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Santaris Again Looks to Safe Harbor Provision to End Isis Patent Lawsuit

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Santaris Pharma last week made another push to end the legal attack against it by Isis Pharmaceuticals, asking for the court that is hearing the companies' intellectual property lawsuit to rule that there was no infringement of the patents at the heart of the case.

Santaris' request hinges on the legal provision known as 35 U.S.C. 271 (e)(1), which allows companies to “make, use, offer to sell, or sell ... a patented invention … solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”

In a landmark 2005 US Supreme Court case, the provision was extended to the use of patented inventions that are “reasonably related to the development and submission of any information” to the US Food and Drug Administration.

Its allegedly infringing activities, Santaris said in a legal filing obtained by Gene Silencing News, explicitly involved the design and development of drugs, the generation of data, and the use of such data to apply for FDA approval of promising drugs. As such, they are protected by 35 U.S.C. 271 (e)(1), it added.

It is the second time that Santaris has tried to use the safe harbor provision to put an end to the lawsuit, after previously being told by the court that it did not provide enough support for its argument.

The dispute began in 2011 when Isis sued Santaris for infringing two of its US patents by providing antisense drug candidates and drug-discovery services to five pharmaceutical partners: Enzon, GlaxoSmithKline, Wyeth (now a part of Pfizer), Shire, and Pfizer.

The first patent is No. 6,326,199, entitled “Gapped 2' Modified Oligonucleotides” and claims oligos and macromolecules that have increased nuclease resistance, substituent groups for increasing binding affinity to complementary strands, and sub-sequences of 2'-deoxy-erythro-pentofuranosyl nucleotides that activate RNase H enzyme. The patent expired in 2011.

The second, No. 6,066,500, is entitled “Antisense Modulation of Beta Catenin Expression” and claims the use of antisense compounds “targeted to nucleic acids encoding beta catenin,” as well as methods of using these agents to treat diseases associated with the protein.

In early 2012, Santaris attempted to use the 35 U.S.C. 271 (e)(1) statute to fend off Isis' charges, but the court rejected the bid later that year. Specifically, the court said Santaris' argument was supported solely by a declaration by CSO Henrik Orum, who told the court that the company does not begin using the antisense technology at issue until “a therapeutic target has been identified by someone else, and Santaris is sufficiently satisfied that it may achieve a therapeutic effect against a human disease by modulating the identified target with ... antisense drugs.”

This testimony, the court added, fell short of the “evidentiary burden placed on an accused infringer claiming exemption from infringement” under 35 U.S.C. 271 (e)(1).

Last week, however, Santaris once again asked the patent-infringement charges be dropped in light of the legal provision, this time providing specific details about the corporate arrangements at issue to highlight their focus on generating FDA-approved drugs — although much of this information was redacted in order to guard trade secrets.

Each of the collaborations, Santaris told the court, contemplated that the pharmaceutical partner would "select specific RNA targets that were each related to a human disease," and that for each target, Santaris would design in its native Denmark a library of antisense compounds directed to it.

Santaris would conduct in vitro experiments on those compounds and, after further work by the pharmaceutical firms, drugs based on lead compounds would be the subject of investigational new drug application submissions to the FDA, it stated. These "would enable human clinical trials, followed by the submission of a [new drug application], further review by FDA, and eventual marketing approval."

Each transaction also includes a schedule for milestone payments to Santaris that would be made upon the completion of the traditional stages of drug development, further demonstrating that the deals were geared toward drug commercialization, the company added.

According to Santaris, Isis has argued that the safe harbor of 35 U.S.C. 271 (e)(1) applies only to the actual development and submission of information to the FDA, but "not to the 'purely commercial transactions' that would result in the generation of such information.

"But an additional goal such as making money does not abrogate the safe harbor," Santaris argued. "Regardless of when or how Santaris … books the revenue from its contracts, the transactions contemplate experiments that may generate data for submission to FDA. And so the safe harbor applies."

Additionally, the fact that certain of Santaris' allegedly infringing activities, such as its early-stage in vitro work, never gave rise to INDs does not eliminate the protection provided by 35 U.S.C. 271 (e)(1), the company stated.

"The Supreme Court recognized that the safe harbor applies even though the drug development process is plagued by uncertainty about 'exactly which kinds of information, and in what quantities, it will take to win'" FDA approval, it noted.

Isis' argument that Santaris has infringed its patents because of the availability of other, non-patented methods to obtain the same data also fails, Santaris claimed, in light of another court ruling that found that the safe harbor provision is "not limited to the dire situation where the patented invention is the only way to develop and submit information. Instead, the safe harbor expressly allows the submitter the freedom to use an otherwise patented means to develop" the information required by the FDA.

For these and other reasons, Santaris concluded, the court should find that it has not infringed the '199 and '500 patents.

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