Friday, August 04, 2006

Ranbaxy beats Pfizer over 112 P 4 issue in Lipitor case

from Pfizer v. Ranbaxy, 2006 U.S. App. LEXIS 19416:

The district court explicitly recognized that "there may be a
technical problem in the drafting of claim 6." Pfizer, 405 F. Supp. 2d at 508.
Yet, it declined to find that "this drafting problem is sufficient to render
the claim invalid if the claim is read consistently with its meaning [*17] to
those skilled in the art" because it was unable to find any Federal Circuit
precedent applying § 112, P4 to invalidate a patent. Id. at 508-09. The district
court understood § 112, P4 "to be limited to matters of form, rather than
matters of substance," noting that the PTO treats a claim that fails to comply
with this provision "as a matter to be addressed through an objection" rather
than rejected as unpatentable. Id. at 509. In any event, it emphasized that
no objections were made to claim 6, (or any of the other similarly-worded
dependent claims), during prosecution. Id. at 509 n.7.

It is true that at the time the district court wrote its opinion,
there was no applicable Federal Circuit precedent. More recently, however, we
have suggested that a violation of § 112, P4 renders a patent invalid just
as violations of other paragraphs of § 112 would.
Curtiss-Wright Flow
Control Corp., 438 F.3d 1374, 1380 (Fed. Cir. 2006). In Curtiss-Wright, the
issue was one of claim differentiation. The court reasoned that "reading an
additional limitation from a dependent claim into an independent claim would not
only [*18] make that additional limitation superfluous, it might render the
dependent claim invalid" for failing to add a limitation to those recited in the
independent claim, as required by 35 U.S.C. § 112, P4. Id. Indeed, "[i]nvalidity of
the patent or any claim in suit for failure to comply with any requirement
of sections 112 or 251 of this title" is expressly included among the
available defenses to an infringement suit. 35 U.S.C. § 282(3) (emphasis added).
[IPBiz note: The name Curtiss-Wright does come from Glenn Curtiss and the Wright Brothers. Ironically, the companies combined, after Wilbur was dead and Orville sold his interests. But the name lives on.]

We recognize that the patentee [Pfizer] was attempting to claim what might
otherwise have been patentable subject matter.
n7 Indeed, claim 6 could have been
properly drafted either as dependent from claim 1 or as an independent
claim--i.e., "the hemicalcium salt of atorvastatin acid." But, we "should not rewrite
claims to preserve validity." Nazomi Commc'ns, Inc. v. Arm Holdings, PLC, 403
F.3d 1364, 1368 (Fed. Cir. 2005); see also Rhine v. Casio, Inc., 183 F.3d 1342,
1345 (Fed. Cir. 1999)

The case does make a comment about the patent claim drafting skills at large pharma companies.


Blogger finalverdict2 said...

I am not a lawyer, but am looking for a straight as possible answer from an investment perspective. From reading the appeals verdict, it would seem that Pfizer has a good clear path to a re-issue by the PTO that will block Ranbaxy through June 2011 and withstand court scrutiny. Agree?

9:57 PM  

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