NMR and other parameters to “fingerprint” asubstance, it is appropriate to be as specific aspossible. After all, the more specific and numerousthe steps, the better the claimed product could beidentified. Any product that could be identified to bethe same as that made by the recited process wouldinfringe. After Atlantic Thermoplastics, it is advisableto draft any product-by-process claim withoutunnecessary steps or limitations. Or, follow theexample of Mentor or Hazani, where the claims wereheld not to be product-by-process claims. It may alsobe appropriate to present a pure process claim or apure product claim depending on the invention andcircumstances. In litigation, it can be seen thatarguing either way may be successful at the trial courtlevel. Compare Tropix, supra with ColumbiaUniversity, supra.

The question of infringement under the doctrineof equivalents for product-by-process claims is farfrom clear, since there are no known reported casesspecifically addressing this question post-AtlanticThermoplastics. But given the fact that an accused

product will not infringe unless made by the recitedprocess, it is believed that there is a danger thatequivalency will not be afforded to a product made bya different process. On the other hand, if the accusedproduct is made by an equivalent method to thatrecited in the product-by-process claim, perhapsinfringement may be found.2

Keep in mind that in prosecution that the USPTOwill still review the claims as if they were productclaims. Prior art tending to show the lack of noveltyor non-obviousness of the product will be cited againstthe product-by-process claims during prosecution. See Atlantic Thermoplastics:

The PTO's treatment of product-by-processclaims as a product claim for patentability isconsistent with policies giving claims theirbroadest reasonable interpretation. The same rule,however, does not apply in validity andinfringement litigation. In any event, claims meanthe same for infringement and validity. See, e.g.,Senmed, Inc. v. Richard-Allan Medical Indus .,888 F.2d 815, 818 n.7, 12 USPQ2d 1508, 1511n.7 (Fed. Cir. 1989); Kimberly-Clark Corp. v.Johnson & Johnson, 745 F.2d 1437, 223 USPQ603 (Fed. Cir. 1984).

23 USPQ2d at 1491.

2 See also Ex parte Logan, 38 USPQ2d 1852 ( Bd. Pat.

App. & Interferences 1994) (unpublished). InLogan, the Board was faced with possiblydetermining if claims had been impermissiblyenlarged during reexamination by using aninfringement test. The Board decided the case onother grounds, but commented:

The current state of the law is such that we areunsure as to the circumstances, if any, under whichthe process recitations in product claims 1 and 3 ofthe appellant's patent should be consideredlimitations at least for purposes of determininginfringement (the test for resolving whether claim scope has been impermissibly enlarged duringreexamination is based upon an infringementanalysis; In re Freeman, 30 F.2d 1459, 31 USPQ2d1444, 1447 (Fed. Cir. 1994)). Cf., Scripps Clinic &Research Foundation v. Genetech [sic] Inc. , 927F.2d 1565, 18 USPQ2d 1001 (Fed. Cir. 1991) andAtlantic Thermoplastics Co. Inc. v. Faytex Corp.,970 F.2d 834, 23 USPQ2d 1481 (Fed. Cir. 1992). Asindicated above, this issue need not be addressed in light of our disposition of the Section 305rejection under consideration.











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On occasion, only product-by-process claims arepossible, because the product cannot otherwise bedescribed. It is advisable to determine if method ofuse claims may provide a needed complement to fullycover the invention.

4. ProdrugsA prodrug is a pharmaceutical that converts upon

ingestion or administration into an active ingredient. See Ortho Pharmaceutical Corp. v. Smith, 959 F.2d936, 22 USPQ2d 1119, 1122 n.4 (Fed. Cir. 1992). InOrtho, claims were infringed under the doctrine ofequivalents because the accused product broke downin the body to two compounds claimed by the patentand responsible for the biological activity. See id. Asomewhat related, but unpublished, case presentsinteresting facts. American Home Products Corp. v.Johnson & Johnson, 25 USPQ2d 1954 (Fed. Cir.1992) (unpublished). In this case, the patentee ownedthe patent in suit, directed to a method of preventingconception by administering norgestrel-17 acetate(hereinafter Compound B). Prior patents, sinceexpired, had claimed a method of preventingcontraception by administering norgestrel (hereinafterCompound C) or Compound B and had also claimedCompounds C and B as compositions of matter. Thecomposition of matter claims had been the subject oflitigation between the parties in the previous Ortholawsuit, discussed supra.

The defendant’s compound, subject to its ownpatent, was called norgestimate (hereinafter CompoundA). It was conceded by the plaintiff that the use ofCompound A was not within the literal language of theclaim, however, it was contended that the use ofCompound A was equivalent to the use of CompoundB (recited in the method claim of the patent in suit). Inthe prior lawsuit, it was held that Compound A was aninfringement of composition of matter claims recitingeither Compound B or Compound C under the doctrineof equivalents.

As a first theory of infringement, it wascontended that Compound A metabolized toCompound C through an intermediate, namelyCompound B. This was denoted “the directequivalence theory.” Second, it was contended thatCompound A and Compound B were equivalent toeach other, since both were equivalent to CompoundC. All were contended to exert their contraceptiveeffect by metabolism to Compound C. This wasdenoted the “double equivalence theory.” Thedefendant contended that only Compound A’sconversion to Compound B was relevant to theequivalence inquiry.

In its discussion, the court pointed out thatconsideration of infringement under the doctrine ofequivalents is not an automatic second prong in everycase. What needed to be done was to construe theclaim at issue, a method of use claim requiring “aprogestationally effective amount” of Compound B. Only contraceptives which would work via therequired amount of Compound B were covered. Thepreliminary injunction was vacated.

There are several opinions, both published anddesignated unpublished, that concern cefadroxil andwhether a particular pharmaceutical compositionconstitutes a prodrug of cefadroxil.

At issue was whether the sale of cefadroxil DCinduced infringement of a patent claim to cefadroxil byforming crystals of cefadroxil in the stomach afteringestion. The court reversed the district court’sconclusion of inducement because it determined therewas a failure of proof - an absence of evidencecomparing the patent claim with the cefadroxil DCafter ingestion. See Zenith Labs. v. Bristol-MyersSquibb, 19 F.3d 1418, 1422, 30 USPQ2d 1285, 1288(Fed. Cir. 1994) (although infringement may occur ifthe administered product is converted in vivo into theclaimed product, there was a failure of proof in thiscase).

The testimony was quite interesting, as itprovides a picture of the type of proof that isaddressed in such cases. The expert's testing andopinion is reported in the (unpublished) district courtdecision. A portion is presented below:

Dr. Pfeiffer testified that in his opinion, it wasunlikely that cefadroxil DC could convert in vivoto the Bouzard monohydrate.... a number ofconditions existed in the stomach that wouldpreclude the dissolution and recrystallizationprocesses that would be required forconversion....cefadroxil DC would dissolve veryquickly in the stomach and prevent the creationof a super-saturated environment needed forrecrystallization....the mixing action of thestomach would tend to disperse any super-saturated region that might otherwise form.

[Certain] conditions...were necessary forconversion to occur. In addition to the super-saturated solution...nucleation must occur. Conditions that could produce nucleation includeevaporation, cooling of the solution, andinducement of mechanicalstress....Recrystallization could also occur if





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nuclei were already present....none of theseconditions are present in the stomach.

[C]efadroxil DC did not convert to Bouzardmonohydrate because at the end of ten hours insimulated gastric acid, different amounts of thetwo material dissolved into identical volumes ofthe fluid....no conversion occurred because if ithad, equal amounts of material would havedissolved....This is true even though, in theirdissolved states, cefadroxil DC and Bouzardmonohydrate are identical -- they are simply thecompound cefadroxil....

See Zenith Laboratories Inc. v. Bristol-Myers SquibbCo., 24 USPQ2d 1652, 1655-66 (D. N.J. 1992)(unpublished), rev’d, 19 F.3d 1418 (Fed. Cir. 1994).

For purposes of obtaining a patent extension, thefact that the FDA approved product metabolized intothe claimed invention was insufficient. See Hoechst-Roussel Pharmaceuticals Inc. v. Lehman, 109 F.3d756, 42 USPQ2d 1220 (Fed. Cir. 1997). In Hoechst-Roussel it was noted that the active ingredient in theFDA-approved pharmaceutical was tacrinehydrochloride. Tacrine hydrochloride metabolized into1-hydroxy-tacrine and other compounds afteringestion by the patient. See 42 USPQ2d at 1221.

A patent owned by the plaintiff claimed 1-hydroxy-tacrine and a method of treatment byadministering 1-hydroxy-tacrine. A lawsuit in whichthe patent was asserted against the pharmaceuticalproduct tacrine hydrochloride was settled. Meanwhile,the patent owner tried to obtain a patent extension,which was denied by the Commissioner of Patentsbecause the patent did not claim tacrine hydrochloride. See id. The Federal Circuit affirmed. See id. at 1223.

In dicta, the court noted that the patentee "maybe entitled to exclude others from administering tacrinehydrochloride to patients," but that the right to excludewould emanate from the patent claim to 1-hydroxy-tacrine, and the fact that tacrine hydrochloridemetabolized to 1-hydroxy tacrine upon administration. Id. at 1223.

In the opinions discussed above, the accusedproduct was the alleged prodrug. There are situationsin which the patented invention is the prodrug – theprecursor of the active ingredient to be formed invivo. See e.g., Marion Merrell Dow Inc. v. GenevaPharmaceuticals, Inc., 877 F.Supp 531, 33 USPQ2d1673, 1674 (D. Colo 1994) (pharmaceutical subject toa patent metabolized into TAM, later patent claimedadministration of TAM)

5. Dosage Form and Pharmaceutical CompositionsA known chemical substance might be novel if

claimed in a pharmaceutical dosage form. Forexample, the drug AZT was claimed as apharmaceutical dosage form as well as a part ofmethods for treating patients infected with HIV or whohave acquired immunodeficiency syndrome (AIDS). For example, the claims of various patents included:

[A] method of treating a human having acquiredimmunodeficiency syndrome comprising the oraladministration of an effective acquiredimmunodeficiency syndrome treatment amountof 3'-azido-3'-deoxythymidine to said human.

[A] pharmaceutical preparation comprising acapsule containing 5 to 500 mg of 3'- azido-3'-deoxythymidine.

[A] method of treating a human having an HTLVIII virus infection comprising administering tosaid human an effective HTLV III virus treatmentamount of 3'- azido-3'deoxythymidine.

[A] method of treating a human having antibodiesto the HTLV III virus which comprisesadministering to said human an effective HTLVIII treatment amount of 3'-azido-3'-deoxythymidine.

[A] sealed container including a pharmaceuticalcomposition in unit dosage form comprising 5 to500 mg of 3'-azido-3'-deoxythymidine togetherwith a pharmaceutically acceptable solid carrier.

[A] sealed container including a pharmaceuticalcomposition in unit dosage form comprising 5 to500 mg of 3'-azido-3'-deoxythymidine togetherwith a pharmaceutically acceptable solid carrier.

See Burroughs Wellcome Co. v. Barr LaboratoriesInc., 40 F.3d 1223, 32 USPQ2d 1915, 1917 n.3 (Fed.Cir. 1994), cert. denied, 516 U.S. 1070 (1996).

The issue in the case was inventorship. Thedefendant alleged that scientists at NIH were inventors,but not named. The court affirmed the district court'sdetermination that inventorship was correct except asto one patent:

" [a] method of increasing the number of T-lymphocytes in a human infected with the HTLVIII virus comprising administering to said humanan effective amount of 3'-azido-3'-







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deoxythymidine or a pharmaceutically acceptablealkali metal, alkaline earth or ammonium saltthereof."

Id. at 1923 n.4The majority, over a dissent, agreed with the

defendant that there was no evidence of conception ofthis invention until after a Phase I study at NIH.

In Richardson-Vicks Inc. v. Upjohn Co., 122F.3d 1476, 44 USPQ2d 1181(Fed. Cir. 1997), thepatent at issue was addressed to an over-the-counter("OTC") medicine that combined, in various ratios,two well-known ingredients, the analgesic ibuprofenand the decongestant pseudoephedrine. The patentcontained both composition of matter claims andmethod claims. The first composition of matter claimrecited a 1.5:1 to 8:1 dose ratio range of ibuprofen topseudoephedrine. A dependent claim required 200 mgof ibuprofen and 30 mg of pseudoephedrine. Themethod-of-use claims corresponded to thecomposition claims. All of the claims required that theibuprofen and pseudoephedrine be present in a"combinatory immixture," which the trial judgeunderstood to mean in a single unit dosage, such as asingle tablet or capsule.

The patent was held invalid as obvious, sinceprior art combinations of other analgesics withpseudoephedrine were known along with suggestionsthat ibuprofen could substitute for other analgesics. Inaddition, ibuprofen and pseudoephedrine had beenadministered at the same time in the prior art, albeit inseparate dosage forms.

In Research Corporation Technologies, Inc. v.Gensia Laboratories, Inc., 2001 U.S. App. LEXIS4444, 10 Fed. Appx. 856 (Fed. Cir. 2001)(unpublished), the patent at issue claimed in pertinentpart:

A therapeutic composition comprising atherapeutically effective amount of an inorganicplanar dsp2 platinum (II) coordination complex,which complex is protected from light, andwhich is suitable for therapeutic administration byinjection in solution therefor wherein the donorligands are [an array of choice of donor ligandsare set forth, one combination of which formscisplatin] and wherein the donor ligands of thecomplex form coordinate covalent bonds with thecentral platinum ion.

A prior patent with a common parent claimed amethod for treating animal malignant tumor cellssensitive to [cisplatin] which comprised parenterally

administering cisplatin to an animal in an amountsufficient to cause regression of the animal tumorcells. A dependant claim indicated that the platinumcomplex could be administered in a saline-saltcontaining buffer solution. The district courtinvalidated the composition claims on the basis ofobviousness-type double patenting, and the FederalCircuit affirmed. The patentees introduced evidencethat cisplatin could undergo an aquation reaction inwater, but disputed that a prior art referenceintroduced by the defendant taught that this reactionwas light sensitive. Rather, the patentees argued, itwas the irreversible formation of a trichloroamminewhen cisplatin was place in saline solution to protectit from aquation that occurred irreversibly in thepresence of light.

The Federal Circuit decided that the “protectedfrom light” language in the claim did not providedistinguishing structure to the claim, but was no morethan “ a direction for care.” It was not a structural orotherwise meaningful claim limitation. See id at *14 -*15. Neither did the other limitation “suitable fortherapeutic administration by injection in solution”provide a non-obvious modification over the priormethod claims. Although the patentee argued thatsaline in the method claims was used to impartisotonicity with the body, while saline in thecomposition claims was acting to stabilize thecomposition during storage, the court was notpersuaded that the written description shared by thetwo patents made that distinction. Therefore, thedistrict court’s determination of obviousness-typedouble patenting was affirmed.

In McNeil-PPC Inc. v. L. Perrigo Co., 200F.Supp2d 356, 63 USPQ2d 1493, (E.D. Pa. 2002),claims in a patent to an old pharmaceutical incombination with another old pharmaceutical was heldinvalid as obvious by the court. The court observedthat the prior art disclosed that flatulence is frequentlya concurrent symptom of diarrhea, and that thisproblem can be addressed by combining a knownantidiarrheal with simethicone. Loperamide was awell-known and successful antidiarrheal. Accordingly,said the court, “there was a clear motivation tocombine the loperamide and simethicone.” Thedefendant was also awarded attorney fees, the courtfinding that the plaintiff’s “repeated erroneousrepresentations, failure to disclose relevant prior art,and overall persistence in prosecuting exceedinglyobvious “inventions” make this case exceptional.” Thecourt was also bothered by plaintiff’s “scheme forextending the life of a drug about to go off patent, andits execution of this scheme without the slightest






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regard for the intent and purposes of the patentlaws…[its] sole motive… to compromise thesestatutes and constitutional protections for the sake ofprofits. “

6. Methodsa. Introduction and Statutory Authority for And

History of The Process ClaimMethod or process claims are not appreciated by

all litigators. When it comes time to enforce a patentagainst others, it believed that it is easier to proveinfringement when a composition or apparatus claimis involved. Not only can one more easily determinewho is making, using, selling or importing acomposition or apparatus, it is easier to tell if thepatent is infringed by inspection of the ingredientlistings or the accused device per se.

However, a process claim may be construedbroadly enough to include a potential competitor’sconduct even if the competitor is able to successfullydesign around a composition or device claim. Aprocess claim may survive a patentability or validitychallenge when a composition or device claim does not The value of process claims is evident in enforcementactions.

Section 101 of Title 35 of the United States Codeprovides:

Whoever invents or discovers any new anduseful process, machine, manufacture, orcomposition of matter, or any new and usefulimprovement thereof, may obtain a patenttherefor, subject to the conditions andrequirements of this title.

(July 19, 1952), ch.950 § 1, 66 Stat. 797) (emphasisadded)

An interesting patent is that of Samuel Morse, theinventor of the telegraph. O'Reilly v. Morse, 56 U.S.(15 How.) 62 (1853). In addition to apparatus claims,Mr. Morse obtained the following claim:

Eighth. I do not propose to limit myself to thespecific machinery or parts of machinerydescribed in the foregoing specification andclaims; the essence of my invention being theuse of the motive power of the electric orgalvanic current, which I call electro-magnetism,however developed for marking or printingintelligible characters, signs, or letters, at anydistances, being a new application of that powerof which I claim to be the first inventor ordiscoverer.

(emphasis added)

The Supreme Court invalidated the claim becauseit did not correspond in scope to Mr. Morse’sinvention.:

If this claim can be maintained, it matters notby what process or machinery the result isaccomplished. For aught that we know somefuture inventor, in the onward march of science,may discover a mode of writing or printing at adistance by means of the electric or galvaniccurrent, without using any part of the process orcombination set forth in the plaintiff'sspecification. His invention may be lesscomplicated—less liable to get out of order—lessexpensive in construction, and in its operation.But yet if it is covered by this patent the inventorcould not use it, nor the public have the benefit ofit without the permission of this patentee.

See In re Tarczy-Hornoch, 397 F.2d 856, 158 USPQ141, 142, quoting 56 U.S. (15 How.) at 113 (emphasisadded).

The expanded right to exclude Mr. Morse wouldhave had if his method claim had been held valid is adramatic illustration of the potential power of methodclaims. Claims covering an apparatus developed tocarry out a method may be construed in a limitedmanner. But if one is able to obtain a method claimwhich will cover the employment of a methodindependent of the apparatus, the potential right toexclude is perhaps greater.

b. New Use for Old Composition of MatterMethod of treatment claims are often used when

a new use for an old substance is invented. They arealso useful in case the composition is thought to benovel, but turns out to be anticipated or renderedobvious by the prior art.

The Federal Circuit addressed new use claims inIn re Schreiber, 128 F.3d 1473, 44 USPQ2d 1429,1432 (Fed. Cir. 1997). When a composition orstructure is old, one cannot obtain claims to thecomposition or structure. However, one can obtainclaims to a new use for a known composition. SeeLoctite Corporation v. Ultraseal, Ltd., 781 F.2d 861,228 USPQ 90, 99 (Fed. Cir. 1985); see also In reZierden, 411 F.2d 1325, 162 USPQ 102, 104 (CCPA1969) (There is express statutory authority in 35U.S.C. §§100(b) and 101 for a patent on a processwhich is a new use of a known process, composition






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of matter, or material). Schreiber collects pertinentcases on this issue:

It is well settled that the recitation of a newintended use for an old product does not make aclaim to that old product patentable. See In reSpada, 911 F.2d 705, 708, 15 USPQ2d 1655,1657 (Fed. Cir. 1990) ("The discovery of a newproperty or use of a previously knowncomposition, even when that property and useare unobvious from prior art, can not impartpatentability to claims to the knowncomposition."); Titanium Metals Corp. of Am. v.Banner, 778 F.2d 775, 782, 227 USPQ 773, 778(Fed. Cir. 1985) (composition claim reciting anewly discovered property of an old alloy did notsatisfy section 102 because the alloy itself wasnot new); In re Pearson, 494 F.2d 1399, 1403,181 USPQ 641, 644 (CCPA 1974) (intended useof an old composition does not rendercomposition claim patentable); In re Zierden, 411F.2d 1325, 1328,162 USPQ 102, 104 (CCPA1969) (" [M]ere statement of a new use for anotherwise old or obvious composition cannotrender a claim to the composition patentable.");In re Sinex, 309 F.2d 488, 492, 135 USPQ 302,305 (CCPA 1962) (statement of intended use inan apparatus claim failed to distinguish over theprior art apparatus); In re Hack, 245 F.2d 246,248, 114 USPQ 161, 162 (CCPA 1957) ("thegrant of a patent on a composition or a machinecannot be predicated on a new use of thatmachine or composition"); In re Benner, 174F.2d 938, 942, 82 USPQ 49, 53 (CCPA 1949)("no provision has been made in the patentstatutes for granting a patent upon an old productbased solely upon discovery of a new use forsuch product").

In In re Woodruff, 919 F.2d 1575, 16 USPQ2d1934, 1937 (Fed. Cir. 1990), the patentability of a newuse for an old process was addressed. It wasacknowledged that new uses for old compositionscould be patented, but a new use for a known processraised issues of obviousness that the particular patentapplicant could not overcome:

Therefore, there are two differences between theclaimed invention and the prior art: one, theslightly different ranges of carbon monoxideconcentration used in the modified atmosphere;and two, the newly disclosed benefit of inhibitingthe growth of fungi. We are of the opinion that

these differences do not render the claimedprocess patentable. It is a general rule that merelydiscovering and claiming a new benefit of an oldprocess cannot render the process againpatentable. Verdegaal Bros., Inc. v. Union OilCo. of Calif ., 814 F.2d 628, 632-33, 2 USPQ2d1051, 1054 (Fed. Cir.), cert. denied, 484 U.S.827 (1987); Bird Provision Co. v. OwensCountry Sausage, Inc., 568 F.2d 369, 375, 197USPQ 134, 139 (5th Cir. 1978). While theprocesses encompassed by the claims are notentirely old, the rule is applicable here to theextent that the claims and the prior art overlap.

The cases of In re Shetty, 566 F.2d 81, 195USPQ 753 (CCPA 1977) and In re Marshall, 578F.2d 301, 198 USPQ 344 (CCPA 1978) do not,as urged by Woodruff, compel a contrary result. In both of these cases, the applicant haddiscovered a completely new use for either an oldcompound (Marshall) or an obvious compound(Shetty). In the present case, what Woodruffterms a "new use" (preventing fungal growth) isat least generically encompassed by the prior artpurpose of preventing the deterioration of leafyand head vegetables.

Nor can patentability be found in the difference incarbon monoxide ranges recited in the claims....These cases have consistently held that in sucha situation, the applicant must show that theparticular range is critical, generally by showingthat the claimed range achieves unexpectedresults relative to the prior art range. There aremany pharmaceutical patents that cover theinvention through claims to a new use for an oldcomposition.

In the case of In re Schreiber, 128 F.3d 1473,44 USPQ2d 1429 (Fed. Cir. 1997), the claims onappeal were directed to an apparatus which fit on thetop of a popcorn container and allowed for dispensingone or two popped kernels at a time. Claim 1 read asfollows:

A dispensing top for passing only several kernelsof a popped popcorn at a time from an open-ended container filled with popped popcorn, having a generally conical shape and an openingat each end, the opening at the reduced endallows several kernels of popped popcorn to passthrough at the same time, and means at theenlarged end of the top to embrace the open end




















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of the container, the taper of the top beinguniform and such as to by itself jam up thepopped popcorn before the end of the cone andpermit the dispensing of only a few kernels at ashake of a package when the top is mounted onthe container.

Prior art was cited against the claim that did notaddress popcorn, but was addressed to dispensing oilfrom an oil can. Nevertheless, the art anticipated theclaim because it contained all of the structure recitedin the claim. Setting forth the law in this area,applicable to chemical compositions and apparatusclaims, the Federal Circuit provided some usefulcitations:

It is well settled that the recitation of a newintended use for an old product does not make aclaim to that old product patentable. See In reSpada, 911 F.2d 705, 708, 15 USPQ2d 1655,1657 (Fed. Cir. 1990) ("The discovery of a newproperty or use of a previously knowncomposition, even when that property and useare unobvious from prior art, can not impartpatentability to claims to the known composition."); Titanium Metals Corp. of Am.v. Banner, 778 F.2d 775, 782, 227 USPQ 773,778 (Fed. Cir. 1985) (composition claim recitinga newly discovered property of an old alloy didnot satisfy section 102 because the alloy itselfwas not new); In re Pearson, 494 F.2d 1399,1403, 181 USPQ 641, 644 (CCPA 1974)(intended use of an old composition does notrender composition claim patentable); In reZierden, 411 F.2d 1325, 1328, 162 USPQ 102,104 (CCPA 1969) (" [M]ere statement of a newuse for an otherwise old or obvious compositioncannot render a claim to the compositionpatentable."); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement ofintended use in an apparatus claim failed to distinguish over the prior art apparatus); In reHack, 245 F.2d 246, 248, 114 USPQ 161, 162(CCPA 1957) ("the grant of a patent on acomposition or a machine cannot be predicatedon a new use of that machine or composition");In re Benner, 174 F.2d 938, 942, 82 USPQ 49,53 (CCPA 1949) ("no provision has been made inthe patent statutes for granting a patent upon anold product based solely upon discovery of a newuse for such product"). Accordingly, Schreiber'scontention that his structure will be used todispense popcorn does not have patentable

weight if the structure is already known,regardless of whether it has ever been used inany way in connection with popcorn.

It is stated in the opinion that several of Schreiber’s claims had been allowed, and the USPTOdatabase indicates he did receive a patent concerninga popcorn dispenser, U.S. Patent 6,431,415 in 2002. It is not clear exactly how this was accomplishedprocedurally, but the issued claims read as follows:

1. A dispensing top for passing only severalkernels of a popped popcorn at a time from anopen-ended container filled with popped popcorn,having a generally conical shape and an openingat each end, the opening at the reduced end beingof a diameter greater than one inch and allowsseveral kernels of popped popcorn to passthrough at the same time, and means at theenlarged end of the top to embrace the open endof the container, the taper of the top beinguniform and such as to by itself jam up thepopped popcorn at the end of the cone andpermit the dispensing of only a few kernels at ashake of the container when the top is mountedon the container.

14. In a dispensing device, a conically-shapeddispensing mechanism having a vertex, saidvertex being divided in-two to form opposingflaps, said division being to a depth to provide adesired size opening when the sides of theconically-shaped dispensing mechanism in linewith the flaps are pushed together to enableswinging the flaps outward and downward.

18. A disk-sector for fabricating a conically-shaped dispensing top having attachment tabs atits enlarged end and two opening-closing flapsconstituting the vertex of the conically-shapedtop at its pointed end, wherein said attachmenttabs are cut in side-by-side relation in disk-sector's circular periphery, and said opening-closing flaps are formed at the disk sector'scenter.

19. A mechanism for holding a conically-shapedtop having a generally circular edge onto acontainer having a generally circular edge formedwith a bead, including tabs of the same materialas the rest of the top and folded over therefromto define creases about which they are yieldablypivoted thus readily swingable on said top's









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circular edge for freely passing over the bead inone direction only and for resistively interactingwith the bead when moved in the oppositedirection thereafter to lock the top onto thecontainer and preclude its removal withoutdestroying the container or the top or a tab, saidtabs having their free ends extending towards thecontainer but being freely movable.

There are no method claims in the Schreiber patent,but this would perhaps be another way of obtainingcoverage without additional structural limitations.

c. Mechanism of ActionIn a recent case, the Federal Circuit determined

that one patent claimed a method of treating anxiety inhumans with fluoxetine hydrochloride while a secondpatent claimed a method of using fluoxetinehydrochloride to block serotonin uptake in animals. SeeEli Lilly & Co. v. Barr Laboratories, Inc., 251 F.3d955, 58 USPQ2d 1869, 1879 (Fed. Cir. 2001),amended, 58 USPQ2d 1865, cert. denied, __U.S.__,122 S.Ct. 913 (2002).

The court decided that the difference between theclaims did not render them patentably distinct. Itreasoned that serotonin uptake inhibition was “a naturalbiological activity that occurs when fluoxetinehydrochloride is administered to an animal, such as ahuman, for any purpose, including the treatment ofanxiety. That is, serotonin uptake inhibition is aninherent property of fluoxetine hydrochloride upon itsadministration.” See id.

The court noted the evidence it believed supportedthis conclusion:

1. Lilly’s 10-K filing with the Securities andExchange Commission, wherein it pointed outthat serotonin uptake inhibition is the “process bywhich Prozac works.”

2. The title of a 1995 article published by Lilly: Minireview Prozac (Fluoxetine, Lilly 110140),The First Selective Serotonin Uptake Inhibitorand Antidepressant Drug: Twenty Years Since ItsFirst Publication.

3. The summary of the article which“describe[s] the evolutionary process involved inthe discovery of the selective 5-HT [serotonin]uptake inhibitor, fluoxetine....fluoxetine (Prozac)first appeared in scientific literature as Lilly110140 (the hydrochloride form), a selectiveserotonin uptake inhibitor, in the August 15, 1974

issue of Life Sciences.” “After twenty-plus yearsof extensive investigations, inhibition of serotoninuptake remains the major mechanism of actionfor fluoxetine....several tables in the articlespecifically demarcate amounts of serotoninuptake inhibition resulting from fluoxetineadministration illustration of chemical structuresof several serotonin uptake inhibitors, one ofwhich is fluoxetine. "despite “intensiveinvestigation,” including over 5500 researchpapers on the subject, fluoxetine “is still regardedas a selective [serotonin] uptake inhibitor.” Seeid.

The claim to using fluoxetine to block serotoninuptake was held invalid for obviousness-type doublepatenting.

In the context of a claim to a durable sheet forprinting, the accused infringer Delta Airlines arguedthat its luggage tags could not have a “print receivinglayer” as required in the claim, since its tags weredesigned for use in direct thermal printing. The courtnoted that “[d]irect thermal printing uses neither inknor toner to produce an image, but instead creates animage by causing a chemical reaction to occur withinthe top layer of the print stock.”

In this case, the court ruled that Delta was notentitled to summary judgment of non-infringement,since the top layer of Delta's baggage tags bore thewords "Delta Air Lines." printed in ink and thereforethe top layer of Delta's baggage tags was “a printreceiving layer.” Even though the image appeared onthe top layer as a result of the heat-induced chemicalreaction, it was “print.” See Process Resources Corp.v. Delta Air Lines Inc., 53 USPQ2d 1995 (S.D.N.Y.2000).

One could envision a claim which specificallyrecited the printing mechanism which could provide adifferent type of coverage to the patentee. In thiscase, at least at this stage of the case, the patentee wassuccessful.

d. Plasma Concentration and MethodsIn another case, a once-a-day formulation

described in the treatment method of the '360 patent,resulted in a substantial fluctuation in the opioidconcentration in the patient's blood between themaximum concentration level and the concentrationlevel at the end of the 24-hour dosage period. Claim 1read as follows:

1. A method of effectively treating pain inhumans, comprising orally administering to a



http://www.TexasBarCLE.com/CLE/PMCasemaker.asp?table=US_supremeopinions&volume=122&edition=S.Ct.&page=913&id=40023_01


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human patient on a once-a-day basis an oralsustained release dosage form containing anopioid analgesic or salt thereof which uponadministration provides a time to maximumplasma concentration (Tmax) of said opioid inabout 2 to about 10 hours and a maximumplasma concentration (Cmax) which is more thantwice the plasma level of said opioid at about 24hours after administration of the dosage form,and which dosage form provides effectivetreatment of pain for about 24 hours or moreafter administration to the patient.

The court held that production and sale of theaccused product infringed the asserted claims of thepatent, but that the claims were invalid because theylacked the written description required by 35 U.S.C. §112, first paragraph.

The limitation “a maximum plasma concentration(Cmax) which is more than twice the plasma level ofsaid opioid at about 24 hours after administration ofthe dosage form [C24]” was found to not have beenadequately described in the disclosure of theapplication as originally filed. Purdue Pharma L.P. v.Faulding Inc. 230 F.3d 1320, 56 USPQ2d 1481, 1483,1485-1486 (Fed. Cir. 2000) Therefore, the patent wasinvalid.

Compare Purdue Pharma LP v. BoehringerIngelheim GmbH, 237 F.3d 1359, 57 USPQ2d 1647(Fed. Cir. 2001), in which controlled releaseoxycodone medications for the treatment of moderateto severe pain were developed by the patentee ownerof several related patents. A representative claim wasas follows:

A controlled release oxycodone formulation fororal administration to human patients, comprisingfrom about 10 to about 40 mg oxycodone or asalt thereof, said formulation providing a meanmaximum plasma concentration of oxycodonefrom about 6 to about 60 ng/ml from a mean ofabout 2 to about 4.5 hours after administration,and a mean minimum plasma concentration fromabout 3 to about 120 ng/ml from a mean of about10 to about 14 hours after repeated administrationevery 12 hours through steady-state conditions. '912 patent, col. 20, ll. 45-54.

The accused infringer was preliminarily enjoinedby the district court, having failed to prove substantialmerit to its invalidity and inequitable conduct defensesand the injunction was affirmed.

e. Process of AdministrationIn Bristol-Myers Squibb Co. v. Ben Venue

Laboratories Inc., 246 F.3d 1368 (Fed. Cir. 2001), aclaim reciting a method of treatment was at issue:

1. A method for reducing hematologic toxicityin a cancer patient undergoing [t]axol treatmentcomprising parenterally administering to saidpatient an antineoplastically effective amount ofabout 135-175 mg/m2 taxol over a period ofabout three hours.

Another patent was also directed to three-hourpaclitaxel administration but its claims required apremedication step:

1. A method for treating a patient sufferingfrom a taxol-sensitive tumor comprising :

(i) premedicating said patient with amedicament that reduces or eliminateshypersensitivity reactions, and

(ii) parenterally administering to saidpatient about 135-175 mg/m2 taxol overabout three hours.

Abbreviated New Drug Applications (“ANDAs”)were filed by the patent challengers, and it was allegedthat the patents were invalid over, inter alia, an articleby Kris in which Kris treated patients with three-hourinfusions of paclitaxel within the claimed dosageranges but observed no antitumor response.

The patentee argued that new uses of oldprocesses are patentable, the expressions of efficacyshould be treated as limitations because theydistinguish the new use of the process over the priorart, and that claims should be read to preserve theirvalidity.

Though the court agreed that new uses of knownprocesses may be patentable, it concluded that theclaimed process was:

not directed to a new use; it is the same use, andit consists of the same steps as described byKris. Newly discovered results of knownprocesses directed to the same purpose are notpatentable because such results are inherent. In reMay, 574 F.2d 1082, 1090, 197 USPQ 601,607(CCPA 1978); Verdegaal Bros., Inc. v. UnionOil Co., 814 F.2d 628, 633, 2 USPQ2d 1051,1054 (Fed. Cir. 1987) (holding claimed processfor making fertilizer anticipated by a disclosure of







17

the same process for making fertilizer eventhough prior art did not disclose the “inventiveconcept”); cf. Mehl/Biophile Int'l Corp. v.Milgraum, 192 F.3d 1362, 1366, 52 USPQ2d1303, 1306-1307 (Fed. Cir. 1999) (findinganticipation of a method of hair depilation by anarticle teaching a method of skin treatment butrecognizing the disruption of hair follicles).

58 USPQ2d at 1514.

f. Step-Plus FunctionStep-Plus-Function claims are authorized by 35

U.S.C. § 112, ¶ 6. The same kind of difficulties orrewards that are presented in construing means plusfunction claims are present when a claim is consideredto be a step plus function claim.

In Micro Chemical, Inc. v. Great PlainsChemical Co., 194 F.3d 1258, 52 USPQ2d 1258 (Fed.Cir. 1999), a method claim was at issue:

A method of dispensing and deliveringmicroingredient feed additives into a livestockfeed ration shortly before delivering the feedration to the livestock for consumption,comprising the steps: storing separately multiplesaid additives in concentrate form; dispensingpredetermined weights of selected said additiveconcentrates into a liquid carrier with nosubstantial intermixing of the additiveconcentrates before they enter the liquid carrier:

intermixing the additive concentrates in the liquidcarrier to dilute, disperse, and suspend them andform a liquid carrier-additive slurry;

directing the slurry to a receiving station whilemaintaining the suspension and dispersion of theadditives until delivered into a feed ration;

and determining the predetermined weights ofselected additives by the step of measuring thepredetermined weights while isolating themeasuring means from influences that wouldaffect the measuring function so that accurateweight determinations are obtained.

In claim 94, the following was disputed: “weighing predetermined amounts of selected saidadditives, with no substantial intermixing of theselected additives during the weighing process." Thedistrict court had rejected the contention that theseclaim terms required step-plus-function treatment

under Section 112, Para. 6. The district court limitedtheir scope to cover only the cumulative weighmethod, which had not been disavowed. The FederalCircuit stated: “If these claims are in step-plus-function form, they therefore encompass the weighdump method used by the accused device and theseclaims are literally infringed.” It further noted “If,however, the claims are not in step-plus-functionform, they are also literally infringed. Claimtreatment outside of the requirements of Section 112,Para. 6 generally gives the claims a broader scope. Ifthe meaning of these claim elements is not limited tothe specific acts described in the specification andtheir equivalents through operation of Section 112,Para. 6, then they will be given their ordinarilyunderstood meanings in the art.”52 USPQ2d at 1265 (emphasis added).

The Federal Circuit also addressed step-plus-function claims in O.I. Corp. v. Tekmar Co., 115 F.3d1576, 42 USPQ2d 1777 (Fed. Cir. 1997):

We first address the application of section 112,Para. 6, generally to method claims. Appellantasserts, as have other parties, that we have notdone so previously. Section 112, Para. 6,provides that:

An element in a claim for a combination may beexpressed as a means or step for performing aspecified function without the recital of structure,material, or acts in support thereof, and suchclaim shall be construed to cover thecorresponding structure, material, or actsdescribed in the specification and equivalentsthereof.

35 U.S.C. Section 112, Para. 6 (1994) (emphasisadded). This statutory provision clearly applies toclaims for a combination. It is well-established ofcourse that, in combinations that are apparatusclaims, means for performing a specifiedfunction are subject to this paragraph when theylack recital of definite structure or material.Logically, structure and material make up thevarious means of apparatus. However, " [t]heword 'combination' in this paragraph includes 'notonly a combination of mechanical elements, butalso a combination of substances in acomposition claim, or steps in a process claim .'" In re Fuetterer , 319 F.2d 259, 264, 138 USPQ217, 222 (CCPA 1963) (quoting P.J. Federico,Commentary on the New Patent Act, 35U.S.C.A. Vol. 1, p. 25 (1954), reprinted in, 75 J.







18

Pat. & Trademark Off. Soc'y 161, 186 (Mar.1993)) (emphasis added).

In the O.I. case, the claim at issue was held notto be a step-plus-function claim. The language “thesteps of...passing the analyte through a passage” wasnot step-plus-function language.

Recently, the Federal Circuit again discussedwhether a claim constituted a step plus function claimin Generations II Orthotic Inc. v. Medical Technology,Inc., 263 F.3d 1356, 59 USPQ2d 1919 (Fed. Cir.2001) (method claim drafted parallel to means-plus-function claim not necessarily a step-plus-functionclaim).

g. Method of Making vs. Recipe ClaimsMethods of making a product are another type of

patent claim that may prove to be valuable. In TanabeSeiyaku Co. v. U.S. International Trade Commission,109 F.3d 726, 41 USPQ2d 1976, (Fed. Cir 1997), cert.denied, 522 U.S. 1027 (1997), there was an expiredproduct patent and a method of synthesizing patent. However, the method of synthesizing patent was heldnot infringed under doctrine of equivalents.

In Exxon Chemical Patents Inc. v. LubrizolCorp., 64 F.3d 1553, 35 USPQ2d 1767 (Fed. Cir.1996), cert. denied, 518 U.S. 1020 (1996), Exxon’sclaims were to a lubricating oil composition suitablefor use as a crankcase lubricant in internal combustionengines. The claimed composition was defined ascomprising at least five specific ingredients. Exxoncontended that its patent claimed “recipe” ofingredients that extends to any product made by usingthe claimed ingredients, even if the product itself--asa result of chemical complexing--failed to include oneof the claimed ingredients. Lubrizol argued that sinceExxon claimed a composition product--not a processfor making a product or a product made by a claimedprocess--the ‘890 patent only extended to finalproducts that include the specified claimed ingredients. The Federal Circuit held that a jury could not havereasonably found that Lubrizol’s product, which didnot contain one of the ingredients, infringed the claim.

III. CONCLUSIONCreative patent claiming may involve

consideration of different statutory classes to definethe invention – for example the use of method claimswhen traditional thought indicates using a compoundper se claim or an apparatus claim. In addition,chemical claims provide for a multitude of possibilities,particularly when the chemical composition is a

pharmaceutical and the biological mechanism can beemployed.






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