By Suresh Pillai --
Breach of Contract Claims Dismissed in AIA-Mayo
Suit
The District Court for the Middle District of
Florida has dismissed two claims brought by the Alzheimer's Institute of
America (AIA)
against the Mayo Clinic and Myriad Pharmaceuticals alleging that the defendants had breached the no-challenge clause contained
within the institutional licensing agreement. This is the latest decision in a case that began in 2003
when the AIA sued Mayo and Myriad for patent infringement in the U.S. District
Court for the District of Kansas. In the original filing, the AIA alleged that the companies infringed U.S. Patent Nos. 5,795,963
and 5,455,169,
which cover nucleic acids and methods for diagnosing and modeling Alzheimer's
disease.
The litigation was stayed pending the outcome of
arbitration on the issue of whether the license between the AIA and the
defendants covered the use of cell lines and whether the AIA was owed
compensation under the agreement for benefits received by Mayo through third
party agreements. The arbitration
panel concluded that the licensing agreement did not include the use of
the patented technology with cell lines; however, the panel also concluded that
Mayo owed nothing to the AIA in the way of compensation for the licensed use of
the technology. Following the
conclusion of the arbitration, the AIA refiled the patent infringement suit,
including counterclaims of unjust enrichment and equitable interest. Both of these counterclaims had been
dismissed in a June ruling (see "Biotech/Pharma Docket," July 7,
2009). The AIA subsequently filed an amended
counterclaim that included the breach of contract claims.
In its latest ruling, the District Court concluded that,
because the no-challenge clause was neither part of a settlement agreement for
litigation nor a consent decree, the Court could, under federal patent policy, invalidate
the clause, thereby clearing the way for Mayo to challenge the patents'
validity. The Court also concluded
that, because the breach of contract claim arose from the same set of facts as
those presented in the earlier arbitration, the claim was barred by res
judicata, as the arbitration had reached a decision on the breach of contract
claims based on the merits.
Settlement Announced in Loprox® and Vanos® Patent
Dispute
Glenmark Pharmaceuticals has
announced that it has reached an agreement with Medicis Pharmaceuticals that should settle
the companies' patent dispute over Glenmark's marketing of generic versions of
Medicis' patented Loprox® topical skin gel
and Vanos® steroidal skin cream (covered by U.S. Patent Nos. 6,765,001
and 7,220,424). Under the terms of the licensing and settlement
agreement, Medicis has granted Glenmark permission to market a generic version
of Vanos® by December 2013 at the earliest as well as permission to market a
generic version of Loprox® immediately. In return for the license, Glenmark has agreed to pay Medicis a
sales-based royalty.
This settlement is the latest agreement
reached with a generic manufacturer of Medicis' products. In April, Medicis reached a
settlement with Perrigo Israel Pharmaceutical over Perrigo's marketing of a generic version of Vanos® (see "Biotech/Pharma
Docket," April 21, 2009).
Ranbaxy Admits Infringment in OxyContin® Suit
The U.S. District Court for the Southern District
of New York has approved a consent judgment between Ranbaxy Pharmaceuticals and Purdue Pharma,
the rights holder for U.S. Patent No. 5,508,042,
covering controlled-released compositions of oxycodone, including the trade
drug OxyContin®. Purdue originally
filed suit in October after Ranbaxy had submitted an Abbreviated New Drug Application to the FDA seeking regulatory approval to market generic versions
of OxyContin®. Purdue's complaint
also alleged that Ranbaxy's ANDA included a Paragraph IV certification that the
'042 patent was invalid, unenforceable, and would not be infringed by the
proposed generic version. Earlier
this month, the suit joined the multidistrict litigation already in progress
related to allegations of Purdue engaging in sham patent infringement
litigation as a means to prevent generic versions of OxyContin® from reaching
the market.
The consent judgment dismisses Purdue's suit
against Ranbaxy without costs and establishes the present and future validity
of the '042 patent in litigations involving Ranbaxy. The judgment also permanently enjoins Ranbaxy from
infringing the '042 patent by the marketing of generic versions of OxyContin®. Ranbaxy also agreed not to seek FDA
approval to market a generic version until the expiry of the patent and any
period of exclusivity.
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