Biotech/Pharma Docket

    By James DeGiulio --

Covidien's Patent for Restoril Found Obvious

Covidien PLC suffered a setback in its infringement suit with URL Pharma Inc. after the claims of its patent for sleep aid Restoril were found obvious.  In March 2007, Tyco Healthcare Group LP, now Covidien, brought suit against Pharmaceutical Holdings Corp., and its subsidiary Mutual Pharmaceuticals Co. Inc., now URL Pharma.  Covidien alleged that the defendants had infringed four patents for Restoril when they filed their ANDA with the FDA.  Three of those patents have expired, leaving only U.S. Patent No. 5,211,954 at issue in the case.  In August, the judge denied Covidien's motion to enjoin URL Pharma from marketing or selling a generic 7.5 mg temazepam product.

Judge Chesler of the U.S. District Court for the District of New Jersey found that the lower dose of temazepam was obvious based on the dosage range disclosed in the prior art, thus invaliding the two claims of the '954 patent for obviousness.  Covidien unsuccessfully argued that other prior art taught away from the lower dosage and that the lower dosage showed unexpected results.

Judge Chesler's opinion granting summary judgment for obviousness can be found here.  The corresponding order can be found here.

Genetic Technologies' Patent in Suit against Monsanto and Pioneer Hi-Bred Upheld on Reexamination

Genetic Technologies announced that the USPTO has upheld all the claims of U.S. Patent No. 5,612,179 in a reexamination action initiated June 30, 2009.  The '179 patent covers a method for facilitating the detection of specific gene variations and noncoding DNA.  The patent is at issue in an infringement suit against Monsanto Inc., Pioneer Hi-Bred International Inc., and other rival laboratories, where Genetic Technologies has accused the defendants of willfully infringing the '179 patent.  Genetic Technologies' complaint accuses the defendant laboratories of using the '179 patent in their genetic risk assessment services and to isolate certain genes in cows and soybeans.

The USPTO's decision will now make more claims available in Genetic Technologies' infringement case and any future assertion targets.  Genetic Technologies previously announced on February 16, 2010 that it intended to implement a new assertion program to vigorously defend its patents.  The company has recently settled litigation involving the '179 patent with Applera Corp., Gen-Probe, and Monsanto, with each company taking limited licenses to the technology.

Genetic Technologies' May 10, 2010 press release can be found here.

Merck and Glenmark Settle Zetia Patent Suit

Merck and Glenmark Pharmaceuticals Inc. have resolved a lawsuit over the reissued patent for Merck's cholesterol drug Zetia, with Glenmark getting permission to launch its proposed generic ahead of the asserted patent's expiration date on April 25, 2017.  Under the terms of the agreement, Glenmark will be able to launch its generic on December 12, 2016, or earlier under certain circumstances.

The settlement follows the recent order that certain claims of the reissued patent RE37,721 covering Zetia were invalid (see "Biotech/Pharma Docket," May 10, 2010).  Judge Linares vacated that April 19 order which granted Glenmark's motion for summary judgment and invalidated three of the reissued patent's claims.

The consent judgment 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 degiulio@mbhb.com.

Comments

[Dan Feigelson]

Nice to see that the reexam was completed in less than a year. I wonder when that will become the norm?