Friday, December 07, 2018

Complicated double-patenting issue in Novartis v. Breckinridge

The outcome was reversal; Novartis wins:

Novartis Pharmaceuticals Corporation and Novartis
AG (collectively, Novartis) appeal the district court’s
decision to invalidate U.S. Patent No. 5,665,772 based on
obviousness-type double patenting. The invalidating
reference, Novartis’s U.S. Patent No. 6,440,990, was filed
after, and issued after, but expired before the ’772 patent.
Both patents claimed the same priority date. The ’990
patent expired before the ’772 patent because the ’990
patent was filed after the June 8, 1995 effective date of
the Uruguay Round Agreements Act of 1994 (URAA)
The patents at issue in Gilead were both filed after
the effective date of the URAA and claimed different
priority dates. 753 F.3d at 1210. Because Gilead’s earlier-filed
patent claimed an earlier priority date, despite
issuing after the later-filed patent, that earlier-filed
patent expired before the later-filed patent. Id. As the
district court correctly summarized, we held in Gilead
that the expiration date is the benchmark of obviousnesstype
double patenting. But our opinion was limited to the
context of when both patents in question are post-URAA
patents. Id. at 1216. Here we have one pre-URAA patent
(the ’772 patent) and one post-URAA patent (the ’990
patent), governed by different patent term statutory
regimes. Our decision in Gilead thus does not control the
present situation.
Instead, 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.
Under this 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. Accordingly, we reverse.

Of note:

“While the ultimate conclusion that a patent is invalid
under the doctrine of obviousness-type double patenting is
reviewed de novo, the underlying factual determinations—including
the existence of secondary factors such
as unexpected results—are reviewed for clear error.”
AbbVie, 764 F.3d at 1372 (citing Eli Lilly & Co. v. Teva
Parenteral Meds., Inc., 689 F.3d 1368, 1376 (Fed. Cir.
2012)). This appeal presents a narrow legal question: can
a post-URAA patent that issues after and expires before a
pre-URAA patent qualify as a double patenting reference
against the pre-URAA patent? We conclude under the
circumstances of this case that it cannot. Therefore, the
district court erred in using the ’990 patent as a double
patenting reference for the ’772 patent.


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