Robert F. Green

PARTNER

 

Robert is a founding partner of Green Griffith. He practices intellectual property law exclusively, with a concentration in pharmaceutical, biochemical and chemical litigation and opinions.

Robert 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 over 40 generic drug products and has served both plaintiffs and defendants in such actions.

In addition, Robert has argued 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 PhRMA and generic pharmaceutical companies.

Prior to co-founding Green Griffith in 2015, Robert served as Vice President of Leydig, Voit & Mayer. He also served as patent counsel for both Akzo and Celanese Chemical Company.

HONORS

  • Listed in The Best Lawyers in America® in the area of Litigation – Intellectual Property Law, 2016
  • Recognized by Illinois Super Lawyers in Intellectual Property Litigation, 2009, 2010, 2011, 2012, 2013, 2014, 2015, 2016
  • Selected as a “Life Sciences Star” – LMG Life Sciences, 2012, 2013, 2014, 2015
  • Listed in Intellectual Asset Management’s (IAM) Patent 1000 in Litigation, 2015
  • Named as one of “The World’s Leading Patent Practitioners” – Intellectual Asset Management’s (IAM) 1000, 2012
  • Named as one of “The World’s Leading Patent Litigators” – Intellectual Asset Management’s (IAM) Patent Litigation 250, 2011
  • Named as one of “The World’s Leading Life Sciences Patent Litigators” – Intellectual Asset Management’s (IAM) Life Sciences 250, 2010
  • 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
  • AV® Preeminent™ Peer Review Rated (Highest Rating) – Martindale-Hubbell

REPRESENTATIVE MATTERS

Pending Litigation

  • Horizon v. Watson – Bob is counsel for Horizon in litigation against Watson related to Watson’s Abbreviated New Drug Application that is seeking approval to market a generic equivalent to Horizon’s Pennsaid 2% diclofenac sodium topical solution.
  • Clarus v. Lipocine – Bob is counsel in litigation against Lipocine related to Lipocine’s Abbreviated New Drug Application that is seeking approval to market a generic equivalent to Clarus’ Rextoro® oral testosterone replacement therapy.
  • Horizon v. Par Pharmaceutical – Bob is lead counsel in litigation against Par related to Par’s Abbreviated New Drug Application that is seeking approval to market a generic equivalent to Horizon’s Ravicti® oral liquid.

Concluded Litigation

  • Helsinn v. Cipla – Bob was lead 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.
  • 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. This matter settled.
  • Warner Chilcott v. Lupin – Bob is lead counsel for Lupin in litigation related to Lupin’s Abbreviated New Drug Application that is seeking approval to market a generic equivalent to Warner Chilcott’s Generess Fe® norethindrone and ethinyl estradiol chewable tablets product. After a district court judgement in favor of Lupin, the matter was settled.
  • Pfizer v. Lupin – Bob is lead counsel in litigation related to Lupin’s Abbreviated New Drug Application that is 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.
  • 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.
  • 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 v. Mutual Pharmaceutical – 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).
  • 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’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.

Other Matters

  • Involved in FDA Citizen Petitions and litigation relating to 180-day patent-challenge exclusivity for ranitidine hydrochloride OTC (Zantac® 75) and cisplatin (Platinol®).

SPEAKING ENGAGEMENTS & PRESENTATIONS

  • Moderated IP track “The Impact of KSR, Seagate, Quanta, and Bilski on Business Decisions,” Inside Counsel SuperConference, Chicago, IL, 2009
  • “Non-Patent Exclusivity,” presented at the FDA Boot Camp-Chicago Edition, Chicago, IL, 2007
  • “Non-Patent Exclusivity,” presented at the FDA Boot Camp-Chicago Edition, Chicago, IL, 2006
  • “Innovation and its Discontents,” presented at the John Marshall Law School, Chicago, IL, 2005
  • “Shared Exclusivity Past, Present and Future,” presented at the Generic Pharmaceutical Association (GPhA), Legal Symposium, Boca Raton, FL, 2004
  • “Patent Litigation Issues,” presented at the Generic Pharmaceutical Association (GPhA), Industry Legal Symposium, Washington, D.C., 2003
  • “Patentable Inventions or Invented Patents?”, Regulatory Affairs Focus, 2002
  • “Poly(patent)morphs, Inducement and More,” presented at the Generic Pharmaceutical Association (GPhA) Annual Meeting, Coral Gables, FL, 2002
  • “Patent FDA Strategies,” presented at the National Association of Pharmaceutical Manufacturers (NAPM) Bulk Workshop Program, New York, NY, 2001
  • “Patent Extension Issues,” presented at National Association of Pharmaceutical Manufacturers (NAPM) Annual Meeting (2001), Puerto Rico, 2001
  • “Patent-FDA Strategies,” Keynote Speaker, presented at UBS Warburg Global Specialty Pharmaceuticals Conference, New York, NY, 2000
  • “Recently Enacted Changes to Patent Trademark Laws: How They Affect Your Practice, presented at Center for Intellectual Property Law, The John Marshall Law School, Chicago, IL, 2000
  • “Patent Extension Issues,: presented at the National Association of Pharmaceutical Manufacturers (NAPM) Annual Meeting, Puerto Rico, 2000
  • “Generic Versus Pharmaceutical Patent Strategies and Challenges – What’s the Score,” presented at Rx and Biotech Generics, International Business Communications, Washington, D.C., 1999
  • “Gaming the System”, presented at National Association of Pharmaceutical Manufacturers (NAPM) Annual Meeting, Puerto Rico, 1999
  • “Generic Versus Pharmaceutical Patent Strategies and Challenges – What’s the Score,” presented at Chicagoland Pharmaceutical Discussion Group, Chicago, IL,1999