Christopher T. Griffith

Practice Summary

Intellectual property (IP) litigation, strategic planning, opinions (e.g., freedom-to-operate/patent landscape/IP issues) and portfolio development (including patent application preparation and prosecution), specializing in the Life Sciences (pharmaceuticals and biotechnology) and Chemistry-related technologies. Expertise in NDAs (505(b)(1) and 505(b)(2)), ANDAs (Paragraph IV - Hatch-Waxman litigation), BLAs and Biosimilars. Inter Parte Reviews (IPR) and Post Grant Reviews (PGR). Trade secrets (DTSA). Local counsel for IP-related matters in the US District Court for the Northern District of Illinois (member, ND Illinois Trial Bar). Counseling and transactional activity for start-ups and established businesses with existing or in-development intellectual property, including identifying and undertaking legal activity necessary to protect innovations and meet business goals. Expertise in educating clients on IP issues, as well as developing and implementing strategies to be used in developing IP portfolios - especially for companies who have previously not focused on IP issues. Support new product R&D and commercialization (e.g., technology assessments, patentability and freedom-to-operate opinions). Identify and develop strategies to address prospective and actual competitive threats. Patent, trademark and copyright application preparation and prosecution (US, PCT and foreign). IP portfolio development, analysis and management directed to maximizing value and meeting business goals. USPTO Registered Attorney (33,392) Due diligence and counseling relative to portfolio valuations, mergers, acquisitions and divestments. Consultant to Venture Capital (VC) and Private Equity firms on critical IP issues. - US District Court Litigation (DNJ, SDNY, NDIL, SDFL, CDCA, DDel, WDMI, EDPA, DAZ) and appeals before the Court of Appeals for the Federal Circuit - Representative Cases include: - 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 was counsel for USV concerning USV’s Abbreviated New Drug Application that sought approval for a generic equivalent of Amgen’s Parsabiv® (etelcalcetide injection) peptide product. This case was pending in the U.S. District Court in Delaware, and settled on terms favorable to USV. - 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. Other Concluded Litigation 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)