By Eric Schweibenz
On October 23, 2012, K-V Pharmaceutical Company of St. Louis, Missouri (“KV”) filed a complaint requesting that the ITC commence an investigation pursuant to Section 337.

The complaint alleges that the following entities (collectively, the “Proposed Respondents”) unlawfully import into the U.S., sell for importation, and/or use imported 17α hydroxyprogesterone caproate (“HPC”) to unlawfully manufacture copies of the drug Makena®:

  • New England Compounding Pharmacy, Inc. of Framingham, Massachusetts

  • Alwan Pharmacy & Compounding Center of West Peoria, Illinois

  • Avella Specialty Pharmacy of Phoenix, Arizona

  • Bellevue Pharmacy of St. Louis, Missouri

  • Betapharma (Shanghai) Co., Ltd. of China

  • Boudreaux’s Specialty Compounding of Shreveport, Louisiana

  • California Pharmacy & Compounding Center of Newport Beach, California

  • College Pharmacy of Colorado Springs, Colorado

  • Compound Care Pharmacy of Louisville, Kentucky

  • Compounding Solutions of Birmingham, Alabama

  • Daniel Drug of Fort Worth, Texas

  • Five-Star Compounding Pharmacy of Clive, Iowa

  • Fagron, Inc. of Saint Paul, Minnesota

  • Hawthorne Pharmacy of Columbia, South Carolina

  • Health Dimensions Compounding Pharmacy of Farmington Hills, Michigan

  • Hopewell Pharmacy & Compounding Center of Hopewell, New Jersey

  • Hubei Gedian Humanwell Pharmaceutical Co., Ltd. of China

  • Hubei Saibo Chemical Co., Ltd. of China

  • Jinan Haohua Industry Co., Ltd. of China

  • Kelley-Ross & Associates, Inc. of Seattle, Washington

  • Lacey Drug Company/Marietta Medical Center of Marietta, Georgia

  • Letco Medical of Decatur, Illinois

  • Medisca, Inc. of Las Vegas, Nevada

  • Owens Healthcare Compounding Pharmacy of Redding, California

  • Partners In Care, Inc. of Gainesville, Georgia

  • People’s Custom Rx of Memphis, Tennessee

  • Pharmerica Corporation of Louisville, Kentucky

  • Prescription Compounds of Baton Rouge, Louisiana

  • Rye Beach Pharmacy of Rye, New York

  • Sherry’s Drug Compounding and Natural Pharmacy of Edmond, Oklahoma

  • Shanghai Jinhong Biopharmaceutical, Ltd. of China

  • Stark Pharmacy of Overland Park, Kansas

  • The Compounder Pharmacy of Aurora, Illinois

  • The Compounding Shoppe of Homewood, Alabama

  • The Medicine Shoppe Pharmacy of Springfield, Illinois

  • Triangle Compounding Pharmacy of Cary, North Carolina

  • Trinity Healthcare Medical Center of Ocala, Florida

  • Universal Arts Pharmacy of Hialeah, Florida

  • Village Compounding of Houston, Texas

  • Wedgewood Pharmacy of Swedesboro, New Jersey

  • Westmoreland Pharmacy & Compounding of New Albany, Indiana

  • Williams Bros. Healthcare Pharmacy of Bloomington, Indiana

  • Wilson Pharmacy, Inc. of Johnson City, Tennessee

  • Women’s International Pharmacy of Madison, Wisconsin

  • Wuhan Xianghe Pharmaceutical Co., Ltd. of China

  • Xianju Hongyan Pharmaceutical Chemicals Co., Ltd. of China

According to the complaint, KV’s Makena® has been designated an “orphan drug” by the FDA (a drug developed to treat a condition affecting fewer than 200,000 people per year) and is the only FDA-approved HPC drug that may be marketed in the United States to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth until February 2018.  Thus, KV has exclusive marketing rights, akin to patent exclusivity, for a period of seven years.  KV asserts that the Proposed Respondents’ importation, sale and/or use of imported HPC is intended to support an unlawful drug manufacturing and distribution enterprise that proceeds under the fiction of individualized drug “compounding” (the process by which a pharmacist combines or alters ingredients to create a medication customized to the particular needs of individual patients).  As alleged in the complaint, this unlawful enterprise is not only substantially injuring the lawful domestic HPC pharmaceutical industry (such as “greatly contribut[ing] to KV’s decision to seek protection under Chapter 11 of the United States Bankruptcy Code”), but also subjecting women at risk of premature delivery to treatment with unapproved new drug products whose ingredients are manufactured in foreign facilities not under FDA-mandated Good Manufacturing Practice standards and not subject to routine FDA inspection.

Regarding domestic industry, KV states in the complaint that it is the owner of Makena®, the Makena® orphan drug designation, and the Makena® NDA.  KV also asserts that it advertises, sells and distributes its drugs nation-wide through its wholly-owned subsidiary, Ther-Rx Corporation.  KV further states that it employs personnel in the United States in positions ranging from specialized technical research and development staff to marketing and administrative staff.  In addition, KV asserts that its Makena® is manufactured in the United States by an unaffiliated third party, Hospira, Inc.  KV maintains that “[g]iven the status of Makena®’s orphan drug designation and market exclusivity, KV constitutes the entire domestic [HPC] pharmaceutical industry.”

As to related litigation, KV states that the following four actions relate indirectly to the “unfair methods of competition and substantial injury arising from” importation of HPC:  (1) K-V Pharmaceutical Co., et al. v. Cook, et al., No. 1:12-cv-02491-CAP (N.D. Ga.), filed on July 17, 2012 by KV against the Georgia Department of Community Health challenging the latter’s formal prior authorization policy favoring compounded HPC formulations over Makena® (ongoing; preliminary injunction granted in favor of KV on August 9, 2012); (2) K-V Pharmaceutical Co., et al. v. Keck, et al., No. 3:12-cv-02088 (D.S.C.), filed on July 25, 2012 by KV against the South Carolina Department of Health and Human Services challenging the latter’s prior authorization policy favoring compounded HPC formulations over Makena® (ongoing); (3) K-V Pharmaceutical Co., et al. v. Hamos, et al., No. 1:12-cv-06697-CAP (N.D. Ill.), filed on August 21, 2012 by KV against the Illinois Department of Healthcare and Family Services challenging the latter’s formal prior authorization policy favoring compounded HPC formulations over Makena® (parties reached settlement); and (4) K-V Pharmaceutical Company v. FDA, No. 1:12-cv-01105 (D.D.C.), filed on July 5, 2012 by KV against the FDA and other parties seeking injunctive relief, including restoration of KV’s rights to marketing exclusivity for Makena® as an orphan drug (complaint dismissed).

With respect to potential remedy, KV requests that the Commission issue a general exclusion order and a cease and desist order barring imports of HPC.