Challenges to Allergan patents fail at the CAFC

The bottom line :


For the reasons that follow, we affirm in all respects.



The background of this Hatch-Waxman case:


After Allergan received FDA-approval of Lumigan 0.01%, Sandoz, Lupin,
Hi-Tech, and Watson each submitted an Abbreviated New
Drug Application (“ANDA”) to the FDA, seeking approval
to engage in the commercial manufacture, use, importation,
sale, or offer for sale of generic versions of Lumigan
0.01% prior to the expiration of the ’504, ’353, ’118, ’605,
and ’479 patents. In response, Allergan sued each of the
ANDA applicants in the United States District Court for
the Eastern District of Texas, asserting that their ANDA
filings infringed those patents. The district court consolidated
those actions into one case.



The district court had found the disputed claims not obvious:


The district court reasoned that “Allergan
has met its burden of producing rebuttal evidence, i.e.,
‘that (1) the prior art taught away from the claimed
invention; (2) there were new and unexpected results
relative to the prior art; or (3) there are other pertinent
secondary considerations.’” Opinion at 75 (quoting Galderma,
737 F.3d at 738). The court again emphasized
that the prior art taught away from 200 ppm BAK, noting
that the defendants’ own expert, Dr. Samples, had serious
concerns about BAK and strongly warned against its use.
Id. at 75–76. The court also emphasized that the unexpected
results were “of a different kind, not just of different
degree.” Id. at 76 (emphases in original).



Of the legal burdens:


Following a bench trial, we review a district court’s
conclusions of law de novo and its findings of fact for clear
error. Golden Blount, Inc. v. Robert H. Peterson Co., 365
F.3d 1054, 1058 (Fed. Cir. 2004). A factual finding is
clearly erroneous if, despite some supporting evidence, we
are left with a definite and firm conviction that a mistake
has been made. United States v. U.S. Gypsum Co., 333
U.S. 364, 395 (1948); Alza Corp. v. Mylan Labs., Inc., 464
F.3d 1286, 1289 (Fed. Cir. 2006).
Furthermore, patents are presumed to be valid and
overcoming that presumption requires clear and convincing
evidence. 35 U.S.C. § 282; Microsoft Corp. v. i4i Ltd.
P’ship, 564 U.S. __, 131 S. Ct. 2238, 2242 (2011).



The Galderma case is discussed:


We agree with Allergan that the district court did not
err in concluding that the asserted claims would not have
been obvious. That conclusion is supported by underlying
factual findings, which are not clearly erroneous on this
record. In particular, the district court did not clearly err
in finding that the prior art taught away from a formulation
comprising 0.01% bimatoprost and 200 ppm BAK,
and that such a formulation exhibited unexpected results.
It is undisputed that the asserted claims all require a
formulation comprising 0.01% bimatoprost and 200 ppm
BAK. Although the prior art does not teach that particular
combination of amounts of bimatoprost and BAK,
those amounts do fall within the ranges disclosed in a
single reference: Woodward discloses a composition comprising
0.001%–1% bimatoprost and 0–1000 ppm of a
preservative, including BAK. Those disclosed ranges also
encompass Lumigan 0.03%, a prior art commercial embodiment,
which contains 0.03% bimatoprost and 50 ppm
BAK.
As we explained in Galderma, where there is a range
disclosed in the prior art, and the claimed invention falls
within that range, a relevant inquiry is whether there
would have been a motivation to select the claimed composition
from the prior art ranges. Galderma, 737 F.3d at
737–38 (prior art disclosing 0.01%–1% adapalene encompassing
the claimed composition comprising 0.3% adapalene).
In those circumstances, “the burden of production
falls upon the patentee to come forward with evidence
that (1) the prior art taught away from the claimed invention;
(2) there were new and unexpected results relative to
the prior art; or (3) there are other pertinent secondary
considerations.” Id. at 738.




The CAFC by-passed an issue in the case:


Here in this case, the prior art ranges are broader
than the range in Galderma, and the record shows that
the claimed amounts of the two different ingredients
could and did materially and unpredictably alter the
property of the claimed formulation. Thus, Galderma
does not compel a conclusion of obviousness in this case.
It may also be true here that “the disclosed range[s are] so
broad as to encompass a very large number of possible
distinct compositions,” In re Peterson, 315 F.3d 1325, 1330
n.1 (Fed. Cir. 2003), such that they do not teach any
specific amounts or combinations and that the burden of
producing evidence of teaching away, unexpected results,
and other pertinent secondary considerations did not shift
to Allergan. But we need not decide that issue, as it
would not affect our affirmance of the district court’s
conclusion of nonobviousness, because, as indicated infra,
we conclude that the district court did not clearly err in
finding that Allergan had produced ample evidence of
teaching away and unexpected results, and that such
evidence fully supports a conclusion of nonobviousness.




Of teaching away:


“Whether the prior art teaches away from the claimed
invention is a question of fact.” Spectralytics, Inc. v.
Cordis Corp., 649 F.3d 1336, 1343 (Fed. Cir. 2011). “A
reference may be said to teach away when a person of
ordinary skill, upon reading the reference, would be
discouraged from following the path set out in the reference,
or would be led in a direction divergent from the
path that was taken by the applicant.” In re Gurley, 27
F.3d 551, 553 (Fed. Cir. 1994).
The district court did not clearly err in finding that
the prior art taught away from using 200 ppm BAK in a
bimatoprost formulation. (...)

The record thus shows that the prior art “criticize[d],
discredit[ed], or otherwise discourage[d]” the use of
200 ppm BAK in a bimatoprost formulation. In re
Mouttet, 686 F.3d 1322, 1334 (Fed. Cir. 2012) (quoting In
re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004)). We
therefore need not address the Appellants’ additional
argument that the district court erred in finding that
Laibovitz and Lyons taught away from 0.01% bimatoprost.
The Appellants do not argue, and there is no
evidence to suggest, that Laibovitz and Lyons favored
using 200 ppm BAK in a bimatoprost formulation. Accordingly,
we conclude that the district court did not
clearly err in finding that the prior art taught away from
the claimed formulation.



Of unexpected results to show nonobviousness:


We also conclude that the district court did not clearly
err in finding that the claimed formulation exhibited
“unexpected results,” which differed in kind, not just in
degree, from the prior art. Opinion at 57–58, 76. As
indicated, the prior art taught that 200 ppm BAK would
either have no impact on the permeability of bimatoprost
or decrease it. Allergan’s inventors surprisingly determined
that the opposite was true, namely, that 200 ppm
BAK enhanced the permeability of bimatoprost. That is
an unexpected difference in kind that supports nonobviousness.
In re Applied Materials, Inc., 692 F.3d 1289,
1298 (Fed. Cir. 2012)



There is some text which illustrates that anticipation is not
the epitome of obviousness:



Finally, we reject the Appellants’ argument that the
unexpected results do not support nonobviousness because
they are merely the inherent properties of an otherwise
obvious formulation. As indicated, the prior art
did not disclose, either explicitly or implicitly, the claimed
formulation; rather, it taught away from such a formulation.
A person of ordinary skill in the art thus would not
have had a reason to select the claimed formulation from
the prior art ranges or to modify Lumigan 0.03% to arrive
at the claimed formulation. The unexpected properties of
the claimed formulation, even if inherent in that formulation,
differ in kind from the prior art, thereby supporting
a conclusion of nonobviousness. See W.L. Gore & Assocs.,
Inc. v. Garlock, Inc., 721 F.2d 1540, 1555 (Fed. Cir. 1983)
(“Inherency and obviousness are distinct concepts.”); In re
Spormann, 363 F.2d 444, 448 (CCPA 1966) (“That which
may be inherent is not necessarily known. Obviousness
cannot be predicated on what is unknown.”).


In contrast to inherent anticipation, which can be predicated
on that which is unknown, obviousness cannot be predicated on what is unknown.

Something can be anticipated, and not obvious.

The CAFC observed:


Here, the previously unknown and unexpected
properties of a new and nonobvious formulation constitute
additional, objective evidence of nonobviousness.



Relevant to certain arguments once made by law professors:


“[T]his statutory language
mandates satisfaction of two separate and independent
requirements: an applicant must both describe the
claimed invention adequately and enable its production
and use.” Alcon Research Ltd. v. Barr Labs., Inc., 745
F.3d 1180, 1188 (Fed. Cir. 2014) (citing Ariad Pharm.,
Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1344 (Fed. Cir.
2010) (en banc); Vas-Cath Inc. v. Mahurkar, 935 F.2d
1555, 1562–63 (Fed. Cir. 1991)).



Of relevance to "written description" inquiries:


We do find, however, that the district court erred by
relying on the undisclosed clinical protocol to support its
written description determination. As we have explained,
“[i]t is the disclosures of the applications that count.”
Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1571 (Fed.
Cir. 1997). The clinical protocol is not part of the specifications
of the asserted patents. It should not form the
basis of the written description inquiry, even if it shows
that the inventors had invented the claimed invention
before the time of filing. The written description requirement
requires possession as shown in the specification,
not as shown by prior experimental work.
Nevertheless, as indicated, because the specifications
contain an adequate disclosure of the claimed formulation,
the district court’s erroneous reliance on the clinical
protocol does not affect the outcome of this case.



The tension between enablement and obviousness arises:


Lupin argues that if the claims are held to be nonobvious, then
they must fail the enablement requirement because the
district court found that ophthalmic formulation is unpredictable
and that the prior art taught away from the
claimed invention.

Allergan responds that there is no inconsistency in
the district court’s decision that the asserted claims would
not have been obvious and that they are also enabled.
Allergan argues that the specifications disclose the exact
formulation of Lumigan 0.01% and the permeability data
of test formulations, which would enable the skilled
artisan to make and use the claimed invention. (...)

We agree with Allergan that the asserted claims are
not invalid for lack of enablement. “[A] patent does not
need to guarantee that the invention works for a claim to
be enabled.” Alcon, 745 F.3d at 1189. And efficacy data
are generally not required in a patent application. Only a
sufficient description enabling a person of ordinary skill
in the art to carry out an invention is needed. “Similarly,
a patentee is not required to provide actual working
examples; we have rejected enablement challenges based
on the theory that there can be no guarantee that prophetic
examples actually work.” Id. at 1189–90.

(...)

Lupin argues that “if the asserted claims are nonobvious,
they cannot possibly be enabled.” Lupin’s Opening
Br. 28. We disagree. The obviousness inquiry turns
on what the prior art would have taught a person of
ordinary skill in the art and whether the claimed inven-
tion would have been obvious in view of the prior art. As
indicated, the claims here would not have been obvious
because, among other reasons, the prior art taught that
BAK would not increase the permeability of bimatoprost.
In contrast, the enablement inquiry turns on whether the
skilled artisan, after reading the specification, would be
able to make and use the claimed invention without
undue experimentation, based on the ordinary skill in the
art. Because the specifications here provide sufficient
guidance to the skilled artisan, there is no tension in the
district court’s decision that the asserted claims would not
have been obvious and also are not invalid for lack of
enablement.



The text "decimal place" arises:



It is undisputed that Hi-Tech’s ANDA specifies that
its proposed product has a pH of 6.8–7.2 during the product’s
shelf life. The district court thus correctly evaluated
infringement based on the proposed product. Sunovion
Pharm., Inc. v. Teva Pharm. USA, Inc., 731 F.3d 1271,
1278–80 (Fed. Cir. 2013). After considering the expert
testimony proffered by both sides, the district court found
that Hi-Tech’s product would infringe the Group I claims
literally. We find no clear err in that determination.
Moreover, if “about 7.3” is to mean anything other than
7.3, it is not clearly erroneous for it to include a value that
differs from it by only one decimal place. Because we
affirm the district court’s finding of literal infringement,
we do not need to address whether the district court erred
in finding infringement under the doctrine of equivalents.



The bottom line: Accordingly, we affirm the district court’s determination
that the asserted claims are not invalid for obviousness
or for lack of an adequate written description and
enablement, and that Hi-Tech infringed the claims of the
’504, ’605, and ’479 patents.

link: http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/14-1275.Opinion.7-31-2015.1.PDF