Digene Corp. v. Third Wave Technologies, Inc.

536 F. Supp. 2d 996, 86 U.S.P.Q. 2d (BNA) 1406, 2008 U.S. Dist. LEXIS 2307, 2008 WL 450467
CourtDistrict Court, W.D. Wisconsin
DecidedJanuary 11, 2008
Docket3:07-cv.-00022-bbc
StatusPublished
Cited by2 cases

This text of 536 F. Supp. 2d 996 (Digene Corp. v. Third Wave Technologies, Inc.) is published on Counsel Stack Legal Research, covering District Court, W.D. Wisconsin primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Digene Corp. v. Third Wave Technologies, Inc., 536 F. Supp. 2d 996, 86 U.S.P.Q. 2d (BNA) 1406, 2008 U.S. Dist. LEXIS 2307, 2008 WL 450467 (W.D. Wis. 2008).

Opinion

OPINION AND ORDER

BARBARA B. CRABB, District Judge.

In response to plaintiff Digene Corporation’s complaint suing defendant Third Wave Technologies, Inc. for infringement of one of plaintiffs patents, defendant filed an answer and nine counterclaims, in four of which it alleged that plaintiff had violated various provisions of the Sherman Act and the Robinson-Patman Act. (Of the remaining five, four related to plaintiffs infringement charges, which have been dismissed, and one alleged that this is an *999 exceptional case under 35 U.S.C. § 285, for which attorney fees should be awarded to defendant. I leave this last issue for another day, as explained below.)

In its amended antitrust counterclaims, defendant asserted that plaintiff had both monopolized and attempted to monopolize the market for human papilloma virus (HPV) testing in violation of § 2 of the Sherman Act, 15 U.S.C. § 2. According to defendant, plaintiffs monopolizing acts consisted of selling its HPV test kits through exclusionary contracts imposing onerous termination fees, by either giving away equipment or renting it at low prices, making false statements about defendant’s analyte specific reagents (ASRs) and engaging in sham litigation, as demonstrated by the bringing of this allegedly baseless lawsuit for patent infringement.

In addition to its § 2 counterclaim, defendant asserted a violation of § 1 of the Sherman Act based on plaintiffs alleged monopolization of the market for its HPV test kits, again by using its market power to exclude competition. Finally, defendant contended that plaintiff violated the Robinson-Patman Act by using free or low-cost gifts of equipment, cash payments for marketing and differential pricing of products in an effort to hinder competition.

I conclude that defendant has failed to show any violations of the Sherman Act or the Robinson-Patman Act. Plaintiff has had a natural, but short-lived dominant position in the market for high risk HPV testing because it was the first to market a test for this purpose and the first (and still the only company) to secure FDA approval, not because it has engaged in acts prohibited by law. Despite defendant’s lack of FDA approval for its own test, defendant has proved to be a competitor in the HPV testing market, with a gradually increasing share of that market and the clear prospect of obtaining a greater share once it secures FDA approval. It has been able to compete for many of the same customers that had been using plaintiffs test kits and it has no evidence that its failure to win more contracts is attributable to any illegal acts by plaintiff rather than to the customer’s choice to purchase plaintiffs FDA-approved test. Therefore, plaintiffs motion for summary judgment on defendant’s antitrust counterclaims will be granted.

From the facts proposed by the parties, I find that the following are material and undisputed. (The process of finding the undisputed facts would have been much easier if the parties had not proposed as “facts” their own or their opponent’s assertions, e.g., “plaintiff asserts that defendant’s multi-year contracts are compelling customers to enter into exclusive contractual relationships,” and if they had eliminated redundant proposals and ultimate issues of fact, e.g., “contrary to defendant’s allegations, there is no dispute that plaintiffs contracts are not exclusive.” Whether the contracts are exclusive is a decision that cannot be made until the underlying facts are determined.)

UNDISPUTED FACTS

Plaintiff Digene Corporation developed the first commercial test to detect high-risk types of the human papilloma virus (HPV) using genetic procedures. In 2003, it succeeded in obtaining Federal Drug Administration approval for its test kits. No other company has developed an HPV test that is approved by the FDA.

Defendant Third Wave Technologies, Inc. competes for sales against plaintiff, offering HPV analyte specific reagents (ASRs). The ASRs are raw materials and components that neither require nor have FDA approval but can be used by certain certified laboratories to create and validate their own diagnostic tests. Defendant has *1000 not obtained FDA approval for a test kit but is working toward that goal.

Since 2003, when plaintiff received FDA approval to market its HPV test kits for screening adjunctive to routine Pap testing for women over thirty, it has become increasingly common to combine HPV testing with routine Pap testing. Using both tests improves the effective diagnosis of cervical cancer to better than 99%.

Plaintiffs testing system is based on a technology platform known as Hybrid Capture 2, which can detect the presence of 12 HPV types. This in vitro diagnostic system includes the kit, which consists of the reagents and probes used to test for the presence of target DNA, and detection instruments. Plaintiff offers other equipment for automating the testing process, improving workflow and facilitating the process of large sample quantities (high-throughput). Plaintiff markets its testing kit to a variety of testing facilities, including commercial laboratories, such as Quest Diagnostics, Inc. and LabCorp, managed care organizations that perform their own clinical testing and private and public hospitals and clinics.

The equipment for running plaintiffs HPV test ranges in price from approximately $49,000 for a non-automated system to $199,000 for a fully automated system. Although plaintiff does not force customers to buy its equipment, laboratories that want to run FDA-approved tests must acquire five specific pieces of equipment from plaintiff that must be utilized to meet the FDA requirements. The customer could obtain the equipment from other companies but it would not be validated by the FDA. The other equipment necessary to run the tests does not require such validation and is readily available from many suppliers.

As a general rule, plaintiff sells or rents its test kits to customers under long term contracts (usually at least three years). Doing so enables plaintiff to predict its manufacturing needs and protect its investment in the intellectual property it expends in training its customers’ technicians and co-marketing the HPV tests (plaintiffs clinical sales representatives work to increase HPV referrals for their customer laboratories, meeting with doctors and other health care professionals in the laboratory’s service area). Long term contracts offer customers renting equipment the opportunity to spread out the rental payments over an extended period of time.

At the outset of contract negotiations, plaintiff begins by determining its customers’ anticipated test kit supply needs and helping them undertake long-term planning based on known costs. (The kits contain dated material with a limited shelf life.) Once plaintiffs representative has a sense of the volume of test kits a customer will be buying and for how long, it will offer the customer a price that takes those factors into account.

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Related

Nucap Industries, Inc. v. Robert Bosch LLC
273 F. Supp. 3d 986 (N.D. Illinois, 2017)
Digene Corp. v. Third Wave Technologies, Inc.
323 F. App'x 902 (Federal Circuit, 2009)

Cite This Page — Counsel Stack

Bluebook (online)
536 F. Supp. 2d 996, 86 U.S.P.Q. 2d (BNA) 1406, 2008 U.S. Dist. LEXIS 2307, 2008 WL 450467, Counsel Stack Legal Research, https://law.counselstack.com/opinion/digene-corp-v-third-wave-technologies-inc-wiwd-2008.