Commissioner of Patents and Trademarks
Patent and Trademark Office (P.T.O.)
IN RE ALCON LABORATORIES, INC. PATENT NO.
3,691,279
September 1, 1989
Donald J. Quigg
Commissioner of Patents and Trademarks
Final Decision on Request for Patent Term
Extension Under 35 U.S.C. § 156
*1 An application
for patent term extension has been filed under 35 U.S.C. § 156. [FN1] The application raises a question
of eligibility for patent term extension of a patent claiming one of two active
ingredients in a drug product that was approved for commercial marketing and
use by the Food and Drug Administration (FDA). Each of the active ingredients
had been approved separately for commercial marketing and use in previous
regulatory reviews by the FDA. For the reasons set forth below, the application
is denied.
Facts
An application for patent
term extension of U.S. Patent No. 3,691,279, granted September 12, 1972, was
filed in the Patent and Trademark Office (PTO) on October 17, 1988. The basis
for the application is stated to be 35 U.S.C. § 156. The application was filed by Alcon Laboratories, Inc.
(Alcon) as agent [FN2] for the owner of record of the patent, Eli Lilly
Industries, Inc., a wholly owned subsidiary of Eli Lilly and Company.
Tobradex is a drug
product that was approved for commercial marketing or use by the FDA on August
18, 1988, [FN3] pursuant to § 507 of
the Federal Food, Drug and Cosmetic Act (Act). [FN4] Tobradex was approved for
steroid-responsive inflammatory ocular conditions for which a corticosteroid is
indicated and where superficial bacterial ocular infection or a risk of
bacterial ocular infection exists. [FN5] According to the application, the
active ingredients in Tobradex are tobramycin and dexamethasone. [FN6] The
application for patent term extension was filed within sixty (60) days of the
date the new drug application (NDA) for Tobradex was approved by the FDA, and
otherwise appears to comply with the requirements of § 156(d) and the provisions of 37 CFR § § 1.740 and 1.741.
The application states
that Patent No. 3,691,279 claims one of the active ingredients (tobramycin) because the product
claimed in claim 5 contains tobramycin. [FN7] No other claim in the patent
covers tobramycin, and none of the claims are directed to dexamethasone nor to
a combination of tobramycin and dexamethasone.
Letters from the FDA
advised PTO that the active ingredients in Tobradex have been approved
previously as single entities (i.e., drug products having a single active
ingredient) by the FDA. Thus, in a letter dated November 30, 1988, from Ronald
L. Wilson, Director of the Health Assessment Policy Staff at FDA, PTO was
advised as follows with respect to Tobradex:
A review of the Food
and Drug Administration's official records confirms that Tobradex was subject
to a regulatory review period before its commercial marketing or use, as
required under 35 U.S.C. 156(a)(4). Our records also indicate, however, that
FDA has previously approved drug products containing either tobramycin,
dexamethasone, or related compounds.
*2 ....
The applicant correctly
states that FDA has not previously approved a drug product containing both
tobramycin and dexamethasone, and that the relevant provisions of law under
which the above products were approved were sections 505 and/or 507 of the
Federal Food, Drug, and Cosmetic Act. Tobradex's approval occurred under
section 507 of the Act.
In a letter dated May 10,
1989, from Stuart Nightingale, M.D., Associate Commissioner
for Health Affairs at FDA, PTO was advised as follows about FDA's prior
approval of the active ingredients of Tobradex and approval of drug products
containing a combination of active ingredients in general:
As noted in our prior
letter to you of November 30, 1988, Tobradex is a combination of tobramycin and
dexamethasone, whichFDA approved on August 18, 1988 under the provisions for
approval of antibiotics in section 507 of the FD & C Act. Prior to
approving Tobradex, FDA had approved a number of tobramycin and dexamethasone
products as single entities. The tobramycin products were approved under § 507, as was Tobradex. The dexamethasone
products, which are not antibiotics, were approved under FDA's new drug
provisions found in section 505 of the FD & C Act.
....
FDA's policy for
fixed-combination prescription drugs is in 21 CFR § 300.50. In general, the policy requires that each component
contribute to the claimed effects of the product, e.g., an added component may
enhance the safety or effectiveness of the principal active component. The
policy is used in determining the type of evidence required for approval of
fixed combination drugs and antibiotics under § § 505 and 507 of the Act. Products are not, however, "approved
under" 21 CFR § 300.50. They are
approved under § § 505 or 507.
On June 16, 1989, the PTO
issued an order giving Alcon an opportunity to show cause why its application should not be
denied. Alcon's response focused on the failure of the PTO to consider FDA's
Fixed-Combination Policy (21 CFR §
300.50) directed to drug products containing more than one drug or
active ingredient as a "provision of law" within the meaning of
§ 156(a)(5)(A). Alcon alleged that the
PTO position suggests that FDA's Fixed-Combination Policy does not have the
force and effect of law. [FN8]
Discussion of Eligibility Criteria For Patent Term Extension
The starting point for
statutory interpretation is the plain language of the statute. The statute
itself must be regarded as conclusive of the meaning absent a clearly contrary
legislative intent. Burlington Northern R.R. Co. v. Oklahoma Tax Comm'n, 481
U.S. 454, 461 (1987); Ethicon v. Quigg, 849 F.2d 1422, 7 USPQ2d 1152
(Fed.Cir.1988). Statutory words are normally presumed, unless the contrary
appears, to be used in their ordinary and usual sense, and with the meaning
commonly attributed to them. Calminetti v. United States, 242 U.S. 470, 485
(1917) (the meaning of a statute must, in the first instance, be sought in the
language in which the act is framed and, if that is plain, the sole function of
the court is to enforce it according to its terms).
*3 Under 35 U.S.C.
§ 156(a), a patent must
"claim," inter alia, a product in order to be eligible for patent
term extension. In addition, the following
conditions enumerated in § 156(a) must
be satisfied for a patent to be eligible for patent term extension: [FN9]
(1) the term of the
patent has not expired before an application is submitted under subsection (d)
for its extension;
(2) the term of the
patent has never been extended;
(3) an application for
extension is submitted by the owner of record of the patent or its agent and in
accordance with the requirements of subsection (d);
(4) the product has been
subject to a regulatory review period before its commercial marketing or use;
(5)(A) except as provided
in subparagraph (B), the permission for the commercial marketing or use of the
product after such regulatory review period is the first permitted commercial
marketing or use of the product under the provision of law under which such
regulatory review period occurred; or
(B) ... [pertains to a
patent claiming a method of manufacturing a product which primarily uses
recombinant DNA technology]....
The enumerated conditions in paragraphs (1) through (4) appear to
be satisfied in the instant case, and the provisions of paragraph (5)(B) are
not applicable.
The determination of
eligibility of U.S. Patent 3,691,279 for patent term extension turns on the
provisions in § 156(a)(5)(A). Thus, the
statutory requirement that the product claimed in the patent has been subject
to a regulatory review period before its commercial marketing or use (§ 156(a)(4))
is qualified in § 156(a)(5)(A) by the
provision that the permission for the commercial marketing or use of the product
after such regulatory review period [i.e., the period applicable to the product
which forms the basis of the application for patent term extension] is the
first permitted commercial marketing or use of the product under the provision
of law under which such regulatory review period occurred.
The term product is
defined in 35 U.S.C. § 156(f) as
follows:
(f) For purposes of
this section:
(1) The term
"product" means:
(A) A human drug
product.
(B) ...
(2) The term
"human drug product" means the active ingredient of 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)
including any salt or ester of the active ingredient, as a single entity or in
combination with another active ingredient. [Emphasis supplied.]
Where, as in the present
case, no salts or esters of active ingredients are involved, the definition of
"product" provided in section 156(f) can be applied to the extension
requirements of sections 156(a) and 156(a)(5)(A) as they would apply to a human
drug product as follows:
§ 156(a) The term of a patent which claims
[the active ingredient ..., as a single entity or in combination with another
active ingredient] ... shall be extended ... if--
*4 (5)(A) ...
the permission for the commercial marketing or use of [the active ingredient
..., as a single entity or in combination with another active ingredient] after
such regulatory review period is the first permitted commercial marketing or
use of [the active ingredient ..., as a single entity or in combination with
another active ingredient] under the provision of law under which such
regulatory review period occurred;
Thus, eligibility under
§ 156(a) requires that the patent claim
the active ingredient of a new drug, as a single entity or in combination with
another active ingredient. Section 156(a)(5)(A) permits patent term extension
based on FDA approval of the active ingredient as a single entity or in
combination with another active ingredient, provided it is the first FDA
approval of the active ingredient, as a single entity or in combination with
another active ingredient.
For a product which
contains a plurality of active ingredients, as here, the statute must be
analyzed with respect to each active ingredient. Active ingredient, as defined
in § 156(f), is singular and the
definition of "human drug product" explicitly recognizes that the
"active ingredient" may be used "in combination with another
active ingredient" to embrace a human drug product with a combination of active ingredients. If
the term "active ingredient" was interpreted to include a plurality
of active ingredients, the phrase "including any salt or ester of the
active ingredient" would not make any sense because there is no such thing
as a salt or ester of two ingredients. A statute should be construed, if
possible, to avoid absurd results. United States v. Turkette, 452 U.S. 576
(1981).
The "provision of
law under which such regulatory review period occurred" [§
156(a)(5)(A) ] refers to the applicable provision of law defined in the
definitional section for regulatory review period, [FN10] which is further
defined in § 156(f)(4) as being the
corresponding section in the Act or the Public Health Service Act. For a human
drug product, the applicable provision of law can be section 505 [FN11] of the
Act for a new drug, section 507 of the Act for an antibiotic drug, or section
351 of the Public Health Service Act for a human biological product. Tobradex
was approved under § 507.
Application of Eligibility Criteria to Patent
3,691,279 and Tobradex
Under § 156(a), Patent No. 3,691,279 may be
considered eligible for patent term extension if a claim of the patent covers
Tobradex. As tobramycin and dexamethasone are the active ingredients in
Tobradex, a patent claim would cover Tobradex within the meaning of § 156(a) if it claimed:
1) tobramycin alone
[single entity];
2) dexamethasone alone
[single entity]; or
3) the mixture of
tobramycin and dexamethasone [active ingredient ... in combination with another
active ingredient]
Patent No. 3,691,279 satisfies §
156(a) because it is said to claim one of the active ingredients
[tobramycin] in Tobradex "... as a single entity...." If the mixture
of active ingredients [tobramycin and dexamethasone] in Tobradex was to be
considered "the active ingredient" for the purposes of § 156, Patent No. 3,691,279 would not be
eligible for patent term extension because the patent does not claim the
mixture of active ingredients in Tobradex.
*5 Under § 156(a)(5)(A), as it pertains to the active
ingredient claimed in the patent [tobramycin], the patent would be eligible for
patent term extension if:
... the permission for
the commercial marketing or use of [the active ingredient ..., as a single
entity (tobramycin) or in combination with another active ingredient] after
such regulatory review period [Tobradex] is the first permitted commercial
marketing or use of [the active ingredient ..., as a single entity (tobramycin)
or in combination with another active ingredient] under the provision of law
[§ 507 of the Act] under which such
regulatory review period occurred.
Here, the patent is not eligible because the active ingredient
claimed in the patent [tobramycin]
previously was permitted to be commercially marketed and used under the same
provision of law [§ 507 of the Act]
under which the regulatory review for Tobradex occurred. The approval of
Tobradex did not represent the first permitted commercial marketing or use of
tobramycin under § 507 of the Act. The
fact that the other active ingredient [dexamethasone] in Tobradex had not been
previously permitted to be commercially marketed or used under § 507 of the Act does not give rise to eligibility,
because dexamethasone is not claimed in the patent.
Alcon has argued that
FDA's rule (21 CFR § 300.50) stating
its policy on approval of combination drug products should be considered a
provision of law within the meaning of §
156(a)(5)(A) because it is a substantive rule and has the force and
effect of law. Assuming, arguendo, that §
300.50 is a substantive rule and has the force and effect of law, that
rule is not "the provision of law" within the meaning of § 156(a)(5)(A). Quite the contrary, FDA has
specifically noted [FN12] that § 300.50
"is used in determining the type of evidence required for approval of
fixed combination drugs and antibiotics under § § 505 and 507 of the Act." Further, if § 300.50 is considered to be "the provision
of law" under which the regulatory review period for Tobradex occurred,
the subject patent and Tobradex would not be eligible for patent term extension
under § 156 because (1) § 156(g) does not refer to § 300.50 and (2) therefore, there would have been
no "regulatory review period"
within the meaning of § 156(g).
The Legislative History Supports the PTO
Position
The PTO's position is
that the patent is not eligible for patent term extension. The permission for
commercial marketing of Tobradex was not the first permitted commercial
marketing or use of the active ingredient claimed in the patent within the
meaning of § 156(a)(5)(A). This
position is consistent with the statute itself, including the statutory
definition of the term "product" in § 156(f), and the legislative history supports the PTO position.
From the beginning of the
congressional debate that led to enactment of § 156, attention focused on the decline of effective patent life
for new chemical entity (NCE) drugs. [FN13] Although acknowledging that
pharmaceutical innovation was not limited to the introduction of NCEs, the
reason for focusing on the introduction of NCEs was explained in a report by
the Congressional Office of Technology Assessment to the 97th Congress as follows:
[FN14]
*6 Although
important pharmaceutical innovations may result from new therapeutic
applications of existing chemicals, new processes for making chemicals, or new
combinations or formulations of existing chemicals, this study concentrates
primarily on innovations resulting from the discovery or synthesis of NCEs. This approach is used for
several reasons. Many of the pharmaceutical breakthroughs that have occurred
have resulted from NCE research and the development of NCEs generally has
required more time and money than other types of innovation and has involved
greater risks. Moreover, because FDA testing requirements generally have been
more time- consuming for NCEs than for other types of innovation, they have had
their greatest impact on the effective patent terms of NCEs. By focusing on
NCEs, the most extreme reductions in effective patent terms can be determined,
but these effects are not representative of the average effects for all new
pharmaceuticals.
Congress adopted the
focus on NCEs when it proscribed patent term extension [§
156(a)(5)(A) ] if the active ingredient had received permission for
commercial marketing or use in a regulatory review period that was concluded
prior to a subsequent regulatory review period upon which the application for
patent term extension is based. If the active ingredient had already received
permission for commercial marketing from FDA under the same provision of law,
it would not be considered to be an NCE in a subsequent regulatory review
period--whether the active ingredient was used alone or in combination with
another active ingredient or approved for a different indication. According to
a report by the House Committee on Energy and Commerce accompanying H.R. 3605,
98th Cong., 2d Sess. (1983): [FN15]
Paragraphs (6) and (7
[FN16] describe two conditions which must be met by the product which is
claimed in the product patent to be extended, or the use or manufacture of
which is claimed in the use or process patent to be extended. First, the
product must have been subjected to a regulatory review period under an
applicable federal law, and approved, before the product was allowed to be
commercially marketed. (The product which can be the subject of a patent
extension is hereafter referred to as the "approved product.")
Second, with one exception, the approved product must have been approved for
commercial marketing for the first time. The exception involves an approved
product made under a patented process which primarily uses recombinant DNA technology.
Such an approved product could have received its second approval for commercial
marketing, but it must be the first time a product made by the claimed process
has been approved.
The Committee's bill
requires extensions to be based on the first approval of a product because the
only evidence available to Congress showing that patent time has been lost is
data on so-called class I, new chemical entity drugs. These drugs had been
approved by the Food and Drug Administration (FDA) for the first time. An
exception was allowed for products made through recombinant DNA because this
innovative, new technique is being employed to improve already approved drugs.
[Emphasis supplied.]
*7 The legislative history shows Congress intended that the
condition expressed in § 156(a)(5)(A) should apply to the product
[active ingredient] claimed in the patent [§
156(a) ], and that patent term extension should be available only to
active ingredients that are NCEs--approved by the FDA for the first time. The
only evidence available to Congress showing that patent time had been lost in
the regulatory review process before the FDA related to NCE drugs.
Thus, the legislative
history of § 156 shows that Congress
intended to grant patent term extensions only to those products [active
ingredients] classified by FDA as new chemical [or new molecular] entities
under FDA's long- standing drug classification system. [FN17] According to this
classification system, Type I drugs are new molecular entities--i.e., the
active moiety [FN18] is not yet marketed in the United States by any drug
manufacturer either as a single entity or as part of a combination product.
Type I drugs are contrasted to other types under the classification system
which are directed to new salts, esters or derivatives of active moieties
marketed in the U.S. (Type 2), new formulations (Type 3), new combinations of
drugs not previously marketed together (Type 4), and already marketed drug
products (Types 5 and 6). These Types are not mutually exclusive, but where the
drug product falls into more than one category, all appropriate categories are
reflected in the overall classification for the drug.
Congress found no
evidence relating to new combinations of old active ingredients, old active ingredients administered
in a new dosage form and no evidence relating to an old active ingredient
approved for a new indication (use) that would justify patent term extension
based on products of these types. As noted in Fisons plc v. Quigg, 876 F.2d 99,
10 USPQ2d 1869 (Fed.Cir.1989), there is strong support in the legislative
history of § 156 for the interpretation
of § 156(a)(5)(A) adopted by the PTO in
the Fisons plc applications that patent term extension is available only to
drug products that are NCEs--i.e., active ingredients that had been approved
for the first time by the FDA.
Each of the active
ingredients in the approved product Tobradex was a well- known therapeutic
agent that individually had been approved for commercial marketing and use
prior to FDA approval of Tobradex. Since both active ingredients had been
previously approved and were marketed in the United States, neither tobramycin
nor dexamethasone was a new chemical/molecular entity at the time of FDA
approval of Tobradex. Accordingly, it is consistent with the legislative
history of § 156 that a patent claiming
an active ingredient [tobramycin] which has enjoyed commercial marketing and
use for its anti-bacterial activity since the mid-1970s and as an ophthalmic
product since 1981 be denied patent term extension based on the 1988 approval
of a drug product containing that active ingredient.
*8 There is a
direct parallel between the facts in the instant case and those considered by the Federal Circuit in
the Fisons cases. In each case, the active ingredient had been previously
approved for commercial marketing and use and the application for patent term
extension was based on a subsequent approval of the same active ingredient for
a new indication [use] that did not fall within the scope of the previous
approval (here, the use of tobramycin with dexamethasone). For the reasons
endorsed by the Federal Circuit in Fisons in interpreting § 156(a)(5)(A), FDA approval of new uses for
an old and well-known active ingredient does not form a proper basis for patent
term extension under § 156.
In addition to the clear
meaning of the statute as a whole, and achieving a result which comports with
the Congressional intent to make patent term extension available only to new
active ingredients (pioneer chemical entities), the legislative history also
reflects that Congress intended to refer to the laws specified in § 156(g)(1) when it referred to a provision of
law under which a regulatory review period occurred. According to a report by
the House Committee on the Judiciary accompanying H.R. 3605, 98th Cong., 2d
Sess. (1983): [FN19]
Under section 156(g)(1)
the regulatory review period for drug products is the sum of the periods: (1)
beginning when an exemption under 505(i) or 507(d) was granted and ending when
the initial submission of an application for approval under section 351 of the
Public Health Service Act, 505, 507, of the
Federal Food, Drug, and Cosmetic Act; and (2) beginning when an application for
approval was initially submitted under the mentioned laws and ending when the
application was approved. [Emphasis supplied.]
As it applies to the drug product Tobradex, the applicable
provision of law under which the regulatory review period occurred is § 507 of the Act.
It is further noted that
the application indicates [FN20] that an application for patent was filed on
March 9, 1988, directed to the topical ophthalmic use of tobramycin and
dexamethasone combinations. It is further stated that the approved product,
Tobradex, is covered by this patent application. Whatever the ultimate
disposition of this application for patent, it is clear that none of the normal
seventeen (17) year term of any patent which may be granted on this application
for patent would have been eroded by the time elapsed in the regulatory review
process of Tobradex at the FDA.
Application of Eligibility Criteria to Drug
Products Containing Two Active
Ingredients
The PTO has completed
review of several applications for patent term extension based on drug products
containing two active ingredients. These applications have presented a variety
of fact patterns that have led to different conclusions regarding eligibility
for patent term extension under § 156. Representative of these different fact
patterns are the following:
1. U.S. Patent No.
3,957,982 was denied eligibility for patent term extension. The application was
based on FDA approval under § 505 of
the Act of the drug product known as Triphasil-21 which contained two active ingredients:
(A) ethinyl estradiol and (B) levonorgestrel. The patent claimed the
combination of A + B. FDA previously had approved, under § 505 of the Act, drug products which
contained A + B. Eligibility was denied on the basis of § 156(a)(5)(A) since each of the active
ingredients in the approved product that was claimed in the patent (A and B)
previously received permission for commercial marketing or use by the FDA under
the same provision of law [§ 505 of the
Act] in combination with another active ingredient (A with B and B with A).
There was no NCE contained in the approved product which formed the basis of
the application.
*9 2. U.S. Patent
No. 4,194,047 was granted an extension of the patent term under § 156. The application was based on FDA
approval under § 505 of the Act of the
drug product known as Primaxin which contained two active ingredients: (A)
cilastatin sodium and (B) imipenem. The patent claimed B. FDA had not approved
previously either active ingredient in any form (acid, salt or ester).
Eligibility was not precluded under §
156(a)(5)(A) because the active ingredient claimed in the patent (B) had
not received permission previously for commercial marketing or use under § 505 of the Act either singly or in combination with another active
ingredient. The active ingredient (B) was an NCE contained in the approved
product upon which the application was based.
3. U.S. Patent No.
4,217,347 was denied eligibility for patent term extension. The application was
based on FDA approval under § 505 of
the Act of a drug product known as Capozide which contained two active
ingredients: (A) captopril and (B) hydrochlorothiazide. The patent claimed the
combination A + B. FDA had approved previously, under § 505 of the Act, each of A and B separately
and the combination A+C [C being an active ingredient different from A or B].
Eligibility was denied on the basis of §
156(a)(5)(A) because each of the active ingredients in the approved
product claimed in the patent (A and B) previously received permission for
commercial marketing or use by the FDA under the same provision of law [§ 505 of the Act] singly (i.e., A and B
separately) and in one case (A+C) in combination with another active
ingredient. There was no NCE contained in the approved product which formed the
basis of the application.
4. U.S. Patent No.
4,234,579 was granted an extension of patent term under § 156. The application was based on FDA
approval under § 505 of the Act of a
drug product known as Unasyn which contains two active ingredients: (A)
sulbactum sodium and (B) ampicillin sodium. The patent claimed both (A) alone
and the combination (A+B). FDA had approved previously (B) alone, but had not
previously approved (A) in any form. Eligibility was not precluded by § 156(a)(5)(A)
because the active ingredient (A) claimed in the patent did not receive
permission previously for commercial marketing or use under the same provision
of law [§ 505 of the Act] either singly
or in combination with another active ingredient. The active ingredient (A) was
an NCE contained in the approved product upon which the application was based.
In each case, the PTO
acted consistently with the terms of the statute in achieving the intent of the
legislation to grant patent term extension to an NCE drug that is claimed in
the patent, the term of which is to be extended. So long as the patent for
which an extension of term is sought claims an active ingredient of an approved
drug product which is an NCE, the letter and intent of § 156 are served in granting patent term
extension. In each case where the patent either does not claim an NCE, or where
the active ingredients in the new drug product are not NCEs, the letter and
intent of § 156 are served by denying
eligibility for patent term extension.
Decision
*10 The PTO
concludes that U.S. Patent No. 3,691,279, which is said to claim one of the
active ingredients [tobramycin] in the approved product Tobradex, is not
eligible for patent term extension under 35 U.S.C. § 156. Accordingly, the application for extension of the term of
Patent No. 3,691,279 is denied because the
permission for commercial marketing or use of tobramycin in Tobradex was not
the first permitted commercial marketing or use of tobramycin under the
provision of law [§ 507 of the Act]
under which regulatory review of Tobradex occurred. 35 U.S.C. § 156(a)(5)(A).
FN1. 35 U.S.C. § 156
codifies Title II, § 201 of the Drug
Price Competition and Patent Term Restoration Act of 1984, Pub.L. 98-417, 98
Stat. 1585 (1984), as amended by the Generic Animal Drug and Patent Term
Restoration Act, Pub.L. 100-670, 102 Stat. 3971 (1988).
FN2. Exhibit A of the application is an authorization signed by
the Executive Vice President of Lilly authorizing Alcon to act as Lilly's agent
solely for the purposes of applying for and securing patent term extension of
U.S. Patent No. 3,691,279.
FN3. Letter from FDA to Alcon dated August 18, 1988, indicating
that Tobradex is safe and effective for use as recommended, and that the New
Drug Application (NDA 50-592) was approved. Exhibit D of the application.
FN4. 21 U.S.C. § 357.
FN5. Package insert
and product monograph for Tobradex.
Exhibits B and C of the application.
FN6. As explained in the product monograph for Tobradex, Exhibit C
of the application, tobramycin and dexamethasone are individually well known
therapeutic agents. Tobramycin is the antibiotic component of Tobradex which
has been in medical use for its anti-bacterial activity since the mid-1970s and
as an ophthalmic product since 1981. Dexamethasone is an ocular steroid that
has been in use since the late 1950s and has proved to be an effective agent
for the treatment of ocular inflammation.
FN7. A determination that a patent is eligible for extension may
be made by the Commissioner solely on the basis of the representations
contained in the application for the extension. 35 U.S.C. § 156(e)(1).
FN8. Alcon response filed August 11, 1989, page 12.
FN9. Although some of the provisions of § 156 were amended by the enactment of the
Generic Animal Drug and Patent Term Restoration Act, supra, n. 1, the
application in issue was filed (October 17, 1988) one month before the date of
enactment (November 16, 1988). Since this decision would not be affected by any
change made to the statutory language, the
wording of the statute at the time the application for patent term extension
was filed, i.e., the language of the statute prior to the 1988 amendments, is
referenced in this decision.
FN10. § 156(g), and
particularly paragraph (g)(1) related to human drug products.
FN11. 21 U.S.C. § 355.
FN12. FDA letter to PTO dated May 10, 1989, footnote 1.
FN13. In a study reported by Martin M. Eisman and William M.
Wardell in "The Decline in Effective Patent Life of New Drugs,"
Research Management 18-21 (Jan. 1981), reprinted in Innovation and Patent Law
Reform: Hearings Before the Subcommittee on Courts, Civil Liberties, and the
Administration of Justice of the House Committee on the Judiciary, Part 2, 98th
Cong., 2d Sess. 1211, 1214 (1984), the term new chemical entities (NCEs) was
defined as compounds of molecular structure not previously marketed in the
U.S., excluding new salts or esters, vaccines, antigens, antisera,
immunoglobins, surgical products, and diagnostic agents.
FN14. Patent-Term
Extension and The Pharmaceutical Industry, Congress of the United States,
Office of Technology Assessment 12 (1981), reprinted in Patent Term Restoration
Act of 1981: Hearings on H.R. 1937, H.R. 6444, and S. 255 Before the
Subcommittee on Courts, Civil Liberties, and the Administration of Justice of
the House Committee on the Judiciary, 97th Cong., 1st Sess. 99, 112 (1982).
FN15. H.R.Rep. No. 98-857, Part I, 98th Cong., 2d Sess. 37-38
(1984), reprinted in 1984 U.S.Code Cong. & Admin.News 2647, 2670-2671.
FN16. Now paragraphs (a)(4) and (a)(5).
FN17. Copy of FDA Staff Manual Guide No. BD 4820.3, dated February
19, 1982, describing the IND/NDA Classification System is attached to this
decision.
FN18. The active moiety of a drug is that part of the chemical
compound that is responsible for the drug's therapeutic effect.
FN19. H.R.Rep. No. 98-857, Part II, 98th Cong., 2d Sess. 25
(1984), reprinted in 1984 U.S.Code Cong. & Admin.News 2686, 2709.
20. Page 12 of the
application for patent term extension makes reference to pending U.S. Patent Application No. 165,950
(Cagle), filed March 9, 1988. Inspection of the copy of the patent application
(Exhibit G of the application for patent term extension) reveals that claims to
both a product containing a combination of tobramycin and dexamethasone and a
method of using that product were presented for examination.
13 U.S.P.Q.2d 1115
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