By James DeGiulio --
AstraZeneca has settled its infringement claims
against Teva over its Crohn's disease treatment Entocort, striking a deal that
grants Teva an exclusive license to market a generic oral budesonide capsule on
Feb. 15, 2012. The companies will seek approval for the deal through a consent
judgment in the U.S. District Court for the District of Delaware.
AstraZeneca brought suit against Barr in May 2008
following Barr's January ANDA filing, claiming Barr's generic budesonide
infringed U.S. Patent Nos. 6,423,340 and 5,643,602. AstraZeneca later brought a similar suit against Mylan,
alleging infringement of the same Entocort patents (see "Court Report," July 27, 2008). The Barr and Mylan suits, though initially separate, were
consolidated in early 2009.
On May 14, Mylan's generic alfuzosin drug was
confirmed as infringing Sanofi's patent covering the prostate treatment Uroxatral
after Mylan's contention that the patent was invalid for obviousness was
rejected. Sanofi brought an
infringement suit against Mylan in 2007 following Mylan's ANDA filing, alleging
Mylan's generic alfuzosin hydrochloride infringes U.S. Patent No. 4,661,491 (see "Court Report," October 14, 2007) Mylan asserted that the '491 patent
was obvious in view of three pieces of prior art.
In his May 14 order, Judge Sleet of the U.S.
District Court for the District of Delaware held that the three prior art
references asserted by Mylan fail to invalidate the '491 patent because they do
not suggest that alfuzosin would prove an effective treatment for frequent
urination and other symptoms of benign prostatic hyperplasia. Judge Sleet then finalized an earlier
bench ruling that Mylan's generic alfuzosin hydrochloride would infringe Sanofi's
'491 patent. However, Judge Sleet
refused to award attorneys' fees to Sanofi, finding no bad faith or vexatious
litigation on the part of Mylan.
In the latest development in AstraZeneca's
long-running Prilosec infringement suit, AstraZeneca's motion to dismiss Mylan's
antitrust counterclaims was granted and Mylan's motion for attorney's fees was
denied.
On May 18, Judge Jones granted AstraZeneca's motion
to dismiss with prejudice Mylan's counterclaims that AstraZeneca forced generic
manufacturers out of the omeprazole market by launching sham patent litigation
to delay the release of generic versions of the drug. Judge Jones agreed with AstraZeneca's contention that its
patent infringement litigation cannot give rise to antitrust liability under
the Sherman Act because its claims were supported by probable cause.
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 [email protected].
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