By James DeGiulio --
Celgene
and Novartis Reach Settlement with Barr Laboratories in Ritalin ANDA Suit
Celgene
Corp. and Novartis AG have reached a settlement with Barr Laboratories Inc.
over Barr's attempt to market a generic version of the ADHD drug Ritalin. Celgene and
Novartis brought suit claiming infringement of Celgene's U.S. Patent Nos. 5,837,284 and 6,635,284 after
Barr filed an ANDA in May 2007. Barr claimed that Celgene's patents were
unenforceable due to the plaintiffs' inequitable conduct during prosecution.
Judge
Freda L. Wolfson of the U.S. District Court for the District of New Jersey
dismissed the claims and counterclaims without prejudice after staying the suit
in March to give federal officials a chance to review the settlement. Each side
agreed to pay its own costs and attorneys' fees, though further details of the
settlement remained confidential.
Three
Claims of Schering's Zetia Patent Found Invalid
The
U.S. District Court for the District of New Jersey found three of Schering's
patent claims for Zetia invalid based on improper reissue in the patent
infringement suit between plaintiff Schering and defendant Glenmark. Following Glenmark's ANDA filing in
2007, Schering launched suit against Glenmark claiming infringement of its reissued
U.S. Patent No. RE37,721 covering ezetimibe, the active ingredient in the anti-cholesterol treatment Zetia.
Schering's
patent covering ezetimibe was reissued in 2002 after the original 1996 patent
application inadvertently failed to include "bullet" claims for ezetimibe. Glenmark argued that Schering's
declaration to the USPTO provided an insufficient basis for reissuance, so the
patent should not have been reissued and the three claims that were added to
the patent on reissue were invalid. Judge Linares found that the "bullet" claims were omitted by inadvertent
error, the reissue was improperly granted, and thus the three new claims were
invalid. However, Judge Linares
found that the remaining claims were sufficient to cover ezetimibe, and denied
Glenmark's separate motion to invalidate the remaining claims due to double
patenting of Schering's U.S. Patent No. 5,631,365.
Judge
Linares' opinion granting summary judgment for invalidity based on improper
reissue can be found here. Judge
Linares' opinion denying Glenmark's motion for summary judgment for invalidity
due to double patenting can be found here.
Jury
Upholds Validity of Pfizer's Protonix Patent
A
jury in the U.S. District Court for the District of New Jersey found that
Pfizer's U.S. Patent No. 4,758,579 covering the heartburn drug Protonix is valid, disagreeing with allegations by Teva
and other generic firms that the patent was invalid based on obviousness and
double-patenting. However, other legal issues still need to be decided by the
judge, including certain double-patenting defenses.
Wyeth,
the licensee of the '579 patent and now part of Pfizer, and Altana Pharma AG,
now part of Nycomed, brought a patent infringement suit against Teva in May
2004 following Teva's ANDA filing. In September 2007, Judge Linares found that
Teva had raised sufficient issues over the patent's validity, and denied a
motion for preliminary injunction to stop Teva from launching generic
versions of Protonix. Teva has
been commercially shipping its generic pantoprazole sodium since December 2007.
The
jury verdict form 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.
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