Source: https://www.greengriffith.com/team/detail/christopher-t-griffith
Timestamp: 2019-04-22 19:11:40+00:00

Document:
Chris is a founding partner of Green Griffith. As a seasoned IP trial lawyer with over 30 years experience in IP law, Chris concentrates his practice in pharmaceuticals, chemicals, medical devices and biotechnology. He has been lead counsel in trials and appeals, representing both patentees and defendants before the U.S. District Courts and the Federal Circuit.
A Hatch-Waxman expert, he partners with clients to provide strategic formulation, portfolio and pre-litigation counseling concerning IP and related FDA issues affecting 505(b)(1), 505(b)(2) and ANDA applications.
With expertise gained by representing brand and generic companies, he provides strategies and opinions (validity, freedom-to-operate) directed toward attaining client goals, whether this involves API/excipient selection, trade dress, formulation attributes, or labeling, and then works with clients to execute the desired strategy – whether this involves litigation in the federal courts (Paragraph IV and/or Section viii), IPRs or arbitration.
Chris and his team are also skilled in inter partes reviews (IPRs), as well as in reexaminations, reissues and post-grant proceedings under the AIA.
He has significant experience in navigating the 505(b)(2) pathway, including advising clients on PIV certifications, Orange Book issues, related FDA issues, and portfolio development. Due diligence is also a strength.
Chris enjoys lecturing and teaching, and is a former adjunct professor at The John Marshall Law School, where he developed a Master's level course in patent law, and taught that course for many years.
Prior to co-founding Green Griffith in 2015, Chris was Corporate Secretary of Leydig, Voit & Mayer, Ltd. and served on its Board of Directors.
Clarus Therapeutics v. Lipocine – Chris is counsel for Clarus in an ongoing interference proceeding concerning patent rights relative to oral testosterone formulations.
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). 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.

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