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Isis Opposes Santaris Bid to Throw out Patent-Infringement Suit

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By Doug Macron

Isis Pharmaceuticals this week asked a US District Court to reject Santaris Pharma's bid to have a patent-infringement suit against it dismissed, arguing that Santaris failed to give sufficient reason that the case shouldn't proceed to the evidence-discovery phase.

Isis took issue with Santaris' claim that its allegedly infringing activities are protected by a statutory patent exemption, stating that safe harbor is not granted to “the use of research tools in drug-discovery research, or to early-stage drug-discovery research” itself.

Isis also called into question Santaris' defense that its alleged infringement took place in its native Denmark and is therefore not subject to US patent law, dubbing the move a legal “red herring.”

The legal row began late last year when Isis sued Santaris for allegedly for infringing two patents (GSN 9/29/2011).

The first, No. 6,326,199, is 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 last year.

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.

Isis charged that Santaris infringed the intellectual property in locked nucleic acid molecules it developed for and sold to collaborators including Enzon, Shire, Pfizer, and GlaxoSmithKline.

Isis noted in its suit that US law allows for the use of patented inventions that are “reasonably related to the development and submission of any information” to the US Food and Drug Administration, but claimed that Santaris' commercial transactions for the disputed technology “are not themselves related to the generation of data for submission to the FDA.”

In response, Santaris asked the court earlier this year to dismiss Isis' suit, stating that its alleged infringement is covered by the statutory safe harbor provision since, “by its very nature, Santaris' drug design and testing is reasonably related to the development and submission of information to the FDA for purposes of drug approval (GSN 2/2/2012). The entire focus of Santaris' activities is to design and develop LNA drug candidates that may be submitted to [the] FDA for regulatory approval.”

At the same time, even if infringement occurred, all such activity is conducted at its facilities in Denmark and is therefore not subject to US patent law, Santaris added in its motion for dismissal.

This week, however, Isis argued that the exemption claimed by Santaris “does not apply to commercial transactions not directly attributable to generation of FDA data” and doesn't cover the use of “research tools used in drug-discovery research.”

At the same time, Santaris focused on its “extraterritorial use of Isis' inventions in Denmark” even though it is selling and offering patented inventions in the US, which counts as infringement, Isis added.

According to Isis, the patents relate to methods “in line with the definition of a research tool as put forth by the National Institutes of Health,” rather than drugs or particular drug compositions that would require FDA approval.

At the same time, the money Santaris received from its partners was recognized as revenue “unrelated to any research activity,” and thus are not related to the generation of data for submission to the FDA, Isis claimed.

The safe harbor provision claimed by Santaris “does not exempt from infringement all acts of selling, offering for sale, making, and using [a] patented invention,” Isis noted.

The company's patented in vitro methods covered by the patents “are not themselves drugs that are the subject of FDA approval, but instead are non-exempt, patented research tools to assist in discovering and characterizing a potential drug product.”

Isis pointed out that Santaris “does not need to use the in vitro methods of the … [patents] to discover antisense compounds. It could altogether skip such in vitro tests and move to in vivo testing in animals, or use different antisense compounds than those identified in the [patented] claims.

“Further, the use of this tool in early-stage research is not required to obtain regulator approval,” it added.

Isis also charged that Santaris' activities fail to meet the safe harbor requirement that a drugmaker must have a “reasonable basis” for believing that a patented compound “may work, through a particular biological process, to produce a particular physiological effect.”

Santaris did not have such a belief when it struck its deals with its partners because they were discovery arrangements and, in some cases, covered targets that were to be specified at a later date, Isis maintained. “Santaris performed the alleged infringing acts of selling or offering for sale [Isis' inventions] … in the absence of any particular compound having been identified because no target was even specified in the contract that forms the basis of the infringing sale.”

As for Santaris' claim that since it conducted work for its partners outside of the US, its allegedly infringing activities are not subject to US patent law, Isis said that Santaris “is on the wrong side of the law."

Its contracts with its partners “constitute a 'sale' or 'offer to sell' of the patented inventions … within the United States … even if acts flowing from the offer or sale are performed abroad,” Isis said. At the same time, an offer to sell need not be accepted to constitute infringement, the company added.

“Santaris admits that it contracts with pharmaceutical partners in the United States and that antisense gapmer oligonucleotides and related data are imported into the United States to its contract partners,” Isis pointed out.

For these reasons, Isis said Santaris' motion to dismiss should be rejected. Isis further said it should be “afforded the opportunity to discover facts essential to justify its opposition. Discovery has yet to commence, but should be opened fully.

“At a minimum, the court should permit Isis to obtain the discovery needed to fully rebut Santaris' motion, which raises issues heavily intertwined with those underlying the complaint,” Isis added.


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