By
James DeGiulio —

Covidien's
Patent for Restoril Found Obvious

Covidien
PLC suffered a setback in its infringement suit with URL Pharma Inc. after the
claims of its patent for sleep aid Restoril were found obvious.  In March 2007, Tyco Healthcare Group
LP, now Covidien, brought suit against Pharmaceutical Holdings Corp., and its
subsidiary Mutual Pharmaceuticals Co. Inc., now URL Pharma.  Covidien alleged that the defendants had
infringed four patents for Restoril when they filed their ANDA with the
FDA.  Three of those patents have
expired, leaving only U.S. Patent No. 5,211,954 at issue in the
case.  In August, the judge denied Covidien's
motion to enjoin URL Pharma from marketing or selling a generic 7.5 mg
temazepam product.

Judge
Chesler of the U.S. District Court for the District of New Jersey found that
the lower dose of temazepam was obvious based on the dosage range
disclosed in the prior art, thus invaliding the two claims of the '954 patent for
obviousness.  Covidien unsuccessfully
argued that other prior art taught away from the lower dosage and that the
lower dosage showed unexpected results.

Judge
Chesler's opinion granting summary judgment for obviousness can be found here.  The
corresponding order can be found here.

Genetic
Technologies' Patent in Suit against Monsanto and Pioneer Hi-Bred Upheld on Reexamination

Genetic
Technologies announced that the USPTO has upheld all the claims of U.S. Patent No. 5,612,179 in a reexamination action initiated June 30, 2009.  The '179 patent
covers a method for facilitating the detection of specific gene variations and
noncoding DNA.  The patent is at
issue in an infringement suit against Monsanto Inc., Pioneer Hi-Bred
International Inc., and other rival laboratories, where Genetic Technologies
has accused the defendants of willfully infringing the '179 patent.  Genetic
Technologies' complaint accuses the defendant laboratories of using the '179 patent
in their genetic risk assessment services and to isolate certain genes in cows
and soybeans.

The
USPTO's decision will now make more claims available in Genetic Technologies'
infringement case and any future assertion targets.  Genetic Technologies
previously announced on February 16, 2010 that it intended to implement a new assertion
program to vigorously defend its patents.  The company has recently settled litigation involving the '179 patent
with Applera Corp., Gen-Probe, and Monsanto, with each company taking limited
licenses to the technology.

Genetic
Technologies' May 10, 2010 press release can be found here.

Merck
and Glenmark Settle Zetia Patent Suit

Merck
and Glenmark Pharmaceuticals Inc. have resolved a lawsuit over the reissued
patent for Merck's cholesterol drug Zetia, with Glenmark getting permission to
launch its proposed generic ahead of the asserted patent's expiration date on April
25, 2017.  Under the terms of the agreement, Glenmark will be able to launch its
generic on December 12, 2016, or earlier under certain circumstances.

The
settlement follows the recent order that certain claims of the reissued patent RE37,721
covering Zetia were invalid (see "Biotech/Pharma Docket," May 10, 2010).  Judge Linares vacated that April 19 order which granted Glenmark's
motion for summary judgment and invalidated three of the reissued patent's
claims.

The
consent judgment can be found here.

James
DeGiulio has a doctorate in molecular biology and genetics from
Northwestern University and is a third-year law
student at the Northwestern University School of Law.  Dr. DeGiulio
was a member of MBHB's 2009 class of summer associates, and he can be
contacted at degiulio@mbhb.com.