Richard T. Ruzich

Richard is an internationally recognized patent attorney who focuses on complex patent litigation, representing generic pharmaceutical companies in Abbreviated New Drug Application (ANDA) litigation under the Hatch-Waxman statutory framework. An accomplished trial and appellate advocate, registered patent attorney, and frequent lecturer and author, Richard is known worldwide for his legal work on behalf of his generic clients, including biosimilars sponsors. His experience covers the entire lifecycle spectrum from product selection, Paragraph IV development and through to market entry, including at-risk launches.

In addition, Richard has broad experience managing patent, copyright, trademark and trade secrets matters for clients in other industries as well, such as computer hardware and software, medical devices and industrial chemicals industries.

Richard counsels clients on IP portfolio management and protection strategies, files and prosecutes IP asset applications and negotiates major IP transactions, such as licensing, joint venture, mergers and acquisitions and government research and development agreements in private litigation. He has led trials involving widely varying technologies, from injectable cancer drugs and high blood pressure medications to radio transmission systems and microprocessors. He has experience first-chairing cases at the trial level through appeal, including to the Court of Appeals for the Federal Circuit. Richard has been recognized in Illinois Super Lawyers since 2012.

• As lead counsel for Apotex in the widely-followed celecoxib (Celebrex) ANDA matter against Pfizer, Richard recently secured a favorable decision for Apotex. The Eastern District of Virginia granted Apotex’s motion for summary judgment holding that the ‘048 Reissue Patent was improperly granted under Section 251 of the Patent Act, which was upheld by the Court of Appeals for the Federal Circuit (2015).
• Lead counsel for Apotex in the febuxostat, milnacipran, and bivalirudin patent litigations currently pending in various U.S. federal district courts.
• Represented Lockheed Martin Corp. in opposing an effort by Zoltek Corp to substitute it as a defendant in a patent-infringement action Zoltek had originally brought against the United States stemming from the U.S.’s alleged use of Zoltek’s patent in the manufacture of the F-22 fighter plane. Obtained a favorable, interlocutory decision from the Federal Circuit on the issue of government-contractor immunity under and ultimately leading to the en banc dismissal of Lockheed Martin as a party.
• Represented Sandoz Inc. regarding its ANDA concerning a generic version of Medicis’ acne production SOLODYN® (minocycline hydrochloride).
• Represented Sandoz Inc. regarding its ANDA concerning a generic version of Endo’s pain product OPANA® ER (oxymorphone hydrochloride).
• Represented Apotex Inc. regarding its ANDA concerning a generic version of Wyeth’s anti-depressant product EFFEXOR XR® (venlafaxine hydrochloride). Settled on favorable terms during trial.
• Represented Apotex Inc. regarding its ANDA concerning a generic version of Sanofi-Aventis’ anticancer product TAXOTERE®, the active ingredient of which is docetaxel. Following a two-week trial, obtained an order for Apotex striking down the patents-in-issue as invalid as obvious and unenforceable due to Sanofi-Aventis’ inequitable conduct in procuring the patents. Successfully argued on appeal with the Federal Circuit affirming trial court decision (April 2012). Of importance is that inequitable conduct defense remains viable in ANDA litigations because of this ruling.
• Represented Sandoz Inc. regarding its ANDA concerning a generic version of Allergan’s glaucoma drops COMBIGAN® (brimonidine tartrate/timolol maleate).
• Represented Sandoz Inc. regarding its ANDA concerning a generic version of Alcon’s eye allergy product PANTANOL® (olopatadine hydrochloride).
• Represented Sandoz Inc. regarding its ANDA concerning a generic version of Merck’s anti-nausea product EMEND® (aprepitant).
• Represented Mylan Pharmaceuticals, Inc. regarding its ANDA concerning a generic version of Pfizer’s cardiovascular product CADUET®, the active ingredients of which are atorvastatin calcium and amlodipine besylate. Settled prior to trial.
• Represented Apotex Inc. regarding its ANDA concerning a generic version of Procter’s osteoporosis product ACTONEL® (risedronate).
• Represented Sandoz inc. regarding its ANDA concerning a generic version of Abbott’s ZEMPLAR® (paricalcitol).
• Represented Apotex Inc. regarding its ANDA concerning a generic version of LYSTEDA (tranexamic acid).
• Represented Apotex Inc. regarding its ANDA concerning a generic version of ACULAR LS® (0.4% ketorolac tromethamine).
• Represented Apotex Inc.regarding its ANDA concerning a generic version of PRISTIQ® (desvenlafaxine).
• Represented Sandoz Inc. regarding its ANDA concerning a generic version of Shire’s ADHD product INTUNIV® (guanfacine hydrochloride).
• Represented Sandoz Inc. regarding its ANDA concerning a generic version of Roche’s VALCYTE® (valganciclovir hydrochloride).
• Represented Sandoz Inc. regarding its ANDA concerning a generic version of Helsinn’s anti-nausea product ALOXI® (palonosetron hydrochloride injection).
• Represented Vetter Software, Inc. and VetPort against BillingNetwork Patent, Inc., case No. 1:14-cv-09964 (ND IL) and Case No. 14-cv-05828 (ND IL), respectively, in a patent infringement matter regarding U.S. patent 6,374,229 (integrated internet facilitated billing, data processing and communication system).
• Represented client regarding its ANDA concerning a generic version of Spectrum’s FUSILEV® (levoleucovorin).
• Represented Sandoz Inc. regarding its ANDA concerning a generic version of Abbott’s cholesterol medication TRILIPIX® (fenofibric acid).
• Represented Sandoz Inc. regarding its ANDA concerning a generic version of Abbott’s cholesterol product NIASPAN® (niacin).
• Represented Sandoz Inc. regarding its ANDA concerning a generic version of Alcon’s eye allergy product PATANOL® (olopatadine hydrochloride).
• Represented Apotex Inc. regarding its ANDA concerning a generic version of AVODART® (dutasteride).

Recent Publications

• Pre-Clinical R&D in ANDA Litigation: Strategies & Tactics for Pharmaceutical Patent Litigators, 2nd ed. (in press)
• Where State and Federal Interests Collide, Intellectual Property Magazine, Ocober 10, 2013
• In Practice: In-House Counsel Can Inadvertently Waive Conflicts, The Recorder, June 21, 2013
• In Practice: Obamacare’s Constitutional Impact on Patents, InsideCounsel, April 30, 2013
• In Practice: Supreme Court Holds That the “First Sale” Doctrine Applies to Copies of a Copyrighted Work Lawfully Made Abroad, InsideCounsel, April 16, 2013
• In Practice: Compound Patents Take a Hit in Delaware District Court, Inside Counsel, March 19, 2013
• In Practice: Protecting your brands against online counterfeit sellers, Inside Counsel, March 5, 2013
• In Practice: 5 practice tips from the recent Rambus rulings, Inside Counsel, February 19, 2013
• Generics Versus Brands: New Fronts on a Shifting Battleground, BNA’s Pharmaceutical Law & Industry Report, June 3, 2011
• Interview with Intellectual Property Attorney Richard Ruzich, Lawyer Monthly, February 1, 2011
• FDA Labeling Requirements and Intent to Induce Patent Infringement, FDLI Update, March 1, 2010
• Smart Pill: So, Post-MMA, Who Gets First Slice?, IP Law & Business, August 1, 2009

Recent Presentations

• Panelist, “On Sale Bar – Round II: Understanding The Impact of Helsinn on Pharmaceutical Patents in a Post – AIA Setting,” ACI’s Paragraph IV Disputes Conference, New York, April 2017
• Speaker, “Due Diligence and Risk Management,” Biotechnology Law and New Frontiers Seminar, Budapest, April 2014
• Panelist, “Looking Beyond 180 Days: New Exclusivity Challenges for Brand Names and Generics and Related Implications for Paragraph IV Challenges,” ACI’s 8th Annual Paragraph IV Disputes Conference, New York, April 2014
• Speaker, “Supremely Looking Forward in 2014 – U.S. Supreme Court Review,” SIU Law Intellectual Property Seminar, April 2014