Overview
The 1984 amendments to the Federal Food, Drug, and Cosmetic Act (commonly known as the Hatch-Waxman Amendments, or “Hatch-Waxman”) have provided a framework for generic drug companies to seek expedited U.S. Food and Drug Administration approval of generic drug products and generic marketing exclusivity. Locke Lord Bissell & Liddell attorneys are among the most experienced Hatch-Waxman practitioners in the country and help clients get approval and overcome the hurdles brought about by the rise in patent infringement litigation resulting from the submission of Abbreviated New Drug Applications (ANDAs) and Section 505 (b)(2) applications/paper NDAs.
We are intimately familiar with the statutory and frequently changing regulatory guidelines set in place by Hatch-Waxman and the FDA. We advise our clients through the process of taking a generic drug product to market. We counsel our clients on design around opportunities, providing opinions of counsel on patent non-infringement and invalidity, assist with the filing of ANDAs or 505(b)(2) applications and patent certifications and notice letters, prosecute and defend patent infringement lawsuits, and protect our clients’ approval and exclusivity interests before the FDA.
Our lawyers are registered to practice before the U.S. Patent and Trademark Office and have the technical skills and experience and understanding of analytical techniques in a variety of fields, including: pharmaceuticals; organic, inorganic and industrial chemistry; biochemistry; biotechnology and genetics. This real world experience enables us to assist with virtually any legal issue surrounding our clients’ product development without losing sight of the science behind the product.
The firm’s guidance includes the following:
- Analyzing U.S. and foreign patents, applications and related file histories related to drug products of interest
- Conducting targeted searches to locate relevant prior art references
- Providing independent opinions of counsel on patent validity and non-infringement
- Providing individualized strategies for filing an ANDA or 505 (b)(2) application in light of possible regulatory exclusivities and patent hurdles
- Preparing patent certifications to accompany and/or amend an ANDA or 505(b)(2) application
- Assisting with ANDA or 505(b)(2) application filing and submission
- Preparing notice letters to NDA-holders and patentees regarding patent certifications
- Monitoring FDA listings of new Orange Book patents, paragraph IV certifications filed by other generic drug manufacturers and related pending litigation
- Enforcing and defending our clients’ interests in Hatch-Waxman litigation
- Representing and advocating clients' interests before the FDA and, if necessary, litigating approval and exclusivity issues against the agency
The preeminent interest of any pharmaceutical manufacturer is to secure market entry. Our attorneys help clients negotiate a minefield of statutory, regulatory and litigation hurdles to secure freedom to operate in the marketplace.
Pharmaceutical industry clients turn to Locke Lord when the stakes are high. Our attorneys have unprecedented experience at both the trial and appellate level litigating Hatch-Waxman and other actions involving blockbuster prescription drugs, including Neurontin® (gabapentin), Paxil® (paroxetine hydrochloride), Depakote® (divalproex sodium), Prozac® (fluoxetine hydrochloride), Zantac® (ranitidine hydrochloride), and Coumadin® (warfarin sodium).
Management of product lifecycles is crucial to maintaining the profitability of a drug product. Locke Lord attorneys maximize the value of clients' products by devising strategies for acquiring, licensing and asserting their intellectual property rights and identifying joint venture opportunities. Our attorneys work closely not just with scientists, but with business, marketing and product development managers to identify and implement clients’ long range options and business goals.
In an environment where competition is fierce, clients must often prosecute or challenge intellectual property interests in a patent infringement lawsuit. Our lawyers have significant experience representing clients in Markman hearings, at trial before the federal district courts, as well as on appeal before the U.S. Court of Appeals for the Federal Circuit. Our lawyers are also well-versed in administrative law and have considerable experience handling the regulatory issues that arise during the FDA approval process.
The Firm has represented clients in several important areas, including the areas of polymorph patents and off-label use patents. We defended a patent infringement lawsuit 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, held that GlaxoSmithkline had failed to prove that its hemihydrate patent would be infringed by the client’s anhydrous form of the drug, thus opening the door to getting a generic version of Paxil® to market. The firm’s 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.
The Firm defended a generic pharmaceutical company in a patent infringement suit brought by Warner-Lambert involving the blockbuster drug Neurontin® (gabapentin). In that case, the Federal Circuit affirmed a ruling of summary judgment, holding that it had neither literally infringed nor induced infringement of one of Warner-Lambert’s use patents, which covered a method of using gabapentin the FDA has not approved. Marking a milestone 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.