Tuesday, June 13, 2017

Purdue loses appeal of interference ruling in hydrocodone case

Purdue lost in the interference for lack of written description:

Purdue Pharma L.P. (“Purdue”), the senior party in
an interference proceeding, appeals from a judgment of
the Patent Trial and Appeal Board (“Board”) refusing
claims in Purdue’s Applications 13/833,263 (“’263 Application)
and 14/094,968 (’968 Application) (collectively, the
“Applications”). The Board granted junior party Recro
Technology, LLC’s (“Recro”) motion for judgment that
Purdue’s claims lack written description, concluding that
claims 1, 6, 9, 10, 12–15, 23–26, 32, 39, 41–46, and 53–55
of the ’968 Application and claims 63–67 and 70–71 of the
’263 Application (collectively, the “involved claims”) are
unpatentable for lack of written description support under
35 U.S.C. § 112. We affirm.

The issue

Having concluded that the involved claims are unpatentable,
the Board issued a judgment terminating the
interference. Purdue appeals the Board’s written description
decision with respect to Purdue’s involved claims.


The test for written description “is whether the disclosure
of the application relied upon reasonably conveys to
those skilled in the art that the inventor had possession of
the claimed subject matter as of the filing date.” Ariad,
598 F.3d at 1351. “Based on that inquiry, the specification
must describe an invention understandable to that
skilled artisan and show that the inventor actually invented
the invention claimed.” Id. “[W]hile the description
requirement does not demand any particular form of
disclosure, or that the specification recite the claimed
invention in haec verba, a description that merely renders
the invention obvious does not satisfy the requirement.”
Id. (citations omitted).
The issue here is whether the specifications adequately
disclose the claimed separate populations of IR and CR
multiparticulates, which each comprise inert beads coated
with hydrocodone, combined in a single dosage form.
Both parties submitted expert testimony to the Board on
this issue. The Board found that the claimed formulation
is not disclosed. We conclude that substantial evidence
supports the Board’s finding.


Although the written description generally discloses
that a single dosage form may include both IR and CR
hydrocodone components, it does not disclose a formulation
wherein the IR and CR components exist as separate
multiparticulates each containing an inert bead core.

There was an "incorporation by reference" issue:

Purdue finally urges that the claimed formulations
are supported by U.S. Patent No. 5,472,712, (“the ’712
Patent”), which was incorporated by reference into the
Purdue applications. The Board was “not persuaded that
the ’712 [P]atent sufficiently describes the specific dosage
forms Purdue claims. The descriptions do not recite the
actual elements of Purdue’s claims, most notably inert
beads coated with hydrocodone. Instead, the examples of
. . . [the] ’712 [P]atent describe formulations of [a] different
drug[]: . . . hydromorphone . . . .” J.A. 39 (emphasis
added). Recro’s expert, Dr. Palmieri, stated at deposition
that “the examples . . . in the [’712 Patent] are to a different
active pharmaceutical ingredient than the applications.”
J.A. 1329

Of this portion of Purdue's argument:

“[A] description that merely renders the
invention obvious does not satisfy the [written description]
requirement.” Ariad, 598 F.3d at 1352; see also
Novozymes A/S v. DuPont Nutrition Biosciences APS, 723
F.3d 1336, 1349 (Fed. Cir. 2013) (explaining that the
written description analysis requires “[t]aking each claim
. . . as an integrated whole rather than as a collection of
independent limitations”). Substantial evidence supports
the Board’s findings in this regard.


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