UCB SA - BNP Paribas Fortis

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Patent laws in UCB’s major markets are substantially similar, but the protection provided by a patent varies from country to country, depending on the type of claim granted, the scope of those claims’ coverage (the way claims are interpreted) and the legal remedies available for enforcement. Although there are certain exceptions as to when and how generic pharmaceutical manufacturers may apply for regulatory approval with respect to patent expiry, patent protection in key markets such as the United States, Europe and Japan is generally strong. The UCB Group currently has approximately 510 active patent families, comprising approximately 3,080 granted patents and 2,310 pending patent applications. Although patents are important to the business of the UCB Group, UCB believes that no single patent (or group of related patents) is material to the UCB Group’s business as a whole. However, the Issuer believes that patents relating to key products such as Cimzia®, Neupro®, Vimpat® and Keppra®XR are of particular importance. Term and Expiration of Patent The term of a patent varies depending on the laws of the particular jurisdiction which has granted the patent. However, in all jurisdictions which are of key importance to the UCB Group, patent protection, once granted, is valid for 20 years from the date on which the corresponding patent application was filed. The European Union, the United States, Japan and certain other countries provide extensions of patent term or supplementary protection certificates to compensate for patent term loss due to regulatory review thus allowing adequate time to recoup the substantial investment in research and development and regulatory approval of products. In accordance with its product life-cycle management policy, the UCB Group will seek such extensions wherever and whenever they are available. Although expiration of the basic patent protection for a product (usually the API or a key formulation) normally results in the loss of market exclusivity, the UCB Group may continue to derive commercial benefits from: • patents relating to specific uses for the API; • patents relating to novel compositions and formulations; • patents relating to processes and intermediates used in manufacturing the active ingredient; and • in certain markets (including the U.S. and the EU), market exclusivity under laws other than patent laws, in particular, regulatory data protection and exclusivity provisions. The following summary sets forth the expected expiration dates of the basic patent protection for key products of the UCB Group in its major markets (including any patent extensions, where applied for or already granted). Marketed Products EU U.S. Japan Keppra® (levetiracetam; API) September 2 2010 3 Expired None 2 The basic patent in Europe expires in May 2010 however data exclusivity applies to until September 2010 making this the date of expiration of exclusivity 3 Including extensions where applied for or already granted A11250830/2.25/23 Oct 2009 76
Neupro® (rotigotine; patch) February 2021 3 March 2021 3 March 2019 Vimpat® (lacosamide; API) March 2022 3 March 2022 3 Under negotiation Cimzia® (certolizumab; API) June 2021 March 2024 3 June 2021 Products in Development: The UCB Group’s key products in development are expected to enjoy basic patent protection of 10 years or longer from their projected introduction dates in the core markets of the UCB Group. Licenses from third parties which the UCB Group deems to be important for its business activities, such as those relating to Neupro® (rotigotine), Vimpat® (lacosamide), Cimzia® (certiluzimab) have been secured. See Section 15, “Legal Proceedings” of this Part VI, for a description of patent-related litigation in which companies of the UCB Group are involved. (b) Trademarks The following table sets forth the best-known trademarks of the UCB Group which have been registered on behalf of the UCB Group and enjoy trademark protection: • UCB and the logo • KEPPRA® • NEUPRO® • XYZAL® • ZYRTEC® • CIRRUS® • VIMPAT® • METADATE® • TUSSIONEX® • CIMZIA® In contrast to patents, registrations for trademarks can be renewed indefinitely, although in many jurisdictions it is required to use the trademark in commerce to preserve its registration and protection. Even though many jurisdictions recognise common law rights in trademarks, it is the policy of the UCB Group to register its trademarks whenever a jurisdiction provides for such registration. Although the trademark portfolio of the UCB Group is important to its business activities, the UCB Group does not believe that a single trademark in its portfolio is material to the business of the UCB Group as a whole. 13. GOVERNMENTAL REGULATION The business activities of the UCB Group are subject to significant governmental regulation. Its pharmaceutical products must be examined and approved by regulatory agencies for quality, safety and effectiveness before they may be marketed. The distribution and marketing of its products is subject to A11250830/2.25/23 Oct 2009 77
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A11250830/2.25/23 Oct 2009 UCB SA (
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A11250830/2.25/23 Oct 2009 3 RESPON
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A11250830/2.25/23 Oct 2009 5 WARNIN
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A11250830/2.25/23 Oct 2009 7 PART I
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Specified Denomination per Bond Min
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Trading on the regulated market of
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- Reliance on the procedures of the
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and federal governmental entities,
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If any of the UCB Group’s major p
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The UCB Group relies upon third-par
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other U.S. federal and state govern
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either to remediate certain sites o
Page 25 and 26: (iii) have sufficient financial res
Page 27 and 28: (i) EU Savings Directive Under the
Page 29 and 30: (o) The Domiciliary Agent is not re
Page 31 and 32: PART III: DOCUMENTS INCORPORATED BY
Page 33 and 34: • Press release of 26 June 2009:
Page 35 and 36: The Bonds constitute direct, uncond
Page 37 and 38: “Interest Payment Date” has the
Page 39 and 40: When interest is required to be cal
Page 41 and 42: "Calculation Agent" means Fortis Ba
Page 43 and 44: The Issuer reserves the right under
Page 45 and 46: any step is taken to enforce it (in
Page 47 and 48: 12 Notices Notices to the Bondholde
Page 49 and 50: 1. SUMMARY PART VI: DESCRIPTION OF
Page 51 and 52: Marketing & selling expenses Resear
Page 53 and 54: In 2008, the Issuer announced sever
Page 55 and 56: Issuer is developing from its stron
Page 57 and 58: Parkinson’s disease. Following a
Page 59 and 60: Keppra® is one of the core product
Page 61 and 62: that remission is possible with no
Page 63 and 64: (d) Manufacturing and supply of raw
Page 65 and 66: NET SALES FOR MAIN PRODUCTS BY REGI
Page 67 and 68: (a) a strategic focus on severe CNS
Page 69 and 70: ongoing and results are expected du
Page 71 and 72: Cimzia® (certolizumab pegol) Cimzi
Page 73 and 74: • Pfizer Inc.: The UCB Group is p
Page 75: esearch, regulatory, manufacturing,
Page 79 and 80: Before a drug can qualify for marke
Page 81 and 82: control mechanisms operate differen
Page 83 and 84: year term following a specific regu
Page 85 and 86: pain; which expires with the last t
Page 87 and 88: Group. The UCB Group treats any cla
Page 89 and 90: (g) Distilbène Litigation As of th
Page 91 and 92: (n) Competition enquiry in France T
Page 93 and 94: 3 These Directors are representativ
Page 95 and 96: Norman J-Ornstein was appointed to
Page 97 and 98: Mark McDade joined the Issuer as ex
Page 99 and 100: esults or information which is liab
Page 101 and 102: Peter Fellner......................
Page 103 and 104: • the closing price of the Ordina
Page 105 and 106: A11250830/2.25/23 Oct 2009 105 PART
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Page 109 and 110: Company name Registered office Cist
Page 111 and 112: Company name Registered office Schw
Page 113 and 114: Company name Registered office UCB
Page 115 and 116: Company name Registered office UCB
Page 117 and 118: PART XI: DESCRIPTION OF THE SHARES
Page 119 and 120: According to article 32 of the Arti
Page 121 and 122: Under UCB’s Articles, the Issuer
Page 123 and 124: The Board can also determine when s
Page 125 and 126: 1. BELGIAN TAXATION PART XIII: TAXA
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(b) Belgian tax on income and capit
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more detailed proposal for amendmen
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PART XIV: SUBSCRIPTION AND SALE For
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On the date that the subscriptions
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12. DISTRIBUTION OF THE PROSPECTUS
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PART XV: GENERAL INFORMATION 1. App
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A11250830/2.25/23 Oct 2009 139 Subs
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Addressee UCB SA (the « Issuer »)
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UCB SA - BNP Paribas Fortis

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