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Isis Pharmaceuticals Files Patent Infringement Suit Against Santaris Pharma
Date:9/23/2011

CARLSBAD, Calif., Sept. 23, 2011 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today it has filed a patent infringement lawsuit against Santaris Pharma A/S and Santaris Pharma A/S Corp. in the United States District Court of the Southern District of California.  Isis' infringement suit against Santaris is based upon Santaris' activities providing antisense drugs and antisense drug discovery services to several pharmaceutical companies.  As alleged in the complaint, these activities are not protected under the exemption from patent infringement for drug development.

Isis is the leading antisense company.  Through its commitment to innovation in antisense technology, Isis has generated a large patent estate that provides the Company with extensive protection for its drugs and technology.  Isis is the owner or exclusive licensee of approximately 1,550 issued patents worldwide that cover all facets of antisense drugs.  One portion of Isis' patent estate includes patents covering basic oligonucleotide chemical modifications, drug designs that optimize therapeutic properties of antisense drugs, and the use of antisense compounds in drug discovery.  In the filed complaint, Isis alleges infringement of U.S. Patent No. 6,326,199, entitled "Gapped 2' Modified Oligonucleotides" and U.S. Patent No. 6,066,500, entitled "Antisense Modulation of Beta Catenin Expression" as the basis of its action.

"Since Isis' inception, our commitment has been to create a platform technology that has the power to change drug discovery and the treatment of disease.  We have actively protected our inventions resulting in a substantial patent estate.  A key element of our business is to make our patented technology available to researchers and drug developers who want to work in the antisense field. This strategy has resulted in a broad constellation of collaborative relationships with large and small companies advancing antisense drugs and the antisense technology platform," said B. Lynne Parshall, COO and CFO of Isis.  "A necessary component of our strategy is that we vigorously pursue infringement of our intellectual property.  The exemption from patent infringement for drug development was created to encourage rapid introduction of generic medicines.  We allege Santaris' activities are not protected by this exemption and that case law affirms our position."  

ABOUT ISIS PHARMACEUTICALS, INC.

Isis is exploiting its leadership position in antisense technology to discover and develop novel drugs for its product pipeline and for its partners.  Isis' broad pipeline consists of 24 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic and severe and rare/neurodegenerative diseases, and cancer.  Isis' partner, Genzyme, plans to commercialize Isis' lead product, mipomersen, following regulatory approval, which is expected in 2012.  Isis' patents provide strong and extensive protection for its drugs and technology.  Additional information about Isis is available at www.isispharm.com.

ISIS PHARMACEUTICALS' FORWARD-LOOKING STATEMENT

This press release includes forward-looking statements regarding Isis' intellectual property position and its value in drug discovery and development.  Any statement describing Isis' goals, expectations, financial or other projections, intentions or beliefs, including the planned commercialization of mipomersen, is a forward-looking statement and should be considered an at-risk statement.  Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs.  Isis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements.  Although Isis' forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis.  As a result, you are cautioned not to rely on these forward-looking statements.  These and other risks concerning Isis' programs are described in additional detail in Isis' annual report on Form 10-K for the year ended December 31, 2010 and its most recent quarterly report on Form 10-Q, which are on file with the SEC. Copies of these and other documents are available from the Company.

In this press release, unless the context requires otherwise, "Isis," "Company," "we," "our," and "us" refers to Isis Pharmaceuticals and its subsidiaries, including Regulus Therapeutics Inc., its jointly owned subsidiary.

Isis Pharmaceuticals® is a registered trademark of Isis Pharmaceuticals, Inc.  Regulus Therapeutics™ is a trademark of Regulus Therapeutics Inc.  


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SOURCE Isis Pharmaceuticals, Inc.
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