FDA Lawyers Blog

On March 27, FLH attorneys Brian Malkin and Christopher Gosselin attended the International Trade Commission ("ITC") Trial Lawyer's Association ("ITCTLA") luncheon with administrative law judge ("ALJ") Thomas B. Pender. Judge Pender joined the ITC in October, 2011, and is one of six ALJs at the Commission.

Judge Pender arrived at the luncheon with a number of themes that he wanted to discuss. Chief among them is a concern shared by many other ALJs and district court judges about the scope of electronic discovery in today's litigation. He urged the practitioners in the room not to lose control of the paper, and to reign in the costs and scope of electronic discovery. In Pender's experience, less than 1% of all discovery becomes an exhibit, and less than 5% of those exhibits are ever argued. In addition to paring back discovery, Pender would like to see fewer patents and patent claims being asserted by complainants. Ultimately, Pender would like to see more efforts taken to reduce the cost of litigation at the ITC, and hopes that more streamlined cases will allow him to finish an Initial Determination in a year or less.

Written by Christopher Gosselin

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Judge Pender also suggested, on a related note, that big firms make an effort to send their associates "to the podium," both to give the associates valuable experience, and to reduce the cost of a trial. In his experience, well-prepared associates perform as well or better than partners who had less time to prepare. Pender cautioned parties to think twice before betting an entire case on one witness, and suggested that secondary witnesses could and should be handled by associates.

On November 7, 2012, FLH Partner Brian J. Malkin and Associate Christopher Gosselin were in attendance at this year's International Trade Commission Trial Lawyers Association Annual Meeting at the International Trade Commission ("ITC") in Washington, D.C. The theme of this year's meeting was the enforcement of ITC exclusion orders at the border, and the relationship between customs and the ITC.

ITC Chairman Irving A. Williamson opened the meeting, stressing his commitment to reducing the overall length of Section 337 Investigations from 16 months to 13.5 months. He also promised to continue efforts to reign in the cost of discovery during Section 337 Investigations.

Written by Christopher Gosselin

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During the refreshment break, guests were invited to view the new courtroom on the second floor, and heard brief remarks from Chief Administrative Law Judge ("ALJ") Charles E. Bullock. The new courtroom is spacious and well equipped with modern technology ranging from video projection screens to LCD monitors at every table. The courtroom should see plenty of use once it opens for business, as even with the new courtroom, the ITC still has more ALJs than available space. Although the ITC saw a 30% decrease in newly instituted investigations in 2012 after a record setting number in 2011, the ALJs continue to manage a near record level of active investigations.

K-V Pharmaceutical Company ("K-V") has taken the fight over its preterm-birth prevention drug, Makena® (17-hydroxypreogesterone caproate solution) ("HPC"), to the International Trade Commission ("ITC"). In its complaint, K-V asks the ITC to: (1) issue a temporary general exclusion order prohibiting any unauthorized importation of HPC and (2) issue a temporary cease and desist order stopping owners, importers, and consignees from importing, selling, offering for sale, distributing, or soliciting any HPC unless authorized by K-V.

K-V states that its merits argument will focus on the importation of HPC for the purpose of making compounded versions of Makena®. K-V argues that importation of HPC for use in compounding copies of Makena® is a violation of Section 337 of the Tariff Act of 1930. According to Section 337, "[u]nfair methods of competition and unfair acts in the importation of articles . . . in the United States, or in the sale of such articles by the owner, importer, or consignee, the threat or effect of which is . . . to destroy or substantially injure an industry in the United States," are "unlawful." 19 U.S.C. § 1337(a)(1)(A). K-V argues that, because all HPC in the United States comes from abroad, and the only use for HPC is in the manufacture of Makena® or allegedly unlawful copies of Makena®, the importation of HPC undermines federal law and K-V's statutory orphan drug exclusivity and "is clearly an unfair act and an unfair method of competition."

Written by Scot B. Pittman

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According to the Complaint, all the requisites for temporary relief are present. First, there will be immediate and irreparable harm to K-V because the pharmacies compounding copies of Makena® have diverted so much potential revenue from K-V that the drug company has had to file for Chapter 11 bankruptcy. Second, as mentioned above, there is a likelihood of success on the merits. K-V argues that the importation of HPC for the use in compounding violates the prohibition against mass-scale compounding and undermines K-V's statutory orphan drug exclusivity. These unfair acts and unfair methods of competition are threatening to destroy K-V, i.e., the domestic industry. Third, K-V argues that the following public interest factors favors granting the desired relief: (1) prevention of preterm births; (2) ensuring safe and effective drugs; (3) preservation of a domestic industry; and (4) effectuating Congress's intent to promote development of treatments for rare conditions. Finally, K-V states that it faces the balance of hardships. K-V argues that the compounding pharmacies have few, if any, protectable rights, whereas K-V has a "Congressionally-granted seven-year exclusive right to market Makena." Additionally, K-V notes that its business's survival depends on the success of Makena®, whereas the proposed respondents compound many other products and will survive if they are unable to compound Makena® during the exclusivity period.