Merck Asks US To Reconsider Singulair Patent Rejection
By Peter Loftus, Of DOW JONES NEWSWIRES
Merck & Co. (MRK) has asked the U.S. Patent and Trademark Office to reconsider
its tentative rejection of Merck's patent for the blockbuster asthma drug
Singulair.
In early September, after re-examining the Singulair patent, the PTO issued a
"nonfinal action" rejecting key claims in the patent, which is due to expire in
2012. The PTO said the claims were "unpatentable" partly because they were
anticipated by another patent. The PTO views so-called double-patenting as an
unjustified extension of patent exclusivity beyond the term of a patent.
The PTO had launched its re-examination in May at the request of Article One
Partners LLC, an online patent-research service that said it uncovered new
information raising questions about the validity of the Singulair patent, which
was issued in the 1990s.
Still, the PTO's tentative rejection of the patent might not result in generic
competition anytime soon for Singulair, which is Merck's best-selling product,
with $3.4 billion in sales for the first nine months of 2009. There is precedent
for the PTO reversing itself in final decisions, after patent holders provide
more information.
Earlier this year, for instance, the PTO granted the reissue of a key patent
for Pfizer Inc.'s (PFE) Lipitor cholesterol drug, after initially rejecting
Pfizer's request for a reissuance.
What's more, a federal judge in New Jersey upheld the validity of the
Singulair patent in August, rejecting a challenge by generics manufacturer Teva
Pharmaceutical Industries Ltd. (TEVA), which has since appealed the ruling.
Last week, Merck filed its response disputing the PTO's initial rejection,
essentially asking that the claims be upheld.
"This is standard action in these matters," Merck spokesman Ron Rogers said
Monday. He added that such re-exams usually take about 24 months to complete.
Merck shares rose 80 cents, or 2.45%, to $33.39 in Monday afternoon trading.
-Peter Loftus; Dow Jones Newswires; 215-656-8289; peter.loftus@dowjones.com
(END) Dow Jones Newswires
11-09-091548ET
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