Client Alert

What Are the Top Hatch-Waxman and BPCIA Developments for December 2018?

08 Jan 2019

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


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, including “antibody.”The court construed the term to mean “an immunoglobulin molecule, having a specific amino acid sequence that only binds to the antigen that induced its synthesis or very similar antigens, consisting of two identical heavy chains (H chains) and two identical light chains (L chains).” Baxalta conceded that Hemlibra did not infringe under that construction.

Damages on Bond After Improvidently Granted TRO

Takeda Pharmaceuticals, U.S.A., Inc. v. West-Ward Pharmaceutical Corp., 12/12/18 (D. Del. Civil Action No. 14-1268-RGA) – subscription required

The district court granted defendants’ motion for recovery of damages on a temporary restraining order bond and awarded $31,871,072.09 in damages and pre-judgment interest. The court held that “Defendants are entitled to their lost profits caused by the loss of its first mover advantage under the TRO.” The court then examined a number of factors to determine what defendants’ profits would have been in the “but-for” world where the TRO had not been granted.

No Dismissal of Sham Litigation Antitrust Counterclaims

Takeda Pharmaceutical Co. v. Zydus Pharmaceuticals (USA) Inc.,12/19/18 (D.N.J. Civil Action No. 18-1994 (FLW)) – subscription required

The district court denied plaintiffs’ motion to dismiss defendants’ antitrust counterclaims alleging, among other things, violations of section 2 of the Sherman Act, 15 U.S.C. § 2. Defendants pled sufficient facts to allege “sham litigation” and causation, and dismissal. “[D]istrict courts within this Circuit have routinely prohibited parties from invoking the protections of Noerr-Pennington at the dismissal stage of a case in the context of patent suits, at which time the factual record remains undeveloped and insufficient for the purpose of determining whether a ‘sham litigation’ has been filed.”

Federal Trade Commission

FTC Weighs in on FDA’s Revised Draft Guidance on Citizen Petitions

On December 4, 2018, the FTC issued its comments on the FDA’s Revised Draft Guidance on Citizen Petitions. In its press release, the FTC stated that it “shares the FDA’s concerns about patient access to lower-cost generic drugs and supports the FDA’s efforts to deter abuse of the citizen petition process.” The FTC also indicated that it “stands ready to work closely with the FDA on citizen petition abuse and other issues that may harm competition and lead to higher prescription drug costs.” The FTC press release and comments are available from the FTC here and here.

The FDA’s Revised Draft Guidance and related statement are available here and here.



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