By James DeGiulio --
Roche Boniva Patent Dispute with Apotex, Cobalt Goes to Jury
Cross-motions for summary judgment by Roche and defendants Apotex and Cobalt were denied in Roche's infringement suit regarding generic versions of Boniva. The case will now go before a jury to resolve questions of fact.
Apotex and Cobalt filed ANDAs for generic ibandronate, the active ingredient in Boniva. In September 2007, Roche sued Apotex and Cobalt in the U.S. District Court for the District of New Jersey for infringement of U.S. Patent Nos. 6,143,326, 6,294,196, 7,192,938, 4,927,814, and 7,410,957. Eventually, a total of six lawsuits were consolidated into two pretrial proceedings, and the claims relating to the '326, '196, and '938 patents were settled. In August, the District Court granted summary judgment to Roche, finding that Apotex's ANDA literally infringes the '814 patent. The defendants maintain that the '814 patent is unenforceable due to inequitable conduct.
On September 30, Judge Stanley R. Chesler denied cross-motions for summary judgment on inequitable conduct, finding that fact questions remain and therefore, that summary judgment was improper. Cobalt and Apotex made eighteen specific allegations of omission of material information or material misstatements to the USPTO, arguing that the acts in the aggregate showed an intent to deceive. Roche argued that the defendants had failed to sufficiently allege intent to deceive the USPTO with regard to any of the allegations, instead pointing to mere oversight as the source of the errors. Judge Chesler decided that the issue of intent could go either way, and consequently must go to the jury. Judge Chesler's opinion can be found here.
Salix Pharma and Novel Labs Settle OsmoPrep Patent Litigation
Salix Pharmaceuticals has announced a settlement with Novel Labs, thus resolving the parties' dispute over infringement of the patent covering Salix's OsmoPrep product.
On September 8, 2008, Salix filed a lawsuit in the United States District Court for the District of New Jersey against Novel for the infringement of U.S. Patent No. 5,616,346 after Novel filed an ANDA seeking approval to market a generic version of OsmoPrep (see "Court Report," September 21, 2008). Novel also joined the CDC as a party.
On September 30, the parties entered a settlement which resolves all of the parties' outstanding claims and defenses in the lawsuit. The settlement provides that Novel's proposed generic product would infringe the '346 patent and further provides that Novel agrees not to contest the validity and enforceability of the '346 patent. Salix granted Novel a license to the '346 patent, and also entered into a supply agreement with Novel, agreeing to purchase from Novel all of their OsmoPrep requirements beginning October 1, 2011.
Medtronic Settles with Wall Cardiovascular in Stent Patent Dispute
In its suit over cardiovascular stent patents, Wall Cardiovascular Technologies has entered into a settlement agreement with Medtronic.
In November 2007, Wall filed suit in the U.S. District Court for the Eastern District of Texas against Johnson & Johnson, Cordis, and Boston Scientific, claiming that its cardiovascular stents infringed U.S. Patent No. 6,974,475. Wall filed a second complaint in March 2008, adding Medtronic as a defendant. In response, Medtronic filed counterclaims seeking to invalidate Wall's patent and block any future claims against Medtronic over the '475 patent.
On September 30, Judge T. John Ward dismissed Medtronic from the case after approving both parties' claims and counterclaims. Each party is to bear its own attorney's fees, but the rest of the terms of the agreement remain confidential. Judge Ward's order can be found here.
James DeGiulio has a doctorate in molecular biology and genetics from Northwestern University and is a graduate of Northwestern University School of Law. Dr. DeGiulio is a member of MBHB's 2010 associate class and he can be contacted at [email protected].
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