Here's a summary of a conference call held today by Jeffries, with a patent attorney discussing the pros and cons of the 214 patent challenge. Good luck to all
Following investors' inquiries about Korlym ANDA litigations and patent reviews, we held a call w/ an experienced pharma IP lawyer. While there are numerous moving pieces, our lawyer views '214 patent to be the center of entire Gx dispute. As a key inflection point, he sees a good chance that PTAB would not institute '214 PGR by 11/7 based on current arguments from both parties. Recent claim construction for court case validates the importance of '214 validity.
Over the next ~12 months, investors should pay attention to Gx dispute-related inflection points, particularly the '214 PTAB decision. On the call, Shashank Upadhye provided an overview of the timelines and key moving parts in the ongoing dispute between CORT and Teva on several Korlym patents. Over the remainder of the year and through 2020, the critical events to pay attention to are 1) PTAB decision by 11/7/19 whether to institute a PGR on the '214 patent (the most important of the six patents in question), 2) the Markman hearing for the CORT vs Teva trial in Jan '20, 3) the final decision on the '348 IPR in Feb '20, and 4) if instituted, the final decision on the '214 patent in Nov '20, which may be followed by an appeal. We note that although the case appears complicated, the upcoming PTAB decision on '214 will likely carve out a path forward, for better or for worse, and help us simplify the proceedings.
Based on current arguments filed by CORT and Teva, our lawyer believes there is a good chance that the PTAB would not institute '214 PGR by 11/7, representing an upside scenario. As PGR is focused on the novelty and obviousness, the prior arts and "try with a reasonable expectation of success” test are the key topics of interest. While Teva challenges Korlym 2012 label as the prior art, our lawyer notes this has been thoroughly vetted by examiner during the patent application process and such prior art is typically considered "bad" prior art to challenge the patent validity vs. "good" ones that have not been used in the patent application. In addition, given the unpredictable Korlym's concentration associated w/ this co-administration, our lawyer believes that '214 passes the obviousness test. Dr. Greenblatt, who is Teva's declarant, confirms that a POSA would not have had a reasonable expectation of success in arriving at the claimed inventions as “drug interactions involving CYP3A inhibitors/substrates are not quantifiable in advance.” CORT cited multiple physicians that limited their dose to 300mg, suggesting up-titration to 600mg is not a routine optimization as Teva claimed. Taken together, our lawyer does not think the PTAB would institute '214 PGR in Nov. However, he points out that due to the low bar of proof at the PTAB vs. court and Dr. Greenblatt appears to serve on both sides, the PTAB may decide to institute and see/hear more evidence before making a final decision. We currently assume the PTAB would institute PGR, and view non-institution as an upside. We expect to see +~30%/-~15% move on the no/yes headline, although the rationale behind the decision could be material and serve a road map for further proceedings.