Review and Analysis of Pfizer, Inc. V. Ranbaxy Laboratories Limited
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)
InPfizer, 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 under the fourth paragraph of 35 USC 112 for failing to further limit the claim from which it depends.
Claim 1 reads as follows: "1. [R-(R*,R*)]-2-(4-fluorophenyl)-[beta],[delta]-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenyla mino)-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 salts thereof."
Claim 2 reads as follows: "2. A compound of claim 1 which is [R-(R*R*)]-2-(4-fluorophenyl)-ß-d-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carb onyl]-1H-pyrrole-1-heptanoic acid."
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 Court found claim 6 invalid because it interpreted claim 6's reference to claim 2 to require claim 6 to include 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 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 alsoRhine v. Casio, Inc., 183 F.3d 1342, 1345 (Fed. Cir. 1999) ("[I]f the only claim construction that is consistent with the claim's language and the written description renders the claim invalid, then . . . the claim is simply invalid."). Ranbaxy correctly argues that claim 6 fails to "specify a further limitation of the subject matter" of the claim to which it refers because it is completely outside the scope of claim 2. We must therefore reverse the district court with respect to this issue and hold claim 6 invalid 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 legal reasoning.
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 good chance 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 two reasons. 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 possibility unlikely in view of the Court's reasoning. Second, a specification thoeretically could expressly define "acid" to also include within its meaning "salt" since a patentee can be his own lexicographer. 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 portfolio of patents, licenses, and due diligence files, to see which U.S. patents and applications have claims of this nature, and then determine suitable follow up actions. Such actions would include canceling licenses, reissuing patents, presenting new claims in continuation applications, and proceeding with commercial activity otherwise precluded.
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Richard Neifeld,
President,Neifeld IP Law, PC
Richard Neifeld, Ph.D.
Patent Attorney
Email address: general @ neifeld.com
Education
J.D. The George Washington University Law School 1994 Ph.D. Rutgers University (Solid State Physics) 1985 B.S./B.A. University of Rochester (Physics and Mathematics)
(Cum Laude and Honors) 1980
Experience
Neifeld IP Law P.C. - 2002
Partner in the IP law firm of Oblon, Spivak, McClelland, Maier & Neustadt, PC. - 1996
Patent Attorney - 1994
Patent Agent - 1992
Patent Technical Consultant - 1990
Staff Scientist for the U.S. Army's Laboratory Command - 1986
Post-doctoral Fellow, Rutgers University - 1985-1986
Former chair of the Interference Committee and current chair of the Services Subcommittee of the Interference Committee of the American Intellectual Property Lawyers Association (AIPLA). Member of the AIPLA, American Bar Association, Maryland Patent Lawyers Association, and the Patent Information Users Group. Extensive experience in "specialty matters" in the U.S. patent office, such as appeals, petitions, reexaminations, reissues, public protests, and extensive experience in foreign prosecution, and interferences and related litigation. Extensive experience in due diligence work, including investigations, database searching, and opinions.
Admitted to practice before the United States Patent and Trademark Office, the Virginia State Courts, the United States Court of Appeals for the Fourth Circuit, and the United States District Court for the District of Columbia.
Widely published in IP law publications, frequent lecturer to patent attorneys on patent law topics, and an active member of the patent bar associations. Founder and moderator for the popular "patentinterference" group on thegroups.yahoo.com/group/patentinterference web site, which is a forum for general information on patent law and practice with a focus on patent interference issues.
Co-founder of thewww.PatentValuePredictor.com automated patent valuation service, co-inventor of the underlying macro-economic model for valuing patents, and programmer of some of the code powering the automated valuations.
Five years of scientific research in applied physics areas of electro-optics, III-V materials, microwaves, vacuum deposition technology, superconductors, and electronics directed towards the U.S. Army's electronics, communication, and signal processing needs.
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