UPDATED: Novartis falls short in controversial IPR process as board nixes Gilenya patent

The U.S. Patent and Trademark Office's review board has dealt its first blow to Big Pharma. The appeal panel nixed a patent on Novartis' ($NVS) multiple sclerosis blockbuster Gilenya, handing a win to challenger Torrent Pharmaceuticals--and fellow generics makers Mylan and Apotex, which had filed a separate challenge.

It's the first successful inter partes review challenge filed by a generics maker, Torrent's attorneys noted. Most of the attention on the new IPR process, installed by the America Invents Act, has focused on investors, such as hedge funder Kyle Bass and his Coalition for Affordable Drugs. Bass' group has filed multiple challenges to what it calls "low-quality" pharma patents; most recently, Celgene ($CELG) failed to persuade the board to toss out a Bass challenge to its Revlimid IP.

The Gilenya patent in question--referred to as the '283 patent--expires in 2026, according to the FDA Orange Book. It would give the MS med a good long time with market exclusivity--a lot longer than its other two Orange Book patents, the latest of which expires in 2019. The blockbuster drug brought in $2.5 billion for Novartis last year, and its most recent quarterly sales amounted to $700 million.

The board's 59-page decision states that Novartis' first 32 patent claims are "unpatentable" because of obviousness. The board also denied the company's motion to amend the patent with new claims, saying Novartis hadn't proven that they were worthy.

The decision primarily focuses on one key claim that covers Gilenya's combination of ingredients--the active ingredient, fingolimod, with the sugar alcohol mannitol. The board says previous patents show that the combination makes sense, so there's no justification for special IP protection there. Novartis set forth a variety of defenses--including Gilenya's commercial success, which should help indicate that it's a significant, patentable advance--but the board didn't buy any of them.

The strikedown doesn't mean that Gilenya will necessarily be vulnerable to generic competition sooner than expected, however. At the very least, Novartis can petition for judicial review of the board's decision.

Novartis is "disappointed" with the board's decision on the '283 patent, a spokeswoman told FiercePharma in an emailed statement. "It's important to point out this decision is related to the formulation patent and does not impact the compound patent covering Gilenya," the statement said; the company is "evaluating the opinion and options, including a potential appeal of that decision."

- read the PTAB decision (PDF)
- check out Gilenya's Orange Book patents

Special Reports: The top 10 best-selling multiple sclerosis drugs of 2013 -Gilenya | The top 15 pharma companies by 2014 revenue - Novartis

Editor's note: This story was updated with a statement from Novartis.

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