By Doug Macron
Santaris Pharma this week asked a US District Court to dismiss a patent-infringement lawsuit filed against it by Isis Pharmaceuticals, arguing that its research and development activities at issue in the case occur outside of the US and therefore are not subject to the nation's patent laws.
Even if they did occur in the US, Santaris argued, such activities would be protected by a statutory patent exemption and therefore no infringement would have occurred.
In seeking a summary judgment of non-infringement and dismissal of the case, Santaris also painted Isis as a jilted competitor, spurned by “a decade of failed attempts” to acquire or license Santaris' core technology, that has “turned to claims of patent infringement to bar Santaris and its partners from designing new drugs and developing information necessary to proceed” through the US regulatory process.
The legal battle began in September when Isis sued Santaris 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 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.
Notably, the '199 patent expired late last year.
In its suit, Isis claims that Santaris used the patented technology in locked nucleic acid molecules it has developed for collaborators including Enzon, Shire, Pfizer, and GlaxoSmithKline. It further alleges that Santaris uses the patented technology in antisense compounds in cell assays to help identify "potential gene targets and/or to screen the ability of synthesized oligonucleotides to inhibit the production of a specific protein."
Key to Isis' complaint is its claim that Santaris' activities do not fall under the protection of 35 U.S.C. 271 (e)(1), a legal provision that 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 2005, the US Supreme Court ruled that this protection extends 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.
According to Isis, the “millions of dollars in revenue” Santaris has generated from the sale of disputed antisense technology to its partners “are not reasonably related” to the development and submission of information to the FDA for regulatory approval.
“Rather … the substantial sums received by Santaris, and the significant future payments contemplated by [its agreements with pharmaceutical partners], constitute commercial revenue that Santaris uses to fund and develop its business,” Isis wrote in its complaint. “Regardless of whether the pharmaceutical company customers later develop some of the resulting compounds and eventually advance a drug to a phase of development where the … exemption attaches, Santaris' commercial transactions are not themselves related to the generation of data for submission to the FDA.”
In its request for a dismissal of the suit this week, Santaris argues that the use of its LNA technology and its LNA drug candidates infringe neither of Isis' patents, but notes that the issue of infringement is irrelevant because “all of [its] allegedly infringing activities fall squarely within the 271 (e)(1) safe harbor provision.
“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,” the company stated. “The entire focus of Santaris' activities is to design and develop LNA drug candidates that may be submitted to [the] FDA for regulatory approval.”
Further, while Isis suggested that Santaris' discovery work is conducted before its has a reasonable basis for believing a specific compound may work through a particular biological process, Santaris said it “only undertakes LNA antisense drug design efforts once there are data showing that modulation of the activity of the proposed target RNA molecules has potential therapeutic value.”
Santaris also noted that the 271 (e)(1) exemption extends to preclinical tests on “potential drug candidates,” thus protecting work done on drug candidates that are never submitted to the FDA.
The Supreme Court, it said, “recognized that the real world of drug development — including the inherent uncertainty as to which drug candidate might eventually become a marketed drug in a real-world situation — requires that the exemption 'leaves adequate space for experimentation and failure on the road to regulatory approval.'”
But even if Santaris' activities did infringe the patents in question, the company said, all such work is conducted at its facilities in Denmark and are therefore not subject to US patent law.
“Isis has advanced no theory — and can advance no theory — under which Santaris could be liable for the activities alleged in the complaint to the extent that they take place outside the United States,” it said.
In the end, Santaris indicated to the court, Isis is using patent-infringement litigation to gain an advantage over a competitor.
“Isis holds, and has long held, an equity position in Santaris,” Santaris said. “For over a decade, Isis has tried to license Santaris' proprietary LNA technology, but Santaris has reduced to do so on the commercially unreasonable terms that Isis has demanded.
“Recently, Isis requested that the US Patent and Trademark Office re-examine and cancel Santaris' key patents covering its LNA technology,” it added. “When those efforts failed, Isis filed this lawsuit.”
Santaris asked the court to dismiss the suit with prejudice, which would bar Isis from re-filing at a later date. Santaris had previously asked for the court for a declaration that it did not infringe Isis' patents and a ruling that the intellectual property was invalid (GSN 12/15/2011).
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