Source: https://www.scribd.com/document/228814007/Warner-Chilcott-Company-v-Lupin-Atlantis-Holdings-et-al
Timestamp: 2016-08-29 00:02:58
Document Index: 145575537

Matched Legal Cases: ['§ 271', '§ 355', '§ 1331', '§ 1391', '§ 271', '§ 271', '§ 271', '§ 271', '§ 271', '§ 271', '§ 271', '§ 271', '§ 285', '§ 271', '§ 285', 'application No. 09', 'art26', 'artc4', 'art29']

BrowseUploadSign inJoinBooksAudiobooksComicsSheet MusicWelcome to Scribd! Start your free trial and access books, documents and more.Find out moreIN THE UNITED STATES DISTRICT COURTFOR THE DISTRICT OF MARYLAND WARNER CHILCOTT COMPANY, LLC, Union St., Road 195, Km. 1.1 Fajardo, Puerto Rico Plaintiff, v. LUPIN ATLANTIS HOLDINGS SA Mühlentalstrasse 2 8200 Schaffhausen Schaffhausen, Switzerland LUPIN LTD. B/4 Laxmi Towers, Bandra Kurla Complex, Bandra (E), Mumbai 400 051 India LUPIN PHARMACEUTICALS, INC. 111 S. Calvert Street, 21st Floor, Baltimore, MD 21202 Baltimore City Defendants. C.A. No. _________________ COMPLAINT FOR PATENT INFRINGEMENT Plaintiff Warner Chilcott Company, LLC, by its undersigned attorneys, brings this action against Defendants Lupin Atlantis Holdings SA; Lupin Ltd.; and Lupin Pharmaceuticals, Inc. (collectively “Lupin”), and hereby alleges as follows: THE PARTIES 1. Plaintiff Warner Chilcott Company, LLC (“Warner Chilcott”) is a limited liability company organized and existing under the laws of Puerto Rico, having offices at Union St., Road 195, Km 1.1, Fajardo, Puerto Rico. 2. Upon information and belief, Defendant Lupin Limited (“Lupin Ltd.”) is a corporation organized and existing under the laws of India. 3. Upon information and belief, Defendant Lupin Atlantis Holdings SA (“Lupin Atlantis”) is a wholly-owned subsidiary of Lupin Ltd., and is a corporation organized and existing under the laws of Switzerland. 4. Upon information and belief, Defendant Lupin Pharmaceuticals, Inc. (“Lupin Pharmaceuticals”) is a wholly-owned subsidiary of Lupin Ltd. and is a corporation organized and existing under the laws of the Commonwealth of Virginia. Lupin Pharmaceuticals has a principal place of business located at 111 S. Calvert Street, 21st Floor, Baltimore, MD 21202. 5. Upon information and belief, Lupin Ltd. has engaged in continuous and systemic contacts with the United States by, among other things, filing with the United States Food and Drug Administration (“FDA”) Abbreviated New Drug Applications (“ANDAs”) to sell various products in the United States. Upon information and belief, 2 Lupin Ltd. manufactures generic drug products for sale and use in the United States, including in this judicial district. 6. Upon information and belief, Lupin Ltd., Lupin Atlantis, and Lupin Pharmaceuticals are agents of each other with respect to the development, regulatory approval, marketing, sale and/or distribution of generic pharmaceutical products. Upon information and belief, Lupin Ltd. and Lupin Pharmaceuticals, through their affiliate, agent, and alter-ego Lupin Atlantis, filed the ANDA with FDA that is at issue in this patent infringement suit. Upon information and belief, the acts of Lupin Atlantis complained of herein were done and are being done with the cooperation, participation, and assistance of, and at least in part for the benefit of, Lupin Ltd. and Lupin Pharmaceuticals. JURISDICTION AND VENUE 7. This is an action for patent infringement arising under the patent laws of the United States, 35 U.S.C. § 271(e)(2) and 21 U.S.C. § 355. This Court has subject matter jurisdiction over this action based on 28 U.S.C. §§ 1331 and 1338(a). 8. This Court has personal jurisdiction over Lupin Pharmaceuticals by virtue of, at least, its principal place of business in Baltimore, MD. 9. This Court has personal jurisdiction over Lupin Atlantis at least under Federal Rule of Civil Procedure 4(k)(2). 10. This Court has personal jurisdiction over Lupin Ltd. at least under Federal Rule of Civil Procedure 4(k)(2). 3 11. Venue is proper in this Court under 28 U.S.C. §§ 1391 and 1400(b). COUNT I: CLAIM FOR INFRINGEMENT OF THE ’050 PATENT 12. Warner Chilcott LLC is the holder of New Drug Application (“NDA”) No. 203667 for Minastrin
24 Fe, which contains the active ingredients ethinyl estradiol and norethindrone acetate. Minastrin
24 Fe was approved by FDA on May 8, 2013, and is indicated for use by women to prevent pregnancy. Minastrin
24 Fe is sold as a 28-day oral contraceptive regimen that includes 24 chewable tablets comprising 1.0 mg norethindrone acetate and 0.020 mg ethinyl estradiol, and 4 chewable ferrous fumarate tablets (placebo). 13. U.S. Patent No. 6,667,050 (the “’050 Patent”) entitled “Chewable Oral Contraceptive” was lawfully issued by the United States Patent and Trademark Office on December 23, 2003. A copy of the ’050 Patent is attached as Exhibit A. 14. Warner Chilcott is the sole owner of the ’050 Patent. 15. The ’050 Patent claims, among other things, chewable, palatable oral contraceptive tablets; methods of administering said tablets to a human female; and methods of enhancing compliance with the oral contraception regimen. 16. Minastrin
24 Fe and its use in accordance with the FDA-approved labeling are covered by the claims of the ’050 Patent. The ’050 Patent is listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) for Minastrin
24 Fe. 4 17. Upon information and belief, Lupin Ltd. and Lupin Pharmaceuticals, through their affiliate, agent, and alter-ego Lupin Atlantis, submitted ANDA No. 206287 to FDA seeking approval to engage in the commercial manufacture, use, offer for sale, and sale of a generic version of Minastrin
24 Fe before the expiration of the ’050 Patent. Defendants’ manufacture, use, offer for sale, or sale in the United States, or importation into the United States, of such product would infringe the claims of the ’050 Patent under 35 U.S.C. § 271(a), (b), and/or (c). 18. Defendants’ manufacture, use, offer for sale, or sale in the United States, or importation into the United States, of the generic Minastrin
24 Fe product for which approval is sought in ANDA No. 206287 would actively induce and contribute to infringement of the ’050 Patent, and Defendants would be liable under 35 U.S.C. § 271(b) and/or (c). 19. As part of their ANDA filing, Lupin Ltd. and Lupin Pharmaceuticals, through their affiliate, agent, and alter-ego Lupin Atlantis, have purportedly provided written certification (“Paragraph IV certification”) to FDA that the claims of the ’050 Patent are invalid and/or will not be infringed by the manufacture, use, or sale of Defendants’ generic version of Minastrin
24 Fe. 20. By letter dated April 24, 2014, Defendants’ counsel gave written notice of the certification of invalidity and/or noninfringement of the ’050 Patent, alleging that the claims of the ’050 Patent are invalid due to obviousness, indefiniteness, and lack of enablement, and that claims 18, 36, and 54 are not infringed by Defendants’ generic 5 Minastrin
24 Fe product. The letter additionally informed Warner Chilcott that Defendants seek to engage in the commercial manufacture, use, and sale of a product bioequivalent to Minastrin
24 Fe prior to the expiration of the ’050 Patent. 21. Lupin Atlantis has infringed the ’050 Patent under 35 U.S.C. § 271(e)(2)(A) by virtue of submitting ANDA No. 206287 with a Paragraph IV certification and seeking FDA approval of ANDA No. 206287 prior to the expiration of the ’050 Patent. Moreover, if Lupin Atlantis commercially manufactures, uses, offers for sale, or sells in the United States, or imports into the United States, Defendants’ generic version of Minastrin
24 Fe, it would further infringe the ’050 Patent under 35 U.S.C. § 271(a), (b), and/or (c). Upon approval of ANDA No. 206287, Lupin Atlantis will actively induce and/or contribute to infringement of the ’050 Patent under 35 U.S.C. § 271(b) and/or (c). 22. Lupin Pharmaceuticals and Lupin Ltd. are jointly and severally liable for any infringement of the ’050 Patent by virtue of submitting ANDA No. 206287 through their agent, affiliate, and alter-ego Lupin Atlantis. Upon information and belief, Lupin Pharmaceuticals and Lupin Ltd. contributed to, aided, abetted, and/or induced the submission of ANDA No. 206287 and its Paragraph IV certification to FDA. Additionally, upon information and belief, Lupin Pharmaceuticals will market and/or distribute Defendants’ generic version of Minastrin
24 Fe if ANDA No. 206287 is approved by FDA. 23. Lupin Pharmaceuticals and Lupin Ltd.’s participation in, contribution to, aiding, abetting, and/or inducement of the submission of ANDA No. 206287 and its Paragraph IV certification to FDA constitute infringement of the ’050 Patent under 35 6 U.S.C. § 271(e)(2)(A). Moreover, if Lupin Pharmaceuticals and/or Lupin Ltd. commercially manufacture, use, offer for sale, or sell within the United States, or import into the United States, Defendants’ generic version of Minastrin
24 Fe, they would further infringe the ’050 Patent under 35 U.S.C. § 271(a), (b), and/or (c). Upon approval of ANDA No. 206287, Lupin Pharmaceuticals and Lupin Ltd. will actively induce and/or contribute to infringement of the ’050 Patent under § 271(b) and/or (c). 24. This case is an exceptional one, and Warner Chilcott is entitled to an award of its reasonable attorneys’ fees under 35 U.S.C. § 285. 25. Warner Chilcott will be irreparably harmed if Defendants are not enjoined from infringing or actively inducing or contributing to infringement of the ’050 Patent. Warner Chilcott does not have an adequate remedy at law. PRAYER FOR RELIEF WHEREFORE, Warner Chilcott respectfully requests the following relief: A. A judgment that Defendants have infringed one or more claims of the ’050 Patent by submitting ANDA No. 206287; B. A permanent injunction restraining and enjoining Defendants, their officers, agents, servants, employees, parents, subsidiaries, divisions, affiliates, and those persons in active concert or participation with any of them, from making, using, selling, offering to sell, or importing any product that infringes the ’050 Patent, including the product described in ANDA No. 206287; 7 C. A judgment declaring that making, using, selling, offering to sell, or importing the product described in ANDA No. 206287, or inducing or contributing to such conduct, would constitute infringement of the ’050 Patent by Defendants pursuant to 35 U.S.C. § 271(a), (b), and/or (c); D. An order that the effective date of any approval of Defendants’ ANDA be a date that is not earlier than the expiration of the ’050 Patent or any later expiration of exclusivity to which Warner Chilcott is or becomes entitled; E. A finding that this is an exceptional case, and an award of attorneys’ fees in this action pursuant to 35 U.S.C. § 285; F. Costs and expenses in this action; and G. Such other and further relief as the Court may deem just and proper. 8 Dated: June 6, 2014 Respectfully submitted, /s/ Benjamin C. Block George F. Pappas (D. Md. Bar No. 15339) Jeffrey B. Elikan (D. Md. Bar No. 26179) Benjamin C. Block (D. Md. Bar No. 15811) Eric R. Sonnenschein Erica N. Andersen Sumon S. Dantiki Jeremy D. Cobb COVINGTON & BURLING LLP 1201 Pennsylvania Avenue, NW Washington, DC 20004 Tel. (202) 662-6000 Fax. (202) 662-6291 bblock@cov.com EXHIBIT A u 7342803 . UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office February 24, 2012 THIS IS TO CERTIFY THAT ANNEXED HERETO IS A TRUE COPY FROM THE RECORDS OF THIS OFFICE OF: U.S. PATENT: 6,667,050 ISSUE DATE: December 23, 2003 By Authority of the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office c:Jtaw T. LAWRENCE Certifying Officer (12) United States Patent Boissonneault et al. (54) CHEWABLE ORAL CONTRACEPTIVE (75) Inventors: Roger M. Boissonneault, Long Valley, NJ (US); Tina M. deVries, Long Valley, NJ (US) (73) Assignee: Galen (Chemicals) Limited, Dunlaoghaire (IE) ( *) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 U.S.C. 154(b) by 0 days. (21) Appl. No.: 09/879,028 (22) Filed: Jun. 12, 2001 Related U.S. Application Data (63) Continuation-in-part of application No. 09/286,908, filed on Apr. 6, 1999. (51) Int. Cl.
7 ••••.••••••...•••••••••..•••.•.•••••.••..••••••• A61K 47/00 (52) U.S. Cl •.............. ......... 424/439; 424/400; 424/440; 424/441; 424/464; 424/484; 424/489; 514/841; 514/843 (58) Field of Search ................... .............. 424/400, 439, 424/440, 441, 464, 484, 489; 514/841, 843 11• m 111111111111111111111111111111111111 US006667050Bl (10) Patent No.: US 6,667,050 Bl Dec. 23, 2003 (45) Date of Patent: (56) References Cited U.S. PAIENT DOCUMENTS 3,960,911 A 4,036,983 A 4,038,413 A 4,136,162 A 4,512,986 A 4,684,534 A 5,135,744 A 5,569,456 A 5,576,014 A 5,747,480 A 6/1976 Suschitzky et al. 7/1977 Rutherford et al. 7/1977 Suschitzky et al. 1/1979 Fuchs et al. 4/1985 Reel et al. 8/1987 Valentine 8/1992 Alexander et al. 10/19% Gorinskyt 11/19% Mizumoto et al. • 5/1998 Gast ...................... ..•.. 514/170 * cited by examiner Primary Examiner-Thurman K. Page Assistant Examiner--Olaresse Evans (74) Attorney, Agent, or Firm-Akin, Hauer & Feld, L.L.P. (57) ABSTRACT Gump, Strauss, The present invention relates to a chewable, palatable oral contraceptive tablet, comprising an oral contraceptive agent, a chewable carrier suitable for human consumption, and not comprising a ferrocene compound, as well as use of these tablets in a method of human female oral contraception, and in a method of enhancing compliance with a human female oral contraceptive regimen. 60 Clalms, No Drawings __ US 6,667,050 Bl 1 CHEWABLE ORAL CONTRACEPTIVE CROSS-REFERENCE TO RELATED APPUCMIONS This is a continuation-in-part of U.S. patent application Ser. No. 09/286,908, filed Apr. 6, 1999. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not Applicable. REFERENCE TO MICROFICHE APPENDIX Not Applicable. BACKGROUND OF THE INVENTION The present invention generally relates to an oral contra-
ceptive delivery system, and in particular an oral contracep-
tive delivery system involving novel alternate dose forms to improve compliance. The efficacy of oral contraceptives tends to be particularly patient compliance dependent, largely due to the lack of a disease state or symptoms to remind a human female patient (sometimes referred to simply as "patient" or "woman") to take a pill. The single most significant reason for failure with oral contraceptives is use, rather than method, failure. That is, unless the contraceptives are used according to the prescribed regimen, the contraceptives can fail to effectively help a patient avoid pregnancy. Further, in order to be most effective in preventing pregnancy and maintaining men-
strual cycle control, proper compliance with an oral contra-
ceptive dosage regimen requires that the oral contraceptives be taken at about the same time each day. 2 to conceal, they are not necessarily easy to ingest. Access to water to facilitate contraceptive pill taking remains a prob-
lem. Most medications are typically stored in a medicine cabinet and therefore are likely to be near a water source. On 5 the contrary, oral contraceptive pills are often carried on the person and a source of water is not always available when it is time to take the oral contraceptive pill. Additionally, a certain segment of the patient population will have trouble 10 IS swallowing pills, irrespective of access to water. The present invention provides an improved oral contra-
ceptive tablet. The technology encompassed in the invention involves a chewable, palatable oral contraceptive tablet that has appropriate size and hardness for blister packaging and compliant use. BRIEF SUMMARY OF THE INVENTION One aspect of the present invention relates to a chewable, palatable oral contraceptive tablet, comprising an oral con-
20 traceptive agent, a chewable carrier suitable for human consumption, and not comprising a ferrocene compound. Another aspect of this invention relates to a method of human female oral contraception, the method comprising providing a chewable, palatable oral contraceptive tablet 25 comprising a contraceptively effective amount of an oral contraceptive agent, and a chewable carrier suitable for human consumption, and not comprising a ferrocene compound, and administering the tablet to a human female. Yet another aspect of this invention relates to a method of 30 enhancing compliance with a human female oral contracep-
tive regimen involving oral contraceptive tablets, the method comprising providing chewable, palatable oral con-
traceptive tablets comprising a contraceptively effective amount of an oral contraceptive agent, and a chewable 35 carrier suitable for human consumption, and not comprising a ferrocene compound, and administering the tablets to the human female in accordance with the contraceptive regi-
men. Various attempts have been made to improve patient compliance with contraceptive regimens. For example, it has been suggested that progestin rods can be inserted subder-
mally. This procedure has been described, for example, in U.S. Pat. No. 5,756,115. This technique has the significant disadvantage of requiring a surgical incision, a procedure 40 that is highly disfavored by a relatively large segment of the patient population. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS Not Applicable. As another example, it has been suggested that DEPO-
PROVERA® (Pharmacia, Inc.) medroxyprogesterone acetate can be injected subcutaneously every three months. 45 This technique has been described, for example, in U.S. Pat. No. 4,639,439. This procedure has the disadvantage of requiring an injection via hypodermic needle, which is also a procedure that is disfavored by many patients. 50 In many cases, the patient prefers to carry the contracep-
tive pills on her person as a matter of lifestyle or personal discretion. This is especially true for younger patients, and it is not uncommon for such patients to exchange pills. Members of this population tend to view portable packaging 55 of the pills, immediate access to the pills, and ease of pill use as significant benefits. Prior proposed solutions to the compliance problem have tended to focus primarily or exclusively on optimizing compliance packaging, rather than on changes to the dosage 60 form. It has been suggested that instead of being packaged DETAILED DESCRIPTION OF THE INVENTION The present invention relates to chewable, palatable oral contraceptive tablets for administering an oral contraceptive agent to human females. The tablets of this invention may simply be chewed, and therefore are easy for a patient to ingest, even in the absence of a liquid. The oral contracep-
tive agent formulation of this invention improves dosage regimen compliance, and thereby enhances the desired con-
traceptive effect of the oral contraceptive. This invention also includes methods for administering the oral contracep-
tive formulations to a woman. Definitions The articles "a" and " an" are used herein to refer to one or more than one (i.e., to at least one) of the grammatical objects of the article. By way of example, "an element" means one element or more than one element. in vials, contraceptive pills can be packaged in 21 or 28 day blister packages. It has also been suggested that the size of these packages can be reduced to improve portability and confidentiality. The term "oral contraceptive agent," as used herein, refers to any compound or combination of compounds which, 65 when administered orally, prevents pregnancy. Although oral contraceptive pills provided in a small blister package are somewhat more convenient to carry and The term "estrogen," as used herein, refers to any natural or synthetic compound which exlubits an effect on the Copy provided by USPTO from the PIRS Image Database on 02121/2012 US 6,667,050 Bl 3 female reproductive organs in a manner similar to the natural female hormone estrogen. Examples of an estrogen include, but are not limited to, ethinyl estradiol, estradiol, estradiol valerate, and estradiol acetate. The term "progestin," as used herein, refers any natural or synthetic compound which exhibits a progestational effect 5 4 levonorgestrel, ethynodiol diacetate, norgestrel, norgestimate, gestodene, drospirenone, trimegestone, levodesogestrel, gestodyne, and nesterone. Preferably, the progestin is norethindrone. on the female reproductive organs. Examples of a progestin include, but are not limited to, norethindrone, norethindrone acetate, desogestrel, levonorgestrel, ethynodiol diacetate, 10 norgestrel, norgestimate, gestodene, drospirenone, trimegestone, levodesogestrel, gestodyne and nesterone. The dosage of the oral contraceptive agent employed would tend to be that conventionally used in the art for the particular oral contraceptive agent selected. The proportion of the oral contraceptive agent in the tablet may be a pharmaceutically effective trace amount to about 10% by weight. Thus, the quantity of oral contraceptive agent per tablet may be varied as desired, typically about 10 micro-
grams to about 5 milligrams, but the lower and upper dosages may be reduced or increased. Examples of approxi-
mate dosage ranges of oral contraceptive agents in milli-
grams per tablet are summarized in Table 1. The term "palatable," as used herein, means that the tablet of this invention has a taste, mouth feel, chewability, texture, aroma, and lack of grittiness and bad aftertaste that makes 15 the tablet agreeable to a woman to chew. TABLE 1 Ennmles of Dose Ranges of 011!1 Contrac•ptive Ments Cmilli&!'l!ms por tablet) Description Examples Broad Intermediate Preferred Progestin Estrogen A tablet is "chewable," as used herein, such that when the tablet is chewed, it breaks into smaller pieces that can be swallowed. This is in contrast to gum, for example, which does not break into smaller pieces when chewed. Description of the Invention The first aspect of the invention relates to a chewable, palatable oral contraceptive tablet comprising an oral con-
traceptive agent, a chewable carrier suitable for human consumption and not compr'.sing a ferrocene compound. The tablet of this invention expressly does not contain a ferrocene compound. Ferrocene compounds are used in the treatment of anemia and it should not be assumed that all patients desiring an oral contraceptive agent are anemic. Administering ferrocene compounds when they are not needed can lead to iron poisoning. Additionally, ferrocene compounds may not be palatable when chewed. In principle, virtually any oral contraceptive agent used in human medicine could be employed in accordance with the principles of the present invention. The oral contraceptive agent may be an estrogen, a progestin, or a combination of an estrogen and a progestin. In one embodiment, the oral contraceptive agent is an estrogen selected from the group consisting of ethinyl estradiol, estradiol, estradiol valerate, and estradiol acetate. Preferably, the estrogen is ethinyl estradiol. Norethindrone, 0.1 to 2.5 0.25 to 2.0 0.4 to 1.5 Norethindrone acetate 0.1 to 2.5 0.25 to 2.0 0.4 to 1.5 Desogestrel 0.05 to 0.5 0.1 to 0.3 0.1 to 0.2 Levonorgestrel 0.025 to 1.5 0.025 to 1.0 0.05 to 0.6 Ethynodiol diacetate 0.5 to 2.5 0.75 to 1.25 0.9 to 1.1 Norgestrel 0.05 to 3.0 0.05 to 2.0 0.1 to 1.2 Norgestimate 0.1 to 0.5 0.15 to 0.35 0.18 to 0.25 Gestodene O.Q3 to 0.15 0.05 to 0.10 0.06 to 0.075 Drospirenone 1.0 to 5.0 2.0 to 4.0 2.5 to 3.5 Trimegcstone 0.05 to 0.5 0.1 to 0.3 0.1 to 0.2 Ethinyl Estradiol, 0.01 to O.Q75 O.Q15 to 0.05 0.020 to 0.050 Estradiol 0.5 to 4.0 lto3 1.5 to 2.5 Estradiol valerate 0.5 to 5.0 1.5 to 3.5 1.9 to 3.0 Estradiol acetate 0.5 to 5.0 1.5 to 3.5 1.8 to 3.0 In one preferred embodiment, the tablet comprises estro-
gen in the form of ethinyl estradiol in an amount of about 10 micrograms to about 75 microgranlS. In another preferred 40 embodiment, the tablet comprises progestin in the form of norethindrone in an amount of about 0.1 milligram to about 2.5 milligrams. The invention also includes a tablet in which the oral contraceptive agent is a combination of an estrogen and a 45 progestin. Preferably, the estrogen is ethinyl estradiol and the progestin is norethindrone. In a more preferred embodiment, the amount of ethinyl estradiol in the tablet is about 10 micrograms to about 75 micrograms and the amount of norethindrone in the tablet is about 0.1 milligram 50 to about 2.5 milligrams. The tablets of this invention can be used in conjunction with an oral contraceptive regimen. The regimen can com-
prise administering tablets on a daily basis for multiple consecutive days. As such, throughout the duration of the 55 regimen the amount of oral contraceptive agent in the oral contraceptive tablets may remain constant, thereby compris-
ing a uniphasic regimen. Additionally, the amount of oral contraceptive agent in the oral contraceptive tablets may vary throughout the duration of the regimen, thereby com-
prising a multiphasic regimen. In tablets comprising an 60 estrogen and a progestin, the ratio of the estrogen to the progestin can be constant throughout the duration of the regimen. Additionally, the ratio of the estrogen to the proges-
tin in the oral contraceptive tablets can vary throughout the regimen. In another embodiment, the oral contraceptive agent is a 65 progestin selected from the group consisting of norethindrone, norethindrone acetate, desogestrel, It is also possible to form placebo tablets which otherwise correspond in composition to the tablet of the present invention but are free of the oral contraceptive agent Copy provided by USPTO from the PIRS Image Database on 02/21/2012 US 6,667,050 Bl 5 The oral contraceptive agent may be present in a carrier either in a dissolved or a uniformly suspended state. A carrier comprises all but the active oral contraceptive agent or agents and includes an inactive ingredient or a combina-
tion of one or more inactive ingredients. The carrier imparts chewable and palatable characteristics to the tablet and must Ingre-
dient 6 TABLE 2-continued Sweetener and Flavor Amounts Used in Chewable Om! Contraceptive Formulations 10 be suitable for human consumption, that is, free of harmful amounts of any toxins or components that are adverse to humans. All ingredients in the carrier should be generally recognized as safe (GRAS), as determined by the Food and Drug Administration (FDA) or the Flavor and Extract Manu-
facturers' Association (FEMA). The carrier selected for the invention must be chewable and should not confer a dis-
agreeable taste to the tablet. Thus, the carrier itself must be 15 palatable. The primary ingredient of a carrier is one or more diluents. Non-limiting examples of diluents that can be used Type Examples Broad Intermediate Preferred Flavor Spearmint 0.5 to 5% 1 to 3% 1.5 to 2.5% Agent Winter- 0.5 to 5% 1 to 3% 1.5 to 2.5% green Wild berry 0.1 to 3% 0.2 to 1% 0.3 to 0.5% Optionally, a color agent may be added to aid in tablet identification and to enhance the visual appearance of the tablet. A visually pleasing color enhances patient acceptance and thereby compliance with an oral contraceptive regimen. The color agent may be any that are well known to those in the tablet-making art in view of the present disclosure, and in accordance with this invention include microcrystalline cellulose, com starch, modified starch, calcium carbonate, dicalcium phosphate, and poly-alcohol sugars such as 20 dextrose, maunitol, sorbitol, xylitol, lactose, sucrose, and fructose. Many other diluents or other ingredients suitable as components of carriers for a chewable, palatable oral con-
traceptive tablet are available and would be well known to 25 those skilled in the art in view of the present disclosure. could be used in any amount to impart the desired color. The tablet can be manufactured by standard pharmaceu-
tical techniques of solid dose formulation, such as granula-
tion and compression. These processes are well known to those skilled in the art of making tablets (See Lieberman, Lachman, and Schwartz, Pharmaceutical Dosage Fonns, Volume 1, New York, 1989). During the granulation process, other ingredients typically used in tablet formulation for human consumption can be included, such as binders, lubricants, anti-adherents, glidants, disintegrants and fillers In another aspect of the invention, the tablet optionally further comprises at least one of a flavor agent, a sweetener, and a color agent. A flavor agent can be used to enhance the taste of the tablet, making the tablet more palatable than a tablet without a flavor agent. Spray dried flavor agents are preferred because they are easy to incorporate into a chew-
able tablet. Non-limiting examples of preferred flavor agents impart the following flavors: strawberry, wild berry, spearmint, wintergreen, black cherry, orange, orange cream, and lemon. The flavoring agents are readily available from many commercial sources. Exemplary compounds suitably used in preparing flavors are listed in G. Burdock, Ed., Fenaroli's Handbook of Flavor Ingredients, 3m edition, Volumesl and II, CRC Press, New York, 1995. Other flavors and flavoring agents suitable for the tablet would be well known to those skilled in the art in view of the present disclosure. A sweetener can also be used to enhance to taste of the tablet, making the tablet more palatable than a tablet without a sweetener. Sweeteners include natural sugars and artificial sugar substitutes. Non-limiting examples of sweeteners that can be used in accordance with this invention include aspartame, sucralose, xylitol, soroitol, mannitol, dextrose, sucrose, and fructose. Non-limiting examples of the amount of flavor agents or sweeteners that can be used in the tablet composition of the present invention are listed in Table 2. The amounts in Table 2 are given as percentage of the total tablet weight. Ingre-
dient Type Sweet-
ener TABLE 2 Sweetener and Flavor Amounts Used in Chewable Oral Omtmceptjvs Formul•tiOJJs Examples Broad Intermediate l'Teferred Aspartame 0.02 to 1.0% 0.02% to 0.2% 0.03% to 0.05% Sucralose 0.01 to 0.5% 0.01% to 0.1% 0.02 to 0.04% 30 or other optional ingredients that do not adversely affect chewability or palatability of the tablet or its active oral contraceptive agent ingredient(s). Binders aid the formation of granulated particles of active 35 oral contraceptive agents and carrier ingredients. Non-
limiting examples of binders include glucose, acacia, guar gum, gelatin, simple syrup, sucrose, sorbitol, starch, alginic acid, alginate salts, polyethylene glycol, polyvinylpyrrolidone, polymethacrylates, pregelatinized 40 starch, and celluloses such as methylcellulose, sodium carl>oxymethylcellulose, hydroxypropylmethylcellulose, hydroxypropylcellulose, and ethylcellulose. A solution of binder is prepared (concentrations dependent on the particu-
lar binder used), and the binder solution is mixed with the 45 other excipients to form the wet granulation. A binder such as polyvinylpyrrolidone (Povidone) is typically used in a solution of about 3% to about 15% by weight and is added to the other tablet ingredients resulting in a final formulation concentration of about 2% to about 5%. Similarly, cellulose 50 derivatives are typically used in granulating solutions of about 5% to about 10% by weight and concentrations would be known to one skilled in the art of making tablets using wet granulation in view of the present disclosure. Disintegrants facilitate breakup of the tablet after admin-
55 istration during chewing. Non-linliting examples of disinte-
grants include crospovidone, croscarmellose sodium, starches, com starch, potato starch, modified corn starch, sodium starch glycolate, and pregelatinized starch. Disinte-
grants can be included in the tablet formulation in amounts 60 generally less than about 25% of the tablet weight, prefer-
65 ably less than about 20%, and more preferably about 1 to about 20% (natural starches such as com or potato starch), about 5 to about 10% (pregelatinized starch), and about 3 to 8% (modified com starch). Crospovidone and croscarmel-
lose sodium are used at levels of about 5% or lower. As a final step in the manufacture of the tablet, a lubricant, an anti-adherent, and a glidant can be added to the tablet Copy provided by USPTO from the PIRS Image Database on 02/21/2012 US 6,667,050 Bl 7 granulation. A lubricant facilitates tablet manufacture by reducing friction in the tablet die during compression and ejection. An anti-adherent prevents the tablet from sticking to the tablet punch and die wall. A glidant improves ftow characteristics of the granulation. Non-limiting examples of s a lubricant include stearates, such as magnesium, calcium, and sodium stearates, stearic acid, hydrogenated vegetable oils, waxes, talc, boric acid, sodium benzoate, sodium acetate, sodium chloride, DL-leucine, sodium oleate, sodium lauryl sulfate, magnesium lauryl sulfate, and CAR- 10 BOWAX® (Union Carbide Chemicals & Plastics Technol-
ogy Corp.) polyethylene glycols. Non-limiting examples of an anti-adherent include talc, com starch, colloidal silicon dioxide, DL-leucine, sodium lauryl sulfate, and metallic stearates. Non-limiting examples of a glidant include talc, 15 com starch, and colloidal silicon dioxides such as CAB-0-
SIL® (Cabot Corp.), SYLOID® (W.R. Grace & Co.), and AEROSIL® (Degussa). Some ingredients, such as talc, can contribute to the formulation with combined functions, acting as a lubricant, and an anti-adherent, and a glidanl 20 A lubricant is typically included in the tablet formulation in amounts less than about 10% of the tablet weight, preferably less than about 6%, and more preferably about 0.25 to about 2% (stearates, stearic acid, hydrogenated vegetable oil), about 1 to about 5% (talc, waxes, DL-leucine, 25 CARBO WAX®, sodium lauryl sulfate), about 1 to about 2% (magnesium lauryl sulfate) and about 4 to about 6% (sodium chloride, sodium oleate, sodium benzoate, sodium acetate). Anti-adherents are typically included in the tablet formu-
lation in amounts generally less than about 15% of the tablet 30 weight, preferably less than about 12%, and more preferably about 3 to about 10% (cornstarch, DL-leucine), about 1 to about 5% (talc), about 0.1 to about 0.5% (colloidal silicon dioxide) and less than about 1% (sodium lauryl sulfate, metallic stearates ). 35 A glidant is typically included in the tablet formulation in amounts generally less than about 15% of the tablet weight, preferably less than about 12%, and more preferably less than about 5 to about 10% (com starch), about 0.1 to about 40 0.5% (CAB-0-SIL®, SYLOID®), about 1 to about 3% (AEROSIL®), and about 5% (talc). 8 The hardness of the tablet may be any hardness that allows for tablet formation and that is still palatable and chewable. One aspect of the invention includes a tablet having a hardness sufficient for blister packaging while still remaining palatable and chewable. Blister packaging is common in the art of oral contraceptive tablet dispensing. In a preferred embodiment, the tablet of the invention has a hardness of about 5 kilopond (kp) to about 15 kp, and preferably about 7 kp to about 12 kp. Another aspect of this invention relates to a method of human female oral contraception comprising providing a chewable, palatable oral contraceptive tablet comprising a contraceptively effective amount of an oral contraceptive agent, and a chewable carrier suitable for human consumption, and not comprising a ferrocene compound, and administering the tablet to a human female. The tablet is the tablet described above, and typically and preferably, a number of such tablets as part of a contraceptive regimen. The tablet can be administered to the woman in a variety of ways. Typically, the tablet is administered once daily. The tablet routinely contains a contraceptively active amount of an oral contraceptive agent, and some tablets used in a regimen may be a placebo. The placebo tablets are admin-
istered on days where the oral contraceptive agent is not required. As such, the woman is administered a tablet every day to help maintain the contraceptive regimen of taking a daily tablet. For example, a dosage regimen may utilize about 21 to about 63 days of tablets containing the oral contraceptive agent followed by about 3 to about 7 days of tablets comprisiog a placebo. Preferably, the regimen entails administering tablets for total of about 24 to about 32 days, wherein tablets containing the oral contraceptive agent are administered for about 21 to about 25 days, followed by about 3 to about 7 days of placebo tablets not containing the contraceptive. In one preferred embodiment, the tablets are administered for a total of about 28 days. As explained above, the contraceptive dosage in the tablets can be uniphasic or multiphasic. Another aspect of this invention relates to a method of enhancing compliance with a human female oral contracep-
traceptive tablets comprising a contraceptively effective The chewable tablet generally is not coated with a film or sugar coating. However, thin tablet coatings of a type known to those skilled in making coated tablets can be used. 45 amount of an oral contraceptive agent, and a chewable carrier suitable for human consumption, and not comprising a ferrocene compound, and administering the tablets to the human female in accordance with the contraceptive regi-
men. In one preferred embodiment of the invention, the oral contraceptive agent comprises norethindrone and ethinyl estradiol, the carrier comprises dicalcium phosphate, lactose monohydrate, and maltodextrin, and the tablet further com-
prises sucralose, a ftavor agent, sodium starch glycolate, so povidone, and magnesium stearate. The overall size of the tablet may be any tablet size that incorporates the desired contraceptively effective amount of the oral contraceptive agent and the carrier and is still chewable and palatable. In a preferred embodiment, the size 55 of the tablet is small, on the order of about 50 milligrams to about 300 milligrams. More preferably, the tablet weight is about 70 milligrams to about 120 milligrams, and most preferably, the tablet weight is about 90 milligrams to about 110 milligrams. A smaller tablet is more portable than a 60 larger tablet and therefore more appealing to patients pre-
ferring to carry oral contraceptive pills on their person, particularly in blister packaging. Further, smaller tablets are more likely than larger tablets to be accepted as chewable. Therefore, smaller tablets are more likely to enhance a 65 patient's compliance with an oral contraceptive regimen. The shape of the tablet of the present invention is not critical. In connection with this aspect of the invention, each tablet of the regimen preferably comprises a daily dosage of the oral contraceptive agent. As such, daily administration of one of the tablets would be part of the regimen. The chewable, palatable oral contraceptive of this invention allows the woman the convenience of ingesting the tablet in a manner that does not require taking the tablet with liquid, without chewing it. Therefore, the woman can take the tablet each day at a time and place that is suitable to her lifestyle. Ingesting the tablets at the same time of day on a daily basis enhances compliance with any given contraceptive regimen. The regimen can comprise any number of days of admin-
istration of the tablets to the woman. In one preferred embodiment, the regimen comprises providing about 21 to about 63 tablets, each tablet comprising the daily dosage of the oral contraceptive agent, followed by about 3 to about 7 tablets, each comprising a placebo. Preferably, a total of about 24 to about 32 tablets are administered daily, wherein Copy provided by USPTO from the PIRS Image Database on 02/21/2012 US 6,667,050 Bl 9 about 21 to about 25 tablets each comprising the oral contraceptive agent are administered, followed by about 3 to about 7 tablets each comprising a placebo. In one preferred embodiment, a total of about 28 tablets is administered. Ingredient Sweetener Flavor Agent Disintegrant 10 EXAMPLE 1-continued Composition of a 90 milligram tablet Ingredient Sucralose Spearmint Amount (milligrams/tablet) The amount of the oral contraceptive agent through the duration of the regimen can remain constant or can be varied for tablets containing an oral contraceptive agent (rather than placebo tablets without an oral contraceptive agent). In one embodiment, the amount of the oral contraceptive agent is present in the same amount in the oral contraceptive tablets of the regimen, thereby comprising a uniphasic regimen. In another embodiment, the amount of the oral 10 Binder Sodium starch glycolate Povidone 0.02 1.8 4.1 1.5 0.41 Lubricant Magnesium 6tearate One technique of making the tablets of the present inven-
tion is a wet granulation technique. In a wet granulation technique, the active oral contraceptive agents are blended in a solution of binder which is then blended with the diluent(s) to form a wet granulation. After drying, the granulation is contraceptive agent is present in varying amounts in the oral contraceptive tablets of the regimen, thereby comprising a multiphasic regimen. In tablets comprising an estrogen and 15 a progestin, the ratio of the estrogen to the progestin can be constant throughout the duration of the regimen. Alternatively, the ratio of the estrogen to the progestin in the tablets can vary throughout the regimen. 20 blended with the flavor ingredient(s), the disintegrant, the lubricant and any other optional ingredients. The final blend is compressed into tablets. This wet granulation method is exemplified by Examples 1 and 2. Any number of the tablets may be dispensed in any type of packaging commonly used in the art of tablet dispensing. Blister packages are often and preferably used for dispens-
ing oral contraceptives. Blister packages are generally small and portable, usually and preferably containing the number of ·tablets required for a month of dosing. Many patients 25 desiring oral contraceptive tablets find this method of dis-
pensing convenient. In a preferred embodiment, the tablets for the oral contraceptive regimen of this invention are dispensed in a blister package. The packaging is preferably in the form of a 28-daily dosage units blister package 30 comprising about 21 to about 25 tablets comprising the oral contraceptive agent and the remaining respective about 7 to about 3 tablets comprising a placebo. Alternatively, a dry granulation technique can be used. In a dry granulation technique, the active oral contraceptive agents are blended with the diluent(s) to form a dry granu-
lation. This is then blended with the flavor ingredient(s), the lubricant and any other optional ingredients, and finally compressed into tablets. This dry granulation method is exemplified by Examples 3, 4 and 5. Alternatively, the active pharmaceutical ingredients are wet granulated as described previously, then blended with 35 additional diluent(s) to form a dry granulation. This is then blended with the flavor ingredients, the lubricant and any other optional ingredients, and finally compressed into tab-
lets. This method is exemplified by Example 6. A tablet made in accordance with the present invention may simply be chewed. This substantially reduces the exist-
ing barriers to compliance. The use of a chewable, palatable tablet in accordance with the present invention eliminates the need to incorporate liquid to facilitate swallowing and makes oral contraceptives more agreeable for patients who 40 have difficulty or reluctance to swallowing tablets. The chewable, palatable tablets of this invention have a tablet size aod hardness suitable for use in blister packaging and EXAMPLE2 Composition of a 90 milligram tablet are synergistic with the existing design and intent of oral Amount contraceptive package portability and convenience. 45 _lngredie __ _ ___ 1
•_sr_ed_
_· •_t ______ <_mil _. _Hgra _ ms _ fm_b_le..;. t)_ Therefore, the oral contraceptive formulations of this Oral Contraceptive Agent Norethindrone 0.40 invention, administered according to this invention, provide Oral Contraceptive Agent Ethinyl Estradiol 0.035 a method of enhancing compliance with a human female Diluent Dicalcium Phosphate 40.8 oral contraceptive regun · en. Diluent Lactose Monohydrate 40.8 Diluent Maltodextrin 0.36 The invention will now be described in more detail with so Sweetener Aspartame 0.04 reference to the following specific, non-limiting examples. Flavor Agent Spearmint 1.8 Disintegrnnt Sodium starch glycolate 4.11 Compositions that have been prepared in accordance with Binder Povidone 1.54 this invention are given in Examples 1-2. Additional Lubricant Magoesium stearnte 0.41 examples of compositions that can be formulated in accor-
dance with this invention are given in Examples 3-6. EXAMPLE 1 Composition of a 90 milligram tablet Amount Ingredient (milligrams/tablet) Oral Contraceptive Agent Norethindrone 0.40 Oral Contraceptive Agent Ethinyl Estradiol 0.035 Diluent Dicalcium Phosphste 40.8 Diluent lactose Monohydrate 40.8 Diluent Maltodextrin 0.16 55 60 65 EXAMPLE3 Composition of a 100 milligram tablet Amount Ingredient (milligrams/tablet) Oral Contraceptive Agent Norethindrone 0.40 Oral Contraceptive Agent Ethinyl Estradiol 0.035 Diluent Dextrose 97 Flavor Agent Spearmint 2 Luhricant Magnesium stearate o.s Copy provided by USPTO from the PIRS Image Database on 02/21/2012 US 6,667,050 Bl 11 EXAMPLE4 Composition of a 100 milligram tablet Ingredient Type Oral Contraceptive Agent Oral Contraceptive Agent Diluent Flavor Agent Lubricant Ingredient Norethindrone Ethinyl Estradiol Mannitol Strawberry Magnesium stearate EXAMPLE6 Amount (milligrams/tablet) 0.40 0.035 97 2 0.5 Composition of a 100 milligram tablet Amount Ingredient TYPe Ingredient (milligrams/tablet) Oral Contraceptive Agent Norethindrone 0.40 Oral Contraceptive Agent Ethinyl Estradiol 0.035 Diluent Dextrose 60 Diluent Lactose 37 Flavor Agent Strawberry 2 Lubricant Magnesium stearate 0.5 EXAMPLE6 Composition of a 120 milligram tablet Ingredient TYPe Ingredient Oral Contraceptive Agent Norethindrone Oral Contraceptive Agent Ethinyl Estradiol Diluent Dicalcium Phosphate Diluent lActose Monohydrate Diluent Dextrose Diluent Maltodexuin Sweetener Sucralose Flavor Agent Spearroint Disintegrant Sodium starch glycolate Binder Povidone Lubricant Magnesium stearate Amouot (milligrams/tablet) 0.40 0.035 20.8 20.8 70 0.16 0.02 1.8 4.1 1.5 0.41 12 5. The tablet of claim 1, wherein the oral contraceptive agent comprises an estrogen. 6. The tablet of claim 5, wherein the estrogen is selected from the group consisting of ethinyl estradiol, estradiol, 5 estradiol valerate, and estradiol acetate. 7. The tablet of claim 6, wherein the carrier is selected from the group consisting of dicalcium phosphate, lactose, corn starch, microcrystalline cellulose, maltodextrin, dextrose, mannitol, sorbitol, xylitol, fructose, sucrose, and 10 calcium carbonate. 8. The tablet of claim 1, wherein the oral contraceptive agent comprises a progestin. 9. The tablet of claim 8, wherein the progestin is selected from the group consisting of norethindrone, norethindrone 15 acetate, desogestrel, levonorgestrel, ethynodiol diacetate, norgestrel, norgestimate, gestodene, drospirenone, trimegestone, levodesogestrel, gestodyne, and nesterone. 20 25 10. The tablet of claim 9, wherein the carrier is selected from the group consisting of dicalcium phosphate, lactose, corn starch, microcrystalline cellulose, maltodextrin, dextrose, mannitol, sorbitol, xylitol, fructose, sucrose, and calcium carbonate. 11. The tablet of claim 1, wherein the oral contraceptive agent comprises an estrogen and a progestin. 12. The tablet of claim 11, wherein the estrogen is selected from the group consisting of ethinyl estradiol, estradiol, estradiol valerate, and estradiol acetate, and the progestin is selected from the group consisting of norethindrone, nore-
thindrone acetate, desogestrel, levonorgestrel, ethynodiol 30 diacetate, norgestrel, oorgestimate, gestodene, drospirenooe, trimegestone, levodesogestrel, gestodyne, and nesterone. 13. The tablet of claim 12, wherein the carrier is selected from the group consisting of dicalcium phosphate, lactose, corn starch, microcrystalline cellulose, maltodextrin, 35 dextrose, mannitol, sorbitol, xylitol, fructose, sucrose, and calcium carbonate. 14. The tablet of claim 13, further comprising at least one of a flavor agent, a sweetener, and a color agent. 15. The tablet of claim 1, wherein the tablet weighs about 40 50 mi!ligranlS to about 300 milligrams. 16. The tablet of claim 1, wherein the tablet has a hardness sufficient for blister packaging. It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. 45 It is understood, therefore, that this invention is not limited 17. The tablet of claim 1, wherein the tablet has a hardness of about 5 kiloponds to about 15 kiloponds. 18. The tablet of claim 1, wherein the oral contraceptive agent comprises norethindrone and ethinyl estradiol, the carrier comprises dicalcium phosphate, lactose monohydrate, and maltodextrin, and the tablet further com-
prises sucralose, a flavor agent, sodium starch glycolate, to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the appended clainls. We claim: 1. A chewable, palatable oral contraceptive tablet, com-
prising an oral contraceptive agent, a chewable carrier suitable for human consumption, wherein the contraceptive tablet is chewable and palatable and does not contain a ferrocene compound. 2. The tablet of claim 1, wherein the oral contraceptive agent is selected from the group consisting of an estrogen, a progestin, and a combination thereof. 3. The tablet of claim 2, wherein the carrier is selected from the group consisting of dicalcium phosphate, lactose, corn starch, microcrystalline cellulose, maltodextrin, dextrose, mannitol, sorbitol, xylitol, fructose, sucrose, and calcium carbonate. 4. The tablet of claim 1, wherein the carrier is selected from the group consisting of dicalcium phosphate, lactose, corn starch, microcrystalline cellulose, maltodextrin, dextrose, mannitol, sorbitol, xylitol, fructose, sucrose, and calcium carbonate. so povidone, and magnesium stearate. 19. A method of human female oral contraception, the method comprising providing a chewable, palatable oral contraceptive tablet comprising a contraceptively effective amount of an oral contraceptive agent, and a chewable 55 carrier suitable for human consumption, and does not con-
tain a ferrocene compound, and administering the tablet to a human female. 20. The method of claim 19, wherein the oral contracep-
tive agent is selected from the group consisting of an 60 estrogen, a progestin, and a combination thereof. 21. The method of claim 20, wherein the carrier is selected from the group consisting of dicalcium phosphate, lactose, corn starch, microcrystalline cellulose, maltodextrin, dextrose, mannitol, sorbitol, xylitol, fructose, 65 sucrose, and calcium carbonate. 22. The method of claim 19, wherein the carrier is selected from the group consisting of dicalcium phosphate, Copy provided by USPTO from the PIRS Image Database on 0212112012 US 6,667,050 Bl 13 lactose, corn starch, microcrystalline cellulose, maltodextrin, dextrose, mannitol, smbitol, xylitol, fructose, sucrose, and calcium carbonate. 14 39. The method of claim 38, wherein the carrier is selected from the group consisting of dicalcium phosphate, lactose, corn starch, microcrystalline cellulose, maltodextrin, dextrose, mannitol, sorbitol, xylitol, fructose, 23. 1be method of claim 19, wherein the oral contracep-
tive agent comprises an estrogen. 5 sucrose, and calcium carbonate. 24. The method of claim 23, wherein the estrogen is selected from the group consisting of ethinyl estradiol, estradiol, estradiol valerate, and estradiol acetate. 40. The method of claim 37, wherein the carrier is selected from the group consisting of dicalcium phosphate, lactose, corn starch, microcrystalline cellulose, maltodextrin, dextrose, mannitol, sorbitol, xylitol, fructose, sucrose, and calcium carbonate. 41. The method of claim 37, wherein the oral contracep-
tive agent comprises an estrogen. 25. The method of claim 24, wherein the carrier is selected from the group consisting of dicalcium phosphate, 10 lactose, corn starch, microcrystalline cellulose, maltodextrin, dextrose, mannitol, sorbitol, xylitol, fructose, sucrose, and calcium carbonate. 42. The method of claim 41, wherein the estrogen is 15 selected from the group consisting of ethinyl estradiol, estradiol, estradiol valerate, and estradiol acetate. 26. The method of claim 19, wherein the oral contracep-
tive agent comprises a progestin. 27. The method of claim 26, wherein the progestin is selected from the group consisting of norethindrone, nore-
thindrone acetate, desogestrel, levonorgestrel, ethynodiol diacetate, norgestrel, norgestimate, gestodene, drospirenone, trimegestone, levodesogestrel, gestodyne, and nesterone. 28. The method of claim 27, wherein the carrier is selected from the group consisting of dicalcium phosphate, lactose, corn starch, microcrystalline cellulose, maltodextrin, dextrose, mannitol, sorbitol, xylitol, fructose, sucrose, and calcium carbonate. 43. The method of claim 42, wherein the carrier is selected from the group consisting of dicalcium phosphate, lactose, corn starch, microcrystalline cellulose, 20 maltodextrin, dextrose, mannitol, sorbitol, xylitol, fructose, sucrose, and calcium carbonate. 44. The method of claim 37, wherein the oral contracep-
tive agent comprises a progestin. 45. The method of claim 44, wherein the progestin is 29. The method of claim 19, wherein the oral contracep-
tive agent comprises an estrogen and a progestin. 25 selected from the group consisting of norethindrone, nore-
thindrone acetate, desogestrel, levonorgestrel, ethynodiol diacetate, norgestrel, norgestimate, gestodene, drospirenone, trimegestone, levodesogestrel, gestodyne, and nesterone. 30. The method of claim 29, wherein the estrogen is selected from the group consisting of ethinyl estradiol, estradiol, estradiol valerate, and estradiol acetate, and the 30 progestin is selected from the group consisting of norethindrone, norethindrone acetate, desogestrel, levonorgestrel, ethynodiol diacetate, norgestrel, norgestimate, gestodene, drospirenone, trimegestone, levodesogestrel, gestodyne, and nesterone. 46. The method of claim 45, wherein the carrier is selected from the group consisting of dicalcium phosphate, lactose, corn starch, microcrystalline cellulose, maltodextrin, dextrose, mannitol, sorbitol, xylitol, fructose, sucrose, and calcium carbonate. 35 47. The method of claim 37, wherein the oral contracep-
tive agent comprises an estrogen and a progestin. 48. The method of claim 47, wherein the estrogen is selected from the group consisting of ethinyl estradiol, estradiol, estradiol valerate, and estradiol acetate, and the 31. The method of claim 30, wherein the carrier is selected from the group consisting of dicalcium phosphate, lactose, corn starch, microcrystalline cellulose, maltodextrin, dextrose, mannitol, sorbitol, xylitol, fructose, sucrose, and calcium carbonate. 32. The method of claim 31, wherein the tablet further comprises at least one of a flavor agent, a sweetener, and a color agent. 40 progestin is selected from the group consisting of norethindrone, norethindrone acetate, desogestrel, levonorgestrel, ethynodiol diacetate, norgestrel, norgestimate, gestodene, drospirenone, trimegestone, 33. The method of claim 19, wherein the tablet weighs about 50 milligrams to about 300 milligrams. 34. The method of claim 19, wherein the tablet has a hardness sufficient for blister packaging. 35. The method of claim 19, wherein the tablet has a hardness of about 5 kiloponds to about 15 kiloponds. 45 levodesogestrel, gestodyne, and nesterone. 49. The method of claim 48, wherein the carrier is selected from the group consisting of dicalcium phosphate, lactose, corn starch, microcrystalline cellulose, maltodextrin, dextrose, mannitol, sorbitol, xylitol, fructose, sucrose, and calcium carbonate. 50. The method of claim 49, wherein the tablets further comprise at least one of a flavor agent, a sweetener, and a color agent. 36. The method of claim 19, wherein the oral contracep- 50 tive agent comprises norethindrone and ethinyl estradiol, the carrier comprises dicalcium phosphate, lactose monohydrate, and maltodextrin, and the tablet further com-
prises sucralose, a flavor agent, sodium starch glycolate, povidone, and magnesium stearate. 51. The method of claim 37, wherein each tablet weighs 55 about 50 milligrams to about 300 milligrams. 52. The method of claim 37, wherein the tablets have a hardness sufficient for blister packaging. 37. A method of enhancing compliance with a human female oral contraceptive regimen involving oral contracep-
tive tablets, the method comprising providing chewable, palatable oral contraceptive tablets comprising a contracep-
tively effective amount of an oral contraceptive agent, and a 60 chewable carrier suitable for human consumption, and not comprising a ferrocene compound, and administering the tablets to the human female in accordance with the contra-
ceptive regimen. 53. The method of claim 37, wherein the tablet has a hardness of about 5 kiloponds to about 15 kiloponds. 54. The method of claim 37, wherein the oral contracep-
tive agent comprises norethindrone and ethinyl estradiol, the carrier comprises dicalcium phosphate, lactose monohydrate, and maltodextrin, and the tablet further com-
prises sucralose, a flavor agent, sodium starch glycolate, 38. The method of claim 37, wherein the oral contracep-
tive agent is selected from the group consisting of an estrogen, a progestin, and a combination thereof. 65 povidone, and magnesium stearate. 55. The method of claim 37, wherein each tablet com-
prises a daily dosage of the oral contraceptive agent. Copy provided by USPTO from the PIRS Image Database on 02/21/2012 US 6,667,050 Bl 15 56. The method of claim 55, wherein the regimen com-
prises providing about 21 to about 25 tablets comprising the oral contraceptive agent. 57. The method of claim 56, wherein the regimen further comprises about 3 to about 7 tablets comprising a placebo. 58. The method of claim 56, wherein the regimen is a uniphasic regimen wherein the oral contraceptive agent is present in the same amount in the tablets. 16 59. The method of claim 56, wherein the regimen is a multiphasic regimen wherein the oral contraceptive agent is present in differing amounts in the tablets. 60. The method of claim 37, wherein the tablets are 5 provided in a blister package. * * * * * Copy provided by USPTO from the PIRS lma11e Database on 02/21/2012 Like kind card game (US patent 6193235)Like kind money board table game (US patent 6186505)Intelligent user interface including a touch sensor device (US patent 8288952)User interface with proximity sensing (US patent 8035623)Wine cellar alarm system (US patent 8710985)Cell regulatory genes, encoded products, and uses related thereto (US patent 7030227)Multicasting method and apparatus (US patent 6434622)Method and apparatus for retrieving data from a network using linked location identifiers (US patent 6226655)Casino bonus game using player strategy (US patent 6645071)High-speed serial linking device with de-emphasis function and the method thereof (US patent 7313187)Casing spacer (US patent 6736166)Advance Products & Systems v. CCI Piping SystemsModern Telecom Systems LLCTracBeam v. AppleRichmond v. Creative IndustriesSenju Pharmaceutical et. al. v. Metrics et. al.VIA Technologies et. al. v. ASUS Computer International et. al.Perrie v. PerrieEckart v. Silberline ManufacturingSenju Pharmaceutical et. al. v. Metrics et. al.Kenzinc v. imblowingup et. al.Sun Zapper v. Devroy et. al.Merck Sharp & Dohme v. Fresenius KabiTracBeam v. T-Mobile et. al.ATEN International v. Uniclass Technology et. al.
Warner Chilcott Company v. Lupin Atlantis Holdings et. al. by PriorSmart26 viewsEmbedDownloadDescriptionOfficial Complaint for Patent Infringement in Civil Action No. 1:14-cv-01827-RDB: Warner Chilcott Company, LLC v. Lupin Atlantis Holdings SA et. al. Filed in U.S. District Court for the District of...Official Complaint for Patent Infringement in Civil Action No. 1:14-cv-01827-RDB: Warner Chilcott Company, LLC v. Lupin Atlantis Holdings SA et. al. Filed in U.S. District Court for the District of Maryland, the Hon. Richard D Bennett presiding. See http://news.priorsmart.com/-lay3 for more info.Interests: Types, Business/Law, Court FilingsRead on Scribd mobile: iPhone, iPad and Android.Copyright: Public DomainDownload as PDF, TXT or read online from ScribdFlag for inappropriate contentShow moreShow less
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