Life Sciences and Hatch-Waxman Intellectual Property Litigation
At Robins, Kaplan, Miller & Ciresi L.L.P., our intellectual property trial attorneys represent companies in the generic pharmaceutical, biopharmaceutical, biotechnology, and medical device industries in patent, trade secret, and other disputes involving intellectual property. Among others, the technologies have included pharmaceutical formulations and active drug compounds, polymers, biofuels, MRI and catheter technologies, erythropoietin products, protein production from host cells, recombinant DNA technology, and transgenic mice. When it comes to litigation under the Hatch-Waxman Act, we have worked the full spectrum of cases—representing small and large generic and innovator pharmaceutical companies, companies that do both, and start-ups. This breadth of trial and litigation experience allows us to bring a big-picture perspective to what companies need when they pursue matters under the Hatch-Waxman Act. We also draw on the knowledge and experience of the attorneys and scientific advisors throughout the firm who have relevant technological backgrounds, including advanced degrees in biology, chemistry, biochemistry, biomedical engineering, pharmacology, and physics.
Selected Life Sciences Experience*
- Rembrandt Vision Technologies v. Johnson & Johnson Vision Care: Lead trial counsel in an action pending in the Middle District of Florida in which our client Rembrandt Vision Technologies has sued Johnson & Johnson Vision Care for patent infringement involving silicon hydrogel contact lenses. The matter is scheduled for trial in 2012.
- Prometheus Laboratories, Inc., et al. v. Quest Diagnostics, Inc.: Represented Quest Diagnostics, Inc. in patent case involving genotyping technology in which all claims were dismissed.
- American Medical Systems Stress Urinary Incontinence Litigation: Lead counsel in complex patent litigation in several jurisdictions, including cross claims for infringement of seven patents on surgical methods and devices. Matter was settled on confidential terms involving cross-licenses.
- Fonar v. General Electric: Represented Fonar Corporation and Dr. Raymond V. Damadian in a patent infringement action against General Electric involving patents on magnetic resonance imaging (MRI) machines. At trial the jury awarded Fonar $110.5 million. The Court of Appeals for the Federal Circuit affirmed almost the entire award, ordering General Electric to pay $103.4 million, reported at the time to be the largest patent infringement jury verdict ever upheld on appeal (IP Worldwide). Fonar Corporation v. General Electric Co., 107 F.3d 1543 (Fed. Cir.), cert. denied, 118 S.Ct. 266 (1997). After the Supreme Court denied certiorari, General Electric paid Fonar $128 million (judgment plus interest).
- TriStrata Technology, Inc. v. Mary Kay Inc.: Patent infringement case relating to alpha-hydroxy acid (AHA) anti-aging skin technology. Our client, TriStrata Technology, Inc., was awarded $26,359,405 in damages plus interest. The jury ruled in TriStrata's favor on all issues of infringement and validity. The U.S. District Court for the District of Delaware in Wilmington, Del. issued a final judgment March 31, 2006 granting prejudgment and post-judgment interest to TriStrata Technology, Inc. bringing the total award to over $43 million. Case was summarily affirmed by the Federal Circuit on January 10, 2007.
- Defended ev3, Inc. in an action brought by Boston Scientific Corporation and Boston Scientific Scimed, Inc. for misappropriation of trade secrets and infringement of patents related to medical devices known as embolic protection filters. Also represented ev3, Inc. in patent counterclaims against the Boston Scientific defendants involving embolic protection technology. Claims for misappropriation of trade secrets was dismissed in part. The patent claims and counterclaims were settled before trial on a confidential basis.
- Trial counsel for Canadian biopharmaceutical company in 3-week arbitration of trade secrets and breach of contract case involving inventorship and ownership of patent applications for methods of treating Alzheimer's disease and Type 2 diabetes, held under the auspices of the ICC International Court of Arbitration. The arbitration panel found for the client on all but one minor claim. (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
- Trial counsel for U.S. technology company in patent litigation involving colloidal silica sols and particles for electronic applications such as chemical mechanical polishing (CMP). (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
- Trial counsel for U.S. and German pharmaceutical company in case involving a formulation patent for a proton pump inhibitor. Case settled night before jury selection. (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
- Represented U.S. and Japanese pharmaceutical companies in action before the International Trade Commission involving diltiazem hydrochloride. (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
- Represented U.S. pharmaceutical companies in arbitration regarding inventorship of erythropoietin peptide mimetics. (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
- Represented Japanese biotechnology research institute in patent litigation involving immunodeficient transgenic mice. (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
- Trial counsel for manufacturer of water-soluble polymers in patent litigation involving the use of water-soluble polymers for waste-water treatment. (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
- Trial counsel for major U.S. medical technology company in patent litigation involving catheter technology. (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
- Trial counsel for Spanish engineering company in patent and trade secret litigation involving extraction technology for the production of high purity zinc. (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
- Representation of a start-up developer and designer of solar power generation structures in counseling on IP.
- Representation of Japanese pharmaceutical company in intellectual property due diligence for major multi-billion dollar potential acquisition of rival US pharmaceutical company. (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
- Representation of Japanese pharmaceutical company on various patent due diligence projects regarding acquiring or licensing patent rights in various jurisdictions and to various technologies, ranging from small molecules to antibodies. (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
- Representation of U.S., European and Asian companies in opinions of counsel, due diligence investigations and counseling on patent issues concerning various technologies, including pharmaceuticals, assay systems for the Cdc7-ASK kinase inhibitor, bone implants from autologous tissue, specialty chemicals, skincare products and water-soluble polymers. (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
- Trial counsel for a Swiss, German and U.S. pharmaceutical company in a patent infringement case involving modified human erythropoietin therapeutic products. Represented client before the International Trade Commission as well as in the United States District Court and Court of Appeals for the Federal Circuit. (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
- Trial and appellate counsel for a U.S. biotechnology company and three academic and research institutions in a patent infringement case concerning methods for modulating immune system function. (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
- Representation of a U.S. chemical and agricultural company in a patent infringement and antitrust case involving recombinant DNA technology applied to crop seeds. (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
- Representation of U.S. pharmaceutical company and U.S. biotechnology company in a patent infringement case involving methods for protein production from transformed mammalian host cells. (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
- Representation of a U.K. medical company in a patent infringement case involving Down syndrome screening methods. (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
Selected Hatch-Waxman Experience*
- Medicis Pharmaceutical Corporation v. Upsher-Smith Laboratories, et al. Lead trial counsel defending Upsher-Smith Laboratories in a patent suit to enjoin the sale of a pharmaceutical formulation. Following a two-day bench trial on the issues of infringement, validity and enforceability of the plaintiff's patent, the Court denied a request to temporarily enjoin the client from making and selling its products. All claims asserted against our client were subsequently invalidated during an ex parte re-examination based on the same arguments and evidence we presented during the bench trial. The invalidity of the claims was summarily affirmed on appeal to the CAFC. The district court action is No. CV05-3458 (D. Az. filed October 27, 2005). The re-examination appeal is No. 2009-1291 (Reexamination No. 90/008,068).
- Braintree Laboratories v. Novel Laboratories: Representing generic pharmaceutical company relating to gastric lavage treatment Suprep (sodium sulfate, potassium sulfate, magnesium sulfate).
- Auxilium Pharmaceuticals v. Upsher-Smith Laboratories: Representing first-to-file generic company seeking to market a testosterone replacement therapy.
- Forest Laboratories v. Upsher-Smith Laboratories: Represented a generic company seeking to market a generic form of the Alzheimer's drug Namenda (memantine hydrochloride).
- Represented a generic company seeking to market a generic form of the epilepsy drug.
- Trial counsel for Japanese pharmaceutical company in multiple patent litigations under the Hatch-Waxman Act involving drug for treating ear infections. After prevailing at trial, the patent was held invalid on appeal. (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
- Trial counsel for U.K. and U.S. pharmaceutical company in multiple patent litigations under the Hatch-Waxman Act involving antidepressant and smoking cessation medication. (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
- Trial counsel for U.K. and U.S. pharmaceutical company in multiple patent litigations under the Hatch-Waxman Act involving oral syrup for anti-ulcer medication. (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
- Trial counsel for U.K. and U.S. pharmaceutical company in patent litigations under the Hatch-Waxman Act involving serotonin 5-HT3 receptor antagonist used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
- Trial counsel for a U.S. and German pharmaceutical company in multidistrict litigation under the Hatch-Waxman Act involving a formulation for a proton pump inhibitor. After prevailing at trial on its non-infringement defense, client launched product and Federal Circuit later affirmed. (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
- Trial counsel for U.S. and German pharmaceutical company in first-to-file Hatch-Waxman litigation for polyethylene glycol preparation. (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
- Trial counsel for U.S. and German pharmaceutical company in Hatch-Waxman case involving formulation for hyoscyamine sulfate tablet. (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
- Represented U.S. pharmaceutical companies in Hatch-Waxman litigation and two-week trial involving a formulation for a famotidine-antacid combination tablet. (Prior to joining Robins, Kaplan, Miller & Ciresi L.L.P.)
Litigation Practices > Life Sciences and Hatch-Waxman Intellectual Property Litigation