MOVING FORWARD IN HATCH-WAXMAN LITIGATION GETTING YOUR GENERICS TO MARKET

Transcription

1 MOVING FORWARD IN HATCH-WAXMAN LITIGATION GETTING YOUR GENERICS TO MARKET

2 STRATEGIES ALIGNED WITH THE TIMES Generic pharmaceutical companies need counsel who understand all aspects of their business. Brinks Hatch-Waxman litigation practice group clears the legal and regulatory pathway for our generic pharmaceutical clients. We leverage our legal experience and strong technical backgrounds to provide useful advice and solve the legal problems faced by the contemporary pharmaceutical marketplace. Performs flawlessly when it comes to the procurement of patents and adds tremendous value with its wider portfolio development and invention capture services. IAM PATENT 1000 (2016) We understand clients top priorities, including responsiveness, efficiency, and budgeting. Litigation tactics must align with the client s business objectives; hence we invest the time to understand those objectives, and develop a litigation plan to achieve them. It s our way of thinking forward.

3 EXPERIENCE ANDA litigation requires an intimate knowledge of patent litigation strategies, Hatch- Waxman regulations and FDA procedures. Brinks pharmaceutical litigators have that knowledge and experience as a result of dozens of Hatch-Waxman cases involving drugs from A (atomoxetine) to Z (zolpidem). These cases have covered virtually every type of drug technology, including compounds, formulations, polymorphs, and methods of treatment. STAGE Preliminary Injunction Summary Judgment Trial Appeal DESCRIPTION In a case directed to a $600 million/year antibiotic, Brinks defeated a TRO and motion for preliminary injunction and then successfully defended that decision at the Federal Circuit. In a first-to-file opportunity for its generic client, Brinks obtained summary judgment of invalidity and non-infringement for the majority of asserted claims. All remaining claims were settled on the eve of trial, allowing Brinks client to launch its generic drug product three years before patent expiry. In a case related to a $1B/year asthma drug, Brinks lawyers obtained a final judgment of invalidity after a seven-week bench trial. The judgment was affirmed on appeal. Prior to Brinks involvement, the district court and Federal Circuit ruled against another generic company on the exact same patent. Brinks took over a case on appeal after an adverse district court judgment. Brinks convinced the Federal Circuit to vacate the district court judgment. In the interim, Brinks filed a successful request for reexamination that resulted in the invalidity of every asserted claim.

4 OUR ACCOLADES AT A GLANCE 1917 FIRM WAS FOUNDED ALL ASPECTS OF IP 100+ LAWYERS, SCIENTIFIC ADVISORS AND PATENT AGENTS 10+ LANGUAGES Brinks Hatch-Waxman Litigators are recognized leaders in intellectual property law, receiving awards from a range of organizations CHAMBERS USA AMERICA S LEADING LAWYERS FOR BUSINESS Top-ranked for Intellectual Property Law in Illinois, IAM PATENT THE WORLD S LEADING PATENT PRACTITIONERS Silver Band, Patent Litigation Illinois, Individual honors: Ralph Gabric, Mark Remus U.S. NEWS & WORLD REPORT BEST LAWYERS Best Law Firm - National - IP Law, 2016 Tier 1 - Patent Law, Brinks attorneys are listed in The Best Lawyers in America SUPER LAWYERS Twenty individual honors EXPERT GUIDES: WORLD S LEADING PATENT LAWYERS Individual honors, 2017: Ralph Gabric, Mark Remus IP LAW, ILLINOIS BAND CHAMBERS USA IP LITIGATION TIER US NEWS & WORLD REPORT MOVE FORWARD IN Chicago, IL Washington, DC Ann Arbor, MI Indianapolis, IN Research Triangle Park, NC Salt Lake City, UT Tampa, FL Shenzhen, China I brinksgilson.com

5 MOVING FORWARD IN HATCH-WAXMAN LITIGATION Brinks conducts validity and infringement reviews in connection with Paragraph IV certifications for abbreviated new drug applications or 505(b)(2) applications, and represents clients in related Hatch-Waxman litigation and other litigation in this and related fields. A representative list of compounds that we have worked on is below. GENERIC PRODUCT BRANDED PRODUCT GENERIC PRODUCT BRANDED PRODUCT Alcaftadine Lastacaft Levocetirizine Xyzal Aspirin/dipyradimole Aggrenox Memantine Namenda XR Besifloxacin Besivance Methylphenidate osmotic release Concerta Bimatoprost Lumigan Methylphenidate transdermal patch Daytrana Budesonide Pulmicort Respules Montelukast sodium Singulair Buprenorphine/naloxone Suboxone sublingual film Omeprazole Prilosec Bupropion Wellbutrin XL Pantoprazole Protonix Cabazitaxel Jevtana Paroxetine mesylate Brisdelle Caspofungin Cancidas Pemetrexed Alimta Celecoxib Celebrex Polycarbophil/chitosan opthalmic DuraSite 2 Choline fenofibric acid Trilipix Pramipexole Mirapex ER Cefdinir Omnicef Pregabalin Lyrica Clindamycin phosphate and benzoyl peroxide Onexton Gel Repaglinide Prandin Dextromethorphan/quinidine Nuedexta Repaglinide/metformin PrandiMet Diclofenac sodium Pennsaid Ropivacaine hydrochloride monohydrate Naropin Dorzolamide-timolol Cosopt PF Rosuvastatin calcium Crestor Doxercalciferol Hectorol Saxagliptin Onglyza Duloxetine Cymbalta Saxagliptin/metformin extended release Kombiglyze Enoxaparin sodium Lovenox Sevelamer hydrochloride Renagel Eptifibatide Integrilin Teriflunomide Aubagio Esomeprazole Nexium Testosterone AndroGel Festerodine Toviaz Ticagrelor Brilinta Febuxostat Uloric Valganciclovir hydrochloride Valcyte Galantamine hydrobromide Razadyne ER Venlafaxine Effexor Gemcitabine Gemzar Zolpidem Ambien I brinksgilson.com