Leydig, Voit & Mayer, LTD. Intellectual Property Law
Robert F. Green Law Professional

312-616-5600 (phone)
312-616-5700 (fax)
Chicago Office

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Education

The John Marshall Law School, J.D., 1974

University of Illinois, B.S. in Chemistry, 1971

Robert F. Green

Member

Mr. Green practices law exclusively in the field of intellectual property, concentrating in the areas of pharmaceutical, biochemical, and chemical litigation, and opinions, with emphasis in patent litigation and consultation arising under the Hatch-Waxman Act, Section 505(j) of the Federal Food, Drug and Cosmetic Act.  Mr. Green’s expertise as lead counsel in Hatch-Waxman litigation spans over two decades and forty generic drug products.  Mr. Green has represented both plaintiffs and defendants in such actions.

Mr. Green is serving and has served as lead trial counsel in numerous patent lawsuits, including bench and jury trials before the U.S. district courts and proceedings before the U.S. International Trade Commission. He has argued numerous appeals in front of the U.S. Court of Appeals for the Federal Circuit, related to pharmaceutical patents.

Mr. Green has extensive experience in formulating patent strategies and in managing patent portfolios, as well as in counseling and rendering opinions on patent validity, patent infringement, technology licensing, and the protection of trade secrets and other proprietary information. He specializes in developing patent strategies in the pharmaceutical field for both PhRMA and generic pharmaceutical companies.

Prior to joining Leydig, Voit & Mayer in 1985, Mr. Green served as patent counsel for both the chemical division and the membrane division of Akzo, involving industrial, chemical, and pharmaceutical technology and licensing; bio-medical applications of microporous membranes; and controlled release of bioactive compounds. He also served as the patent counsel for Celanese Chemical Company, which was principally involved with chemical and pharmaceutical processing technology.
Mr. Green presently serves as the Vice President of the firm.  He is also a member of the Intellectual Property Advisory Board at the John Marshall Law School where he previously served as an adjunct professor in the Center for Intellectual Property Law.
 

Professional Affiliations

  • The Lawyers Club of Chicago
  • Intellectual Property Owners Associations (IPO)

Articles and Publications

Honors

  • Selected as a "Life Sciences Star" – LMG Life Sciences (2012; 2013)
  • 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)
  • Named in the Illinois Super Lawyers list, Intellectual Property Litigation (2009-2014)
  • 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

Mr. Green represents a broad range of clients, including Lupin Ltd., Osmotica Pharmaceutical Corporation, Cipla, and First Horizon.

Concluded Litigation

  • Bayer v. Lupin - Mr. Green 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. Action No. 10-cv-1166. (D.NV.)
  • Ortho-McNeil v. Lupin - Mr. Green 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.  Action No. 10-cv-322. (D.N.J.)  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.
  • Shire v. Natco Pharma - Mr. Green 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.
    Action No. 09-cv-3165 (S.D.N.Y.)
  • Abbott v. Lupin - Mr. Green 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 successful settled.
    Action No. 10-cv-1578. (D.N.J.)
  • Bayer Schering Pharma AG and Bayer Healthcare Pharmaceuticals Inc. v. Lupin Limited and Lupin Pharmaceuticals, Inc - Mr. Green 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. Action No.: 1:10-cv-05423-PGG (SDNY)
  • Eli Lilly v. APP Pharmaceuticals - Mr. Green 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. 
    Action No. 08-CV-335 (D.Del.) 
  • Medicis v. Lupin - Mr. Green 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. Action No. 09-cv-3062. (D.Md.)
  • Ortho-McNeil v. Lupin - Mr. Green 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. Action No. 06-4999 (D.N.J.)
  • Wyeth v. Lupin Ltd. - Mr. Green 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. Action No. 07-cv-632 (D.Md.) That matter was settled.
  • AstraZeneca v. Dexcel - Mr. Green 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 successfully settled and the litigation was dismissed with prejudice, 2007. Action Nos. 06-358 (D. Del.) and 06-634 (E.D.Va.). After the dismissal of the litigation, Mr. Green’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. - Mr. Green 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). Action No. 03-740 (E.D.P.A.)
  • Janssen v. Mylan Labs and Dr. Reddy’s - Mr. Green 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. Action No. 2:03-CV-06220 (D.N.J.)
  • Jones Pharma et.al. v. Mylan Pharmaceuticals, Inc. - Mr. Green 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. Action No. 1:03-CV-153 (N.D.W.VA.) As a result, Mylan was able to market its generic levothyroxine tablets.
  • AstraZeneca v. Mutual Pharmaceutical - Mr. Green 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, October 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). Mr. Green’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). Mr. Green was lead trial counsel and argued the case on appeal. As a result of the litigation, Mr. Green’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 - Mr. Green 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). Mr. Green was lead trial counsel and argued the case on appeal.
  • Glaxo v. Novopharm - Mr. Green represented Novopharm in litigation involving the validity of Glaxo’s patent on Form 2 ranitidine hydrochloride, the active ingredient in Zantac®. Mr. Green 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 - Mr. Green 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). He 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 - Mr. Green represented Novopharm in litigation involving the validity of Torpharm’s patent on Form 1 ranitidine hydrochloride. (Unpublished) He was lead trial and appellate counsel. The patent was held invalid and the ruling was affirmed on appeal.
  • Torpharm v. Shalala et al. - Mr. Green 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. (Unpublished) He 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 - Mr. Green 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. Mr. Green was lead counsel.
  • Sloan-Kettering v. Fujisawa - Mr. Green represented Fujisawa in litigation involving the validity of SK’s patent alleged to cover Fujisawa’s Nebupent® aerosolized pentamidine. (Settled) He was lead trial counsel.
  • Bristol-Myers Squibb v. American Pharmaceutical Partners - Mr. Green 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 - Mr. Green 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. Mr. Green was lead trial counsel.
  • Lupin v. Apotex - Mr. Green 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. Action No. 11-cv-03860 (S.D.N.Y)
  • Lupin v. Paddock - Mr. Green 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. Action No. 11-cv-0668 (S.D.N.Y)
  • Paddock v. Ethypharm - Mr. Green 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. Action No. 09-cv-3779. (D.N.J.)
  • Lupin v. Ranbaxy - Mr. Green 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. Action No. 10-cv-3897. (E.D.PA.)

Pending Litigation

  • AstraZeneca v. Lupin - Mr. Green is lead counsel in litigation relating to Lupin’s Abbreviated New Drug Application that is seeking approval to market a generic equivalent to AstraZeneca’s Vimovo® naproxen and esomeprazole magnesium delayed-release product. Action No. 11-cv-04275 (D.N.J.)
  • Pfizer v. Lupin - Mr. Green 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 Lyrica® pregabalin product.  Action No. 09-CV-309 (D.Del.)
  • Gilead v. Sigmapharm - Mr. Green is lead counsel for Sigmapharm in litigation related to Sigmapharm’s Abbreviated New Drug Application that is seeking approval to market a generic equivalent to Gilead’s Hepsera® adefovir dipivoxil product. Action No. 10-cv-4931.  (D.N.J.)
  • Shire v. Osmotica - Mr Green is lead counsel in litigation related to Osmotica’s Abbreviated New Drug Application that is seeking approval to market a generic equivalent to Shire’s Lialda® mesalamine product.  Action No. 1:12-cv-00904. (N.D.GA.)
  • Warner Chilcott v. Lupin - Mr. Green is lead counsel in litigation related to Lupin’s Abbreviated New Drug Application that is seeking approval to market a generic equivalent to Warner Chilcott’s Lo Loestrin® norethindrone acetate and ethinyl estradiol product. 
    Action No. 3:11-cv-05048. (D.N.J.)
  • Warner Chilcott v. Lupin - Mr. Green is lead counsel 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.
    Action No. 3:11-cv-07228. (D.N.J.)
  • Horizon v. Par - Mr. Green is lead counsel for Horizon in litigation related to Par’s Abbreviated New Drug Application that is seeking approval to market a generic equivalent to Horizon’s Duexis® ibuprofen and famotidine product.
    Action No. 1:12-cv-00393 (D.DEL)
  • Apotex v. Lupin – Mr. Green is lead counsel for Lupin in litigation related to Lupin’s generic quinapril products.
    Action No. 0:12-CV-60708-PAS
  • Bayer v. Lupin – Mr. Green is lead counsel for Lupin in litigation related to Lupin’s Abbreviated New Drug Application that is seeking approval to market a generic equivalent of Natazia®.
    Action No. C.A. No. 12-1592 (LPS)(CJB)
  • Pfizer v. Lupin – Mr. Green is lead counsel for Lupin in litigation related to Lupin’s Abbreviated New Drug Application that is seeking approval to market a generic equivalent of Pristiq® desvenlafaxine.
    Action No. C.A. No. 1:12-cv-00808-SLR

Other Matters

  • Mr. Green has been 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 and Presentations

  • Moderated the IP track titled, “The Impact of KSR, Seagate, Quanta, and Bilski on Business Decisions,” 2009 Inside Counsel SuperConference, Chicago, IL, May 5, 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, Florida, 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, October 2002
  • “Poly(patent)morphs, Inducement and More,” presented at the Generic Pharmaceutical Association (GPhA) Annual Meeting, Coral Gables, 2002
  • “Patent FDA Strategies,” presented at the National Association of Pharmaceutical Manufacturers (NAPM) Bulk Workshop Program, New York, 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, 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, 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, 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, 1999

Bar Admissions and Registrations

  • Illinois State Bar, 1974
  • Registered to practice before the U.S. Patent and Trademark Office

Courts

  • State of Illinois Supreme Court
  • U.S. Supreme Court
  • U.S. Court of Appeals for the Federal Circuit
  • U.S. Court of Appeals for the Fourth Circuit
  • U.S. Court of Appeals for the District of Columbia
  • U.S. District Court for the Northern District of Illinois