[Ip-health] Wall Street Journal's Pharmalot: Hepatitis C Spurs Unusual Patent Wars Among Big Drug Makers

Thiru Balasubramaniam thiru at keionline.org
Tue Jul 22 05:59:54 PDT 2014


10:22 am ET
Jul 21, 2014HEPATITIS C
<http://blogs.wsj.com/pharmalot/category/hepatitis-c/>Hepatitis C Spurs
Unusual Patent Wars Among Big Drug Makers

   - By
   - ED SILVERMAN

http://blogs.wsj.com/pharmalot/2014/07/21/hepatitis-c-spurs-unusual-patent-wars-among-big-drug-makers/

The intense rivalry to grab a dominating share of the lucrative market for
hepatitis C treatments has largely focused on potential pricing and
clinical research showing which medicines can cure the largest number of
patients in the shortest amount of time.

But there is another intriguing aspect to this classic pharmaceutical horse
race – a series of lawsuits filed over patents. Specifically, Gilead
Sciences
<http://online.wsj.com/public/quotes/main.html?type=djn&symbol=GILD> ,
which was first out of the gate with the expensive and successful Sovaldi
treatment, is fighting no fewer than three other drug makers in court –
Merck, AbbVie
<http://online.wsj.com/public/quotes/main.html?type=djn&symbol=ABBV> and
Roche – over valuable patent rights.

As The Wall Street Journal notes in an interesting overview
<http://online.wsj.com/articles/lucrative-drug-niche-sparks-legalscramble-1405898259>
of
this multi-faceted battle, patent skirmishes in the pharmaceutical industry
usually involved brand-name drug makers trying to block generic rivals from
selling cheap copies of their medicines.

But the litigation over the hepatitis C patents is unusual because this
pits brand-name drug maker against brand-name drug maker in disputes that,
the paper writes, are more typical of smart phone manufacturers and other
tech companies.

The litigation “speaks to the blockbuster aspect of this drug [Sovaldi],
both from a scientific standpoint and obviously from a monetary standpoint,
that we’re seeing very involved litigation from many different players,”
says Theresa Kavanaugh, a patent lawyer at Goodwin Procter, who has
represented drug makers, but is not involved in the hepatitis C litigation.

Sovaldi, you may recall, has racked up some $5 billion in sales in the
first half of 2014, although its $84,000 price tag for 12 weeks of
treatment per patient has generated enormous controversy. Gilead is
expected by Wall Street to receive FDA approval shortly to market a newer
treatment that combines Sovaldi with another compound that offers the
convenience of taking one pill a day.

A couple of interesting highlights about the litigation: AbbVie has taken a
particularly aggressive stance by obtaining U.S. patents covering
combinations
<http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8,466,159.PN.&OS=PN/8,466,159&RS=PN/8,466,159>
 of dozens of drugs
<http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8,492,386.PN.&OS=PN/8,492,386&RS=PN/8,492,386>
to
treat the disease, including those developed by Gilead, because it is
developing its own combination treatment. And so, AbbVie wants monetary
damages <http://freepdfhosting.com/70f12b56d8.pdf>if Gilead begins selling
a combination treatment.

As for Merck, Gilead filed a preemptive lawsuit
<http://freepdfhosting.com/4863cf3477.pdf> after receiving a phone call
from a Merck executive who proposed licensing two Merck patents to Gilead
in exchange for a 10% royalty on sales of all medicines including Sovaldi.
Gilead called this a “prohibitive demand.” Merck later responded in court
by claiming that Sovaldi infringes on its patents that cover compounds
related to the active ingredient in Sovaldi.

Roche, meanwhile, claims it has rights to Sovaldi thanks to a decade-old
research collaboration with Pharmasset, which developed the drug and was
purchased by Gilead two years ago for more than $11 billion. Roche wants an
exclusive license and claims Gilead infringed on its rights. A Roche
spokeswoman tells the Journal that an arbitration decision is expected
later this year.

A spokesperson for Merck declined to comment and an AbbVie spokesperson
maintains its patents were infringed, while a Gilead spokesperson says the
drug maker has the right to commercialize Sovaldi. [You can read the entire
legal arguments in the links provided in the highlighted words in this
post.]

   -



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