Ferring Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc.

765 F.3d 205, 112 U.S.P.Q. 2d (BNA) 1257, 2014 U.S. App. LEXIS 16426, 2014 WL 4194094
CourtCourt of Appeals for the Third Circuit
DecidedAugust 26, 2014
Docket13-2290
StatusPublished
Cited by226 cases

This text of 765 F.3d 205 (Ferring Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Third Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Ferring Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc., 765 F.3d 205, 112 U.S.P.Q. 2d (BNA) 1257, 2014 U.S. App. LEXIS 16426, 2014 WL 4194094 (3d Cir. 2014).

Opinion

OPINION

CHAGARES, Circuit Judge.

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. Natural Resources Defense Council, 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.

I.

A.

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 em *207 bryo 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 Cri-none 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 En-dometrin; and (3) he mischaracterized the results of certain studies of Endometrin’s effectiveness in women over the age of thirty-five.

1.

First, during the 7:30 webcast, Dr. Sil-verberg 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]ffi-cacy 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. Silver-berg’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.

2.

During the two presentations, Dr. Sil-verberg 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 *208 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.

App. 182-83.

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 En-dometrin. 2 Watson Br. 9-10. Dr. Silver-berg 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.

3.

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 En-dometrin 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.

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765 F.3d 205, 112 U.S.P.Q. 2d (BNA) 1257, 2014 U.S. App. LEXIS 16426, 2014 WL 4194094, Counsel Stack Legal Research, https://law.counselstack.com/opinion/ferring-pharmaceuticals-inc-v-watson-pharmaceuticals-inc-ca3-2014.