High Stakes Litigation and Blockbuster Drugs
When the stakes are high and the outcome is crucial to the bottom line, pharmaceutical industry clients turn to Rakoczy Molino Mazzochi Siwik LLP for assistance. Our attorneys have unprecedented experience at both the trial and appellate level litigating Hatch-Waxman and other actions involving blockbuster prescription drugs, including Paxil® (paroxetine hydrochloride), Neurontin® (gabapentin), Pravachol® (pravastatin sodium), Accupril® (quinapril hydrochloride), Zoloft® (sertraline hydrochloride), Tricor® (fenofibrate), Imitrex® (sumatriptan succinate), Alphagan® (brimonidine), Depakote® (divalproex sodium), Prozac® (fluoxetine hydrochloride), Zantac® (ranitidine hydrochloride), Glucophage® (metformin hydrochloride), and Coumadin® (warfarin sodium).
Success in the Courtroom
In an environment where competition is fierce, clients must either prosecute or challenge intellectual property interests in a patent infringement lawsuit. Our attorneys have significant experience representing clients in Markman hearings, at trial before the federal district courts, and on appeal before the United States Court of Appeals for the Federal Circuit. Our attorneys are also well-versed in administrative law and have considerable experience handling the regulatory issues that arise during the FDA approval process — issues which, themselves, are often resolved through litigation.
Our attorneys have been in the news for numerous notable victories, including one involving the Federal Circuit's watershed decision regarding off-label use patents and inducement of infringement lawsuits.
In February 2003, our attorneys were highlighted in The National Law Journal for successfully defending a generic pharmaceutical company in a patent infringement suit brought by Warner-Lambert involving the blockbuster drug Neurontin® (gabapentin). There, the Federal Circuit affirmed a ruling of summary judgment of noninfringement for our client, holding that the client had neither literally infringed nor induced infringement of one of Warner-Lambert's use patents, which covered a method of using gabapentin that the FDA has not approved. Marking a victory for all generic manufacturers, the court ruled that so-called "off-label" use patents are not cognizable under Hatch-Waxman, and that traditional elements of inducement must be proved to uphold such a claim. The decision was listed in the article, "The top 10 patent decisions by the U.S. Court of Appeals for the Federal Circuit from October 2002 through January 2003," published in the March 24, 2003 issue of Legal Times.
The attorneys also made news after successfully defending another patent infringement lawsuit, this time brought by GlaxoSmithKline involving the world's best-selling anti-depressant and anti-anxiety medication, Paxil® (paroxetine hydrochloride). After a three-week trial, Seventh Circuit Judge Richard Posner, sitting by designation, ruled in favor of our client, holding that GlaxoSmithKline had failed to prove that its hemihydrate patent would be infringed by our client's anhydrous version of the drug, thus opening the door to getting a generic version of Paxil® to market. The attorneys' victory was named the "Defense Win of the Month" in the April 28, 2003 issue of the National Law Journal, and was also highlighted in the article "Big Suits" in the May 2003 issue of The American Lawyer.
Our attorneys followed up these successes with a victory on appeal before the United States Court of Appeals for the Federal Circuit, which issued an opinion invalidating GlaxoSmithKline's main patent for Paxil®.
In a related action, after FDA threatened to jeopardize our client's lucrative 180-day generic marketing exclusivity for generic Paxil® by awarding "shared exclusivity" to competing companies, our attorneys obtained emergency relief setting aside the FDA's decision; awarding our client sole 180-day marketing exclusivity for generic Paxil®; and enjoining the FDA from approving any other generic Paxil® products until the expiration of that exclusivity. The decision preserved our client's exclusivity and more than $50 million in additional generic Paxil® sales.
With a proven track record of success on the patent and regulatory fronts, the attorneys at Rakoczy Molino Mazzochi Siwik LLP have the experience and know-how to shepherd a product from inception to the marketplace.
