Source: https://www.greengriffith.com/team/detail/robert-f-green
Timestamp: 2019-04-22 19:11:14+00:00

Document:
Bob is a founding partner of Green Griffith. He practices intellectual property law exclusively, with a concentration in pharmaceutical, biochemical and chemical litigation and opinions.
Bob has represented clients under the Hatch‐Waxman Act since it was passed in 1984. In his decades of experience as lead counsel in Hatch‐Waxman litigation, he has represented both plaintiffs and defendants in matters concerning over 40 drug products.
In addition, Bob has argued numerous pharmaceutical patent appeals before the U.S. Court of Appeals for the Federal Circuit. He has broad experience in managing patent portfolios as well as in counseling and rendering opinions on patent validity, patent infringement and other proprietary information. He also specializes in formulating patent strategies in the pharmaceutical field for both brand and generic pharmaceutical companies.
Prior to co‐founding Green Griffith in 2015, Bob served as Vice President of Leydig, Voit & Mayer, Ltd. Earlier in his career, Bob served as inside patent counsel for the chemical division of Akzo for about ten years and subsequently as inside patent counsel for Celanese Chemical Company.
Adapt v. Teva and Perrigo – Bob is lead counsel for Opiant Pharmaceuticals, Inc., patent owner and licensor to Adapt Pharma, in litigations against Teva and Perrigo related to their Abbreviated New Drug Applications that seek approval to market a generic equivalent to Adapt’s Narcan® nasal rescue product, which was developed by Opiant for emergency rescue of patients suffering from opioid overdose.
Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc. (PTAB) – Bob is counsel for Opiant Pharmaceuticals, Inc. in defending multiple IPR proceedings (IPR2019-00685, -00686, -00687, -00688, -00689, -00690, -00691, -00692, -00693, -00694, -00695, -00696, -00697, -00698, and -00699) filed by Nalox-1 against Opiant’s patents relating to Adapt’s Narcan® nasal rescue product, which was developed by Opiant for emergency rescue of patients suffering from opioid overdose.
Horizon Medicines LLC v. Alkem Laboratories, Ltd. (D. Del.) – Bob is counsel for Horizon in Hatch-Waxman litigation against Alkem related to Alkem’s Abbreviated New Drug Application that seeks approval to market a generic equivalent to Horizon’s DUEXIS® Ibuprofen and Famotidine Tablets.
Horizon v. Actavis – Bob was counsel in successfully upholding the validity of Horizon’s Orange Book-listed patent for its PENNSAID® 2% topical diclofenac sodium product 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. Actavis has appealed the ruling to the Federal Circuit and the appeal is currently pending.
Lipocine v. Clarus (D. Del.) ‐ Bob is 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 v. Lipocine (PTAB and D. Del.) ‐ Bob is counsel for Clarus in a pending Patent Interference with Lipocine involving Clarus’s U.S. Patent 8,828,428, which claims an oral form of testosterone undecanoate. Clarus also brought a declaratory judgment suit against Lipocine in D. Del. for infringement of U.S. Patent 8,828,428 in anticipation of FDA approval of Lipocine’s New Drug Application seeking to market an oral testosterone replacement formulation LPCN-1021. The declaratory judgment suit was dismissed without prejudice after Lipocine failed to receive FDA approval.
Horizon v. Iancu (PTAB) – Bob is lead counsel for Horizon in a pending IPR proceeding (IPR2016-00829) defending one of Horizon Therapeutics’ patents relating to Horizon’s RAVICTI® product used for the treatment of Urea Cycle Disorders (UCDs) in patients two months of age and older. The Federal Circuit appeal remains pending in this matter.
Dexcel v. Takeda Pharmaceutical – As lead counsel, Bob successfully defended Dexcel against alleged infringement of Takeda’s Orange Book-listed patents for lansoprazole delayed-released orally disintegrating tablets (“ODT”). As a result of this ruling, Dexcel launched the first lansoprazole ODT product sold Over-The-Counter (“OTC”) in the US market.
Dexcel v. Sun and Dr. Reddy’s Laboratories – Bob was counsel for Dexcel in litigation against generic applicants Sun and DRL involving Dexcel’s patents relating to Dexcel’s Omeprazole DR Tablets, 20 mg (OTC). That matter settled.
Dexcel v. Apotex – Bob was counsel for Dexcel in litigation against generic applicant Apotex involving Dexcel’s patents relating to Dexcel’s Omeprazole DR Tablets, 20 mg (OTC). That matter settled.
Par v. Horizon (PTAB) – Bob was counsel in successfully defending one of Horizon Therapeutics’ Orange Book-listed patents for its RAVICTI® oral liquid product in a PTAB inter partes review (“IPR”) proceeding against Par, IPR2015-01117. Par appealed PTAB’s decision to the Federal Circuit, where Bob presented oral arguments. The Federal Circuit affirmed per curiam PTAB’s decision upholding the patentability of Horizon’s ’012 patent.
Par v. Horizon (PTAB) – Bob was lead counsel for Horizon in defending multiple IPR proceedings (IPR2017-0167, -01768, -01769, and -01550) filed by Par against Horizon’s patents relating to Horizon’s RAVICTI® product used for the treatment of Urea Cycle Disorders (UCD) in patients two months of age and older. Pursuant to a settlement agreement reached between the parties, the IPRs were terminated.
Horizon v. Par (E.D. Tex.) – Bob was lead counsel for Horizon in Hatch-Waxman litigation against Par related to Par’s Abbreviated New Drug Application that seeks approval to market a generic equivalent to Horizon’s RAVICTI® oral formulation for the treatment of Urea Cycle Disorders (UCD) in patients two months of age and older. Subsequent to the Federal Circuit per curiam affirmation of PTAB’s decision upholding the patentability of Horizon’s ’012 patent, this litigation in E.D. Tex. was voluntarily dismissed and a new suit was filed in Delaware.
Horizon v. Par (D. Del. and D.N.J.) – Bob was lead counsel for Horizon in Hatch-Waxman litigations against Par related to Par’s Abbreviated New Drug Application that seeks approval to market a generic equivalent to Horizon’s RAVICTI® oral formulation for the treatment of Urea Cycle Disorders (UCD) in patients two months of age and older. Those litigations were successfully settled.
Horizon v. Lupin – Bob was lead counsel for Horizon in Hatch-Waxman litigation against generic applicant Lupin involving Horizon’s patents relating to its PENNSAID® topical diclofenac sodium product. That litigation was successfully settled.
Horizon v. Amneal, Horizon v. Teligent – Bob was counsel for Horizon in Hatch-Waxman litigation involving Horizon’s patents relating to its PENNSAID® topical diclofenac sodium product. Horizon successfully settled the actions against Amneal and Teligent. As a result of these settlements, Amneal and Teligent will not be able to enter the market with a generic equivalent of the PENNSAID® product until January 10, 2029 (about 1 year prior to expiration of the last-expiring Orange Book-listed patent).
Horizon v. Lupin – Bob was lead counsel for Horizon in Hatch-Waxman litigations against Lupin related to Lupin’s Abbreviated New Drug Application that seeks approval to market a generic equivalent to Horizon’s RAVICTI® oral formulation for the treatment of Urea Cycle Disorders (UCD) in patients two months of age and older. Those matters settled.
Lupin v. Horizon (PTAB) – Bob was lead counsel for Horizon in defending IPR proceedings (IPR2017-01159 and IPR2017-01160) filed by Lupin against Horizon’s patents relating to Horizon’s RAVICTI® product used for the treatment of Urea Cycle Disorders (UCD) in patients two months of age and older. Pursuant to a settlement agreement reached between the parties, the IPRs were terminated.
Lupin v. Horizon (PTAB) – Bob was lead counsel for Horizon in defending IPR proceedings (IPR2016-00829) filed by Lupin against Horizon patents relating to Horizon’s RAVICTI® product used for the treatment of Urea Cycle Disorders (UCD) in patients two months of age and older. Horizon appealed PTAB’s final written decision to the Federal Circuit. Pursuant to a settlement agreement reached between the parties, Lupin withdrew as Appellees from the Federal Circuit Appeal.
Helsinn v. Cipla – Bob was counsel in litigation relating to Cipla’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Helsinn’s Aloxi® palonsetron product. That matter settled.
Horizon v. Watson – Bob was lead counsel for Horizon in litigation against Watson related to Watson’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Horizon’s Rayos® tablet product. That litigation was successfully settled.
Warner Chilcott v. Lupin – Bob was lead counsel for Lupin in litigation related to Lupin’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Warner Chilcott’s Generess Fe® norethindrone and ethinyl estradiol chewable tablets product. After a district court judgment in favor of Lupin, the matter was settled.
Pfizer v. Lupin – Bob was lead counsel in litigation related to Lupin’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Pfizer’s Toviaz® fesoterodine fumarate product.
Horizon v. Par – Bob was lead counsel for Horizon in litigation related to Par’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Horizon’s Duexis® ibuprofen and famotidine product. That action was settled with Par agreeing to not market the product prior to January 1, 2023.
Pfizer v. Lupin – Bob was lead counsel for Lupin in litigation related to Lupin’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent of Pristiq® desvenlafaxine. That matter settled.
Merck v. Cipla – Bob was lead counsel in litigation related to Cipla’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Merck’s Sustiva® efavirenz product. That matter settled.
Warner Chilcott v. Lupin – Bob was lead counsel in litigation related to Lupin’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Warner Chilcott’s Lo Loestrin® norethindrone acetate and ethinyl estradiol product. That matter settled.
Bayer v. Lupin – Bob was lead counsel in litigation related to Lupin’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Bayer’s Yaz® drosperinone: ethyinyl estradiol product. In a precedential decision by the U.S. Court of Appeals for the Federal Circuit, Lupin prevailed in the litigation with a holding that Bayer’s patent‐in‐suit was invalid as obvious.
Ortho‐McNeil v. Lupin – Bob was lead counsel in litigation related to Lupin’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Ortho‐McNeil’s Ortho‐Tricyclen Lo® norgestimate/ethinyl estradiol product. That litigation was successfully settled with Lupin being granted a license that allows Lupin to market the product in December, 2015, prior to expiration of the patent in suit.
Gilead v. Sigmapharm – Bob was lead counsel for Sigmapharm in litigation related to Sigmapharm’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Gilead’s Hepsera® adefovir dipivoxil product. Gilead voluntarily dismissed the action prior to trial.
Pfizer v. Lupin – Bob was lead counsel in litigation related to Lupin’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Pfizer’s Lyrica® pregabalin product.
Apotex v. Lupin – Bob was lead counsel for Lupin in litigation related to Lupin’s generic quinapril products. That matter settled.
Bayer v. Lupin – Bob was lead counsel for Lupin in litigation related to Lupin’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent of Natazia®.
Shire v. Natco Pharma – Bob was lead counsel in litigation relating to Natco’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Shire’s Fosrenol® lanthanum carbonate product. That litigation was dismissed with prejudice, allowing Natco to move forward to obtain FDA approval for marketing.
Abbott v. Lupin – Bob was lead counsel in litigation related to Lupin’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Abbott’s Trilipix® choline fenofibrate product. That litigation was successfully settled.
Bayer Schering Pharma AG and Bayer Healthcare Pharmaceuticals Inc. v. Lupin Limited and Lupin Pharmaceuticals, Inc. – Bob was lead counsel in litigation related to Lupin’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Bayer’s Yasmin® drosperinone and ethinylestradiol product. Lupin prevailed in that litigation with a holding of no infringement because the asserted patent did not cover the approved use of the Yaz product.
Eli Lilly v. APP Pharmaceuticals – Bob was lead counsel at trial in litigation related to APP Pharmaceutical’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Eli Lilly’s Alimta® pemetrexed product.
Medicis v. Lupin – Bob was lead counsel in litigation related to Lupin’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Medicis’ Solodyn® minocycline product. That litigation was settled successfully.
Ortho‐McNeil v. Lupin – Bob was lead counsel in litigation involving Lupin’s Abbreviated New Drug Application that was seeking approval to market a generic version of Levaquin® levlofloxacin tablets.
Wyeth v. Lupin Ltd. – Bob was lead counsel in litigation involving Lupin’s Abbreviated New Drug Application that was seeking approval to market a generic version of Effexor® XR Capsules. That matter was settled.
AstraZeneca v. Dexcel – Bob was lead counsel in litigation involving Dexcel’s New Drug Application that was seeking approval to market a generic version of Prilosec® OTC omeprazole tablets. The litigation was settled successfully and the litigation was dismissed with prejudice, 2007. After the dismissal of the litigation, Bob’s client, Dexcel, became the first company to manufacture a generic omeprazole over‐the‐counter product for the U.S. market.
Pfizer Inc., et al. v. Mutual Pharmaceutical Company et al. – Bob was lead counsel in litigation involving Mutual’s Abbreviated New Drug Application that was seeking approval to market generic versions of Neurontin® gabapentin tablets. The district court granted summary judgment of noninfringement and the case was subsequently dismissed with prejudice (2008).
Janssen v. Mylan Labs and Dr. Reddy’s – Bob was lead counsel in litigation involving Mylan’s Abbreviated New Drug Application that was seeking approval to market a generic version of Risperidal® risperidone tablets. Janssen prevailed in the litigation, which was based upon a molecule patent.
Jones Pharma et.al. v. Mylan Pharmaceuticals, Inc. – Bob was lead counsel in litigation involving Mylan’s Abbreviated New Drug Application that was seeking approval to market a generic version of Levoxyl® levothyroxine tablets. The case was dismissed with prejudice (2006). As a result, Mylan was able to market its generic levothyroxine tablets.
AstraZeneca AB, Aktiebolaget Hassle, KBI‐E, Inc. v. Mutual Pharmaceutical Co., Inc., 384 F.3d 1333, 72 U.S.P.Q.2d 1726 (Fed. Cir. Sep 30, 2004) (NO. 04‐1100) – Bob was lead counsel in litigation involving the validity and alleged infringement of AstraZeneca’s patent relating to felodipine (Plendil®). A holding of non‐infringement was issued by the U.S. Court of Appeals for the Federal Circuit (2004). Bob’s client, Mutual Pharmaceutical, was then the first company to market a generic equivalent of Plendil® and was granted 180 days of patent‐challenge exclusivity.
Glaxo v. Novopharm – The litigation involved the alleged infringement of Glaxo’s patent on Form 2 ranitidine hydrochloride, the active ingredient in Zantac®. The U.S. Court of Appeals for the Federal Circuit affirmed a holding of noninfringement, 42 USPQ2d 1257 (Fed. Cir. 1997). Bob was lead trial counsel and argued the case on appeal. As a result of the litigation, Bob’s client, Novopharm, was the first to market a generic equivalent of prescription Zantac® and also was the first to market a generic equivalent to the over‐the‐counter product Zantac® 75 (for which Novopharm was granted 180 days of patent‐challenge exclusivity).
Abbott v. Novopharm – Bob represented Novopharm in litigation successfully challenging the expiration date of Abbott’s basic patent on terazosin, the active ingredient in Hytrin®. 41 USPQ2d 1535 (Fed. Cir. 1997), 38 USPQ2d 1309 (N.D. IL 1996). Bob was lead trial counsel and argued the case on appeal.
Glaxo v. Novopharm – Bob represented Novopharm in litigation involving the validity of Glaxo’s patent on Form 2 ranitidine hydrochloride, the active ingredient in Zantac®. Bob was lead trial counsel and argued the case on appeal. 34 USPQ2d 1565 (Fed. Cir. 1995), 29 USPQ2d 1126 (E.D. N.C. 1993). The lower court ruling of validity was affirmed in a 2‐1 ruling. Novopharm subsequently prevailed in related litigation regarding the issue of infringement.
Burroughs‐Wellcome v. Novopharm – Bob represented Novopharm in litigation involving the validity of BW’s patent on AZT – 32 USPQ2d 1915 (Fed. Cir. 1994), 29 USPQ2d 1126 (E.D.N.C. 1993). Bob was lead trial counsel and argued the case on appeal. The lower court ruling of validity was reversed in part, remanded and settled.
Torpharm v. Novopharm – Bob represented Novopharm in litigation involving the validity of Torpharm’s patent on Form 1 ranitidine hydrochloride. He was lead trial and appellate counsel. The patent was held invalid and the ruling was affirmed on appeal.
Torpharm v. Shalala et al. – Bob represented Novopharm in litigation filed by Torpharm to challenge the FDA’s grant of 180‐day patent‐challenge exclusivity to Novopharm for generic Zantac® 75. Bob was lead trial and appellate counsel. The lower court ruling in Novopharm’s favor was granted summary affirmance on appeal without argument.
Pharmacia & Upjohn v. Novopharm – Bob represented Novopharm in litigation involving the validity of P&U’s patent covering the formulation used in Glynase®. The lower court found the patent to be invalid and no appeal was taken. Bob was lead counsel.
Sloan‐Kettering v. Fujisawa – Bob was lead trial counsel representing Fujisawa in litigation involving the validity of SK’s patent alleged to cover Fujisawa’s Nebupent® aerosolized pentamidine. The case was settled.
Bristol‐Myers Squibb v. American Pharmaceutical Partners – Bob represented APP in litigation involving the validity of BMS’s patent on Platinol® cisplatin. The lower court judgment of invalidity was affirmed on appeal, unpublished. He was lead trial counsel and argued the case on appeal. As a result of the successful litigation APP was the first company to market a generic equivalent of Platinol® with 180 days of patent‐challenge exclusivity.
Novartis v. American Pharmaceutical Partners – Bob represented American Pharmaceutical Partners in litigation involving the validity and alleged infringement of Novartis’ patent relating to pamidronate (Aredia®). A consent order of noninfringement was entered allowing APP to market its generic equivalent product. Bob was lead trial counsel.
Lupin v. Apotex – Bob was lead counsel for Lupin in litigation relating to Apotex’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Lupin Atlantis Holding’s Antara® fenofibrate product.
Lupin v. Paddock – Bob was lead counsel for Lupin in litigation relating to Paddock’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Lupin Atlantis Holding’s fenofibrate product.
Paddock v. Ethypharm – Bob was lead counsel for Lupin Atlantis Holdings’ and Ethypharm in litigation related to Paddock’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Lupin Atlantis Holdings’ Antara® fenofibrate product.
Lupin v. Ranbaxy – Bob was lead counsel for Lupin in litigation related to Ranbaxy’s Abbreviated New Drug Application that was seeking approval to market a generic equivalent to Lupin’s Antara® fenofibrate product.
Involved in FDA Citizen Petitions and litigation relating to 180‐day patent‐challenge exclusivity for ranitidine hydrochloride OTC (Zantac® 75) and cisplatin (Platinol®).

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