[Federal Register Volume 67, Number 83 (Tuesday, April 30, 2002)]
[Notices]
[Pages 21248-21252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-10578]


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FEDERAL TRADE COMMISSION

[File No. 011 0094]


Biovail Corporation; Analysis To Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed consent agreement.

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SUMMARY: The consent agreement in this matter settles alleged 
violations of federal law prohibiting unfair or deceptive acts or 
practices or unfair methods of competition. The attached Analysis to 
Aid Public Comment describes both the allegations in the draft 
complaint that accompanies the consent agreement and the terms of the 
consent order--embodied in the consent agreement--that would settle 
these allegations.

DATES: Comments must be received on or before May 23, 2002.

ADDRESSES: Comments filed in paper form should be directed to: FTC/
Office of the Secretary, Room 159-H, 600 Pennsylvania Avenue, NW, 
Washington, DC 20580. Comments filed in electronic form should be 
directed to: [email protected], as prescribed below.

FOR FURTHER INFORMATION CONTACT: Joseph Simons or Bradley Albert, 
Bureau of Competition, 600 Pennsylvania Avenue, NW, Washington, DC 
20580, (202) 326-3300 or 326-3670.

SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal 
Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and Section 2.34 
of the Commission's Rules of Practice, 16 CFR 2.34, notice is hereby 
given that the above-captioned consent agreement containing a consent 
order to cease and desist, having been filed with and accepted, subject 
to final approval, by the Commission, has been placed on the public 
record for a period of thirty (30) days. The following Analysis to Aid 
Public Comment describes the terms of the consent agreement, and the 
allegations in the complaint. An electronic copy of the full text of 
the consent agreement package can be obtained from the FTC home page 
(for April 23, 2002), on the World Wide Web, at ``http://www.ftc.gov/os/2002/04/index.htm.'' A paper copy can be obtained from the FTC 
Public Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW, 
Washington, DC 20580, either in person or by calling (202) 326-2222.
    Public comments are invited, and may be filed with the Commission 
in either paper or electronic form. Comments filed in paper form should 
be directed to: FTC/Office of the Secretary, Room 159-H, 600 
Pennsylvania Avenue, NW, Washington, DC 20580. If a comment contains 
nonpublic information, it must be filed in paper form, and the first 
page of the document must be clearly labeled ``confidential.'' Comments 
that do not contain any nonpublic information may instead be filed in 
electronic form (in ASCII format, WordPerfect, or Microsoft Word) as 
part of or as an attachment to email messages directed to the following 
e-mail box: [email protected]. Such comments will be considered 
by the Commission and will be available for inspection and copying at 
its principal office in accordance with Section 4.9(b)(6)(ii) of the 
Commission's Rules of Practice, 16 CFR 4.9(b)(6)(ii)).

Analysis To Aid Public Comment

    The Federal Trade Commission has accepted for public comment an 
agreement and proposed consent order with Biovail Corporation, settling 
charges that Biovail illegally acquired an exclusive patent license and 
wrongfully listed that patent with the U.S. Food and Drug 
Administration. The Commission has placed the proposed consent order on 
the public record for thirty days in order to receive comments by 
interested persons. The proposed consent order has been entered into 
for settlement purposes only and does not constitute an admission by 
Biovail Corporation that it violated the law or that the facts alleged 
in the complaint, other than the jurisdictional facts, are true.

Background

    Biovail Corporation is a Canadian manufacturer of branded and 
generic pharmaceutical products, including Tiazac. Tiazac, a once-a-day 
diltiazem-based prescription drug that is at issue in this case, is 
used to treat high blood pressure and to decrease the occurrence

[[Page 21249]]

of chronic chest pain. In 2000, Tiazac's sales reached almost $200 
million, accounting for 38 percent of Biovail's gross sales.
    Andrx Pharmaceuticals, Inc., a Florida-based company that develops 
generic versions of branded pharmaceuticals, was the first company to 
submit an application to the U.S. Food and Drug Administration 
(``FDA'') to make and sell a generic version of Tiazac. Andrx's 
application to the FDA included a certification asserting that its 
generic product would not infringe any patent claiming Tiazac. At that 
time, the only patent known to claim Tiazac was U.S. Patent Number 
5,529,791 (``the ``791 patent''), which covers aspects of Tiazac's 
once-a-day formulation.
    As in several recent Commission matters, the facts of this case are 
set against the backdrop of the Drug Price Competition and Patent Term 
Restoration Act of 1984, commonly known as ``the Hatch-Waxman Act.'' 
Congress enacted the Hatch-Waxman Act to facilitate the entry of lower 
priced generic drugs, while maintaining incentives for pharmaceutical 
companies to invest in developing new drugs. In particular, the Hatch-
Waxman Act established certain rights and procedures in situations 
where a company seeks approval from the FDA to market a generic product 
prior to the expiration of a patent or patents relating to the branded 
drug upon which the generic is based.
    A generic drug is a pharmaceutical product that the FDA has 
determined to be bioequivalent to a branded drug. Generic drugs are 
chemically identical to their branded counterparts, but they typically 
are sold at substantial discounts from the branded drug's price. A 
Congressional Budget Office Report estimates that U.S. consumers saved 
an estimated $8-10 billion on prescriptions at retail pharmacies in 
1994 by purchasing generic drugs instead of the branded product.\1\
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    \1\ Congressional Budget Office, How Increased Competition from 
Generic Drugs Has Affected Prices and Returns in the Pharmaceutical 
Industry at xiii & 13 (July 1998).
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    Under the provisions of the Hatch-Waxman Act, a company seeking 
approval from the FDA to market a new drug must file a New Drug 
Application (``NDA'') demonstrating the safety and efficacy of its 
product. As part of this process, the NDA applicant also is required to 
submit to the FDA information on any patent claiming the approved drug 
and for which a claim of patent infringement could reasonably be 
asserted against another party. The FDA then lists the approved drug 
and its related patents in a publication entitled ``Approved Drug 
Products with Therapeutic Equivalence Evaluations,'' commonly known as 
the ``Orange Book.''
    The Hatch-Waxman Act also allows the listing of patents that are 
issued by the U.S. Patent and Trademark Office after an NDA has been 
approved.\2\
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    \2\ 21 U.S.C. Sec. 355(c)(2).
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    In order to receive FDA approval to market a generic version of a 
branded drug, a company must file an Abbreviated New Drug Application 
(``ANDA'') demonstrating that its product is bioequivalent to its 
branded counterpart. As part of the ANDA application process, the ANDA 
applicant also must provide a certification to the FDA regarding its 
generic product and any patents listed in the Orange Book that claim 
the reference branded drug. Under one form of certification, known as a 
``Paragraph IV certification,'' the ANDA applicant certifies that the 
patents listed in the Orange Book either are invalid or will not be 
infringed by the manufacture, use, or sale of the drug products for 
which the ANDA is submitted.
    The Hatch-Waxman Act further provides that notice of the Paragraph 
IV certification must be provided to each patent owner and the NDA 
holder for the listed drug. After receiving notice of a Paragraph IV 
certification, if the branded drug owner does not initiate a patent 
infringement suit within forty-five days, then the FDA's review and 
generic approval process may proceed according to the FDA's schedule. 
If, however, a patent infringement suit is filed within the forty-five 
day window, the FDA's approval of the ANDA is automatically stayed 
until the earliest of: (1) The date the patents expire; (2) a final 
determination of non-infringement or patent invalidity by a court in 
the patent litigation; or (3) the expiration of thirty months from the 
receipt of notice of the Paragraph IV certification (the ``30-month 
stay'').
    Andrx filed the first ANDA for a generic version of Tiazac in June 
1998. At that time, it provided a Paragraph IV certification to the FDA 
regarding the only patent then claiming Tiazac, the `791 patent. Within 
forty-five days of receiving Andrx's notice of certification, Biovail 
filed a patent infringement lawsuit, alleging that Andrx's generic 
Tiazac product would infringe the `791 patent. This lawsuit triggered a 
30-month stay of final regulatory approval of Andrx's ANDA, which was 
to expire on February 26, 2001 (or earlier, if an appellate court 
decision was granted in Andrx's favor before that date).
    On March 6, 2000, the U.S. District Court presiding over the patent 
infringement suit found that Andrx's product did not infringe the `791 
patent.\3\ Biovail appealed this decision to the U.S. Court of Appeals 
for the Federal Circuit. On September 29, 2000, while the appeal was 
still pending, the FDA tentatively approved Andrx's ANDA and informed 
Andrx that it would be eligible to receive final FDA approval upon 
expiration of the 30-month stay. This stay would have expired on 
February 13, 2001, the day the Federal Circuit affirmed the district 
court's ruling that Andrx's product did not infringe Biovail's `791 
patent.
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    \3\ Biovail Corp. Int'l v. Andrx Pharm. Inc., 2000 WL 33354427 
(S.D.. Fla. March 6, 2000).
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    Before the Federal Circuit issued its decision, however, Biovail, 
on January 8, 2001, listed a second patent in the Orange Book as 
claiming Tiazac. Biovail acquired this patent, U.S. Patent No. 
6,162,463 (``the `463 patent''), from DOV Pharmaceuticals, Inc., of New 
Jersey, through an exclusive licensing arrangement that also included 
plans to jointly develop new diltiazem products using the `463 patent. 
Because of this listing, Andrx was required to submit a second 
Paragraph IV certification asserting non-infringement of the `463 
patent. After receiving Andrx's certification, Biovail filed a second 
patent infringement suit, triggering a second 30-month stay of the 
final approval of Andrx's ANDA, and further delaying the potential 
entry of Andrx's generic Tiazac product.

The Challenged Conduct

    The Commission's complaint alleges that Biovail acquired exclusive 
rights to the `463 patent from DOV Pharmaceuticals, Inc., for the 
purpose of listing it in the FDA's Orange Book and thereby blocking 
Andrx's entry into the Tiazac market.
    Two days after the U.S. Patent and Trademark Office issued the `463 
patent, Biovail met with DOV to discuss a potential licensing 
agreement. Biovail sought to complete an exclusive licensing agreement 
with DOV by no later than January 19, 2001, the last date on which it 
could list the patent in the Orange Book and still be eligible to 
trigger Hatch-Waxman provisions that could result in a 30-month stay. 
Biovail listed the `463 patent in the Orange Book on January 8, four 
days before it actually completed the exclusive license agreement with 
DOV.
    In its certification to the FDA supporting the listing of the 
patent, Biovail attested that the `463 patent claimed FDA-approved 
Tiazac.

[[Page 21250]]

According to the complaint, however, Biovail was aware that the `463 
patent did not claim the formulation of Tiazac that it had been 
marketing. The product described in the `463 patent contains at least 1 
percent of uncoated or ``free'' immediate-release diltiazem, in 
addition to extended-release diltiazem in the form of coated beads. By 
contrast, the only form of Tiazac that Biovail has ever sold contains 
only negligible amounts--that is, well below 1 percent--of uncoated 
immediate-release diltiazem. Accordingly, Biovail did not need the `463 
patent in order to make or sell its existing FDA-approved formulation 
of Tiazac, and it could have continued to do so without infringing the 
`463 patent. Moreover, in prosecuting the patent before the U.S. Patent 
and Trademark Office, Dr. Lippa of DOV was required to distinguish the 
`463 patent from the prior art--including Biovail's Tiazac--before the 
patent examiner approved the patent. This suggests that the `463 patent 
could not simultaneously be valid and properly listed in the Orange 
Book for Tiazac.
    After learning that DOV was unable to give it a license to the `463 
patent because of Biovail's exclusive license, Andrx petitioned the FDA 
to require Biovail to de-list the `463 patent from the Orange Book. 
Although the FDA has publicly stated that it lacks the resources and 
the expertise to review patents submitted with NDAs and that it has 
only a limited ``ministerial role'' in listing patents,\4\ a party may 
dispute the propriety of a patent listing, as Andrx did, by notifying 
the FDA. The FDA will then request that the NDA holder confirm that the 
listed patent information is correct. Unless the NDA holder voluntarily 
withdraws or amends its listing, however, the FDA will not change the 
patent information in the Orange Book. As one court has observed, the 
FDA's listing of a patent does ``not create any presumption that [a] 
patent was correctly listed'' in the Orange Book.\5\
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    \4\ 59 FR 50338, 50345 (Oct. 3, 1994).
    \5\ Ben Venue Labs., Inc. v. Norvartis Pharm. Corp., 10 F. Supp. 
2d 446, 456 (D.N.J. 1998).
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    On February 7, 2001, and again on February 22, 2001, the FDA, 
consistent with its limited ``ministerial role'' in listing patents in 
the Orange Book, sought confirmation from Biovail that the `463 patent 
was properly listed. The complaint alleges that on February 26, 2001, 
as a result of a court filing by Biovail in a federal lawsuit brought 
by Andrx to force Biovail to de-list the `463 patent,\6\ the FDA 
learned that Biovail's position was that the `463 patent covered a new 
formulation of Tiazac that Biovail had developed only after it acquired 
and listed the `463 patent, rather than the version of Tiazac that the 
FDA had approved and that Biovail had been marketing. The FDA notified 
Biovail on March 20, 2001, that its new formulation of Tiazac was not 
approved by the FDA under the Tiazac NDA. Accordingly, the FDA would 
de-list the `463 patent from the Orange Book unless Biovail amended its 
certification to indicate that the patent claimed the version of Tiazac 
the FDA had approved.
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    \6\ The federal district court eventually rules that there is no 
private right of action under the Food, Drug, and Cosmetic Act for 
one company to require another to de-list a patent from the Orange 
Book. Amdrx Pharm., Inc. v. Biovail Corp., 175 F. Supp. 2d 1362, 
1373 (S.D. Fla. 2001).
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    In response to the FDA's inquiries, Biovail submitted a signed 
declaration stating that the `463 patent was eligible for listing in 
the FDA's Orange Book as claiming Tiazac. The complaint alleges that 
this declaration was misleading because it did not clarify whether the 
term ``Tiazac'' as used by Biovail meant the form of Tiazac the FDA had 
approved for marketing (as the FDA intended) or Biovail's revised form 
of the product. The FDA understood Biovail's March 26, 2001, 
declaration as affirming that the `463 patent covers the currently 
approved Tiazac product. On that basis, the FDA decided not to de-list 
the `463 patent from the Orange Book. According to the complaint, 
however, Biovail continued to assert that listing the `463 patent in 
the Orange Book was justified because it covers a revised form of 
Tiazac that Biovail believed fell within the Tiazac NDA, but which the 
FDA did not.
    The complaint concludes that as a result of Biovail's conduct, 
consumers of Tiazac have been deprived of the benefits of lower-priced 
generic competition that might have been possible had Biovail not 
acquired exclusive rights to, and then listed, the `463 patent, thereby 
precluding the FDA from granting final approval to Andrx's generic 
Tiazac in February 2001.

Competitive Analysis

    The complaint alleges that the relevant product market in which to 
assess the anticompetitive effects of Biovail's conduct is Tiazac and 
generic bioequivalent versions of Tiazac. Although other therapeutic 
agents can be used to treat high blood pressure and chronic chest pain, 
including several other branded and generic formulations of once-a-day 
diltiazem, these other therapeutic agents do not significantly 
constrain Tiazac's pricing. In contrast, entry of a generic 
bioequivalent version of Tiazac likely would result in a significant, 
immediate decrease in the sales of branded Tiazac, and lead to a 
significant reduction in the average market price paid for Tiazac and 
its generic bioequivalents. In fact, Biovail's own sales forecasts 
projected that generic Tiazac would have captured 40 percent of branded 
Tiazac sales within the first year alone.
    The relevant geographic market in which to assess the competitive 
effects of Biovail's conduct is the United States, given the FDA's 
elaborate regulatory process for approving drugs for sale in the United 
States, and the fact that the marketing, sales, and distribution of 
pharmaceuticals, like Tiazac, occur on a nationwide basis.
    The complaint thus alleges that, at all times relevant to this 
case, Biovail's market share of the relevant antitrust market has been 
100 percent.
    Biovail's conduct as described above, and as alleged in the 
complaint, violated the antitrust laws in two ways. First, Biovail's 
acquisition of an exclusive license to the `463 patent substantially 
lessened competition in the U.S. market for Tiazac and its generic 
equivalents. As stated in the complaint, Biovail's acquisition of the 
exclusive license to the `463 patent raised substantial barriers to 
Andrx's entry into the relevant market and gave Biovail the power to 
exclude competition, thereby protecting Biovail's monopoly in the 
Tiazac market, in violation of section 7 of the Clayton Act, 15 U.S.C. 
18, and section 5 of the FTC Act, 15 U.S.C. 45.
    The complaint also alleges that Biovail violated Section 5 of the 
FTC Act by engaging in acts that willfully maintained its Tiazac 
monopoly. These acts included: (a) acquiring an exclusive license to 
the `463 patent for the purpose of listing it in the Orange Book; (b) 
wrongfully listing the `463 patent in the Orange Book as claiming 
Tiazac, in order to be eligible for an automatic 30-month stay of FDA 
approval for any generic Tiazac product; and (c) giving non-responsive 
answers to questions raised by the FDA about the propriety of listing 
the `463 patent in the Orange Book, so as to avoid the possibility of 
de-listing. As the complaint states, Biovail's illegal monopolization 
raised substantial barriers to entry into the relevant market and gave 
Biovail the power to exclude competition. Biovail thereby deprived 
consumers of the benefits of lower-priced generic competition that 
might have been possible had the FDA not been precluded from granting 
final approval to Andrx's generic Tiazac. These acts and practices are 
anticompetitive in

[[Page 21251]]

nature and tendency, and constitute an unfair method of competition in 
violation of section 5 of the FTC Act, 15 U.S.C. 45.

The Proposed Order

    The proposed order is designed to address the anticompetitive 
effects of Biovail's illegal conduct charged above, by requiring 
Biovail to divest part of its exclusive rights to the `463 patent and 
by providing other relief, on a prospective basis, to prevent or 
discourage recurrence of such conduct in the future. In essence, the 
proposed order:
     Requires that Biovail divest to DOV the exclusive rights 
to the `463 patent, as it applies for use in making any form of the 
currently marketed and FDA-approved Tiazac product.
     Prevents Biovail from taking any actions that would result 
in an additional 30-month stay of final FDA approval for a generic form 
of Tiazac.
     Prohibits Biovail from wrongfully listing any patents in 
the Orange Book in violation of applicable law.
     Requires that Biovail give the Commission prior written 
notice before it acquires an exclusive license to any patent that it 
plans to list in the Orange Book for a product for which Biovail 
already has an FDA-approved NDA.
    By requiring that Biovail divest its exclusive rights in the ``463 
patent in the ``Tiazac Field,'' that is, for use in making any form of 
the currently FDA-approved Tiazac, Paragraph II returns the market for 
Tiazac products to the status quo as it existed before the patent 
acquisition occurred. Paragraph II.A requires that Biovail divest to 
DOV its exclusive interest in the ``463 patent as it relates to the 
Tiazac Field. Paragraph II.B prevents Biovail from structuring the 
divestiture in such a way that it would be able to continue reaping the 
benefits of its acquisition of the patent. Paragraph II.C proscribes 
the creation of a confidentiality agreement that could hinder future 
Commission enforcement actions against Biovail under the order or the 
antitrust laws. Paragraph II.D prohibits Biovail from having any input 
into the future utilization of the patent in the Tiazac Field. 
Paragraph II.E prevents Biovail from participating in any lawsuits to 
enforce the ``463 patent in the Tiazac Field. Paragraph II.F requires 
Biovail to dismiss its patent infringement claim against Andrx.
    Taken as a whole, Paragraph II removes Biovail's possession of 
exclusive rights in the ``463 patent (through which it was able to 
erect barriers to Andrx's potential entry), while preserving Biovail's 
and DOV's ability to innovate and develop new products using that same 
patent. Paragraph II allows Biovail to continue to use the ``463 
patent, on an exclusive basis, to develop new diltiazem products that 
may result in the filing of an NDA with the FDA. Moreover, nothing in 
the paragraph prevents Biovail from holding non-exclusive rights to the 
``463 patent to develop improved forms of the currently marketed Tiazac 
product.
    If Biovail fails to complete the divestiture required in Paragraph 
II.A within ninety days of signing the Agreement Containing Consent 
Order in this matter, Paragraph III of the Proposed Order requires 
Biovail to enter into a trust agreement and transfer the assets set 
forth in Paragraph II.A to a trustee appointed by the Commission. The 
trustee will then have the sole and exclusive power to divest the 
assets required in Paragraph II.A, subject to the prior approval of the 
Commission. The trustee will have twelve months to accomplish the 
divestiture, at no minimum price, to a buyer or buyers approved by the 
Commission.
    Paragraph IV is intended to remedy Biovail's allegedly illegal 
monopolization. By preventing Biovail from engaging in strategies that 
pharmaceutical companies have used to exploit the Hatch-Waxman Act to 
thwart generic entry, Paragraph IV seeks to ensure the entry of a 
generic Tiazac product at the earliest possible moment.
    Paragraph V is intended to deter Biovail from listing patents in 
the Orange Book that do not actually claim the drug product at issue, 
and thus prevent the triggering of procedures under the Hatch-Waxman 
Act that could improperly block generic entry. The Commission is 
concerned that improper patent listings may be a recurring problem in 
the pharmaceutical industry, and that such listings have a significant 
potential to affect competition and harm consumers. NDA holders have 
the ability unilaterally to list patents in the Orange Book--and thus 
exclude potential generic competitors from entering the market and 
competing for up to thirty months--whether or not the patent they list 
actually claims the product approved under the NDA. Because the FDA 
views its role in listing patents as ``purely ministerial,'' and 
because there is no private right of action to challenge a patent 
listing under the Food, Drug, and Cosmetic Act,\7\or NDA holders, such 
as Biovail in this case, to obtain an additional thirty months free 
from generic competition by listing inappropriate patents in the Orange 
Book.
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    \7\ Mylan v. Bristol-Myers Squibb Co. 268 F.3d 1323, 1331-32 
(Fed. Cir. 2001). See also Andrx Pharm., Inc. v. Biovail Corp., 175 
F. Supp. 2d 1362, 1373 (S.D. Fla. 2001).
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    The Commission believes that the operative provisions in Paragraphs 
II through V of the proposed order strike an appropriate balance 
between Biovail's interests in acquiring patents for legitimate 
business purposes, such as developing new products using that 
intellectual property, and the Commission's intention to remedy an NDA 
holder's creation of barriers to generic competition through strategic 
patent acquisitions and the misuse of the Hatch-Waxman regulatory 
framework. By not imposing broad prohibitions on Biovail's ability to 
develop new products based on the ``463 patent, and by not preventing 
Biovail from legitimately acquiring and listing patents for other NDAs 
it may hold, the order maintains Biovail's incentive to develop and 
sell new drug products, while curbing the potential for Hatch-Waxman 
Act abuse.
    Paragraph VI requires that Biovail submit written notification to 
the Commission before acquiring any patent or exclusive license on a 
patent, if Biovail also intends to seek the patent's listing in the 
Orange Book. Biovail will thus be free to continue acquiring 
intellectual property for legitimate business purposes, but the 
Commission will be notified in situations where there is a possibility 
that the acquisition of an exclusive license may serve to protect 
Biovail's dominant position in a relevant pharmaceutical market.
    Paragraph VII sets forth the form of notice that Biovail must 
provide to the Commission under Paragraph VI of the order. In addition 
to supplying a copy of the patents to be acquired, Paragraph VII 
requires Biovail to provide certain other information to assist the 
Commission in assessing the potential competitive effect of the patent 
acquisition. Accordingly, the order requires Biovail to identify, among 
other things, the parties participating in the acquisition, the 
approved NDA(s) with respect to which the acquired patent will be 
submitted for listing in the Orange Book, and all persons who have 
filed an ANDA referencing the identified NDAs. In addition, Biovail 
must provide the Commission with copies of all transactional documents 
and other documents that evaluate the proposed licensing agreement.
    Paragraphs VIII, IX, and X of the proposed order contain certain 
reporting and other standard Commission order provisions designed to 
assist the Commission in monitoring compliance with the order.
    The order will expire in ten years.

[[Page 21252]]

Opportunity for Public Comment

    The proposed order has been placed on the public record for thirty 
days in order to receive comments from interested persons. Comments 
received during this period will become part of the public record. 
After thirty days, the Commission will again review the proposed order 
and the comments received and will decide whether it should withdraw 
from the agreement containing the proposed order or make the proposed 
order final.
    By accepting the proposed order subject to final approval, the 
Commission anticipates that the competitive issues alleged in the 
complaint will be addressed. The purpose of this analysis is to 
facilitate public comment on the agreement. It is not intended to 
constitute an official interpretation of the agreement, the complaint, 
or the proposed consent order, or to modify their terms in any way.

    By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 02-10578 Filed 4-29-02; 8:45 am]
BILLING CODE 6750-01-P