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Court Affirms Ruling That Insulin Delivery-System Patents Are Invalid for Obviousness

September 19, 2002

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Last Month at the Federal Circuit - October 2002

Judges: Newman (author), Schall, and Bryson

In Novo Nordisk A/S v. Becton Dickinson and Co., No. 01-1095 (Fed. Cir. Sept. 19, 2002), the Federal Circuit affirmed a district court’s ruling that all of the claims of three of Novo Nordisk A/S’s (”Novo”) patents are invalid and dismissed Becton Dickinson and Company’s (“Becton”) cross appeal of the district court’s denial of its pretrial motion for SJ on anticipation.

Novo asserted that Becton infringed U.S. Patent Nos. 5,462,535 (“the ‘535 patent”), 5,999,323 (“the ‘323 patent”), and 5,984,906 (“the ‘906 patent”), which relate to a pen-shaped insulin delivery system for diabetic patients designed to inject a measured amount of insulin.The system comprises a pen-shaped syringe, a cartridge containing insulin, and a needle. The claims of the ‘535 and ‘323 patents recite a 30-gauge (G- 30) needle, while the ‘906 patent defines a needle that is “thinner than G-29.” The higher the needle gauge, the thinner the outer diameter of the needle.

Becton stipulated to infringement if the patents were valid, and Novo agreed that there was double patenting if the district court’s construction of the ‘906 patent was correct.

The first issue on appeal was motivation to combine the teachings of two categories of references, where the obviousness determination turned on the diameter of the needle. The jury had found that the ‘535 and ’323 patents were invalid for obviousness in view of two categories of references supplied by Becton. The first category of references described pen-style injection systems having G-27 and G-28 needles. The second category of references disclosed G-30 insulin injection needles, but not their use in insulin pens. Becton’s experts offered as a motivation to combine the fact that thinner needles resulted in less pain to the patient. The Federal Circuit concluded that a reasonable jury could have found such pain reduction to provide the motivation to combine and affirmed the jury’s verdict of invalidity.

Novo sought a new trial based on the district court’s refusal to include a jury instruction that “obvious to try” was not the proper legal standard for determining obviousness. Becton’s expert testified that it would have been obvious to try to reduce pain by using a smaller needle. Although the Federal Circuit agreed that “obvious to try” was not the correct standard, it nevertheless found no prejudicial error in the district court’s denial.

Novo also claimed that it was prejudiced by Becton’s arguments that patents are monopolies and that patent examiners are prone to error, overworked, and inexperienced. Becton made these comments despite the district court’s instructions not to make such arguments. Novo failed to object at trial, however, and also failed to ask for corrective jury instructions or raise the issue in post-trial motions. The Federal Circuit warned that it did not condone inflammatory insinuations, but concluded that a new trial was not warranted on the ground of prejudice because Novo had taken no action at trial.

Novo appealed the district court’s finding that the ‘906 patent was invalid for same-invention type double patenting, arguing that the district court had erred in its conclusion because it had improperly construed the term “thinner than G-29” used in the ‘906 patent to mean “thinner than 29 gauge, but not thinner than 30 gauge.“ Because Novo conceded at oral argument that an affirmance of the jury verdict of invalidity of the ‘535 and ‘323 patents would mean that the ’906 patent was also invalid, the Federal Circuit determined that it was not necessary to construe the limitation and affirmed the judgment of invalidity of the ‘906 patent.