Judge Gorton denied Oxford’s motion for a preliminary injunction on sales of Qiagen’s QFT-Plus one-tube option for the diagnosis of tuberculosis. According to the opinion, tuberculosis is detected in two ways – through skin tests or through in vitro blood test known as interferon gamma release assay (“IGRA”). Currently, Oxford and Qiagen offer the only IGRA’s available in the United States. Oxford’s test utilizes a single, standardized tube, while Qiagen’s test requires multiple specialized tubes. Qiagen’s next generation product contains a single tube option that Oxford believes would infringe its patents. Oxford sought to prevent the sale of the next generation product, scheduled for launch in October 2017, until after a trial on the infringement claims. The asserted claims have already survived an Alice-based motion to dismiss, as well as five different petitions, all rejected, for inter partes review on obviousness grounds, and at Markman, all claims were construed on Oxford’s favor.
In considering the preliminary injunction factors, Judge Gorton determined that the claims were likely to be directed to patentable subject matter, because they included non-naturally-occurring peptides. He found that Oxford was likely to succeed in proving the patents valid over the prior art because, although Qiagen could show that researchers were exploring the use of the specific peptide, this showed only that it was “obvious to try” which does not rise to a finding of obviousness. He also noted that Qiagen’s arguments to this effect had previously been rejected by the PTO in its denial of the inter partes petitions. Judge Gorton found that Oxford would also likely prevail on a written description challenge, as well as on infringement by the Qiagen product. He determined, however, that Oxford had not made a “clear showing” that substantial and immediate harm is likely in the absence of an injunction. This was due both to the delay between finding out in January that Qiagen was about to apply for FDA approval and its filing the motion for preliminary injunction in August and because Oxford had not shown that money damages would be insufficient – “evidence of potential lost sales alone does not demonstrate irreparable harm.” This factor also weighed heavily in the balance of hardship consideration, offsetting the hardships that Oxford, a one-product company, would face in allowing Qiagen to continue selling, and ultimately led to denial of the motion.