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SCHERING CORP. v. GENEVA PHARMACEUTICALS
Cite as 339 F.3d 1373 (Fed. Cir. 2003)
the parties intended that all files that were 1. Federal Courts O766
officially kept would be purged as agreed.
Grant of summary judgment is re- viewed without deference.
2. Patents O72(1)
Patent is invalid for anticipation if sin- gle prior art reference discloses each and every limitation of claimed invention.
3. Patents O72(1)
Prior art reference may anticipate GENEVA PHARMACEUTICALS, INC.
patent without disclosing feature of and Novartis Corporation, and Teva
claimed invention if that missing charac- Pharmaceuticals USA, Inc., and Andrx
teristic is necessarily present, or inherent, Corporation, Andrx Pharmaceuticals
in single anticipating reference.
LLC, and Andrx Pharmaceuticals,
4. Patents O65
Inc., and Mylan Pharmaceuticals,
Inc., and Wyeth, ESI–Lederle, Wyeth

Inherent anticipation of later patent Pharmaceuticals, and Wyeth Consum-
does not require that person of ordinary er Healthcare (formerly American
skill in art at time would have recognized Home Products Corporation, Wyeth–
Ayerst Laboratories, and Whitehall
5. Patents O66(1.12)
Robbins Healthcare), and Impax Lab-
Patent for metabolite of previously oratories, Inc., Apotex, Inc. and Novex
patented antihistamine was inherently an- Pharma, Copley Pharmaceutical, Inc.,
ticipated, even though prior patent did not and Genpharm, Inc., Defendants–Ap-
disclose any compound identifiable as claimed invention; metabolite necessarily Nos. 02–1540, 02–1541, 02–1542, 02–1543,
and inevitably formed upon ingestion of 02–1544, 02–1545, 02–1546, 02–1547, 02–
previously patented antihistamine under 1548, 02–1549, 03–1021, 03–1022, 03–
normal conditions.
1023, 03–1025, 03–1027.
6. Patents O65
United States Court of Appeals, Inherency operates to anticipate en- Federal Circuit.
tire inventions as well as single limitations Aug. 1, 2003.
within patented inventions.
7. Patents O65
Owner of patent for antihistamine me- Patent anticipation does not require tabolite sued manufacturers of generic ver- actual creation or reduction to practice of sions for infringement. The United States prior art subject matter; anticipation re- District Court for the District of New Jer- quires only enabling disclosure.
sey, 2002 WL 2001552, John W. Bissell,Chief Judge, held that patent was invalid, 8. Patents O66(1.12)
and appeal was taken. The Court of Ap- Prior patent for antihistamine con- peals, Rader, Circuit Judge, held that pat- tained enabling disclosure of metabolite ent was inherently anticipated by prior art formed when drug was ingested, and thus patent for underlying antihistamine.
anticipated later patent for that metabol- ite; although prior patent did not mention 339 FEDERAL REPORTER, 3d SERIES
metabolite, it did disclose administration of dant-appellee Genpharm Inc.; antihistamine to patient.
Underwood, Soloman, Zauderer, Ellen- 9. Patents
horn, Frischer & Sharp, of New York, NY, for defendants-appellees Andrx Corpora- Broad compound claims are inherently tion, Andrx Pharmaceuticals LLC, and anticipated by prior art disclosure of phar-maceutical drug that metabolizes into Andrx Pharmaceuticals, Inc.; E. Anthony claimed compound.
Figg, Joseph A. Hynds, Rothwell, Figg,Ernst & Manbeck, of Washington, DC, for defendant-appellee Mylan Pharmaceuti- 4,282,233. Cited as Prior Art.
Robert S. Silver and William J. Castillo, 4,659,716. Invalid.
Caesar, Rivise, Bernstein, Cohen & Poko-tilow, Ltd., of Philadelphia, PA, for defen-dants-appellees Apotex, Inc. and NovexPharma.
Robert G. Krupka, Kirkland & Ellis, of Thomas L. Creel, Goodwin Procter, Los Angeles CA, argued for plaintiff-ap- LLP, of New York, NY, for defendants- pellant. Of counsel on the brief were appellees Teva Pharmaceuticals USA, Inc.
David P. Swenson, Kirkland & Ellis, of and Copely Pharmaceutical, Inc. With him John M. Desmarais, on the brief were Frederick H. Rein and Sandra A. Bresnick, Peter J. Armenio, Keith A. Zullow.
Maxine Y. Graham, Monica V. Bhattacha- Douglass C. Hochstetler, Schiff, Hardin ryya, and Young J. Park, Kirkland & Ellis, & Waite, of Chicago, IL, argued for defen- of New York, NY. Of counsel were John F.
dants-appellees Geneva Pharmaceuticals, Hoffman and Arthur Mann, Schering Cor- Inc. and Novartis Corporation. With him poration, of Kenilworth, NJ.
on the brief were Patricia J. Thompson Robert D. Bajefsky, Finnegan, and Jo–Anne M. Kokoski. Of counsel on Henderson, Farabow, Garrett & Dunner, the brief was Kevin M. Flowers, Ph.D., L.L.P., of Washington, DC, argued for de- Marshall Gerstein & Borun, of Chicago, fendants-appellees Wyeth, ESI–Lederle, Wyeth Pharmaceuticals and Wyeth Con-sumer Healthcare (formerly American Before RADER, Circuit Judge, Home Products Corporation, Wyeth–Ay- PLAGER, Senior Circuit Judge, and erst Laboratories, and Whitehall Robbins BRYSON, Circuit Judge.
Healthcare). With him on the brief were RADER, Circuit Judge.
Barbara R. Rudolph and Matthew J. Ma-son. Of counsel on the brief were David On summary judgment, the United A. Manspeizer and Lawrence Alaburda, States District Court for the District of Wyeth, of Madison, NJ. On the brief was New Jersey determined that claims 1 and Julie A. Petruzzelli, Venable, Baetjer, 3 of U.S. Patent No. 4,659,716 (the 8716 Howard, & Civiletti, LLP, of Washington, patent) are invalid. Schering Corp. v. Ge- DC, for defendant-appellee Impax Labora- neva Pharm., Inc., No. 98–1259, 2002 WL tories, Inc. Of counsel were Peter J. Curtin 2001552 (D.N.J. Aug.8, 2002). Because and James E. Gray. Also on the brief were the district court correctly found that U.S.
Edgar H. Haug, Daniel G. Brown, and Patent No. 4,282,233 (the 8233 patent) in- Porter F. Fleming, Frommer Lawrence & herently anticipates claims 1 and 3 of the Haug LLP, of New York, NY; for defen- 8716 patent, this court affirms.
SCHERING CORP. v. GENEVA PHARMACEUTICALS
Cite as 339 F.3d 1373 (Fed. Cir. 2003)
ceutical. The ingested pharmaceutical un-dergoes a chemical conversion in the di- Schering Corporation (Schering) owns gestion process to form a new metabolite the 8233 and 8716 patents on antihista- compound. The metabolite DCL is also a mines. Antihistamines inhibit the hista- non-drowsy antihistamine. The 8716 pat- mines that cause allergic symptoms.
ent issued in April 1987 and will expire in The prior art 8233 patent covers the April 2004 (the 8233 patent issued in 1981 antihistamine loratadine, the active compo- and has since expired). See 35 U.S.C.
nent of a pharmaceutical that Schering § 154(c)(1) (2000) (defining the term of a markets as CLARITIN{. Unlike conven- patent in force before June 8, 1995, as the tional antihistamines when CLARITIN{ greater of twenty years from the earliest was launched, loratadine does not cause U.S. priority date or seventeen years from The more recent 8716 patent at issue in Structurally, loratadine and its metabol- this case covers a metabolite of loratadine ite DCL differ only in that loratadine has a called descarboethoxyloratadine (DCL). A carboethoxy group (i.e., -COOEt) on a ring metabolite is the compound formed in the nitrogen, while DCL has a hydrogen atom patient's body upon ingestion of a pharma- on that ring nitrogen: Claim 1 of the 8716 patent covers DCL 1. A compound of the formula (for X = Cl), its fluorine analog, and theirsalts; claim 3 covers only DCL and itssalts: or a pharmaceutically acceptable salt 3. A compound having the structural thereof, wherein X represents Cl or F.
339 FEDERAL REPORTER, 3d SERIES
or a pharmaceutically acceptable salt that the 8716 patent was invalid. See id. § 355(b)(2)(A), 355(j)(2)(A)(vii). The ap- The 8233 patent issued on August 4, pellees notified Schering of the FDA fil- 1981, over one year before the earliest See id. § priority date of the 8716 patent, February 15, 1984. The 8233 patent is thus prior art After receiving notice of the FDA fil- to the 8716 patent. See 35 U.S.C. § 102(b) ings, Schering filed suit for infringement.
(2000) (‘‘A person shall be entitled to a See 35 U.S.C. § 271(e)(2)(A) (2000). After patent unless TTT the invention was pat- discovery, the parties filed cross motions ented TTT in this or a foreign country TTT for summary judgment on the validity is- more than one year prior to the date of the sue. The district court construed claims 1 application for patent in the United and 3 of the 8716 patent to cover DCL in States.''). The 8233 patent discloses a all its forms, including ‘‘metabolized within class of compounds including loratadine the human body'' and ‘‘synthetically pro- (disclosed in Example 1B). 8233 patent, duced in a purified and isolated form.'' col. 3, ll. 5–12. The 8233 patent claims The parties agreed to that construction.
loratadine in claim 7. Id., col. 6, ll. 38–40.
Applying that claim construction, the dis- The 8233 patent claims four other com- trict court found that the 8233 patent did pounds in claims 8–11. Examples 6–7 are not expressly disclose DCL. Nonetheless, prophetic 1 examples of pharmaceutical
the district court also found that DCL was compositions (a syrup and a tablet), each necessarily formed as a metabolite by car- containing an unidentified ‘‘active com- rying out the process disclosed in the 8233 pound.'' The 8233 patent does not ex- patent. The district court concluded that pressly disclose DCL and does not refer to the 8233 patent anticipated claims 1 and 3 metabolites of loratadine.
of the 8716 patent under 35 U.S.C.
The numerous defendants-appellees § 102(b). The district court therefore sought to market generic versions of lora- granted the appellees' motions for sum- tadine once the 8233 patent expired. Seek- mary judgment of invalidity. Schering ing regulatory approval, each appellee sub- timely appealed to this court under 28 mitted an application to the Food and U.S.C. § 1295(a)(1) (2000).
Drug Administration (FDA). 355(b), (j) (2000). Schering included the 8716 patent in the [1] This court reviews a grant of sum-
Orange Book listing for loratadine, the mary judgment without deference. Tele- applications also contained a certification mac Cellular Corp. v. Topp Telecom, Inc., 1. Prophetic examples are set forth in the pres-
Nemours & Co., 750 F.2d 1569, 1578 (Fed.Cir.
ent tense to indicate that they were not car- ried out. Atlas Powder Co. v. E.I. du Pont De SCHERING CORP. v. GENEVA PHARMACEUTICALS
Cite as 339 F.3d 1373 (Fed. Cir. 2003)
247 F.3d 1316, 1323 (Fed.Cir.2001). In necessarily known.''). Thus, recognition reviewing a summary judgment determi- by a person of ordinary skill in the art nation, this court draws all reasonable in- before the critical date of the 8716 patent ferences in favor of the non-movant.
is not required to show anticipation by Anderson v. Liberty Lobby, Inc., 477 U.S.
inherency. The district court therefore 242, 255, 106 S.Ct. 2505, 91 L.Ed.2d 202 did not err in allowing for later recognition of the inherent characteristics of the priorart 8233 patent.
Contrary to Schering's contention, Con- [2, 3] A patent is invalid for anticipa-
tinental Can does not stand for the propo- tion if a single prior art reference discloses sition that an inherent feature of a prior each and every limitation of the claimed art reference must be perceived as such by invention. Lewmar Marine, Inc. v. Bar- a person of ordinary skill in the art before ient, Inc., 827 F.2d 744, 747 (Fed.Cir.1987).
the critical date. In Continental Can, this Moreover, a prior art reference may antici- court vacated summary judgment of antici- pate without disclosing a feature of the pation of claims reciting a plastic bottle claimed invention if that missing charac- with hollow ribs over a prior art reference teristic is necessarily present, or inherent, disclosing a plastic bottle. The record in the single anticipating reference. Con- contained conflicting expert testimony tinental Can Co. v. Monsanto Co., 948 about whether the ribs of the prior art F.2d 1264, 1268 (Fed.Cir.1991).
plastic bottle were solid. The accused in- [4] At the outset, this court rejects the
fringer's expert testified that the prior art contention that inherent anticipation re- plastic bottle was made by blow molding, a quires recognition in the prior art. Scher- process that would inherently produce hol- ing relies on Elan Pharmaceuticals, Inc. v. low ribs. The patentee's experts testified Mayo Foundation for Medical Education that the prior art plastic bottle had solid & Research, 304 F.3d 1221 (Fed.Cir.2002) ribs. The patentee disputed whether the for that proposition. This court has since blow molding inherently produced hollow vacated Elan. See 304 F.3d 1221 (Fed.Cir.
ribs. Given the disputed material fact, 2002). Other precedents of this court have this court vacated the summary judgment held that inherent anticipation does not as improper. Continental Can, 948 F.2d require that a person of ordinary skill in at 1269. Continental Can makes no refer- the art at the time would have recognized ence to whether the inherent feature, hol- the inherent disclosure. E.g., In re Cruci- low ribs, was recognized before or after ferous Sprout Litig., 301 F.3d 1343, 1351 the critical date of the patent at issue.
Read in context, Continental Can stands Corp. v. Milgraum, 192 F.3d 1362, 1366 for the proposition that inherency, like an- (Fed.Cir.1999) (‘‘Where TTT the result is a ticipation itself, requires a determination necessary consequence of what was delib- of the meaning of the prior art. Thus, a erately intended, it is of no import that the court may consult artisans of ordinary skill article's authors did not appreciate the re- to ascertain their understanding about sults.''); Atlas Powder, 190 F.3d at 1348– subject matter disclosed by the prior art, 49 (‘‘Because ‘sufficient aeration' was in- including features inherent in the prior herent in the prior art, it is irrelevant that art. A court may resolve factual questions the prior art did not recognize the key about the subject matter in the prior art aspect of [the] inventionTTTT An inherent by examining the reference through the structure, composition, or function is not eyes of a person of ordinary skill in the 339 FEDERAL REPORTER, 3d SERIES
art, among other sources of evidence about fered for sale inherently possesses each of the meaning of the prior art. Thus, in the limitations of the claims, then the in- Continental Can, this court did not require vention is on sale, whether or not the past recognition of the inherent feature, parties to the transaction recognize that but only allowed recourse to opinions of the product possesses the claimed charac- skilled artisans to determine the scope of teristics.''); Scaltech, Inc. v. Retec/Tetra, the prior art reference.
LLC, 269 F.3d 1321, 1330 (Fed.Cir.2001) Cases dealing with ‘‘accidental, unwit- (‘‘[A]ppreciation of the invention is not a ting, and unappreciated'' anticipation also requirement to trigger the statutory [on do not show that inherency requires recog- sale] bar.''). In those cases, the product nition. See Eibel Process Co. v. Minn. & sold or offered for sale had an inherent, Ontario Paper Co., 261 U.S. 45, 43 S.Ct.
but unrecognized, feature that was a limi- 322, 67 L.Ed. 523 (1923); Tilghman v. tation of the asserted claims. Id. Thus, Proctor, 102 U.S. 707, 26 L.Ed. 279 (1880).
this court has distinguished Eibel and In contrast to the present case, the record Tilghman, which therefore do not bind in Eibel and Tilghman did not show that this court to find no anticipation because the prior art produced the claimed subject skilled artisans did not recognize that the matter. The patent at issue in Tilghman prior art 8233 patent inherently produced claimed a method of forming free fatty the claimed invention, DCL.
acids and glycerine by heating fats with In the context of accidental anticipation, water at high pressure. In Tilghman, the DCL is not formed accidentally or under record did not show conclusively that the unusual conditions when loratadine is in- claimed process occurred in the prior art.
gested. The record shows that DCL neces- In reviewing the prior art, the Court re- sarily and inevitably forms from loratadine ferred hypothetically to possible disclosure under normal conditions. DCL is a neces- of the claimed process. For example, theCourt stated ‘‘[w]e do not regard the acci- sary consequence of administering lorata- dental formation of fat acid in Perkins's dine to patients. The record also shows steam cylinder TTT (if the scum which rose that DCL provides a useful result, because on the water issuing from the ejection pipe it serves as an active non-drowsy antihista- was fat acid) as of any consequence in this mine. In sum, this court's precedent does inquiry.'' Tilghman, 102 U.S. at 711. In not require a skilled artisan to recognize Eibel, the Court found no evidence of the the inherent characteristic in the prior art claimed subject matter in the prior art.
that anticipates the claimed invention.
Eibel, 261 U.S. at 66, 43 S.Ct. 322 (‘‘[W]efind no evidence that any pitch of the wire TTT had brought about such a result TTT [5] This court recognizes that this may
and TTT if it had done so under unusual be a case of first impression, because the conditions, accidental results, not intended prior art supplies no express description of and not appreciated, do not constitute an- any part of the claimed subject matter.
The prior art 8233 patent does not disclose Applying an inherency principle in the any compound that is identifiable as DCL.
context of an on sale bar under 35 U.S.C.
In this court's prior inherency cases, a § 102(b), this court has distinguished Eibel single prior art reference generally con- and Tilghman. See Abbott Labs. v. Gene- tained an incomplete description of the va Pharms., Inc., 182 F.3d 1315, 1319 anticipatory subject matter, i.e., a partial (Fed.Cir.1999) (‘‘If a product that is of- description missing certain aspects. In- SCHERING CORP. v. GENEVA PHARMACEUTICALS
Cite as 339 F.3d 1373 (Fed. Cir. 2003)
herency supplied the missing aspect of the 955, 970 (Fed.Cir.2001); see also In re description. Upon proof that the missing Kratz, 592 F.2d 1169, 1174 (CCPA 1979) description is inherent in the prior art, (suggesting inherent anticipation of a com- that single prior art reference placed the pound even though the compound's exis- claimed subject matter in the public do- tence was not known).
main. This case does not present the is- In reaching this conclusion, this court is sue of a missing feature of the claimed aware of In re Seaborg, 51 C.C.P.A. 1109, invention. Rather, the new structure in 328 F.2d 996 (CCPA 1964). In that case, this case, DCL, is not described by the this court's predecessor considered claims prior 8233 patent.
drawn to an isotope of americium made by Patent law nonetheless establishes that nuclear reaction in light of a prior art a prior art reference which expressly or patent disclosing a similar nuclear reaction inherently contains each and every limita- process but with no disclosure of the tion of the claimed subject matter antici- claimed isotope. The court reversed a pates and invalidates. See, e.g., EMI United States Patent and Trademark Of- Group N. Am., Inc., v. Cypress Semicon- fice rejection of the claims for lack of ductor Corp., 268 F.3d 1342, 1350 (Fed.Cir.
novelty. This court's predecessor found 2001) (‘‘A prior art reference anticipates a that the prior art process did not antici- patent claim if the reference discloses, ei- pate the claims because the process would ther expressly or inherently, all of the have produced at most one billionth of a limitations of the claim.''); gram of the isotope in forty tons of radio- Bros., Inc. v. Union Oil Co. of Cal., 814 active material, i.e., the isotope would have F.2d 628, 631 (Fed.Cir.1987) (‘‘A claim is been undetectable. Id. at 998–99 (‘‘[T]he anticipated only if each and every element claimed product, if it was produced in the as set forth in the claim is found, either Fermi process, was produced in such mi- expressly or inherently described, in a sin- nuscule amounts and under such condi- gle prior art reference.''). In these prior tions that its presence was undetectable.'').
cases, however, inherency was only neces- In this case, DCL forms in readily detecta- sary to supply a single missing limitation ble amounts as shown by the extensive that was not expressly disclosed in the record evidence of testing done on humans prior art. This case, as explained before, to verify the formation of DCL upon in- asks this court to find anticipation when gestion of loratadine.
the entire structure of the claimed subjectmatter is inherent in the prior art.
[6] This court sees no reason to modify
Because inherency places subject matter the general rule for inherent anticipation in the public domain as well as an express in a case where inherency supplies the disclosure, the inherent disclosure of the entire anticipatory subject matter. The entire claimed subject matter anticipates patent law principle ‘‘that which would lit- as well as inherent disclosure of a single erally infringe if later in time anticipates if feature of the claimed subject matter.
earlier,'' Bristol–Myers Squibb Co. v. Ben The extent of the inherent disclosure does Venue Labs., Inc., 246 F.3d 1368, 1378 not limit its anticipatory effect. In gener- (Fed.Cir.2001), bolsters this conclusion.
al, a limitation or the entire invention is Similarly, ‘‘if granting patent protection on inherent and in the public domain if it is the disputed claim would allow the paten- the ‘‘natural result flowing from'' the ex- tee to exclude the public from practicing plicit disclosure of the prior art. See Eli the prior art, then that claim is anticipat- Lilly & Co. v. Barr Labs., Inc., 251 F.3d ed.'' Atlas Powder, 190 F.3d at 1346. ‘‘The 339 FEDERAL REPORTER, 3d SERIES
public remains free to make, use, or sell prior art compositions or processes, re- This court next examines whether gardless of whether or not they under- Schering's secret tests of loratadine before stand their complete makeup or the under- the critical date placed DCL in the public lying scientific principles which allow them domain. Before the critical date, Schering to operate. The doctrine of anticipation by only tested loratadine in secret. Thus, ac- inherency, among other doctrines, enforces cording to Schering, ‘‘DCL was not public- that basic principle.'' Id. at 1348. Thus, ly used, or described in any printed publi- inherency operates to anticipate entire in- cation, until after February 15, 1983, the ventions as well as single limitations within critical date for the 8716 patent under 35 an invention.
U.S.C. § 102(b).'' Schering thus argues Turning to this case, the use of lorata- that DCL did not ‘‘exist'' in the public dine would infringe claims 1 and 3 of the domain such that DCL could be prior art 8716 patent covering the metabolite DCL.
against the 8716 patent.
This court has recognized that a personmay infringe a claim to a metabolite if the [7] Anticipation does not require the
person ingests a compound that metabo- actual creation or reduction to practice of lizes to form the metabolite. See Hoechst– the prior art subject matter; anticipation Roussel Pharms., Inc. v. Lehman, 109 requires only an enabling disclosure. In F.3d 756, 759 (Fed.Cir.1997) (‘‘[T]he right re Donohue, 766 F.2d 531, 533 (Fed.Cir.
to exclude may arise from the fact that 1985). Thus, actual administration of lora- when administered, [the accused product] tadine to patients before the critical date metabolizes into another product TTT of the 8716 patent is irrelevant. The 8233 which Hoechst has claimed.''); see also patent suffices as an anticipatory prior art Zenith Labs., Inc. v. Bristol–Myers Squibb reference if it discloses in an enabling Co., 19 F.3d 1418, 1421–22 (Fed.Cir.1994) manner the administration of loratadine to (stating that a compound claim could cover a compound formed upon ingestion). An [8] Thus, this court examines whether
identical metabolite must then anticipate if the 8233 patent contains an enabling dis- earlier in time than the claimed compound.
closure of DCL. A reference may enable The record shows that the metabolite of one of skill in the art to make and use a the prior art loratadine is the same com- compound even if the author or inventor pound as the claimed invention. Claims 1 did not actually make or reduce to prac- and 3 are compound claims in which indi- tice that subject matter. Bristol–Myers, vidual compounds are claimed in the alter- 246 F.3d at 1379; see also In re Donohue, native in Markush format. DCL is within 766 F.2d at 533 (sustaining an anticipation the scope of claims 1 and 3. Because the rejection over a reference disclosing a prior art metabolite inherently disclosed compound and other references disclosing DCL, claims 1 and 3 are anticipated and sufficient information to make that com- invalid. In other words, the record shows pound). Indeed, information arising after that a patient ingesting loratadine would the critical date may show that the necessarily metabolize that compound to claimed subject matter, as disclosed in a DCL. That later act would thus infringe prior art reference, ‘‘was in the public's claims 1 and 3. Thus, a prior art reference possession.'' Bristol–Myers, 246 F.3d at showing administration of loratadine to a 1379 (citing In re Donohue, 766 F.2d at patient anticipates claims 1 and 3.
SCHERING CORP. v. GENEVA PHARMACEUTICALS
Cite as 339 F.3d 1373 (Fed. Cir. 2003)
An anticipatory reference need only en- disclosure of a drug that metabolizes into able subject matter that falls within the the claimed compound.
scope of the claims at issue, nothing more.
A skilled patent drafter, however, might To qualify as an enabled reference, the fashion a claim to cover the metabolite in a 8233 patent need not describe how to make way that avoids anticipation. For exam- DCL in its isolated form. The 8233 patent ple, the metabolite may be claimed in its need only describe how to make DCL in pure and isolated form, as in Kratz and any form encompassed by a compound Bergstrom, or as a pharmaceutical compo- claim covering DCL, e.g., DCL as a meta- sition (e.g., with a pharmaceutically accept- bolite in a patient's body. The 8233 patent able carrier). The patent drafter could discloses administering loratadine to a pa- also claim a method of administering the tient. A person of ordinary skill in the art metabolite or the corresponding pharma- could practice the 8233 patent without un- ceutical composition. The 8233 patent due experimentation. The inherent result would not provide an enabling disclosure of administering loratadine to a patient is to anticipate such claims because, for in- the formation of DCL. The 8233 patent stance, the 8233 patent does not disclose thus provides an enabling disclosure for isolation of DCL.
The 8716 patent contains claims 5–13 covering pharmaceutical compositions and claims 14–16 covering methods of treating Finally, this court's conclusion on inher- allergic reactions by administering com- ent anticipation in this case does not pre- pounds that include DCL. These claims clude patent protection for metabolites of were not found anticipated by the 8233 known drugs. With proper claiming, pat- ent protection is available for metabolites of known drugs. Cf. In re Kratz, 592 F.2d1169, 1174 (CCPA 1979) (stating that a The district court found that ‘‘there is no naturally occurring strawberry constituent genuine issue that the consumption of lora-tadine by humans, with a wide variety of compound does not anticipate claims to the health statuses, necessarily results in the substantially pure compound); In re Berg- natural production in the human body of strom, 57 C.C.P.A. 1240, 427 F.2d 1394, the DCL metabolite.'' This court must 1401–02 (CCPA 1970) (stating that a mate- also examine the record for any genuine rial occurring in nature in less pure form issue of material fact about whether in- does not anticipate claims to the pure ma- gestion of loratadine necessarily produces DCL. The record does, for instance, con- [9] But those metabolites may not re-
tain expert testimony, including a pro- ceive protection via compound claims. In posed metabolic scheme and animal data, this case, for instance, claims 1 and 3 that questions whether ingestion of lorata- broadly encompass compounds defined by dine always forms DCL.
structure only. Such bare compound A dispute about a material fact is genu- claims include within their scope the recit- ine ‘‘if the evidence is such that a reason- ed compounds as chemical species in any able jury could return a verdict for the surroundings, including within the human nonmoving party.'' Anderson v. Liberty body as metabolites of a drug. As this Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct.
case holds, these broad compound claims 2505, 91 L.Ed.2d 202 (1986). In this case, are inherently anticipated by a prior art the evidence supporting the district court's 339 FEDERAL REPORTER, 3d SERIES
conclusion is extensive. In thirteen clini- tadine to DCL, and that ‘‘[t]here is no cal studies that Schering ran before May scientific data in the published literature 1, 1987, all 144 patients involved had that says that DCL is not formed from measurable amounts of DCL in their sys- loratadine in humans.'' Based on this rec- tems after ingesting loratadine. The dis- ord, no reasonable jury could find that trict court found ‘‘no reports in any of the DCL is not produced when a human in- studies of any individual who did not meta- gests loratadine. This court therefore dis- bolically produce DCL following the ad- cerns no genuine issue of material fact.
ministration of loratadine.'' The appelleesreported twenty-one clinical studies in which loratadine was administered to a The district court did not err in finding total of 864 patients, all of whom formed that the 8233 patent discloses administer- measurable amounts of DCL in their sys- ing loratadine to a patient, and that DCL tems. In addition, the record shows that forms as a natural result of that adminis- since 1985 Schering's technical articles and tration. The district court correctly con- Securities and Exchange Commission fil- cluded that DCL is inherent in the prior ings referred to DCL as the metabolite of art. Without any genuine issues of mate- loratadine. Also the Food and Drug Ad- rial fact, the district court correctly grant- ministration, the corresponding European ed summary judgment that claims 1 and 3 agency, the Physician's Desk Reference, are invalid as anticipated by the 8233 pat- and Schering's CLARITIN package insert referred to DCL as the major metabolite of loratadine.
Each party shall bear its own costs.
The record presents no data on humans to show that a genuine factual dispute exists about the formation of DCL afteringesting loratadine. Indeed Schering's own expert testified that no human hasbeen found that does not metabolize lora-

Source: https://www.law.berkeley.edu/files/Schering_v_Geneva.pdf

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INTERNATIONAL JOURNAL FOR RESEARCH IN EMERGING SCIENCE AND TECHNOLOGY, VOLUME-2, ISSUE-4, APRIL-2015 E-ISSN: 2349-7610 Investigation into Beneficial Effect of Ketoconazole in Management of Complications Associated with Upasana Bhalani1 and Pravin Tirgar 2 1School of Pharmacy, RK University, Kasturbadham, Rajkot, Gujarat, India. 1upasana1311@gmail.com