Novartis AG; Analysis of Proposed Agreement Containing Consent Orders to Aid Public Comment, 51460-51461 [2010-20709]

Agencies

• FEDERAL TRADE COMMISSION

[Federal Register Volume 75, Number 161 (Friday, August 20, 2010)]
[Notices]
[Pages 51460-51461]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-20709]



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FEDERAL TRADE COMMISSION

[File No. 101 0068]


Novartis AG; Analysis of Proposed Agreement Containing Consent 
Orders 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 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 September 16, 2010.

ADDRESSES: Interested parties are invited to submit written comments 
electronically or in paper form. Comments should refer to ``Norvartis 
AG, File No. 101 0068'' to facilitate the organization of comments. 
Please note that your comment -- including your name and your state -- 
will be placed on the public record of this proceeding, including on 
the publicly accessible FTC website, at (https://www.ftc.gov/os/publiccomments.shtm).
    Because comments will be made public, they should not include any 
sensitive personal information, such as an individual's Social Security 
Number; date of birth; driver's license number or other state 
identification number, or foreign country equivalent; passport number; 
financial account number; or credit or debit card number. Comments also 
should not include any sensitive health information, such as medical 
records or other individually identifiable health information. In 
addition, comments should not include any ``[t]rade secret or any 
commercial or financial information which is obtained from any person 
and which is privileged or confidential. . . .,'' as provided in 
Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and Commission Rule 
4.10(a)(2), 16 CFR 4.10(a)(2). Comments containing material for which 
confidential treatment is requested must be filed in paper form, must 
be clearly labeled ``Confidential,'' and must comply with FTC Rule 
4.9(c), 16 CFR 4.9(c).\1\
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    \1\ The comment must be accompanied by an explicit request for 
confidential treatment, including the factual and legal basis for 
the request, and must identify the specific portions of the comment 
to be withheld from the public record. The request will be granted 
or denied by the Commission's General Counsel, consistent with 
applicable law and the public interest. See FTC Rule 4.9(c), 16 CFR 
4.9(c).
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    Because paper mail addressed to the FTC is subject to delay due to 
heightened security screening, please consider submitting your comments 
in electronic form. Comments filed in electronic form should be 
submitted by using the following weblink: (https://ftcpublic.commentworks.com/ftc/novartis) and following the instructions 
on the web-based form. To ensure that the Commission considers an 
electronic comment, you must file it on the web-based form at the 
weblink: (https://ftcpublic.commentworks.com/ftc/novartis). If this 
Notice appears at (https://www.regulations.gov/search/index.jsp), you 
may also file an electronic comment through that website. The 
Commission will consider all comments that regulations.gov forwards to 
it. You may also visit the FTC website at (https://www.ftc.gov/) to read 
the Notice and the news release describing it.
    A comment filed in paper form should include the ``Norvartis AG, 
File No. 101 0068'' reference both in the text and on the envelope, and 
should be mailed or delivered to the following address: Federal Trade 
Commission, Office of the Secretary, Room H-135 (Annex D), 600 
Pennsylvania Avenue, NW, Washington, DC 20580. The FTC is requesting 
that any comment filed in paper form be sent by courier or overnight 
service, if possible, because U.S. postal mail in the Washington area 
and at the Commission is subject to delay due to heightened security 
precautions.
    The Federal Trade Commission Act (``FTC Act'') and other laws the 
Commission administers permit the collection of public comments to 
consider and use in this proceeding as appropriate. The Commission will 
consider all timely and responsive public comments that it receives, 
whether filed in paper or electronic form. Comments received will be 
available to the public on the FTC website, to the extent practicable, 
at (https://www.ftc.gov/os/publiccomments.shtm). As a matter of 
discretion, the Commission makes every effort to remove home contact 
information for individuals from the public comments it receives before 
placing those comments on the FTC website. More information, including 
routine uses permitted by the Privacy Act, may be found in the FTC's 
privacy policy, at (https://www.ftc.gov/ftc/privacy.shtm).

FOR FURTHER INFORMATION CONTACT: Kari A. Wallace (202-326-3085), Bureau 
of Consumer Protection, 600 Pennsylvania Avenue, NW, Washington, D.C. 
20580.

SUPPLEMENTARY INFORMATION: Pursuant to section 6(f) of the Federal 
Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and Sec.  2.34 the 
Commission 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 August 16, 2010), on the World Wide Web, at (https://www.ftc.gov/os/actions.shtm). A paper copy can be obtained from the FTC Public 
Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW, Washington, 
D.C. 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. All comments should be filed as 
prescribed in the ADDRESSES section above, and must be received on or 
before the date specified in the DATES section.

Analysis of Agreement Containing Consent Order to Aid Public Comment

I. Introduction

    The Federal Trade Commission (``Commission'') has accepted, subject 
to final approval, an Agreement Containing Consent Orders (``Consent 
Agreement'') from Novartis AG (``Novartis'') that is designed to remedy 
the anticompetitive effects of Novartis' acquisition of a controlling 
interest in Alcon, Inc. (``Alcon'') from Nestle, S.A. The proposed 
Consent Agreement requires Novartis to divest its rights and assets in 
its injectable miotics product, Miochol-E, to Bausch & Lomb, Inc. 
(``B&L'').
    The proposed Consent Agreement has been placed on the public record 
for thirty days for receipt of comments by interested persons. Comments 
received during this period will become part of the public record. 
After thirty days, the Commission will again review the proposed 
Consent Agreement and the comments received, and will decide whether it 
should withdraw from the proposed Consent Agreement, modify it, or make 
final the Decision and Order (``Order'').
    Pursuant to a Purchase and Option Agreement dated April 6, 2008, 
and the

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execution of the call option on January 4, 2010, Novartis proposes to 
acquire all of the outstanding shares of Alcon held by Nestle in a 
transaction valued at approximately $28.1 billion. After consummating 
the transaction, Novartis will hold 77 percent of Alcon. Novartis also 
proposes to acquire the remaining 23 percent of Alcon held by public 
shareholders. The Commission's Complaint alleges that the proposed 
acquisition, if consummated, would violate Section 7 of the Clayton 
Act, as amended, 15 U.S.C. Sec.  18, and Section 5 of the Federal Trade 
Commission Act, as amended, 15 U.S.C. Sec.  45, by lessening 
competition in the U.S. market for the research, development, 
marketing, manufacture and sale of injectable miotics. The proposed 
Consent Agreement will remedy the alleged violations by replacing the 
lost competition that would result from the acquisition in this market.
    Novartis is a global manufacturer and supplier of numerous branded 
and generic pharmaceuticals headquartered in Basel, Switzerland. Nestle 
is the world's largest food company, and is headquartered in Vevey, 
Switzerland. Among Nestle's holdings is a 52 percent stake in Alcon, 
which provides Nestle with a controlling interest in the company. 
Alcon, a global medical specialty company focused on eye care, is also 
a Swiss corporation, based in H[uuml]nenberg. Alcon develops, 
manufactures, and sells surgical devices used in surgical eye 
procedures, branded and generic pharmaceuticals, and over-the-counter 
consumer eye care products.

II. Injectable Miotics

    Injectable miotics are a class of prescription pharmaceutical 
products that are used to induce miosis, or constriction of the pupil. 
Injectable miotics are used in a variety of applications, most commonly 
during cataract surgery. Novartis introduced its product, Miochol-E, in 
1993; Alcon's product, Miostat, was launched in 1972. Though patents no 
longer cover the formulation of the active ingredient of either Miostat 
or Miochol-E, no generic versions of either product have been launched. 
For years, Novartis and Alcon have been the only suppliers of 
injectable miotics in the United States, with respective market shares 
of approximately 67 and 33 percent. U.S. sales of injectable miotic 
products in 2009 totaled $12.4 million.
    Entry into the market for the research, development, manufacture 
and sale of injectable miotics would not be timely, likely or 
sufficient in its magnitude, character, and scope to deter or 
counteract the anticompetitive effects of the acquisition. Entry would 
not take place in a timely manner because the combination of branded 
drug development times and U.S. Food and Drug Administration (``FDA'') 
approval requirements takes at least two years. Entry would not be 
likely because the relevant market is relatively small and in decline, 
so the limited sales opportunities available to a new entrant are 
likely insufficient to warrant the time and investment necessary to 
enter.
    In sum, the proposed acquisition of Alcon by Novartis would create 
a monopoly in the market for injectable miotics. The evidence indicates 
that customers have benefitted from direct pricing competition between 
the two companies, and that the price of Miostat-E is currently 
constrained by Miostat pricing. The reduction in the number of 
competitors in this market from two to one would allow the merged 
entity to unilaterally exercise market power and result in an increase 
in prices to consumers.

III. The Consent Agreement

    The proposed Consent Agreement effectively remedies the proposed 
acquisition's anticompetitive effects in the relevant product market. 
Pursuant to the Consent Agreement, Novartis is required to divest 
certain rights and assets related to its injectable miotics product to 
a Commission-approved acquirer no later than ten (10) days after the 
acquisition. Specifically, the proposed Consent Agreement requires that 
Novartis divest its rights and assets related to Miochol-E to B&L.
    Pursuant to the Consent Agreement, the acquirer of divested assets 
must receive the prior approval of the Commission. As always, the 
Commission's goal in evaluating a possible purchaser of divested assets 
is to maintain the competitive environment that existed prior to the 
acquisition. A proposed acquirer of divested assets must not itself 
present competitive problems.
    B&L is an eye-health company that develops, sells, and distributes 
products in over 100 countries. B&L is particularly well-positioned to 
manufacture and market Miochol-E and compete effectively in the 
injectable miotics market. The acquisition by B&L does not create a 
competitive problem in the injectable miotics market because B&L does 
not participate in the market. With its resources, capabilities, strong 
reputation, and experience marketing eye care products, specifically 
other cataract surgery products, B&L is expected to replicate the 
competition that would be lost if the proposed transaction were to 
proceed unremedied.
    If the Commission ultimately determines after the public comment 
period that B&L is not an acceptable acquirer of the assets to be 
divested, or that the manner of the divestitures is not acceptable, the 
parties must unwind the sale and divest the assets within six months of 
the date the Order becomes final to another Commission-approved 
acquirer. If the parties fail to divest within six months, the 
Commission may appoint a trustee to accomplish the divestiture.
    The proposed remedy contains several provisions to ensure that the 
divestiture is successful. The Order requires Novartis to provide 
transitional services to enable the Commission-approved acquirer to 
successfully transfer the manufacturing from Novartis. Much of the 
manufacturing process for Miochol-E is performed for Novartis by third-
party manufacturers. As part of the divestiture, Novartis will transfer 
its manufacturing arrangements to B&L. Additionally, Novartis will 
provide technical assistance to help B&L manufacture Miochol-E.
    The Commission has appointed Karl L. Hoffman Jr. of Rondaxe Pharma 
(``Rondaxe'') to oversee the asset transfer and to ensure Novartis' 
compliance with all of the provisions of the proposed Consent 
Agreement. Mr. Hoffman is a Quality Systems and Support Director at 
Rondaxe and has an extensive background in the pharmaceutical industry. 
He is a highly-qualified expert on FDA regulatory matters and currently 
advises Rondaxe clients on achieving satisfactory regulatory compliance 
and interfacing with the FDA. In order to ensure that the Commission 
remains informed about the status of the proposed divestiture and the 
transfers of assets, the proposed Consent Agreement requires Novartis 
and Alcon to file reports with the Commission periodically until the 
divestitures and transfers are accomplished.
    The purpose of this analysis is to facilitate public comment on the 
proposed Consent Agreement, and it is not intended to constitute an 
official interpretation of the proposed Order or to modify its terms in 
any way.
    By direction of the Commission, Commissioner William E. Kovacic 
recused.

Richard C. Donohue
Acting Secretary.
[FR Doc. 2010-20709 Filed 8-19-10: 8:45 am]
BILLING CODE: 6750-01-S