by Dennis Crouch
Mayne Pharma v. Merck Sharp & Dohme (Fed. Cir. 2019)
Mayne’s U.S. Patent 6,881,745 covers an azole antifungal drug with a particular formulation designed to increase absorption and bioavailability. Back in 2015, Mayne sued Merck for infringement — accusing Merck’s Noxafil product. In the Inter Partes Review (IPR), the PTAB agreed with Merck — finding the claims unpatentable as obvious. That decision has now been affirmed on appeal.
Time Bar under 315(b): An IPR may not be instituted if the petitioner (or its proxy or a real-party-in-interest) was served with an infringement complaint more than one year beforehand. 35 U.S.C. § 315(b). Here’s the timeline:
- May 29, 2015, Mayne sued both Merck & Co, Inc. (MCI) and the company’s international subsidiary Merck Sharp & Dohme (MSD) for infringing the ‘745 patent.
- June 12 2015, MCI and MSD both served with a summons for the lawsuit.
- June 11, 2016, MSD (but not MCI) filed for inter partes review challenging the ‘745 patent. This appears to fall within the 1-year time limit. Mayne asked the PTAB to require MCI be joined as a real-party-in-interest, but the PTAB refused at the institution stage. At institution, MSD did not respond to the allegations regarding real party in interest; and the Board found insufficient evidence of Control.
- December 2017, PTAB required MSD to add MCI as a real party in interest to the case. Although MCI was added to the case well after the one-year 315(b) deadline, the PTAB found that MCI’s addition did not alter the filing date.
The Board had provided “guidance” that it would not allow correction of non-clerical errors in the petition without also changing the filing date, 80 Fed. Reg. 50, and Mayne argued that the rule applies here.
On appeal, the Federal Circuit sided with the patent challenger and PTAB — holding that the Board did not commit reversible error based upon a no-harm no-foul rule of law:
There was no evidence suggesting that MSD intended to conceal MCI’s identity. In fact, Mayne was aware of MCI because MCI was a named defendant in parallel district court litigation, and, had MSD named MCI as a real party in interest in its original petition, Mayne would be in the same position it is in now.
With regard to the PTAB guidance, the court noted that such guidance was “non binding” [upon whom?] and that the Board had allowed several petition corrections without changing the filing date.
Why Do It? – Privileged: The gaping hole in in the analysis is any discussion of why MSD did not name its parent company who was being sued for infringement as a real party in interest.
In the IPR, Merck’s attorneys (who represented both companies) indicated that they had intentionally omitted MCI as a real-party-in-interest, but did not explain their actions other than: “privileged legal strategy immune from discovery” (although this is in quotes, it is my paraphrasing). The key patent-related reason here that comes to mind is that – at the time – Merck thought it might get around IPR estoppel by having its subsidiary file the petition. It was not until more than a year later that Merck agreed that both companies would be bound by any resulting estoppel.
Appealable: The patent challenger also argued that the issue here is not appealable because it is tied to institution. On appeal, the Federal Circuit ducked that issue and instead held that the case is affirmed whether or not it is appealable. (Interesting jurisprudence dance on this one).