Christopher T. Griffith

• Illinois
• Texas
• District of Columbia
• U.S. District Court for the Northern District of Illinois (Member, Trial Bar)
• U.S. Court of Appeals for the Federal Circuit
• Registered Patent Attorney, U.S. Patent and Trademark Office (Reg. No. 33,392)

• Selected as a “Life Sciences Star,” LMG Life Sciences
• Named as an “IP Star,” Managing IP
• Listed in Intellectual Asset Management’s (IAM) Patent 1000 in Litigation
• Recognized by Illinois Super Lawyers in Intellectual Property Litigation
• Selected by peers as a “Leading Lawyer” in Intellectual Property Law – Leading Lawyers Network
• Listed among the “Top Lawyers in Illinois” in Intellectual Property Law – Chicago Lawyer

Clients Represented During Career (Partial List)

• Abraxis BioScience, Inc.
• Adhesives Research, Inc.
• AGFA-Gevaert N.V.
• Alberto-Culver, Inc.
• American Pharmaceutical Partners (APP)
• ARx LLC
• Cargill, Inc.
• Celgene
• Cipla Ltd.
• Clarus Therapeutics
• Corning, Inc.
• Deublin Company
• DSM N.V.
• Ecolab
• Elkay
• Fujisawa
• Horizon Pharma plc
• Ingenus Pharmaceuticals
• J.L. Clark
• Leiutis Pharmaceuticals
• Lupin Ltd.
• Medicure Pharmaceuticals
• Mylan Pharmaceuticals
• Nalco
• Natco Pharmaceuticals
• National Institutes of Health (US)
• Osmotica Pharmaceuticals
• Pall Corporation
• RVL Pharma
• Sigmapharm Laboratories
• Santa Cruz Nutritionals

• Ingenus v. Nexus – Chris is local and co-counsel for Ingenus in the U.S. District Court for the Northern District of Illinois against Nexus relating to Nexus’s Abbreviated New Drug Application that seeks approval to market a generic version of Ingenus’s cyclophosphamide injectable product. This case is currently pending.
• Amgen v. USV – Chris is counsel for USV concerning USV’s Abbreviated New Drug Application that seeks approval for a generic equivalent of Amgen’s Parsabiv® (etelcalcetide injection) peptide product. This case is currently pending in the U.S. District Court in Delaware.
• Medicure v. Nexus – Chris was local counsel for Medicure in the U.S. District Court for the Northern District of Illinois against Nexus related to Nexus’s Abbreviated New Drug Application that sought approval to market a generic equivalent to Medicure’s Aggrastat® (tirofiban hydrochloride injection premix) product. This case was settled on terms favorable to Medicure.
• Lipocine v. Clarus ‐ Chris was counsel in defending Clarus against alleged infringement of Lipocine’s patents related to Lipocine’s New Drug Application seeking to market an oral delivery testosterone undecanoate product.  Clarus invalidated Lipocine’s asserted patent under Section 112 (indefiniteness) via Summary Judgment, and settled the remaining Clarus counterclaims against Lipocine of inequitable conduct, patent misuse and exceptional case on terms favorable to Clarus.
• Clarus Therapeutics v. Lipocine – Chris was counsel for Clarus in an interference proceeding concerning patent rights relative to methods for using oral testosterone formulations.  Clarus obtained judgment in its favor.
• Horizon v. Actavis – Chris was counsel for Horizon in litigation against Actavis related to Actavis’ Abbreviated New Drug Application that sought approval to market a generic equivalent to Horizon’s Pennsaid® 2% (diclofenac sodium topical) solution. The firm successfully upheld the validity of Horizon Pharma’s Orange Book-listed patent in Hatch Waxman litigation against generic applicant Actavis Labs-UT (now Teva).  The district court decision was affirmed by the Federal Circuit on appeal. As a result of this ruling, Teva is barred from launching a generic version of PENNSAID® 2% in the United States until October 2027.
• Dexcel v. Takeda – Chris was counsel for Dexcel in litigation against Takeda related to Dexcel’s proposed 505(b)(2) delayed-release orally-disintegrating lansoprazole tablets for OTC marketing.  The firm successfully obtained a judgement of non-infringement in favor of Dexcel.  This decision was not appealed by Takeda and, as a result, the Dexcel product is now marketed in the US.
• Shire v. Osmotica – Chris was lead counsel for Osmotica in litigation related to Osmotica’s Abbreviated New Drug Application that seeks approval to market a generic equivalent to Shire’s Lialda® mesalamine product.  This action settled, and was dismissed.
• Clarus Therapeutics v. Lipocine – Chris was counsel for Clarus against Lipocine relating to Lipocine’s New Drug Application that seeks approval to market an oral testosterone formulation.  This action was dismissed based on a subsequent FDA decision.
• Warner Chilcott v. Lupin – Chris was counsel for Lupin in litigation related to Lupin’s Abbreviated New Drug Application that seeks approval to market a generic equivalent to Warner Chilcott’s Generess Fe® (norethindrone and ethinyl estradiol chewable tablets) product. The district court (Pisano, J.) invalidated the asserted claims, and entered judgment in favor of Lupin.
• Forest Laboratories v. Sigmapharm – Chris was counsel for Sigmapharm in litigation related to Sigmapharm’s Abbreviated New Drug Application that seeks approval to market a generic equivalent to Forest Laboratories’ Saphira® (asenapine maleate tablet) product.
• Pfizer v. Lupin – Chris was counsel for Lupin in litigation related to Lupin’s Abbreviated New Drug Application that seeks approval to market a generic equivalent to Pfizer’s Toviaz® (fesoterodine fumarate) product.
• AstraZeneca v. Lupin – Chris was counsel for Lupin in litigation relating to Lupin’s Abbreviated New Drug Application that seeks approval to market a generic equivalent to AstraZeneca’s Vimovo® (naproxen and esomeprazole magnesium delayed-release) product.
• Pfizer v. Osmotica – Chris was lead counsel representing Osmotica in litigation involving the alleged infringement by Osmotica’s generic equivalent of Pfizer’s Detrol® LA product. The district court action was ultimately dismissed on terms favorable to Osmotica.
• AstraZeneca v. Mutual Pharmaceuticals – Chris was counsel for Mutual in litigation involving the validity and alleged infringement of AstraZeneca’s patent by Mutual relating to felodipine (Plendil®). A judgment of noninfringement, in favor of Mutual was issued by the U.S. Court of Appeals for the Federal Circuit.
• Pfizer v. Lupin – Chris was counsel for Lupin in litigation related to Lupin’s Abbreviated New Drug Application that sought approval to market a generic equivalent of Pristiq® desvenlafaxine. This matter settled.
• Ortho-McNeil v. Lupin – Chris was counsel for Lupin in litigation related to Lupin’s Abbreviated New Drug Application that sought approval to market a generic equivalent to Ortho-McNeil’s Ortho-Tricyclen Lo® (norgestimate/ethinyl estradiol) product. This litigation was successfully settled, with Lupin being granted a license permitting Lupin to market the product in December 2015—a date prior to expiration of the patent in suit.
• Gilead v. Sigmapharm – Chris was counsel for Sigmapharm in litigation related to Sigmapharm’s Abbreviated New Drug Application that sought approval to market a generic equivalent to Gilead’s Hepsera® (adefovir dipivoxil) product. Gilead voluntarily dismissed the action prior to trial.
• Shire v. Natco Pharma – Chris was counsel in litigation relating to Natco’s Abbreviated New Drug Application that sought approval to market a generic equivalent to Shire’s Fosrenol® (lanthanum carbonate) product. This action was dismissed with prejudice, allowing Natco to move forward to obtain FDA approval for marketing.
• Abbott v. Lupin – Chris was counsel in litigation related to Lupin’s Abbreviated New Drug Application that sought approval to market a generic equivalent to Abbott’s Trilipix® (choline fenofibrate) product. This action was settled on terms that were very favorable to Lupin.
• Bayer Schering Pharma AG and Bayer Healthcare Pharmaceuticals Inc. v. Lupin Limited and Lupin Pharmaceuticals, Inc. – Chris was counsel in litigation related to Lupin’s Abbreviated New Drug Application that sought approval to market a generic equivalent to Bayer’s Yasmin® (drosperinone and ethinylestradiol product). Lupin prevailed in this action with a holding of no infringement because the asserted patent did not cover the approved use of the product.
• Medicis v. Lupin – Chris was counsel in litigation related to Lupin’s Abbreviated New Drug Application that sought approval to market a generic equivalent to Medicis’ Solodyn® minocycline product. This litigation was settled on terms very favorable to Lupin.
• Ortho-McNeil v. Lupin – Chris was counsel in litigation involving Lupin’s Abbreviated New Drug Application that sought approval to market a generic version of Levaquin® levlofloxacin tablets.
• Wyeth v. Lupin – Chris was counsel in litigation involving Lupin’s Abbreviated New Drug Application that sought approval to market a generic version of Effexor® XR Capsules. This action was settled.
• Abbott v. Novopharm – Chris represented Novopharm in litigation successfully challenging the expiration date of Abbott’s basic patent on terazosin, the active ingredient in Hytrin®. This case was decided in favor of Novopharm.
• Sloan-Kettering v. Fujisawa – Chris represented Fujisawa in litigation involving the validity of SK’s patent alleged to be infringed by Fujisawa’s Nebupent® aerosolized pentamidine. This action was settled on terms favorable to Fujisawa.
• Lupin Atlantis Holdings v. Paddock – Chris was counsel for Lupin in litigation relating to Paddock’s Abbreviated New Drug Application that sought approval to market a generic equivalent to Lupin Atlantis Holding’s fenofibrate product.

Concluded Litigation in Other Technologies

• Pall Corp. v. PTI Technologies (filtration technology)
• Weatherchem Corp. v. J.L. Clark, Inc. (sealing technology)
• Lemelson Foundation v. Cargill, Inc. et al. (machine vision)
• Henderson Mfg. Co. v. Highway Equipment Co. (custom truck equipment)
• Elkay Manufacturing Co. v. Ebco Manufacturing Co. (water coolers)
• KV Pharmaceuticals v. Integrity Pharmaceuticals (nutritional supplements)
• Sessions (Ferris) Pharmaceuticals v. Biopol (Korean Patent Office proceedings) (wound care)
• Deublin Company (EP Oppositions)

• “Current Developments in US IP Law,” 12th Annual Pharma IPR Conference, Mumbai, India, March 2023
• “Current US IP Issues and Decisions Relevant to Pharma & Biopharma Companies,” World Intellectual Property Forum (WIPF), April 26 – May 5, 2021
• “Inter Partes Review, Litigation or Both: Strategic Considerations for Pharmaceutical Companies,” 9th Annual Pharma IPR Conference, Mumbai, India, March 2020
• “Biosimilars in US, EU and China: Where Are We Now and Where Are We Going?” 4th China Pharma IP Summit 2019, Shanghai, China, October 2019
• “Section 101: Analysis of Recent Developments and Proposed Legislation,” International IP Skills Summit (IIPSS), Hyderabad, India, August 2019
• “Patent Fundamentals Bootcamp 2019: An Introduction to Patent Drafting, Prosecution, and Litigation,” Moderator and Faculty Member, Practising Law Institute, Chicago, IL, May 2019
• “Recent US Legal Developments Affecting Pharma-Related Contentious Matters,” 8th Annual Pharma IPR Conference, Mumbai, India, March 2019
• “Navigating the IP Waters – Portfolio Development, FDA Exclusivities and Current Legal Issues Affecting the Journey Toward Commercialization of Biopharmaceutical Products in the US,” Asia Pharma R&D Leaders, Beijing, China, January 2019
• “US Patent Litigation Trends: Past, Present and Future,” IIPLA 5th Dubai IP Congress, Dubai, UAE, January 2019
• “IP in the Courts: The Latest in IP Litigation,” World Intellectual Property Forum 2018 (WIPF), New Delhi, India, November 2018
• “Navigating the IP/FDA Exclusivity Waters – Recent Developments Affecting the Journey to 505(b)(1), 505(b)(2), ANDA and Biologics Approval in the US,” 3rd Annual China Pharma IP Summit, Beijing, China, October 2018
• “Paragraph IV Litigation Trends, Analysis and Future Predictions,” panelist; “Strategic Considerations Concerning Inter Partes Reviews (IPRs) – Appearing in Dual Proceedings Before the U.S. District Court and PTAB,” 3rd International IP Skills Summit (IIPSS), Hyderabad, India, June 2018
• “Interplay Between FDA Exclusivity, PTAB/IPRs and Hatch-Waxman Litigation on the Filing and Approval of 505(b)(2) and ANDA Applications,” 8th Annual Generic International Summit Asia, Shanghai, China, April 2018
• “Latest Developments: Federal Courts and PTAB,” 7th Annual Pharma IPR Conference, Mumbai, India, March 2018
• “505(b)(2) NDAs v. ANDAs: Case Studies and Implications for Patent Portfolio Development and US Litigation,” 2nd China Pharma IP Summit 2017, Shanghai, China, December 2017
• “Exploring New Developments in the Law of Divided and Inducement Infringement and Its Continuing Impact on Paragraph IV Litigation,” Paragraph IV Disputes Master Symposium, Chicago, IL, October 2017
• “Patent Portfolio Development, Management and Monetization,” Chinese IP Resource Center—Training for Chinese Attorneys and Patent Agents, Chicago, IL, November 2016
• “Selected U.S. Patent Law Topics Relevant to Pharmaceutical and Biotech Practice (Patentability, Validity and Infringement),” Advanced Training Seminars for the All-China Patent Agents Association, Chicago, IL, September 2014, July and November 2013
• “Current Issues and Strategies in U.S. Patent Prosecution,” Advanced Training Seminar for Patent Reexaminers of the People’s Republic of China (SIPO), Chicago, IL, June and October 2013
• “Selected U.S. Patent Law Topics Relevant to Pharmaceutical and Biotech Practice (Patentability, Validity and Infringement),” Advanced Training Seminars for the All-China Patent Agents Association and State Intellectual Property Organization (SIPO), Chicago, IL, May, September and October 2012
• “Patent Litigation Issues in the Context of Biotechnology and Pharmaceutical Patents,” Advanced Training Seminar for the All-China Patent Agents Association, Chicago, IL, June and September 2011
• “Current Issues and Strategies in U.S. Patent Prosecution,” Advanced Training Seminar for Patent Reexaminers of the People’s Republic of China (SIPO), Chicago, IL, April, July and October 2010; April and October 2009; April and October 2008
• “Recent Developments in U.S. Patent Law Affecting the Pharmaceutical Industry,” Global Generic Pharmaceutical Conference 2007, Mumbai, India, February 2007
• “Patent Considerations in the Pharmaceutical Industry,” 58th Indian Pharmaceutical Congress, Mumbai, India, December 2006
• “Current Issues and Strategies in U.S. Patent Prosecution,” Advanced Training Seminar for Patent Reexaminers of the People’s Republic of China (SIPO), Chicago, IL, October 2006
• “Patent Barriers to Generic Pharmaceutical Entry,” AIPLA Road Shows, Boston, MA, Houston and San Jose, TX, June 2006
• “The Changing Landscape of U.S. Patent Law,” Global Generic Pharmaceutical Conference 2006, Mumbai, India, March 2006
• “Patent Issues and Trends In Cosmetic Formulations,” Society of Cosmetic Chemists, Chicago, IL, October 2005
• “Due Diligence in IP Business Transactions,” Practicing Law Institute, Chicago, IL, March 2003 and 2004
• “Senate Passes Bill Revising Hatch-Waxman Framework for Generic Drug Approval,” Regulatory Affairs FOCUS (Regulatory Affairs Professionals Society), September 2002
• “Presentation on Process Patents,” National Association of Pharmaceutical and Manufacturers (NAPM) Bulk Drug Workshop, New York, NY, March 2001
• “Presentation on Process Patents and Related Issues,” National Association of Pharmaceutical Manufacturers (NAPM) Annual Meeting, San Juan, Puerto Rico, January 2000
• Presentations on patent law (patentability/freedom-to-operate/opinions) and patent litigation to client R&D teams, including “Patent Portfolio Development, Management and Monetization” and “Overview of Hatch-Waxman Litigation and Pre-Litigation Preparation”