Tuesday, July 21, 2015

CAFC interprets BPCIA in Amgen v. Sandoz related to filgrastim

In 2010, as part of the Patient Protection and Afford-
able Care Act (aka "Obamacare"), Congress enacted the Biologics Price
Competition and Innovation Act [BPCIA].

Here, the plaintiff Amgen has marketed filgrastim under the brand
name Neupogen ® (“Neupogen”) since 1991. Sandoz wanted to market a
filgrastim product.

Sandoz filed an aBLA,
seeking FDA approval of a biosimi-
lar filgrastim product, for which Neupogen is the refer-
ence product. On July 7, 2014,
Sandoz received notification from the FDA that
it had accepted Sandoz’s application for review. Sandoz
intended to launch its filgrastim product
under the trade name Zarxio.

There was a Clinton-esque discussion of whether statutory language
"should" meant "must." The CAFC, by a 2-1 vote, decided it did not.

As to statutory construction:

Importantly, mandating compliance with paragraph (l)(2)(A)
in all circumstances would render paragraph (l)(9)(C) and 35 U.S.C. §
271(e)(2)(C)(ii) superfluous, and
statutes are to be interpreted if possible to avoid render-
ing any provision superfluous.
Marx v. Gen. Revenue Corp.,568 U.S. __,
133 S. Ct. 1166, 1178 (2013)(“[T]he
canon against surplusage is strongest when an interpre-
tation would render superfluous
another part of the same
statutory scheme. ”); TRW Inc. v. Andrews, 534 U.S. 19, 31
(2001) (“It is a cardinal principle of statutory construction
that a statute ought, upon the whole, to be so construed
that, if it can be prevented, no clause, sentence, or word
shall be superfluous, void, or insignificant.
” (internal quotation marks omitted))

Bottom line. Sandoz wins on this point.

Because Sandoz took a path expressly
contemplated by the BPCIA, it did
not violate the BPCIA by not disclosing its aBLA and the
manufacturing infor-
mation by the statutory deadline

Judge Newman dissented on the "should" issue:

notice of acceptance of the
filing of the sub-
section (k) application is also mandatory, along with the
accompanying documentary and
information exchanges
set in the BPCIA
in accordance with 42 U.S.C. §262(l)(2)(A).I
respectfully dissent from the court’s
holding that this activity is not required
because the Sponsor might file an infringement suit
in which it might learn this information
though discovery.
Sandoz did not comply with either of these statutory
requirements. These deliberate violations
of the require-
ments of the BPCIA forfeit Sandoz’
access to the benefits
of the BPCIA.

link: http://www.cafc.uscourts.gov/images/stories/opinions-orders/15-1499.Opinion.7-17-2015.1.PDF


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