CAFC affirms DNJ in Combigan® case; Sandoz loses

The case is of interest because of the concurring opinion of CJ Prost:


Therefore, I would affirm the district court’s decision
for the reasons stated in the majority’s opinion, except that
I would start by explaining why the plain language of the
claim compels us to reject Sandoz’s position that the
“wherein” clauses here are mere statements of inherent or
intended results.



The issue in the case was whether or not two "wherein" clauses
expressed meaningful claim limitations. The majority opinion (by J. Wallach)
noted:



The District Court found the disputed “wherein”
clauses to constitute claim limitations. Allergan Sales,
2018 WL 3675235, at *7. Specifically, the District Court
“f[ound] that the ‘wherein’ clauses are limiting because
they are material to patentability and express the inventive
aspect of the claimed invention,” viz.,
“Combigan®’s ability to reduce daily administrations from
TID to BID without a loss of efficacy, and with reduced adverse events.”
Id. at *5–6. On appeal, Sandoz disputes the
District Court’s construction, arguing, inter alia, that:
(1) the “wherein” clauses “merely state the intended results
of administering Combigan[®] twice daily,” Appellant’s
Br. 36; see id. at 36–49; and (2) the recited results are not
“material to patentability,” id. at 50; see id. at 50–62. We
disagree with Sandoz.

(...)

Sandoz contends that these clauses
“merely state . . . intended results,” Appellant’s Br. 36, because they
reflect the results of administering the Example I formulation, viz., Combigan®,
as witnessed during
the Example II clinical study, see, e.g., id. at 36 (“The asserted method claims
have one and only one step: administration of the claimed composition. Everything else is
literally the results observed during clinical trials of
Combigan[®].”); see also Minton v. Nat’l Ass’n of Sec.
Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003) (“A
whereby [or wherein] clause in a method claim is not given
weight when it simply expresses the intended result of a
process step positively recited.”); Bristol–Myers Squibb Co.
v. Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir.
2001) (explaining that claim language that “is only a statement of purpose and intended result” and that “does not
result in a manipulative difference in the steps of [a] claim”
is generally not limiting). We disagree. While we recognize
some overlap between the language of the “wherein”
clauses and those results, we must read the claims in view
of the “entire specification.” Sinorgchem Co., Shandong v.
Int’l Trade Comm’n, 511 F.3d 1132, 1145 (Fed. Cir. 2007)
(emphasis added); see Trs. of Columbia Univ. v. Symantec
Corp., 811 F.3d 1359, 1363 (Fed. Cir. 2016) (“[T]he specification is always highly relevant to the claim construction
analysis and is, in fact, the single best guide to the meaning
of a disputed term.” (internal quotation marks and citation
omitted)).



The majority noted that the "wherein" clauses were material in
securing allowance, and cited Southwall:


Consistent with this understanding, Allergan relied on
the efficacy and safety of the claimed methods during prosecution of the Patents-in-Suit
in responding to the examiner’s rejections. See Southwall Techs., Inc. v. Cardinal IG
Co., 54 F.3d 1570, 1579 (Fed. Cir. 1995) (“[A]rguments
made during prosecution regarding the meaning of a claim
term are relevant to the interpretation of that term in
every claim of the patent absent a clear indication to the
contrary.”).



The only mention of "inherent" in the majority opinion appears in discussion of
the prosecution history


[Allergan] disagreeing with the Examiner “that
the reduction in side effects is inherently present in the
prior art combination”



The end of the concurring opinion states:


I offer one final point about the importance of the plain
language of the claim here. Sandoz’s arguments raise general concerns about the role of claim language in claim construction.
Sandoz attempts to label over half the claim language
in claim 1 as a mere “intended result.” By doing so, Sandoz
invites us to start from a place of uncertainty about
whether most of the text in the body of the claim is limiting.
Accepting that invitation threatens the broader notice
function of the patent claim. “It is a ‘bedrock principle’ of
patent law that ‘the claims of a patent define the invention
to which the patentee is entitled the right to exclude.’”
Phillips, 415 F.3d at 1312 (quoting Innova/Pure Water,
Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111,
1115 (Fed. Cir. 2004)). Indeed, “[b]oth the Supreme Court
and this court have adhered to the fundamental principle
that claims define the scope of patent protection . . . . The
claims thus give notice of the scope of patent protection.”
Johnson & Johnston Assocs. v. R.E. Serv. Co., 285 F.3d
1046, 1052 (Fed. Cir. 2002) (en banc).
As it is, claim construction can be difficult. For instance, litigants often encounter uncertainty over whether
a claim’s preamble is limiting or not. I see no reason to
inject further uncertainty into the notice provided by the
body of a claim. Given the specificity, clarity, and material
limits the “wherein” clauses add to the scope of claim 1 on
their face, Sandoz’s position deserves rigorous scrutiny
from the start. We should not begin with the presumption
that text in the body of the claim may be meaningless and
can only be saved by clear statements in the specification
or prosecution history.
Therefore, I would affirm the district court’s decision
for the reasons stated in the majority’s opinion, except that
I would start by explaining why the plain language of the
claim compels us to reject Sandoz’s position that the
“wherein” clauses here are mere statements of inherent or
intended results.




One notes that "intended results" and "inherent results" are two different things.