Monday, February 01, 2016

Purdue Pharma loses oxycontin appeal at the CAFC

The CAFC affirmed SDNY in the oxycontin case:

For the foregoing reasons, we affirm the district
court’s invalidity determinations as to the low-ABUK
patents and the ’383 patent and the district court’s dis-
missal of the Epic, Mylan, and Amneal actions.

The appellant Purdue Pharma was represented by:

GREGORY A. CASTANIAS, Jones Day, Washington, DC,
argued for all plaintiffs-appellants. Plaintiffs-appellants
Purdue Pharma L.P., The P.F. Laboratories, Inc., Purdue
Pharmaceuticals L.P., Rhodes Technologies also represented
& Gray LLP, East Palo Alto, CA; SONA DE, CHRISTOPHER
J. HARNETT, New York, NY.

The general background:

Oxycodone hydrochloride—the active pharmaceutical
ingredient (“API”) in OxyContin®—is an opioid analgesic
used to treat moderate to severe pain. This consolidated
appeal concerns four patents associated with the reformulated
version of OxyContin®: U.S. Patent No. 7,674,799
(“’799 patent”), U.S. Patent No. 7,674,800 (“’800 patent”),
U.S. Patent No. 7,683,072 (“’072 patent”) (collectively,
“the low-ABUK patents”), and U.S. Patent No. 8,114,383
patent (“’383 patent”).

As to the legal issue of anticipation:

A patent is invalid for anticipation under 35 U.S.C.
§ 102 if a single prior art reference discloses each and
every limitation of the claimed invention. Schering Corp.
v. Geneva Pharm., 339 F.3d 1373, 1377 (Fed. Cir. 2003).
A single prior art reference may anticipate without disclosing
a feature of the claimed invention if such feature
is necessarily present, or inherent, in that reference. Id.
Anticipation is a question of fact, which we review for
clear error. Atlas Powder Co. v. Ireco, Inc., 190 F.3d 1342,
1346 (Fed. Cir. 1999).

As to Purdue's Eibel Process argument:

Purdue’s reliance on Eibel Process is misplaced. Even
if determining the source of 14-hydroxy in the end product
was not obvious, that problem did not need to be solved to
arrive at the claimed invention; thus, Eibel Process does
not apply. As discussed above, the claimed invention in
Eibel Process was a machine that remedied the problem of
wrinkled paper at high-speed printing. But, here, Purdue
did not claim the remedy of the problem of remaining 14-
hydroxy in the oxycodone API—performing a second
hydrogenation step. Instead, it claimed the end product—
an oxycodone API with low ABUK levels. And, as the
district court found, identification of the source of the
remaining 14-hydroxy as being 8α had no effect on the
structure or nature of the low-ABUK oxycodone product.
Because “[o]ne molecule of 14-hydroxy is the same as the
next, whether derived from 8α or 8β,” knowledge of 8α
“did not make hydrogenation more or less effective as a
technique for converting 14-hydroxy to oxycodone.”
District Court Decision, 994 F. Supp. 2d at 405.

The "derived from" argument:

Purdue next argues that, because the asserted claims
require that the remaining 14-hydroxy in the oxycodone
API is derived from 8α and because 8α was not previously
known in the art as being the source of 14-hydroxy, the
claims must be nonobvious. Indeed, Purdue points out
that the reason it added that limitation was because of
our decision in Chapman where we said the claims were
obvious because the claims did not differentiate between
the 8α and 8β. 315 F. App’x at 297. The district court
rejected that argument because it found that the “derived
from 8α[]” limitation was a process limitation and thus
immaterial to the obviousness analysis.
We also conclude that, because “derived from 8α[]” is a
process limitation, the district court did not err in disregarding
the limitation in its obviousness analysis. We
have clearly stated that “‘[i]n determining validity of a
product-by-process claim, the focus is on the product and
not the process of making it.’” Greenliant Sys., Inc. v.
Xicor LLC, 692 F.3d 1261, 1268 (Fed. Cir. 2012) (quoting
Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340,
1369 (Fed. Cir. 2009)). “That is because of the . . . longstanding
rule that an old product is not patentable even if
it is made by a new process.” Id.; see also SmithKline
Beecham Corp. v. Apotex Corp., 439 F.3d 1312, 1317 (Fed.
Cir. 2006) (“It has long been established that one cannot
avoid anticipation by an earlier product disclosure by
claiming . . . the product as produced by a particular
process.”); In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985)
(“If the product in a product-by-process claim is the same
as or obvious from a product of the prior art, the claim is
unpatentable even though the prior product was made by
a different process.”).


Purdue looks to the exception we carved out in
Amgen: “if the process by which a product is made imparts
‘structural and functional differences’ distinguishing
the claimed product from the prior art, then those differences
‘are relevant as evidence of no anticipation’ although
they ‘are not explicitly part of the claim.’”
Greenliant, 692 F.3d at 1268 (quoting Amgen, 580 F.3d at
1340). As previously discussed, however, the fact that the
14-hydroxy is derived from 8α imparts no structural or
functional differences in the low-ABUK hydrocodone API
as compared to the prior art products.

As to secondary considerations:

Finally, Purdue contends that the court erroneously
discounted the secondary considerations which it argues
demonstrate nonobviousness. Purdue first points to
Rhodes’s commercial success; it says that Rhodes became
Purdue’s oxycodone API supplier by marketing the lowABUK
features of its product to Purdue, which resulted in
almost $71 million in sales in 2010. As the district court
found, however, Rhodes was not successful at marketing
its low-ABUK oxycodone API to any significant customer
other than Purdue, which is its corporate affiliate. The
district court further found that Purdue invested in
Rhodes not because of the low-ABUK features, but because
it could get oxycodone API at a lower cost from its
subsidiary than it could from an unaffiliated manufacturer
during times of high demand. Purdue does not persuasively
rebut these findings on appeal. Thus, the district
court did not clearly err in concluding that there was no
nexus between the low-ABUK product of the patents and
the commercial success of Purdue or Rhodes.

As to praise from competitors:

Finally, Purdue points to the fact that Noramco credited
Purdue and Rhodes with the discovery of 8α and
contends that such recognition shows praise from competitors.
But recognition that Rhodes discovered that 8α is a
byproduct of thebaine oxidation does not equal praise for
the invention—the low-ABUK oxycodone API. Purdue
also argues that industry praise is shown because
Noramco copied its process for creating low-ABUK oxycodone,
but provides no support whatsoever for that argument.
Finally, Purdue contends that the court wholly
ignored evidence showing that Purdue and Rhodes were
surprised over their discovery and solution. But, again,
there was no surprise as to the patented product. Even if
it was unexpected that thebaine oxidation would create
8α, it was not surprising that, after the FDA mandate,
manufacturers would create a low-ABUK oxycodone API
or that they would do so using the known technique of

Of Arkley and anticipation:

Finally, Grunenthal argues that the district court
erred by using distinct sections of McGinity and reassembling
them into an embodiment to find that all of the
limitations were present. See Application of Arkley, 455
F.2d 586, 587 (C.C.P.A. 1972) (noting that an anticipating
reference “must clearly and unequivocally disclose the
claimed compound or direct those skilled in the art to the
compound without any need for picking, choosing, and
combining various disclosures not directly related to each
other by the teachings of the cited reference”). For example,
Grunenthal points out that the court selected only
“analgesics” from the long list of pharmaceutical categories
that could be used as the active ingredient, and then
further picked oxycodone, which was not even disclosed,
to find anticipation. Moreover, Grunenthal notes that
McGinity teaches that the amount of PEO will vary
depending on various factors and does not consistently
disclose formulations with at least sixty weight percent
PEO, as required by the claims. Thus, Grunenthal argues
that the court impermissibly chose only those examples
that included the claimed amount of PEO to find anticipation.

These arguments are without merit. The disclosures
pointed to by the district court are all “directly related”
and thus there is no impermissible picking and choosing.
Arkley, 455 F.2d at 587.
In that single disclosure, McGinity describes
the controlled-release formulation and the use of over
sixty weight percent PEO. It does not specifically say
what therapeutic compound is used, but it provides a list
of the types of therapeutic compounds contemplated.
That list of compounds, although in a distinct section of
the reference, is directly related to the disclosure reproduced
above. Thus, the district court did not impermissibly
combine distinct disclosures in McGinity to arrive at
the claimed invention.
We conclude that the district court did not clearly err
in finding that the McGinity reference discloses each and
every limitation in the asserted claims of the ’383 patent.
We thus affirm the district court’s anticipation determination
and do not reach the question of obviousness.

In some sense, this finding of anticipation is one of a genus anticipating
a species [the prior art does not specifically say
what therapeutic compound is used ]

The CAFC noted the law in Osram:

We disagree. While it is true that an earlier disclosed
genus may, in certain circumstances, anticipate a later
species, this inquiry necessarily includes a factual component.
See, e.g., Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d
1075, 1083 (Fed. Cir. 2008) (“[W]hether a generic disclosure
necessarily anticipates everything within the genus .
. . depends on the factual aspects of the specific disclosure
and the particular products at issue.”); Atofina, 441 F.3d
at 999; In re Baird, 16 F.3d 380, 382 (Fed. Cir. 1994). For
example, in Atofina we analyzed a patent claiming a
method of synthesizing difluoromethane at a temperature
between 330-450 degrees Celsius. Atofina, 441 F.3d at
993. The prior art, in contrast, disclosed a broad temperature
range of 100-500 degrees Celsius. Id. at 999. In
Atofina, we reversed the district court’s finding of anticipation
following a bench trial and we explained that our
holding was premised on the “considerable difference
between the claimed [temperature] range and the range
in the prior art.” Id. Our decision in Atofina clarified
that the prior art’s teaching of a broad genus does not
necessarily disclose every species within that genus. Id.
Under the circumstances presented in Atofina, “no reasonable
fact finder could conclude that the prior art
describes the claimed range with sufficient specificity to
anticipate this limitation of the claim.” Id.


Note: high molecular
weight polyethylene oxide (“PEO”)



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