765 F.3d 205 (3rd Cir. 2014), 13-2290, Ferring Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc.
|Citation:||765 F.3d 205|
|Opinion Judge:||CHAGARES, Circuit Judge.|
|Party Name:||FERRING PHARMACEUTICALS, INC., Appellant v. WATSON PHARMACEUTICALS, INC|
|Attorney:||Arne M. Olson, Esq. (Argued), Dennis H. Ma, Esq., Brian R. Michalek, Esq., Olson & Cepuritis, Chicago, IL, Counsel for Appellant. David W. Phillips, Esq. (Argued), Karol C. Walker, Esq., LeClairRyan, Newark, NJ, Counsel for Appellee. David H. Bernstein, Esq., Debevoise & Plimpton, New York, NY, C...|
|Judge Panel:||Before: CHAGARES, SHWARTZ, and ALDISERT, Circuit Judges.|
|Case Date:||August 26, 2014|
|Court:||United States Courts of Appeals, Court of Appeals for the Third Circuit|
Argued: February 12, 2014
On Appeal from the United States District Court for the District of New Jersey. (No. 2-12-cv-05824-DMC-JAD). District Judge: Honorable Dennis M. Cavanaugh.
Appellant Ferring Pharmaceuticals, Inc. appeals from a District Court order denying its motion for a preliminary injunction against appellee Watson Pharmaceuticals, Inc.1 This appeal requires us to determine, inter alia, whether a party seeking a preliminary injunction pursuant to a Lanham Act claim is entitled to a presumption of irreparable harm. We conclude that, in light of the Supreme Court's decisions in eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388, 126 S.Ct. 1837, 164 L.Ed.2d 641 (2006), and Winter v. NRDC, Inc., 555 U.S. 7, 129 S.Ct. 365, 172 L.Ed.2d 249 (2008), a party bringing a claim under the Lanham Act is not entitled to a presumption of irreparable harm when seeking a preliminary injunction and must demonstrate that irreparable harm is likely. We also conclude that the District Court did not err in finding that Ferring failed to demonstrate irreparable harm. We will, therefore, affirm the District Court's order.
Ferring and Watson are pharmaceutical companies that market competing prescription progesterone products. Progesterone is a hormone that plays a key role in helping women become pregnant and maintain their pregnancies, specifically by preparing the uterine lining for the embryo
and maintaining the lining to support the embryo during the early stages of pregnancy. Although women naturally produce progesterone, women seeking to become pregnant through assisted reproductive technology (" ART" ) procedures, such as in vitro fertilization, generally require progesterone supplementation. Historically, women have received progesterone through intramuscular shots, which are not approved by the Food and Drug Administration (" FDA" ) and which patients consider painful. Ferring and Watson each manufacture a product that administers progesterone to women through vaginal inserts rather than intramuscular shots. Ferring's product, Endometrin, is delivered in capsule form and applied two or three times per day. Watson's product, Crinone, is a gel delivered via applicator and is applied once daily. Endometrin and Crinone are currently the only two vaginal progesterone inserts for ART approved by the FDA.
Ferring's claims arise out of two presentations made by Watson on September 11, 2012. On that date, Watson hosted and invited doctors and healthcare professionals to view two presentations about Crinone made by Dr. Kaylen M. Silverberg, a paid consultant. The presentations were streamed online at 7:30 p.m. and 9:00 p.m. throughout the United States and viewed by medical professionals in-person and over the Internet with a password. The webcasts were designed to encourage attendees to purchase Crinone and consisted of a series of PowerPoint slides prepared by Watson.
During the presentations, Dr. Silverberg made three statements with which Ferring takes issue: (1) he referenced a " Black Box" warning on Endometrin's package insert; (2) he discussed a patient preference survey comparing Crinone and Endometrin; and (3) he mischaracterized the results of certain studies of Endometrin's effectiveness in women over the age of thirty-five.
First, during the 7:30 webcast, Dr. Silverberg stated that " if you read the package insert, for Endometrin there is a black box warning showing the efficacy has not been demonstrated with . . . patients 35 years of age and older." Appendix (" App." ) 174-75. A Black Box warning is of special note in the medical community, as it signifies that medical studies indicate that the drug carries a significant risk of serious or life-threatening effects. See 21 C.F.R. § 201.57(c)(1) (providing that " [c]ertain contraindications or serious warnings, particularly those that may lead to death or serious injury, may be required by the FDA to be presented in a box" ). The package insert does state that " [e]fficacy in women 35 years of age and older has not been clearly established." App. 6. However, that statement is not contained in a Black Box warning on the package insert. Watson admits that Dr. Silverberg's statement was, therefore, made in error. Watson Br. 8.
Dr. Silverberg was alerted to the inaccuracy of his characterization of the statement as a Black Box warning after the 7:30 webcast, and the 9:00 webcast did not contain such a statement. Dr. Silverberg also certified to Ferring and to the District Court that he would not repeat this statement in the future.
During the two presentations, Dr. Silverberg also told the audience that high percentages of women preferred Crinone to Endometrin. Specifically, during the 7:30 webcast, Dr. Silverberg stated:
When you look at Crinone compared to Endometrin, similar findings. 94 percent
of patients thought that Crinone was easier to incorporate into their daily lifestyle, probably because it's given once a day compared to three times a day for Endometrin, 82 percent thought that it was more convenient, or I'm sorry, that may be 88 percent, 94 percent thought that it was more comfortable to use Crinone than the Endometrin.
App. 175. During the 9:00 webcast, Dr. Silverberg stated:
Now looking at Crinone compared to Endometrin, telephone survey, 94 percent of patients thought that Crinone was easier to incorporate into a daily lifestyle than the Endometrin given three times a day. 88 percent thought it was more convenient. 84 percent thought it was more comfortable to use.
The slide used by Dr. Silverberg during the presentations states that these percentages are based on a survey of women who used Crinone or Endometrin. The slide also states that the percentages are derived from a " tally of yes/no questions about whether CRINONE was easy to incorporate into a daily lifestyle, was convenient, and was comfortable to use." App. 376. Thus, the text of the slide indicated that the survey was not actually a comparison of Crinone and Endometrin. Watson has admitted that Dr. Silverberg's claims were false, because the figures cited were not based on a survey comparing patient preferences for Crinone and Endometrin.2 Watson Br. 9-10. Dr. Silverberg certified to the District Court that he was aware of his mistake in misreading the survey results and will not repeat it in the future.
Dr. Silverberg also made several statements regarding the efficacy of Crinone and Endometrin in women over thirty-five years of age. Dr. Silverberg stated that " if you read the package insert, for Endometrin there is a black box warning showing the efficacy has not been demonstrated with . . . Endometrin for patients 35 years of age and older," App. 174-75 (emphasis added), but Endometrin's package insert actually states that " [e]fficacy in women 35 years of age and older has not been clearly established," App. 6 (emphasis added).
In addition, Dr. Silverberg discussed studies performed by Schoolcraft WB, et al.,3 and Doody KJ, et al.,4 concerning the use of Crinone and Endometrin in women over thirty-five years of age. App. 191, 193-98. During the 7:30 webcast, Dr. Silverberg stated:
We know that efficacy has been established for Crinone in patients under the age of 35 as well as over the age of 35. Schoolcraft's analysis of the Doody study and also our study found the exact same thing.
App. 176. During the 9:00 webcast, Dr. Silverberg stated:
The efficacy of Crinone, unlike the other products, has been established in women
throughout the entire reproductive spectrum from 22 to 47, including women age 35 years of age and older. Schoolcraft's study found that, our study found that.
App. 184. He also stated, during the same webcast:
Bill Schoolcraft has some published data showing that in fact that the efficacy of Endometrin given three times a day is not -- it was not found to be efficacious for women over the age of 35.
The Schoolcraft study involved the administration of Endometrin twice or three times a day or Crinone to participants who were up to forty-two years old. The study lists the results for the participants who took Crinone, but the data analysis section and conclusion concern only Endometrin. The study concludes that " Endometrin was well tolerated and provided successful luteal support in poor-prognosis patients" such as " those older than 35." App. 191. However, the study also includes a chart comparing the results for the participants taking Endometrin with the participants taking Crinone, and the chart indicates that Crinone has higher pregnancy rates than Endometrin for participants over the age of thirty-five.
The Doody study, structured similarly to the Schoolcraft study, directly compared Endometrin to Crinone and concludes that " [n]o clinically meaningful differences were observed across the three treatment groups in pregnancy rates or live birth rates," and that " Endometrin provides a safe, well tolerated, and effective method for providing luteal phase support in women...
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