Court Offers Insights On When The 271(E)(1) Safe Harbor Applies To The Use Of Patented Technology In Early – And Late -- Drug Development

FDA-regulated firms -- drug, device, biologic or otherwise -- on both sides of the patent aisle concerned with the bounds of the "Safe Harbor" exception to patent infringement under 35 U.S.C. § 271(e)(1) can learn several key lessons from the recent decision in Isis Pharmaceuticals, Inc. v Santaris Pharma A/S Corp. (hereafter: "Isis"), particularly how to properly prove the safe harbor defense once the litigation unfolds and also when the harbor provides shelter from post-approval patent storms.

A Lesson on Proper Safe Harbor Pleading

In Isis, the district court for the Southern District of California held that, if a drug developer establishes a reasonable basis for believing that a "patented invention" will have a "particular biological effect" through a "particular biological process," such a showing would be sufficient, although not the only way, to establish a safe harbor defense to patent infringement under 35 U.S.C. § 271(e)(1) [hereafter: "271(e)(1)"]. The safe harbor provision in § 271(e)(1) exempts otherwise infringing acts from patent liability when those acts are performed "solely for uses reasonably related to the development and submission of information under a Federal law which regulates the . . . use . . . of drugs."

In reaching its holding, the Isis court relied on the Supreme Court's observation in Merck v Integra that otherwise infringing experimentation on the road to regulatory approval comes within the safe harbor "[a]t least where a drug maker has a reasonable basis for believing that a patented compound may work, through a particular biological process, to produce a particular biological effect . . . ." Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 207 (2005) (emphasis added).

By way of background, Isis sued Santaris (a Danish corporation not to be confused with Isis's fellow San Diego-based firm Santarus, recently bought by Salix Pharmaceuticals), accusing Santaris of infringing Isis patents to antisense compounds and methods of making the antisense compounds when Santaris contracted to sell antisense drug discovery services and products to four pharmaceutical company customers in the United States. Santaris moved for summary judgment on its affirmative defense that the alleged acts of infringement fell within the safe harbor provision of 35 U.S.C. § 271.

The court denied Santaris's summary judgment motion, finding that Santaris failed to provide undisputed evidence of the belief that the Merck I Court found was needed to...