United States Court of
Appeals for the Federal Circuit
PFIZER
INC.,
Plaintiff-Appellant,
v.
DR.
REDDY'S LABORATORIES, LTD.
and
DR. REDDY'S LABORATORIES, INC.,
Defendants-Appellees.
__________________________
DECIDED: February 27,
2004
__________________________
Before
MAYER, Chief Judge, NEWMAN and LOURIE, Circuit Judges.
Opinion
for the court filed by Circuit Judge NEWMAN. Dissenting opinion filed by Chief Judge
MAYER.
NEWMAN,
Circuit Judge.
Pfizer Inc. appeals the judgment
of the United States District Court for the District of New Jersey, ruling that
defendants Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc.
(together "Dr. Reddy's") do not infringe the extended term of
Pfizer's United States Patent No. 4,572,909 ("the '909 patent"), and
on this ground dismissing the complaint.[1] We conclude not only that the extended patent
term includes the claims that cover Dr. Reddy's product, but also that the
dismissal was improperly granted. The
judgment is reversed.
BACKGROUND
Pfizer is the owner of the '909
patent, which claims certain dihydropyridine compounds and their acid addition
salts, including the compound having the common name amlodipine, and its
salts. Amlodipine is the compound of
claim 8. The relevant claims
follow:
1. A dihydropyridine
compound of the formula
|
|
or a pharmaceutically acceptable acid addition salt thereof,
wherein Y is C(CH2)2C, C(CH2)3C,
CCH2 CH(CH3)C or CCH2C(CH3)2C;
R is aryl; R1 and R2 are each independently C1CC4
alkyl or 2-methoxyethyl; and R3 is hydrogen, C1CC4
alkyl, 2-(C1CC4 alkoxy)ethyl, cyclopropylmethyl, benzyl,
or C(CH2)mCOR4 where m is 1, 2 or 3 and R4
is hydroxy, C1CC4 alkoxy or CNR5R6
where R5 and R6 are each independently hydrogen or C1CC4
alkyl; wherein aryl is phenyl; phenyl substituted by one or two of nitro, halo,
C1CC4 alkyl, C1CC4 alkoxy, hydroxy,
trifluoromethyl or cyano; 1‑naphthyl; or 2-naphthyl.
7.
A compound
according to claim 1 wherein R is 2‑chlorophenyl or 2,3-dichlorophenyl, R1
is CH3, R2 is C2H5, Y is C(CH2)2C
and R3 is H or CH3.
8. A compound
according to claim 7 wherein R is 2‑chlorophenyl and R3 is H.
Pfizer obtained federal
registration of an anti-hypertensive, anti-ischemic drug product whose active
ingredient is amlodipine, as the besylate salt.
In obtaining the registration, Pfizer submitted clinical data obtained
using both amlodipine besylate and amlodipine maleate. The besylate salt was selected by Pfizer for
ease of tableting. The seventeen-year
term of the '909 patent ended on February 25, 2003, but was extended for 1,252
days, until July 31, 2006, measured as a portion of the time consumed by the
federal regulatory approval process, as authorized by the Drug Price
Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98
Stat. 1585 (the Hatch-Waxman Act), codified at portions of Title 35 and Title
21. Pfizer's expert declaration stated:
In the Patent Certification section of the NDA for Norvasc® . . . Pfizer certified that "the drug, amlodipine, which is the subject of this application (NDA-19,787) and the formulation for such drug claimed by the listed patent (patent No. 4,572,909) provided in Section 14 of this NDA is the subject of the approval being sought under Section 505 of the Federal Food, Drug, and Cosmetic Act."
In Pfizer's application to the
PTO requesting term extension under 35 U.S.C. §156, Pfizer identified Norvasc®
as the product for which regulatory approval had been obtained, and stated that
Norvasc® was "further identified" as amlodipine besylate.
In December 2001 Dr. Reddy's
filed a new drug application, known as a "paper NDA" under 21 U.S.C.
§355(b)(2), proposing to market amlodipine as the maleate salt, for the uses
for which Pfizer had obtained federal approval, based on the data that Pfizer
had provided to the Food & Drug Administration (FDA). Dr. Reddy's acknowledges that amlodipine
maleate is covered by the claims of the '909 patent, but argues that the term
extension applies only to the besylate salt because that is the registered
product. The district court agreed with
Dr. Reddy's.
DISCUSSION
The
patent term restoration provision of the Hatch-Waxman Act is directed to new
drug and medicinal products that are subject to pre-market federal regulatory
approval. By restoring a portion of the
patent term that is consumed during the approval phase, the incentive to
develop and market products that require lengthy pre-marketing approval is
intended to be preserved:
The purpose of Title II [Patent Term Restoration] is to
create a new incentive for increased expenditures for research and development
of certain products which are subject to premarket government approval. The incentive is the restoration of some of
the time lost on patent life while the product is awaiting pre-market
approval.
H.R. Rep. No. 98-857 at 15
(1984), reprinted in 1984 USCCAN 2647, 2670. The Hatch-Waxman Act balanced the
term-extension benefit to patentees, with new benefits to generic
producers. As discussed in Glaxo,
Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1568 (Fed. Cir. 1997), the
legislation was "designed to benefit makers of generic drugs,
research-based pharmaceutical companies, and not incidently the
public." See also Eli
Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 672 (1990). Balancing the Title II patent term extension
benefit to patentees, Title I of the Act gave generic producers freedom from
infringement during production and testing of generic counterparts intended to
be sold after patent expiration. The Act
also gave generic producers the right to rely on the patentee's data and approved
uses to support approval of their generic counterparts, superceding the prior
requirement that the generic product be independently shown to be safe and
affective. See Id. at 672
(recognizing the equilibrium between the grant to generic producers of the
right to use the patentee's data and conduct otherwise infringing activities,
and the restoration of a portion of the time required for federal approval).
Dr. Reddy's application relied on
the safety and efficacy data submitted to the FDA by Pfizer, which had included
testing of amlodipine as both the maleate and besylate salts. Dr. Reddy's argues that Pfizer's term extension
is limited to amlodipine as the besylate salt, and that amlodipine maleate is a
different "active ingredient."
Dr. Reddy's concedes that both products have the identical "active
moiety," as it must in order to use Pfizer's approved registration. However, Dr. Reddy's argues that only the
specific salt for which Pfizer obtained approval is protected by the extended
term of the patent. In particular, Dr.
Reddy's argues that the district court properly held that §156(b) limits the
rights derived under the extended term of a patent to the specific form of the
approved product, i.e., a free base or a specific salt, citing Merck
& Co. v. Kessler, 80 F.3d 1543 (Fed. Cir. 1996), for support.
Pfizer argues that the patent
term extension statute itself contemplated that a therapeutic product could be
administered as a "salt or ester of the active ingredient," and that
the extension is not defeated by simply changing the salt or ester. The codification states this scope:
35 U.S.C. §156(f) For
purposes of this section:
(1) The term
"product" means:
(A) A drug product.
(B) Any medical device, food additive, or color
additive subject to regulation under the Federal Food, Drug, and Cosmetic Act.
(2) The term "drug product" means
the active ingredient of --
(A) a new drug,
antibiotic drug, or human biological product (as those terms are used in the
Federal Food, Drug, and Cosmetic Act and the Public Health Service Act), or
(B) a new animal drug
. . .
including any salt or ester of the active ingredient, as a
single entity or in combination with another active ingredient.
The Food, Drug & Cosmetic Act
similarly provides that a "drug product" includes any salt or ester
of the active ingredient:
21 C.F.R. §60.3(b)(10)
Human drug product means the active ingredient of a new drug or human
biologic product (as those terms are used in the [FD&C] Act and the Public
Health Service Act), including any salt or ester of the active ingredient, as a
single entity or in combination with another active ingredient.
Pfizer stresses that the FDA's
approval describes the approved product as "amlodipine." Dr. Reddy's stresses that in filing its
request for term extension, Pfizer identified the approved product as
amlodipine besylate.
The district court held that the
term extension is limited to amlodipine besylate, and that although amlodipine
maleate is covered by the claims, it is not subject to the extended term. The court reasoned that the statute limits
the term extension to "the first permitted commercial marketing or use of
the product," 35 U.S.C. §156(a)(5)(A), and that this was only for
amlodipine besylate. Pfizer responds
that the commercial marketing and use are the same for Dr. Reddy's salt form of
amlodipine, and that 35 U.S.C. §156(f) makes clear that "drug
product" means the active ingredient "including any salt or ester of
the active ingredient." Pfizer
points out that a changed salt does not affect the therapeutically active
agent, which is the same amlodipine, whatever the salt. Pfizer argues that if a change in the salt
removes amlodipine from the Hatch-Waxman Act's term extension benefit to the
patentee, it also removes it from the Act's counterpart benefits to the generic
producer.
We conclude that the active
ingredient is amlodipine, and that it is the same whether administered as the
besylate salt or the maleate salt. The
statutory definition of "drug product" is met by amlodipine and its
salts. Dr. Reddy's is proposing to
market the "drug product," as defined in 35 U.S.C. §156(f), for the
same approved uses. The statute foresaw
variation in the salt or ester of an active ingredient, and guarded against the
very loophole now urged. See 35
U.S.C. §156(f); 21 U.S.C. §355(j)(5)(D)(i) and (v). As several amici curiae point out,[2] the
Hatch-Waxman Act established a balance whereby the patent term extension is
offset by facilitating generic entry when the extended term expires, yet
preserving the innovation incentive.
Whether or not this bargain achieved "perfect symmetry" -- Dr.
Reddy's argues that it was not intended to do so, but was designed to favor the
generics -- the text of the statute shows that it was not intended to be
defeated by simply changing the salt.
None of the aspects offered to the district court or on this appeal
suggests a statutory intent to provide the generic producer with access to the
pioneer's approved uses and data while barring extension of patent coverage of
the drug product whose approvals and data are provided. To the contrary, as we have discussed, the
Hatch-Waxman Act foresaw and averted the potential loophole of a change in the
salt of the active ingredient.
As we have observed, 35 U.S.C.
§156(f) defines the drug product as including "any salt or ester of the
active ingredient." See Abbott
Laboratories, Inc. v. Young, 920 F.2d 984, 985-89 (D.C. Cir. 1990). The FDA ruled that "the term 'active
ingredient' as used in the phrase 'active ingredient including any salt or
ester of the active ingredient' means active moiety." Abbreviated New Drug Application
Regulations: Patent and Exclusivity Provisions, 59 Fed. Reg. 50,338, 50,358
(F.D.A. Oct. 3, 1994). The FDA has
defined "active moiety" as "the molecule or ion, excluding those
appended portions of the molecule that cause the drug to be an ester, salt . .
. responsible for the physiological or pharmacological action of the drug
substance." 21 C.F.R. §314.108(a).
The district court misconstrued
the statute, in holding that the extended patent term did not cover any
amlodipine salts except the besylate.
The Act by its terms extended the term of the patent for the registered
uses of the drug product including its salt esters. The "rights derived" provision of
§156(b) specifically limits the extension to "any use approved for the
product," which means that other, e.g., non-pharmaceutical uses,
are not subject to the extension. That
provision does not contain any limitation regarding the form of the product
subject to the extension. In fact,
§156(f) clearly provides otherwise, in defining the term "product" as
"including any salt or ester of the active ingredient." Thus, Dr. Reddy's attempt to limit the
extension to the specific approved salt on the basis of the "rights
derived" provision of §156(b) to the approved product is unsound. The district court's reliance on Merck,
80 F.3d 1543, is inappropriate, for the issue of that case is unrelated to that
before the district court. The issue in Merck
was whether a patent whose term at the time of grant was 17-years-from-grant,
and whose term had duly been extended under §156, could obtain a second
extension after the 20-years-from-filing term became available to that patent. The court in Merck held that a second
extension was not available. The Merck
case is not relevant.
We conclude that the extended term of the '909 patent covers amlodipine and any salt or ester, as provided by §156(f) and as claimed in claims 1, 7, and 8. The extension is not limited to the besylate salt of amlodipine. The judgment of non-infringement and ensuing dismissal, is reversed.
REVERSED