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Isis Pharmaceuticals, Inc., A Delaware Corporation v. Santaris Pharma A/S Corp.

September 18, 2012

ISIS PHARMACEUTICALS, INC., A DELAWARE CORPORATION, PLAINTIFF,
v.
SANTARIS PHARMA A/S CORP., A DELAWARE CORPORATION, AND SANTARIS PHARMA A/S, A DANISH CORPORATION, DEFENDANTS.



The opinion of the court was delivered by: Honorable Barry Ted Moskowitz United States District Judge

MOTION FOR SUMMARY ORDER DENYING DEFENDANTS' JUDGMENT WITHOUT PREJUDICE

Plaintiff Isis Pharmaceuticals, Inc. ("Isis" or "Plaintiff") alleges that Defendants Santaris Pharma A/S Corp. and Santaris Pharma A/S (collectively, "Santaris" or "Defendants") have infringed upon two of Isis's patents. Pending before the Court is Defendants' motion for summary judgment, in which Defendants argue that their activities are protected by the "Safe Harbor" provision of 35 U.S.C. § 271(e)(1) (the "Safe Harbor").

I. BACKGROUND

The two patents at issue in this litigation provide for a form of biotechnology called antisense molecules. This background section provides an overview of antisense technology generally, the two relevant patents, and Plaintiff's specific infringement claims.

a. Overview of antisense technology

Proteins, fundamental molecules found in all living cells, are primary actors within a cell. They perform a variety of essential functions such as catalyzing chemical reactions, communicating between cells, and providing structural support. The overproduction or abnormal production of proteins can cause disease. One method for treating a disease caused by the overproduction of a certain "target" protein is to create an "antisense" molecule that interrupts the cellular process of creating that protein.

The cellular process of creating proteins begins with genetic information ("genes") stored in DNA and proceeds in two stages: transcription and translation. During transcription, the gene for a particular protein is copied from a strand of DNA to a molecule called messenger RNA ("mRNA"). During translation, cellular machinery converts the information on the mRNA into proteins.

Antisense molecules-typically a type of a nucleic acid that is similar to DNA and mRNA molecules, but much shorter-are able to interrupt the genesis of the target protein at the translation stage by binding to the mRNA molecules containing the genetic information for that protein. Once bound to an mRNA molecule, the antisense molecule can obstruct the chemical process that translates the mRNA into a protein. The two biotechnology patents at issue in this litigation relate to antisense technology.

b. The '199 Patent

U.S. Patent No. 6,326,199, "Gapped 2' Modified Oligonucleotides" (the "'199 Patent"), claims, in independent claim 1, a method of enhancing an antisense molecule by creating structural features (a) enabling the antisense molecule to resist degradation before it reaches its target mRNA; (b) enhancing "binding affinity" (the strength of the chemical bond between the antisense molecule and the target mRNA); and (c) activating an enzyme called Rnase H that, once activated, severs the target mRNA, preventing translation into the target protein.

See Cplt. ¶¶ 19-21; '199 Patent Col. 31, ll. 39-49. Many of the dependent claims claim methods of modifying the molecule described in Claim 1 in additional ways.

Independent claim 11 claims a method of "modifying a sequence-specific ribo-nucleic acid" (i.e., a target mRNA or other type of RNA) using a molecule having the properties claimed in claim 1. ('199 Patent Col. 33, ll. 3-15.) In other words, claim 11 claims the method of using the antisense molecule described in claim 1 to affect the function of its target.

c. The '500 Patent

U.S. Patent No. 6,066,500, "Antisense Modulation of Beta Catenin Expression" (the '500 Patent"), is directed toward antisense technology that is designed specifically to inhibit the expression of a protein called Beta catenin. Beta catenin has been implicated in the development of several types of cancer, including cancer of the colon and of the skin. Independent claims 1 and 3 claim an antisense molecule of a particular size that hybridizes with the mRNA molecule responsible for generating Beta catenin, and thereby "inhibits the expression of Beta catenin." (Col. 65, ll. ...


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