Novartis Pharmaceuticals Corporation et al v. Breckenridge Pharmaceutical Inc.

Filing 69

MARKMAN ORDER (see Order for further details). Signed by Judge Richard G. Andrews on 10/6/2015. Associated Cases: 1:14-cv-01043-RGA, 1:14-cv-01196-RGA, 1:14-cv-01289-RGA(nms)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
NOVARTIS PHARMACEUTICALS
CORPORATION and NOVARTIS AG,
Plaintiffs,

v.

Civil Action No. 14-1043-RGA

BRECKENRIDGE PHARMACEUTICAL,
INC.,
Defendant.

NOVARTIS PHARMACEUTICALS
CORPORATION and NOVARTIS AG,
Plaintiffs,
Civil Action No. 14-1196-RGA

v.
ROXANE LABO RA TORIES INC.,
Defendant.

NOVARTIS PHARMACEUTICALS
CORPORATION and NOV ARTIS AG,
Plaintiffs,

v.

Civil Action No. 14-1289-RGA

PAR PHARMACEUTICAL INC.,
Defendant.

MARKMAN ORDER

Pending before the Court is the Joint Claim Construction Brief. There is one disputed
term and two agreed-upon terms. The Court adopts the two agreed-upon terms. The disputed
term is "synergistically effective amounts." I do not think oral argument is necessary, as the
Brief fully and clearly sets forth the parties' respective positions.
I am going to adopt Plaintiffs' proposed construction. I think the inventors acted as their
own lexicographer. E.g., '518 patent, col. 5, lines 34-45. The phrase "synergistically effective
amounts" is set off in quotation marks, and the inventors state that the phrase "is meant" to mean
one thing, and also "may mean" another thing. I think this makes it clear that the inventors
meant to limit the disputed phrase to the two described things.
The key root word in this dispute is "synergistic." The parties agree that a POSITA
would understand that the plain and ordinary meaning of synergistic is "more than additive."
The only reason to set forth what appears to be definitional material would be to distinguish its
use in the patent from that plain and ordinary meaning.
The more limited lexicographic definition of the disputed phrase is consistent with the
rest of the specification. For example, the specification sets forth the "surprising[] discover[y]"
"that effective immunosuppression is seen upon co-administration at dosages which would be
well below the effective dosages individually." Id, col. 2, lines 38-44.
I do not interpret "at or below effective dose" in the proposed construction to be the same
as "at or below the minimum effective dose." Thus, I do not think that Plaintiffs have added an
unwarranted additional limitation. (See Jt. Cl. Constr. Br., pp. 21-22).

I also do not think the Butamax case 1 helps defendants. Butamax is really about
interpreting what was meant by the definition, not whether there was a definition in the first
place. Here the question is, is there a definition? If there is, and I think there is, there is no
question that it is more limited than the plain and ordinary meaning of the disputed phrase.
Thus, I construe "synergistically effective amounts" as meaning, "amounts which are
individually equal to or below their respective effective dosages for the relevant indication and
which together have a more than additive effect."
IT IS SO ORDERED this

1

4-

day of October 2015.

Butamax Advanced Biofuels LLC v. Gevo, Inc., 746 F.3d 1302 (Fed. Cir. 2014), vacated
on other grounds, 135 S.Ct. 1173(2015).