By James DeGiulio --
AstraZeneca Settles Entocort Patent Suit with Teva,
Stipulates with Mylan
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 19, AstraZeneca and Mylan stipulated to a
judgment against Mylan, agreeing that both Entocort patents are valid and that
Mylan infringed the '340 patent. The only remaining issue in that case is
whether the '340 patent is enforceable.
AstraZeneca's settlement terms with Teva were not
available. The stipulation in the
Mylan case can be found here.
Sanofi-Aventis' Uroxatral Patent Valid, Mylan's
Generic Infringes
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.
Judge Sleet's order can be found here.
Mylan's Antitrust Claims Dismissed In AstraZeneca
Prilosec Suit
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.
AstraZeneca first sued several generic-drug makers
in 2000, accusing them of infringing patents 4,786,505 and 4,853,230, covering
the gastric-acid inhibitor Prilosec. Mylan joined the litigation after releasing a generic version of omeprazole
in August 2003. At the May 2006
trial, Judge Barbara Jones of the U.S. District Court for the Southern District
of New York found that AstraZeneca's two patents were valid, but defendants
Mylan, LDE, and Lek did not infringe. Other defendants Apotex and Impax were
found liable for infringement. The U.S.
Court of Appeals for the Federal Circuit upheld the finding of noninfringement
with respect to Mylan in June 2008 (as reported by Patent Docs on June 11,
2008).
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.
Mylan also moved for attorneys' fees on the grounds
that AstraZenca's infringement suit was meritless. Judge Jones denied Mylan's motion for attorney's fees,
finding that the case is not exceptional.
Judge Jones' May 18 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 [email protected].
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