Tuesday, January 23, 2018

CAFC finds no 121 safe harbor for Janssen as to claims of U.S. Patent No. 6,284,471

In the Janssen case reported on 23 Jan 2018, the CAFC noted

Janssen Biotech, Inc., and New York University (collectively,
“Janssen”) appeal from a decision of the United
States Patent and Trademark Office (“PTO”), Patent Trial
and Appeal Board (“Board”) resulting from an ex parte
reexamination of U.S. Patent No. 6,284,471 (“’471 patent”).
The Board affirmed the rejection of claims 1–7 of
the ’471 patent as unpatentable under the doctrine of
obviousness-type double patenting. Because the claims
are barred under that doctrine, we affirm.

The main issue:

In this case, Janssen’s principal argument
is that obviousness-type double patenting is not
applicable because the safe-harbor provision of 35 U.S.C.
§ 121 protects the ’471 patent claims. Thus, as in Searle,
the double-patenting issue in this case turns on whether
Janssen is entitled to invoke § 121 as a defense against a
double patenting rejection. That issue depends, in turn,
on an interpretation of the prosecution history of the ’471
patent and that patent’s relationship to application
No. 08/013,413 (“’413 application”).


The main issue on appeal is whether the safe-harbor
provision of 35 U.S.C. § 121 applies to the ’471 patent and
protects it from invalidation based on the ’272 and ’195
reference patents. If the safe harbor applies, then the
reference patents cannot be used as references against the
’471 patent in a double-patenting rejection. Conversely,
the reference patents are available as references against
the ’471 patent if the safe harbor does not apply. Whether
the requirements of § 121 have been satisfied is a question
of law that we address de novo. Bristol-Myers Squibb
Co. v. Pharmachemie B.V., 361 F.3d 1343, 1348 n.1 (Fed.
Cir. 2004).

The CAFC observed:

The § 121 safe harbor, “by its literal terms, protects
only divisional applications (or the original application)
and patents issued on such applications.” Pfizer, Inc. v.
Teva Pharm. USA, Inc., 518 F.3d 1353, 1360 (Fed. Cir.
2008) (internal quotation marks omitted). Accordingly,
patents issued on CIP applications are not within the
scope of § 121. Id. at 1362. Nor are patents issued on
continuation applications. Amgen, 580 F.3d at 1354. Our
precedent is clear: aside from the original application and
the original patent, the protection afforded by § 121 is
limited to divisional applications and patents issued on
divisional applications.3 Pfizer, 518 F.3d at 1362.

Some of the reasoning:

This case presents the question of whether, several
years after a challenged patent issues on a CIP application,
a patent owner can retroactively bring the challenged
patent within the scope of the § 121 safe harbor by
amending the CIP application during a reexamination
proceeding to redesignate it as a divisional application.
In Searle we answered this question in the reissue context,
holding that the patent owner could not take advantage
of the safe-harbor provision simply by
designating the CIP as a divisional application in a reissue
application years after the fact. 790 F.3d at 1354–55.
Leading up to the Searle case, this court in Pfizer concluded
that the statutory safe-harbor provision did not
shield a challenged patent when it issued on a CIP and
not a divisional application. Searle, 790 F.3d at 1352
(citing Pfizer, 518 F.3d at 1362). Following the disposition
in Pfizer, the patent owner filed an application with the
PTO seeking reissue of the patent challenged in Pfizer.
Searle, 790 F.3d at 1353. Just as Janssen’s reexamination
amendments do here, the patent owner’s preliminary
amendments accompanying the reissue application deleted
portions of the challenged patent’s specification that
were not present in the original application and changed
the designation of the application on which the challenged
patent had issued from a CIP to a divisional application.
Id. The preliminary amendments also cancelled claims
that were not present in the original application. Id. The
PTO eventually allowed the claims of the reissue application,
which issued as a reissue patent. Id.

Fish and Richardson had written in 2016:

Janssen’s suit against Celltrion in the District of Massachusetts (C.A. No. 1:15-cv-10698) relating to a biosimilar of Janssen’s Remicade® (infliximab) is one of the few currently pending BPCIA litigations. Over the last week, there have been two important developments with respect to Janssen’s infringement claims: (1) the invalidation of the asserted ’471 patent by the district court and (2) Celltrion’s motion for entry of final judgment to allow for a speedy appeal and final resolution of any infringement claims with respect to that patent.

See https://www.fr.com/fish-litigation/janssen-double-patenting/

**See also
Johnson & Johnson Loses Remicade Patent in Appeal Ruling


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