By James DeGiulio --
Genzyme Dismisses One Inequitable Conduct Count in Hectorol Suit
Genzyme has won the dismissal of one of the three inequitable conduct counts raised by Cobrek Pharmaceuticals in a patent infringement suit between the two companies over the kidney disease treatment Hectorol.
In February 2008, Genzyme sued Pentech Pharmaceuticals in the U.S. District Court for the Northern District of Illinois to prevent it from marketing a generic version of Hectorol, asserting that Pentech infringed U.S. Patent Nos. 6,903,083 and 5,602,116 by filing an Abbreviated New Drug Application (ANDA) on the drug. Cobrek was later added as a defendant, and in February 2009, the '083 patent was dropped, leaving only the '116 patent at issue. Cobrek originally asserted seven affirmative defenses and counterclaims, but four of them were dismissed.
On September 17, Judge Robert M. Dow Jr. granted summary judgment for Genzyme on one count of inequitable conduct, finding that Genzyme did not need to cite certain references in the most recent patent applications because the prior art references were cited the ancestor applications. Furthermore, Judge Dow noted that the same examiner had reviewed the ancestor applications and the most recent application, and thus determined that Genzyme had satisfied its duty of candor. Judge Dow's order granting summary judgment for Genzyme can be found here.
In a separate ruling, Judge Dow declined to dismiss two other inequitable conduct counts, where Cobrek alleged that Genzyme intentionally failed to disclose certain prior art and submitted an article that knowingly obscured the existence of that prior art. Judge Dow's order denying summary judgment for Genzyme on these counts can be found here.
Mylan Enjoins Release of Apotex's Generic Paxil
In a suit involving Apotex's alleged breach of Mylan's exclusivity agreement regarding GSK's anti-depressant Paxil, Mylan successfully blocked Apotex from producing a generic form of the drug.
Mylan filed suit on September 20 in the U.S. District Court for the District of New Jersey, claiming the exclusive right to market a generic form of Paxil based on an agreement reached with GSK in an earlier patent infringement litigation. The exclusivity agreement gives Mylan the sole right to manufacture and sell generic Paxil. According to the complaint, GSK recently offered to allow Apotex to market its own version of the drug, despite the agreement. The complaint further alleges that Apotex knew or should have known about the agreement between Mylan and GSK.
In a September 21 Order, Judge Joel A. Pisano granted an injunction against Apotex, preventing the company from manufacturing or marketing the drug until an October 18 hearing. Mylan's complaint can be viewed here.
Sanofi's Taxotere Patents Found Invalid
Last week, a District Court allowed Hospira to move one step closer towards being able to market a generic version of Sanofi's cancer drug Taxotere after the Court found two patents covering the drug to be invalid and unenforceable.
Sanofi filed an infringement action against Hospira and Apotex in November 2007 alleging that the two companies infringed U.S. Patent Nos. 5,714,512 and 5,750,561 by filing ANDAs for docetaxel (see "Court Report," November 18, 2007). In November 2009, following a bench trial in the U.S. District Court for the District of Delaware, the parties were ordered to present post-trial proposed findings of fact and conclusions of law concerning the validity and enforceability of the '512 and '561 patents.
On September 27, Judge Gregory Sleet ruled that the defendants had established by clear and convincing evidence that Sanofi's '512 and '561 patents were invalid due to indefiniteness and obviousness, and unenforceable due to inequitable conduct. In a lengthy opinion, Judge Sleet found that the specific formula for Taxotere was obvious in view of U.S. Patent No. 4,814,470, which issued in 1989. Judge Sleet also found that Sanofi did not disclose two highly material prior art references to the Patent Office during the prosecution of the '512 and '561 patents, thus rendering them unenforceable. Judge Sleet'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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