Review and Analysis of Pfizer, Inc. v. Ranbaxy Laboratories Limited, F.3d 1284; 2006
U.S. App. LEXIS 19416; 79 USPQ2d 1583 (Fed. Cir. August 2, 2006)
by Richard Neifeld, Neifeld IP Law, PC, Alexandria VA1
In Pfizer, Inc. v. Ranbaxy Laboratories Limited, F.3d 1284; 2006 U.S. App. LEXIS
19416; 79 USPQ2d 1583 (Fed. Cir. August 2, 2006), the CAFC held patent claim 6 invalid underthe fourth paragraph of 35 USC 112 for failing to further limit the claim from which it depends.
[R-(R*,R*)]-2-(4-fluorophenyl)-[beta],[delta]-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)-carbonyl]-1H-pyrrole-1-heptanoic acid n4 or(2R-trans)-5-(4-fluorophenyl)-2-(1-methylethyl)-N,4-diphenyl-1-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1H-pyrrole-3-carboxamide; n5 or pharmaceutically acceptable saltsthereof."
Claim 2 reads as follows: "2. A compound of claim 1 which is
Claim 6 reads as follows: "6. The hemicalcium salt of the compound of claim 2."
The important points are that claim 2 is limited to an acid compound, and that claim 6
attempts to define the salt of the acid compound of claim 2 by refering to claim 2. The Courtfound claim 6 invalid because it interpreted claim 6's reference to claim 2 to require claim 6 toinclude all limitations of claim 2, and therefore to define an acid. However, claim 6's recitation"hemicalcium salt" does not define (and in fact is inconsistent with) an acid.
An excerpt of the opinion showing the Court's legal reasoning follows:
We recognize that the patentee was attempting to claim what might
otherwise have been patentable subject matter.[note 7 omitted] Indeed, claim 6could have been properly drafted either as dependent from claim 1 or as anindependent 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) ("[I]f the only claim construction thatis consistent with the claim's language and the written description renders theclaim invalid, then . . . the claim is simply invalid."). Ranbaxy correctly arguesthat claim 6 fails to "specify a further limitation of the subject matter" of the claimto which it refers because it is completely outside the scope of claim 2. We musttherefore reverse the district court with respect to this issue and hold claim 6invalid for failure to comply with § 112, ¶ 4.
The opinion also notes in footnote 3 that both parties stipulated that claim 6 was in fact a
dependent claim. However, the stipulation was not a factor in the court relied upon it in its legalreasoning.
What this means in practical terms (unless this holding is overruled, and barring unusual
facts) is that any claim in the form: "A first 'thing' of the second 'thing' of claim X" has a goodchance of being invalid if the first 'thing' is not a species of the second 'thing.' In particular,claims like "2. A salt of the acid of claim 1" are likely invalid. The 'may' caveat exists for tworeasons. As the opinion states, the parties stipulated that claim 6 was a dependent claim. Otherwise, it might have been construed as an incorporation claim. I find this possibilityunlikely in view of the Court's reasoning. Second, a specification thoeretically could expresslydefine "acid" to also include within its meaning "salt" since a patentee can be his ownlexicographer. I doubt many issued patents having this type of claim contain such a definition.
Clearly, a large number of issued patent claims are likely invalid in view of this decision.
An obvious course of action for all patentees in view of this decision is to review their portfolioof patents, licenses, and due diligence files, to see which U.S. patents and applications haveclaims of this nature, and then determine suitable follow up actions. Such actions would includecanceling licenses, reissuing patents, presenting new claims in continuation applications, andproceeding with commercial activity otherwise precluded.
RANDate/time code: September 27, 2006 (5:14pm)Y:\Prof\pubs\articles\Pfizer_v_Roxbury.wpd
I can be reached via my contact information on www.Neifeld.com.
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