Mylan Obtains Federal Circuit Victory in Celebrex Litigation

On June 23, 2015, the U.S. Court of Appeals for the Federal Circuit affirmed the Eastern District of Virginia's March 2014 grant of summary judgment in favor of Wilson Sonsini Goodrich & Rosati client Mylan Pharmaceuticals Inc., a leading provider of generic pharmaceutical drugs.

The plaintiffs, G.D. Searle LLC and Pfizer Asia Pacific Pte, Ltd. (collectively "Pfizer"), had accused Mylan and several other defendants of infringing a patent directed to Pfizer's painkiller drug, Celebrex. Specifically, Pfizer had accused Mylan of infringing U.S. Reissued Patent No. RE44,048 (the '048 patent). Mylan moved for summary judgment that the '048 patent was invalid due to obviousness-type double patenting, and an invalid reissue patent. Co-defendants Lupin Pharmaceuticals, Watson Laboratories, Apotex Inc., and Apotex Corp. also moved for summary judgment that the '048 patent was invalid due to obviousness-type double patenting, and an invalid reissue patent, although on slightly different grounds. The U.S. District Court for the Eastern District of Virginia granted both Mylan's motion and the co-defendants' motion with respect to obviousness-type double patenting, and granted the co-defendants' motion with respect to the invalid reissue patent.

In the Federal Circuit, a three-judge appellate panel—consisting of Chief Judge Prost, Judge Bryson, and Judge Hughes—affirmed the district court's grant of summary judgment. On appeal, Mylan focused at oral argument on whether the '048 patent was invalid for obviousness-type double patenting because the '048 patent did not qualify for the safe harbor provision under 35 U.S.C. 121. Separately, the co-defendants focused on whether the '048 patent was an invalid reissue patent. Notably, the Federal Circuit did not reach the issues the co-defendants argued and instead largely agreed with Mylan's analysis concluding that the Section 121 safe harbor provision did not apply to the '048 patent. Specifically, the court held that "[b]ecause we find that the safe harbor provision of section 121 does not apply to the RE '048 patent, even assuming it was proper to grant the reissue patent under section 251, we affirm the district court's judgment."

The Wilson Sonsini Goodrich & Rosati team that represented Mylan included partners Stu Williams, Douglas Carsten, and T.O. Kong; Of Counsel Ellie Steiner; associates Wendy Devine, Adam Burrowbridge, Nancy Zhang, and Peter Kang; and paralegal Kathryn Robinson. Robert McFarland of McGuireWoods LLP represented Mylan as local counsel in the Eastern District of Virginia.

Lupin Pharmaceuticals was represented by Douglass Clifford Hochstetler, Beth Jacob, and Clifford Katz of Kelley Drye & Warren LLP.

Apotex Inc. and Apotex Corp. were represented by Richard Hooper Ottinger and Dustin Mitchell Paul of Vandeventer Black LLP and Ian Scott and Richard T. Ruzich of Taft Stettinius & Hollister LLP.

Teva was represented by Henry C. Dinger, David Hashmall, William M. Jay, and Keith Adam Zullow of Goodwin Procter LLP, and Sonja Garrelts, Wendy Cohen McGraw, Gregory N. Stillman, and Brent Lee VanNorman of Hunton & Williams LLP.