Plexxikon Inc. v. Novartis Pharmaceuticals Corporation

Background

Novartis Pharmaceuticals Corporation moved to exclude the testimony of Plexxikon Inc.’s expert, Dr. Michael L. Metzker. Novartis did not challenge the substance of Dr. Metzker’s opinions. Instead, it argued that his education and experience did not qualify him as a person of ordinary skill in the art, or “POSITA,” for the patent issues in the case.

The parties agreed that the relevant field was synthetic organic chemistry or medicinal chemistry. They also agreed that a POSITA would generally have a doctorate or equivalent degree in organic or medicinal chemistry and two to three years of postgraduate experience in medicinal chemistry, synthetic organic chemistry, or kinase chemistry, including developing potential drug candidates. The parties also agreed to an alternative definition covering someone with a bachelor’s or master’s degree in organic or medicinal chemistry and more than two to three years of relevant experience.

Legal standard

Federal Rule of Evidence 702 governs expert testimony. It permits a qualified expert to testify when the testimony will help the factfinder understand the evidence or decide an issue, is based on sufficient facts or data, uses reliable principles and methods, and reliably applies those methods to the case. Under the Supreme Court’s decision in Daubert v. Merrell Dow Pharmaceuticals, expert testimony must be relevant and reliable.

Novartis relied on Federal Circuit precedent stating that an expert testifying about patent infringement or invalidity must be qualified in the pertinent technical field. Plexxikon argued that the Federal Rules of Evidence, rather than the parties’ POSITA definition alone, govern admissibility and that an expert may have sufficient technical expertise even without matching the exact POSITA definition.

Court’s analysis

The court concluded that this was not the unusual situation addressed in Sundance. Dr. Metzker was a scientist, not a patent attorney with no relevant technical expertise. He had a bachelor’s degree in biochemistry and biophysics from the University of California, Davis, and a Ph.D. in molecular and human genetics. The court found that he had sufficient relevant technical expertise under Rule 702.

The court alternatively found that Dr. Metzker satisfied the parties’ agreed-upon secondary POSITA definition. It rejected a formal approach that treated the title of his degree as decisive. Dr. Metzker explained that medicinal chemistry was an application of his biochemistry education, and the court found that the cited materials supported a relationship between biochemistry, organic chemistry, and medicinal chemistry.

The court also found that Dr. Metzker had substantially more than the required two to three years of experience developing potential drug candidates. His work included synthesizing inhibitors at Baylor College of Medicine, identifying drug targets during three years at Merck & Co., and designing, synthesizing, and testing modified nucleosides and nucleotides as potential drug therapies while teaching at Baylor College of Medicine and Rice University. The court noted that the agreed POSITA definition was not limited to experience with kinase inhibitors.

The court rejected Novartis’s arguments that Dr. Metzker had not provided enough detail about his work or records documenting his career. It also declined to credit Novartis’s speculation that he had embellished his qualifications. Novartis could question the relative strength of Dr. Metzker’s qualifications and compare them with its own experts at trial, but the court did not need to decide which experts were better credentialed or more persuasive for this motion.

Disposition

The court found that Plexxikon had sufficiently shown that Dr. Metzker possessed the relevant knowledge, skill, experience, training, and education to qualify as an expert under Rule 702. Judge Haywood S. Gilliam, Jr. therefore denied Novartis’s motion to exclude Dr. Metzker’s testimony.