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Wolf Greenfield Wins Three More Years of Patent Protection for Shire Pharmaceuticals’ ELAPRASE

Monday, August 18, 2008

Boston, MA -- Wolf, Greenfield & Sacks, P.C., a Boston intellectual property law firm, has announced that, on behalf of its client, Shire Pharmaceuticals, it has recently obtained an additional 1,126 days of patent term for ELAPRASE (idursulfase), a treatment for patients with Hunter Syndrome (Mucopolysaccharidosis II, MPS II). Hunter syndrome is a rare, life-threatening genetic condition that results from the absence or insufficient levels of the lysosomal enzyme iduronate-2-sulfatase. Without this enzyme, cellular waste products accumulate in tissues and organs, which then begin to malfunction.

Shire's ELAPRASE product is the first and only treatment approved for people suffering from Hunter syndrome. The product, which is given as weekly infusions, replaces the missing enzyme that Hunter syndrome patients fail to produce in sufficient quantities.

Shire is the exclusive licensee of patent #5,932,211 ('211 patent), which covers ELAPRASE. The '211 patent had an original expiration date of August 3, 2016. The Certificate Extending Patent Term extends the expiration of the '211 patent up to September 3, 2019 -- more than an additional 3 years. The market for ELAPRASE is estimated to exceed $300 million/year.

The Drug Price Competition and Patent Term Restoration Act of 1984 (known as the "Hatch-Waxman Act") established the ability for companies to recoup some of the patent term lost during the lengthy FDA approval process required to market a drug, biologic, or medical device in the US.

Wolf Greenfield attorneys have assisted clients with Patent Term Extension issues for drugs, biologics, and medical devices. Shareholder Michael Siekman is available as expert source on issues relating to patent term extensions.

Founded in 1986, Shire Limited is a global specialty biopharmaceutical company with revenues for the full year 2007 of $2.44 billion. Its world headquarters are in Basingstoke, UK and its US headquarters are in Wayne, Pennsylvania.

Wolf Greenfield, the largest law firm in New England devoted exclusively to intellectual property law, serves companies that make everything from pharmaceuticals to software to electronics to snowboards, as well as representing academic research centers. The firm counsels clients in the areas of patents, trademarks, copyrights, designs, trade secrets, and related licensing and litigation. Web:

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