[Ip-health] Novartis falls short in controversial IPR process as board nixes Gilenya patent

Tahir Amin tahir at i-mak.org
Wed Sep 30 11:42:17 PDT 2015


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
<http://www.fiercepharma.com/tags/novartis>) multiple sclerosis blockbuster
Gilenya <http://www.fiercepharma.com/tags/gilenya>, handing a win to
challenger Torrent Pharmaceuticals
<http://www.fiercepharma.com/tags/torrent-pharmaceuticals>--and fellow
generics makers Mylan <http://www.fiercepharma.com/tags/mylan> and Apotex
<http://www.fiercepharma.com/tags/apotex>, which had filed a separate

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
<http://www.fiercepharma.com/tags/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
<http://www.fiercepharma.com/tags/celgene>) 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--and
undoubtedly will, though the company could not be reached for comment at
press time. Other court battles could apply, too.

Tahir Amin
Co-Founder and Director of Intellectual Property
Initiative for Medicines, Access & Knowledge (I-MAK)
*Website:* www.i-mak.org
*Email:* tahir at i-mak.org
*Skype: *tahirmamin
*Tel:* +1 917 455 6601/+44 771 853 9472

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