On February 25, 2011, Femina Pharma Incorporated of Miami, Florida (“Femina”) 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 sell within the U.S. after importation certain vaginal ring birth control devices known as the Nuvaring that infringe at least claim 1 of U.S. Patent No. 6,086,909 (the ‘909 patent):
- Merck & Co., Inc. of Whitehouse Station, New Jersey
- Schering Plough Corporation of Kenilworth, New Jersey
- Organon USA, Inc. of Roseland, New Jersey
- N.V. Organon of the Netherlands
- CVS Caremark Corporation of Woonsocket, Rhode Island
- CVS Pharmacy, Inc. of Woonsocket, Rhode Island
- Wal-Mart Stores, Inc. of Bentonville, Arkansas
- Walgreens Co. of Deerfield, Illinois
- The Canamerican Drugs Inc. of Canada
- The Canamerican Global Inc. of Canada
- Canadian Med Service of Canada
- Panther Meds Inc. of Canada
- Canada Drugs Online of Canada
- Drug World Canada of Canada
- CanDrug Health Solutions Inc. of Canada
- Big Mountain Drugs of Canada
- BestBuyRx.com of Canada
- Blue Sky Drugs of Canada
- ABC Online Pharmacy of Canada
- Canadadrugs.com LP of Canada
- North Drug Store of Canada
- Canada Pharmacy of Blaine, Washington
According to the complaint, the ‘909 patent generally relates to a medicated intravaginal device, such as a vaginal ring, for transvaginal delivery of a pharmaceutical agent to the uterus of a female. The complaint states that the drug delivery system described in the ‘909 patent allows delivery of a drug transvaginally in lower concentrations than those needed for systemic treatment and thus provides for lower systemic concentration and fewer side effects.
In the complaint, Femina states that the Proposed Respondents import and sell products that infringe the ‘909 patent. The complaint specifically names the Nuvaring as an infringing product. According to the complaint, the Nuvaring is manufactured in the Netherlands by N.V. Organon, which is a wholly owned subsidiary of Merck & Co., Inc. and is related to Organon USA, Inc. and Schering Plough Corporation. The complaint alleges that all of the Proposed Respondents are involved with the importation and sale of the Nuvaring.
Regarding domestic industry, Femina states that it, UMD Inc. (the previous owner of the ‘909 patent) (“UMD”) and Kimberly-Clark Corporation and Kimberly-Clark Worldwide Inc. (past parties to a joint development agreement with UMD in connection with the ‘909 patent) (collectively, “Kimberly-Clark”) have made significant investments in plant and equipment and have engaged in significant employment of labor and capital in the U.S. relating to the ‘909 patent. The complaint further states that Femina, UMD, and Kimberly-Clark have made substantial investments in the exploitation of the ‘909 patent, including substantial engineering, patent procurement, licensing, R&D, consultation, manufacturing, product sales, and sales support activities. The complaint names a UMD/Kimberly-Clark medicated tampon product as a representative product covered by certain claims of the ‘909 patent.
With respect to potential remedy, Femina requests that the Commission issue a permanent general exclusion order (or in the alternative, a permanent limited exclusion order) and permanent cease and desist orders directed at the Proposed Respondents.