The Federal Circuit decision in Genetics Institute, LLC v. Novartis Vaccines & Diagnostics, Inc. is interesting in several respects. In this article, I look at the court’s decision to permit unexpected results discovered after the patent applications at issue were filed to support non-obviousness.
In Tyco Healthcare Group LP v. Mutual Pharmaceutical Co., Inc., the Federal Circuit affirmed the district court’s finding that product claims reciting a specific dose of temazepam were obvious in view of an entry in a medical reference book. Although Tyco tried to overcome the disclosure with evidence of unexpected results and commercial success, its arguments were unavailing.
The Federal Circuit decision in Tokai Corp. v. Easton Enterprises, Inc. touches on several “hot” issues in patent law. While the case involved a mechanical invention, the principles are applicable across the board, and may arise in the context of pharmaceutical and biotech patent challenges.
The Patents At Issue
As summarized by the Federal Circuit and illustrated in these figures from the ’775 patent, the lighters have a trigger (120) and a safety device that includes a locking member (125) and a spring (26). To operate the lighter, the user depresses the locking member against the force of the spring and pulls the trigger. When the user releases the locking member, the spring automatically returns the locking member to its initial position, where the trigger is blocked from inadvertent actuation.
(It’s good to know how these work. I usually end up pushing and squeezing various parts of our lighter to no avail, and then give up and ask my (teenage) son to light the grill.)
Burden of Proof
The asserted prior art included a combination of references that had been considered by the USPTO during examination and newly cited references. Tokai argued that an “enhanced burden” should apply because “some of the asserted prior art references were considered during prosecution.”
The Federal Circuit acknowledged the principle that an “enhanced burden” can apply if the invalidity challenge “relies on the same prior art as considered during examination,” but noted that the principle does not apply when “not all of the asserted prior art was considered by the PTO.”
(The Federal Circuit noted that the “clear and convincing” standard of proof would apply either way. In Microsoft Corp. v. i4i Limited Partnership, the Supreme Court will consider whether a lower burden of proof—preponderance of the evidence—should apply when none of the prior art was considered by the USPTO.)
Post-KSR Obviousness Analysis
There was no dispute that all elements of the claimed lighting rods could be found in the prior art. Although several of the safety features were found in prior art cigarette lighters rather than prior art lighting rods, the parties had agreed that cigarette lighters were in an analogous art. Additionally, Tokai had acknowledged that the safety devices involved “simple mechanical parts.” Thus, there was no question that the cigarette lighter safety features could be incorporated in lighting rods.
The “reason” to combine was found “in the nature of the problem to be solved.” It was “undisputed” that “a need for safer utility lighters was recognized in the art as of the priority date.” Thus, the Federal Circuit agreed with district court that the skilled artisan would have combined features of cigarette lighters with lighting rods in an effort to design safer lighting rods.
The Federal Circuit summarized the obviousness determination as follows:
[T]he undisputed facts in this case—including the state of the prior art, the simplicity and availability of the components making up the claimed invention, and an explicit need in the prior art for safer utility lighters—compel a conclusion of obviousness as to the subject matter of each of the asserted claims.
Tokai presented evidence of commercial success, but it was not probative because no “nexus” was shown between the commercial success and the claimed invention. For example, although Tokai’s corporate representative discussed the “marketing and sales of Tokai’s utility lighters,” he did “not once” discuss the automatic locking feature that purportedly distinguished the claimed invention from prior art utility lighters.
Moreover, the Federal Circuit noted that even if a nexus had been shown, the evidence might not overcome “the strong showing of prima facie obviousness.”
(Compare this decision to In re Glatt Air Techniques, where the Federal Circuit reversed a Board decision that had found that the evidence of commercial success was not sufficiently commensurate with the scope of the claims.)
Tokai’s Take Home Message
As someone who practices in the pharmaceutical and biotech space, the most striking aspect of the Federal Circuit’s decision in Tokai is the idea that a prima facie case of obviousness can be so strong that it cannot be overcome with evidence supporting secondary considerations of non-obviousness. Perhaps the court would not apply this reasoning if the evidence related to unpredictability or unexpected results, but it is not always possible or practical to provide such evidence (such as comparative data) that is “commensurate” with the full scope of the desired claims.