Under Federal Circuit precedent, indirect (induced or contributory) infringement requires a patent owner to show that the alleged infringer had the specific intent to cause direct infringement. To challenge a patent owner’s proof of specific intent to cause infringement, parties have relied on their good-faith belief of noninfringement or invalidity. Such a belief may arise from or draw support from an opinion of counsel. Although in the past the Federal Circuit has endorsed reliance on noninfringement opinions as support for a lack of intent to cause infringement, it has not addressed the effect of an invalidity opinion. In Gen-Probe Inc. v. Becton Dickinson & Co.,1 a district court in the Southern District of California denied a motion for summary judgment of contributory and induced infringement, reasoning that because the defendant had obtained an invalidity opinion before bringing its accused product to market, it had a reasonable defense to liability for indirect infringement.


Plaintiff Gen-Probe owns a series of patents related to testing patient samples for the presence of specific pathogens. The Automation Patents relate to a method of nucleic acid-based testing that allows for identification of the presence of a target pathogen’s nucleic acid, where the steps are automated in a single instrument. The Cap Patents relate to a seal or seals on a collection vessel that are penetrated by a fluid-transfer device during this automated process. After defendant Becton Dickinson began marketing its own line of automated instruments for testing nucleic acid and penetrable cap products, Gen-Probe brought an infringement suit in the Southern District of California.

Before trial, the parties filed five motions for summary judgment and a motion to dismiss for lack of subject-matter jurisdiction. Gen-Probe moved for summary judgment of contributory and induced infringement. Becton Dickinson responded to the motion by arguing that it had obtained an invalidity opinion regarding the patent-at-issue and reasonably relied on it for a belief that the patent was not valid, thus showing at a minimum that factual issues precluded summary judgment of indirect infringement. The district court agreed with Becton Dickinson, denied Gen-Probe’s motion, and held that a disputed issue of material fact existed regarding whether Becton Dickinson had the requisite intent.

The Automation Patents and Becton Dickinson’s Invalidity Opinion

Gen-Probe’s nucleic acid-based testing allows for the detection of the presence of a target pathogen in a patient sample by using nucleotide sequence complementary to that of a target pathogen’s nucleic acid, known as a probe. If the target pathogen is present, the probe will bind that pathogen’s nucleic acid when introduced into the sample. Fluorescent or luminescent molecules may be incorporated into the probe so that they emit light at a specific wavelength upon binding. A luminometer measures the intensity of this light, thereby allowing for detection of a pathogen-containing sample. United States Patent No. 7,118,892 is drawn to automation of these detection steps in a single instrument. Becton Dickinson obtained an opinion letter in November 2008—almost a year before Gen-Probe filed this case. The opinion indicated that the claims of the ’892 patent, the only patent issued at the time, were invalid for obviousness. As other patents issued, Becton Dickinson obtained additional legal opinions of invalidity of their claims. Relying on these opinions, Becton Dickinson proceeded to market its VIPER XTR and BD Max automated instruments for testing nucleic acid.

The Gen-Probe Decision

It is well established that induced infringement "requires that the accused inducer act with knowledge that the induced acts constitute patent infringement." Akamai Techs., Inc. v. Limelight Networks, Inc. (Fed. Cir. 2012). And contributory infringement requires the same specific intent. The district court here recognized that the Federal Circuit has yet to address the effect of invalidity opinions on charges of indirect infringement. It further noted that various district courts have come out inconsistently. For example, a court in the District of Connecticut held that opinions regarding invalidity are irrelevant to the intent element of inducement. In contrast, a court in the District of Massachusetts found that a patentee could not reasonably prove indirect infringement where the parties agreed that the defendant believed an invalidity opinion it had obtained.

The court here took a middle ground and reasoned that Becton Dickinson’s reliance on invalidity opinions created a triable issue of fact regarding whether Becton Dickinson had the specific intent to cause infringement. Gen-Probe argued that, because infringement and invalidity are separate issues, an invalidity opinion could not overcome Becton Dickinson’s alleged encouragement of infringement. The district-court judge rejected this argument, reasoning that because "invalid claims cannot give rise to liability for infringement," invalidity opinions remain relevant to the analyses on contributory infringement and inducement. It therefore denied Gen-Probe’s motion for summary judgment.

Strategy and Conclusion

This case demonstrates the value that may come from opinions of counsel – both to provide advice and to provide evidence that positions taken were reasonable and not intended to infringe because they relied on well-reasoned advice of counsel. Although the legal effect of these opinions cannot be known at least until the Federal Circuit resolves the question addressed by the district court here, there appears to be a reasonable probability that both noninfringement and invalidity opinions can offer reasonable defenses to indirect infringement. This has become all the more important in view of the recent focus on that issue, particularly by the Federal Circuit in its recent en-banc Akamai decision.