Biotech/Pharma Docket

    By James DeGiulio --

Medicis' Solodyn Patent Upheld on Reexamination

The U.S. Patent and Trademark Office has issued a reexamination certificate reaffirming Medicis' U.S. Patent No. 5,908,838 covering the skin treatment Solodyn.  The '838 patent, which issued in June 1999 and has been asserted in several infringement suits, covers a slow-dissolving form of tetracycline, a class of oral antibiotics that are commonly used to treat acne.  According to a Medicis SEC filing, the USPTO confirmed the patentability of claims 3, 4, 12, and 13, as well as new claims 19-34.

Medicis has launched litigation against several drug companies over its Solodyn drug and the '838 patent, including Lupin Ltd., Mylan Inc., and Novartis AG unit Sandoz International GmbH (see "Court Report," January 18, 2009).  Recent developments in the Solodyn litigation include an amended complaint filed in the District of Maryland which broadened Medicis' claims against Lupin for patent infringement.  In May, Medicis reached consent and licensing agreements with Ranbaxy, settling patent infringement claims over Solodyn and enjoining Ranbaxy from continuing to market the generic without a license (see "Biotech/Pharma Docket," May 13, 2010).

Apotex Found Not to Have Willfully Infringed AstraZeneca Prilosec Patents

AstraZeneca was precluded from receiving increased damages in its infringement win against Apotex concerning Prilosec, as Apotex was found not to have willfully infringed two patents held by AstraZeneca when Apotex began selling a generic version of Prilosec in 2003.

AstraZeneca sued several generic drug makers in 2000, accusing them of infringing U.S. Patent Nos. 4,786,505 and 4,853,230, covering the gastric-acid inhibitor Prilosec.  AstraZeneca brought suit against Apotex in April 2001 after Apotex's ANDA filing, which was approved by the FDA in October 2003.  In March 2005, AstraZeneca amended its complaint to add a claim of willful infringement, alleging that Apotex lacked a meritorious defense and engaged in litigation misconduct.  At trial in May 2006, Judge Barbara Jones of the U.S. District Court for the Southern District of New York found that defendant Apotex was liable for infringement.

On May 9, Judge Jones found that AstraZeneca had failed to prove Apotex's willful infringement.  Apotex based its argument on In re Seagate Technology, LLC, a 2007 Federal Circuit ruling where the Court found that a patent holder that does not attempt to stop an infringer cannot get increased damages based on the infringer's post-filing conduct.

In the instant case, Judge Jones noted the filing at issue here was not the original complaint, but the amended complaint where the claims for willful infringement were added.  Those claims, she noted, were based on Apotex's sale of generic drugs, which occurred before the complaint was amended.  Thus, Judge Jones found that AstraZeneca's claims were not based solely on the infringer's post-filing conduct, and enhanced damages were unavailable.

Judge Jones' order can be found here.

Sanofi-Aventis Secures Injunction against Dr. Reddy's over Generic Allegra

Just a few days after Dr. Reddy's agreed to hold off selling a generic form of Allegra, Sanofi-Aventis and Albany Molecular Research, Inc. (AMRI) conclusively blocked such action by successfully securing a preliminary injunction against Dr. Reddy's.

Sanofi and AMRI launched the current suit in September 2009, accusing Dr. Reddy's of infringing U.S. Patent No. 7,390,906, which issued in June 2008 and which covers Allegra-D (see "Court Report," September 27, 2009).  Dr. Reddy's generic fexofenadine hydrochloride was approved in March 2010.  Soon after the approval, on June 2, Dr. Reddy's agreed not to sell generic Allegra in the U.S. before June 25, or until the judge handed down his decision on Sanofi's request for preliminary injunction.  This order can be found here.

On June 12, Judge Garrett E. Brown Jr. of the U.S. District Court for the District of New Jersey enjoined Dr. Reddy's from commercial sales of its generic version of Allegra.  The Court found that AMRI and Sanofi had successfully established that they were likely to succeed on the merits and likely to suffer irreparable harm in the absence of injunctive relief.  The Court also found that the balance of equities was in the plaintiff's favor, and further that an injunction was in the public interest.  Dr. Reddy's said it intended to appeal the verdict.

Judge Brown's order granting the injunction 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].

Comments

[Jason S]

Allegra for half the price sounds good. As someone who suffers from allergies terribly, I am a true advocate for fexofenadine hydrochloride