12.04.2013 Views

UCB SA - BNP Paribas Fortis

UCB SA - BNP Paribas Fortis

UCB SA - BNP Paribas Fortis

SHOW MORE
SHOW LESS

Create successful ePaper yourself

Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.

Patent laws in <strong>UCB</strong>’s major markets are substantially similar, but the protection provided by a patent<br />

varies from country to country, depending on the type of claim granted, the scope of those claims’<br />

coverage (the way claims are interpreted) and the legal remedies available for enforcement. Although<br />

there are certain exceptions as to when and how generic pharmaceutical manufacturers may apply for<br />

regulatory approval with respect to patent expiry, patent protection in key markets such as the United<br />

States, Europe and Japan is generally strong.<br />

The <strong>UCB</strong> Group currently has approximately 510 active patent families, comprising approximately<br />

3,080 granted patents and 2,310 pending patent applications. Although patents are important to the<br />

business of the <strong>UCB</strong> Group, <strong>UCB</strong> believes that no single patent (or group of related patents) is material<br />

to the <strong>UCB</strong> Group’s business as a whole. However, the Issuer believes that patents relating to key<br />

products such as Cimzia®, Neupro®, Vimpat® and Keppra®XR are of particular importance.<br />

Term and Expiration of Patent<br />

The term of a patent varies depending on the laws of the particular jurisdiction which has granted the<br />

patent. However, in all jurisdictions which are of key importance to the <strong>UCB</strong> Group, patent protection,<br />

once granted, is valid for 20 years from the date on which the corresponding patent application was<br />

filed.<br />

The European Union, the United States, Japan and certain other countries provide extensions of patent<br />

term or supplementary protection certificates to compensate for patent term loss due to regulatory<br />

review thus allowing adequate time to recoup the substantial investment in research and development<br />

and regulatory approval of products. In accordance with its product life-cycle management policy, the<br />

<strong>UCB</strong> Group will seek such extensions wherever and whenever they are available.<br />

Although expiration of the basic patent protection for a product (usually the API or a key formulation)<br />

normally results in the loss of market exclusivity, the <strong>UCB</strong> Group may continue to derive commercial<br />

benefits from:<br />

• patents relating to specific uses for the API;<br />

• patents relating to novel compositions and formulations;<br />

• patents relating to processes and intermediates used in manufacturing the active ingredient; and<br />

• in certain markets (including the U.S. and the EU), market exclusivity under laws other than patent<br />

laws, in particular, regulatory data protection and exclusivity provisions.<br />

The following summary sets forth the expected expiration dates of the basic patent protection for key<br />

products of the <strong>UCB</strong> Group in its major markets (including any patent extensions, where applied for or<br />

already granted).<br />

Marketed Products EU U.S. Japan<br />

Keppra® (levetiracetam; API) September 2 2010 3 Expired None<br />

2<br />

The basic patent in Europe expires in May 2010 however data exclusivity applies to until September 2010 making this the date of expiration of<br />

exclusivity<br />

3<br />

Including extensions where applied for or already granted<br />

A11250830/2.25/23 Oct 2009 76

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!