Docket No. 2013-1386
NEWMAN (D), BRYSON, MOORE
August 6, 2014
Brief Summary: In decision relating to ANDA for marketing generic temazepam (marketed by Tyco for insomnia as Restoril), grants of SJ that “Tyco’s assertion of the validity of its patents was a sham”, “that Tyco’s infringement claims were not a sham”, and “that Tyco’s citizen petition to the FDA was not a sham” were vacated.
Summary: Mutual appealed DC conclusion that Tyco did not violate antitrust laws by filing suit against Mutual or a “citizen petition” with the FDA seeking to bar Mutual from obtaining FDA permission to market generic temazepam (marketed by Tyco for insomnia as Restoril). The patents-at-issue are directed to formulations or methods of treatment. Mutual argued that the litigation was a “sham” (e.g., “objectively baseless”) and that Tyco was not protected from antitrust liability by “Noerr-Pennington immunity” (the exception to a party ordinarily being exempt from antitrust liability for brining a lawsuit against a competitor). However, the FC concluded that it was not unreasonable for Tyco to allege infringement under 271(e)(2)(A) since there was “evidence that the as-marketed commercial ANDA product will infringe, even though the hypothetical product specified in the ANDA could not infringe” (e.g., Mutual’s ANDA product described in the application as being outside the claimed size range but “further inquiry is needed into the effect of the outgassing temperature on the specific surface area of Mutual’s generic product”; Bayer AG v. Elan (FC 2000), Bayer AG v. Biovail Corp. (FC 2002), Glaxo (FC 1997), Abbott (FC 2002)). Mutual also alleged Tyco’s claims were objectively baseless since a “reasonable litigant…would have known” its patents “would be found invalid for obviousness” because the 7.5 mg dose was disclosed in the prior art (dosing range of 5 to 15 mg). The FC disagreed, however, because the “burden of persuasion…remains with the accused infringer” and “Tyco offered to meet its burden of production” (Galderma Labs., FC 2003; Taurus IP, FC 2013; Novo Nordisk, FC 2013). Regarding the citizen’s petition, the FC concluded that SJ should not have been granted because “there are disputed issues of fact…with respect to whether the citizen petition was objectively baseless” (e.g., the FDA “denied the petition in terms indicating that, in the FDA’s view, it was wholly without merit” and an email from Tyco’s R&D group to its IP VP stating that a bioequivalent product “could be made that would have a particle size and specific surface area different from Restoril…[constituting] evidence that could support a finding that Tyco knew the theory in its citizen petition lacked merit.”) Mutual also alleged Tyco did not have immunity because it knew the patents were fraudulently obtained as applicant Sandoz omitted material information from the PTO (e.g., redacted relevant portions of FDA approvable letter submitted “for the limited purpose of overcoming an obviousness rejection”; citing Walker Process, US 1965) but the FC disagreed. Thus, the SJ that “Tyco’s assertion of the validity of its patents was a sham”, “that Tyco’s infringement claims were not a sham”, and “that Tyco’s citizen petition to the FDA was not a sham” were vacated. Judge Newman’s dissent argued that the reversal “creates several new grounds of antitrust liability”, converting “routine patent litigation into antitrust violation”.