By
James DeGiulio —

Graceway's
Injunction and Nycomed's Dismissal Denied In Aldara Suit

Graceway Pharmaceuticals'
suit against Nycomed alleging infringement of a patent for skin lesion
treatment Aldara continues to move forward, after a ruling denied both
defendant Nycomed's motion for dismissal and plaintiff Graceway's motion for a
preliminary injunction.

Graceway
filed suit in February, alleging that Nycomed's generic Aldara drug infringes
Graceway's U.S. Patent No. 7,655,672, which covers Aldara (see "Court Report," February 28, 2010).  The complaint also named Perrigo Co. as a defendant, but Perrigo
settled with Graceway in April and became the authorized generic distributor
for Aldara.  Recently, in March,
Graceway's motion for a temporary restraining order against Nycomed was denied.

On
June 10, Judge William Martini of the U.S. District Court for the District of
New Jersey rejected Nycomed's argument for dismissal due to Graceway's failure to
perform a pre-filing infringement investigation of Nycomed's product.  The judge found that while Graceway did
not obtain a sample of Nycomed's allegedly infringing product before filing
suit in February, it did engage in other investigations, including testing
generic formulations similar to Nycomed's.  The judge found that this was enough to support a conclusion that
Nycomed's product was substantially the same, and thus protected by the patent.

In
a separate order issued that same day, Judge Martini rejected Graceway's motion
for a preliminary injunction.  The
judge found that Graceway had not established a likelihood of success on the
merits because Nycomed has raised a substantial question regarding the validity
of the patent due to obviousness, and that Graceway had not made a sufficient
showing of irreparable harm.

Judge
Martini's order denying Nycomed' dismissal can be found here.

Judge
Martini's order denying Graceway's preliminary injunction can be found here.

Infosint's
Infringement Verdict over Lexapro Overturned, Patent Ruled Invalid

Infosint
SA's $15 million infringement verdict against defendants H. Lundbeck A/S and
Forest Laboratories Inc. in the Lexapro dispute has been overturned, following a
ruling that the patent related to the antidepressant drug's manufacture was
invalid.

Infosint
sued Lundbeck and Forest in 2006, claiming the processes Lundbeck uses to make
their generic Lexapro infringe U.S. Patent No. 6,458,973, which covers an improved
process for making 5-carboxyphthalide.  Lundbeck and Forest contended the patent was invalid because it was
anticipated by the prior art and obvious.  The defendants also said a number of the '973 patent claims interfered
with claim 1 of Lundbeck's U.S. Patent No. 6,403,813.  However, in June 2009, the District Court
invalidated claim 1 of the '813 patent because it found that the company had
suppressed its invention.  The case
went to trial in 2009, and in October, a jury found for Infosint, awarding the
company $15 million as a reasonable royalty (see "Biotech/Pharma Docket,"
October 21, 2009).  However, both sides were disappointed
by the verdict and moved for judgment as a matter of law.

On
June 17, Judge Lewis Kaplan of the U.S. District Court for the Southern
District of New York granted the defendants judgment as a matter of law,
finding Infosint's '973 patent invalid for obviousness.  Judge Kaplan rejected Infosint's
arguments for nonobviousness as being unpersuasive, and ruled that the method in
the '973 patent was merely an obvious optimization.  The judge was not convinced that any of the improvements claimed,
including temperature optimization and the use of a specific reactor type,
would have been beyond someone with ordinary skill in the art.  Consequently, Judge Kaplan declared the
'973 patent invalid, and granted the defendant's motion for judgment as a
matter of law.  Judge Kaplan also
denied Infosint's motion to increase the $15 million reasonable royalty award
to $43 million by adding additional damages and interest.

Judge
Kaplan's order can be found here.

Patent for Argatroban Found Valid, Injunction Issued against Barr

GlaxoSmithKline
PLC, Mitsubishi Chemical Corp. and Encysive Pharmaceuticals Inc. enjoyed a
victory in their patent infringement battle with Barr Laboratories over the
anti-blood-clotting drug Argatroban, after a ruling that rejected Barr's claims
of patent invalidity and enjoined Barr from producing a generic version of the
drug until after the Argatroban patent has expired.

Encysive
holds the approved NDA for Argatroban and has licensed the North American
marketing rights for the drug to GlaxoSmithKline.  Mitsubishi Chemical holds
U.S. Patent No. 5,214,052, issued in May 1993, which covers use of Argatroban to treat
thrombocytopenia induced by the blood thinner Heparin.  The plaintiffs launched
their suit on December 28, 2007 after Barr submitted an ANDA for generic
Argatroban injections with the FDA in September of that year.  In response to the complaint, Barr
argued that the '052 patent was invalid, unenforceable, and would not be
infringed by its manufacture and sale of a generic version of the drug.

On
June 16, Judge John Koeltl of the U.S. District Court for the Southern District
of New York issued his findings of fact and conclusions of law, ruling that the
'056 patent is valid.  Barr's argued that several prior art
references, including a 1986 article written by a Mitsubishi employee on the
results of a preclinical study of Argatroban, anticipated the claims of the
patent and rendered the drug's formula obvious.  Judge Koeltl rejected this argument, determining that the
Mitsubishi article and other prior art did not enable a person skilled in the
art of pharmaceuticals to produce the drug.  He also relied on evidence of failed attempts by others to
develop Argatroban to support his finding that the '052 patent was not obvious.  Finally,
the judge enjoined Barr from producing a generic version of the drug until
after June 30, 2014 when the '052 patent expires.

Judge
Koeltl's (156 page) order 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.