What Are The Top Hatch-Waxman And BPCIA Developments For December 2018?

This month we highlight two Federal Circuit obviousness-type double patenting decisions.

CASES

Federal Circuit

Section 156 Patent Term Extension and Obviousness-Type Double Patenting

Novartis AG v. Ezra Ventures LLC, 12/7/18 (Fed. Cir. No. 2017-2284)

The Federal Circuit held that obviousness-type double patenting does not invalidate an otherwise validly obtained patent term extension under 35 U.S.C § 156. “By applying statutory construction principles, following this court's precedent in Merck, [see Merck & Co. v. Hi-Tech Pharmacal Co., 482 F.3d 1317 (Fed. Cir. 2007)], and addressing traditional obviousness-type double patenting principles, we hold that a PTE pursuant to § 156 is valid so long as the extended patent is otherwise valid without the extension. Thus, the district court was correct in finding that the '565 patent is not a double patenting reference to the '229 patent and that the '229 patent is valid through the end of its PTE.”

The URAA and Obviousness-Type Double Patenting

Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc., 12/7/18 (Fed. Cir. Nos. 2017-2173, 2017-2175, 2017-2176, 2017-2178, 2017-2179, 2017-2180, 2017-2182, 2017-2183, and 2017-2184)

The Federal Circuit held that the district court erred in finding that a post-Uruguay Round Agreements Act of 1994 (URAA) patent was a proper obviousness-type double patenting reference for a pre-URAA patent. The Federal Circuit explained that its prior decision in Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208, 1212 (Fed. Cir. 2014), does not control for pre-URAA patents. Rather, “the correct framework here is to apply the traditional obviousness-type double patenting practices extant in the pre-URAA era to the pre-URAA '772 patent and look to the '772 patent's issuance date as the reference point for obviousness-type double patenting.” Using that framework, and “because a change in patent term law should not truncate the term statutorily assigned to the pre-URAA '772 patent, we hold that the '990 patent is not a proper double patenting reference for the '772 patent.”

District Court

Defining an Antibody

Baxalta Inc. v. Genentech, Inc., 12/03/18 (D. Del. Civil Action No. 17-509-TBD) - subscription required

In this brand-vs-brand litigation, the district court (Judge Dyk, sitting by designation) construed disputed terms, includingantibody.The court construed the term to meanan immunoglobulin molecule, having a specific amino acid sequence that only binds to...